[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)]
[Proposed Rules]
[Pages 6732-6823]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29272]



[[Page 6731]]

Vol. 82

Thursday,

No. 12

January 19, 2017

Part II

Book 2 of 3 Books

Pages 6731-7274





 Department of Agriculture





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Food Safety and Inspection Service



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9 CFR Parts 301, 304, 316, et al.



 Revision of the Nutrition Facts Labels for Meat and Poultry Products 
and Updating Certain Reference Amounts Customarily Consumed; Proposed 
Rule

  Federal Register / Vol. 82 , No. 12 / Thursday, January 19, 2017 / 
Proposed Rules  

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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 301, 304, 316, 317, 318, 319, 320, 327, 362, 381, 412 
and 413

[Docket No. FSIS-2014-0024]
RIN 0583-AD56


Revision of the Nutrition Facts Labels for Meat and Poultry 
Products and Updating Certain Reference Amounts Customarily Consumed

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: Consistent with the recent changes that the Food and Drug 
Administration (FDA) finalized, the Food Safety and Inspection Service 
(FSIS) is proposing to amend the nutrition labeling requirements for 
meat (including fish of the order Siluriformes) and poultry products to 
better reflect the most recent scientific research and dietary 
recommendations and to improve the presentation of nutrition 
information to assist consumers in maintaining healthy dietary 
practices. FSIS is proposing to update the list of nutrients that are 
required or permitted to be declared; provide updated Daily Reference 
Values (DRVs) and Reference Daily Intake (RDI) values that are based on 
current dietary recommendations from consensus reports; and amend the 
labeling requirements for foods represented or purported to be 
specifically for children under the age of 4 years and pregnant women 
and lactating women and establish nutrient reference values 
specifically for these population subgroups. FSIS is also proposing to 
revise the format and appearance of the Nutrition Facts label; amend 
the definition of a single-serving container; require dual-column 
labeling for certain containers; and update and modify several 
reference amounts customarily consumed (RACCs or reference amounts). 
Finally, FSIS is proposing to consolidate the nutrition labeling 
regulations for meat and poultry products into a new Code of Federal 
Regulations (CFR) part.

DATES: Comments must be received by March 20, 2017.

ADDRESSES: FSIS invites interested persons to submit comments on this 
proposed rule. Comments may be submitted by one of the following 
methods:
     Federal eRulemaking Portal: This Web site provides the 
ability to type short comments directly into the comment field on this 
Web page or attach a file for lengthier comments. Go to http://www.regulations.gov. Follow the on-line instructions at that site for 
submitting comments.
     Mail, including CD-ROMs, etc.: Send to Docket Clerk, U.S. 
Department of Agriculture, Food Safety and Inspection Service, Patriots 
Plaza 3, 1400 Independence Avenue SW., Mailstop 3782, Room 8-163B, 
Washington, DC 20250-3700.
     Hand- or Courier-Delivered Submittals: Deliver to Patriots 
Plaza 3, 355 E Street SW., Room 8-163B, Washington, DC 20250-3700.
    Instructions: All items submitted by mail or electronic mail must 
include the Agency name and docket number FSIS-2014-0024. Comments 
received in response to this docket will be made available for public 
inspection and posted without change, including any personal 
information, to http://www.regulations.gov.
    Docket: For access to background documents or comments received, go 
to the FSIS Docket Room at Patriots Plaza 3, 355 E Street SW., Room 8-
164, Washington, DC 20250-3700 between 8:00 a.m. and 4:30 p.m., Monday 
through Friday.

FOR FURTHER INFORMATION CONTACT: Jeff Canavan, Deputy Director, 
Labeling and Program Delivery Staff, Office of Policy and Program 
Development, Food Safety and Inspection Service, U.S. Department of 
Agriculture, Stop Code 3784, Patriots Plaza 3, 8-161A, 1400 
Independence Avenue SW., Washington, DC 20250-3700; Telephone (301) 
504-0879; Fax (202) 245-4792.

SUPPLEMENTARY INFORMATION: 

Executive Summary

    The Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.) and 
the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.) 
direct the Secretary of Agriculture to maintain meat and poultry 
product inspection programs designed to assure consumers that meat and 
poultry products distributed to them (including imports) are safe, 
wholesome, not adulterated, and properly marked, labeled, and packaged. 
The FMIA and PPIA (``the Acts'') also provide that the labels of meat 
and poultry products must be approved by the Secretary of Agriculture, 
who has delegated this authority to FSIS, before these products can 
enter commerce. The Acts prohibit the sale or offer for sale by any 
person, firm, or corporation of any article in commerce under any name 
or other marking or labeling that is false or misleading or in any 
container of a misleading form or size (21 U.S.C 607(d); 21 U.S.C 
457(c)). The Acts also prohibit the distribution in-commerce of meat or 
poultry products that are adulterated or misbranded. The FMIA and PPIA 
give FSIS broad authority to promulgate such rules and regulations as 
are necessary to carry out the provisions of the Acts (21 U.S.C. 621 
and 463(b)).
    To prevent meat and poultry products from being misbranded, the 
meat and poultry product inspection regulations require that the labels 
of meat and poultry products include specific information, and that 
such information be displayed as prescribed in the regulations (9 CFR 
part 317 and part 381). The nutrition labeling requirements for meat 
and meat food products are in 9 CFR 317.300-317.400, and the nutrition 
labeling requirements for poultry products are in 9 CFR 381.400-
381.500. The nutrition labeling regulations for meat and poultry 
products include requirements regarding: Location of nutrition 
information; labeling with number of servings; nutrition label content; 
reference amounts customarily consumed per eating occasion; and 
nutrient content claims.
    On March 3, 2014, the Food and Drug Administration (FDA) published 
two proposed rules, ``Food Labeling: Revision of the Nutrition and 
Supplement Facts Labels'' (the ``FDA Nutrition Labeling Proposed 
Rule'')(79 FR 11880) 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'' (the ``FDA Serving Size Proposed Rule'')(79 FR 
11989). FDA proposed these rules to update the Nutrition Facts label to 
reflect newer nutrition and public health research and recent dietary 
recommendations from expert groups and to improve the presentation of 
nutrition information to help consumers make more informed choices and 
maintain healthy dietary practices. On July 27, 2015, FDA published a 
supplemental notice of proposed rulemaking ``Food Labeling: Revision of 
the Nutrition and Supplement Facts Labels; Supplemental Notice of 
Proposed Rulemaking'' (the ``FDA Nutrition Labeling Supplemental 
Proposed Rule'') (80 FR 44303) to revise certain provisions of the FDA 
Nutrition Labeling Proposed Rule. On May 27, 2016, FDA published two 
final rules, ``Food Labeling: Revision of the Nutrition and Supplement 
Facts Labels''

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(the ``FDA Nutrition Labeling Final Rule'')(81 FR 33742) 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'' (the ``FDA Serving 
Size Final Rule'') (81 FR 34000).
    FSIS has reviewed FDA's analysis, and to ensure that there is 
consistency in how nutrition information is presented across the food 
supply, FSIS is proposing to amend the nutrition labeling regulations 
for meat and poultry products to parallel, to the extent possible, 
FDA's final regulations. This approach will clarify information for 
consumers and improve efficiency in the marketplace.
    FSIS is proposing to consolidate the nutrition labeling regulations 
that currently are presented separately for meat and for poultry 
products (in 9 CFR 317.300-317.400 and 381.400-381.500, respectively) 
into a single part, 9 CFR part 413. Consistent with FDA's final 
regulations, FSIS is also proposing to update the list of nutrients 
that are required or permitted to be declared and to provide updated 
DRVs and RDIs that are based on current dietary recommendations from 
consensus reports. For example, FSIS is proposing to remove the 
requirement to declare ``Calories from Fat;'' require the declaration 
of ``Added Sugars,'' vitamin D, and potassium; permit the voluntary 
declaration of vitamins A and C; and update the reference value for the 
declaration of percent Daily Value (DV) for sodium from the current 
value of 2,400 mg (milligrams) to 2,300 mg. FSIS is also proposing to 
amend the requirements for foods represented or purported to be 
specifically for children under the age of 4 years and pregnant women 
and lactating women and establish nutrient reference values 
specifically for these population subgroups.
    FSIS is also proposing to revise the format and appearance of the 
Nutrition Facts label. Some of the proposed changes include increasing 
the type size for ``Calories,'' ``servings per container,'' and the 
``Serving size'' declarations, and bolding the number of calories and 
the ``Serving size'' declaration to highlight this information.
    FSIS is also proposing to amend the definition of a single-serving 
container; require dual-column labeling for certain containers; and 
update and modify several RACCs. These proposed changes will provide 
consumers information to assist them in maintaining healthy dietary 
practices.
[GRAPHIC] [TIFF OMITTED] TP19JA17.000

Summary of Costs and Benefits

    Quantitative costs for the proposed rule include relabeling, 
recordkeeping, and reformulation. Quantitative benefits are a measure 
of expected health improvements experienced from increased label-use by 
overweight and hypertensive adults. The summary of cost and benefits in 
Table 1 are annualized at a 3 percent discount rate over 20 years with 
a compliance period of 24 months for large manufacturers and 36 months 
for small.

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                                     Table 1--Summary of Costs and Benefits
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                                                                       Costs         Benefits      Net benefits
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Annualized (3% Discount Rate, 20 Years).........................     $10,802,809     $36,894,007     $26,091,198
Annualized (7% Discount Rate, 20 Years).........................      14,603,562      22,541,264       7,937,702
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Table of Contents

I. Background
II. The Proposed Rule
    A. Consolidating the Nutrition Labeling Requirements Into 9 CFR 
Part 413
    B. Calories
    1. Calories From Fat
    2. Calories From Saturated Fat
    3. Two Thousand Calories as the Reference Caloric Intake Level
    4. Percent Daily Value (DV) Declaration for Calories
    C. Fat
    1. Total Fat
    a. Definition
    b. DRV
    2. Saturated Fat
    a. Definition
    b. Mandatory Declaration
    c. Dietary Reference Value (DRV)
    3. Trans Fat
    4. Polyunsaturated Fat
    a. Voluntary Declaration
    b. DRV
    c. Declaration of Individual Polyunsaturated Fatty Acids
    5. Monounsaturated Fat
    a. Voluntary Declaration
    b. DRV
    D. Cholesterol
    1. Mandatory Declaration
    2. DRV
    E. Carbohydrate
    1. Total Carbohydrate
    a. Calculation of Total Carbohydrate
    b. Classification of Carbohydrates Based on a Chemical 
Definition or Physiological Effect
    c. Separate Declaration of Additional Individual Types of 
Carbohydrates
    d. Mandatory Declaration
    e. DRV
    f. Calculation of Calories From Carbohydrate
    2. Sugars
    a. Mandatory Declaration
    b. DRV
    3. Added Sugars
    a. Declaration
    b. Proposed Definition
    c. Daily Value
    d. Compliance
    4. Sugar Alcohols
    a. DRV
    b. Caloric Value
    5. Fiber
    a. Dietary Fiber
    i. Definition
    ii. Mandatory Declaration
    iii. Analytical Methods
    iv. DRV
    b. Soluble and Insoluble Fiber
    i. Analytical methods
    ii. DRV
    iii. Caloric Value
    6. Other Carbohydrate
    F. Protein
    1. Analytical Methods
    G. Sodium
    H. Fluoride
    I. Essential Vitamins and Minerals
    1. Updates to Declaration of Vitamins and Minerals and Reference 
Daily Intakes
    2. Terms for Vitamins and Minerals
    J. Labeling of Foods for Infants, Young Children, and Pregnant 
or Lactating Women
    1. Age Range for Infants and Young Children
    2. Mandatory Declaration of Calories and Other Nutrients
    a. Declaration of Saturated Fat and Cholesterol
    b. Percent DV Declaration
    c. Mandatory Declaration of Added Sugars
    d. Mandatory Declaration of Trans Fat
    3. Voluntary Declaration of Nutrients Other Than Essential 
Vitamins and Minerals
    a. Voluntary Declaration of Calories From Saturated Fat, and the 
Amount of Polyunsaturated and Monounsaturated Fat
    b. Voluntary Declaration of Soluble Fiber, Insoluble Fiber, and 
Sugar Alcohols
    c. Voluntary Declaration of Fluoride
    4. Declaration of Essential Vitamins and Minerals
    a. Mandatory Declaration of Calcium and Iron
    b. Mandatory Declaration of Vitamin D and Potassium
    c. Voluntary Declaration of Vitamin A and Vitamin C
    d. Voluntary Declaration of Other Vitamins and Minerals
    5. DRVs and Reference Daily Intakes (RDIs) for Infants Through 
12 Months of Age
    a. Calories
    b. Total Fat
    c. Saturated Fat, Trans Fat, Cholesterol, Dietary Fiber, and 
Sugars
    d. Polyunsaturated Fat, Monounsaturated Fat, Insoluble Fiber, 
Soluble Fiber, Insoluble Fiber, Added Sugars, and Sugar Alcohols
    e. Total Carbohydrate
    f. Protein
    g. Sodium
    h. Fluoride
    i. Vitamins and Minerals
    6. DRVs and RDIs for Children 1 Through 3 Years of Age
    a. Calories
    b. Total Fat
    c. Saturated Fat, Trans Fat, and Cholesterol
    d. Polyunsaturated Fat, Monounsaturated Fat, Sugars, Added 
Sugars, Insoluble Fiber, Soluble Fiber, and Sugar Alcohols
    e. Total Carbohydrate
    f. Dietary Fiber
    g. Protein
    h. Sodium
    i. Fluoride
    j. Vitamins and Minerals
    7. DRVs and RDIs for Pregnant Women and Lactating Women
    a. Calories
    b. Total Fat, Saturated Fat, Cholesterol, Total Carbohydrate, 
Sodium, Added Sugars, and Dietary Fiber
    c. Trans Fat, Polyunsaturated Fat, Monounsaturated Fat, Soluble 
Fiber, Insoluble Fiber, Sugars, and Sugar Alcohols
    d. Protein
    e. Fluoride
    f. Vitamins and Minerals
    K. Format
    1. Increasing the Prominence of Calories and Serving Size
    2. Changing the Order of the ``Serving Size'' and ``Servings Per 
Container'' Declarations and Increasing the Prominence of ``Servings 
Per Container''
    3. Right-Justifying the Quantitative Amounts Declared in the 
``Serving size'' Statement
    4. Presentation of Percent DVs
    5. Placement of ``Added Sugars''
    6. Declaration of Absolute Amounts of Vitamins and Minerals
    7. The Footnote
    8. Addition of a Horizontal Line Beneath the Nutrition Facts 
Heading
    L. Single-Serving Containers/Units and Dual-Column Labeling
    1. Single-Serving Containers/Units
    2. Dual-Column Labeling
    3. Use of Nutrient Content Claims and Health Claims on Products 
With Dual-Column Labeling per Serving and per Container
    4. Additional Changes to Serving Size Regulations
    M. Reference Amounts Customarily Consumed
    1. Factors Considered To Determine the Existing RACCs To Update
    2. Changes to Table 1: Reference Amounts Customarily Consumed 
per Eating Occasion: Food Labeling for Infants and Children 1 
Through 3 Years of Age
    3. Changes to Table 2: Reference Amounts Customarily Consumed 
per Eating Occasion: General Food Supply
    N. Compliance
    1. Level of Variance Allowed for the Label Declaration of 
Specific Nutrients
    2. Methods Used To Determine Compliance
    3. Records Requirements
    4. Inclusion of Potassium as a Mineral
    5. Requirements for Other Carbohydrate, Soluble and Insoluble 
Fiber, Added Sugars, and Sugar Alcohols
    O. Technical Amendments
    III. Executive Order 12866 and Executive Order 13563
    IV. Regulatory Flexibility Act
    V. Paperwork Requirements
    VI. E-Government Act

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    VII. Executive Order 12988, Civil Justice Reform
    VIII. Executive Order 13175
    IX. USDA Nondiscrimination Statement
    X. Additional Public Notification
    XI. Proposed Regulatory Amendments

I. Background

    The Nutrition Labeling and Education Act (NLEA) of 1990 required 
the nutrition labeling of most foods regulated by the FDA. Because FSIS 
is committed to providing consumers with the most informative labeling 
system possible, FSIS published regulations establishing comparable 
nutrition labeling requirements for meat and poultry products on 
January 6, 1993 (58 FR 632). These regulations required nutrition 
labels on the packages of all multi-ingredient and heat-processed meat 
and poultry products, unless an exemption applied. The required 
nutrition labeling provisions were referred to as ``the mandatory 
nutrition labeling program.'' The Agency's 1993 regulations also 
established guidelines for voluntary nutrition labeling of single-
ingredient, raw meat and poultry products, including single-ingredient, 
raw ground or chopped products.
    FSIS published technical amendments to the 1993 final rule (August 
18, 1993, 58 FR 43787; September 10, 1993, 58 FR 47624; and March 16, 
1994, 59 FR 12157), a final rule on the placement of nutrition labeling 
on meat and poultry products (August 8, 1994), a final rule with 
additional technical amendments to the nutrition labeling regulations 
(September 1, 1994; 59 FR 45189), and a final rule to provide codified 
language for provisions that previously cross-referenced FDA's 
nutrition labeling regulations on January 3, 1995 (60 FR 174). FSIS 
also published a final rule to require nutrition labeling of the major 
cuts of single-ingredient raw meat and poultry products and ground or 
chopped meat and poultry products on December 29, 2010 (75 FR 82164).
    Currently, FSIS requires nutrition labels on the packages of all 
multi-ingredient and heat-processed meat and poultry products, and all 
ground or chopped products, unless an exemption applies (9 CFR 317.300; 
317.301; 381.400; 381.401). FSIS also requires that nutrition 
information be provided on the label or at the point-of-purchase for 
the major cuts of single-ingredient, raw meat and poultry products 
identified in 9 CFR 317.344 and 381.444 that are not ground or chopped, 
except for certain exemptions. The following exemptions in 9 CFR 
317.400 and 381.500 from the nutrition labeling requirements apply to 
the major cuts of single-ingredient, raw meat and poultry products and 
ground or chopped meat and poultry products:
     Products intended for further processing, provided that 
the labels for these products bear no nutrition claims or nutrition 
information;
     Products that are not for sale to consumers, provided that 
the labels for these products bear no nutrition claims or nutrition 
information;
     Products in small packages that are individually wrapped 
packages of less than \1/2\ ounce net weight, provided that the labels 
for these products bear no nutrition claims or nutrition information;
     Products that are custom slaughtered or prepared; and
     Products intended for export.
    FSIS also provides the following additional exemptions in 9 CFR 
317.400 and 381.500 for ground or chopped products:
     Ground or chopped products that qualify for the small 
business exemption in 9 CFR 317.400(a)(1) or 381.500(a)(1);
     Products that are ground or chopped at an individual 
customer's request and that are prepared and served at retail, provided 
that the labels or labeling of these products bears no nutrition claims 
or nutrition information;
     Ground or chopped products in packages that have a total 
surface area for labeling of less than 12 square inches, provided that 
the product's labeling includes no nutrition claims or nutrition 
information and provided that an address or telephone number that a 
consumer can use to obtain the required information is included on the 
label; and
     Ground products produced by small businesses that use 
statements of percent fat and percent lean on the label or in labeling 
of ground products, provided they include no other nutrition claims or 
nutrition information on the product labels or labeling.
    Generally, ready-to-eat products that are packaged and portioned at 
a retail store or similar retail-type establishment and multi-
ingredient products (e.g., sausage) processed at a retail store or 
similar retail-type establishment are exempt from nutrition labeling, 
provided that this exemption does not apply to ready-to-eat or multi-
ingredient ground or chopped products described in 9 CFR 317.301 or 
381.401. Restaurant menus also do not generally fall within the scope 
of FSIS's current nutrition labeling regulations (9 CFR 317.400 and 
381.500). However, FDA requires that restaurants and similar retail 
food establishments that are part of a chain with 20 or more locations 
doing business under the same name and offering for sale substantially 
the same menu items disclose certain nutrition information for standard 
menu items (see ``Food Labeling; Nutrition Labeling of Standard Menu 
Items in Restaurants and Similar Retail Food Establishments''; December 
1, 2014; 79 FR 71155). FDA also requires that operators who own or 
operate 20 or more vending machines disclose calorie information for 
food sold from vending machines, subject to certain exemptions (see 
``Food Labeling; Calorie Labeling of Articles of Food in Vending 
Machines''; December 1, 2014; 79 FR 71259).
    FSIS does not require nutrition information for single-ingredient, 
raw meat and poultry products that are not major cuts and that are not 
ground or chopped. But, if nutrition information is provided for these 
products, it must be provided in accordance with the nutrition labeling 
requirements for the major cuts (9 CFR 317.300 and 381.400).

II. The Proposed Rule

    Nutrition labeling continues to be an integral part of USDA's 
efforts to educate consumers about nutrition and diet. Since 1980, USDA 
and the Department of Health and Human Services (HHS) have jointly 
published the Dietary Guidelines for Americans (DGA) every five years. 
The 2015-2020 DGA provides advice on food choices that promote overall 
health, reduce the risk of chronic disease, and help individuals attain 
and maintain a healthy weight.\1\ The nutrition labeling information 
that FSIS is proposing to require in this rule would assist consumers 
in maintaining healthy dietary practices. The information should also 
help consumers follow the advice in the 2015-2020 DGA.
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    \1\ U.S. Department of Agriculture and U.S. Department of Health 
and Human Services, 2015--2020 Dietary Guidelines for Americans, 8th 
edition, Washington, DC: U.S. Government Printing Office, December 
2015. Available at http://www.health.gov/dietaryguidelines/2015.asp.
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    For example, the 2015-2020 DGA concluded that some Americans do not 
consume enough vitamin D or potassium, and inadequate intake of these 
nutrients presents public health concerns (pages 60). Vitamin D is 
important for bone health, and potassium helps to reduce the effects of 
excess sodium on blood pressure. This proposed rule would require 
vitamin D and potassium to be declared on nutrition labels, to assist 
consumers in maintaining healthy dietary practices. Moreover, 
consistent with the 2015-2020 DGA, the information should help 
consumers follow the 2015-2020 DGA's

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advice to select foods that provide more of these nutrients (page 60). 
Additionally, the 2015-2020 DGA does not consider low intake of 
vitamins A and C to be a major public health concern (page 60). 
Currently, vitamins A and C must be declared on the Nutrition Facts 
label, but this proposed rule would make their declaration voluntary.
    This proposed rule also proposes changes to the Daily Values for 
certain nutrients, consistent with the more recent scientific evidence 
from the 2015-2020 DGA. For example, FSIS is proposing to amend the 
current DV for sodium of 2,400 to 2,300 mg, which is consistent with 
the scientific evidence reflected in the 2015-2020 DGA's recommendation 
to limit intake of sodium to less than 2,300 mg per day and is the 
upper limit for individuals ages 14 years and older set by the 
Institute of Medicine. (page 15). Revising DVs to reflect the most 
current science on nutrient requirements will help consumers choose a 
better overall diet.
    The 2015-2020 DGA also supports listing added sugars on nutrition 
labels. It affirms that poor diet and physical inactivity are primary 
factors contributing to overweight, obesity, and chronic illness (pages 
2-3). Calories from added sugars, solid fats (including saturated and 
trans fats), and refined grains replace nutrient-dense foods and make 
it difficult to consume sufficient nutrients while controlling caloric 
intake (page 14). FSIS is proposing to require that added sugars be 
listed on nutrition labels to assist consumers in selecting a more 
nutrient-dense diet while controlling the total number of calories 
consumed (see section II.E.3 for discussion of the rationale for the 
proposed changes).
    Section 403(q)(1)(A) of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) (21 U.S.C. 343(q)(1)(A)) defines serving size as an amount 
customarily consumed and which is expressed in a common household 
measure that is appropriate to the food. FSIS, consistent with FDA, is 
proposing to update, modify, and establish certain RACCs and require 
that packages which contain more than 150 percent and less than 200 
percent of a given RACC be labeled as containing one serving, 
regardless of the RACC of the product. Certain packages that contain at 
least 200 percent and up to and including 300 percent of a given RACC 
would be required to include dual column labels that provide nutrition 
information per serving or per package, as applicable. These changes 
will ensure that serving sizes are based on current consumption data 
and will provide consumers with information on the Nutrition Facts 
label related to the serving size that will assist them in maintaining 
healthy dietary practices.
    Finally, FSIS is proposing several updates to the design of the 
current Nutrition Facts labels, including making the caloric content 
and serving size declarations more prominent. These and other changes 
aim to address current public health problems such as obesity, chronic 
disease, and nutrient deficiency by emphasizing important nutritional 
information and providing additional information to consumers.

A. Consolidating the Nutrition Labeling Requirements Into 9 CFR Part 
413

    Currently, the nutrition labeling regulations for meat and poultry 
products are presented separately (in 9 CFR 317.300-317.400 and 
381.400-381.500, respectively). FSIS believes that the public would be 
better served by consolidating these regulations in one part of title 
9. Rather than searching through two separate parts of title 9-CFR 
parts 317 and 381-- to find the nutrition labeling regulations, 
interested parties would only have to read part 413. Therefore, FSIS is 
proposing to consolidate the nutrition labeling regulations for meat 
and poultry products into a single part, 9 CFR part 413.

B. Calories

    FSIS requires the total number of calories per serving of a meat or 
poultry product to be declared on the Nutrition Facts label (9 CFR 
317.309(c)(1); 9 CFR 381.409(c)(1); and proposed 9 CFR 413.309(c)(1)). 
FSIS is not proposing to change this requirement but is proposing 
changes to the requirements related to ``Calories from fat'' and 
``Calories for saturated fat.''
1. Calories from Fat
    FSIS currently requires that ``Calories from Fat'' be declared on 
Nutrition Facts labels (9 CFR 317.309(c)(1)(ii); 9 CFR 
381.409(c)(1)(ii)). FSIS is proposing to no longer require, and to not 
allow voluntarily, the declaration of ``Calories from fat'' on the 
Nutrition Facts label.
    Section 403(q)(2)(B) of the FD&C Act (21 U.S.C. 343(q)(2)(B)) 
grants the Secretary of HHS (and by delegation, FDA) discretion to 
remove information relating to a nutrient required to be declared on 
food labels by regulation if the Secretary determines that it is not 
necessary to assist consumers in maintaining healthy dietary practices. 
FDA considered a number of factors related to the declaration of 
``Calories from Fat,'' including dietary recommendations and consensus 
reports that emphasize intake of total calories and the type of fat 
consumed, as well as comments from their 2005 and 2007 Advanced Notices 
of Proposed Rulemaking (ANPRMS) (April 4, 2005, 70 FR 17008; November 
2, 2007; 72 FR 62149) that supported eliminating the declaration of 
``Calories from fat'' in order to place greater emphasis on total 
calories. FDA determined that the declaration of ``Calories from fat'' 
is not necessary to assist consumers in maintaining healthy dietary 
practices (81 FR 33780). Under FDA's Nutrition Labeling Final Rule, FDA 
no longer requires, and does not allow voluntarily, the declaration of 
``Calories from fat'' on the Nutrition Facts label (81 FR 33780). FSIS 
has reviewed FDA's analysis and has tentatively concluded that the 
declaration of ``Calories from fat'' is not necessary to assist 
consumers in maintaining healthy dietary practices. FSIS agrees with 
FDA that ``the amount of fat being consumed can still be obtained from 
the total fat declaration elsewhere on the Nutrition Facts label, and 
consumers can still use the percent DV for total fat to put fat content 
in the context of a total daily diet, compare products, and plan 
diets'' (79 FR 11891; 81 FR 33780).
2. Calories From Saturated Fat
    Under current FSIS regulations, the declaration of ``Calories from 
saturated fat'' on the Nutrition Facts label is voluntary (9 CFR 
317.309(c)(1)(iii); 9 CFR 381.409(c)(1)(iii); will be consolidated in 
proposed 9 CFR 413.309(c)(1)(ii)). FSIS continues to believe that 
``Calories from saturated fat'' can be declared voluntarily. The amount 
of saturated fat can be obtained from the total saturated fat 
declaration on the Nutrition Facts label, and consumers can use the 
percent DV for saturated fat to put saturated fat content in the 
context of a total daily diet, compare products, and plan diets (79 FR 
11892; 81 FR 33781). Therefore, FSIS does not believe it is necessary 
to require the mandatory declaration of ``Calories from saturated fat'' 
on the Nutrition Facts label. But with the revisions to the Nutrition 
Facts label, FSIS is proposing to require that ``Calories from 
saturated fat'' be indented when declared under the statement of 
calories (proposed 9 CFR 413.309(c)(1)(ii)).
3. Two Thousand Calories as the Reference Caloric Intake Level
    FSIS regulations (9 CFR 317.309(c)(9) and 381.409(c)(9)) set a 
percent DRV for fat, saturated fatty acids, cholesterol, total 
carbohydrate, fiber, sodium, potassium, and protein, based on a 
reference caloric intake of 2,000

[[Page 6737]]

calories. Just as FDA did not make any changes to the reference calorie 
intake, FSIS is not proposing any changes to the reference caloric 
intake currently used to set the DRVs under 9 CFR 317.309(c)(9) and 
381.409(c)(9) (which will both be consolidated in proposed 9 CFR 
413.309(c)(9)).
    FDA considered a number of factors related to the reference calorie 
intake of 2,000 calories, including the relevant recommendations from 
the IOM macronutrient report \2\ that provided estimated energy 
requirements, the IOM Labeling Report,\3\ and the comments regarding 
the 2,000 calorie reference intake level received in response to FDA's 
2007 ANPRM (79 FR 11892). FDA decided not to propose changes to the 
reference calorie intake level (81 FR 33782). ``The IOM Labeling 
Committee concluded that retaining the current 2,000 reference calorie 
intake level would be the best approach as it would provide continuity 
and would not encourage higher calorie intake and overconsumption of 
energy'' (79 FR 11892). FSIS agrees with FDA and the recommendation of 
the IOM Labeling Committee.
---------------------------------------------------------------------------

    \2\ Institute of Medicine (IOM) of the National Academies. 
``Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, 
Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients), 
Chapter 5: Energy'', Washington, DC: National Academies Press; 2002.
    \3\ The amount of vitamin D may, but is not required to, be 
expressed in international units (IU), in addition to the mandatory 
declaration in mcg. Any declaration of the amount of vitamin D in IU 
must appear in parentheses after the declaration of the amount of 
vitamin D in mcg.
---------------------------------------------------------------------------

4. Percent Daily Value (DV) Declaration for Calories
    FSIS's current regulations do not establish a DRV for calories and 
do not require a percent DV declaration for calories. FDA reviewed 
recommendations in current consensus reports, including the IOM 
macronutrient report,\4\ and comments received in response to their 
2005 and 2007 ANPRMs (79 FR 11892, 11893). FDA decided not to require a 
percent DV for total calories because of a lack of an appropriate 
quantitative intake recommendation or other data or information on 
which FDA could rely to establish a DRV for calories (81 FR 33782). 
FSIS agrees with FDA's conclusion.
---------------------------------------------------------------------------

    \4\ 1 mg [alpha]-tocopherol (label claim) = 1 mg [alpha]-
tocopherol = 1 mg RRR- [alpha]-tocopherol = 2 mg all rac-[alpha]-
tocopherol.
---------------------------------------------------------------------------

C. Fat

1. Total Fat
a. Definition and Mandatory Declaration
    FSIS is not proposing any changes to its definition of ``total 
fat'' under 9 CFR 317.309(c)(2) and 381.409(c)(2) (which will both be 
consolidated in proposed 9 CFR 413.309(c)(2)). FSIS is proposing to 
define ``fatty acids'' in 9 CFR 413.309(c)(2) as aliphatic carboxylic 
acids consisting of a chain of alkyl groups and characterized by a 
terminal carboxyl group to harmonize with FDA's Nutrition Labeling 
Final Rule and clarify what FSIS considers to be a fatty acid. FSIS is 
not proposing to change the requirement for mandatory declaration for 
total fat on the Nutrition Facts label.
b. DRV
    FSIS's regulations 9 CFR 317.309(c)(9) and 381.409(c)(9), which 
would be consolidated in proposed 9 CFR 413.309(c)(9), set 65 grams as 
the DRV for total fat based on a reference calorie intake of 2,000 
calories (i.e., 30 percent of a 2,000 calorie diet). In FDA's Nutrition 
Labeling Final Rule, FDA increased the DRV for total fat to 78 grams, 
or 35 percent of a 2,000 calorie diet. The upper level of the IOM 
Acceptable Macronutrient Distribution Range (AMDR) \5\ for total fat 
for adults is 35 percent and serves as an appropriate basis on which to 
set the DRV for total fat (81 FR 33784). FDA reviewed new information 
and evidence that corroborated the position that the types of fats 
consumed are more important in influencing the risk of heart disease 
than is the total amount of fat (81 FR 33784). FDA stated that keeping 
the DRV for total fat at 30 percent of calories could be misinterpreted 
as advising consumers to limit their intake of total fat to 30 percent 
or less, and that it is conceivable that consumers could view foods 
that are good sources of mono and polyunsaturated fats negatively 
because their percent DV declaration for total fat is high (81 FR 
33784). FSIS agrees with FDA's analysis, and is proposing to increase 
the DRV for total fat from 30 percent of calories to 35 percent of 
calories for a DRV of 78 grams.
---------------------------------------------------------------------------

    \5\ ``The AMDR for a macronutrient is based on the amount of the 
macronutrient that is associated with a reduced risk of chronic 
disease while providing adequate intakes of essential nutrients'' 
(79 FR 11886).
---------------------------------------------------------------------------

2. Saturated Fat
a. Definition
    FSIS regulations currently define ``Saturated fat'' as the sum of 
all fatty acids, including stearic acid, containing no double bonds 
(see 9 CFR 317.309(c)(2)(i); 381.409(c)(2)(i); and 21 CFR 
101.9(c)(2)(i)). However, in FSIS's 1993 Nutrition Labeling of Meat and 
Poultry Products final rule, based on requests from the red meat 
industry and the scientific knowledge in 1993 that stearic acid did not 
have the same serum cholesterol-raising effects of the other three 
saturated fatty acids, myristic, palmitic, and lauric acids, FSIS 
provided for the voluntary declaration of stearic acid as a 
subcomponent of saturated fat (58 FR 641). FDA had no similar request 
for the voluntary listing of stearic acid and did not provide for such 
listing.
    In FDA's Nutrition Labeling Proposed Rule, FDA considered voluntary 
declaration of stearic acid on the Nutrition Facts label, as 
recommended by a few comments to their 2007 ANPRM (79 FR 11894). The 
effects of stearic acid on Low-density lipoprotein (LDL) cholesterol 
levels appear to vary depending on the macronutrient component that is 
replaced by stearic acid (79 FR 11894). FDA found that moderate 
evidence indicates that when stearic acid substitutes for other 
saturated fatty acids or trans fat, plasma LDL cholesterol levels 
decrease, whereas when it replaces monounsaturated or polyunsaturated 
fatty acids, LDL cholesterol levels increase (79 FR 11894). Considering 
such scientific data, the Report of the Dietary Guidelines Advisory 
Committee on the Dietary Guidelines for Americans, 2010 (2010 DGAC),\6\ 
concluded that the potential effects of changes in dietary intake of 
stearic acid on the risk of CVD remain unclear (79 FR 11894). In FDA's 
Nutrition Labeling Proposed Rule, FDA tentatively concluded that the 
individual declaration of stearic acid is not necessary to assist 
consumers in maintaining healthy dietary practices, and proposed to not 
permit the declaration on the Nutrition Facts label (79 FR 11894). FDA 
addressed the evidence for a role of stearic acid in human health 
(e.g., changes in plasma LDL cholesterol levels), which is not well-
established, and the fact that there is no quantitative intake 
recommendation available for stearic acid (Id.) In FDA's final rule, 
FDA did not exclude stearic acid from the calculation of the percent DV 
for

[[Page 6738]]

saturated fat because the scientific evidence supporting the current 
dietary recommendations for saturated fat does not differentiate among 
the individual saturated fatty acids (81 FR 33786).
---------------------------------------------------------------------------

    \6\ U.S. Department of Agriculture and U.S. Department of Health 
and Human Services. (2010) ``Report of the Dietary Guidelines 
Advisory Committee on the Dietary Guidelines for Americans, 2010'', 
Washington, DC: U.S. Government Printing Office. Retrieved from 
http://www.cnpp.usda.gov/dietary-guidelines-2010.
---------------------------------------------------------------------------

    Based on this updated scientific information and the fact that few 
if any companies have included stearic acid as a voluntary nutrient in 
the current Nutrition Facts label, FSIS is proposing to remove the 
voluntary declaration of stearic acid below saturated fat.
    Also, consistent with FDA's final rule, FSIS is not proposing to 
exclude acetic, propionic, and butyric acids from the definition of 
saturated fat.
b. Mandatory Declaration
    FSIS requires the mandatory declaration of the number of grams of 
saturated fat per serving (9 CFR 317.309(c)(2)(i) and 381.409(c)(2)(i) 
will be consolidated in proposed 9 CFR 413.309(c)(2)(i)). FSIS is not 
proposing to change this requirement because FSIS is unaware of any 
evidence that supports that this information is no longer needed to 
assist consumers in maintaining healthy dietary practices.
c. Dietary Reference Value (DRV)
    FSIS's regulations 9 CFR 317.309(c)(9) and 381.409(c)(9), which 
will be consolidated in proposed 9 CFR 413.309(c)(9), set 20 grams as 
the DRV for saturated fat based on a reference calorie intake of 2,000 
calories. FSIS is not proposing to change the DRV for saturated fat.
    FDA reviewed the IOM Labeling Committee recommendation,\7\ the 
comments in response to their 2007 ANPRM, and current consensus reports 
relating to the DRV for saturated fat, and stated that ``the existing 
scientific evidence does not support a change to the current 20 g DRV'' 
for saturated fat (79 FR 11895-11896). FDA determined ``the existing 
DRV of 20 grams is consistent with the scientific evidence supporting a 
maximum intake level that covers the general U.S. population.'' (81 FR 
33786). FSIS has reviewed FDA's analysis and has tentatively concluded 
not to change the DRV for saturated fat.
---------------------------------------------------------------------------

    \7\ Institute of Medicine (IOM) of the National Academies, 
``Dietary Reference Intakes: Guiding Principles for Nutrition 
Labeling and Fortification'', Washington, DC: National Academies 
Press; 2003.
---------------------------------------------------------------------------

3. Trans Fat
    On July 11, 2003, FDA published a final rule requiring 
manufacturers to declare trans fatty acids, or trans fat, on the 
Nutrition Facts label of conventional foods and some dietary 
supplements (68 FR 41461). At that time, FSIS published information on 
its Web site stating that FSIS was planning rulemaking on trans fat 
label declarations to consider provisions in the meat and poultry 
regulations that are consistent with FDA's rules.\8\ In the interim, 
FSIS has not objected to the voluntary declaration of trans fat in 
Nutrition Facts labels on food products under its jurisdiction if the 
declaration is made in accordance with FDA regulations published in the 
Federal Register on July 11, 2003, that amended 21 CFR part 101. There 
are no FDA or FSIS provisions for claims regarding trans fatty acids. 
Thus, any labeling that includes a statement regarding trans fatty 
acids that is outside of and in addition to the Nutrition Facts label 
declaration would need to be submitted to FSIS (the Labeling and 
Program Delivery Staff (LPDS)) for evaluation. To date, FSIS has not 
permitted any claims regarding trans fatty acids.
---------------------------------------------------------------------------

    \8\ http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/labeling/labeling-policies/trans-fat-declarations.
---------------------------------------------------------------------------

    Based on FSIS's label review, FSIS believes that the majority of 
meat and poultry product Nutrition Facts labels voluntarily declare 
trans fat. However, because FSIS is now proposing major modifications 
to the Nutrition Facts label, FSIS believes it is time to address the 
need for trans fat labeling on meat and poultry products. According to 
FDA's Nutrition Labeling Proposed Rule, trans fat continues to be a 
nutrient with public health significance because of its role in chronic 
disease (79 FR 11896). FDA is unaware of evidence to support a 
determination that information relating to trans fat on the Nutrition 
Facts label is not necessary to assist consumers in maintaining healthy 
dietary practices (79 FR 11896). FDA tentatively concluded that 
information on the amount of trans fat in food products allows 
consumers to reduce their intake of trans fat and thus reduce the risk 
of coronary heart disease (CHD) (79 FR 11896). However, in 2013, FDA 
published a tentative determination that partially hydrogenated oils 
(PHOs), the source of industrially produced trans fat, may not be 
generally recognized as safe (GRAS)(78 FR 67169; November 8, 2013). FDA 
requested comment on whether mandatory labeling of trans fat would 
still be necessary if this determination is finalized (79 FR 11896). 
Per 21 CFR 101.9(c)(2)(ii), if a food contains less than 0.5 g of trans 
fat per serving, the content, when declared, is to be expressed as 
zero. On June 17, 2015, FDA published a final determination that there 
is no longer a consensus among qualified experts that PHOs, which are 
the primary dietary source of industrially-produced trans fatty acid 
are GRAS for any use in human food and therefore are food additives 
subject to section 409 of the FD&C Act (80 FR 34650). FDA has set a 
compliance period of three years for companies to either reformulate 
products without PHOs or petition FDA to permit specific uses of PHOs. 
Following the compliance period, no PHOs can be added to human food 
unless they are otherwise approved by FDA. In FDA's Nutrition Labeling 
Final Rule, FDA did not make any changes to the requirement for 
mandatory declaration of trans fat on the Nutrition Facts label in 21 
CFR 101.9(c)(2)(ii), stating ``it is premature to consider removing 
trans fat from the Nutrition Facts label at this time.'' (81 FR 33786-
88).
    Although FDA's final determination that PHOs are not GRAS for use 
in any human food may eliminate the source of industrially produced 
trans fat, FSIS recognizes that there are trans fats caused by the way 
that some animals, such as cattle, sheep and goats, digest their food 
(the ruminating process). Consistent with FDA's Nutrition Labeling 
Final Rule (81 FR 33786-33787), FSIS is proposing to require the 
declaration of trans fat in the Nutrition Facts label (proposed 9 CFR 
413.309(c)(2)(ii)). The mandatory declaration of trans fat will assist 
consumers in making informed choices and maintaining healthy dietary 
practices.
4. Polyunsaturated Fat
a. Voluntary Declaration
    FSIS permits the voluntary declaration of the number of grams of 
polyunsaturated fat per serving (defined as cis, cis-methylene 
interrupted polyunsaturated fatty acids) on the Nutrition Facts label 
(9 CFR 317.309(c)(2)(ii) and 381.409(c)(2)(ii), which will be 
consolidated in proposed 9 CFR 413.309(c)(2)(iii)). FDA considered 
current consensus reports and comments received in response to their 
2007 ANPRM when deciding to propose to continue to permit the voluntary 
declaration of polyunsaturated fat on the Nutrition Facts label (79 FR 
11897; 81 FR 33788). FDA recognized that, although polyunsaturated fat 
is related to public health as a replacement for saturated fat, there 
is no dose-response relationship between polyunsaturated fat and risk 
of CHD, independent of saturated fat, and therefore continued to permit 
the voluntary declaration of polyunsaturated fat (81 FR 33788-89). FSIS 
has reviewed FDA's analysis and agrees with its conclusion and 
therefore,

[[Page 6739]]

is not proposing to make any changes to the voluntary declaration of 
polyunsaturated fat. Polyunsaturated fat has public health significance 
because replacing saturated fatty acids with polyunsaturated and 
monounsaturated fatty acids reduces blood LDL cholesterol levels and in 
turn the risk of cardiovascular disease (CVD).\9\ Polyunsaturated fat 
is a macronutrient, not an essential vitamin or mineral, does not have 
a quantitative intake recommendation, but does have public health 
significance. Therefore, FSIS believes it is appropriate to continue to 
permit the voluntary declaration of polyunsaturated fat consistent with 
FDA's final rule.
---------------------------------------------------------------------------

    \9\ U.S. Department of Agriculture and U.S. Department of Health 
and Human Services. (2010) ``Report of the Dietary Guidelines 
Advisory Committee on the Dietary Guidelines for Americans, 2010'', 
4 . Washington, DC: U.S. Government Printing Office. Retrieved from 
http://www.cnpp.usda.gov/dietary-guidelines-2010.
---------------------------------------------------------------------------

b. DRV
    FSIS's regulations do not provide a DRV for polyunsaturated fat. 
FDA did not propose a DRV for polyunsaturated fat, tentatively 
concluding ``that there is no appropriate quantitative intake 
recommendation to form a basis for setting a DRV for polyunsaturated 
fat'' (79 FR 11898). FDA did not change its position in the final rule 
(81 FR 33789). Consistent with FDA's final rule, FSIS is not proposing 
to provide a DRV for polyunsaturated fat.
c. Declaration of Individual Polyunsaturated Fatty Acids
    FSIS's regulations do not permit the declaration of individual 
polyunsaturated fatty acids on the Nutrition Facts label. Consistent 
with FDA's final rule, FSIS is not proposing to provide for the 
individual declaration of either n-3 or n-6 polyunsaturated fatty acids 
or the declaration of eicosapentaeneoic acid (EPA) or docosahexaenoic 
acid (DHA) on the Nutrition Facts label (81 FR 33789).
5. Monounsaturated Fat
a. Voluntary Declaration
    FSIS's regulations currently allow the voluntary declaration of 
monounsaturated fat (defined as cis-monounsaturated fatty acids (e.g., 
oleic acid)) on the Nutrition Facts label (9 CFR 317.309(c)(2)(iii) and 
381.409(c)(2)(iii), which would be consolidated in proposed 9 CFR 
413.309(c)(2)(iv)). Consistent with FDA's final rule, FSIS is not 
proposing to change the voluntary declaration of monounsaturated fat 
(81 FR 33788).
b. DRV
    FSIS's regulations do not provide a DRV for monounsaturated fat. 
FDA did not provide a DRV for monounsaturated fat for the same reasons 
it did not set a DRV for polyunsaturated fat (81 FR 33789). Consistent 
with FDA's final rule, FSIS is not proposing to set a DRV for 
monounsaturated fat.

D. Cholesterol

1. Mandatory Declaration
    FSIS's regulations require the amount of cholesterol be declared on 
the Nutrition Facts label (9 CFR 317.309(c)(3) and 381.409(c)(3), which 
would be consolidated in proposed 9 CFR 413.309(c)(3)). Consistent with 
FDA's final rule, FSIS is not proposing changes to the requirement for 
mandatory declaration of cholesterol.
2. DRV
    FSIS sets 300 mg as the DRV for cholesterol based on the reference 
calorie intake of 2,000 calories (9 CFR 317.309(c)(9) and 
381.409(c)(9), which would be consolidated in proposed 9 CFR 
413.309(c)(9)). FSIS is not proposing to change the DRV for 
cholesterol.

E. Carbohydrate

1. Total Carbohydrate
a. Calculation of Total Carbohydrate
    FSIS requires the number of grams of total carbohydrate per serving 
be listed on the Nutrition Facts label (9 CFR 317.309(c)(6) and 
381.409(c)(6), which would be consolidated in proposed 9 CFR 
413.309(c)(6)). Total carbohydrate content must be calculated by 
subtracting the sum of the crude protein, total fat, moisture, and ash 
from the total weight of the product (9 CFR 317.309(c)(6) and 
381.409(c)(6), which would be consolidated in proposed 9 CFR 
413.309(c)(6)).
    FDA considered a citizen petition requesting that dietary fiber be 
excluded from the calculation of total carbohydrate, comments received 
on its 2007 ANPRM, and scientific evidence and declined to change the 
current method for calculating total carbohydrate (79 FR 11899-11900; 
81 FR 33794-33795). Just as FDA is not making any change, FSIS has 
reviewed FDA's analysis and has decided not to propose to change the 
current method for calculating total carbohydrate.
b. Classification of Carbohydrates Based on a Chemical Definition or 
Physiological Effect
    FSIS is not proposing to change its requirements for the 
classification or declaration of carbohydrates (9 CFR 317.309(c)(6) and 
381.409(c)(6), which would be consolidated in proposed 9 CFR 
413.309(c)(6)). FSIS agrees with FDA that a chemical definition for 
total carbohydrate is still consistent with the classification and 
declaration of fat on the Nutrition Facts label (79 FR 11901; 81 
33795). It would be difficult to apply a definition for total 
carbohydrates based on physiological effects because the different 
components of carbohydrates have different physiological effects.
c. Separate Declaration of Additional Individual Types of Carbohydrates
    FSIS is not proposing to require the separate declaration of 
additional types of individual carbohydrates (e.g., starch) because, as 
FDA also concluded, the comments to the 2007 ANPRM did not support the 
declaration of additional types of carbohydrates, such as starch (81 FR 
33795).
d. Mandatory Declaration
    FSIS requires the number of grams of total carbohydrate per serving 
be listed on the Nutrition Facts label (9 CFR 317.309(c)(6) and 
381.409(c)(6), which would be consolidated in proposed 9 CFR 
413.309(c)(6)), and has tentatively concluded, that the mandatory 
declaration of total carbohydrates continues to be necessary to assist 
consumers in making informed choices. Therefore, consistent with FDA's 
Nutrition Labeling Final Rule, FSIS is not proposing to change the 
requirement for mandatory declaration of total carbohydrate.
e. DRV
    FSIS sets 300 grams as the DRV for total carbohydrate based on 60 
percent of a 2,000 calorie diet ((0.60 x 2,000 calories)/4 calories per 
gram of carbohydrate = 300 grams) (9 CFR 317.309(c)(9) and 
381.409(c)(9), which would be consolidated in proposed 9 CFR 
413.309(c)(9)). The percentage of calories from total carbohydrate, 
total fat, and protein must add up to 100 percent on the Nutrition 
Facts label. Because, as discussed in part (II)(C)(1), FSIS is 
proposing to increase the DRV for total fat from 30 to 35 percent of 
calories consistent with FDA's final rule, either the DRV for total 
carbohydrate or protein must be decreased. As discussed in FDA's 
Nutrition Labeling Final Rule, decreasing the DRV for protein from 10 
percent of calories to 5 percent of calories to account for the 
increase in the DRV for total fat would result in a DRV of 5 grams of 
protein, which falls below the RDA for protein for children

[[Page 6740]]

and adults 9 years and older (81 FR 33784). Therefore, consistent with 
FDA's final rule, FSIS is proposing to decrease the DRV for total 
carbohydrate from 60 percent of calories to 55 percent of calories for 
a DRV of 275 grams to account for the increase in the DRV for total 
fat.
f. Calculation of Calories From Carbohydrate
    FSIS requires that calories from total carbohydrate be calculated 
using the general factor of 4 calories per gram total carbohydrate less 
the amount of insoluble dietary fiber (9 CFR 317.309(c)(1)(i)(C) and 
381.409(c)(1)(i)(C)). Consistent with FDA's final rule, FSIS is 
proposing a new definition for dietary fiber (see section II.E.5) that 
only allows for the declaration of dietary fibers that FDA has 
determined to have a physiological effect that is beneficial to human 
health. The new definition of dietary fiber includes: (1) Non-
digestible soluble and insoluble carbohydrates (with 3 or more 
monomeric units) and lignin that are intrinsic and intact in plants; 
and (2) isolated or synthetic non-digestible carbohydrates (with 3 or 
more monomeric units) determined by FDA to have physiological effects 
that are beneficial to human health. For the purpose of calculating 
calories from carbohydrate, all soluble and insoluble non-digestible 
carbohydrates should be excluded from the calculation, not just those 
known to meet the definition of dietary fiber. Therefore, FSIS is 
proposing that all soluble and insoluble non-digestible carbohydrates 
be excluded from the calculation for calories from total carbohydrate 
(proposed 9 CFR 413.309(c)(1)(i)(C)).
2. Sugars
a. Mandatory Declaration
    FSIS requires a statement of the number of grams of sugars per 
serving on the Nutrition Facts label, except for products that contain 
less than 1 gram of sugars per serving if no claims are made about 
sweeteners, sugars, or sugar alcohol content (9 CFR 317.309(c)(6)(ii) 
and 381.409(c)(6)(ii); would be consolidated in proposed 9 CFR 
413.309(c)(6)(ii)). FSIS defines sugars as the sum of all free mono- 
and disaccharides (such as glucose, fructose, lactose, and sucrose) (9 
CFR 317.309(c)(6)(ii) and 381.409(c)(6)(ii)). Consistent with FDA's 
final rule, FSIS has tentatively concluded that the mandatory 
declaration of sugars continues to be necessary to assist consumers in 
making informed choices and maintaining healthy dietary practices. But, 
FSIS is proposing to replace the declaration of ``Sugars'' with the 
term ``Total Sugars,'' which is also consistent with FDA's final rule. 
The rationale for this proposed change is discussed in part K(5).
b. DRV
    FSIS's regulations do not provide a DRV for sugars. FDA did not 
propose a DRV for sugars because there are no upper limits or set 
dietary reference values on which a DRV for sugars could be based (79 
FR 11902). Consistent with FDA's final rule, FSIS is not proposing to 
set a DRV for sugars.
3. Added Sugars
a. Declaration
    FSIS's regulations do not define ``added sugars'' nor permit its 
declaration on the Nutrition Facts label. FDA is requiring the 
declaration of added sugars on the Nutrition Facts label and 
considered, in its review, new data and information from U.S. consensus 
reports and scientific evidence supporting recommendations related to 
the consumption of added sugars, a citizen petition, and public 
comments (79 FR 11902-11906; 81 FR 33799-33851) and FDA's consumer 
study on added sugars \10\ (80 FR 44306). FSIS has reviewed FDA's 
analysis and is also proposing to require the declaration of added 
sugars on the Nutrition Facts label to provide consumers with the 
information they need to make more informed choices and meet the 
dietary recommendation to reduce caloric intake from added sugars. FSIS 
is proposing changes consistent with FDA's final rule. FSIS is 
proposing to require the mandatory declaration of added sugars as an 
indented line item underneath the declaration of ``Total Sugars'' on 
the Nutrition Facts label. FSIS is also proposing that the phrase ``Not 
a significant source of added sugars'' be placed at the bottom of the 
table of nutrient values if a statement of the added sugars content is 
not required and, as a result, is not provided. FSIS is also proposing 
that a statement of added sugars content would not be required for 
products that contain less than 1 gram of added sugars in a serving if 
no claims are made about sweeteners, sugars, or sugar alcohol content 
(proposed 9 CFR 413.309(c)(6)(iii)). FSIS is also proposing to permit 
alternative statements for added sugars similar to the current 
alternative statements for total carbohydrate, dietary fiber, soluble 
fiber, insoluble fiber, sugars, and sugar alcohol, when a serving 
contains less than 1 gram of the nutrient. Proposed 9 CFR 
413.309(c)(6)(iii) would provide for the alternative statements 
``Contains less than 1 gram'' or ``less than 1 gram,'' or, if the 
serving contains less than 0.5 g of added sugars, the content can be 
expressed as zero.
---------------------------------------------------------------------------

    \10\ U.S. Food and Drug Administration. Memorandum to the File--
``Experimental study on consumer responses to Nutrition Facts labels 
with declaration of amount of added sugars (OMB No. 0910-0764),'' 
2015.
---------------------------------------------------------------------------

b. Proposed Definition
    FSIS regulations do not currently define the term ``added sugars.'' 
Because FSIS is proposing to require the mandatory declaration of added 
sugars on the Nutrition Facts label, FSIS is also proposing to define 
the term ``added sugars.'' Proposed 9 CFR 413.309(c)(6)(iii) defines 
``added sugars'' as sugars that are either added during the processing 
of foods or are packaged as such and include sugars (free, mono- and 
disaccharides), sugars from syrups, honey, and fruit juice concentrates 
(see proposed 9 CFR 413.309(c)(6)(iii) for specific requirements for 
fruit juice concentrates) (see proposed 9 CFR 413.309(c)(6)(iii) for 
the complete ``added sugars'' definition). Examples of ``added sugars'' 
added to meat and poultry products include: Table sugar, brown sugar, 
corn sweetener, corn syrup, dextrose, fructose, apple juice concentrate 
glucose, Glucono-Delta-Lactone (GDL), high-fructose corn syrup, invert 
sugar, lactose, maltose, malt sugar, maple syrup, molasses, raw sugar, 
turbinado, sugar, trehalose, and sucrose. Sugar alcohols would not be 
considered added sugars.
c. Daily Value
    FDA established a DRV for added sugars of 10 percent of total 
energy intake based on new information in the ``Scientific Report of 
the 2015 Dietary Guidelines Advisory Committee'' (the ``2015 DGAC 
report'' \11\) regarding added sugars (80 FR 44308; 81 FR 33842). 
Consistent with FDA's final rule, FSIS is proposing a DRV for added 
sugars of 50 g for children and adults 4 years of age and older, 
including pregnant women and lactating women, and that the percent DV 
for added sugars be declared on the Nutrition Facts label. As discussed 
in FDA's supplemental proposed rule, the 2015 DGAC report recommended 
reducing the intake of added sugars, including an added sugars 
declaration and a percent DV for added sugars declaration in the 
Nutrition Facts label, and recommended that Americans keep added sugars 
intake below 10 percent of total energy intake (80 FR

[[Page 6741]]

44308). FSIS's proposed DRV of 50 g for added sugars was determined by 
taking 10 percent of the 2,000 reference calorie intake for adults and 
children 4 years of age and older (.10 x 2,000 = 200 calories) and then 
dividing by 4 calories/gram, which provides a 50 g reference amount for 
added sugars as the DRV.
---------------------------------------------------------------------------

    \11\ http://www.health.gov/dietaryguidelines/2015-scientific-report/.
---------------------------------------------------------------------------

d. Compliance
    FSIS is not aware of an analytical method that is capable of 
distinguishing between added and intrinsically occurring sugars in a 
food product, nor did FDA identify such a method (79 FR 11906). 
Therefore, to verify compliance with the proposed mandatory declaration 
of added sugars, FSIS is proposing in 9 CFR 413.309(h)(8)(iv) that 
establishments make and keep certain records to verify the amount of 
added sugars in the product (see compliance section II.N. below for 
more details about this requirement). For example, FSIS is proposing 
that a manufacturer must make and keep written records of the amount of 
sugars added to the product during the processing of the product and, 
if packaged as a separate ingredient, as packaged (whether as part of a 
package containing one or more ingredients or packaged as a single 
ingredient).
    FSIS is aware that sugars in some foods may undergo chemical 
changes as a result of non-enzymatic browning (i.e., Maillard reactions 
and caramelization) or fermentation during food processing. Some sugars 
are metabolized or otherwise transformed and converted into compounds 
that are no longer recognizable or detectable as sugars through 
conventional analytical methods.\12\ As FDA concluded, FSIS expects 
that the amount of added sugars transformed during non-enzymatic 
browning reactions in most products is insignificant relative to the 
initial levels of sugars (81 FR 33830-33831). Unlike browning 
reactions, fermentation is a process that typically involves the action 
of desirable microorganisms (e.g., yeasts and lactic acid bacteria) and 
enzymes that convert organic compounds, especially sugars and other 
carbohydrates, into simpler compounds such as carbon dioxide, lactic 
acid, and ethyl alcohol.13 14 Fermented sausages are one 
example of a fermented meat product and include certain types of 
pepperoni, salami, Lebanon bologna, mettwurst, and certain types of 
chorizo. Fermentation can affect the flavor, color, and microbiological 
safety of meat products. Both natural and controlled meat fermentation 
involve lactic acid bacteria. This type of bacteria converts naturally 
occurring glycogen and added sugars into lactic acid. This conversion 
reduces the amount of sugar in a meat product.\15\ However, FSIS 
expects that the majority of manufacturers would be able to use the 
amount of sugars added as an ingredient as a reasonable approximation 
of the amount of added sugars in a serving of their product. When the 
amount of added sugars is reduced through non-enzymatic browning or 
fermentation, FSIS is proposing in 9 CFR 413.309(h)(8)(v) to require: 
(1) Records of scientific data and information that demonstrate the 
amount of added sugars in the food after non-enzymatic browning or 
fermentation and a narrative explaining why the data and information 
are sufficient to demonstrate the amount of added sugars declared in 
the finished food, provided the data and information used is specific 
to the type of food manufactured; or (2) records of the amount of 
sugars added to the food before and during the processing of the food, 
and if packaged as a separate ingredient, as packaged (whether as part 
of a package containing one or more ingredients or packaged as a single 
ingredient) and in no event shall the amount of added sugars declared 
exceed the amount of total sugars on the label.
---------------------------------------------------------------------------

    \12\ Skibsted, L.H., Risbo, J., Andersen, M.L. ``Chemical 
Deterioration and Physical Instability of Food and Beverages''. 
Woodhead Publishing; 2010; pp. 70-94.
    \13\ Lewis, R.J., Sr., editor. Hawley's Condensed Chemical 
Dictionary. 15th Ed. John Wiley & Sons, 2007; pp. 549-550.
    \14\ Murano, P.S. ``Understanding Food Science and Technology''. 
Belmont, California: Wadsworth/Thomas Learning; 2003; pp. 123-125.
    \15\ Toldr[aacute], et al., ``Handbook of Fermented Meat and 
Poultry,'' Wiley Blackwell; 2015; Chapters 1-2.
---------------------------------------------------------------------------

    In some food products, non-enzymatic browning or fermentation could 
result in a significant reduction in the amount of added sugars, 
leaving manufacturers with no way to reasonably approximate the amount 
of added sugars in a serving of the finished food. Similar to FDA, FSIS 
is proposing that manufacturers may submit a request to FSIS's LPDS to 
use an alternative means of compliance. The request must provide 
scientific data or other information for why the amount of added sugars 
in a serving of the product is likely to have a significant reduction 
in added sugars compared to the amount added prior to non-enzymatic 
browning or fermentation.
4. Sugar Alcohols
    For nutrition labeling purposes, consistent with FDA, FSIS defines 
sugar alcohols ``as the sum of saccharide derivatives in which a 
hydroxyl group replaces a ketone or aldehyde group and whose use in the 
food is listed by FDA (e.g., mannitol or xylitol) or is generally 
recognized as safe (e.g., sorbitol)'' (9 CFR 317.309(c)(6)(iii) and 
381.409(c)(6)(iii), which would be consolidated in proposed 9 CFR 
413.309(c)(6)(iv)). Consistent with FDA, FSIS permits the voluntary 
declaration of sugar alcohols on the Nutrition Facts label (9 CFR 
317.309(c)(6)(iii) and 381.409(c)(6)(iii)). FSIS is not proposing to 
change the voluntary declaration of sugar alcohols on the Nutrition 
Facts label, just as FDA did not.
a. DRV
    Consistent with FDA, FSIS does not provide a DRV for sugar alcohols 
and is not proposing a DRV for sugar alcohols because there is no 
quantitative reference intake recommendation for sugar alcohols from 
current consensus reports on which to base a DRV.
b. Caloric Value
    Caloric content for total carbohydrate less the amount of insoluble 
dietary fiber is calculated using a factor of 4 calories per gram (9 
CFR 317.309(c)(1)(i)(C) and 381.409(c)(1)(i)(C)). FSIS has reviewed the 
Life Sciences Research Office reports 16 17 that recommended 
the following caloric values for sugar alcohols: isomalt (2.0 kcal/g); 
lactitol (2.0 kcal/g), xylitol (2.4 kcal/g); maltitol (2.1 kcal/g); 
sorbitol (2.6 kcal/g); hydrogenated starch hydrolysates (3.0 kcal/g); 
and mannitol (1.6 kcal/g). FSIS has tentatively concluded that the 
values recommended by the Life Sciences Research Office are closer to 
the energy contribution of sugar alcohols than the current factors. 
FSIS also reviewed FDA's analysis for determining a caloric value for 
erythritol and agrees with the analysis (81 FR 33852). Therefore, 
consistent with FDA's final rule (81 FR 33852), FSIS is proposing to 
amend its regulations to establish the following general factors for 
caloric values for sugar alcohols: isomalt (2.0 kcal/g); lactitol (2.0 
kcal/g), xylitol (2.4 kcal/g); maltitol (2.1 kcal/g); sorbitol (2.6 
kcal/g); hydrogenated starch hydrolysates (3.0 kcal/g); mannitol (1.6 
kcal/g); and erythritol (0 kcal/g). Proposed 9 CFR 413.309(c)(1)(i)(F) 
will establish these values, and proposed 9 CFR 413.309(c)(1)(i)(C) 
will clarify that the

[[Page 6742]]

factor of 4 kcal/g does not apply to sugar alcohols.
---------------------------------------------------------------------------

    \16\ Life Sciences Research Office. ``The Evaluation of the 
Energy of Certain Sugar Alcohols Used as Food Ingredients'', 
Bethesda, MD: Life Sciences Research Office; 1994.
    \17\ Life Sciences Research Office. ``Evaluation of the Net 
Energy Value of Maltitol'', Bethesda, MD: Life Sciences Research 
Office; 1999.
---------------------------------------------------------------------------

5. Fiber
a. Dietary Fiber
i. Definition
    FSIS's regulations do not define ``dietary fiber.'' After 
considering IOM recommendations, comments received on FDA's 2007 ANPRM, 
and international guidelines (e.g., The Codex Alimentarius Commission's 
definition of dietary fiber), FDA adopted a definition of dietary fiber 
that is equivalent to the IOM's definition of ``total fiber'' and 
emphasizes the beneficial physiological effects in humans (81 FR 
33853). FSIS has reviewed FDA's analysis and is proposing to include a 
definition for dietary fiber in 9 CFR 413.309(c)(6)(i) that is 
consistent with FDA's definition. FSIS is proposing the following 
definition for dietary fiber: (1) Non-digestible soluble and insoluble 
carbohydrates (with 3 or more monomeric units) and lignin that are 
intrinsic and intact in plants; and (2) isolated or synthetic non-
digestible carbohydrates (with 3 or more monomeric units) determined by 
FDA to have physiological effects that are beneficial to human health.
    FSIS is proposing to include isolated or synthetic non-digestible 
carbohydrates that have been determined by FDA to have a physiological 
effect that is beneficial to human health in the proposed definition of 
dietary fiber in 9 CFR 413.309(c)(6)(i). For example, [beta]-glucan 
soluble fiber and psyllium husk that are added to foods meet the 
proposed definition of dietary fiber and would be listed in 9 CFR 
413.309(c)(6)(i). FSIS would consider amending 9 CFR 413.309(c)(6)(i) 
to list any additional isolated or synthetic non-digestible 
carbohydrates that FDA determines have a physiological effect that is 
beneficial to human health.
ii. Mandatory Declaration
    FSIS requires that a statement of the number of grams of total 
dietary fiber per serving be declared on the Nutrition Facts label, 
except when a serving contains less than 1 gram of total dietary fiber 
(9 CFR 317.309(c)(6)(i) and 381.409(c)(6)(i), which would be 
consolidated in proposed 9 CFR 413.309(c)(6)(i)). FSIS is not proposing 
to change the requirement for mandatory declaration of dietary fiber, 
just as FDA did not.
iii. Analytical Methods
    The amount of dietary fiber may be calculated by subtracting the 
amount of non-digestible carbohydrates added during processing that do 
not meet the proposed definition of dietary fiber from the value 
obtained using AOAC 2009.01, AOAC 2011.25, or an equivalent AOAC method 
of analysis as given in the ``Official Methods of Analysis of the AOAC 
International'' 19th Edition. Because an AOAC method would not 
accurately quantify the dietary fiber that meets the proposed 
definition if the product contains both non-digestible carbohydrates 
that meet the definition and those that do not, consistent with FDA's 
final rule, FSIS is proposing to require that manufacturers maintain 
written records to verify the amount of added non-digestible 
carbohydrates that do not meet the proposed definition of dietary 
fiber. (See Compliance section II.N. below.)
iv. DRV
    Currently, 25 g is the DRV for total dietary fiber based on the 
reference calorie intake of 2,000 calories (9 CFR 317.309(c)(9) and 
381.409(c)(9)). FSIS is proposing to amend its regulations to establish 
28 g as the DRV for total dietary fiber (proposed 9 CFR 413.309(c)(9)). 
FSIS is proposing to use 28 g as the DRV for total dietary fiber 
because: (1) the IOM set an adequate intake level (AI) of 14 g/1,000 
kcal for total fiber primarily based on the intake level that was 
associated with the greatest reduction in the risk of CHD; \18\ and (2) 
FDA now uses 14 g/1,000 kcal as the basis for a DRV for dietary fiber 
and setting a DRV of 28 g for dietary fiber using a reference calorie 
intake of 2,000 calories (81 FR 33865-33866).
---------------------------------------------------------------------------

    \18\ Institute of Medicine (IOM) of the National Academies. 
``Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, 
Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients), 
Chapter 7: Dietary, Functional, and Total Fiber'', Washington, DC: 
National Academies Press; 2002.
---------------------------------------------------------------------------

b. Soluble and Insoluble Fiber
    Soluble fibers (e.g., pectin) dissolve in water and are digested by 
the bacteria in the large intestine. Insoluble fibers (e.g., cellulose) 
do not dissolve in water and are not digested by the bacteria in the 
large intestine. FSIS regulations do not define the terms soluble and 
insoluble fiber, but provide for the voluntary declaration of soluble 
and insoluble fiber (9 CFR 317.309(c)(6)(i) and 381.409(c)(6)(i)), 
which would be consolidated in proposed 9 CFR 413.309(c)(6)(i)). 
Consistent with FDA, FSIS is proposing that when soluble fiber or 
insoluble fiber is declared, the soluble fiber and insoluble fiber must 
meet the definition of ``dietary fiber'' in proposed 9 CFR 
413.309(c)(6)(i) because they are components of dietary fiber.
i. Analytical Methods
    AOAC 2011.25 or an equivalent AOAC method may be used to calculate 
soluble and insoluble fiber that meet the proposed definition of 
dietary fiber and can be declared on the Nutrition Facts label. AOAC 
2011.25 can measure low molecular weight non-digestible carbohydrates, 
as well as separately measure soluble and insoluble non-digestible 
carbohydrates.\19\ Consistent with FDA, if a product contains a mixture 
of non-digestible carbohydrates that do not meet the proposed dietary 
fiber definition, and the label of the product declares soluble or 
insoluble fiber content, FSIS is proposing to require establishments to 
make and keep records to verify the amount of non-digestible 
carbohydrate(s) that does not meet the proposed definition of dietary 
fiber present in the food. (See discussion in compliance section II.N. 
below.)
---------------------------------------------------------------------------

    \19\ McCleary, B.V., DeVries, J.W., Rader, J.I., et al. 
``Determination of Total Dietary Fiber (CODEX definition) by 
Enzymatic-Gravimetric Method and Liquid Chromatography: 
Collaborative Study''. Journal of AOAC International. 2010;93:221-
233.
---------------------------------------------------------------------------

ii. DRV
    FDA did not find a basis on which to derive DRVs for soluble or 
insoluble fiber. Consistent with FDA's final rule, FSIS is not 
proposing DRVs for soluble fiber or insoluble fiber.
iii. Caloric value
    FSIS regulations provide that the caloric content of a product may 
be calculated by, among other methods, using general factors of 4, 4, 
and 9 calories per gram for protein, total carbohydrate less the amount 
of insoluble dietary fiber, and total fat, respectively (9 CFR 
317.309(c)(1)(i)(C) and 381.409(c)(1)(i)(C)). Soluble fiber, which is 
included in total carbohydrate, is assigned a general factor of 4 kcal/
g. FDA established a general factor of 2 kcal/g as the caloric value of 
soluble non-digestible carbohydrates (81 FR 33867). Insoluble non-
digestible carbohydrates are not included in the caloric calculation 
(81 FR 33867). FDA required that calories from carbohydrate be 
calculated using a general factor of 4 kcal/g of total carbohydrate 
less the amount of non-digestible carbohydrates, which includes soluble 
(2 kcal/g) and insoluble non-digestible carbohydrates (0 kcal/g) that 
do and do not meet the definition of dietary fiber (81 FR 33867). The 
calorie contribution of soluble non-digestible carbohydrate would be 
added

[[Page 6743]]

to that sum to determine the total carbohydrate calorie contribution 
(Id.). Therefore, in order to harmonize with FDA's regulations, FSIS is 
proposing the same changes to the caloric value for soluble non-
digestible carbohydrates and the calculation of calories from 
carbohydrate.
6. Other Carbohydrate
    FSIS's regulations define ``Other carbohydrate'' as the difference 
between total carbohydrate and the sum of dietary fiber, sugars, and 
sugar alcohol, except that if sugar alcohol is not declared (even if 
present), ``Other carbohydrate'' is defined as the difference between 
total carbohydrate and the sum of dietary fiber and sugars (9 CFR 
317.309(c)(6)(iv) and 381.409(c)(6)(iv)). A statement of the number of 
grams of ``Other carbohydrate'' per serving may be voluntarily declared 
on the Nutrition Facts label (9 CFR 317.309(c)(6)(iv) and 
381.409(c)(6)(iv)).
    FDA concluded that ``Other carbohydrate'' should no longer be 
permitted on the Nutrition Facts label because of its lack of public 
health significance and a quantitative intake recommendation for 
``Other carbohydrate'' is not available from relevant consensus reports 
(81 FR 33867-33868). FDA removed the provision that allows for its 
voluntary declaration in the regulations (81 FR 33867-33868). FSIS has 
reviewed FDA's analysis and is proposing to no longer permit the 
voluntary declaration of ``Other carbohydrate'' on the Nutrition Facts 
label for the reasons above.

F. Protein

    FSIS's regulations require that a statement of the number of grams 
of protein per serving be declared on the Nutrition Facts label (9 CFR 
317.309(c)(7) and 381.409(c)(7), which would be consolidated in 
proposed 9 CFR 413.309(c)(7)). The DRV for protein is 50 g and 
represents 10 percent of the 2,000 reference calories intake level. 
Consistent with FDA, FSIS is not proposing to change the mandatory 
declaration of protein or the DRV for protein.
1. Analytical Methods
    Under FSIS's regulations (9 CFR 317.309(c)(7) and 381.409(c)(7)), 
protein may be calculated on the basis of the factor of 6.25 times the 
nitrogen content of the food as determined by appropriate methods of 
analysis in accordance with 9 CFR 317.309(h) or 9 CFR 381.409(h), 
except when the procedure for a specific food requires another factor. 
According to 9 CFR 317.309(h)(2) and 381.409(h)(2), FSIS determines 
compliance by appropriate methods and procedures used by the Department 
for each nutrient in accordance with the Chemistry Laboratory 
Guidebook, or, if no USDA method is available and appropriate for the 
nutrient, by appropriate methods for the nutrient in accordance with 
the 1990 edition of the Official Methods of Analysis of the AOAC 
International, formerly Association of Official Analytical Chemists, 
15th ed., to determine compliance with the nutrition labeling 
regulations. FSIS is proposing to update the version of the Official 
Methods of Analysis of the AOAC International referenced in the 
regulations because more analytical methods for nutrients have been 
published in later versions. The 20th edition is the most recent 
edition of the published AOAC methods, so FSIS is proposing in 9 CFR 
413.309(h) that the 20th edition be used if no USDA method is 
available. If a newer version of the Official Methods of Analysis of 
the AOAC International is published before a final rule is published 
for this rulemaking, FSIS will consider using the most recent version 
of the official AOAC methods in the final rule.

G. Sodium

    FSIS's regulations require the declaration of the number of 
milligrams of sodium per serving on the Nutrition Facts label (9 CFR 
317.309(c)(4) and 381.409(c)(4), which would be consolidated in 
proposed 9 CFR 413.309(c)(4)). Consistent with FDA, FSIS is not 
proposing to change the requirement that sodium be declared.
    FSIS's regulations set a DRV of 2,400 mg of sodium based on a 
reference caloric intake of 2,000 calories (9 CFR 317.309(c)(9) and 
381.409(c)(9)). FDA considered the following options for updating the 
DRV for sodium: ``(1) A DRV of 2,300 mg which reflects the Upper Intake 
Level (UL) \20\ for individuals aged 14 years and older; (2) An RDI of 
1,500 mg which reflects the AI for individuals 9 to 50 years of age; 
and (3) Alternative approaches such as retaining a DRV of 2,400 mg, 
using a tiered approach or setting a DRV of 1,900 mg based on the UL 
for children 4 to 9 years of age'' (79 FR 11915). In FDA's Nutrition 
Labeling Proposed Rule, FDA tentatively concluded that 2,300 mg is the 
most appropriate DV for sodium to ``assist consumers in maintaining 
healthy dietary practices and in understanding the relative 
significance of the sodium content within the context of a total daily 
diet'' (79 FR 11917). FDA did not change its view in the final rule 
that 2,300 mg/day is an appropriate DRV for sodium (81 FR 33874-33880). 
FSIS has reviewed FDA's analysis, and consistent with FDA's Nutrition 
Labeling Final Rule, FSIS is proposing to set a DRV of 2,300 mg for 
sodium (proposed 9 CFR 413.309(c)(9)).
---------------------------------------------------------------------------

    \20\ ``The UL is the highest average daily intake level likely 
to pose no risk of adverse health effects for nearly all people in a 
particular group. The UL is not intended to be a recommended level 
of intake. The UL is used to assess the risk of adverse health 
effects from excessive nutrient intake. As intake above the UL 
increases, so does the potential for risk of adverse health 
effects'' (79 FR 11885).
---------------------------------------------------------------------------

H. Fluoride

    FSIS's regulations do not permit the declaration of fluoride on the 
Nutrition Facts label. FDA amended its regulations to provide for the 
voluntary declaration of fluoride because fluoride's positive health 
effects are well established (e.g., reduces the risk of dental caries), 
but an appropriate quantitative intake recommendation is not available 
for setting a DRV (81 FR 33880-33884) (proposed 9 CFR 413.309(c)(5)). 
FSIS has reviewed FDA's analysis and consistent with FDA, FSIS is 
proposing to (i) permit the voluntary declaration of fluoride on the 
Nutrition Facts label; (ii) require the mandatory declaration of 
fluoride when a claim about fluoride is made on the label or in 
labeling of the product; and (iii) require that when fluoride content 
is declared, it must be expressed as zero when a serving contains less 
than 0.1 mg of fluoride, to the nearest 0.1 mg increment when a serving 
contains less than or equal to 0.8 mg of fluoride, and the nearest 0.2 
mg when a serving contains more than 0.8 mg of fluoride, consistent 
with how FSIS and FDA have approached incremental values for other 
nutrients that are present in products in small amounts. FSIS is not 
proposing a DRV for fluoride because an appropriate quantitative intake 
recommendation is not available for setting a DRV.

I. Essential Vitamins and Minerals

1. Updates to Declaration of Vitamins and Minerals and Reference Daily 
Intakes
    FSIS currently requires the declaration of vitamin A, vitamin C, 
calcium, and iron on the Nutrition Facts label (9 CFR 317.309(c)(8)(ii) 
and 381.409(c)(8)(ii)). Vitamin D, vitamin E, vitamin B6, 
vitamin B12, thiamin, riboflavin, niacin, folate, biotin, 
pantothenic acid, phosphorus, iodine, magnesium, zinc, copper, and 
potassium may all be declared voluntarily on the Nutrition Facts label 
(9 CFR 317.309(c)(8)(iv),

[[Page 6744]]

381.409(c)(8)(iv), 317.309(c)(9), and 381.409(c)(9)). FSIS has also 
permitted the voluntary declaration of nutrients for which FSIS has not 
codified RDIs, but that are codified in Title 21 of FDA's 
regulations.\21\ These nutrients are vitamin K, selenium, manganese, 
chromium, molybdenum, and chloride.
---------------------------------------------------------------------------

    \21\ http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/labeling/labeling-policies/trans-fat-declarations/trans-fat-declaration.
---------------------------------------------------------------------------

    FDA amended its regulations to: (i) Require the declaration of 
vitamin D, calcium, iron, and potassium on the Nutrition Facts label; 
(ii) allow the voluntary declaration of vitamin A and C; (iii) retain 
the voluntary declaration of vitamin E, vitamin K, vitamin 
B6, vitamin B12, thiamin, riboflavin, niacin, 
folate, biotin, pantothenic acid, phosphorus, iodine, magnesium, zinc, 
selenium, copper, manganese, chromium, molybdenum, and chloride; and 
(iv) allow the voluntary declaration of choline (81 FR 33884-33897). 
FDA made these changes based on its analysis of data and consideration 
of such factors as public health significance, quantitative intake 
recommendations, and the role of a nutrient in chronic disease risk (81 
FR 33884-33897). Consistent with FDA and proposed 9 CFR 
413.309(c)(8)(ii), the vitamins and minerals would be updated in 
proposed 9 CFR 413.363(b)(4) to replace ``vitamin A, vitamin C, 
calcium, and iron'' with ``vitamin D, calcium, iron, and potassium.''
    FDA also revised the existing RDIs for vitamins and minerals after 
considering the Dietary Reference Intakes (DRIs) \22\ set by the IOM 
that reflect current nutrient requirements (81 FR 33897-33901). Percent 
DVs for vitamins and minerals that are required or permitted on the 
Nutrition Facts label are based on RDIs (9 CFR 317.309(c)(8)(iv) and 
381.409(c)(8)(iv)).
---------------------------------------------------------------------------

    \22\ A set of reference values that include the Estimated 
Average Requirement, RDA, Adequate Intake, and Tolerable Upper 
Intake Level. See 79 FR 11885-6 for more background on DRIs.
---------------------------------------------------------------------------

    FSIS is proposing to adopt FDA's list of nutrients as mandatory or 
voluntary components of nutrition labeling, the definition of those 
nutrients, and the increments for declaring nutrients, in the interest 
of harmonizing with FDA (proposed 9 CFR 413.309(c)(8)(iv)). Consistent 
with FDA's final rule, FSIS is also proposing to update the RDIs for 
calcium, copper, folate, iodine, iron, magnesium, niacin, phosphorus, 
riboflavin, thiamin, zinc, and vitamins A, B6, 
B12, C, D, and E and to establish RDIs for vitamin K, 
selenium, manganese, chromium, molybdenum, chloride, and choline 
(proposed 9 CFR 413.309(c)(8)(iv)) (see Table 2). A more extensive 
discussion of FDA's list of nutrients and RDIs can be found in the 
preamble of FDA's Nutrition Labeling Proposed and Final Rules (79 FR 
11918-11931; 81 FR 33897-33901).

                            Table 2--Current and Proposed RDIs for Nutrition Labeling
                [Based on a 2,000 calorie intake for adults and children 4 or more years of age]
----------------------------------------------------------------------------------------------------------------
                Nutrient                          Current RDIs                       Proposed RDIs
----------------------------------------------------------------------------------------------------------------
Vitamins:
    Biotin..............................  .3 milligram...............  30 micrograms.
    Choline.............................  N/A........................  550 milligrams.
    Folate \6\..........................  .4 milligram...............  400 micrograms DFE.\1\
    Niacin..............................  20 milligrams..............  16 milligrams NE.\2\
    Pantothenic acid....................  10 milligrams..............  5 milligrams.
    Riboflavin..........................  1.7 milligrams.............  1.3 milligrams.
    Thiamin.............................  1.5 milligrams.............  1.2 milligrams.
    Vitamin A...........................  5,000 International Units..  900 micrograms RAE.\3\
    Vitamin B6..........................  2.0 milligrams.............  1.7 milligrams.
    Vitamin B12.........................  6 micrograms...............  2.4 micrograms.
    Vitamin C...........................  60 milligrams..............  90 milligrams.
    Vitamin D...........................  400 International Units....  20 micrograms.\4\
    Vitamin E...........................  30 International Units.....  15 milligrams.\5\
    Vitamin K...........................  N/A........................  120 micrograms.
Minerals:
    Calcium.............................  1.0 gram...................  1,300 milligrams.
    Chloride............................  N/A........................  2,300 milligrams.
    Chromium............................  N/A........................  35 micrograms.
    Copper..............................  2.0 milligrams.............  0.9 milligrams.
    Iodine..............................  150 micrograms.............  150 micrograms.
    Iron................................  18 milligrams..............  18 milligrams.
    Magnesium...........................  400 milligrams.............  420 milligrams.
    Manganese...........................  N/A........................  2.3 milligrams.
    Molybdenum..........................  N/A........................  45 micrograms.
    Phosphorus..........................  1.0 gram...................  1,250 milligrams.
    Potassium \7\.......................  3,500 milligrams...........  4,700 milligrams.
    Selenium............................  N/A........................  55 micrograms.
    Zinc................................  15 milligrams..............  11 milligrams.
----------------------------------------------------------------------------------------------------------------
\1\ DFE = Dietary Folate Equivalents; 1 DFE = 1 mcg naturally-occurring folate = 0.6 mcg of folic acid.
\2\ NE = Niacin equivalents, 1 mg NE = 1 mg niacin = 60 mg of tryptophan.
\3\ RAE = Retinol activity equivalents; 1 microgram RAE = 1 microgram retinol, 2 micrograms supplemental [beta]-
  carotene, 12 micrograms [beta]-carotene, or 24 micrograms [alpha]- carotene, or 24 micrograms [beta]-
  cryptoxanthin.
\4\ The amount of vitamin D may, but is not required to, be expressed in international units (IU), in addition
  to the mandatory declaration in mcg. Any declaration of the amount of vitamin D in IU must appear in
  parentheses after the declaration of the amount of vitamin D in mcg.
\5\ 1 mg [alpha]-tocopherol (label claim) = 1 mg [alpha]-tocopherol = 1 mg RRR- [alpha]-tocopherol = 2 mg all
  rac-[alpha]-tocopherol.
\6\ ``Folate'' and ``Folic Acid'' must be used for purposes of declaration in the labeling of conventional foods
  and dietary supplements. The declaration for folate must be in mcg DFE (when expressed as a quantitative
  amount by weight in a conventional food or a dietary supplement), and percent DV based on folate in mcg DFE.
  Folate may be expressed as a percent DV in conventional foods. When folic acid is added or when a claim is
  made about the nutrient, folic acid must be declared in parentheses, as mcg of folic acid.
\7\ These minerals currently have a DRV and we are proposing to establish an RDI.


[[Page 6745]]

2. Terms for Vitamins and Minerals
    FSIS currently allows the term ``Folacin'' to be added in 
parenthesis immediately following the term ``Folate'' on the Nutrition 
Facts label (9 CFR 317.309(c)(8)(v) and 381.409(c)(8)(v)). FSIS is 
proposing to remove the synonym ``folacin'' from 9 CFR 317.309(c)(8)(v) 
and 381.409(c)(8)(v) and require that the term ``folate'' be used on 
meat and poultry products that contain folate, folic acid, or a mixture 
of folate and folic acid (proposed 9 CFR 413.309(c)(8)(vii)). The 
declaration must be folate in mcg DFE (when expressed as a quantitative 
amount by weight) and the percent Daily Value based on folate in mcg 
DFE, or may be expressed as folate and the percent DV based on folate 
in mcg DFE. Because of the proposed changes to the units of measure for 
folate that take into account the differences between folate and folic 
acid, FSIS is proposing that when folic acid is added or when a claim 
is made about the nutrient, folic acid must be declared in parentheses 
as mcg of folic acid after the folate declaration. FSIS's proposed 
changes are consistent with FDA's Nutrition Labeling Final Rule (81 FR 
33909-33912).

J. Labeling of Foods for Infants, Young Children, and Pregnant or 
Lactating Women

    The general labeling requirements for foods in 9 CFR 317.309(c) and 
381.409(c) apply to foods for infants, young children, and pregnant 
women and lactating women with certain exceptions. For example, meat 
and poultry products represented or purported to be specifically for 
infants and children less than 4 years of age are not permitted to 
include declarations of percent DV for the following nutrients: Total 
fat, saturated fat, cholesterol, sodium, potassium, total carbohydrate, 
and dietary fiber (9 CFR 317.400(c)(2)(i) and 381.500(c)(2)(i)). There 
are additional exceptions to labeling for meat and poultry products 
represented or purported to be specifically for infants and children 
less than 2 years of age. For example, these foods are also not 
permitted to declare calories from fat, calories from saturated fat, 
saturated fat, stearic acid, polyunsaturated fat, monounsaturated fat 
and cholesterol on the Nutrition Facts label (9 CFR 317.400(c)(1) and 
381.500(c)(1)).
    FSIS regulations do not include DRVs or RDIs for nutrients, 
generally, for infants, children under 4 years of age, or pregnant 
women and lactating women. However, there are requirements for a DRV 
for protein for children 4 or more years of age, and an RDI for protein 
for each of the following subpopulations: (1) Children less than 4 
years of age; (2) infants; (3) pregnant women; and (4) lactating women 
(9 CFR 317.309(c)(7)(iii) and 381.409(c)(7)(iii)).
    FDA changed its requirements for the labeling of foods, other than 
infant formula, represented or purported to be specifically for 
infants, children under 4 years of age, and pregnant women and 
lactating women after considering current consensus reports, changes to 
the Nutrition Facts label, and comments to its 2007 ANPRM (81 FR 33916-
33932). FSIS has reviewed FDA's analysis and is proposing to make 
consistent changes to its requirements for the labeling of meat and 
poultry products represented or purported to be specifically for 
infants, children under 4 years of age, and pregnant women and 
lactating women (proposed 9 CFR 413.309(c)).
1. Age Range for Infants and Young Children
    FSIS regulations currently use the age ranges ``less than 2 years 
of age'' and ``less than 4 years of age'' to establish labeling 
requirements for meat and poultry products represented or purported to 
be specifically for infants and young children (9 CFR 317.400(c) and 
381.500(c)). FDA amended its regulations so that the age categories 
were changed to infants through 12 months and young children 1 through 
3 years (13 through 48 months) which would be consistent with the age 
ranges used in the IOM's DRIs for infants and children (81 FR 33916-
33917). FDA's new DVs are also based on these age-specific DRIs (81 FR 
33916-33917)
    Consistent with FDA's final rule, FSIS is proposing to replace the 
current category of infants and children less than 4 years in 9 CFR 
317.400(c)(1); 381.500(c)(1); 317.309(c)(7)-(8); 381.409(c)(7)-(8); 
317.309(d)(1); 381.409(d)(1); 317.313(b)(3); 381.413(b)(3); 
317.313(q)(3); and 381.413(q)(3) with infants through 12 months and 
children 1 through 3 years of age (proposed 9 CFR 413.400(c)(1); 
413.309(c)(7)-(9); 413.309(d)(1); 413.313(b)(3); and 413.313(q)(3)).
2. Mandatory Declaration of Calories and Other Nutrients
    Currently, meat and poultry products represented or purported to be 
specifically for infants and children less than 4 years must declare 
certain nutrients, including calories, calories from fat, total fat, 
saturated fat, cholesterol, sodium, total carbohydrate, sugars, dietary 
fiber, and protein (9 CFR 317.400(c)(2) and 381.500(c)(2)). For meat 
and poultry products represented or purported to be for infants and 
children less than 2 years, the declaration of certain nutrients, which 
include calories from fat, saturated fat, and cholesterol, is not 
required or permitted (9 CFR 317.400(c)(1) and 381.500(c)(1)).
a. Declaration of Saturated Fat and Cholesterol
    Because FSIS is proposing new categories of infants through 12 
months and children 1 through 3 years of age, FSIS is considering 
whether there is a need to require or permit the declaration of 
calories from fat, saturated fat, and cholesterol in the labeling for 
foods represented or purported to be specifically for these 
subpopulations. As discussed in section II.B.1. above, FSIS is 
proposing to no longer require and not permit the declaration of 
calories from fat on the Nutrition Facts label (proposed 9 CFR 
413.309(c)(1)(ii)). Therefore, if these proposed changes are finalized, 
the exception in 9 CFR 317.400(c)(1) and 381.500(c)(1) for calories 
from fat will no longer be needed, and the reference to calories from 
fat will be removed. FSIS's regulations currently do not require or 
permit the labeling of any fat, with the exception of total fat, or 
fatty acids on meat and poultry products represented or purported to be 
specifically for children less than 2 years of age.
    FDA considered a recent consensus report suggesting that: Fat 
intake in infants less than 12 months of age should not be restricted. 
Fat is still an important source of calories for infants and young 
children. Evidence suggests a diet with saturated fat of less than 10 
percent of calories and cholesterol intake less than 300 mg/d can 
safely and effectively reduce the levels of total and LDL cholesterol 
in healthy children, and that the 2010 DGA recommended that Americans 2 
years of age and older consume less saturated fatty acids and less than 
300 mg/d of cholesterol (79 FR 11934). FDA requires, except for the 
declaration of calories from fat, the mandatory declaration of 
statutorily required nutrients under section 403(q) of the FD&C Act 
that include saturated fat and cholesterol on the label of foods 
represented or purported to be specifically for infants through 12 
months and children 1 through 3 years of age (81 FR 33917-33918). 
Therefore, consistent with FDA's final rule, FSIS is proposing to 
require the declaration of saturated fat and cholesterol on the label 
of meat and poultry products purported to be for infants through 12 
months and children 1 through 3 years of age (proposed 9 CFR 
413.400(c)(1)).

[[Page 6746]]

    Currently, meat and poultry products consumed by pregnant women and 
lactating women must declare certain nutrients, including calories, 
calories from fat, total fat, saturated fat, cholesterol, sodium, total 
carbohydrate, sugars, dietary fiber, and protein. As discussed in FDA's 
Nutrition Labeling Proposed Rule, women of reproductive age consume the 
same foods as the general population and, in general, continue 
consuming similar foods during pregnancy and lactation (79 FR 11934). 
FDA requires, except for the declaration of calories from fat, the 
mandatory declaration of statutorily required nutrients under section 
403(q) of the FD&C Act (81 FR 33917-33918).
    Accordingly, FSIS is proposing to require the mandatory declaration 
of calories and the amount of total fat, saturated fat, cholesterol, 
sodium, total carbohydrate, dietary fiber, sugars, and protein on foods 
represented or purported to be specifically for infants through 12 
months of age, children 1 through 3 years of age, and pregnant women 
and lactating women and to permit the declaration of calories from 
saturated fat such that these nutrients would be subject to the same 
requirements applicable to meat and poultry products for the general 
population (proposed 9 CFR 413.309(c)).
b. Percent DV Declaration
    Currently, the percent DV declaration is not permitted on the 
Nutrition Facts label for meat and poultry products represented or 
purported to be specifically for infants and children less than 4 years 
of age (which includes infants and children less than 2 years of age) 
for total fat, saturated fat, cholesterol, sodium, potassium, total 
carbohydrate, and dietary fiber (9 CFR 317.400(c)(2)(i) and 
381.500(c)(2)(i)). Percent DV is required for protein and vitamins and 
other minerals and, as discussed in sections II.F and II.I, provides 
information in a manner that enables consumers to understand the 
relative significance of nutrition information in the context of a 
total daily diet. FDA concluded that it is appropriate to require 
declarations of percent DV for those nutrients for which FDA is 
establishing a DRV or RDI for infants through 12 months, for children 1 
through 3 years of age, and for pregnant women and lactating women (81 
FR 33918-33919). Accordingly, FSIS is proposing in 9 CFR 
413.400(c)(2)(i) to require declarations of percent DV for those 
nutrients for which FSIS is establishing a DRV or RDI for infants 
through 12 months, for children 1 through 3 years of age, and for 
pregnant women and lactating women consistent with FDA's Nutrition 
Labeling Final Rule.
c. Mandatory Declaration of Added Sugars
    As discussed in section II.E.3, FSIS is proposing to require the 
mandatory declaration of added sugars on the Nutrition Facts label. The 
2010 DGA provides recommendations for consumption of added sugars for 
the U.S. population 2 years of age and older but not for infants and 
children under age 2. It is expected, however, that the role of added 
sugars are not markedly different between children 1 and 2 years of age 
(79 FR 11936). Similarly, the IOM has established DRI ranges for 1-
through-3-year-olds because growth velocity is most similar during this 
age range (79 FR 11936; 81 FR 33916). FDA has concluded that mandatory 
declaration of added sugars is needed for foods for infants through 12 
months, just as it is for the general population, to provide consumers 
with information to construct a healthy dietary pattern that meets the 
dietary recommendations for added sugars (81 FR 33921).
    Consistent with FDA's Nutrition Labeling Final Rule, FSIS is 
proposing the mandatory declaration of added sugars on the Nutrition 
Facts label of meat and poultry products represented or purported to be 
specifically for infants through 12 months, children 1 through 3 years 
of age, and pregnant women and lactating women.
d. Mandatory Declaration of Trans Fat
    As discussed in section II.C.3, FSIS is proposing to require the 
mandatory declaration of trans fat on the Nutrition Facts label. The 
mandatory declaration of trans fat is needed for foods for infants 
through 12 months, children 1 through 3 years of age, and pregnant 
women and lactating women, just as it is needed for the general 
population to assist in maintaining healthy dietary practices. For 
example, the relationship between the consumption of trans fat and risk 
of CHD is well established 23 24 and cardiovascular disease 
is also known to begin in childhood.25 26
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    \23\ U.S. Department of Agriculture and U.S. Department of 
Health and Human Services. (2010) ``Dietary Guidelines for 
Americans, 2010'', 7th Ed., Washington DC: U.S. Government Printing 
Office. Retrieved from http://www.cnpp.usda.gov/DGAs2010-PolicyDocument.htm.
    \24\ Institute of Medicine (IOM) of the National Academies. 
``Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, 
Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients), 
Chapter 8: Dietary Fats: Total Fat and Fatty Acids'', Washington, 
DC: National Academies Press; 2002.
    \25\ U.S. Department of Health and Human Services, National 
Institutes of Health, and National, Heart Lung and Blood Institute. 
(October, 2012) ``Integrated Guidelines for Cardiovascular Health 
and Risk Reduction In Children and Adolescents: The Report of the 
Expert Panel''; NIH Publication No. 12-7486A. Retrieved from http://www.nhlbi.nih.gov/guidelines/cvd_ped/index.htm.
    \26\ American Academy of Pediatrics. ``Chapter 32: 
Hyperlipidemia and Prevention of Cardiovascular Disease''. In: 
Pediatric Nutrition Handbook 6th Ed. Kleinman, R.E., ed. American 
Academy of Pediatrics; 2009; p.723.
---------------------------------------------------------------------------

    Consistent with FDA's Nutrition Labeling Final Rule, FSIS is 
proposing to require the declaration of trans fat on the Nutrition 
Facts label of meat and poultry products represented or purported to be 
specifically for infants through 12 months, children 1 through 3 years 
of age, and pregnant women and lactating women.
3. Voluntary Declaration of Nutrients Other Than Essential Vitamins and 
Minerals
    Currently, meat and poultry products represented or purported to be 
specifically for infants and children less than 2 years of age are not 
permitted to declare calories from fat, calories from saturated fat, 
and the amount of polyunsaturated fat and monounsaturated fat (9 CFR 
317.400(c)(1) and 381.500(c)(1)), whereas soluble fiber, insoluble 
fiber, and sugar alcohols can be voluntarily declared. Polyunsaturated 
fat, monounsaturated fat, soluble fiber, insoluble fiber, and sugar 
alcohols can be voluntarily declared on the label of meat and poultry 
products represented or purported to be specifically for children 2 
through 4 years of age and pregnant women and lactating women (9 CFR 
317.400(c)(2) and 381.500(c)(2)). FSIS is proposing the following 
changes to voluntary declaration of certain nutrients.
a. Voluntary Declaration of Calories From Saturated Fat, and the Amount 
of Polyunsaturated and Monounsaturated Fat
    For infants through 12 months, there are no specific 
recommendations provided about calories from saturated, 
polyunsaturated, or monounsaturated fat. However, as discussed in FDA's 
Nutrition Labeling Proposed Rule, there is some evidence to suggest 
that reduction of total and LDL cholesterol levels can occur with 
reducing saturated fat intake to less than 10 percent of calories, 
beginning in infancy and sustained throughout childhood into 
adolescence (79 FR 11935). Because consensus reports provide no 
discussion or recommendation about providing nutrient guidelines for 
fatty acids to children under the age of 2 years, and there is no 
evidence to suggest that infants through 12 months of age would

[[Page 6747]]

be different than children 1 through 3 years of age, FDA explained that 
there is no basis to continue to prohibit the declaration of calories 
from saturated fat or polyunsaturated and monounsaturated fats on foods 
represented or purported to be specifically for infants and children 
less than 2 years of age (81 FR 33919-33920).
    Also, as discussed in FDA's Nutrition Labeling Proposed Rule, 
quantitative intake recommendations are not available from relevant 
U.S. consensus reports for monounsaturated and polyunsaturated fats for 
children 1 through 3 years of age or pregnant women and lactating 
women. There is well-established evidence to indicate that replacing 
saturated fatty acids with polyunsaturated and monounsaturated fatty 
acids reduces blood LDL cholesterol levels and, therefore, the risk of 
CVD; and that monounsaturated and polyunsaturated fats have public 
health significance when they replace saturated fat (79 FR 11936). FDA 
finalized its proposed requirements and permits the declaration of 
calories from saturated fat, polyunsaturated and monounsaturated fat on 
foods represented or purported to be specifically for infants through 
12 months and children 1 through 3 years of age (81 FR 33919-33920).
    Consistent with FDA's Nutrition Labeling Final Rule, FSIS is 
proposing to revise 9 CFR 317.400(c)(1) and 381.500(c)(1) (which would 
be consolidated in proposed 9 CFR 413.400(c)(1)) to remove the 
exceptions for the declaration of calories from saturated fat and the 
amount of polyunsaturated fat and monounsaturated fat on meat and 
poultry products represented or purported to be specifically for 
infants through 12 months, children 1 through 3 years of age, or 
pregnant or lactating women. If finalized, these declarations for the 
new age categories, infants through 12 months and children 1 through 3 
years of age, would be the same as the proposed voluntary declarations 
for foods for the general population.
b. Voluntary Declaration of Soluble Fiber, Insoluble Fiber, and Sugar 
Alcohols
    As discussed in section II.E, FSIS is proposing to allow the 
declaration of soluble fiber and insoluble fiber that meet the 
definition of ``dietary fiber'' on the Nutrition Facts label for the 
general population. FDA has concluded that there is no evidence to 
suggest that the role of these nutrients would be different among 
infants through 12 months, children 1 through 3 years of age, or 
pregnant women and lactating women compared to the general population 
(81 FR 33920).
    FSIS has reviewed FDA's analysis and is not proposing any changes 
to the provisions for the voluntary declaration of soluble fiber, 
insoluble fiber, and sugar alcohols on the label of meat and poultry 
products represented or purported to be specifically for infants 
through 12 months, children 1 through 3 years of age, or pregnant women 
and lactating women, consistent with FDA's Nutrition Labeling Final 
Rule (81 FR 33920).
c. Voluntary Declaration of Fluoride
    FSIS regulations currently do not provide for the declaration of 
fluoride on the Nutrition Facts label of any meat or poultry product. 
For the reasons discussed in section II.H, FSIS is proposing to permit 
voluntary declaration of fluoride on the labeling of meat and poultry 
products for the general population. As discussed in FDA's Nutrition 
Labeling Proposed Rule and Final Rule (in which FDA did not change its 
tentative conclusions from the proposed rule), because fluoride 
provides protection against dental caries by strengthening the tooth 
enamel before and after teeth appear, and because excessive fluoride 
intake can cause dental fluorosis in young children, the declaration of 
fluoride on foods represented or purported to be specifically for 
children 1 through 3 years of age and for pregnant women and lactating 
women can assist in maintaining healthy dietary practices (79 FR 11936; 
81 FR 33921). Further, while evidence on dental caries is lacking for 
infants through 12 months of age, there is no reason to expect the role 
of fluoride in the protection against dental caries to be different 
from other age groups (Id.). Therefore, consistent with FDA's Nutrition 
Labeling Final Rule on the voluntary declaration of fluoride for these 
subpopulations, FSIS is proposing to permit the voluntary declaration 
of fluoride on meat and poultry products represented or purported to be 
specifically for infants through 12 months of age, children 1 through 3 
years of age, and pregnant women and lactating women (proposed 9 CFR 
413.309(c)(5)).
4. Declaration of Essential Vitamins and Minerals
    FSIS requires the declarations of vitamin A, vitamin C, calcium, 
and iron on the Nutrition Facts label, and there are no specific 
exceptions to this requirement for meat and poultry products 
represented or purported to be specifically for infants and children 
less than 2 years and children less than 4 years of age, and pregnant 
women and lactating women (9 CFR 317.309(c)(8) and 381.409(c)(8)). FSIS 
is proposing to replace the current categories ``infants and children 
less than 2 years of age and children less than 4 years of age'' with 
``infants through 12 months and children 1 through 3 years of age.''
    Since the needs of essential vitamin and minerals are increased for 
both pregnant women and lactating women, FDA applied its conclusions 
about nutrient inadequacy during pregnancy to lactating women and made 
the requirements related to essential vitamins and minerals in labeling 
of foods for pregnant women and lactating women the same (81 FR 33921-
33922). Consistent with FDA's Nutrition Labeling Final Rule, FSIS is 
proposing to remove the current provision in 9 CFR 317.309(c)(8)(i) and 
381.409(c)(8)(i) that requires separate declaration of percent DVs 
based on both RDI values for pregnant women and for lactating women in 
the labeling of foods represented or purported to be for use by both 
pregnant women and lactating women (proposed 9 CFR 413.309(c)(8)(i)).
a. Mandatory Declaration of Calcium and Iron
    FSIS is not proposing any changes to the mandatory declaration of 
calcium on foods for the general population (see section II.I.1.). As 
discussed in FDA's Nutrition Labeling Proposed Rule, the AI for calcium 
for infants through 12 months of age is based on average calcium 
consumption of this nutrient rather than on chronic disease risk, 
health related-condition, or physiological endpoints (79 FR 11937). For 
children 1 through 3 years of age and pregnant women and lactating 
women, the Recommended Dietary Allowances (RDAs) \27\ for calcium are 
based, in part, on bone health (79 FR 11937).
---------------------------------------------------------------------------

    \27\ ``The RDA is an estimate of the average intake level that 
meets the nutrient requirements of nearly all (97 to 98 percent) 
healthy individuals in a particular life stage and gender group'' 
(79 FR 11885).
---------------------------------------------------------------------------

    FDA's analysis of the Centers for Disease Control and Prevention 
(CDC) National Health and Nutrition Examination Survey (NHANES) 2003-
2006 data estimated that infants ages 7 to 12 months have usual calcium 
intakes above the AI and estimated that about 12 percent of children 1 
through 3 years of age had usual intakes of calcium below the Estimated 
Average

[[Page 6748]]

Requirement (EAR), \28\ based on intakes from conventional foods only 
(79 FR 11937). FDA has found that promoting the development of eating 
patterns that are associated with adequate calcium intake later in life 
is important given that calcium intakes are inadequate for the majority 
of the population. Intakes of calcium, which is necessary for growth 
and bone development, are inadequate among children. Also, similar to 
the general population, approximately 20 percent of pregnant women 
consumed less than the EAR for calcium from conventional foods as well 
as from conventional foods and supplements (79 FR 11937).
---------------------------------------------------------------------------

    \28\ ``The EAR is the average daily nutrient intake level that 
is estimated to meet the requirements of half of the healthy 
individuals in a particular life stage and gender group. EARs are 
used for assessing the statistical probability of adequacy of 
nutrient intakes of groups of people'' (79 FR 11885).
---------------------------------------------------------------------------

    FDA concluded that calcium is a nutrient of public health 
significance for children 1 through 3 years of age and pregnant women 
and lactating women and infants through 12 months and requires the 
mandatory declaration of calcium on foods purported to be specifically 
for infants through 12 months, children 1 through 3 years of age, or 
pregnant and lactating women (81 FR 33922). Consistent with FDA's 
Nutrition Labeling Final Rule, FSIS is not proposing to change the 
mandatory declaration of calcium for meat and poultry products 
purported to be specifically for infants through 12 months, children 1 
through 3 years of age, or pregnant or lactating women.
    FSIS is not proposing any changes to the mandatory declaration of 
iron on foods for the general population (see section II.I.1.). As 
discussed in FDA's Nutrition Labeling Proposed Rule, although the EAR 
and RDA are based on daily iron requirements and not directly on 
chronic disease risk, iron deficiency is associated with delayed normal 
infant motor function (i.e., normal activity and movement) and mental 
function (i.e., normal thinking and processing skills) (79 FR 11937). 
FDA's analysis of NHANES 2003-2006 data estimated that about 18 percent 
of infants ages 7 to 12 months have usual iron intakes below the EAR, 
based on intakes from conventional foods only and 4 percent of infants 
ages 7 to 12 months have usual iron intakes below the EAR based on 
intakes from conventional foods and supplements (79 FR 11937; 81 FR 
33922).
    As discussed in FDA's Nutrition Labeling Proposed Rule, about 1 
percent of children 1 through 3 years of age have usual iron intakes 
below the EAR, based on intakes from conventional foods only, and 0.4 
percent of children have usual iron intakes below the EAR based on 
intakes from conventional foods and supplements (79 FR 11937). The IOM 
set the EAR by modeling components of iron requirements. The prevalence 
of iron deficiency in children ages 1 to 2 years has been reported to 
be 14.4 percent, and the prevalence of iron deficiency anemia in 
children younger than 5 years has been reported to be 14.9 percent. FDA 
requires the mandatory declaration of iron in the labeling of foods for 
infants through 12 months and children 1 through 3 years of age (81 FR 
33922).
    As discussed in FDA's Nutrition Labeling Proposed Rule, inadequate 
iron intakes during pregnancy are of public health significance because 
of the adverse effects for both the mother and the fetus (such as 
maternal anemia, premature delivery, low birth weight, and increased 
perinatal infant mortality) (79 FR 11938). FDA analyzed NHANES 2003-
2006 data and estimated that 5 percent of pregnant women 14 to 50 years 
of age had usual iron intakes below the EAR based on intakes from 
conventional foods, and 4 percent of pregnant women 14 to 50 years of 
age had usual iron intakes below the EAR based on intakes from 
conventional foods and supplements. The EAR for iron for pregnant women 
was based on estimates of iron stores needed during the first trimester 
(79 FR 11938). FDA's analysis of NHANES 2003-2006 data also indicated 
that, among pregnant women aged 12 to 49 years, 25 percent were iron 
deficient, and 13 percent had iron deficiency anemia (79 FR 11938). FDA 
considered iron deficiency based on two out of three cutoffs of iron 
deficiency variables (transferrin saturation, serum ferritin, and 
erythrocyte protoporphyrin) (79 FR 11938).
    FDA found that calcium and iron have quantitative intake 
recommendations and have public health significance for infants through 
12 months, children 1 through 3 years of age, and pregnant women and 
lactating women. FDA did not receive comments to its proposed rule to 
change its tentative conclusion that the declaration of calcium and 
iron is necessary to assist consumers in maintaining healthy dietary 
practices (81 FR 33922). FSIS has reviewed FDA's analysis and is 
proposing to require the mandatory declaration of calcium and iron on 
foods represented or purported to be specifically for infants through 
12 months, children 1 through 3 years of age, or pregnant women and 
lactating women without providing any exceptions for these 
subpopulations from the requirement for declaration of calcium and iron 
applicable to foods for the general population (proposed 9 CFR 
413.309(c)(8)(ii)).
b. Mandatory Declaration of Vitamin D and Potassium
    FSIS is proposing to require the declaration of vitamin D on meat 
and poultry products for the general population (see section II.I.1.). 
FDA identified vitamin D as a nutrient of public health significance in 
children 1 through 3 years of age and pregnant women based on the high 
prevalence of inadequate intakes of vitamin D and its important role in 
bone development and health (81 FR 33922-33923). FDA also identified 
vitamin D as a nutrient of public health significance for infants 
through 12 months of age based on its importance for growth and 
development during infancy (81 FR 33922-33923).
    FSIS is proposing to require the declaration of potassium on foods 
for the general population (see proposed 9 CFR 413.309(c)(8)(ii) and 
section II.I.1.). As discussed in FDA's Nutrition Labeling Proposed 
Rule, the AI for infants is based on average potassium intake from 
breast milk and complementary foods (79 FR 11938). The AI for the other 
life-stage and gender groups is set at a level to maintain blood 
pressure, reduce the adverse effects of sodium chloride intake on blood 
pressure, and reduce the risk of recurrent kidney stones (79 FR 11938).
    FSIS has reviewed FDA's analysis of potassium intake from NHANES 
2003-2006 for infants 7 to 12 months of age; potassium intake for 
children 1 through 3 years of age; and the importance of potassium in 
the risk reduction of chronic diseases for children 2 years of age and 
older (79 FR 11938). Because of the benefits of adequate potassium 
intake in lowering blood pressure and data indicating low likelihood of 
potassium adequacy, FSIS agrees with FDA that it is important to 
establish healthy dietary practices for later life (79 FR 11938). FDA 
tentatively concluded in the Nutrition Labeling Proposed Rule that 
there is no basis to conclude that the public health significance of 
potassium among infants through 12 months of age would be different 
than the science-based evidence for children 1 through 3 years of age, 
and that potassium is of public health significance to infants through 
12 months, children 1 through 3 years of age and pregnant women and 
lactating women (79 FR 11938). FDA did not change its tentative 
conclusion in the final rule (81 FR 33922-33923).

[[Page 6749]]

    Consistent with FDA's Nutrition Labeling Final Rule, FSIS is 
proposing to require the labeling of vitamin D and potassium on foods 
represented or purported to be specifically for infants through 12 
months of age, children 1 through 3 years of age, and pregnant women 
and lactating women based on the quantitative intake recommendations 
for vitamin D and potassium and the public health significance of these 
nutrients. Consequently, FSIS is not providing for any exceptions for 
these subpopulations from the general requirement in proposed 9 CFR 
413.309(c)(8)(ii) to declare vitamin D and potassium.
c. Voluntary Declaration of Vitamin A and Vitamin C
    FSIS is proposing to no longer require the declaration of vitamin A 
and vitamin C on foods for the general population (see section 
II.I.1.). As discussed in FDA's Nutrition Labeling Proposed Rule, none 
of the DRIs (AIs or RDAs) for vitamin A were based on chronic disease 
risk, a health related-condition, or health-related physiological 
endpoints (79 FR 11939).
    FDA looked at vitamin A intake from NHANES 2003-2006 for children 
and pregnant women and found a very low prevalence of inadequate 
intakes of vitamins A and C or inadequate status among children 1 
through 3 years of age or pregnant women and also the lack of evidence 
to indicate that this would be different for infants or lactating women 
(79 FR 11939). FDA concluded that vitamin A and vitamin C are not of 
public health significance among infants through 12 months of age, 
children 1 through 3 years of age, and pregnant women and lactating 
women and that this supports the voluntary declaration of vitamins A 
and C in the labeling of foods for young children (81 FR 33923-33924). 
Consistent with FDA's Nutrition Labeling Final Rule, FSIS is proposing 
to permit, but not to require, that the declaration of vitamin A and 
vitamin C on foods represented and purported to be specifically for 
infants through 12 months, children 1 through 3 years of age, or 
pregnant women and lactating women. Similar to other voluntary 
nutrients, the declaration of vitamins A and C would be required when 
claims are made about them on the label or labeling (proposed 9 CFR 
413.309(c)(8)(ii)).
d. Voluntary Declaration of Other Vitamins and Minerals
    As discussed in section II.I.3., for the general population, FSIS 
is proposing to permit the voluntary declaration of vitamin E, vitamin 
K, vitamin B6, vitamin B12, thiamin, riboflavin, 
niacin, folate, biotin, pantothenic acid, phosphorus, iodine, 
magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, 
chloride, and choline (proposed 9 CFR 413.309(c)(8)(ii)). As discussed 
in FDA's Nutrition Labeling Proposed Rule, vitamins and minerals other 
than iron, calcium, vitamin D, and potassium for infants either have 
DRIs that are not based on chronic disease risk, heath-related 
conditions, or health-related physiological endpoints or are not shown 
to have public health significance because of the prevalence of a 
clinically relevant nutrient deficiency (79 FR 11939). FDA determined, 
in the final rule that, for infants through 12 months, children 1 
through 3 years of age, and pregnant women and lactating women, the 
essential vitamins and minerals, other than iron, calcium, vitamin D 
and potassium, do not have public health significance, and there is no 
basis for the declaration of these nutrients to be different from that 
proposed for the general population (81 FR 33924). Consistent with 
FDA's Nutrition Labeling Final Rule, FSIS is proposing to allow the 
voluntary declaration of vitamin E, vitamin K, vitamin B6, 
vitamin B12, thiamin, riboflavin, niacin, folate, biotin, 
pantothenic acid, phosphorus, iodine, magnesium, zinc, selenium, 
copper, manganese, chromium, molybdenum, chloride, and choline on foods 
represented or purported to be specifically for infants through 12 
months, children 1 through 3 years of age, or pregnant women and 
lactating women, unless the labeling makes a claim about them, in which 
case the nutrients would have to be declared (proposed 9 CFR 
413.309(c)(8)(ii)).
5. DRVs and Reference Daily Intakes (RDIs) for Infants Through 12 
Months of Age
    FSIS regulations do not include DRVs or RDIs for nutrients for 
infants through 12 months of age, except an RDI for protein of 14 g for 
infants. Consistent with FDA, FSIS is considering establishing DRVs and 
RDIs for nutrients for infants through 12 months of age and revisions 
to the current RDI for protein.
a. Calories
    FSIS's regulations do not provide, and FDA has not established, a 
reference calorie intake level for infants and children less than 2 
years of age. As discussed in FDA's Nutrition Labeling Proposed Rule, 
there is no quantitative intake recommendation for calories for 
infants, and FDA is not aware of other scientific data and information 
on which it could rely to establish that level (79 FR 11939). FDA did 
not establish a reference calorie intake for infants through 12 months 
of age in the final rule (81 FR 33925). Therefore, consistent with 
FDA's Nutrition Labeling Final Rule, FSIS is not proposing to establish 
a reference calorie intake level for infants through 12 months (81 FR 
33925).
b. Total Fat
    As discussed in FDA's Nutrition Labeling Proposed Rule, the IOM set 
an AI of 30 g/d for fat for infants through 12 months of age based on 
the average intake of human milk and complementary foods. There was no 
AI available in 1993, and the current AI provides a basis to determine 
an appropriate DRV for total fat for this subpopulation that can assist 
consumers in maintaining healthy dietary practices among this 
subpopulation (79 FR 11939). FDA established a DRV of 30 g for fat for 
infants through 12 months in its final rule (81 FR 33925). Therefore, 
consistent with FDA's Nutrition Labeling Final Rule, FSIS is proposing 
to include a DRV of 30 g for fat for infants through 12 months of age 
(proposed 9 CFR 413.309(c)(9)).
c. Saturated Fat, Trans Fat, Cholesterol, Dietary Fiber, and Sugars
    As discussed in FDA's Nutrition Labeling Proposed Rule, there are 
no quantitative intake recommendations from U.S. consensus reports 
available for saturated fat, trans fat, cholesterol, dietary fiber, and 
sugars for infants (79 FR 11939). FDA was not aware of other reliable 
scientific data and information on which to establish DRVs for these 
nutrients for infants through 12 months of age (79 FR 11939). FDA did 
not establish DRVs for infants through 12 months of age for these 
nutrients in its final rule (81 FR 33925). Accordingly, FSIS is not 
proposing to establish DRVs for these nutrients for infants through 12 
months of age, consistent with FDA's Nutrition Labeling Final Rule 
because appropriate scientific data is not available.
d. Polyunsaturated Fat, Monounsaturated Fat, Insoluble Fiber, Soluble 
Fiber, Insoluble Fiber, Added Sugars, and Sugar Alcohols
    As discussed in FDA's Nutrition Labeling Proposed Rule, 
quantitative intake recommendations from U.S. consensus reports are not 
available for polyunsaturated fat, monounsaturated fat, insoluble 
fiber, soluble fiber, added sugars, or sugar alcohols for infants (79

[[Page 6750]]

FR 11940). FDA was not aware of other reliable scientific data and 
information on which to establish DRVs for these nutrients for this 
subpopulation (79 FR 11940). FDA did not establish DRVs for infants 
through 12 months of age for these nutrients in its final rule (81 FR 
33925). Accordingly, consistent with FDA's Nutrition Labeling Final 
Rule, FSIS is not proposing to establish DRVs for these nutrients for 
infants through 12 months of age because appropriate scientific data 
are not available.
e. Total Carbohydrate
    As discussed in FDA's Nutrition Labeling Proposed Rule, the IOM set 
an AI of 95 g/d for carbohydrate for infants through 12 months of age 
based on the average intake of human milk and complementary foods. 
There was no AI available in 1993, and the current AI provides a basis 
on which FDA could determine an appropriate DRV for total carbohydrate 
for this subpopulation that can assist consumers in maintaining healthy 
dietary practices among this subpopulation (79 FR 11940). FDA 
established a DRV of 95 g for total carbohydrate for infants through 12 
months of age in its final rule (81 FR 33925). Therefore, consistent 
with FDA's Nutrition Labeling Final Rule, FSIS is proposing to 
establish a DRV of 95 g for total carbohydrate for infants through 12 
months of age (proposed 9 CFR 413.309(c)(9)).
f. Protein
    As discussed in FDA's Nutrition Labeling Proposed Rule, the DV for 
protein for infants is an RDI, rather than a DRV. Before 1993, FDA 
established the RDIs for protein for all age groups based on the 1989 
RDA. In 1993, FDA changed the RDI for protein for the general 
population to a DRV (58 FR 2206 at 2216). FDA retained the RDI for 
infants based on the highest 1968 RDA value (14 g/d for infants) to be 
consistent with a population-coverage approach, but it found no reason 
to change the approach of using the RDI for infants through 12 months. 
FDA determined that it would be appropriate to revise the RDI to rely 
on current quantitative intake recommendations. In 2002, the IOM 
established an RDA for infants through 12 months of 1.2 g/kg/d based on 
nitrogen balance studies and using a reference body weight of 9 kg 
consistent with current growth charts for infants. Protein intakes are 
well above the current and proposed RDI, and mean protein intake for 
infants 6 to 11 months of age was well above the RDA of 11 g/d (79 FR 
11940). FDA established an RDI of 11 grams for protein for infants 
through 12 months of age in its final rule (81 FR 33925). Accordingly, 
consistent with FDA's Nutrition Labeling Final Rule, FSIS is proposing 
to establish an RDI of 11 g for protein for infants through 12 months 
of age (proposed 9 CFR 413.309(c)(8)(iv)).
g. Sodium
    FSIS is proposing to establish a DRV for sodium based on the IOM's 
UL for the general population (section II.G.). However, as discussed in 
FDA's Nutrition Labeling Proposed Rule, the IOM did not set a UL for 
sodium for infants through 12 months of age because there was 
insufficient data on adverse effects of chronic overconsumption in this 
age group (79 FR 11940). In addition, FDA was not aware of other 
reliable scientific data and information on which to establish a DRV 
for sodium for this subpopulation (79 FR 11940). FDA did not establish 
a DRV for sodium for infants through 12 months of age in its final rule 
(81 FR 33926). Therefore, consistent with FDA's Nutrition Labeling 
Final Rule, FSIS is not proposing a DRV for sodium for infants through 
12 months of age because of the lack of appropriate scientific data.
h. Fluoride
    As discussed in section II.H, although the IOM set an AI for 
fluoride, the AIs for infants through 12 months and children 1 through 
3 years are close to the Environmental Protection Agency benchmarks for 
total fluoride intake. FDA did not propose a DRV for fluoride for use 
in the labeling of foods for the general population because of a 
concern about excess intakes associated with dental fluorosis (79 FR 
11918). FDA did not establish a DRV for fluoride for infants through 12 
months in its final rule (81 FR 33926). The use of such a DRV to 
calculate percent DV may have the unintended effect of consumers 
selecting foods with higher fluoride amounts, which are not necessary 
or advised (79 FR 11940). Accordingly, consistent with FDA's Nutrition 
Labeling Final Rule, FSIS is not proposing to establish a DRV for 
fluoride for infants through 12 months of age.
i. Vitamins and Minerals
    FSIS regulations do not include DRVs or RDIs for nutrients, 
generally, for infants, children under 4 years of age, or pregnant 
women and lactating women. However, there are requirements for a DRV 
for protein for children 4 or more years of age and an RDI for protein 
for (1) children less than 4 years of age; (2) infants; (3) pregnant 
women; and (4) lactating women (9 CFR 317.309(c)(7)(iii) and 
381.409(c)(7)(iii)).
    FDA reviewed current quantitative intake recommendations for 
vitamins and minerals for infants and considered comments received in 
response to its 2007 ANPRM to determine appropriate RDIs for vitamins 
and minerals for infants through 12 months of age (79 FR 11940). FSIS 
agrees with FDA that it is important to establish RDIs for infants 
through 12 months of age because infants in this age range transition 
from a diet of mostly breast milk and infant formula to infant cereal 
and baby foods; that labeling foods for this subpopulation with percent 
DV declarations can assist parents in making nutritious food choices; 
that the DRIs (AIs and RDAs) provide a basis on which to determine RDIs 
for vitamins and minerals for this subpopulation; that it is 
appropriate to use RDAs and, in the absence of RDAs, AIs to determine 
appropriate micronutrient RDIs for infants; that both RDAs and AIs are 
sufficient for setting RDIs because they both represent intake levels 
that are expected to meet or exceed the nutrient needs of the majority 
of infants; that the IOM established DRIs based on scientific knowledge 
that update and supersede previous RDA recommendations; and that DRIs 
are available for infants through 12 months of age (79 FR 11940).
    FDA established RDIs for vitamin A, vitamin C, vitamin D, vitamin 
E, vitamin K, vitamin B12, folate, choline, riboflavin, 
niacin, vitamin B6, calcium, iron, thiamin, biotin, 
pantothenic acid, phosphorous, iodine, magnesium, zinc, selenium, 
copper, manganese, chromium, molybdenum, chloride, and potassium for 
infants through 12 months of age in its final rule (81 FR 33926-33927). 
Accordingly, consistent with FDA's Nutrition Labeling Final Rule (81 FR 
33926-33927), FSIS is proposing to include a listing of RDIs for these 
same nutrients for infants through 12 months of age (proposed 9 CFR 
413.309(c)(8)(iv)).
6. DRVs and RDIs for Children 1 Through 3 Years of Age
    FSIS regulations do not include DRVs or RDIs for nutrients for 
children 1 through 3 years of age, except an RDI for protein of 16 g 
for children less than 4 years of age. As discussed in FDA's Nutrition 
Labeling Proposed Rule, FDA reviewed scientific evidence and current 
recommendations, as well as comments in response to FDA's 2007 ANPRM, 
to consider establishing DRVs and RDIs for nutrients for this 
subpopulation and to consider revisions

[[Page 6751]]

to the current RDI for protein (79 FR 11940).
a. Calories
    FSIS regulations currently do not provide a reference calorie 
intake level for nutrition labeling for children ages 1 through 3 
years. FDA established a reference calorie intake level for children 1 
through 3 years of age and set DRVs using quantitative intake 
recommendations that are based on calories (e.g., total fat, saturated 
fat, and dietary fiber). Current recommendations from the IOM, American 
Heart Association (AHA), American Academy of Pediatrics (AAP), and the 
2015-2020 DGA for caloric intake range from 800 to 900 calories/d for 
children 1 year old, approximately 1,000 calories/d for children 2 
years of age, and from 1,000 to 1,200 calories/d for children 3 years 
of age. FDA considered that an average of the range of these caloric 
intake recommendations (800 to 1,200 calories/d), i.e., 1,000 calories/
d, provides a reasonable reference calorie intake level (79 FR 11941). 
FDA established a reference calorie intake of 1,000 calories/day for 
children aged 1 through 3 years in its final rule (81 FR 33927). FSIS 
has reviewed FDA's analysis and is proposing to provide a reference 
calorie intake level of 1,000 calories/day for children 1 through 3 
years of age (proposed 9 CFR 413.309(c)(9)) consistent with FDA's 
Nutrition Labeling Final Rule.
b. Total Fat
    Currently, FSIS regulations do not provide a DRV for total fat for 
children ages 1 through 3 years. As discussed in FDA's Nutrition 
Labeling Proposed Rule, FDA agreed with a comment to its 2007 ANPRM 
that 35 percent of calories from fat for children 1 through 3 years of 
age, the midpoint of the IOM AMDR of 30 to 40 percent, serves as an 
appropriate basis on which to set the DRV for total fat. The approach 
to calculating the DRV for total fat is consistent with FDA's approach 
to setting the DRV for total fat for the general population. Thirty-
five percent is consistent with AHA and AAP recommendations that 30 to 
40 percent of calories consumed by children 12 through 24 months of 
age, and 30 to 35 percent of calories consumed by children 24 through 
48 months of age, should come from fat (79 FR 11941). In FDA's 
Nutrition Labeling Proposed Rule, FDA tentatively concluded that 35 
percent of total calories from fat (i.e., 39 g using the finalized 
reference calorie intake level of 1,000 calories/d) is an appropriate 
DRV for total fat for children 1 through 3 years of age (Id.). FDA 
established a DRV of 39 grams for total fat in its final rule (81 FR 
33927-33928). FSIS has reviewed FDA's analysis and is proposing to 
establish a DRV of 39 g for fat for children 1 through 3 years of age 
(proposed 9 CFR 413.309(c)(9)) consistent with FDA's Nutrition Labeling 
Final Rule.
c. Saturated Fat, Trans Fat, and Cholesterol
    FSIS has not established DRVs for saturated fat, trans fat, or 
cholesterol for children 1 through 3 years of age. As discussed in 
FDA's Nutrition Labeling Proposed Rule, FDA considered a comment to its 
2007 ANPRM that suggested using the midpoint of 10 to 15 percent of 
calories for saturated fat, 2 percent of calories for trans fat based 
on estimates of mean trans fat intake for the U.S. population 3 years 
of age and older, and less than or equal to 300 mg/d for cholesterol 
based on the 2005 DGA recommendation. CVD is known to begin in 
childhood, and the 2010 DGA recommended that Americans 2 years of age 
and older consume less than 10 percent of calories from saturated fat 
and less than 300 mg/d of cholesterol (79 FR 11941). FDA tentatively 
concluded that it is appropriate to set a DRV of 10 g for saturated 
fat, based on 10 percent of total calories from saturated fat and using 
the proposed reference calorie intake level of 1,000 calories/d which 
equals 11 g, rounded down to 10 g, and a DRV of 300 mg for cholesterol 
for children 1 through 3 years of age (79 FR 11941). FDA established a 
DRV of 10 g for saturated fat and a DRV of 300 mg for cholesterol for 
children 1 through 3 years of age in its final rule (81 FR 33928). 
Consistent with FDA's Nutrition Labeling Final Rule, FSIS is proposing 
to establish a DRV of 10 g for saturated fat and a DRV of 300 mg for 
cholesterol for children 1 through 3 years of age (proposed 9 CFR 
413.309(c)(9)).
    FSIS is not proposing to establish a DRV for trans fat because the 
IOM and 2015-2020 DGA do not provide any specific appropriate levels of 
intake and FDA did not establish a DRV for trans fat (81 FR 33928).
d. Polyunsaturated Fat, Monounsaturated Fat, Sugars, Added Sugars, 
Insoluble Fiber, Soluble Fiber, and Sugar Alcohols
    FSIS has not established DRVs for polyunsaturated fat, 
monounsaturated fat, sugars, added sugars, insoluble fiber, soluble 
fiber, or sugar alcohol for children 1 through 3 years of age. As 
discussed in FDA's Nutrition Labeling Proposed Rule, FDA stated that 
there was no reliable data or information available to establish DRVs 
for polyunsaturated fat, monounsaturated fat, sugars, insoluble fiber, 
soluble fiber, and sugar alcohols, and tentatively concluded that there 
was no basis for setting DRVs for these nutrients (79 FR 11941). FDA 
established a DRV reference point for the added sugars declaration at 
10 percent of calories in its final rule, after considering the 
scientific evidence in the 2015 DGAC report (81 FR 33842). FDA set a 
DRV for children 1 through 3 years of age of 25 g of added sugars 
(1,000 calorie reference amount x .10 = 100 calories and 100 calories / 
4 calories/gram = 25 grams) (81 FR 33928-33929). FSIS has reviewed 
FDA's analysis and is proposing a DRV for added sugars of 25 g for 
children 1 through 3 years of age and that the percent DV for added 
sugars be declared on the Nutrition Facts label consistent with FDA's 
final rule. FSIS is not proposing DRVs for polyunsaturated fat, 
including n-3 or n-6 polyunsaturated fatty acids, monounsaturated fat, 
sugars, soluble fiber, insoluble fiber, or sugar alcohols for children 
1 through 3 years of age consistent with the FDA Nutrition Labeling 
Final Rule.
e. Total Carbohydrate
    FSIS has not established a DRV for total carbohydrate for children 
1 through 3 years of age. As discussed in section II.E.1, consistent 
with FDA, FSIS is proposing a DRV for total carbohydrate for the 
general population based on the percentage of calories in a 2,000 
calorie diet remaining after the sum of the DRV for fat (30 percent) 
plus the DRV for protein (10 percent) have been subtracted consistent 
with FDA's Nutrition Labeling Final Rule. As discussed in FDA's 
proposed rule, FDA considered this method to be appropriate for setting 
a DRV for total carbohydrate for children 1 through 3 years of age 
because it falls within the IOM AMDR recommendation of 45 to 65 percent 
of calories from carbohydrates for children 1 through 3 years of age 
(79 FR 11941). FDA tentatively concluded that an appropriate DRV for 
total carbohydrate is 60 percent of calories (i.e., 150 g using the 
proposed reference calorie intake level of 1,000 calories/d) (Id.) FDA 
did not receive comments on its tentative conclusion and finalized this 
requirement as proposed (81 FR 33929). Consistent with FDA's Nutrition 
Labeling Final Rule, FSIS is proposing to set a DRV of 150 g for total 
carbohydrate for children 1 through 3 years of age (proposed 9 CFR 
413.309(c)(9)).

[[Page 6752]]

f. Dietary Fiber
    FSIS has not established a DRV for dietary fiber for children 1 
through 3 years of age. As discussed in FDA's Nutrition Labeling 
Proposed Rule, FDA tentatively concluded that the AI of 14 g/1,000 
calories for dietary fiber for children 1 through 3 years of age should 
be used to set a DRV for dietary fiber to be consistent with how other 
proposed DRVs are being set; for example, proposing a reference calorie 
intake level of 1,000 calories/d for this subpopulation (79 FR 11941-
11942). FDA established a DRV of 14 g for dietary fiber in its final 
rule (81 FR 33929). Consistent with FDA's Nutrition Labeling Final 
Rule, FSIS is proposing to establish a DRV of 14 g for dietary fiber 
for children 1 through 3 years of age (9 CFR 413.309(c)(9)).
g. Protein
    The current RDI for protein for children less than 4 years of age 
was based on the 1989 RDA for protein of 16 g/d (9 CFR 
317.309(c)(7)(iii) and 381.409(c)(7)(iii)).
    As discussed in FDA's Nutrition Labeling Proposed Rule, FDA 
considered current recommendations and acknowledged that protein 
intakes are well above the current RDI; the mean protein intake for 
children 12 to 23 months of age was 44 g/d; the protein AMDR for 
children 1 through 3 years of age is 5 to 20 percent of calories; and 
the proposed reference calorie intake level and the approaches used for 
the proposed DRVs for fat and carbohydrate are based on percent of 
calories (79 FR 11942). FDA tentatively concluded that the DV for 
protein for children 1 through 3 years of age should be a DRV, rather 
than an RDI (using the RDA), and that a DRV for protein should be based 
on 5 percent of 1,000 calories or 50 calories, which equals 12.5 g or, 
when rounded up, is 13 g (Id.) FDA established a DRV for protein of 13 
g for children 1 through 3 years of age in its final rule (81 FR 
33929). FSIS agrees with FDA's conclusion and is proposing to establish 
a DRV for protein of 13 g for children 1 through 3 years of age 
(proposed 9 CFR 413.309(c)(9)) consistent with FDA's Nutrition Labeling 
Final Rule.
h. Sodium
    For the general population, FSIS is proposing to establish a DRV 
based on the UL for sodium (section II.G.). There is no current DRV for 
sodium for children 1 through 3 years of age.
    As discussed in FDA's Nutrition Labeling Proposed Rule, FDA agreed 
with comments to its 2007 ANPRM that 1,500 mg is an appropriate DRV for 
sodium for children 1 through 3 years of age (79 FR 11942). FDA did not 
receive comments on this proposed requirement and finalized this 
requirement (81 FR 33929). Consistent with FSIS's proposed approach for 
the general population and FDA's Nutrition Labeling Final Rule, FSIS is 
proposing to establish a DRV of 1,500 mg for sodium for children 1 
through 3 years of age (proposed 9 CFR 413.309(c)(9)).
i. Fluoride
    FSIS has not established a DV for fluoride for children 1 through 3 
years of age. As discussed in section II.H, FSIS is not establishing a 
DRV for fluoride for the general population. FSIS agrees with FDA that 
a DRV for fluoride is not warranted for children 1 through 3 years of 
age and is not proposing to establish a DRV for fluoride for children 1 
through 3 years of age (79 FR 11942; 81 FR 33929).
j. Vitamins and Minerals
    FSIS regulations do not currently include a table listing the RDIs 
for children less than 4 years of age. The preamble to FDA's 1993 DRV/
RDI final rule provides a table listing RDIs for children less than 4 
years of age (58 FR 2206 at 2213), which is also provided in FDA's Food 
Labeling Guide. FDA reviewed current quantitative intake 
recommendations for vitamins and minerals for infants and considered 
comments received in response to their 2007 ANPRM to determine 
appropriate RDIs for vitamins and minerals for children 1 through 3 
years of age.
    As discussed in FDA's Nutrition Labeling Proposed Rule, the IOM's 
quantitative intake recommendations (AIs and RDAs) provide a basis on 
which to determine RDIs for vitamins and minerals for this 
subpopulation. The IOM determined that available evidence was 
sufficient to establish appropriate RDAs and AIs for vitamins and 
minerals for this subpopulation; that it is appropriate to use RDAs 
and, in the absence of RDAs, AIs to determine appropriate micronutrient 
RDIs for children 1 through 3 years of age; that the RDA, when 
available, is the best estimate of an intake level that will meet the 
nutrient goals of practically all consumers who would use the Nutrition 
Facts label; that AIs have less certainty than RDAs, but they represent 
goals for nutrient intake for individuals and provide the best estimate 
based on current science for use in setting RDIs for such nutrients; 
that promoting the development of eating patterns associated with 
adequate potassium intake later in life is important because chronic 
conditions such as elevated blood pressure, bone demineralization, and 
kidney stones likely result from inadequate potassium intakes over an 
extended period of time, including childhood; and that the AI for 
potassium is 3,000 mg/d and is considered an appropriate basis for 
establishing a RDI for potassium for children 1 through 3 years of age 
(79 FR 11942). FDA established RDIs for vitamin A, vitamin C, vitamin 
D, vitamin E, vitamin K, vitamin B12, folate, choline, 
riboflavin, niacin, vitamin B6, calcium, iron, thiamin, 
biotin, pantothenic acid, phosphorous, iodine, magnesium, zinc, 
selenium, copper, manganese, chromium, molybdenum, chloride, and 
potassium for children 1 through 3 years of age in its final rule (81 
FR 33929-33930).
    Therefore, consistent with FDA's Nutrition Labeling Final Rule (81 
FR 33927), using the RDAs and AIs, FSIS is proposing to establish RDIs 
as set forth in proposed 9 CFR 413.309(c)(8)(iv) for these same 
nutrients for children 1 through 3 years of age.
7. DRVs and RDIs for Pregnant Women and Lactating Women
a. Calories
    The reference calorie intake of 2,000 used for the general 
population applies to pregnant women and lactating women (9 CFR 
317.309(c)(9) and 381.409(c)(9)). As discussed in FDA's Nutrition 
Labeling Proposed Rule, the calorie needs for pregnant women and 
lactating women are similar to the general population, and few products 
are purported for pregnant women and lactating women (79 FR 11943). FDA 
explained that the calorie needs for pregnant and lactating women are 
similar to the general population (Id.) FDA established a 2,000 
reference calorie intake level for the DRV for pregnant women and 
lactating women in its final rule (81 FR 33931). Consistent with FDA's 
final rule, FSIS is proposing to use the 2,000 reference calorie intake 
level for setting DRVs for pregnant women and lactating women (proposed 
9 CFR 413.309(c)(9)).
b. Total Fat, Saturated Fat, Cholesterol, Total Carbohydrate, Sodium, 
Added Sugars, and Dietary Fiber
    FSIS regulations do not provide DRVs for total fat, saturated fat, 
cholesterol, total carbohydrate, sodium, and dietary fiber for pregnant 
women and lactating women. As discussed in FDA's Nutrition Labeling 
Proposed Rule, quantitative intake recommendations for total fat, 
saturated fat, cholesterol, total carbohydrate, sodium, and dietary 
fiber

[[Page 6753]]

for pregnant women and lactating women are generally similar to the 
general population (79 FR 11943). FDA tentatively concluded that the 
DRVs for total fat, saturated fat, cholesterol, total carbohydrate, 
sodium, and dietary fiber for pregnant women and lactating women should 
remain the same as for the general population (Id.). FDA established 
DRVs for pregnant women and lactating women using the same DRVs for 
these nutrients as used for the general population (81 FR 33931). FDA 
also requires a DRV of 50 g of added sugars for adults and children 4 
years of age and older, including pregnant women and lactating women 
(81 FR 33931). Consistent with FDA's final rule, FSIS is proposing to 
establish DRVs for pregnant women and lactating women using the 
proposed DRVs for the general population for total fat, saturated fat, 
cholesterol, total carbohydrate, sodium, added sugars and dietary fiber 
(proposed 9 CFR 413.309(c)(9)).
c. Trans Fat, Polyunsaturated Fat, Monounsaturated Fat, Soluble Fiber, 
Insoluble Fiber, Sugars, and Sugar Alcohols
    There are no DRVs for trans fat, polyunsaturated fat, 
monounsaturated fat, soluble fiber, insoluble fiber, sugars, or sugar 
alcohol for pregnant women and lactating women. As discussed in 
sections II.C. and II.E., FSIS is not proposing DRVs for these 
nutrients for the general population because of a lack of quantitative 
intake recommendations. Similarly, quantitative intake recommendations 
are lacking for these nutrients for pregnant women and lactating women. 
Therefore, FSIS is not proposing to establish DRVs for trans fat, 
polyunsaturated and monounsaturated fat, soluble fiber, insoluble 
fiber, sugars, or sugar alcohols for pregnant women and lactating women 
consistent with FDA's Nutrition Labeling Final Rule (81 FR 33931).
d. Protein
    FSIS has established RDIs of 60 g protein for pregnant women and 65 
g protein for lactating women (9 CFR 317.309(c)(7)(iii) and 
381.409(c)(7)(iii)). As discussed in FDA's Nutrition Labeling Proposed 
Rule, the IOM established 71 g/d protein as the RDA for pregnant women 
and lactating women based on the needs for maternal and fetal 
development and human milk production (79 FR 11943). FDA tentatively 
concluded that the DV for protein for pregnant women and lactating 
women should remain an RDI (using the RDA) instead of a DRV because the 
DRV approach used to calculate protein for the general population based 
on 10 percent of 2,000 calories, which equals 50 g of protein/d, falls 
short of the recommended protein needs of pregnant women and lactating 
women of 71 g/d (Id.). FDA did not receive comments on its tentative 
conclusion and established an RDI of 71 g for protein for pregnant 
women and lactating women in its final rule (81 FR 33931). Consistent 
with FDA's final rule, FSIS is proposing to establish an RDI of 71 g 
for protein for pregnant women and lactating women (proposed 
413.309(c)(7)(iii)).
e. Fluoride
    There is no DRV for fluoride for the general population or for 
pregnant women and lactating women. While an AI has been established 
for fluoride, FSIS is not proposing to establish a DRV for fluoride for 
the general population for the reasons discussed in section II.H. 
Similarly, because the AI for fluoride for pregnant women and lactating 
women is not different from the general population, as discussed in 
FDA's Nutrition Labeling Proposed Rule (79 FR 11943), FSIS is not 
proposing a DRV for fluoride for pregnant women and lactating women.
f. Vitamins and Minerals
    While not included in FSIS regulations, the preamble to the FDA 
1993 DRV/RDI final rule provides a table listing RDIs for pregnant 
women and lactating women (58 FR 2206 at 2213), which is also provided 
in FDA's Food Labeling Guide (79 FR 11943). As discussed in FDA's 
Nutrition Labeling Proposed Rule, FDA reviewed current quantitative 
intake recommendations for vitamins and minerals for pregnant women and 
lactating women and concluded that it is appropriate to establish RDIs 
for pregnant women and lactating women for vitamins and minerals that 
have DRIs, using population-coverage RDAs and AIs, instead of 
population-weighted EARs (79 FR 11943). In addition, FDA established a 
single set of RDIs intended for both pregnant women and lactating women 
because nutrient needs during pregnancy and lactation are similar and 
because using one set of RDIs would address practical concerns related 
to limited space on food labels (81 FR 33932).
    Therefore, FSIS is proposing to establish RDIs as set forth in 
proposed 9 CFR 413.309(c)(8)(iv) for vitamin A, vitamin C, vitamin D, 
vitamin E, vitamin K, vitamin B12, folate, choline, 
riboflavin, niacin, vitamin B6, calcium, iron, thiamin, 
biotin, pantothenic acid, phosphorous, iodine, magnesium, zinc, 
selenium, copper, manganese, chromium, molybdenum, chloride, and 
potassium for pregnant women and lactating women consistent with FDA's 
Nutrition Labeling Final Rule.

K. Format

    FSIS requires that nutrition information for meat and poultry 
products be presented in a specific format on the labels of those 
products (see 9 CFR 317.309(d)(1)-(f) and 381.409(d)(1)-(f)). Since 
1995 when FSIS last published a final rule effecting the nutrition 
labeling format regulations (60 FR 174; January 3, 1995), more research 
has been done on trends in health conditions and how best to present 
information to consumers. FDA, in its changes to the Nutrition Facts 
label format, took into consideration ``graphic design principles such 
as alignment, consistency, repetition, and contrast,'' emphasizing 
``key nutrients and key information'' through highlighting and 
``removing or modifying parts of the label to assist consumers in 
maintaining healthy dietary practices'' (79 FR 11948; 81 FR 33936). 
FSIS has reviewed FDA's rationale for the changes to the Nutrition 
Facts label format (see 79 FR 11948-11955; 81 FR 33936-33959) and 
agrees with its approach. FSIS believes it is necessary to propose 
changes to the Nutrition Facts label format for meat and poultry 
products that will parallel, to the extent possible, FDA's new 
regulations. This approach will help prevent consumer confusion and 
non-uniformity in the marketplace. Therefore, FSIS is proposing the 
following changes to the Nutrition Facts label format.
1. Increasing the Prominence of Calories and Serving Size
    Consistent with FDA's final rule (81 FR 33937-33940), FSIS is 
proposing (i) to increase the type size for ``Calories'' and the 
numeric value for ``Calories,'' and (ii) to require that the numeric 
value for calories be highlighted in bold or extra bold type (proposed 
9 CFR 413.309(d)). These changes will emphasize the importance of 
calories on the label and draw more consumer attention to the calories 
declaration.
2. Changing the Order of the ``Serving Size'' and ``Servings per 
Container'' Declarations and Increasing the Prominence of ``Servings 
per Container''
    FSIS currently requires that information on serving size, which 
includes a statement of the serving size and the number of servings per 
container, follow the heading ``Nutrition Facts'' (9 CFR 317.309(d)(3) 
and

[[Page 6754]]

381.409(d)(3)). Consistent with FDA's Nutrition Labeling Final Rule 
(see 81 FR 33940-33943), FSIS is proposing to (i) reverse the order of 
the declarations of ``Servings Per Container'' and ``Serving Size;'' 
(ii) require that no capital letters are used for serving size 
information, except for the first letter in ``Serving size;'' (iii) 
require that ``__servings per container'' (with the blank filled in 
with the actual number of servings) be in type size no smaller than 10 
point (except for the tabular and linear displays for small packages) 
(proposed 9 CFR 413.309(d)(3)(i)); and (iv) require that the serving 
size information be highlighted in bold or extra bold type and be in a 
type size no smaller that 10 point (except for the linear display for 
small packages)(proposed 9 CFR 413.309(d)(3)(i)). FSIS has tentatively 
concluded that these proposed changes will help consumers better 
locate, identify, and understand the information in the Nutrition Facts 
label and assist consumers in making informed purchase decisions and 
maintaining health dietary practices.
3. Right-Justifying the Quantitative Amounts Declared in the ``Serving 
size'' Statement
    Currently, the label statement for ``Serving size'' expressed in 
common household measures (e.g., cup, tablespoon, piece or slice) and 
gram amounts is stated immediately adjacent to the ``Serving Size'' 
declaration as seen in 9 CFR 317.309(d)(12) and 381.409(d)(12). FSIS is 
proposing to require that the ``Serving size'' declaration be left-
justified and the corresponding numerical value as determined in 
proposed 9 CFR 413.309(b)(9) be right-justified (proposed 9 CFR 
413.309(d)(3)(i)). FSIS agrees with FDA that the proposed change will 
create more white space on the Nutrition Facts label that ``would 
result in a less cluttered appearance, heightened focus and emphasis, 
and improved readability'' and will improve ease of use for consumers 
(79 FR 11950).
4. Presentation of Percent DVs
    FSIS currently requires that the column heading ``% Daily Value'' 
and a list of nutrient names and amounts as described in 9 CFR 
317.309(d)(7) and 381.409(d)(7) be to the left of and below this column 
heading in the Nutrition Facts label (9 CFR 317.309(d)(6) and (7) and 
381.409(d)(6) and (7)). On all dual column labels, including those (1) 
for two or more forms of the same food (proposed 9 CFR 413.309(e)(5)); 
(2) displaying nutrition information per container and per unit, in 
addition to nutrition information per serving (proposed 9 CFR 
413.309(e)(6)(i); (3) using the tabular display (proposed 9 CFR 
413.309(e)(6)(ii)); and (4) that provide the aggregate display 
(proposed 9 CFR 413.309(d)(13)(ii)), FSIS is proposing to use thin 
vertical lines to separate the information in the ``% Daily Value'' 
column from the information in the column containing the quantitative 
weights. Further, FSIS is proposing to use the same style of thin 
vertical lines to separate each of the dual columns and aggregate 
display columns from each other. FSIS has tentatively concluded that 
the use of these vertical lines will help differentiate the columns and 
make the information easier to read for consumers. In addition, FSIS is 
proposing that protein would no longer be listed with the vitamins and 
minerals at the bottom of these labels as currently required.
5. Placement of ``Added Sugars''
    As discussed in section II.E.3 of this proposed rule, FSIS is 
proposing to require the declaration of added sugars as an indented 
line item underneath the declaration of ``Total Sugars'' on the 
Nutrition Facts label. ``Added Sugars'' would be the only mandatory 
nutrient required to be listed in a double indentation format on the 
Nutrition Facts label.
    FDA conducted a consumer study that, among other things, looked at 
how consumers would use the new information regarding added sugars, but 
did not evaluate the impact of listing a percent DV for added sugars on 
the Nutrition Facts label (80 FR 44306). The study was a controlled, 
randomized, web-based experiment where participants viewed three 
different Nutrition Facts label formats and responded to questions 
regarding their ability to accurately recognize and compare nutrients 
on the Nutrition Facts label and their judgments about the foods' 
overall healthfulness and relative nutrient levels (80 FR 44306). The 
study found that when both total and added sugars declarations appeared 
on the label, the majority of study participants correctly reported the 
added sugars amount and accurately identified which products had less 
added sugars (80 FR 44306). The study also found that where an added 
sugars declaration was indented below a ``Total Sugars'' declaration 
the study participants' understanding that added sugars are part of the 
total amount of sugars in the product improved (80 FR 44306). 
Therefore, consistent with FDA's final rule, FSIS is proposing to use 
the term ``Total Sugars'' instead of ``Sugars'' on the label. A summary 
of FDA's Added Sugars Experiment is available at 80 FR 44306 and a full 
description is available in the FDA Nutrition Labeling Supplemental 
Proposed Rule docket.\29\
---------------------------------------------------------------------------

    \29\ U.S. Food and Drug Administration. Memorandum to the File--
``Experimental study on consumer responses to Nutrition Facts labels 
with declaration of amount of added sugars (OMB No. 0910-0764),'' 
2015.
---------------------------------------------------------------------------

    FDA's Nutrition Labeling Final Rule also addressed commenters' 
concerns regarding potential consumer confusion when including an 
``Added Sugars'' declaration under ``Total Sugars'' on the Nutrition 
Facts label. Based on the recommendations of two independent FDA 
experts, as well as literature suggesting linking terms are useful for 
increasing comprehension, FDA added the word ``Includes'' in front of 
``Added Sugars'' (81 FR 33827.) FDA also minimized the line between 
``Total Sugars'' and ``Added Sugars'' to help denote that ``Added 
Sugars'' are a subcomponent of ``Total Sugars.'' Consistent with FDA, 
FSIS is proposing to add the word ``Includes'' in front of ``Added 
Sugars'' such that the added sugars declaration reads ``Includes X g 
Added Sugars.'' FSIS is also proposing to minimize the hairline between 
``Total Sugars'' and ``Added Sugars.''
 6. Declaration of Absolute Amounts of Vitamins and Minerals
    FSIS currently requires that the quantitative amount by weight of 
mandatory and voluntary nutrients be declared on the Nutrition Facts 
label, except for vitamins and minerals (other than sodium and 
potassium) which must be declared only as percent DVs(9 CFR 
317.309(c)(8) and 381.309(c)(8)). Consistent with FDA's Nutrition 
Labeling Final Rule (81 FR 33946-33949), FSIS is not proposing to 
require the declaration of the absolute amounts of all mandatory and 
voluntary vitamins and minerals as well as the percent DV declaration 
on the Nutrition Facts label. FSIS is, however, proposing to clarify in 
proposed 9 CFR 413.309(c)(8) that the declaration of voluntarily 
declared vitamins and minerals listed in proposed 9 CFR 
413.309(c)(8)(iv) may include the quantitative amount by weight and 
percent of the RDI. FSIS is also proposing that if vitamins or minerals 
are added or there is a claim made about them, the manufacturer must 
include a declaration of the nutrient as a percent DV, or 
alternatively, as a quantitative amount by weight and percent DV 
(proposed 9 CFR 413.309(c)(8)(ii)).

[[Page 6755]]

7. The Footnote
    FSIS currently requires that a footnote, preceded by an asterisk, 
be placed beneath the list of vitamins and minerals and be separated 
from that list by a hairline on the Nutrition Facts label (9 CFR 
317.309(d)(9) and 381.409(d)(9)). The footnote must state ``Percent 
Daily Values are based on a 2,000 calorie diet. Your daily values may 
be higher or lower depending on your calorie needs'' followed by a 
table that lists the DRVs for total fat, saturated fat, cholesterol, 
sodium, total carbohydrate, and dietary fiber based on 2,000 and 2,500 
calorie diets. (9 CFR 317.309(d)(9)(i) and 381.409(d)(9)(i)). Caloric 
conversion information on a per-gram basis for fat, carbohydrate, and 
protein may be presented beneath the information required in paragraph 
9 CFR 317.309(d)(9) and 381.409(d)(9) separated by a hairline (9 CFR 
317.309(d)(10) and 381.409(d)(10)).
    Comments to FDA's 2007 ANPRM cited to research that the comments 
said showed that consumers do not understand what information is being 
conveyed in the footnote (79 FR 11953). In 2014, FDA conducted a 
controlled, randomized, web-based experiment that compared consumer 
reactions to seven footnote formats, which included five modified 
footnotes, in addition to the current footnote and no footnote at all, 
for explaining percent DVs and how to use them (the ``Footnote 
Experiment'').\30\ In FDA's Nutrition Labeling Final Rule, FDA 
finalized a revised footnote requirement (81 FR 33952). FDA removed the 
requirement for the footnote table listing the DRVs for total fat, 
saturated fat, cholesterol, sodium, total carbohydrate, and dietary 
fiber for 2,000 and 2,500 calorie diets that is specified in 21 CFR 
101.9(d)(9)(i) and added the following footnote text: ``*The %Daily 
Value tells you how much a nutrient in a serving of food contributes to 
a daily diet. 2,000 calories a day is used for general nutrition 
advice.'' Id. The footnote text is similar to one of the options tested 
in the Footnote Experiment, except that the sentences in the footnote 
are reversed (80 FR 44309). The study participants perceived the 
language in this footnote to be more useful than the current footnote; 
and FDA switched the order of the sentences in the footnote so the 
explanation of the %DV clearly follows the asterisk that leads to the 
footnote in the %DV column (80 FR 44309).
---------------------------------------------------------------------------

    \30\ U.S. Food and Drug Administration. Memorandum to the File--
``Experimental study on consumer responses to Nutrition Facts labels 
with various footnote formats (OMB No. 0910-0764),'' 2015.
---------------------------------------------------------------------------

    FDA stated that the new footnote ``which explains the term ``% 
Daily Value'' and provides a reference calorie level will assist 
consumers in better understanding the information of the Nutrition 
Facts label and in maintaining healthy dietary practices'' (81 FR 
33952). FDA did not change the caloric conversion information in the 
footnote specified in 21 CFR 101.9(d)(10. FDA stated, in its Nutrition 
Labeling Proposed Rule, that ``increasing the type size, bolding key 
elements of the footnote (space permitting), and adding a bar clearly 
separating it from the micronutrient information directly above will 
assist consumers in using the information'' (79 FR 11953). FDA did not 
finalize this proposed requirement.
    Under the Nutrition Labeling Final Rule, FDA now allows the 
footnote to be omitted from products that qualify for a simplified 
format (21 CFR 101.9(f)), provided that the following abbreviated 
statement is used ``%DV = %Daily Value'' in a type size no smaller than 
6 point on these package labels when Daily Value is not spelled out in 
the column heading (81 FR 33952). FDA is also not requiring the 
footnote on small or intermediate-sized packages (21 CFR 
101.9(j)(13)(ii)(A)(1) and (2)), but manufacturers may voluntarily 
include the abbreviated footnote on these packages. The abbreviated 
statement would allow for more space on the label and informs consumers 
what %DV means. In addition, FDA is providing an exemption from the 
footnote requirement for foods that can use the terms ``calorie free,'' 
``free of calories,'' ``without calories,'' ``trivial source of 
calories,'' ``negligible source of calories,'' or ``dietary 
insignificant source of calories'' on the label or in the labeling of 
foods, as defined in 21 CFR 101.60(b) (81 FR 33952). FDA is also 
allowing the voluntary use of the first part of the footnote statement, 
``*The %Daily Value tells you how much a nutrient in a serving of food 
contributes to a daily diet'' on these products (81 FR 33952). FDA 
stated that such products would have little to no impact on the average 
daily 2,000 calorie intake, which the footnote addresses (80 FR 44309).
    Consistent with FDA's Nutrition Labeling Final Rule (81 FR 33949-
33954), FSIS is proposing to remove the requirement for the footnote 
table listing the DRVs for total fat, saturated fat, cholesterol, 
sodium, total carbohydrate, and dietary fiber for 2,000 and 2,500 
calorie diets (proposed 9 CFR 413.309(d)(9)(i)). FSIS is also proposing 
the following footnote text: ``The %Daily Value tells you how much a 
nutrient in a serving of food contributes to a daily diet. 2,000 
calories a day is used for general nutrition advice.'' Consistent with 
FDA, FSIS is not proposing changes to the caloric conversion 
information in the footnote currently specified in 9 CFR 317.309(d)(10) 
and 381.409(d)(10) (which would be consolidated in proposed 9 CFR 
413.309(d)(10)). FSIS is proposing that the footnote may be omitted 
from products that qualify for a simplified format (proposed 9 CFR 
413.309(f)), provided that the following abbreviated statement is used 
``%DV = %Daily Value,'' when the package labels do not spell out Daily 
Value in the column heading. FSIS is also proposing that the footnote 
may be omitted from small or intermediate-sized packages (proposed 9 
CFR 413.309(g)). FSIS is also proposing an exemption from the footnote 
requirement for foods that can use the terms ``calorie free,'' ``free 
of calories,'' ``no calories,'' ``zero calories,'' ``without 
calories,'' ``trivial source of calories,'' ``negligible source of 
calories,'' or ``dietarily insignificant source of calories'' on the 
label or in the labeling of foods as defined in proposed 9 CFR 
413.360(b). FSIS is also proposing to allow the voluntary use of the 
first part of the footnote statements, ``*The %Daily Value tells you 
how much a nutrient in a serving of food contributes to a daily diet,'' 
on these products.
8. Addition of a Horizontal Line Beneath the Nutrition Facts Heading
    FSIS requires that the ``Nutrition Facts'' heading on the Nutrition 
Facts label be set in a type size larger than all other print size in 
the nutrition label (9 CFR 317.309(d)(2) and 381.409(d)(2)). FDA 
amended its regulations to require a hairline rule be inserted directly 
beneath the ``Nutrition Facts'' heading on all label formats, except 
for the linear display for small packages, to direct the reader's eye 
to the serving size information, place emphasis on the information 
about servings, and break the information into smaller chunks to make 
it easier to process (79 FR 11954; 81 FR 33954). Consistent with FDA's 
final rule, FSIS is proposing to require that a hairline rule be 
inserted immediately below the ``Nutrition Facts'' heading on all 
nutrition label formats except for the linear display for small 
packages (proposed 9 CFR 413.309(d)(1)(iii)).

[[Page 6756]]

L. Single-Serving Containers/Units and Dual-Column Labeling

1. Single-Serving Containers/Units
    FSIS's current regulations require that a product that is packaged 
and sold individually and that contains less than 200 percent of the 
applicable RACC be considered a single-serving container, and that the 
entire content of the product be labeled as one serving, except that 
for products that have RACCs of 100g or 100mL or larger, manufacturers 
may decide whether a package containing more than 150 percent but less 
than 200 percent of the RACC be labeled as 1 or 2 servings (9 CFR 
317.309(b)(8) and 381.409(b)(8)). FSIS's current regulations also 
require that for products that have RACCs of 100g or 100mL or larger 
and are individual units within a multi-serving package, manufacturers 
may decide whether an individual unit that contains more than 150 
percent but less than 200 percent of the RACC be labeled as 1 or 2 
servings (9 CFR 317.309(b)(4)(v) and 381.409(b)(4)(v)).
    Based on a review of recent research, FDA has determined that many 
consumers do not correctly calculate nutrient amounts in food products 
by multiplying the nutrient amount by the number of servings per 
container (79 FR 11998-11999). FDA also found that the exemption from 
the requirement to label a product with a large RACC as a single-
serving container is no longer warranted because ``there is a low 
correlation between the RACCs (whether the reference amount is more 
than or less than 100 g or mL) and the consumption variation for all 
products containing less than 200 percent of the RACC, regardless of 
whether the RACC is `large' (i.e., greater than 100 g or 100 mL) or 
not'' (79 FR 12001). Under pre-existing FDA regulations, if a package 
or discrete unit of food with a ``large'' RACC contained more than 150 
percent but less than 200 percent of the RACC, the manufacturer was 
permitted to decide whether to declare the package or individual unit 
as 1 or 2 servings (81 FR 34004-34008). The FDA Serving Size Final 
Rule, however, removed this exemption and, for products subject to FDA 
requirements, requires that all packages of food containing less than 
200 percent of the RACC be labeled as a single serving (see 21 CFR 
101.9(b)(6)), and that discrete units containing at least 67 percent of 
the RACC but less than 200 percent of the RACC be labeled as a single 
serving (see 21 CFR 101.9(b)(2)(i)(C)). FDA also removed the provision 
that products packaged and sold individually and containing 200 percent 
or more of the applicable RACC may be labeled as a single serving if 
the entire contents of the container can reasonably be consumed at a 
single eating occasion (81 FR 34004-34008).
    FSIS has reviewed FDA's research and analysis and tentatively 
agrees with FDA's conclusions. Therefore, FSIS is proposing to revise 
the requirements for single-serving labeling so that a product packaged 
and sold individually that contains less than 200 percent of the 
applicable RACC must be considered a single serving, and that a 
discrete unit containing at least 150 percent but less than 200 percent 
of the RACC must be labeled as one serving regardless of whether the 
RACC exceeds 100 g or mL (proposed 9 CFR 413.309(b)(8)).
2. Dual-Column Labeling
    FSIS currently permits manufacturers to voluntarily provide an 
additional column of nutrition information (i.e., dual column labeling) 
in the following situations:
     Per 100 g, 100 mL, or 1 oz of the product as packaged or 
purchased (9 CFR 317.309(b)(13)(i) and 381.409(b)(13)(i));
     Per one unit if the serving size of a product in discrete 
units in a multi-serving container is more than one unit (9 CFR 
317.309(b)(13)(ii) and 381.409(b)(13)(ii));
     For the product alone if the product is commonly combined 
with other ingredients or is cooked or otherwise prepared before 
eating, and directions for such combination or preparations are 
provided (e.g., a cream soup mix may be labeled with one set of DVs for 
the dry mix (per serving), and another set for the serving of the final 
soup when prepared (e.g., per serving of cream soup mix and 1 cup of 
vitamin D fortified whole milk)(9 CFR 317.309 (b)(15) and 
381.409(b)(15));
     For two or more forms of the same product (e.g., both 
``raw'' and ``cooked'') as provided in 9 CFR 317.309(b)(3) and (e) and 
381.409(b)(3) and (e); and
     For two or more groups for which RDIs are established 
(e.g., both infants and children less than 4 years of age) as provided 
in 9 CFR 317.309(c)(8)(i) and (e) and 381.409(c)(8)(i) and (e).
    Research has shown that package and portion sizes have a 
considerable impact on the amount of food consumed, and that the size 
of the package or unit of food can set a consumption norm for 
consumers; that consumers do not correctly calculate nutrient amounts 
in food products by multiplying the nutrient amount by the number of 
servings per container; and that dual-column labeling with the 
nutrition information given per serving and per package may help 
certain consumers recognize nutrient amounts per package in certain 
types of packaged food (79 FR 11998-11999). Therefore, consistent with 
FDA's Serving Size Final Rule, FSIS is proposing mandatory dual-column 
labeling on certain packages of meat and poultry products.
    FSIS is proposing that meat and poultry products in packages or 
units that contain at least 200 percent and up to and including 300 
percent of the applicable RACC be required to have two columns in the 
Nutrition Facts label. One column would list the quantitative amounts 
and percent DVs for the entire package or unit, and the other column 
would list the quantitative amounts and percent DVs for a serving, 
based on the amount most closely approximating the RACC, that is less 
than the entire package or unit (proposed 9 CFR 413.309(b)(4)(iv) and 9 
CFR 413.309(b)(16)). FSIS is proposing an upper limit of 300 percent 
for dual-column labeling based on FDA's analysis that showed that '' 
providing an upper limit at 300 percent of the RACC would ensure that 
dual-column labeling captures 90 percent of the consumption habits for 
about 91 percent of food products and limit the possibility that dual-
column labeling will be required for package sizes that are not likely 
to be consumed in a single eating occasion'' (81 FR 34015-34016). 
Providing nutrition information for these products in dual columns will 
make it easier for consumers, regardless of whether they consume the 
entire container or unit in a single eating occasion, consume part of 
the entire container or unit in a single eating occasion, or share the 
container or unit, to identify the amount of nutrients consumed without 
having to perform mathematical calculations.
    FSIS is proposing that meat and poultry products in packages that 
meet the requirements to use a tabular display for small packages or to 
use a linear format be exempt from the dual-column labeling 
requirements (proposed 9 CFR 413.309(b)(16)(i)(A)). FSIS is also 
proposing that products that require further preparation and provide 
two columns of nutrition information (e.g., one column ``as purchased'' 
and one column ``as prepared'') would be exempt from the dual-column 
labeling requirements in proposed 9 CFR 413.309(b)(16). If products 
that already provide two columns of nutrition information for ``as 
purchased'' and ``as prepared'' forms of the product were required to 
have dual-column labeling with nutrition information per serving size 
and per the entire container, the products would have at least three 
columns of nutrition information, or

[[Page 6757]]

manufacturers would decide to no longer provide the voluntary 
information for the prepared form of the product. FSIS is also 
proposing that products that are commonly consumed in combination with 
another food and provide an additional column of nutrition information 
under proposed 9 CFR 413.309(e) be exempt from the dual-column labeling 
requirements in proposed 9 CFR 413.309(b)(16). Similar to the products 
that require further preparation, nutrition information based on the 
entire container of an uncombined food (e.g., the dry mix alone for a 
cream soup mix) (for a food that is commonly combined with another 
food) may be less meaningful to consumers than information on a serving 
of the combined food (e.g., per serving of cream soup mix and 1 cup of 
vitamin D fortified whole milk) because these types of products are 
commonly consumed in combination with another food. FSIS is also 
proposing that products that provide an additional column of nutrition 
information for two or more groups for which RDIs are established 
(e.g., both infants through 12 months and children 1 through 3 years of 
age) and random weight products be exempt from the dual-column labeling 
requirements (proposed 9 CFR 413.309(b)(16)(i)(C)). Information 
provided for subpopulations will be more useful to distinct populations 
for certain products than information per-container or unit.
    FSIS is proposing that the Nutrition Facts label for a meat or 
poultry product that is packaged and sold individually that contains 
more than 150 percent and less than 200 percent of the applicable 
reference amount, may voluntarily provide, to the left of the column 
that provides nutrition information per container (i.e., per serving), 
an additional column that lists the quantitative amounts and percent 
Daily Values per common household measure that most closely 
approximates the reference amount (proposed 9 CFR 317.309(b)(8)).
3. Use of Nutrient Content Claims and Health Claims on Products With 
Dual-Column Labeling per Serving and per Container
    RACCs set forth in 9 CFR 317.312(b)-(e) and 381.412(b)-(e) are 
currently used to determine whether a product meets the criteria for a 
nutrient content claim (9 CFR 317.313(p) and 381.413(p)). Consistent 
with the FDA Serving Size Final Rule, if nutrition information is 
presented on a per serving basis and on a per container or unit basis 
(i.e., the proposed dual-column labeling requirements or if a dual-
column is provided voluntarily) on the Nutrition Facts Label, FSIS is 
proposing to require that the nutrient content claim be followed by a 
statement that sets forth the basis on which the claim is made 
(proposed 9 CFR 413.309(b)(16)(ii)). 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, FSIS is 
proposing that the claim must be followed by the criteria for the claim 
as required by proposed 9 CFR 413.313(p). This criteria statement would 
help clarify that the nutrient content claim or health claim is based 
on the RACC and not the amount in the entire container. FSIS is also 
proposing that this criteria statement would not be 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 (proposed 9 CFR 413.309(b)(16)(ii)).
4. Additional Changes to Serving Size Regulations
    FSIS currently allows by policy the use of an ounce unit in the 
serving size, e.g., 4oz (112g), instead of a household unit, e.g., 1 
piece (112g), when the size of the product naturally varies in weight 
and is not uniform in size (e.g., poultry parts, such as chicken 
breasts and chicken wings, and non-formed meat cuts, such as pork 
chops). Consistent with 21 CFR 101.9(b)(2)(i)(G), proposed 9 CFR 
413.309(b)(4)(vii) would permit the use of an ounce unit in the serving 
size for products that naturally vary in size (e.g., poultry parts or 
non-formed cuts of meat).
    Current FSIS regulations require the serving size to declare the 
as-packaged amount in accordance with 9 CFR 317.309(b)(3) and 
381.409(b)(3). Consistent with 21 CFR 101.9(b)(7)(v), proposed 9 CFR 
413.309(b)(9)(5) would permit the serving size to include the finished 
product amount as part of the serving size when water or other 
ingredients with insignificant amounts of nutrients are instructed to 
be added during preparation. For example, when the consumer is directed 
to add a specific amount of water to prepare a condensed soup, the 
serving size may state ``\1/2\ cup (120g) concentrated soup (makes 1 
cup prepared)'' instead of ``\1/2\ cup (120g).''
    Currently, FSIS requires the serving size for a product marketed 
for two different purposes, e.g., gravy or a soup, to be based on the 
larger serving size, e.g., soup (1 cup RACC) instead of gravy (\1/4\ 
cup RACC) (9 CFR 317.312 and 381.412). Consistent with 21 CFR 
101.9(b)(11), proposed 9 CFR 413.309(b)(13)(iii) would require the 
Nutrition Facts label to include the nutrient information for both 
marketed serving sizes when the amount served for each differs in 
quantity by twofold or greater based on the RACC in accordance with 
proposed 9 CFR 413.313(b) (e.g., the Nutrition Facts label would 
provide nutrient data for both soup (1 cup) and gravy (\1/4\ cup) 
because the soup serving size is greater than twofold over the serving 
size for gravy).

M. Reference Amounts Customarily Consumed

1. Factors Considered To Determine the Existing RACCs To Update
    The current RACCs for meat and poultry products are listed in 9 CFR 
317.312 and 381.412, respectively. The RACCs represent the amount of 
food customarily consumed per eating occasion and are listed by product 
categories. The RACCs and product categories are used as the basis for 
determining serving sizes for specific products. The current RACCs were 
primarily derived from the 1977-1978 (http://www.ars.usda.gov/Services/docs.htm?docid=16184) and the 1987-1988 (http://www.ars.usda.gov/Services/docs.htm?docid=16185) Nationwide Food Consumption Surveys 
conducted by USDA. Since the current RACCs were established, there is 
new consumption data that shows that the amount of foods Americans 
customarily consume has changed, and there are new food products in the 
marketplace. Therefore, FSIS analyzed more up-to-date consumption data 
to determine whether the RACCs and product categories for meat and 
poultry products needed to be updated or revised.
    FSIS analyzed the recent consumption data from the NHANES 2003-2008 
surveys using Statistical Analysis Systems (SAS) \31\ and Survey Data 
Analysis (SUDAAN) \32\ procedures to determine the amount of food being 
consumed by individuals. FSIS

[[Page 6758]]

considered the following factors in determining whether to revise the 
1993 RACCs and product categories: (1) Whether there was an adequate 
sample size from the NHANES 2003-2008 consumption data for the product 
category; (2) whether the median intake estimate from the NHANES 2003-
2008 consumption data for the product significantly differs (i.e., at 
least a 25 percent difference) from the 1993 RACC; (3) whether the 
intake distribution was skewed (based on comparing the median intake 
estimate with the mean intake estimate from the NHANES 2003-2008 
consumption data); (4) the ``reasonable consumption amount'' from the 
Food and Nutrient Database for Dietary Studies (FNDDS) \33\; (5) the 
difference between the median intake estimates, converted to common 
household measures as applicable, and the 1993 RACC for the product; 
(6) the median intake estimates for comparable products; and (7) the 
RACCs for comparable FDA-regulated products. More detailed information 
about how the factors were applied to change or not change the RACCs 
for a specific food product are contained in a rationale chart 
available on the FSIS Web site.\34\ FDA used similar methodology for 
updating the RACCs for foods regulated by FDA. The following sections 
describe the proposed changes to the RACC tables in FSIS's regulations.
---------------------------------------------------------------------------

    \31\ SAS version 9.2 Cary, NC, 2011 http://www.sas.com/technologies/analytics/statistics/stat/index.html.
    \32\ SUDAAN version 10.1 Research Triangle Park, NC, 2011 http://www.rti.org/page.cfm/Survey_Statistics.
    \33\ The reasonable consumption amount is a default consumption 
amount of food that researchers have defined and is used in NHANES 
when survey participants cannot recall the amount of food that was 
consumed at one eating occasion. Agricultural Research Service, Food 
Surveys Research Group, ``U.S. Department of Agriculture, Food and 
Nutrient Database for Dietary Studies, 4.1'' Beltsville, MD, 2010.
    \34\ http://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/federal-register/proposed-rules>.
---------------------------------------------------------------------------

2. Changes to Table 1: Reference Amounts Customarily Consumed per 
Eating Occasion: Food Labeling for Infants and Children 1 Through 3 
Years of Age
    FSIS is proposing to combine the tables containing the RACCs for 
infant and toddler foods that exist in 9 CFR 317.312 for meat products 
and 9 CFR 381.412 for poultry products into a new table for meat and 
poultry products in proposed 9 CFR 413.312 for infants and children 1 
through 3 years of age. FSIS is also proposing to add a third column 
titled ``label statement'' to the RACC table to provide examples of how 
the ``label statement'' may appear in the Nutrition Facts label as a 
formatted serving size and to parallel the FDA proposed RACC table 1 
(21 CFR 101.12(b)). The titles of the combined product categories would 
stay the same, except the combined product category for meat sticks and 
poultry sticks would be titled ``Plain meats, plain poultry, meat 
sticks, poultry sticks, ready to serve.''
    FSIS is also proposing to change the RACC from 60 g to 110 g for 
the product category ``Dinners, ready-to-serve, strained type.'' The 
2003-2008 median intake estimates for dinner, ready-to-serve, strained 
type poultry was 101.8 g, and dinner, ready-to-serve, strained type, 
meat was 88.9 g. FDA, which regulates products containing less than 2% 
cooked meat or poultry, and less than 3% raw meat, increased the RACC 
for the comparable product category, ``Dinner, desserts, fruits, 
vegetables, or soups, ready-to-serve, strained type'' from 60 g to 110 
g. The 2003-2008 median intake estimates for these two product 
categories was 104 g and 103 g, respectively. The products in these FDA 
regulated product categories are comparable to the FSIS regulated 
product category, ``Dinner, ready-to-serve, strained type, poultry'' 
and ``Dinner, ready-to-serve, strained type meat'', because all of the 
products have similar type usage and product characteristics as 
strained baby foods. In addition, the current RACC for ``Dinner, soups, 
ready-to-serve junior type'' is 110 g, and the same RACC for both 
strained type and junior baby foods would help consumers compare 
nutrition information.
    FSIS is also proposing to update the footnotes to proposed RACC 
Table 1 as follows: Footnote 1 would be updated to include new data 
sources, footnote 2 would be updated to include ``brown and serve'' as 
a type of ``almost ready-to-serve'' product and to include ``(e.g., 
ready to serve)'' after ``prepared for consumption,'' and footnote 4 
would be added to explain the purpose and use of the third column 
titled ``label statement'' in RACC Table 1.
 3. Changes to Table 2: Reference Amounts Customarily Consumed per 
Eating Occasion: General Food Supply
    FSIS is proposing to combine the tables containing the RACCs for 
the general food supply that currently exist in 9 CFR 317.312 for meat 
products and 9 CFR 381.412 for poultry products into a new table for 
meat and poultry products in proposed 9 CFR 413.312. FSIS is proposing 
to include a third column titled ``label statement'' in the new RACC 
table for meat and poultry products. The ``label statement'' column, 
which provides similar examples to what FDA provides in FDA RACC table 
2 (21 CFR 101.12(b), provides examples of how serving size statements 
may appear in the Nutrition Facts label as a formatted serving size. 
For example, the RACC for a raw poultry cut is 114 grams but the 
formatted serving size in the Nutrition Facts label would be based on 
instructions in proposed 9 CFR 413.309(b), for example, 4oz (112g).
    FSIS is also proposing to change some of the RACCs and product 
categories, establish new product categories for the general food 
supply, and update the footnotes to RACC table 2 as follows.
    In the product category ``Egg mixtures (western style omelet, 
souffl[eacute], egg foo young),'' FSIS is proposing to combine the meat 
and poultry categories for egg mixtures into one product category. The 
new name for the product category would be ``Egg mixtures with meat or 
poultry; e.g., western style omelet, souffle[eacute], egg foo young.'' 
Egg mixtures with meat and egg mixtures with poultry are comparable 
products with similar dietary usage and product characteristics. The 
same RACC will help consumers compare nutrition information between 
these products.
    FSIS is proposing to combine the meat and poultry categories for 
luncheon meat into one product category as follows, ``Luncheon 
products, luncheon meat, bologna, poultry bologna, Canadian style 
bacon, poultry Canadian style bacon, meat or poultry pattie crumbles, 
blood pudding, meat or poultry luncheon loaf, old fashioned loaf, 
berlinger, bangers, minced luncheon roll, thuringer, liver sausage, 
mortadella, uncured sausage (franks), ham and cheese loaf, P&P loaf, 
scrapple souse, head cheese, pizza loaf, olive loaf, pate, deviled ham, 
sandwich spread, teawurst, cervelat, Lebanon bologna, potted meat or 
poultry food product, taco fillings, pie fillings.'' Luncheon meat and 
luncheon products made with poultry are comparable products with 
similar dietary usage and product characteristics. The same RACC will 
help consumers compare nutrition information between these products.
    FSIS is proposing to combine the meat and poultry categories for 
entrees without sauce into one product category as follows, ``Entrees 
without sauce; e.g., cuts of meat or poultry including marinated, 
tenderized, injected cuts of meat or poultry, patties, corn dogs, 
croquettes, fritters, cured ham, dry cured ham, dry cured cappicola, 
cured poultry ham products, corned beef, pastrami, country ham, pork 
shoulder picnic, meatballs, pureed adult foods.'' Entrees without sauce 
made with meat or poultry are comparable products with similar dietary 
usage and product characteristics. The same RACC will

[[Page 6759]]

help consumers compare nutrition information between these products.
    FSIS is proposing to combine the meat and poultry categories for 
mixed dishes not measurable with a cup into one product category as 
follows, ``Mixed dishes NOT measurable with a cup; e.g., burrito, egg 
roll, enchilada, pizza, pizza roll, quiche, all types of sandwiches 
with meat or poultry, cracker and meat/poultry lunch type packages, 
gyro, Stromboli, burger on a bun, poultry burger on a bun, frank on a 
bun, poultry frank on a bun, calzone, taco, stuffed pockets, foldovers, 
stuffed vegetables with meat or poultry, shish kabobs, empanada, 
chicken cordon bleu.'' Mixed dishes not measurable with a cup made with 
meat or poultry are comparable products with similar dietary usage and 
product characteristics. The same RACC will help consumers compare 
nutrition information between these products.
    FSIS is proposing to combine the meat and poultry categories for 
mixed dishes measurable with a cup into one product category as 
follows, ``Mixed dishes measurable with a cup; e.g., casserole, 
macaroni and cheese with meat or poultry, pot pie, spaghetti with 
sauce, poultry spaghetti with sauce, meat or poultry chili, meat or 
poultry chili with beans, hash, creamed chipped beef, creamed dried 
poultry, ravioli in sauce, stroganoff, Brunswick stew, goulash, poultry 
a la king, meat or poultry stew, ragout, meat or poultry lasagna, meat 
or poultry filled pasta.'' Mixed dishes measurable with a cup made with 
meat or poultry are comparable products with similar dietary usage and 
product characteristics. The same RACC (1 cup) will help consumers 
compare nutrition information between these products.
    FSIS is proposing to combine the meat and poultry categories for 
``Salads-all other'' into one product category as follows, ``Salads--
all other meat salads, all other poultry salads; e.g., chicken salad, 
ham salad, turkey salad.'' Salads made with meat and salads made with 
poultry are comparable products with similar dietary usage and product 
characteristics. The same RACC (100g) will help consumers compare 
nutrition information between these products.
    FSIS is proposing to combine the meat and poultry categories for 
``Soups-all varieties'' into one category as follows, ``Soups with meat 
or poultry-all varieties.'' Soups made with meat and soups made with 
poultry are comparable products with similar dietary usage and product 
characteristics. The same RACC (245g) will help consumers compare 
nutrition information between these products.
    FSIS is proposing to create a new product category ``Appetizers, 
hors d'oeuvres, Mini mixed dishes with meat or poultry; e.g., mini 
bagel pizzas, mini egg rolls, dumplings, mini pizza rolls, mini 
quesadilla, mini quiche'' with a RACC of 85 g ready-to-serve (plus 35 g 
for products with sauce toppings). Recently, several mini or snack-size 
versions of several products in the ``Mixed dishes, not measurable with 
a cup'' product category have become available, such as mini pizza 
rolls, mini egg rolls, mini quiche, and mini sandwiches. Also, since 
1993, other miniature products (smaller individual piece products) that 
are often used as appetizers and hors d'oeuvres have become available 
in the market place. To accommodate appetizer type products, the USDA's 
Guide to Federal Food Labeling Requirements for Meat and Poultry 
Products (2007) \35\ includes a RACC of 85 g for ``Appetizers (e.g., 
meat (or poultry), hors d'oeuvers, mini eggrolls, mini pizza rolls, 
bagel pizza).'' Miniature products with or without meat have similar 
dietary usage and product characteristics and are often used 
interchangeably by consumers. If the product is marketed for use with a 
sauce, FSIS is proposing to use 35 g for the amount of the sauce. This 
amount is calculated proportionally based on adding 55 g of sauce or 
gravy for a RACC of 140 g for the product category, ``Mixed dishes not 
measurable with cup,'' under the general category ``Mixed Dishes.''
---------------------------------------------------------------------------

    \35\ http://www.fsis.usda.gov/shared/PDF/Labeling_Requirements_Guide.pdf. 85 g for Appetizers is a suggested 
RACC provided in Guidance by USDA (see question 68 at http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/labeling/labeling-policies/faq-generic-labeling).
---------------------------------------------------------------------------

    FSIS is proposing to create a new category ``Appetizers, hors 
d'oeuvres--Dips with meat or poultry; e.g., chicken dip, chicken and 
cheese dip, meat dip'' with a RACC of 2 tbsp. ready-to-serve. Recently, 
dip products with amenable amounts of meat or poultry, for example, 
cheesy chicken dip and chicken dip, meant to be served with chips such 
as corn chips, have been introduced into the market place. The ``All 
dips (e.g., bean dips, dairy-based dips, salsa)'' product category in 
FDA's regulations is comparable to the proposed FSIS ``Dip with Meat or 
Poultry'' product category, because dips with meat or poultry have 
similar dietary usage and product characteristics as dips regulated by 
FDA. Therefore, FSIS is proposing to establish a RACC of 2 tablespoons 
for the proposed ``Dip with Meat or Poultry'' product category. 
Establishing the same RACC for products with similar dietary usage, 
similar amounts customarily consumed, and product characteristics 
whether they are regulated by FDA or FSIS will help consumers compare 
nutrition information between these products.
    FSIS is proposing to create a new product category ``Candies with 
meat or poultry; e.g., chocolate with bacon, chocolate dipped bacon, 
chocolate with salami'' with a RACC of 30 g ready-to-serve. Recently, 
candies with amenable amounts of meat or poultry, for example, 
chocolate bars with bacon, chocolate dipped bacon, and chocolate bars 
with salami, have been introduced into the market place. Such products 
have been marketed as ``Candies'' based on information available from 
the Mintel Global New Products Database \36\ for products that are 
currently available in the market, and they are comparable to products 
in the ``All Other Candies'' product category, which is regulated by 
FDA. FDA's Serving Size Final Rule updated the RACC from 40 g to 30 g 
for the ``All Other Candies'' product category. Because the products in 
both FDA's and FSIS's candy product categories have similar usage and 
product characteristics, the same RACC (30g) for FDA's ``All Other 
Candies'' product category and FSIS's ``Candies with meat or poultry; 
e.g., chocolate with bacon, chocolate dipped bacon, chocolate with 
salami'' product category will help consumers compare nutrition 
information between these products.
---------------------------------------------------------------------------

    \36\ Mintel Global New Products Database (GNPD). Mintel Group 
Ltd. 333 West Wacker Drive, Suite 1100, Chicago, IL 60606. Internet: 
http://www.gnpd.com/sinatra/gnpd/frontpage/ (accessed September 23, 
2014).
---------------------------------------------------------------------------

    FSIS is proposing to combine the separate canned meat and poultry 
categories into one product category as follows, ``Canned Meats (e.g., 
canned beef, canned pork) and Canned Poultry (e.g., canned chicken, 
canned turkey).'' FSIS is also proposing to increase the RACC from 55 g 
to 85 g. There was an inadequate sample size for a reliable 2003-2008 
intake estimate (82.1 g) for ``Canned Meats,'' and the 2003-2008 median 
intake estimate (89.5 g) for ``Canned Poultry'' did not show a 
significant change from the 1993 RACC. But, FDA updated the 1993 RACC 
for the ``Fish, shellfish, and game meat, canned'' product category 
from 55 g to 85 g. FDA's ``Fish, shellfish, and game meat, canned'' 
product category is comparable to FSIS's ``Canned Meats (e.g., canned 
beef, canned pork) and Canned Poultry'' category. The same RACC for 
products with similar dietary usage and product characteristics whether 
regulated by FDA or FSIS will

[[Page 6760]]

help consumers compare nutrition information between these products. 
Therefore, FSIS is proposing that the RACC for ``Canned Meats (e.g., 
canned beef, canned pork) and Canned Poultry (e.g., canned chicken, 
canned turkey)'' be 85 g.
    FSIS is proposing to include pork back fat into the category for 
``Bacon'' with the category name of ``Bacon; e.g., bacon, beef 
breakfast strips, pork breakfast strips, pork rinds, pork back fat'' 
because its use is most similar to that of bacon and pork rinds. FSIS 
is proposing the RACC for pork back fat to be 15 g ready-to-eat and 54 
g ready-to-cook to reflect the previously established RACCs for bacon 
and pork rinds. The categories for bacon and poultry bacon products 
were not combined into one category because of their differing ready-
to-cook RACCs. In addition, FSIS is proposing to modify the category 
name for poultry bacon to ``poultry bacon, poultry breakfast strips'' 
to clarify that these are different products as indicated by the 
differing ready-to-cook amounts from the 1993 regulation.
    FSIS is proposing the following category names for the combined 
meat and poultry product categories that have the same RACC values and 
did not meet any of the factors for updating the RACCs: ``Salad and 
potato toppers; e.g., bacon bits, poultry bacon bits,'' ``Dried meat or 
poultry products; e.g., jerky, dried beef or poultry, Parma ham, meat 
or poultry sausage products with a moisture/protein ratio of less than 
2:1; e.g., pepperoni,'' ``Snacks, e.g., meat or poultry snack food 
sticks,'' ``Linked meat or poultry products, Vienna sausage, 
frankfurters, poultry franks, pork sausage, imitation frankfurters, 
bratwurst, kielbasa, Polish sausage, poultry Polish sausage, summer 
sausage, mettwurst, smoked country sausage, smoked sausage, poultry 
smoked sausage, smoked pickled meat or poultry meat, pickled pigs 
feet,'' ``Salads--pasta or potato, potato salad with bacon, potato 
salad with poultry, macaroni and meat or poultry salad,'' ``Major main 
entr[eacute]e type sauce; e.g., spaghetti sauce with meat or poultry, 
spaghetti sauce with meatballs, spaghetti sauce with poultry 
meatballs,'' ``Minor main entr[eacute]e type sauce; e.g., pizza sauce 
with meat or poultry, gravy,'' and ``Seasoning mixes dry, bases, 
extracts, dried broths and stock/juice, freeze dry trail mix products 
with meat or poultry: As reconstituted: Amount to make one Reference 
Amount of the final dish; e.g., Gravy, Major main entr[eacute]e type 
sauce, Soup, Entr[eacute]e measurable with a cup.''
    FSIS is proposing to update the footnotes to proposed 9 CFR 413.312 
Table 2 as follows: Footnote 1 will be updated to include new data 
sources and to clarify that the RACC values presented in the table are 
for the ``edible portion'' of the food, and Footnote 6 will be added to 
explain the purpose and use of the ``label statement'' column.

N. Compliance

    Currently, 9 CFR 317.309(h) and 381.409(h) provide information 
about how FSIS determines compliance with its nutrition labeling 
requirements, including the methods of analysis used, reasonable 
excesses and deficiencies of nutrients, acceptable levels of variance 
from declared values, and records requirements. FSIS is proposing to 
consolidate 9 CFR 317.309(h) and 381.409(h) into a single section 
(proposed 9 CFR 413.309(h)). The following discusses the additional 
revisions that FSIS will be proposing in 9 CFR 413.309(h), as compared 
to current 9 CFR 317.309(h) and 381.409(h).
1. Level of Variance Allowed for the Label Declaration of Specific 
Nutrients
    Proposed 9 CFR 413.309(h)(5) establishes that a meat or poultry 
product with a label declaration of calories, sugars, added sugars 
(when the only source of sugars in the food is added sugars), total 
fat, saturated fat, cholesterol, or sodium shall be deemed to be 
misbranded under sections 1(n) of the FMIA (21 U.S.C. 601(n)(1)) or 
4(h) of the PPIA (21 U.S.C. 453(h)) if the nutrient content of the 
composite is greater than 20 percent in excess of the value for that 
nutrient declared on the label. However, no regulatory action will be 
based on such a determination if the excess is less than the inherent 
nutrient variation in a product or the variability generally recognized 
for the analytical method used in that product at the level involved. 
FSIS is not proposing to change the level of variance allowed for the 
label declaration of nutrients.
2. Methods Used To Determine Compliance
    Under proposed 9 CFR 413.309(h)(2), a sample for nutrient analysis 
must consist of at least six consumer units, each from a production 
lot, or alternatively, chosen randomly to be representative of a 
production lot. In each case, the units may be individually analyzed, 
and the results averaged, or the units may be combined, and the 
composite analyzed. FSIS will consider the results--whether the average 
or the single result from the composite--to be the nutrient content of 
the composite. All analyses must be performed, if possible, by the 
appropriate methods and procedures used by the U.S. Department of 
Agriculture (USDA) for each nutrient in accordance with the ``Chemistry 
Laboratory Guidebook.'' If no USDA method is available, the appropriate 
methods for the nutrient in accordance with the 2016 edition of the 
``Official Methods of Analysis'' of the AOAC International, 20th ed., 
must be used, unless a particular method of analysis is specified in 9 
CFR 413.309(c). If no USDA, AOAC, or specified method is available or 
appropriate, any other reliable and appropriate analytical procedures 
may be used, as determined by FSIS. The current edition (20th ed.) of 
the ``Official Methods of Analysis'' includes many updates to the 15th 
edition.
    When FSIS issued 9 CFR 317.309(h) and 381.409(h) on compliance with 
nutrition labeling requirements, the most current version of the AOAC 
methods was its 15th edition, and, therefore, FSIS identified the 15th 
edition in its regulation. Newer and better methods of analysis have 
since been validated and recognized as ``official'' methods in the 
current 20th edition. Accordingly, FSIS is proposing, in 9 CFR 
413.309(h)(2), to use the 20th edition and incorporate it by reference 
in 9 CFR (h)(9)(i). The ``Official Methods of Analysis of AOAC 
International'' is a comprehensive collection of chemical and 
microbiological methods of analysis. The Official Methods of Analysis 
have undergone rigorous scientific review and validation to determine 
the performance characteristics for the intended analytical application 
and fitness for purpose. Each method includes specific instructions for 
performing the chemical analysis of a substance in a particular matrix. 
If a newer edition of the Official Methods of Analysis is published 
before issuance of a final rule, FSIS intends to finalize this rule 
with the newer edition, as appropriate, provided there are no 
substantive changes in the newer edition requiring additional comment.
    FSIS does not currently sample or conduct routine nutrient analyses 
of products for regulatory purposes because FSIS has not, in the past, 
found gross non-compliance with the nutrition labeling requirements 
(i.e., large variations in the nutrient content of the samples compared 
to the declared nutrition information provided on product labels). 
FSIS, for a limited period of time, is conducting surveillance sampling 
for nutrient content of raw ground beef samples

[[Page 6761]]

collected for pathogen analysis, such as Shiga toxin-producing 
Escherichia coli (STEC) and Salmonella, to ascertain compliance with 
the recent nutrition labeling requirements for raw ground product 
packages. FSIS randomly analyzes samples of raw ground beef products in 
consumer-ready packaging bearing a Nutrition Facts label that have 
already been collected for pathogen analysis at Federally-inspected 
establishments. In addition, when Office of Investigation, Enforcement 
and Audit (OIEA) Investigators collect samples of raw ground beef in 
consumer-ready packaging bearing a Nutrition Facts label at retail for 
pathogen analysis, the FSIS laboratory also randomly selects some of 
these samples for nutrient content analysis. The nutrient content 
results are non-regulatory and are for surveillance purposes only at 
this time. If there is a discrepancy between the laboratory results and 
the Nutrition Facts label, LPDS directly contacts the establishment or 
the OIEA-Compliance and Investigation Division Regional Director with 
the results of the nutrient content testing.
    FSIS will explore its regulatory options, including seeking 
criminal penalties or rescinding label approvals, if it discovers a 
violation of the nutrition labeling requirements. In addition, FSIS 
will consider when additional surveillance sampling for nutrient 
content should be conducted for various products, as well as when 
regulatory verification testing should occur.
3. Records Requirements
    Currently, FSIS regulations require that establishment management 
maintain records to support the validity of nutrient declarations 
contained on meat and poultry product labels (9 CFR 317.309(h)(8) and 
381.409(h)(8)). Such records are required to be made available to the 
inspector or any duly authorized representative of FSIS upon request (9 
CFR 317.309(h)(8) and 381.409(h)(8)). These records are generally 
required to be retained for 2 years (9 CFR 320.3 and 381.177). FSIS is 
proposing to consolidate the requirements in 9 CFR 317.309(h)(8) and 
381.409(h)(8) into proposed 9 CFR 413.309(h)(8).
    As discussed in sections II.E.5.a. (dietary fiber), II.E.5.b. 
(soluble and insoluble fiber), II.E.3. (added sugars), II.J.2. (vitamin 
E), and II.J.3. (folate), there are no suitable analytical procedures 
for measuring the following nutrients under the circumstances 
described: (1) Dietary fiber (when non-digestible carbohydrates that do 
and do not meet the proposed definition of dietary fiber are both 
contained in a food product); (2) soluble fiber (when a mixture of 
soluble fiber and non-digestible carbohydrates that do not meet the 
definition of dietary fiber is present in a food); (3) insoluble fiber 
(when a mixture of insoluble fiber and non-digestible carbohydrates 
that do not meet the definition of dietary fiber is present in a food); 
(4) added sugars (when a food product contains both naturally occurring 
sugars and added sugars); (5) vitamin E (when a food product contains 
both RRR-[alpha]-tocopherol and all rac-[alpha]-tocopherol); and (6) 
folate (when a food product contains both folate and folic acid).
    Because there are no reliable or appropriate analytical procedures 
available for FSIS to ensure that the declared nutrient amount for 
certain nutrients is truthful, accurate, and in compliance with all 
applicable labeling requirements, FSIS is proposing to require specific 
recordkeeping for certain nutrients. FSIS is proposing to require that 
manufacturers make and keep written records to verify the declaration 
of: (1) The amount of added non-digestible carbohydrates that do not 
meet the proposed definition of dietary fiber when the dietary fiber 
present in a food is a mixture of dietary fiber and non-digestible 
carbohydrates that do not meet the definition of dietary fiber 
(proposed 9 CFR 413.309(h)(8)(i)); (2) the amount of added non-
digestible carbohydrates that do not meet the proposed definition of 
dietary fiber when the food contains a mixture of soluble fiber and 
non-digestible carbohydrates that do not meet the definition of dietary 
fiber (proposed 9 CFR 413.309(h)(8)(ii)); (3) the amount of added 
insoluble non-digestible carbohydrates that do not meet the proposed 
definition of dietary fiber when the food contains a mixture of 
insoluble fiber and non-digestible carbohydrates that do not meet the 
definition of dietary fiber (proposed 9 CFR 413.309(h)(8)(iii)); (4) 
the amount of added sugars added to the food during the processing of 
the food, and if packaged as a separate ingredient, as packaged 
(whether as part of a package containing one or more ingredients or 
packaged as a single-ingredient), when both naturally occurring and 
added sugars are present in a food (proposed 9 CFR 413.309(h)(8)(iv)); 
(5)(a) scientific data and information that demonstrate the amount of 
added sugars in the food after non-enzymatic browning or fermentation 
and a narrative explaining why the data and information are sufficient 
to demonstrate the amount of added sugars declared in the finished 
food, provided the data and information used is specific to the type of 
food manufactured; or (b) records of the amount of sugars added to the 
food before and during the processing of the food, and if packaged as a 
separate ingredient, as packaged (whether as part of a package 
containing one or more ingredients or packaged as a single ingredient) 
and in no event shall the amount of added sugars declared exceed the 
amount of total sugars on the label (proposed 9 CFR 413.309(h)(8)(v); 
(6) the amount of all rac-[alpha]-tocopherol added to the food and RRR-
[alpha]-tocopherol in the finished food when a mixture of both forms of 
vitamin E is present in a food (proposed 9 CFR 413.309(h)(8)(vi)); and 
(7) the amount of synthetic folate or folic acid added to the food and 
the amount of naturally-occurring folate in the finished food, when a 
mixture of folate and folic acid is present in a food (proposed 9 CFR 
413.309(h)(8)(vii)).
    Most manufacturers should already have the types of records needed 
to validate the declared amount of each nutrient. They are in the best 
position to know which records will contain the information necessary 
for FSIS to determine compliance. These records may include analyses of 
databases, recipes or formulations, or batch records. FSIS recognizes 
that the nutrient profile of processed foods that have dietary fiber, 
soluble fiber, insoluble fiber, added sugars, vitamin E, or folate/
folic acid can vary depending on the recipe or formulation, the 
suppliers of ingredients, and other factors. Although the nutrient 
levels in foods may change if a manufacturer changes ingredient 
suppliers or recipes, manufacturers still need to ensure that the 
records they maintain substantiate the nutrient composition of the 
specific food. Therefore, manufacturers must be able to distinguish 
among the same or similar products they have in the marketplace that 
may contain differing amounts of a declared nutrient. The records 
required under proposed 9 CFR 413.309(h)(8) must be available for 
review and copying while the product is available for purchase in the 
marketplace. There is a wide range of shelf lives among food products. 
The current retention period for nutrition labeling records under 9 CFR 
320.3 and 381.177--a period not to exceed two years after December 31 
of the year in which the transaction to which the record relates has 
occurred--will be sufficient to enforce the nutrient declarations on 
the nutrition labels.
4. Inclusion of Potassium as a Mineral
    Potassium is currently the only vitamin or mineral specified as a 
Class I and Class II nutrient in 9 CFR

[[Page 6762]]

317.309(h)(4)(i-ii) and 381.409(h)(4)(i-ii). Potassium is a mineral for 
which an RDI is being proposed (proposed 9 CFR 413.309(c)(8)(iv)), and 
the absolute amount would be required to be declared along with a 
percent DV on the Nutrition Facts label. FSIS has tentatively concluded 
that there is no need to separately list potassium under the 
description of Class I and Class II nutrients because it is encompassed 
within the minerals category. Therefore, FSIS is proposing to omit a 
specific reference to potassium in proposed 9 CFR 413.309(h)(4) and 
(h)(6). Any listing of potassium on the Nutrition Facts label will have 
to meet the specific compliance requirements for minerals under 9 CFR 
413.309(h)(4) and (h)(6).
5. Requirements for Other Carbohydrate, Soluble and Insoluble Fiber, 
Added Sugars, and Sugar Alcohols
    The labeling requirements for Class I and Class II nutrients are 
provided in proposed 9 CFR 413.309(h)(4). For the reasons discussed in 
section II.E.6., FSIS is proposing to omit the provision for voluntary 
declaration of ``Other carbohydrate'' in proposed 9 CFR 413.309(c)(6) 
that is in 9 CFR 317.309(c)(6)(iv) and 381.409(c)(6)(iv). Therefore, 
FSIS is proposing to omit the compliance requirements related to 
``Other carbohydrate'' in proposed 9 CFR 413.309(h)(4) and (h)(6) that 
are in 9 CFR 317.309(h)(4) and (h)(6) and 381.409(h)(4) and (h)(6)).
    Dietary fiber is included as both a Class I and Class II nutrient 
because food products may contain only non-digestible carbohydrates 
that meet the definition of dietary fiber and that may be naturally 
occurring or that may be added to fortified or fabricated foods. The 
same is true for soluble and insoluble fiber, yet these nutrients are 
not currently listed as Class I or Class II nutrients (see 9 CFR 
317.309(h)(4) and 381.409(h)(4)). Therefore, FSIS is proposing to 
include dietary fiber in 9 CFR 413.309(h)(4) as both a Class I and 
Class II nutrient.
    Currently, 9 CFR 317.309(h)(5) and 381.409(h)(5) (consolidated in 
proposed 9 CFR 413.309(h)(5)) specify that a food with a label 
declaration of calories, sugars, total fat, saturated fat, cholesterol, 
or sodium is deemed to be misbranded under section 1(n) of the FMIA (21 
U.S.C. 601(n)(1)) or 4(h) of the PPIA (21 U.S.C. 453(h)) if the 
nutrient content of the composite is greater than 20 percent in excess 
of the value for that nutrient declared on the label. The nutrients 
listed in this section can have a negative impact on health in the 
general U.S. population if consumed in excess, and there are current 
dietary recommendations to reduce the consumption of these nutrients. 
Therefore, FSIS is ensuring in proposed 9 CFR 413.309(h)(5) that foods 
do not contain excessive amounts of these nutrients of which the 
consumer is unaware.
    Current dietary recommendations acknowledge that Americans consume 
excess amounts of added sugars and encourage reducing intake of 
calories from added sugars. A FSIS has an interest in ensuring that 
foods do not contain excessive amounts of added sugars that are not 
declared on the label (see section II.E.3) and is proposing to include 
added sugars in 9 CFR 413.309(h)(5). In some food products, all of the 
sugars are added. In such cases, an analytical method could be used to 
determine the amount of added sugars, and the permitted analytical 
variability would be applicable. Accordingly, FSIS is proposing to 
include ``added sugars (when the only source of sugars in the food is 
added sugars)'' among the list of nutrients in proposed 9 CFR 
413.309(h)(5).
    Reasonable excesses or deficiencies in relation to certain declared 
nutrients are acceptable within current good manufacturing practice. 
FSIS is proposing to allow reasonable excesses over the labeled amount 
of soluble and insoluble fiber and sugar alcohols when they are 
acceptable within current good manufacturing practice, and reasonable 
deficiencies under labeled amounts of added sugars when they are 
acceptable within current good manufacturing practice (proposed 9 CFR 
413.309(h)(6)). FSIS expects that when a food product only contains 
added sugars, when all of the dietary fiber (both soluble and 
insoluble) is added non-digestible carbohydrates that meet the 
definition of dietary fiber, when all of the vitamin E is all rac-
[alpha]-tocopherol, and when only folic acid is present in a food, the 
declared amount must be at least equal to the amount of the nutrient 
added to the food.
    In summary, FSIS is proposing the following changes related to 
compliance in 9 CFR 413.309(h) as compared to current 9 CFR 317.309(h) 
and 381.409(h): (1) Cite the 20th edition of the Official Methods of 
Analysis of the AOAC International and incorporate it as the reference 
for the appropriate methods used to determine compliance with amounts 
of nutrients declared on the Nutrition Facts label (proposed 9 CFR 
413.309(h)(2) and (h)(9)(i)); (2) establish general recordkeeping 
requirements when records are necessary to verify information related 
to dietary fiber, soluble and insoluble fiber, added sugars, folate, 
and vitamin E provided on the label (proposed 9 CFR 413.309(h)(8)); (3) 
omit a specific reference to potassium in proposed 9 CFR 
413.309(h)(4)(i-ii) and (h)(6) such that any listing of potassium on 
the Nutrition Facts label would meet the specific compliance 
requirements for minerals under proposed 9 CFR 413.309(h)(4) and 
(h)(6); (4) include dietary fiber, under proposed 9 CFR 413.309(h)(4); 
(5) include added sugars within proposed 9 CFR 413.309(h)(5) such that 
the label declaration of added sugars will be deemed misbranded under 
sections 1(n) of the FMIA (21 U.S.C. 601(n)(1)) or 4(h) of the PPIA (21 
U.S.C. 453(h)) if the nutrient content of the composite is greater than 
20 percent in excess of the added sugars declared on the label, and 
within proposed 9 CFR 413.309(h)(6) such that reasonable deficiencies 
of added sugars would be permitted; (6) include soluble and insoluble 
fiber and sugar alcohols within proposed 9 CFR 413.309(h)(6) such that 
reasonable excesses of these nutrients would be permitted; and (7) 
consistent with the tentative conclusion in section II.E.6., omit 
references to ``Other carbohydrate'' in proposed 9 CFR 413.309(h).

O. Technical Amendments

    FSIS is proposing to update the name of Food Labeling Division in 
proposed 9 CFR 413.312 and 413.369 to the Labeling and Program Delivery 
Staff, Office of Policy and Program Development. FSIS is also proposing 
to update the docket room address in proposed 9 CFR 413.309.
    Proposed 9 CFR 413.400(a)(1)(ii) is updated to remove compliance 
criteria that expired in July 1997.
    FSIS is proposing to update the cross-references to parts 317 and 
381 in sections 301.2, 304.2, 316.8, 316.11, 316.13, 317.16, 318.10, 
319.1, 319.10, 320.1, 327.15, 362.2, 381.172, 381.2, and 412.2.

III. Executive Order 12866 and Executive Order 13563

    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). Executive 
Order 13563 emphasizes the importance of quantifying both costs and 
benefits, of reducing costs, of harmonizing rules, and of promoting 
flexibility. This proposed rule has been designated an ``economically 
significant regulatory

[[Page 6763]]

action'' under section 3(f) of Executive Order 12866. Accordingly, the 
rule has been reviewed by the Office of Management and Budget.

Need for the Rule

    The USDA began requiring nutrition and serving size information on 
food labels in the early 1990's (58 FR 632). The requirements were 
intended to provide producers with a credible way of communicating 
nutrient related information to consumers and ensure consumers had 
access to the necessary information for maintaining a healthy diet. 
Today, nearly 80 percent of U.S. adults report using nutrition labels 
at least some of the time,\37\ Table 1--Use of Nutritional Facts Label 
by Average Daily Caloric, Sodium and Sugar Intake from Food at Home. 
However, over the past 20 years American caloric and nutritional 
consumption and recommendations \38\ for daily nutrition requirements 
have changed and no longer match the current nutrition labeling 
requirements. This gradual reversion to underlying information 
asymmetries raises concerns over the usefulness of the information 
provided on nutritional facts and serving size labels. In addition, 
consumer groups have raised concerns over the required formats. 
According to national consumer surveys,\39\ a sizeable number of 
consumers effectively lack access to the provided information because 
of their inability to simply read or quickly comprehend nutritional 
labels, leading to inadequate information distribution. The proposed 
rule seeks to correct the market failures caused by asymmetric and 
inadequate information by ensuring that nutritional and serving size 
requirements for FSIS products is consistent with FDA's requirements 
and are based on current diets and nutritional needs as well as 
addressing those issues that inhibit consumers from using this 
information.
---------------------------------------------------------------------------

    \37\ NHANES. 2013. ``Questionnaires, Datasets, and Related 
Documentation'' Centers for Disease Control and Prevention. Accessed 
on 5/6/2014. Data derived from the Consumer Behavior Phone Follow-up 
Module--Adult http://www.cdc.gov/nchs/nhanes/nhanes_questionnaires.htm.
    \38\ U.S. Department of Health and Human Services and U.S. 
Department of Agriculture. 2015-2020 Dietary Guidelines for 
Americans. 8th Edition. December 2015. Available at http://health.gov/dietaryguidelines/2015/guidelines/.
    \39\ Health and Diet Survey. 2008. U.S. Food and Drug 
Administration. http://www.fda.gov/Food/FoodScienceResearch/ConsumerBehaviorResearch/ucm193895.htm National Health and Nutrition 
Examination Survey Questionnaire, NHANES. 2009-2010. http://www.cdc.gov/nchs/nhanes/nhanes_questionnaires.htm.

   Table 1--Use of Nutritional Facts Label by Average Daily Caloric, Sodium and Sugar Intake From Food at Home
----------------------------------------------------------------------------------------------------------------
                                          Portion of the     Caloric intake     Sodium intake   Sugar intake \2\
      Nutritional facts label use         population \1\       \2\  (kcal)        \2\  (mg)            (mg)
----------------------------------------------------------------------------------------------------------------
Always or Most of the Time............   102,281,465 (43%)             1,439             2,327                85
Sometimes.............................    83,877,978 (36%)             1,462             2,325                89
Rarely................................    33,653,297 (14%)             1,554             2,429               103
Never.................................     15,807,324 (7%)             1,741             2,517               122
----------------------------------------------------------------------------------------------------------------
\1\ Population includes all individuals 16 years of age and older.
\2\ Intake values are limited to food consumed at home.
Source: NHANES. 2013. ``Questionnaires, Datasets, and Related Documentation'' Centers for Disease Control and
  Prevention. Accessed on 5/6/2014. Table derived from data in the Consumer Behavior Phone Follow-up Module--
  Adult, Dietary Interview--Individual Foods, First Day, and Demographic Variables & Sample Weights. http://www.cdc.gov/nchs/nhanes/nhanes_questionnaires.htm.

    Government labeling requirements provide producers with a credible 
way to communicate product attributes that are not obvious to 
consumers, e.g., calorie count or amount of fiber per serving. In this 
manner, labeling requirements allow producers to compete based on 
nutritional quality. In turn, consumers use nutritional fact and 
serving size labels to select products with desired qualities and tie 
individual decisions to overall health impacts.\40\ More than 185 
million adults reported referencing the Nutrition Facts label at least 
some of the time.\41\ Further still, recent research conducted by the 
Economic Research Service indicated that use of nutritional and health 
information is on the rise.\42\ The 2008 Health and Diet Survey 
conducted by the FDA provides further insight into food label use.\43\ 
When consumers were asked ``when you buy a product for the first time, 
how often do you read (ingredient and nutrition) information,'' 54 
percent reported often, and 23 percent reported sometimes. Ninety 
percent of label users reported using food labels to see how high or 
low the food is in calories and macro- and micro-nutrients like sodium, 
fat, or vitamins either often or sometimes (66 percent often, 24 
percent sometimes). Lastly, 49 percent of survey respondents affirmed 
that during the previous two weeks, they had based a decision to buy or 
use a food product based on the nutrition label. Clearly, many 
consumers demand and use nutritional information on food labels. 
However, the changes in consumers' diets and basing the nutrition facts 
and serving size labels on outdated recommendations does not clearly 
and conspicuously reveal the essential information to consumers.
---------------------------------------------------------------------------

    \40\ Caswell, J. and E.M. Mojduszka. 1996. Using information 
labeling to influence the market for quality in food products. 
American Journal of Agricultural Economics. 29: 47-54.
    \41\ NHANES. 2013. ``Questionnaires, Datasets, and Related 
Documentation'' Centers for Disease Control and Prevention. Accessed 
on 5/6/2014. http://www.cdc.gov/nchs/nhanes/nhanes_questionnaires.htm NHANES.
    \42\ Todd, J. 2014. Changes in eating patterns and diet quality 
among working-age adults, 2005-2010. U.S. Department of Agriculture, 
Economic Research Service. ERR-161. Todd 2014.
    \43\ Choiniere, C.J. and A. Lando. 2008. ``, FDA 2008 Health and 
Diet Survey-Consumer Behavior Research'' Accessed on 5/6/2014. < 
http://www.fda.gov/Food/FoodScienceResearch/ConsumerBehaviorResearch/ucm193895.htm.>

---------------------------------------------------------------------------

[[Page 6764]]

    As is shown on Graph 1, from 1971--2010, mean energy intake 
increased by 240 kcal/day \44\ although recent reports suggest 
overweight and obesity has leveled-off nationally and even declined in 
certain groups.\45\ During this period, an emphasis on health aspects 
such as ``low in sodium'' or ``low in fat'' led consumers to disregard 
other pertinent health information, e.g., calorie count, sugars and 
serving size, leading to overconsumption.\46\ Between 1970 and 2005, 
sugars and sweeteners available for consumption increased by 19 
percent. This increase in supply enabled an increase in consumption 
such that by 2004, the daily sugar intake for men and women averaged 
25.4 tsp (406 kcal) and 18.3 tsp (292 kcal) respectively.\47\ From 
2007-2010, children and adults consumed more than double the amount of 
recommended added sugars, with lower income individuals consuming more 
added sugars than higher income individuals.\48\ For perspective, the 
2015-2020 Dietary Guidelines for Americans recommends less than 10 
percent of calories per day from added sugars combined, yet added 
sugars alone contributed an average of 16 percent of the total calories 
in American diets. The increase in caloric density worsened the 
negative health impacts associated with overconsumption. Updating 
nutrition facts and serving size labels so as to take into 
consideration current consumption patterns, dietary recommendations, 
and scientific evidence will help producers credibly communicate hard 
to distinguish product attributes as well as aid current and future 
label-users overcome the issues presented above.
---------------------------------------------------------------------------

    \44\ Ford, E.S. and W. H. Dietz. 2013. Trends in energy intake 
among adults in the United States: finding from NHANES. American 
Journal of Clinical Nutrition. 97: 848-853. Ford and Dietz, 2013.
    \45\ Fryar, C, Carroll, M., Ogden, C. 2014. Prevalence of 
Overweight, Obesity, and Extreme Obesity Among Adults: United 
States, 1960-162 Through 2011-2012. CDC National Center for Health 
Statistics. http://www.cdc.gov/nchs/data/hestat/obesity_adult_11_12/obesity_adult_11_12.htm.
    \46\ Chandon, P. 2013. How package design and packaged-based 
marketing claims lead to overeating. Applied Economic Perspectives 
and Policy. 35: 7-31.
    \47\ Johnson, R.K., L.J. Appel, M. Brands, B.V. Howard, M. 
Lefevre, R.H. Lustig, F. Sacks, L.M. Steffen, and J. Wylie-Rosett. 
2009. Dietary sugars intake and cardiovascular health a scientific 
statement from the American Heart Association. Circulation. 1012-
1020.
    \48\ Biing-Hwan Lin and Rosanna Mentzer Morrison. 2014. ERS's 
Food Consumption and Nutrient Intake Data-Tool for Assessing 
Americans' Diets. USDA Economic Research Service. https://www.ers.usda.gov/amber-waves/2014/october/erss-food-consumption-and-nutrient-intake-data-tools-for-assessing-americans-diets/.
[GRAPHIC] [TIFF OMITTED] TP19JA17.001

    Of those U.S. adults who rarely or never use Nutrition Facts 
labels, over 31 million of them are overweight or obese; conditions 
linked to increased incidence of coronary heart disease, stroke, type 2 
diabetes, cancer, and high blood pressure. For perspective, overweight 
and obese individuals spend 10 and 43 percent more money on health care 
as compared to normal weight individuals, respectively.\49\ Overall 
annual medical expenditure caused by overweight or obesity has been 
estimated to account for between 5 and 7 percent of national medical 
expenditures \50\ and is projected to increase to 17 percent by 
2030.\51\ With regard to health care providers, obesity accounts for 
8.5 percent of Medicare spending, 12 percent of Medicaid spending, and 
13 percent of private payer spending.\52\
---------------------------------------------------------------------------

    \49\ Tsai, A.G., D.F. Williamson, and H.A. Glick. 2010. Direct 
medical cost of overweight and obesity in the USA: A quantitative 
systematic review. Obesity Reviews. 12: 50-61. Tsai et al. 2010.
    \50\ Tsai, A.G., D.F. Williamson, and H.A. Glick. 2010. Direct 
medical cost of overweight and obesity in the USA: A quantitative 
systematic review. Obesity Reviews. 12: 50-61. Tsai et al. 2010.
    \51\ Wang, Y.C., K.M, T.Marsh, S.L. Gortmaker, and M. Brown. 
2011. Health and economic burden of the projected obesity trends in 
the USA and the UK. The Lancet. 378: 815-825 Wang 2011.
    \52\ Finkelstein, E.A., J.G. Trogdon, J.W. Cohen, and W.Dietz. 
2009. Annual medical spending attributable to obesity: Payer and 
service-specific estimates. Health Affairs Web Exclusive. 33:11.
---------------------------------------------------------------------------

    A daily energy surplus of 50-100 kcals will lead to overweight and

[[Page 6765]]

obesity.\53\ Thus, the 92-279 kcal difference in kcals consumed at home 
between those who rarely or never read labels as compared to those who 
at least sometimes read labels is understood to be significant, Table 
1--Use of Nutritional Facts Label by Average Daily Caloric, Sodium and 
Sugar Intake from Food at Home. When asked why they did not use 
nutritional labels, approximately 10 percent of overweight respondents 
exclusively had issues related to readability and comprehensibility: 
The print is too small, they would not know what to look for, or they 
do not have enough time. Addressing these design limitations would 
provide consumers with information that will convey relevant nutrition 
information.
---------------------------------------------------------------------------

    \53\ Finkelstein, E.A., C.J. Ruhm, and K.M. Kosal. 2005. 
Economic causes and consequences of obesity. Annual Review of Public 
Health. 26. 239-257. and Johnson, R. K., L.J. Appel, M. Brands, B.V. 
Howard, M. Lefevre, R.H. Lustig, F. Sacks, L.M. Steffen, and J. 
Wylie-Rosett. 2009. Dietary sugars intake and cardiovascular health 
a scientific statement from the American Heart Association. 
Circulation: 1012-1020.
---------------------------------------------------------------------------

    These modest reductions are known to lead to significant benefits 
in the form of weight loss, health improvements, and reduced medical 
expenditures.\54\ These issues can be addressed by altering the design 
and content of nutritional and serving size labels, e.g., reducing the 
variance between food labels by more closely aligning FSIS's 
requirements with FDA's, providing a calorie count for the entire 
package and or utilizing a dual column layout when appropriate, along 
with increasing and bolding the font size for the most salient 
information.
---------------------------------------------------------------------------

    \54\ Dall, T.M., V.L. Fulgoni III, Y. Zhang, K.J. Reimers, P.T. 
Packard, and J.D. Astwood. 2009. Potential health benefits and 
medical cost savings from calorie, sodium, and saturated fat 
reductions in the American diet. American Journal of Health 
Promotion. 23. 412-422 and Sturm, R. 2002 The effects of obesity, 
smoking, and drinking on medical problems and costs. Health Risks 
and Costs. 21: 245-253.
---------------------------------------------------------------------------

    In total, the USDA and FDA regulate roughly 50,000 \55\ and 740,000 
\56\ labels. The proposed rule reduces the amount of inconsistent 
information across FSIS and FDA products by more closely aligning 
nutrition labeling requirements with FDA's final changes, which ensures 
that food nutrition information is consistent across food products. 
This proposed rule allows nutrition labeling to more accurately reflect 
current dietary guidelines and is more easily understood by consumers. 
As will be detailed in the following sections, the magnitude of the sum 
of public health benefits brought about by even a small change in 
consumer behavior because of the information provided by the label 
warrants the proposed rule.
---------------------------------------------------------------------------

    \55\ IRI (2012). InfoScan data. Information Resources, Inc. 
(IRI).
    \56\ Nutrition Facts/Serving Sizes Combined PRIA for Docket No. 
FDA-2012-N-1210 and Docket No. FDA-2004-N-0258. Available at: http://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/UCM385669.pdf.
---------------------------------------------------------------------------

Baseline

    FSIS estimates that there are roughly 50,000 different retail 
nutrition labels for meat or poultry products, roughly 25 percent of 
which are private labels (store brand). The Agency estimates that FSIS 
products are produced by 3,307 establishments, of which, 3,125 are 
considered either small or very small establishments. The number of 
labels and establishments is based on Information Resources, 
Incorporated (IRI) scanner data \57\ and the Small Business 
Administration's (SBA's) business size classifications.
---------------------------------------------------------------------------

    \57\ Any opinions, findings, recommendations, or conclusions are 
those of the authors and do not necessarily reflect the views of the 
Economic Research Service, U.S. Department of Agriculture. The 
analysis, findings, and conclusions expressed in this paper also 
should not be attributed to either Nielsen or Information Resources, 
Inc. (IRI). This research was conducted in collaboration with USDA 
under a Third Party Agreement with IRI.
---------------------------------------------------------------------------

    There are almost 50 million adults who rarely or never use the 
Nutrition Facts label. Of this population, nearly 32 million are 
overweight, are obese, or have hypertension, Table 11 and 12. FSIS 
estimated this proposed rule would impact a portion of these consumers 
by increasing the usability of nutrition labeling which will, in turn, 
improve their health and welfare.

Expected Costs of the Proposed Rule

    Quantitative costs for the proposed rule include relabeling, 
recordkeeping, and reformulation costs. FSIS anticipates allowing a 24-
month compliance period with a 36-month compliance for small 
businesses,\58\ consistent with FDA's final rules (81 FR 33742 and 81 
FR 34000). On December 1, 2014, FSIS issued a final rule that 
established January 1, 2018, as the uniform compliance date for new 
meat and poultry product labeling regulations that are issued between 
January 1, 2015 and December 31, 2016 (79 FR 71007). However, according 
to the uniform compliance date final rule, if any food labeling 
regulation involves special circumstances that justify a compliance 
date other than the uniform compliance date, FSIS will determine an 
appropriate compliance date and will publish that compliance date in 
the rulemaking (79 FR 71008). FSIS is proposing not to use the uniform 
compliance date for a final rule resulting from this proposed rule 
because, depending on when the final rule is published, the use of the 
uniform compliance date may result in a compliance period of less than 
24 months.
---------------------------------------------------------------------------

    \58\ Small Businesses are based on the Small Business 
Administration (SBA) size standards. The SBA defines a small 
business in NAICS code 311611--Animal (except Poultry) Slaughter and 
NAICS code 311612--Meat Processed from Carcasses as having less than 
1,000 employees. A business in NAICS code 311615--Poultry Processing 
has a small business standard of less than 1,250 employees and NAICS 
code Seafood Product Preparation and Packaging has a less than 750-
employee standard.
    United States Small Business Administration (SBA), Table of 
Small Business Standards Matched to North American Industry 
Classification System Codes. Effective February 26, 2016. Available 
at https://www.sba.gov/sites/default/files/files/Size_Standards_Table.pdf.
---------------------------------------------------------------------------

    The combined expected annualized costs equal $10.8 million 
annualized at a 3 percent rate over 20 years. The one-time costs, 
staggered over the first three years, are $165,540,072. In addition, 
consumers will incur costs associated with learning how to use new 
labels, which is a form of qualitative costs. What follows are details 
for each of the quantitative costs.

Relabeling Costs

    To estimate the costs associated with relabeling products under 
USDA jurisdiction, this analysis utilized the 2014 FDA Labeling Cost 
Model \59\ and Information Resources, Inc. (IRI) scanner data. The cost 
of relabeling depends on the number of labels required to change, 
whether or not the change can be coordinated with another label update, 
and the type of label change (extensive, major or minor). To determine 
the number of FSIS regulated labels in the retail market, we relied on 
IRI scanner data. Overall, there are 56,905 labels in the retail market 
under FSIS jurisdiction (14,056 private and 42,849 branded), though 
some are exempt from nutrition labeling per 9 CFR 317.400 and 381.500. 
To find the number of labels that are exempt, we utilized data from IRI 
and the National Meat Case Study. Data from IRI estimates 30.64 percent 
(3,619 private and 13,806 branded labels) of meat and poultry products 
are fresh in the retail market, thus possibly eligible for a labeling 
exemption. Of these products, approximately 39 percent do not have

[[Page 6766]]

nutrition labeling.\60\ Therefore, we estimate there are 50,110 FSIS 
labels with nutrition labeling; 12,645 private (14,056 - (3,619 x 39%)) 
and 37,465 branded (42,849 - (13,806 x 39%)). See Table 2 below for 
details.
---------------------------------------------------------------------------

    \59\ RTI International. ``2014 FDA Labeling Cost Model.'' 
Prepared by Mary K. Muth, Samantha Bradley, Jenna Brophy, Kristen 
Capogrossi, Michaela C. Coglaiti, and Shawn A. Karns. Contract No. 
HHSF-223-2011-10005B, Task Order 20, August 2015.
    \60\ National Cattlemen's Beef Association, 2010. A Snapshot of 
Today's Retail Meat Case, 2010 National Meat Case Study Executive 
Summary. Available here: http://www.beefretail.org/CMDocs/BeefRetail/research/2010NationalMeatCaseStudy.pdf.

                         Table 2--Total Number of FSIS UPCs With Nutrition Facts Labels
----------------------------------------------------------------------------------------------------------------
                                                                                  Number of UPCs
                          Type of label                             Total FSIS      exempt from     Total FSIS
                                                                      labels            NFL        UPCs with NFL
----------------------------------------------------------------------------------------------------------------
Branded.........................................................          42,849           5,384          37,465
Private.........................................................          14,056           1,411          12,645
                                                                 -----------------------------------------------
    Total.......................................................          56,905           6,795          50,110
----------------------------------------------------------------------------------------------------------------

    Using SBA's small business definition of small business and IRI 
scanner data, FSIS estimates 53.6 percent of UPCs are from small 
businesses and 46.4 percent of UPCs are from large. The 26,859 UPCs 
(53.6 percent of 50,110) from small manufacturers have 36 months to 
comply with the proposed regulations and the 23,251 (46.4 percent of 
50,110) from large manufacturers will have 24 months to comply. In 
total, there are 6,778 private labels (12,645 x 53.6%) and 20,081 
branded labels (37,465 x 53.6%) for small businesses, and 5,867 private 
labels (12,645 x 46.4%) and 17,384 branded labels (37,465 x 46.4%) for 
large businesses. The Small Business Administration (SBA) defines a 
small business in NAICS code 311611--Animal (except Poultry) Slaughter 
and NAICS code 311612--Meat Processed from Carcasses as having less 
than 1,000 employees.\61\ A business in NAICS code 311615--Poultry 
Processing has a small business standard of less than 1,250 employees 
and NAICS code Seafood Product Preparation and Packaging has a less 
than 750-employee standard. \62\
---------------------------------------------------------------------------

    \61\ United States Small Business Administration (SBA), Table of 
Small Business Standards Matched to North American Industry 
Classification System Codes. Effective February 26, 2016. Available 
at https://www.sba.gov/sites/default/files/files/Size_Standards_Table.pdf.
    \62\ United States Small Business Administration (SBA), Table of 
Small Business Standards Matched to North American Industry 
Classification System Codes. Effective February 26, 2016. Available 
at https://www.sba.gov/sites/default/files/files/Size_Standards_Table.pdf.
---------------------------------------------------------------------------

    To adjust for inflation in the 2014 FDA Labeling Cost Model, we 
updated the wage rates using the most current (2015) wages and applied 
a benefits and overhead factor of two to estimate the total cost per 
type of label change. The cost estimates in 2015 U.S. Dollars (USD) are 
$572 per label (with a range of $141 to $1,620) for minor coordinated 
changes and $3,887 per label (with a range of $1,842 to $7,741) for 
minor uncoordinated changes (FDA Labeling Cost Model, 2014). The cost 
estimates in 2015 USD are $1,152 per label (with a range of $296 and 
$3,204) for major coordinated changes and $9,401 per label (with a 
range of $5,125 to $17,400) for major uncoordinated changes. The cost 
estimate in 2015 USD is $13,858 per label (with a range of $7,038 and 
$25,399) for both coordinated and uncoordinated extensive changes.
    Based on FDA's Labeling Cost Model, the majority of the label 
changes required by the proposed rule are considered minor. Minor 
changes are categorized as alterations that do not require the entire 
label to be redesigned, e.g., changing a single color or updating the 
ingredient list. In contrast, a major change requires completely 
redesigning a label, e.g., changing multiple colors or modifying the 
front of the package. An extensive change is a major format change 
requiring a modification to the product packaging to accommodate 
labeling information. An example of an extensive change is increasing 
the package surface area.
    Over 24 percent of the labels will undergo a major change; 22.8 
percent (11,432/50,110) for the dual column and 1.6 percent (805/
50,110) for removing a front of package (FOP) health or nutrient claim 
in response to changes in the DVs, RACCs, or the definition of dietary 
fiber, Table 3. The estimate of products requiring a dual column label 
was determined using IRI scanner data and identifying packaged products 
containing between 200 to 300 percent of the RACC. From this group, 
packaged products that required further processing before consuming or 
that are traditionally eaten in combination with other products, such 
as raw meat, poultry, and condiments, were excluded as they are 
exempted from the dual column labeling requirements. Alterations of 
health and nutrient claims were dependent on updates in Daily Values, 
RACCs, or the definition of dietary fiber.
    Extensive changes are changes for products that may increase their 
package size to continue to make a health or nutrient content claim in 
response to the change in definition of a single-serving container. The 
proposed rule requires products that have RACCs of 100 g or larger and 
are packaged such that they contain more than 150 percent but less than 
200 percent of the RACC to be defined as a single-serving container. 
Using IRI scanner data, we identified the UPCs with RACCs over 100 g 
that contain more than 150 percent but less than 200 percent of the 
RACC and that make a health or nutrient content claim. Based on these 
criteria, we estimate 13 UPCs may have an extensive change due to 
increasing the package size to continue to make a health or nutrient 
content claim. See Table 3 below for details.

        Table 3--Number of Label Changes by Type of Label Changes
------------------------------------------------------------------------
         Type of change           Description of change   Number of UPCs
------------------------------------------------------------------------
Major..........................  Dual Column Label......          11,432
                                 FOP claim and RACC,                 805
                                  Daily Value, or fiber
                                  change.
Extensive......................  Over 100 g RACC and FOP              13
                                  claim.
Minor..........................  Total Minor Change.....          37,860
                                                         ---------------

[[Page 6767]]

 
    Total Number of NFL under    .......................          50,110
     USDA Jurisdiction.
------------------------------------------------------------------------

    As shown in Table 4--Label Changes That Can Be Coordinated with a 
Planned Change, private (store brand) labels change less frequently 
than branded labels. Allowing a producer to coordinate a required label 
change with a planned change saves costs associated with recordkeeping, 
labor, and materials. As such, under a 24 month compliance period for 
large businesses, changes to all branded labels will be coordinated 
with another planned label change. However, for private (store brand) 
labels only 26 percent will be coordinated with another change, and 74 
percent will be uncoordinated. Allowing small businesses 36 months to 
comply, all branded products can coordinate a change and 57 percent of 
private labels can coordinate the label changes, Table 4--Label Changes 
That Can Be Coordinated with a Planned Change. As a result, the mid-
point annualized cost at a 3 percent discount rate over 20 years for 
updating all of the labels under USDA jurisdiction is estimated to 
equal $4,484,734, with an average per label one-time cost of $1,371, 
Table 5. The total one-time cost, staggered over the total 36-month 
compliance period, is $68,723,156 with a range of $26,933,776 to 
$159,581,369.

                      Table 4--Label Changes That Can Be Coordinated With a Planned Change
----------------------------------------------------------------------------------------------------------------
                                                                                                     Weighted
                   Compliance period (months)                         Branded      Private label    average \1\
                                                                     (percent)       (percent)       (percent)
----------------------------------------------------------------------------------------------------------------
12..............................................................              11               5              10
18..............................................................              37              15              32
24..............................................................             100              26              82
30..............................................................             100              40              85
36..............................................................             100              57              89
42..............................................................             100             100             100
----------------------------------------------------------------------------------------------------------------
\1\ Based on IRI data analysis, 25% of FSIS labels are private and 75% are branded.
Source: August 2015, ``2014 FDA Labeling Cost Model''.


                                                         Table 5--Alternative 2--Labeling Costs
                                                        [24 Month for large, 36 months for small]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                       Small                           Large                                   Costs
                                         ---------------------------------------------------------------------------------------------------------------
                                              Private         Branded         Private         Branded          Lower           Mean            Upper
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Number of Labels..................           6,778          20,081           5,867          17,384  ..............  ..............  ..............
Coordinated Change:
    Major...............................             943           4,904             373           4,245      $3,097,640     $12,055,680     $33,529,860
    Minor...............................           2,919          15,172           1,153          13,134       4,565,298      18,520,216      52,452,360
Uncoordinated Change:
    Extensive...........................               2               5               1               5          91,494         180,154         330,187
    Major...............................             712               0           1,060               0       9,081,500      16,658,572      30,832,800
    Minor...............................           2,202               0           3,280               0      10,097,844      21,308,534      42,436,162
                                         ---------------------------------------------------------------------------------------------------------------
        Total Cost......................  ..............  ..............  ..............  ..............      26,933,776      68,723,156     159,581,369
Annualized Cost (3% DR, 20 Year)........  ..............  ..............  ..............  ..............       1,757,644       4,484,734      10,413,956
Annualized Cost (7% DR, 20 Year)........  ..............  ..............  ..............  ..............       2,376,035       6,062,598      14,077,899
Average Per label one time cost.........  ..............  ..............  ..............  ..............             537           1,371        3,184.62
Per label Annualized Cost (3% DR, 20      ..............  ..............  ..............  ..............              35              89             208
 Year)..................................
Per label Annualized Cost (7% DR, 20      ..............  ..............  ..............  ..............              47             121             281
 Year)..................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

Recordkeeping Cost

    This proposed rule requires that under certain circumstances 
manufacturers must maintain additional records to verify the amount of 
added sugars, dietary fiber, soluble fiber, insoluble fiber, vitamin E, 
and folate/folic acid in products. Thus, if adopted, manufacturers will 
be required to maintain records sufficient to verify the label 
declaration for these nutrients. Examples of appropriate retained 
records include nutrient database analyses, nutrient database 
calculation based on recipes or formulations, batch records, or any 
other information a

[[Page 6768]]

manufacturer retains which verify the nutrient content in the final 
product.
    We assume that manufacturers currently have records for added 
sugars, dietary fiber, soluble fiber, insoluble fiber, vitamin E, and 
folate/folic acid. However, the proposed changes will require 
manufacturers to maintain these records and verify as needed. Thus, the 
recordkeeping cost is the initial time burden for meat and poultry 
product manufacturers to maintain these records to verify the amount of 
such nutrients in a food and to make such records available to 
appropriate regulatory officials upon request. From IRI scanner data, 
we estimate there are roughly 3,307 manufacturers making products 
regulated by FSIS. The declaration of Vitamin E and folate/folic acid 
is not mandatory unless accompanied with a nutrient claim. However, 
consistent with FDA's Final RIA, FSIS estimates each manufacturer would 
incur six hours of recordkeeping burden, one hour for each nutrient, 
resulting in 19,842 recordkeeping hours for the industry as a whole. 
This estimate is likely an overestimate as not all manufacturers will 
need to keep records for added sugars, dietary fiber, soluble fiber, 
vitamin E, and folate/folic acid. According to the Bureau of Labor 
Statistics, Occupational Employment and Wages, the median hourly wage 
of an operations manager is $46.99 \63\ with a range of $31.13 to 73.21 
at the 25th and 75th percentile. In addition to the base wage, FSIS 
increased this cost by 100 percent to account for benefits and 
overhead. Consequently, FSIS assumed a mid-point total hourly 
compensation rate of $93.98 ($46.99 x 2) with a range of $62.26 (31.13 
x 2) to $146.42 (73.21 x 2). The total recordkeeping costs, discounted 
over 20 years using a 3 percent discount rate are an estimated $121,690 
with a range of $80,617 to $189,592.
---------------------------------------------------------------------------

    \63\ Bureau of Labor Statistics, Occupational Employment and 
Wages, May 2015. Mean hourly wage for 11-1021 General and Operations 
Managers. Accessed May 26, 2016. available at: http://www.bls.gov/oes/current/oes111021.htm#(1).

                                     Table 6--Estimated Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
                                                   Total annual                 Cost (in 2015 USD)
               Type of declaration                 recordkeeping -----------------------------------------------
                                                   burden hours        Lower            Mid            Upper
----------------------------------------------------------------------------------------------------------------
Added Sugars....................................           3,307        $205,894        $310,792        $484,211
Dietary Fiber...................................           3,307         205,894         310,792         484,211
Soluble Fiber...................................           3,307         205,894         310,792         484,211
Insoluble Fiber.................................           3,307         205,894         310,792         484,211
Vitamin E.......................................           3,307         205,894         310,792         484,211
Folate/Folic Acid...............................           3,307         205,894         310,792         484,211
                                                 ---------------------------------------------------------------
    Total.......................................          19,842       1,235,363       1,864,751       2,905,266
Annualized 3%, 20 years.........................  ..............          80,617         121,690         189,592
Annualized 7%, 20 years.........................  ..............         108,981         164,504         256,296
Median hourly wage for operations manager.......  ..............  ..............  ..............           93.98
25 percentile wage estimate.....................  ..............  ..............  ..............           62.26
75 percentile wage estimate.....................  ..............  ..............  ..............          146.42
----------------------------------------------------------------------------------------------------------------

Reformulation Costs

    The proposed rule could motivate food manufacturers to reformulate 
their products. Food manufacturers may reformulate their products due 
to the increased visibility of added sugars or to maintain a health or 
nutrient content claim driven by a change in the Daily Values or RACC 
and changes in the definition of dietary fiber. We estimate 
reformulation costs associated with each group in the sections below. 
Note that we do not anticipate reformulation costs for mandating trans 
fat labeling because trans fat in meat and poultry products are usually 
naturally occurring.
    Consistent with FDA, the Agency estimated costs using the 2014 FDA 
Reformulation Cost Model.\64\ The model accounts for variations in food 
product complexity, company size, compliance period, reformulation 
types and activities. Consistent with FDA, the Agency estimated the 
cost of reformulation for a minor nonfunctional ingredient at all 
complexity levels, (low, medium and high) at all company size levels, 
(small, medium and large). As defined by the reformulation model, small 
businesses have less than $1 million in annual sales, medium businesses 
have between $1-500 million in annual sales, and large businesses have 
over $500 million in sales. The reformulation model estimates all 
private label brands are medium businesses and branded products are 
small, medium or large, depending on the type of product or brand.
---------------------------------------------------------------------------

    \64\ RTI International. ``Reformulation Cost Model.'' Prepared 
by Mary K. Muth, Samantha Bradley, Jenna Brophy, Kristen Capogrossi, 
Michaela Coglaiti, Shawn Karns, and Catherine Viator. Contract No. 
HHSF-223-2011-10005B, Task Order 20, August 2015.
---------------------------------------------------------------------------

    The compliance period used in our estimate is 24 months for all 
businesses, as an estimate for a 36-month compliance period for a small 
business is not available in the model. The model only estimates the 
cost for small businesses at the 12 or 24-month compliance period and 
at the 12, 24 or 36 month for large businesses. Therefore, the 
reformulation cost estimates is an overestimate.
    To adjust for inflation in the 2014 Reformulation model, we 
adjusted the wage rates using the most current (2015) Consumer Price 
Index for All Urban Consumers and applied a benefits and overhead 
factor of two to estimate the total cost per formula. The cost per 
formula ranges from $4,723 to $361,371 for a high complexity product, 
$2,898 to $361,371 for a medium complexity product, and $2,264 to 
$338,918 for a low complexity product. The cost varies by the size of 
company, with large and medium businesses having higher costs per 
formula than small businesses.

Number of Product Reformulations for Added Sugars Declaration

    The proposed rule emphasizes the amount of sugar in a product by 
requiring a label to declare both the amount of ``Total Sugar'' and 
``Added Sugars'' with a Daily Reference Value (DRV) for added sugars of 
10 percent of calories.\65\ Manufacturers may decide to reformulate 
products in light of these

[[Page 6769]]

new requirements. This model uses IRI data to identify those USDA 
regulated products that exceed the proposed DRV for added sugars. Based 
on this proposed provision, FSIS regulates roughly 12,080 products 
where sugar contributes to more than 10 percent of the calories. 
Reformulation costs are based on the formula counts, not individual 
product labels. Many of these products have the same formula. For 
example, while there is one original Slim Jim formula, there is a 
plethora of products, e.g., in different sizes. Therefore, the FDA's 
Reformulation Cost Model was used to determine the number of formulas 
from the number of products. We found 10,518 formulas associated with 
these 12,080 products with high sugar content.
---------------------------------------------------------------------------

    \65\ 50 grams for children and adults 4 years of age and older 
and 25 grams for children 1 through 3 years of age.
---------------------------------------------------------------------------

    FSIS does not estimate that manufacturers would reformulate all 
10,518 products because reformulation is voluntary and can be quite 
expensive. We assume 7.5 to 9 percent (8.25%) of all formulas with high 
sugar content will reformulate, which is consistent with FDA's 
assumptions.\66\ Table 7 below summarizes the total formulas that may 
reformulate for added sugars.
---------------------------------------------------------------------------

    \66\ Regulatory Impact Analysis for Final Rules on ``Food 
labeling: Revision of the Nutrition and Supplement Facts Labels''. 
Docket No. FDA-2012-N-1210 and ``Food Labeling: Serving Sizes of 
Foods that can Reasonably be consumed at One Eating Occasion: Dual-
Column Labeling: Updating, Modifying, and Establishing Certain 
Reference Amounts Customarily Consumed; Serving Size for Breath 
Mints: and Technical Amendments'' Docket No. FDA-2004-N-0258., page 
70, available at: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM506797.pdf.

                    Table 7--Total Formulas That May Reformulate for Added Sugars Declaration
----------------------------------------------------------------------------------------------------------------
                                      Branded         Branded         Branded         Private
       Complexity formulas            (small)        (medium)         (large)        (medium)     Total formulas
----------------------------------------------------------------------------------------------------------------
High............................              93             205              87             213             598
Medium..........................              83              86              21              51             241
Low.............................               7               8               2              12              29
----------------------------------------------------------------------------------------------------------------

Number of Product Reformulations to Maintain Health and Nutrient 
Content Claims

    The proposed rule would disqualify some products from bearing a 
health or nutrient claim as a result of changes in the RACC categories, 
changes in Daily Values for certain vitamins and minerals, and 
modifications to the definition of fiber to exclude certain isolated 
and synthetic fibers from the definition. As a result, manufacturers of 
these products would either have to remove the claim from the product's 
label or reformulate in order to continue to make the claim.\67\
---------------------------------------------------------------------------

    \67\ To illustrate, consider these examples:
    1. Reformulate due to DV change--A Beef Tomato Sauce with 12 mgs 
of vitamin C makes a ``High in Vitamin C'' claim since it meets the 
claim requirement of 20 percent or more of the Vitamin C RDI per 
RACC. By increasing the Vitamin C RDI from 60 mg to 90 mg, the 
product can no longer make the claim.
    2. Reformulate due to New Fiber definition--A product with 
mostly synthetic fiber is making an ``excellent source of fiber'' 
fiber since certain synthetic and isolated fibers are included in 
the fiber definition. By removing some synthetic fibers from the 
fiber definition, the product can no longer make the claim.
---------------------------------------------------------------------------

    To determine the reformulation cost related to RACC changes, the 
Agency used IRI scanner data and identified 62 products with new or 
changing RACC categories with a health or nutrient claim (e.g., ``good 
source of . . .,'' ``low cholesterol,'' etc.). To determine the 
reformulation cost of Daily Value (DV) changes, we used IRI scanner 
data and identified 12 products with claims for the proposed vitamins 
and mineral DV changes (e.g., ``good source of Vitamin C''). For the 
fiber claims, we refined the IRI scanner data and identified 731 
products containing a synthetic or isolated fiber with a fiber claim. 
As noted above, reformulation costs are by formula counts, not by 
individual labels. We used FDA's Reformulation Cost Model to determine 
the number of formulas from the number of products. This work 
identified 53 formulas for RACC changes, 11 formulas for DV changes, 
and 654 formulas for new fiber definition. FSIS assumed that 
manufacturers will elect to reformulate 50 percent of their products 
and to remove the claim from the other 50 percent. Therefore, 365 
formulas will incur reformulation costs: 30 formulas for RACC, 6 
formulas for Daily Value and 329 formulas for fiber. The estimates may 
vary due to rounding in the business size and complexity categories. 
See Table 8 below for summary of the formulas that may reformulate due 
to the new fiber definition, or for changes in the Daily Vales or RACC.

               Table 8--Total Formulas That May Reformulate for New Fiber Definition, DV, or RACC
----------------------------------------------------------------------------------------------------------------
                                      Branded         Branded         Branded         Private
       Complexity formulas            (small)        (medium)         (large)        (medium)     Total formulas
----------------------------------------------------------------------------------------------------------------
High............................              56             127              59             103             345
Medium..........................               4               6               4               6              20
----------------------------------------------------------------------------------------------------------------

Total Reformulation Cost for Sugars Declaration and To Maintain Health 
and Nutrient Content Claims

    The mean one-time cost for reformulation is $77,294,020, with an 
average per formula one-time cost of $77,009. The annualized cost at a 
3 percent discount rate over 20 years for reformulation is $6,196,385, 
with a range of $2,908,387 to $10,019,460. One-time reformulation costs 
are $94,952,165 with a range of $44,567,540 to $153,536,199. See Table 
9 below for a summary of the estimated reformulation cost in 2015 
dollars.

                                   Table 9--Alternative 2--Reformulation Cost
----------------------------------------------------------------------------------------------------------------
                                                                       Lower            Mid            Upper
----------------------------------------------------------------------------------------------------------------
High Complexity Formulas........................................     $36,295,355     $77,294,020    $124,785,011

[[Page 6770]]

 
Med Complexity Formulas.........................................       7,488,995      15,983,483      25,998,357
Low Complexity Formulas.........................................         783,190       1,674,662       2,752,831
                                                                 -----------------------------------------------
    Total Cost..................................................      44,567,540      94,952,165     153,536,199
Annualized Cost (3% DR, 20 Year)................................       2,908,387       6,196,385      10,019,460
Annualized Cost (7% DR, 20 Year)................................       3,931,645       8,376,460      13,544,608
Average Per formula one time cost...............................          36,146          77,009         124,522
Per formula Annualized Cost (3% DR, 20 Year)....................           2,359           5,025           8,126
Per formula Annualized Cost (7% DR, 20 Year)....................           3,189           6,794          10,985
----------------------------------------------------------------------------------------------------------------

Quantitative Benefits of the Proposed Rule

    By ensuring that recommendations are based on current dietary 
guidelines and making the most salient information prominent, the 
proposed rule will benefit the nearly 186 million Americans who 
frequently or sometimes use nutritional facts and serving size labels. 
However, this Preliminary Regulatory Impact Analysis (PRIA) limits the 
quantitative benefits to the medical costs savings for overweight or 
hypertensive adults who report not using or rarely using Nutrition 
Facts labels that are expected to experience health benefits with 
increased label use and modified diet. The annual present value of 
benefits at a 3 percent discount rate over 20 years is estimated at 
$36,894,007. A detailed description of this analysis follows.
    As noted in the Need for Rule section above, a significant portion 
of U.S. citizens are overweight, obese, or hypertensive. Such 
conditions afflict individuals and society with poorer health and 
higher medical expenditures. It is well established that improved 
nutrition reduces overweight, obesity, and hypertension rates, which in 
turn reduces medical expenses.\68\ Based on the NHANES analysis, using 
and understanding the Nutrition Facts label is linked to healthier 
diets. If finalized, this proposed rule will improve nutritional labels 
by updating and simplifying the information found on them. The 
frequency of label usage will increase as improved, and simpler to 
understand information will be available to the consumer, which will, 
in turn, promote consumption of healthier diets, e.g., lower caloric or 
sodium consumption.
---------------------------------------------------------------------------

    \68\ Campos, A., J. Doxey, and D. Hammond. 2011. Nutrition 
labels on pre-packaged foods: a systematic review. Public Health 
Nutrition. 14: 1496-1506;, Dall, T.M., V.L. Fulgoni III, Y. Zhang, 
K.J. Reimers, P.T. Packard, and J.D. Astwood. 2009. Potential health 
benefits and medical cost savings from calorie, sodium, and 
saturated fat reductions in the American diet. American Journal of 
Health Promotion. 23: 412-422;, Mokdad, A.H., J.S. Marks, D.F. 
Stroup, and J.L. Gerberdin. 2004. Actual causes of death in the 
U.S., 2000. American Medical Association. 291: 1238-1245; and Young, 
L.R. and M. Nestle. 2002. The contribution of expanding portion 
sizes to the US obesity epidemic. American Journal of Public Health. 
83: 717-724.
---------------------------------------------------------------------------

    In this analysis, quantified benefits are a measure of expected 
health improvements resulting from increased label-use, causing diet 
modification for some overweight and hypertensive adults. The benefits 
analysis can be broken down into a series of steps. The first step is 
determining the baseline caloric and sodium intake for consumers by 
label-use. The second step is estimating the number of consumers who 
could potentially change their behavior from increased label-use 
because of this rule. The third step is estimating the change in diet 
from increased label-use. The final step is measuring the medical cost 
savings benefit using the Dall et al. (2009), Nutrition Impact Model, 
which links the health benefits and medical cost savings from 
reductions in caloric and sodium intake. A description of each step in 
the benefits analysis is given in this section.

Benefits Analysis: Baseline Caloric and Sodium Intake for Consumers by 
Label-Use

    The first step in this analysis is to determine the baseline 
relationship between caloric and sodium intake with label-use. To 
determine this relationship, FSIS used NHANES data to correlate use of 
nutritional and serving size labels with caloric and sodium intake. 
NHANES is a continuous CDC survey with data released in two-year 
segments. This analysis included data from the 2009-2010 survey. NHANES 
collects detailed information through questionnaires, dietary recall, 
and a physical exam. In the Flexible Consumer Behavior Survey (FCBS) 
section of NHANES, respondents provided information on how frequently 
they used nutritional and serving size information found on food 
labels. Also, respondents who reported rarely or never using labels 
provided reasons for not doing so.
    In the dietary recall component, respondents report everything they 
ate or drank, and where the food was obtained, for two days (two 24 
hour periods). Food obtained from a store or catalog was identified as 
food at home (FAH). This analysis excluded calories consumed away from 
home, as these foods typically do not include a Nutrition Facts label. 
Weights were applied to the dataset to account for the survey design 
(including oversampling of certain groups), survey non-response, and 
post stratification so that the population totals represent the U.S. 
Census civilian non-institutionalized adult population.
    The baseline links degree of label use, ranging from always to 
never, with average caloric, sugar and sodium intake, Table 1--Use of 
Nutritional Facts Label by Average Daily Caloric, Sodium and Sugar 
Intake from Food at Home. While data limitations prevent establishing 
causation between label use and behavior, the two are inversely 
correlated. Revealed in Table 1--Use of Nutritional Facts Label by 
Average Daily Caloric, Sodium and Sugar Intake from Food at Home, 
Nutrition Facts label use has an inverse relationship with total 
caloric, sugar and sodium intake. Based on this information, this 
analysis assumes if an average consumer who ``never'' used the 
Nutrition Facts label began to rarely read labels, they would reduce 
their daily caloric intake by 187 kcals. For most overweight or obese 
individuals, a stable daily reduction of 187 kcals would lead to weight 
loss and corresponding reductions in medical expenditures.\69\ Like 
caloric and sodium intake, sugar consumption is greater for

[[Page 6771]]

individuals that use nutrition information less.
---------------------------------------------------------------------------

    \69\ Dall et al. 2009--``With the 100-kcal reduction, for 
example, the number of obese adults would decline by more than 34 
million. Many obese adults would move into the overweight category, 
with a net decrease of overweight adults of close to 37 million . . 
. The prevalence of chronic conditions associated with excess weight 
would decline such that national medical expenditures would be 
approximately $58 billion lower than current spending levels.''
---------------------------------------------------------------------------

    Further, we find as nutritional label usage increases, not only is 
the average caloric intake reduced, but also the portion of calories 
from sugar is reduced. For consumers that ``never'' use the Nutrition 
Facts label, calories from sugar account for 27 percent of their total 
at home consumption.\70\ In contrast, for consumers that most 
frequently use the Nutrition Facts label, calories from sugar account 
for 23 percent of their total at home consumption.\71\ Overall, the 
less an individual uses nutritional information, the more sugar 
accounts for total caloric intake.
---------------------------------------------------------------------------

    \70\ Per Table 1--Use of Nutritional Facts Label by Average 
Daily Caloric, Sodium and Sugar Intake from Food at Home, consumers 
that ``never'' use the Nutrition Facts panel consume 1,741 kcal and 
122 grams of sugar from foods at home each day. A gram of sugar = 
3.87 calories. ((122mg*3.87)/1,741)
    \71\ Per Table 1--Use of Nutritional Facts Label by Average 
Daily Caloric, Sodium and Sugar Intake from Food at Home, consumers 
that ``Always or Most of the Time'' use the Nutrition Facts panel 
consume 1,439 kcal and 85 grams of sugar from foods at home each 
day. A gram of sugar = 3.87 calories. ((85mg*3.87)/1,439)
---------------------------------------------------------------------------

Benefits Analysis: Estimating the Number of Consumers Who Will 
Potentially Change Their Behavior

    This study monetizes the health benefits derived from adults:

--Who report rarely or never reading Nutrition Facts labels;
--Who are overweight or hypertensive;
--Whose reasons for not reading labels will be addressed by the 
proposed rule;
--Who are expected to change their behavior.

    For caloric reduction benefits, we only include overweight 
individuals who are maintaining or losing weight. This is because the 
Nutrition Impact Model assumed that all overweight adults are at weight 
equilibrium and not gaining weight. The overweight and gaining weight 
adults may not experience weight loss from a small reduction in caloric 
intake and therefore will not obtain the medical cost savings from 
weight loss as calculated in the Nutrition Impact Model. The caloric 
reduction benefits from the model is calculated by a constant reduction 
in caloric intake below the Estimated Energy Requirement \72\ (EER) 
(i.e. a level of caloric intake below that required to maintain current 
body weight) for a given weight, age, height and gender and physical 
activity level (PAL) for overweight adults. It takes about four years 
until a new weight equilibrium is reached where the EER equals the new 
daily caloric intake. Utilizing NHANES dietary recall data, most adults 
(72.8 percent \73\) are consuming at or below their EER. Although 
NHANES dietary recall data is self-reported and individuals, especially 
overweight or obese individuals, sometimes underreport caloric intake 
in these types of surveys 74 75, the dietary recall 
component of NHANES is used in reporting for the Dietary Guidelines for 
Americans and many other official government documents. Also, this 
finding is consistent with recent reports in which prevalence of 
obesity and overweight have stabilized and in some population groups 
have reduced in recent years.76 77 Therefore, this analysis 
measures the benefit of caloric reduction among overweight adult 
consumers maintaining or losing weight.
---------------------------------------------------------------------------

    \72\ For adult males: EER = 662 - (9.53 x age) + PAL x (15.91 x 
weight + 539.6 x height);
    For adult females: EER = 354 - (6.91 x age) + PAL x (9.36 x 
weight + 726 x height).
    \73\ The IOM PAL (1.11 for men and 1.12 for women) associated 
with low physical activity was utilized in estimating individuals 
EER. All other components of the IOM EER calculation (gender, age, 
weight, height) were derived from NHANES 2009-2010.
    \74\ Archer E, Hand GA, Blair SN (2013) Correction: Validity of 
U.S. Nutritional Surveillance: National Health and Nutrition 
Examination Survey Caloric Energy Intake Data, 1971-2010. PLoS ONE 
8(10): http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0076632.
    \75\ Champagne C, et al, (2002) Energy Intake and Energy 
Expenditure: A controlled Study Comparing Dietitians and Non-
dietitians, Journal of the American Dietetic Association, Available 
at: http://www.sciencedirect.com/science/article/pii/S0002822302903160.
    \76\ Ogden C.L., Carroll M.D., Kit B.K., Flegal K.M. Prevalence 
of obesity in the United States, 2009-2010. NCHS data brief, no 82. 
Hyattsville, MD: National Center for Health Statistics. 2012.
    \77\ Flegal K.M., Carroll M.D., Kit B.K., Ogden C.L. Prevalence 
of Obesity and Trends in the Distribution of Body Mass Index Among 
U.S. Adults, 1999-2010. JAMA. 2012;307(5):491-497. doi:10.1001/
jama.2012.39.
---------------------------------------------------------------------------

    NHANES data identified the number of overweight adults who are 
maintaining or losing weight that never or rarely use labels, Table 8. 
An overweight adult maintaining or losing weight has a Body Mass Index 
(BMI) of 25 or over, aged 16 years or older and consumes calories equal 
to or less than their Estimated Energy Requirement, EER.\78\ Based on 
NHANES data, 60 percent (9,501,972) of users who never read labels are 
either overweight or obese. Conversely, 64 percent (21,611,037) of 
label-users who rarely read labels are overweight or obese, Table 11. 
To find the number of overweight individuals maintaining or losing 
weight, we relied on NHANES data and the Institute of Medicine (IOM) 
EER calculation. Below are the IOM calculations:
---------------------------------------------------------------------------

    \78\ For adult males: EER = 662 - (9.53 x age) + PAL x (15.91 x 
weight + 539.6 x height);
    For adult females: EER = 354 - (6.91 x age) + PAL x (9.36 x 
weight + 726 x height).
---------------------------------------------------------------------------

    For adult males:

EER = 662 - (9.53 x age) + PAL x (15.91 x weight + 539.6 x height)

    For adult females:

EER = 354 - (6.91 x age) + PAL x (9.36 x weight + 726 x height)

    For a conservative estimate, the IOM PAL coefficient associated 
with sedentary activity estimated individuals EER (1.0 for men and 
women). All other components of the IOM EER calculation (gender, age, 
weight, height) were derived from NHANES 2009-2010 and calculated using 
SAS.\79\ The overweight individuals with a kcal intake at or less than 
their EER are maintaining or losing weight. The analysis found 
approximately 57.5 percent of these overweight rarely label-users are 
maintaining or losing weight, while 55.7 percent of overweight never 
label-users are maintaining or losing weight. In total, there are 
12,428,680 rarely label-users and 5,293,397 never label-users that are 
overweight and maintaining or losing weight, Table 11.
---------------------------------------------------------------------------

    \79\ SAS version 9.2 Cary, NC, 2011 http://www.sas.com/technologies/analytics/statistics/stat/index.html.
---------------------------------------------------------------------------

    Although the same person can experience health costs savings from 
both caloric and sodium reduction, it may overestimate benefits if 
using both the caloric and sodium reduction models. Therefore, to avoid 
double counting for the sodium reduction benefits, the analysis 
excluded the population benefiting from caloric reduction, overweight 
rarely and never label-users maintaining or losing weight. The sodium 
reduction analysis only includes hypertensive individuals who are 
normal weight or overweight and gaining weight. An estimated 461,384 
and 118,705 normal weight hypertensive adults rarely or never use 
labels, respectively. In addition, an estimated 563,394 rarely and 
551,856 never adult label-users are overweight and gaining weight with 
hypertension. In total, there are 1,024,778 rarely and 670,561 never 
hypertensive label-users who are normal weight or overweight and 
gaining weight, Table 12.
    While the proposed changes will help many normal weight, non-
hypertensive consumers use labels to maintain healthy diets, this 
analysis does not quantify these benefits.
    Identifying the reasons overweight or hypertensive consumers do not 
read nutritional and serving size information is another important 
factor in estimating

[[Page 6772]]

increased label use. NHANES respondents that rarely or never read 
nutrition information were able to select multiple reasons for not 
reading labels. Responses provided for not reading labels were mixed, 
Table 10. Many of the reasons for not reading labels are not addressed 
by this proposed rule and will not lead to increased label use: i.e. 
``I can't read English well'' or ``I usually buy food that I'm used to, 
so I don't feel the need to check labels.'' The proposed rule is 
intended to make the most important information more prominent and the 
entire label quicker to read, reducing the time spent gathering 
information on the label. As such, only those overweight or 
hypertensive consumers who exclusively selected a combination of ``the 
print is too small,'' ``I won't know what to look for,'' and ``I don't 
have time'' reasons for not reading labels were considered in the mid-
point benefits estimate. That group constitutes approximately 10 
percent. Of this group, approximately 1 percent exclusively replied 
``the print is too small,'' approximately 2 percent exclusively replied 
``I won't know what to look for,'' approximately 3 percent exclusively 
replied ``I don't have time,'' and approximately 4 percent gave a 
combination of these reasons for not using labels, Table 10. Excluded 
from the mid-point benefits estimate were consumers who reported not 
using labels because for a variety of reasons, they expressed little to 
no interest in the information, or because they could not read English. 
As such, this analysis assumes that only 10 percent of overweight/
hypertensive rarely/never users will increase their label use as a mid-
point estimate, Table 11 and 12.
    For the lower bound estimate, only those overweight or hypertensive 
consumers who exclusively gave ``the print is too small for me to 
read'' reason for not reading labels were considered (1 percent) as 
print size is directly changed by the regulation. The lower bound 
estimate excludes everyone who did not exclusively give ``the print is 
too small for me to read'' as a reason for not reading labels, 99 
percent of consumers.
    For the upper bound estimate, only those overweight or hypertensive 
consumers who selected one or more of the following reasons for not 
reading labels were considered: ``the print is too small,'' ``I won't 
know what to look for,'' and ``I don't have time''. This group 
constitutes approximately 44 percent. The upper bound estimate includes 
consumers who gave the three above reasons and does not exclude anyone 
if they gave other reasons for not using labels.

                      Table 10--Reasons Overweight Rarely and Never Users Do Not Use Labels
----------------------------------------------------------------------------------------------------------------
                                                                                                       Total
                                                                                     Exclusive    responses from
                                                  Total response     Exclusive       group, no       exclusive
         Reasons for not reading labels            with overlap    response \2\     overlap \3\      group w/
                                                      \1\ (%)           (%)             (%)         overlap \4\
                                                                                                        (%)
----------------------------------------------------------------------------------------------------------------
                                               Targeted Population
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr---------------------------------------------------------------
The print is too small for me to read...........              16               1              10              44
I won't know what to look for even if I read the              20               2
 labels.........................................
I don't have time...............................              24               3
----------------------------------------------------------------------------------------------------------------
                                                      Other
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr---------------------------------------------------------------
I usually buy foods that I'm used to, so I don't              53               7
 feel that I need to check labels...............
I buy what I or my family like, I don't care                  51               5
 about the labels...............................
I have a good diet so there is no need to check.              12               1
I'm satisfied with my health so there is no need              25               2
 for me to check................................
I don't think food labels are important to me...              15               2
I can't read English well.......................               8               2
Other/Refused/Don't know........................              14               8
----------------------------------------------------------------------------------------------------------------
 \1\ Total Response with Overlap includes the percentage of NHANES respondents who gave this reason for rarely
  or never using food labels.
\2\ Exclusive Response includes the percentage of respondents who only gave this reason for rarely or never
  using food labels. The lower-bound estimate is 1% for consumers who exclusively gave ``the print is too small
  for me to read'' reason.
\3\ Exclusive Group No Overlap includes the percentage of NHANES respondents who only gave some combination of 3
  reasons that are addressed by the rule: ``The Print is too small for me to read,'' ``I won't know what to look
  for even if I read the labels'' and or ``I don't have time''. This is the mid-point estimate.
\4\ Total Responses from Exclusive Group with Overlap includes the percentage of NHANES respondents who gave
  some combination of 3 reasons that are addressed by the rule: ``The Print is too small for me to read,'' ``I
  won't know what to look for'' and ``I don't have time''. This is the upper-bound estimate.
Source: NHANES. 2013. ``Questionnaires, Datasets, and Related Documentation'' Centers for Disease Control and
  Prevention. Accessed on 1/23/2014. http://www.cdc.gov/nchs/nhanes/nhanes_questionnaires.htm.

    Increasing label use does not necessarily lead to a change in 
behavior. Our analysis further refines the benefits analysis by 
estimating only a portion of the overweight or hypertensive rarely/
never label-users increasing their label use will potentially change 
their diet. This estimate was derived from data in the FDA 2008 Health 
and Diet Survey. In 2008, FDA asked consumers ``In the last two weeks, 
can you remember an instance where your decision to buy or use a food 
product was changed because you read the nutrition label?'' and 49 
percent of respondents said yes.\80\ As such, this analysis assumes 
only 49 percent of overweight/hypertensive consumers who increase label 
use will potentially change their behavior, Table 11 and 12. As a mid-
point estimate, there are 868,382 overweight users maintaining or 
losing weight that could potentially increase label use and reduce 
their caloric intake (1,772,208 * 49%). This estimate ranges from 
86,838 (177,221 * 49%) to 3,820,880 (7,797,714 * 49%) for the lower and 
upper bound, Table 11. As a mid-point estimate, there

[[Page 6773]]

are 83,072 hypertensive normal weight or overweight and gaining weight 
individuals that could potentially increase their label use and reduce 
their sodium intake (169,534 * 49%). This estimate ranges from 8,307 
(16,953 * 49%) to 365,515 (745,949 * 49%) for the lower and upper 
bound, Table 12.
---------------------------------------------------------------------------

    \80\ Choiniere, C.J. and A. Lando. 2008. ``FDA 2008 Health and 
Diet Survey--Consumer Behavior Research'' Accessed on 5/6/2014. 
<http://www.fda.gov/Food/FoodScienceResearch/ConsumerBehaviorResearch/ucm193895.htm.

                  Table 11--Calculating the Targeted Population for Caloric Reduction Benefits
----------------------------------------------------------------------------------------------------------------
                                                                      Rarely           Never          Totals
----------------------------------------------------------------------------------------------------------------
Start with all users............................................      33,653,297      15,807,324      49,460,621
Reduce to only:
    Overweight Users............................................      21,611,037       9,501,972      31,113,009
    Overweight users maintaining or losing weight...............      12,428,680       5,293,397      17,722,077
Lower bound population (1% of users)............................         124,287          52,934         177,221
Mid-point population (10% of users).............................       1,242,868         529,340       1,772,208
Upper bound population (44% of users)...........................       5,468,619       2,329,095       7,797,714
Lower bound population expected to change behavior (49% of lower          60,901          25,938          86,838
 bound pop.)....................................................
Mid-point population expected to change behavior (49% of mid-            609,005         259,376         868,382
 point pop.)....................................................
Upper bound population expected to change behavior (49% of upper       2,679,623       1,141,257       3,820,880
 bound pop.)....................................................
----------------------------------------------------------------------------------------------------------------
Source: NHANES. 2013. ``Questionnaires, Datasets, and Related Documentation'' Centers for Disease Control and
  Prevention. Accessed on 1/23/2014. http://www.cdc.gov/nchs/nhanes/nhanes_questionnaires.htm.


                   Table 12--Calculating the Targeted Population for Sodium Reduction Benefits
----------------------------------------------------------------------------------------------------------------
                                                                      Rarely           Never          Totals
----------------------------------------------------------------------------------------------------------------
Start with all users............................................      33,653,297      15,807,324      49,460,621
Reduce to only hypertensive users:
    Normal weight...............................................         461,384         118,705         580,089
    Overweight and gaining weight...............................         563,394         551,856       1,115,250
Total hypertensive normal weight or overweight and gaining             1,024,778         670,561       1,695,339
 weight.........................................................
Lower bound population (1% of users)............................          10,248           6,706          16,953
Target Population (10% of users)................................         102,478          67,056         169,534
Upper bound population (44% of users)...........................         450,902         295,047         745,949
Lower bound population expected to change behavior (49% of lower           5,022           3,286           8,307
 bound pop.)....................................................
Mid-point population expected to change behavior (49% of mid-             50,214          32,857          83,072
 point pop.)....................................................
Upper bound population expected to change behavior (49% of upper         220,942         144,573         365,515
 bound pop.)....................................................
----------------------------------------------------------------------------------------------------------------
Source: NHANES. 2013. ``Questionnaires, Datasets, and Related Documentation'' Centers for Disease Control and
  Prevention. Accessed on 1/23/2014. http://www.cdc.gov/nchs/nhanes/nhanes_questionnaires.htm.

Benefits Analysis: Estimating Changes in Diet

    FSIS assumed that the population expected to change its behavior 
will do so by moderately increasing its label-use from either never to 
rarely or rarely to sometimes. The expected diet change is the 
difference in caloric and sodium intake between each user group. 
Accordingly, the mid-point estimate of 259,376 overweight consumers who 
never use the Nutrition Facts label could potentially begin to rarely 
use labels and reduce their daily caloric intake by 187 kcals (1,741-
1,554). The mid-point estimate of 609,005 overweight consumers who 
rarely use the Nutrition Facts label could potentially begin to use 
labels sometimes and reduce their caloric intake by 92 kcal (1,554-
1,462). The same formula is followed for the normal weight consumers 
with hypertension resulting in a 87 mg daily sodium reduction for the 
32,857 former never label-users and 104 mg reduction for 50,214 former 
rarely label-users.

Benefits Analysis: Estimate the Economic Benefits of Caloric and Sodium 
Reduction

    To quantify the medical cost savings from reductions in caloric and 
sodium intake, FSIS used the Nutrition Impact Model developed by Tim 
Dall et al. (2009). The Nutrition Impact Model estimates the potential 
health benefits of weight loss by reducing daily caloric intake for 
overweight adults.
    The Nutrition Impact Model also estimates the benefits of sodium 
reduction in adults with hypertension. The model combines these 
benefits to estimate national medical costs savings from changes in 
dietary habits among the general adult population. The model concludes 
modest to aggressive changes in diet can improve health and reduce 
annual national medical expenditures by $60 to $120 billion.
    The Nutrition Impact Model used scientific reports and peer-
reviewed literature to quantify the relationships between dietary 
change, body mass index, and blood pressure (Systolic BP/Diastolic BP) 
and between these same factors and disease risk. By modeling the 
reduction in health conditions associated with long-term improved 
nutritional intake, the model can measure the potential health 
conditions averted by reducing daily caloric and sodium intake in the 
American diet. For example, weight loss can improve or prevent many 
diseases risks such as cancer and diabetes, resulting in a medical 
savings. The benefits of caloric reductions in overweight adults is 
measured by the medical savings of reductions in the following health 
conditions; arthritis, asthma, cancer, cerebrovascular disease, 
congestive heart failure, coronary heart disease, diabetes, esophagus/
stomach disease, gallbladder disease, gynecological conditions, kidney/
urinary disease, other cardiovascular disease, and sleep apnea. The 
benefits of sodium reductions are measured by the medical savings of 
reductions in hypertension cases. Some health conditions are jointly 
attributed to multiple risk factors.

Caloric Reduction Benefits

    For caloric reductions benefits, the Nutrition Impact Model begins 
to calculate the benefits starting in the fourth year of diet as weight 
loss is more

[[Page 6774]]

significant in the first few years then stabilizes in year four with 
little additional weight loss. As discussed in the Nutrition Impact 
Model, if the total overweight and obese population (139 million people 
in 2007) reduced their daily caloric intake by 100 kcal, many obese 
adults would move into the overweight category while many overweight 
adults would move into the normal weight category. In turn, the 
prevalence of chronic health conditions associated with excess weight 
would be reduced. There would be 1.7 million fewer cases of coronary 
heart disease and 1.5 million fewer cases of type 2 diabetes in a given 
year. Overall, a 100 kcal reduction in the diets of all U.S. overweight 
adults (139 million) will lead to $58.4 billion in national medical 
costs savings annually, or $420 ($58.4B/139M) per overweight adult 
after a period of four years. Also, the Nutrition Impact Model 
concludes that if the overweight and obese population reduced its daily 
caloric intake by 500-kcal, almost the entire U.S. adult population 
would stabilize at normal weight levels with national medical savings 
at $110.5 billion, or $795 per overweight person.
    As displayed in Table 13, our analysis expects potentially 259,376 
overweight adults to reduce their total caloric intake by 187 kcal and 
609,005 adults to reduce their total caloric intake by 92 kcal as the 
mid-point estimate. The Nutrition Impact Model estimates a 92 kcal 
reduction could potentially result in $55 billion of annual medical 
savings after 4 years or $395.68 ($55B/139M) dollars per person. For a 
187 kcal reduction, the potential annual medical savings is $84 billion 
or $575.54 ($84B/139M) per person after four years. Table 13 provides 
details of the distribution of increased label users, associated 
reductions in calories, and potential savings.
    Recognizing that individuals will benefit from both improved FDA 
and FSIS labels, this analysis took additional steps to distill out 
benefits specific to FSIS products with Nutrition Facts labeling. 
First, our analysis scaled down the estimate by only including the 
average caloric and sodium intake of FSIS products for adults. Using 
Table 1B--Mean Intake of Energy and Mean Contribution (KCAL) of Various 
Foods among U.S. Population by Age from the National Cancer 
Institute,\81\ we estimate about 397 of the 2,199 daily calorie 
consumption (18.1 percent) from adults are derived from USDA products 
affected by this rulemaking.\82\ These products include all chicken and 
chicken mixed dishes, beef and beef mixed dishes, burgers, sausages, 
franks, bacon and ribs and some pizzas, pasta dishes, and eggs and egg 
mixed dishes.
---------------------------------------------------------------------------

    \81\ Sources of Energy among the U.S. Population, 2005-06. 
Applied Research Program Web site. National Cancer Institute. http://appliedresearch.cancer.gov/diet/foodsources/energy/. Table 1B. 
Updated April 11, 2014. Accessed June 21, 2014.
    \82\ FDA estimated 353 of 2,157 calories (16.4 percent) an 
average American consumes daily come from USDA products in FDAs 
Nutrition Facts/Serving Sizes Combined PRIA. This differs from our 
estimate by age, group and food product category. FDA used the 
average kcal intake for all age groups, including children (2,157) 
and our estimate used the average kcal for adults age 19 plus 
(2,199). Also, we assumed half of pizzas and pasta dishes were USDA 
products and FDA did not. FDA included cold cuts, which was not 
included in the 30 most common food groups in adult diets.
---------------------------------------------------------------------------

    In addition, although the analysis only incorporates sodium and 
caloric intake from food at home, some meat and poultry products are 
exempt from nutrition labeling, and therefore removed from the benefits 
analysis. As discussed in the cost section above, we estimate 
approximately 11.95 percent (30.64% * 39%) of food-at-home meat and 
poultry products are exempt from nutrition labeling. Therefore, our 
analysis further scales back the benefits estimate first by removing 
81.9 percent for the kcal intake of FDA products and second by removing 
11.95 percent for the FSIS products exempt from nutrition labeling. 
This results in the mid-point annual benefits of $79,173,871 (496M * 
(100% - 81.9%) * (100% - 11.95%)) for caloric reduction. The lower 
bound estimate is $7,917,474 and upper bound estimate is $348,365,416, 
Table 13.

                                        Table 13--Annual Medical Savings from Reducing Caloric Intake [supcaret]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                    Lower bound     Mid-point
                                                Lower bound   Mid-point   Upper bound   Potential      total          total         Upper bound total
                   User type                     number of    number of    number of   savings per   potential      potential       potential savings
                                                   users        users        users        person      savings        savings
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sometimes.....................................       60,901      609,005    2,679,623      $395.68  $24,097,308    $240,971,098           $1,060,273,229
Rarely........................................       25,938      259,376    1,141,257       575.54   14,928,357     149,281,263              656,839,054
                                               ---------------------------------------------------------------------------------------------------------
Annual benefits after 4 years ($ 2007)........  ...........  ...........  ...........  ...........   39,025,665     390,252,361            1,717,112,283
Annual benefits after 4 years ($ 2015) *......  ...........  ...........  ...........  ...........   49,679,672     496,791,256            2,185,883,936
Benefits from USDA products ($ 2015)..........  ...........  ...........  ...........  ...........    7,917,474      79,173,871              348,365,416
--------------------------------------------------------------------------------------------------------------------------------------------------------
[supcaret] It is expected to take 4 years for the medical benefits from a reduction in calories to be experienced.
\2\ CPI-U for Medical Care of 1.273% was used to adjust for inflation (2007-2015).

Sodium Reduction Benefits

    While the benefits of caloric reduction weight-loss are measured at 
year four in the Nutrition Impact Model, sodium reduction benefits are 
experienced right away. In most individuals, blood pressure is reduced 
within days to weeks of reducing sodium intake.\83\ Therefore, the 
potential benefits are estimated in the first year for increased label 
use for adults with hypertension. The Nutrition Impact Model estimates 
1.5 million fewer cases of hypertension with a potential annual savings 
of $2.3 billion if adults with hypertension reduced their daily sodium 
intake by 400 mg.
---------------------------------------------------------------------------

    \83\ He F.J., Li J., and G.A. MacGregor. 2013. Effect of longer-
term modest salt reduction on blood pressure. Cochrane Database of 
Systematic Reviews. Issue 4. Art. No,: CD004937. DOI: 10.1002/
14651858.CD004937. pub2.
---------------------------------------------------------------------------

    As displayed in Table 14, our mid-point estimate expects 32,857 
adults with hypertension to reduce their sodium intake by 87 mg for 
food at home, and 50,214 adults with hypertension to reduce their 
sodium intake by 104 mg for food at home. The Nutrition Impact Model 
estimates a 104 mg daily sodium reduction for all adults with 
hypertension results in $1.17B dollars of annual medical savings, or 
$27.86 ($1.17B/42M) dollars per person. For an 87 mg daily sodium 
reduction for all adults with hypertension, the potential annual 
medical savings are $1.11B, or $26.43 ($1.11B/42M) per person.
    As calculated with the caloric benefits, our analysis scaled down 
the estimate for sodium reduction benefits by only incorporating the 
average sodium intake of FSIS products with labeling for adults. Using 
Table 1B--Mean Intake of Sodium, Mean Intake of Energy, and Mean Sodium 
Contribution

[[Page 6775]]

(mg) of Various Foods Among US Population, by Age, NHANES 2005-06,\84\ 
we estimate about 965 of the 3,535 daily sodium consumption (27.3% 
percent) from adults are derived from USDA products. These products 
include all chicken and chicken mixed dishes, beef and beef mixed 
dishes, burgers, cold cuts, sausages, franks, bacon and ribs and some 
pizzas, pasta dishes, and eggs and egg mixed dishes.
---------------------------------------------------------------------------

    \84\ Sources of Energy among the U.S. Population, 2005-06. 
Applied Research Program Web site. National Cancer Institute. http://appliedresearch.cancer.gov/diet/foodsources/energy/. Table 1B. 
Updated April 11, 2014. Accessed June 21, 2014.
---------------------------------------------------------------------------

    In addition, as discussed in the caloric reduction benefits section 
above, we scaled back the potential benefits by 11.95 percent for the 
food-at-home FSIS products that are exempt from nutrition labeling. 
Overall, our benefits estimate scales back the benefits by removing 
72.7 percent for the sodium intake of FDA products and removing 11.95 
percent for the FSIS products exempt from nutrition labeling, resulting 
in the mid-point annual benefits estimate of $693,815 ($2.9M*(100%-
72.7%) * (100%-11.95%)) for sodium reduction. The lower bound estimate 
is $69,389 and upper bound estimate is $3,052,804, Table 14.

                                         Table 14--Annual Medical Savings from Reducing Sodium Intake [supcaret]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                             Lower bound     Mid-point      Upper bound
                                                         Lower bound   Mid-point   Upper bound   Potential      total          total           total
                       User type                          number of    number of    number of   savings per   potential      potential       potential
                                                            users        users        users        person      savings        savings         savings
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sometimes..............................................        5,022       50,214      220,942       $27.86     $139,913      $1,398,962      $6,155,444
Rarely.................................................        3,286       32,857      144,573        26.43       86,849         868,411       3,821,064
Annual benefits after 4 years ($ 2007).................  ...........  ...........  ...........  ...........      226,762       2,267,373       9,976,508
    Annual benefits after 4 years ($ 2015) *...........  ...........  ...........  ...........  ...........      288,668       2,886,366      12,700,095
    Benefits from USDA products ($ 2015)...............  ...........  ...........  ...........  ...........       69,389         693,815       3,052,804
--------------------------------------------------------------------------------------------------------------------------------------------------------
[supcaret] It is expected to take 4 years for the medical benefits from a reduction in calories to be experienced.
\2\ CPI-U for Medical Care of 1.273% was used to adjust for inflation (2007-2015).

Summary of Potential Benefits Over 20 Years With a 24 Month Compliance 
Period for Large and 36 Month Compliance Period for Small Businesses

    The welfare gains from caloric and sodium reduction estimated above 
reflect the full annual potential impact of the regulation without 
adjusting for the potential lag between reaching a particular weight 
and experiencing the associated health outcomes and medical cost 
savings. However, industry would need time to modify labels under the 
new regulations. Table 15 uses the FDA Cost Label model \85\ to 
estimate the frequency of label changes in twelve-month increments. As 
shown in Table 4--Label Changes That Can Be Coordinated with a Planned 
Change, only 10 percent of all labels will be updated by the end of the 
first year and 82 percent by the end of the second year. After 24 
months, all large manufacturers are in compliance and 82 percent of 
small businesses are in compliance. Based on IRI scanner data and SBA 
small business standards, 53.6 percent of FSIS labels are from small 
businesses and 46.4 percent are from Large. Therefore, after 24 months, 
90.35 percent of FSIS's Nutrition Facts labels are updated ((100% of 
Large * 46.4% of labels) + (82% of Small * 53.6% of Labels)). After 36 
months, 100 percent of FSIS's nutrition facts labels are updated.
---------------------------------------------------------------------------

    \85\ RTI International. ``2014 FDA Labeling Cost Model.'' 
Prepared by Mary K. Muth, Samantha Bradley, Jenna Brophy, Kristen 
Capogrossi, Michaela C. Coglaiti, and Shawn A. Karns. Contract No. 
HHSF-223-2011-10005B, Task Order 20, August 2015.
---------------------------------------------------------------------------

    To arrive at the present value estimate of potential benefits, FSIS 
multiplied the percentage of label changes in each 12 month period by 
the annual potential benefits estimate. The percentage of label changes 
estimates the percentage of updated labels at a given time: 10 percent 
after 12 months, 90.35 percent after 24 months, and 100 percent after 
36 or more months. Again, the Nutrition Impact Model estimates benefits 
immediately for reductions in sodium intake and at year four for 
reductions in caloric intake. Therefore, benefits for caloric reduction 
start four years after the labels update while benefits for sodium 
reduction are realized as the labels are updated. For example, as is 
shown in Table 4--Label Changes That Can Be Coordinated with a Planned 
Change, 12 months after publication of the final rule, an estimated 10 
percent of FSIS labels are changed, resulting in 10 percent of the 
annual sodium benefits and no quantified benefits for the caloric 
intake reductions. After 24 months, 90.35 percent of Nutrition Facts 
labels are updated, resulting in 90.35 percent of the annual sodium 
benefits and no quantified benefits for the caloric intake reductions. 
The benefits in year 6 are a product of 100 percent of the sodium 
reduction benefits and 10 percent of the caloric reduction benefits as 
four years have passed since 10 percent of the labels were updated. Not 
until year seven are the full annual sodium and caloric reduction mid-
point benefits without latency applied.
    FSIS could not determine the weight-level-to-health outcome latency 
for each health condition included in the Nutrition Impact Model. But, 
to try and account for this latency, FSIS assumed a uniform health 
impacts time pattern between present age and age 80 and a uniform age 
distribution between age 18 and 79 to determine weighting factors that 
could be applied to the benefits estimates from the Nutrition Impact 
Model to calculate the present and annualized benefits. FSIS multiplied 
average weighting factors of 0.665 (3 percent discount rate) and 0.458 
(7 percent discount rate) by the present value annual benefit from 
caloric and sodium reduction to estimate the total annual health impact 
for each year. FSIS is requesting comment on accounting for latency 
between weight change and health outcomes.
    The mid-point present value, discounted at 3 percent rate is $549 
million and $239 million with a 7 percent discount rate. The mid-point 
annual benefit is $37 million at a 3 percent discount rate and $23 
million at 7 percent. The lower bound estimate is $3,689,445 and upper 
bound estimate is $162,333,818 at a 3 percent discount rate, Table 15.

[[Page 6776]]



   Table 15--Present Value of Benefits Over 20 Years Given a 24 Month Compliance Period for Large and 36 Month
                                     Compliance Period for Small Businesses
----------------------------------------------------------------------------------------------------------------
                                                                                  Mid-point
                                                               Lower bound      benefits from      Upper bound
                           Year                               benefits from      caloric and      benefits from
                                                               caloric and         sodium          caloric and
                                                            sodium reduction     reductions     sodium reduction
----------------------------------------------------------------------------------------------------------------
NPV 3%....................................................       $54,889,631      $548,889,659    $2,415,117,294
NPV 7%....................................................        23,880,540       238,802,476     1,050,732,115
Annual PV 3%..............................................         3,689,445        36,894,007       162,333,818
Annual PV 7%..............................................         2,254,154        22,541,264        99,181,679
----------------------------------------------------------------------------------------------------------------

Uncertainty in the Quantitative Benefits Analysis

    The ramifications of the proposed rule are not expected to have a 
significant impact on the food market. As a mid-point estimate, we 
estimate potentially 609,005 adults would potentially reduce their 
caloric intake by 92 kcals, and 259,376 adults will potentially reduce 
their caloric intake by 187 kcals for FDA and FSIS regulated products. 
Additionally, as a mid-point estimate, we estimate potentially 50,214 
adults would potentially reduce their sodium intake by 104 mg and 
32,857 adults would potentially reduce sodium intake by 87 mg for FDA 
and FSIS regulated products. Only a small portion of the caloric and 
sodium intake are from meat or poultry products as only 18 percent of 
all caloric intake is from FSIS products. Further still, this small 
change in diet may lead to increased consumption of lower calorie or 
lower sodium products, including food products reformulated in response 
to the changes on the label. Therefore, we estimate the market impact 
will distribute across all food markets with minimal impact on meat and 
poultry markets. The benefits analysis for the proposed rule may 
underestimate the full consumer welfare gain for several reasons. This 
analysis only includes the potential medical savings for the overweight 
and hypertension population that sparsely uses labels. The analysis 
does not account for benefits in diet modifications for children under 
the age of 16 or most people of normal weight. Though, we can expect 
the diet behavior of adults to transfer to their children under the age 
of 16. Normal weight consumers and consumers currently using labels 
when buying food may modify their diet and benefit from the new content 
and design on the Nutrition Facts label. The analysis only includes 
benefits from caloric and sodium reductions leading to averted health 
conditions associated with hypertension, overweight and obesity. Many 
major health conditions are associated with obesity; therefore the 
medical savings benefit for calorie reduction weight-loss is 
substantial in overweight and obese individuals. However, other 
modifications to the label, such as updates to RACCs and Daily Values 
for added sugars, nutrients and minerals, may help consumers adjust 
their diet and improve their personal welfare. Modifications such as 
the dual column labels will simplify the calculation for total 
nutrients in an entire package, which may contribute to a healthful 
diet. Additionally, health benefits from caloric reduction do occur 
before four years, and health benefits may continue to increase over 
time; however the Nutrition Impact Model begins to calculate the 
benefits from caloric reductions starting at year four. FSIS has no 
means to quantify these benefits. Further, there may be indirect 
benefits to reducing caloric and sodium intake through improved 
lifestyle, wages, or productivity that are not measured in this 
benefits estimate. Therefore, the resulting potential benefits estimate 
should be interpreted as an underestimate of overall benefits.
    However, data supporting the benefits analysis is from national 
consumer surveys where results are on self-reported behavior changes, 
which could potentially overstate actual results. In addition, the 
consumers in our quantitative benefits estimate may lose utility 
associated with consuming products high in sugar, calories and 
sodium.\86\ Furthermore, as noted earlier in the analysis, the 
available estimates of the relationship between label use and calorie 
and sodium intake generally establish only correlation, but the way 
they are used to develop benefits estimates reflects an assumption of 
causation. Therefore, in some instances, the analysis may overestimate 
the welfare gains.
---------------------------------------------------------------------------

    \86\ Ashley, Elizabeth M., Clark Nardinelli and Rosemarie A. 
Lavaty. ``Estimating the Benefits of Public Health Policies that 
Reduce Harmful Consumption.'' Health Economics 24(5): 617-624. May 
2015. http://onlinelibrary.wiley.com/doi/10.1002/hec.3040/full.
---------------------------------------------------------------------------

Qualitative Benefits

    FSIS believes there are several additional benefits associated with 
the proposed changes which are hard to quantify. To start, the millions 
of normal weight not hypertensive users who currently use nutritional 
information will benefit from the clearer label format. Additionally, 
the proposed changes would harmonize the labels between FDA and USDA 
products, reducing producer administration costs. Further still, the 
proposed changes could potentially simplify the communication of hard 
to distinguish, but sought after, product attributes benefiting both 
producers and consumers.
    The mandatory declaration of trans fat, added sugars, vitamin D and 
potassium and other changes on the Nutrition Facts label will assist 
consumers in making informed choices and maintaining healthy dietary 
practices. Consumers can better determine which products are suitable 
for their personal preference and dietary needs. The more up-to-date 
information included on the Nutrition Facts label better reflects the 
current recommendations for American diets, allowing consumers to make 
informed decisions leading to an increase in consumer welfare.
    Small businesses will benefit from the additional 12-month 
compliance period. Allowing small businesses additional time to comply 
reduces costs of relabeling, reformulation and recordkeeping and allows 
additional time to understand and implement the proposed regulations.
    Also, the Agency believes that the public would be better served by 
having the regulations governing nutrition labeling consolidated in one 
part of title 9. Rather than searching through two separate parts of 
title 9--317 and 381--to find the nutrition labeling regulations, 
interested parties would only have to survey one, 9 CFR part 413, to be 
able to apply nutrition panels to their meat and poultry products.

[[Page 6777]]

Alternative Regulatory Approaches

    Four alternatives, Table 16, are considered for the proposed 
serving size and Nutrition Facts label proposed rule.
     Alternative 1: Take no regulatory action by continuing 
with the existing labeling requirements.
     Alternative 2: The proposed rule, giving large 
manufacturers a 24-month compliance period and small manufacturers 36-
months.
     Alternative 3: The proposed rule, giving manufacturers a 
42-month compliance period.
     Alternative 4: The proposed rule, giving all manufacturers 
24-months to comply.
     Alternative 5: The proposed rule, giving large 
manufacturers a 12-month compliance period and small manufactures 24-
months.

                               Table 16--Comparison of the Considered Alternatives
----------------------------------------------------------------------------------------------------------------
      Considered Alternative             Benefits \1\               Costs \1\               Net benefits \1\
----------------------------------------------------------------------------------------------------------------
1--Take No Action.................  Zero.................  Zero......................  Zero.
2--The Proposed Rule--24-month      About 1 million        Costs equal $10.8 million.  In addition to the $26.1
 compliance large, 36-month          consumers would        Relabeling FSIS products    million in net benefits,
 compliance small.                   increase their label   will be coordinated and     the proposed rule would
                                     use, leading to        uncoordinated and is        harmonize USDA and FDA
                                     roughly $36.9          estimated to cost           labels and give small
                                     million in health      industry $4.5 million.      businesses additional
                                     benefits. Small        Recordkeeping costs are     compliance time.
                                     businesses benefit     estimated at $121,690.
                                     from the additional    Reformulation is expected
                                     compliance time.       to cost industry $6.2
                                                            million.
3--42-month Compliance Period.....  The extended           Costs equal $7.8 million.   Net benefits are $28.6
                                     compliance period      The extended compliance     million. In comparison
                                     delays the speed at    period reduces labeling     to alternative 2,
                                     which an estimated 1   costs to $2.3 million by    benefits are reduced 1.4
                                     million consumers      allowing all coordinated    percent, and costs are
                                     would increase their   changes. Recordkeeping      reduced 27.9 percent.
                                     label use. This        costs remain at $121,690.   However, alternative 3's
                                     delay reduces health   Reformulation costs are     compliance period is
                                     benefits to $36.4      expected to cost $5.3       longer than alternative
                                     million.               million. Consumers and      2's, delaying benefits.
                                                            producers would incur
                                                            costs because FSIS and
                                                            FDA labels would be
                                                            inconsistent.
4--24-month Compliance Period.....  About 1 million        Costs equal to $11.4        Net benefits are $25.8
                                     consumers would        million. Small businesses   million, 1 percent lower
                                     increase their label   do not have additional      than alternative 2's.
                                     use leading to         time to comply,             While benefits are
                                     roughly $37.2          increasing labeling costs   $288,829 higher than
                                     million in health      to $5.1 million for the     alternative 2's, costs
                                     benefits.              additional uncoordinated    are $619,687 higher. The
                                                            changes. In addition,       increase in benefits may
                                                            reformulation is expected   be reduced due to
                                                            to increase to $6.2         confusion between
                                                            million. Recordkeeping      inconsistent FSIS and
                                                            costs remain at $121,690.   FDA labels.
                                                            Consumers and producers
                                                            would incur costs because
                                                            FSIS and FDA labels would
                                                            be inconsistent.
5--12-month compliance large, 24-   Updates to the labels  Costs equal to $17.4        Net benefits are $21.1
 month compliance small.             for FDA and FSIS       million, the highest of     million, almost 20
                                     products have the      all alternatives.           percent lower than
                                     same compliance        Labeling costs increase     alternative 2's. While
                                     date. About 1          to $8.5 million for the     benefits are 4 percent
                                     million consumers      coordinated and             higher than alternative
                                     would increase their   uncoordinated changes.      2's, costs are 61
                                     label use leading to   Recordkeeping costs         percent higher.
                                     roughly $38.5          remain at $121,690.         Qualitative benefits are
                                     million in health      Reformulation costs are     consistency between FSIS
                                     benefits.              expected to cost $8.8       and FDA labels.
                                                            million. In addition,
                                                            both consumers and
                                                            producers would incur
                                                            costs because USDA and
                                                            FDA labels would be
                                                            inconsistent.
----------------------------------------------------------------------------------------------------------------
\1\ All quantified benefits and costs are annualized at 3 percent over 20 years.

Alternative 1--Take No Regulatory Action by Continuing With the 
Existing Labeling
    Both producers and consumers will be worse off absent the proposed 
action. While ``no action'' means the 3,307 manufacturers with roughly 
50,000 products under USDA jurisdiction would continue to be regulated 
in the same manner as they currently are, the market will be impacted 
in several costly ways.
    First, no action would create inconsistencies between USDA and FDA 
labels. As such, the manufacturers that produce products regulated by 
both USDA and FDA will have to operate under two differentiated 
procedures, e.g., maintaining multiple label formats, recording 
different product attributes, and utilizing differing RACCs for 
products with similar uses. This would increase administration costs 
for producers and make label use more difficult for consumers, 
decreasing their benefit.\87\
---------------------------------------------------------------------------

    \87\ Bialkova, S. and H. Trijp. 2010. What determines consumer 
attention to nutrition labels? Food Quality and Preference. 21 1042-
1051 and Campos, A., J. Doxey, and D. Hammond. 2011. Nutrition 
labels on pre-packaged foods: a systematic review. Public Health 
Nutrition. 14: 1496-1506. Bialkova and Trijp, 2010 and Campos et 
al., 2011.
---------------------------------------------------------------------------

    Second, if the USDA were to take ``no action,'' the Agency would 
fail to address the health problems related to diet by making it more 
difficult for consumers to heed dietary guidelines. Third, the ``no 
action'' would fail to make any improvements to address the problems 
that prohibit millions of consumers from using labels: The print being 
too small, not knowing what to look for, or not having enough time. The 
targeted population of nearly 32 million overweight or hypertensive 
adults, whom rarely or never use the Nutrition Facts label, would 
continue to not read the labels and continue with high sodium or 
calorie diets. In combination, these impacts would hinder producers 
vying to compete based on hard to

[[Page 6778]]

distinguish health and nutritional attributes, reducing market 
competition, and would do nothing to address the nation's overweight 
and obesity epidemic.
Alternative 2--The Proposed Rule, Giving Large Manufacturers a 24-Month 
Compliance Period and Small Manufacturers 36-Months
    Alternative 2, the proposed rule, addresses many of the current 
nutritional and serving size labels' short comings by applying the 
changes proposed in the preamble with a 24-month compliance period for 
large and 36-month for small, consistent with FDA's compliance period. 
While industry will incur costs associated with relabeling, 
recordkeeping, and reformulation, consumers will benefit from an 
increase in information which may lead to improved health. The 
estimated net benefits are $26.1 million. The proposed costs and 
benefits associated with this alternative are detailed in Expected 
Costs of the Proposed Rule and Quantitative Benefits of the Proposed 
Rule sections of this PRIA.
Alternative 3--The Proposed Rule, Giving Manufacturers a 42 Month 
Compliance Period
    Alternative 3 would apply the changes detailed in the preamble but 
extends the compliance period to 42 months. Compared to alternative 2, 
this alternative reduces costs while holding benefits nearly constant. 
As shown in Table 4--Label Changes That Can Be Coordinated with a 
Planned Change, a 42-month compliance period would provide industry 
sufficient time to coordinate all required label changes, subsequently 
reducing annualized relabeling costs by about $2.1 million, as compared 
to alternative 2. Recordkeeping costs would remain the same as 
alternative 2 and annualized reformulation costs would be reduced by 
about $1 million.
    Health benefits would be delayed by extending the compliance 
period. Annual benefits at a 3 percent discount rate under alternative 
3 are estimated to be $36.4 million, which is roughly $500,000 less 
than alternative 2's estimated annual benefits. However, a 42-month 
compliance period would result in delayed label updates, and extend 
inconsistencies between USDA and FDA labels for an additional 18 months 
compared to alternative 2.
    Also, extending the compliance period would require a further 
exception to current uniform compliance guidelines \88\ set by the 
Agency. Consistent with FDA's uniform compliance dates for food labels, 
USDA sets uniform compliance dates in 2-year increments to enhance the 
industry's ability to make orderly adjustments to new labeling 
requirements without unduly exposing consumers to outdated labels. 
Further, cost estimates may be understated as producers who market FDA-
regulated and FSIS related products may voluntarily adopt the FDA 
timetable and not use the additional compliance period allotted.
---------------------------------------------------------------------------

    \88\ Uniform Compliance Date for Food Labeling Regulations, 79 
FR 71007 (2014). Depending on the Alternative 2 final publication 
date, Alternative 2 may not deviate from the uniform compliance 
date, except for small businesses as they have an additional 12 
months to comply.
---------------------------------------------------------------------------

Relabeling Costs
    Alternative 3 applies FDA's 2014 Labeling Cost Model to estimate 
the cost of relabeling roughly 50,000 food labels under a 42-month 
compliance period. In this scenario both branded and private (store 
brand) label changes can be coordinated, reducing the average one time 
per label cost from $1,371 to $717, Table 17. In sum, extending the 
compliance period reduces the average annualized relabeling costs to 
$2.3 million, assuming a 3 percent discount rate over 20 years.

                                                         Table 17--Alternative 3--Labeling Costs
                                                                       [42 Month]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                         Costs
                                               Private            Branded      --------------------------------------------------------
                                                                                      Lower               Mid               Upper
---------------------------------------------------------------------------------------------------------------------------------------
Total Number of Labels..................             12,645             37,465  .................  .................  .................
Coordinated Change:
    Major...............................              3,088              9,149         $3,622,152        $14,097,024        $39,207,348
    Minor...............................              9,554             28,306          5,338,260         21,655,920         61,333,200
Uncoordinated Change:
    Extensive...........................                  3                 10             91,494            180,154            330,187
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
        Total Cost......................  .................  .................          9,051,906         35,933,098        100,870,735
Annualized Cost (3% DR, 20 Year)........  .................  .................            590,709          2,344,921          6,582,619
Annualized Cost (7% DR, 20 Year)........  .................  .................            798,538          3,169,935          8,898,583
Average Per label one time cost.........  .................  .................                181                717              2,013
Per label Annualized Cost (3% DR, 20      .................  .................                 12                 47                131
 Year)..................................
Per label Annualized Cost (7% DR, 20      .................  .................                 16                 63                178
 Year)..................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

Recordkeeping Costs
    Alternative 3 does not alter the recordkeeping requirements as 
presented in the Expected Cost section above. As such, we assume the 
recordkeeping costs associated under alternative 3 are equal to those 
under alternative 2.
Reformulation Costs
    Extending the compliance period reduces the cost for product 
reformulation. However, the longest compliance period covered in the 
2014 Reformulation Cost Model is 36 months for large and 24 months for 
small businesses. As such, the reformulation costs associated with 
alternative 3 are based on a 24 month compliance period for small and 
36 month compliance

[[Page 6779]]

period for large. Therefore, the reformulation costs are under 
estimated for this alterative.

                                   Table 18--Alternative 3--Reformulation Cost
                                                   [42 months]
----------------------------------------------------------------------------------------------------------------
                                                                       Lower            Mid            Upper
----------------------------------------------------------------------------------------------------------------
High............................................................     $30,918,175     $65,967,997    $107,198,289
Med.............................................................       6,568,245      14,044,083      22,986,932
Low.............................................................         714,402       1,529,728       2,526,885
                                                                 -----------------------------------------------
    Total Cost..................................................      38,200,822      81,541,808     132,712,106
Annualized Cost (3% DR, 20 Year)................................       2,492,908       5,321,253       8,660,522
Annualized Cost (7% DR, 20 Year)................................       3,369,988       7,193,430      11,707,555
Average Per formula one time cost...............................          30,982          66,133         107,634
Per formula Annualized Cost (3% DR, 10 Year)....................           2,022           4,316           7,024
Per formula Annualized Cost (7% DR, 10 Year)....................           2,733           5,834           9,495
----------------------------------------------------------------------------------------------------------------

Quantitative Benefits
    Again, the present value of health benefits was derived by 
multiplying the percentage of label changes in each 12 month period by 
annual health benefits. The prolonged compliance period reduces the 
rate labels are updated, which in turn reduces the rate at which 
consumers are exposed to updated labels and overall benefits. As is 
shown on Table 19, the expected difference in annual health benefits 
between alternative 2 and alternative 3 is about $0.5 million. 
Alternative 3 has the benefit of saving roughly $3 million annually 
from reductions in labeling and reformulation costs, $2.1 million of 
which is derived from reductions in labeling costs.

                                                      Table 19--Comparison of Alternatives 2 and 3
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                           Alternative 2                                   Alternative 3
                                                         -----------------------------------------------------------------------------------------------
                                                             Benefits        Costs \1\     Net benefits      Benefits        Costs \1\     Net benefits
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual PV2 3%...........................................     $36,894,007     $10,802,809     $26,091,198     $36,382,559      $7,787,864     $28,594,695
Annual PV 7%............................................      22,541,264      14,603,562       7,937,702      22,154,586      10,527,869      11,626,717
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Costs include relabeling, recordkeeping, and reformulation costs.
\2\ Present Value (PV) is the current worth of a future sum of money or stream of cash flows given a specified rate of return.

Qualitative Benefits
    Alternative 3 is expected to have the same type of qualitative 
benefits as alternative 2, but their realization is delayed. Labels 
would not be harmonized as soon as alternative 2, resulting in 
confusion between USDA and FDA labels. Producers who market FDA-
regulated products also may voluntarily adopt the FDA timetable and 
update their labels prior to the 42-month compliance period.
Alternative 4--The Proposed Rule, Giving All Manufacturers 24 Months To 
Comply
    Under this alternative, all manufacturers are given a 24 month 
compliance period. This alternative does not give small businesses 
additional time to comply and is inconsistent with FDA's compliance 
period.
Relabeling Costs
    Under alternative 4, small and large businesses are given 24 months 
to comply with the proposed changes. Under a 24-month compliance 
period, all branded labels and 26 percent of private labels will incur 
a coordinated label change while 74 percent of private labels will 
incur an uncoordinated label change, Table 20.

                                     Table 20--Alternative 4--Labeling Costs
                                          [24 Month compliance period]
----------------------------------------------------------------------------------------------------------------
                                                                                       Costs
                                      Private         Branded    -----------------------------------------------
                                                                       Lower           Mean            Upper
----------------------------------------------------------------------------------------------------------------
Total Number of Labels..........          12,645          37,465  ..............  ..............  ..............
Coordinated Change:
    Major.......................             803           9,149      $2,945,792     $11,464,704     $31,886,208
    Minor.......................           2,484          28,306       4,341,390      17,611,880      49,879,800
Uncoordinated Change:
    Major.......................           2,285  ..............      11,710,625      21,481,285      39,759,000
    Minor.......................           7,070  ..............      13,022,940      27,481,090      54,728,870
    Extensive...................               3              10          91,494         180,154         330,187
                                 -------------------------------------------------------------------------------
        Total Cost..............  ..............  ..............      32,112,241      78,219,113     176,584,065
Annualized Cost (3% DR, 20 Year)  ..............  ..............       2,095,580       5,104,420      11,523,517
Annualized Cost (7% DR, 20 Year)  ..............  ..............       2,832,868       6,900,309      15,577,838

[[Page 6780]]

 
Average Per label one time cost.  ..............  ..............             641           1,561        3,524.00
Per label Annualized Cost (3%     ..............  ..............              42             102             230
 DR, 20 Year)...................
Per label Annualized Cost (7%     ..............  ..............              57             138             311
 DR, 20 Year)...................
----------------------------------------------------------------------------------------------------------------

Recordkeeping Costs
    Compared to alternative 2, alternative 4 does not alter the 
recordkeeping requirements. As such, we assume the recordkeeping costs 
associated under alternative 4 are equal to those under alternative 2.
Reformulation Costs
    Reducing the compliance period for small businesses increases the 
cost for product reformulation. However, the longest compliance period 
covered in the 2014 Reformulation Cost Model for small businesses is 24 
months. Therefore, the reformulation cost for alternative 2 and 
alternative 3 are both estimated on a 24 month compliance period for 
both large and small businesses. Alternative 2 overestimated 
reformulation cost since this alternative is based on a 24 month 
compliance period for large and 36 months for small businesses and 
alternative 4 reformulation cost is most accurate given the compliance 
period is 24 months for large and small businesses.

                                   Table 9--Alternative 2--Reformulation Cost
----------------------------------------------------------------------------------------------------------------
                                                                       Lower            Mid            Upper
----------------------------------------------------------------------------------------------------------------
High Complexity Formulas........................................     $36,295,355     $77,294,020    $124,785,011
Med Complexity Formulas.........................................       7,488,995      15,983,483      25,998,357
Low Complexity Formulas.........................................         783,190       1,674,662       2,752,831
    Total Cost..................................................       4,567,540      94,952,165     153,536,199
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Annualized Cost (3% DR, 20 Year)................................       2,908,387       6,196,385      10,019,460
Annualized Cost (7% DR, 20 Year)................................       3,931,645       8,376,460      13,544,608
Average Per formula one time cost...............................          36,146          77,009         124,522
Per formula Annualized Cost (3% DR, 20 Year)....................           2,359           5,025           8,126
Per formula Annualized Cost (7% DR, 20 Year)....................           3,189           6,794          10,985
----------------------------------------------------------------------------------------------------------------

Quantitative Benefits
    The reduced compliance period increases the rate labels are 
updated, which in turn increases the rate at which consumers are 
exposed to updated labels, resulting in earlier and higher consumer 
welfare benefits. Again, the present value of health benefits was 
calculated by multiplying the percentage of label changes in each 12 
month period by annual health benefits. As is shown in Table 22, the 
expected difference in annual health benefits between alternative 2 and 
alternative 4 is about $288,829. Alternative 4 increases the annual 
labeling cost by over $0.6 million annually. Overall, the net benefit 
decreases by $330,858 under alternative 4.

                                                      Table 22--Comparison of Alternatives 2 and 4
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                           Alternative 2                                   Alternative 4
                                                         -----------------------------------------------------------------------------------------------
                                                             Benefits        Costs \1\     Net Benefits      Benefits        Costs \1\     Net Benefits
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual PV\2\ 3%.........................................     $36,894,007     $10,802,809     $26,091,198     $37,182,836     $11,422,496     $25,760,340
Annual PV 7%............................................      22,541,264      14,603,562       7,937,702      22,763,888      15,441,274       7,322,614
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Costs include relabeling, recordkeeping, and reformulation costs.
\2\ Present Value (PV) is the current worth of a future sum of money or stream of cash flows given a specified rate of return.

Qualitative Benefits
    Alternative 4 may benefit consumers from the potential 
reformulation of products to reduce added sugars. Also, alternative 4 
would still benefit the public by consolidating nutrition labeling 
regulations to one location; however, it would result in 
inconsistencies between products regulated by either the FDA or USDA. 
These inconsistencies would likely increase confusion amongst both 
producers and consumers, reducing overall benefits.
Alternative 5--The Proposed Rule, Giving Large Manufacturers 12-Month 
Compliance Period and Small 24-Month Compliance
    Alternative 5 more closely aligns the compliance date with FDA 
labels. Sharing the same compliance date with FDA products allows for 
harmonized labels across agencies. However, FSIS labels will have a 
shorter time to comply than FDA by sharing the same compliance date. 
FDA is giving a 24-month compliance period for large businesses and 36 
months for small businesses to comply, the same compliance period as 
alternative 2. Also, compared to alternative 2, this alternative 
greatly increases costs while holding benefits nearly constant. For

[[Page 6781]]

these reasons, this is not our preferred alternative. The sections 
below outline the costs and benefits for this alternative.
Relabeling Costs
    Alternative 5 applies FDA's 2014 Labeling Cost Model to estimate 
the cost of relabeling roughly 50,000 food labels under a 12-month 
compliance period for large manufacturers and 24 months for small. 
Reducing the compliance period increases the number of uncoordinated 
changes, resulting in higher labeling costs. For a 12-month compliance 
period, only 11 percent of branded and 5 percent of private labels will 
have a coordinated change. For a 24-month compliance period, only 26 
percent of private brands will have a coordinated change. The average 
one-time per label cost increases from $1,371 to $2,591, Table 23.

                                     Table 23--Alternative 5--Labeling Costs
                                    [12 month for large, 24 months for small]
----------------------------------------------------------------------------------------------------------------
                                                                                       Costs
                                       Small           Large     -----------------------------------------------
                                                                       Lower           Mean            Upper
----------------------------------------------------------------------------------------------------------------
Total Number of Labels..........          26,859          23,251  ..............  ..............  ..............
Coordinated Change:
    Major.......................           5,334           1,828      $2,119,952      $8,250,624     $22,947,048
    Minor.......................          16,504           5,656       3,124,560      12,675,520      35,899,200
Uncoordinated Change:
    Extensive...................               7               6          91,494         180,154         330,187
    Major.......................           1,225           3,850      26,008,391      47,708,270      88,301,659
    Minor.......................           3,789          11,911      28,919,400      61,025,900     121,533,700
        Total Cost..............  ..............  ..............      60,263,797     129,840,468     269,011,794
                                 -------------------------------------------------------------------------------
Annualized Cost (3% DR, 20 Year)  ..............  ..............       3,932,693       8,473,125      17,555,163
Annualized Cost (7% DR, 20 Year)  ..............  ..............       5,316,333      11,454,226      23,731,598
Average Per label one time cost.  ..............  ..............           1,203           2,591        5,368.43
Per label Annualized Cost (3%     ..............  ..............              78             169             350
 DR, 20 Year)...................
Per label Annualized Cost (7%     ..............  ..............             106             229             474
 DR, 20 Year)...................
----------------------------------------------------------------------------------------------------------------

Recordkeeping Costs
    Alternative 5 does not alter the recordkeeping requirements as 
presented in the Expected Cost section above. As such, we assume the 
recordkeeping costs associated under alternative 5 are equal to those 
under alternative 2.
Reformulation Costs
    Reducing the compliance period increases the cost for product 
reformulation. However, the longest compliance period covered in the 
2014 Reformulation Cost Model for a small business is 24 months. 
Therefore, the reformulation cost for small and medium businesses in 
alternative 2 is based on a 24 month compliance period, resulting in an 
overestimate of cost in alternative 2. Even with the overestimation in 
alternative 2 reformulation cost, the one-time cost for reformulation 
increases by $40.2 million with alternative 5, with an average per 
formula cost increasing from $77,009 to $109,638, Table 24. The 
increase is attributed to the 12-month compliance period for large 
manufacturers.

                                   Table 24--Alternative 5--Reformulation Cost
                                        [12 month large, 24 months small]
----------------------------------------------------------------------------------------------------------------
                                                                       Lower            Mid            Upper
----------------------------------------------------------------------------------------------------------------
High Complexity Formulas........................................     $52,426,895    $111,272,089    $177,545,177
Med Complexity Formulas.........................................      10,251,245      21,801,633      35,032,632
Low Complexity Formulas.........................................         989,550       2,109,464       3,430,665
Total Cost......................................................      63,667,690     135,183,186     216,008,474
Annualized Cost (3% DR, 20 Year)................................       4,154,824       8,821,780      14,096,274
Annualized Cost (7% DR, 20 Year)................................       5,616,616      11,925,548      19,055,768
Average Per formula one time cost...............................          51,636         109,638         175,189
Per formula Annualized Cost (3% DR, 20 Year)....................           3,370           7,155          11,433
Per formula Annualized Cost (7% DR, 20 Year)....................           4,555           9,672          15,455
----------------------------------------------------------------------------------------------------------------

Quantitative Benefits
    By reducing the compliance period, labels are updated faster, 
resulting in earlier consumer welfare benefits. Again, the present 
value of health benefits was derived by multiplying the percentage of 
label changes in each 12-month period by annual health benefits. 
Alternative 5 proposed a 12-month compliance period for large and 24 
month compliance period for small. Based on IRI scanner data and SBA 
small business standards, 53.6 percent of labels are from small 
businesses and 46.4 percent are from Large. Utilizing these proportions 
and Table 4--Label Changes That Can Be Coordinated with a Planned 
Change, we estimate that after 12 months, 50.76 percent of FSIS's 
Nutrition Facts labels are updated ((100% of Large * 46.4% of labels) + 
(10% of Small * 53.6% of Labels)). After 24 months, 100 percent of 
FSIS's nutrition facts labels are updated.
    As shown in Table 25, the expected increase in annual health 
benefits between alternative 2 and alternative 5 is about $1.6 million. 
However, alternative 5 increases cost by $6.6

[[Page 6782]]

million annually, of which $4 million is derived from increases in 
labeling costs.

                                                      Table 25--Comparison of Alternatives 2 and 5
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                           Alternative 2                                   Alternative 5
                                                         -----------------------------------------------------------------------------------------------
                                                             Benefits        Costs \1\     Net Benefits      Benefits        Costs \1\     Net Benefits
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual PV 3%............................................     $36,894,007     $10,802,809     $26,091,198     $38,470,229     $17,416,595     $21,053,634
Annual PV 7%............................................      22,541,264      14,603,562       7,937,702      23,794,722      23,544,278         250,444
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Costs include relabeling, recordkeeping, and reformulation costs.
\2\ Present Value (PV) is the current worth of a future sum of money or stream of cash flows given a specified rate of return.

Qualitative Benefits
    Alternative 5 is expected to have similar qualitative benefits as 
alternative 2, with the additional benefit of harmonized labels between 
FSIS and FDA. Assuming FSIS has a one-year lag from FDA's final rule 
(81 FR 33742 and 81 FR 34000), under this alternative, USDA and FDA 
labels will have the same compliance date, resulting in less confusion 
over similar food products.

IV. Regulatory Flexibility Act

    The FSIS Administrator made a preliminary determination that this 
proposed rule will not have a significant impact on a substantial 
number of small entities, as defined by the Regulatory Flexibility Act 
(5 U.S.C. 601). This determination was made because small businesses 
only account for 50 percent of the Nutrition Facts Labels and are given 
an additional 12 months to comply, reducing the costs of the proposed 
regulations.
    All manufacturers are required to update labels if this proposed 
rule is finalized. FSIS considered other alternatives and the preferred 
alternative gives small businesses an additional 12 months to comply 
with the regulations to reduce the impact on small businesses. The 
additional compliance time reduces the burden and cost for small 
business and is consistent with FDA's compliance period.
    On the basis of IRI scanner data, FSIS estimates that 3,307 
manufacturers produce roughly 50,000 different retail labels with 
nutrition labeling for meat or poultry products. Using SBA's small 
business definition \89\and IRI scanner data, FSIS estimates 3,125 
small manufacturers would be affected by the proposed rule. The small 
FSIS manufacturers produce 26,859 labels (53.6 percent of 50,110) as 
shown in Table 5--Alternative 2--Labeling Costs (24 Month for Large, 36 
Months for Small). Note that the disproportionately large percentage of 
labels from the 182 large manufacturers is attributable to the fact 
that they typically produce more labeled products per manufacturer than 
small manufacturers.
    The average one-time cost per label change is $1,208 or $79 
annualized over 10 years at a 3-percent discount rate for small 
businesses. The annualized costs at a 3-percent discount rate for all 
labels changes from small retail manufacturers is $2,116,554 with an 
average cost of $677 ($2.1M/3,125) per small business. Relabeling costs 
for small businesses are less than half ($2.1M out of $4.5M) of the 
total annualized cost at a 3-percent discount rate (Table 5--
Alternative 2--Labeling Costs (24 Month for Large, 36 Months for 
Small)). These estimates in Table 5 include small business relabeling 
costs from minor, major, extensive coordinated and uncoordinated 
changes for a 36-month compliance period.

V. Paperwork Requirements

    In accordance with section 3507(j) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection and 
recordkeeping requirements included in this proposed rule have been 
submitted for approval to OMB.
    Title: Revision of the Nutrition Facts Labels for Meat and Poultry 
Products and Updating Certain Reference Amounts Customarily Consumed.
    Type of Collection: New.
    Abstract: The proposed rule contains information collection 
provisions that are subject to review by the Office of Management and 
Budget (OMB) under the PRA. The provisions include burden for 
recordkeeping, annual reporting, and third-party disclosure for the 
declaration of Added Sugars, Dietary Fiber, Soluble Fiber, Insoluble 
Fiber, Vitamin E, and Folate/Folic Acid. The likely respondents to this 
information collection are manufacturers of FSIS retail food products 
containing Added Sugars, Dietary Fiber, Soluble Fiber, Insoluble Fiber, 
Vitamin E, and Folate/Folic Acid.

Proposed Recordkeeping and Annual Record Reporting Requirements

    Under this proposed rule manufacturers must maintain additional 
records for Added Sugars, Dietary Fiber, Soluble Fiber, Insoluble 
Fiber, Dietary Fiber, Vitamin E, and Folate/Folic Acid. Manufacturers 
are also required to provide these records to the inspector or any duly 
authorized representative of the Agency upon request.\90\
---------------------------------------------------------------------------

    \90\ Proposed 9 CFR 413.309(h)(8).
---------------------------------------------------------------------------

    FSIS believes the new records required from this proposed rule are 
records that responsible manufacturers use and retain as a normal part 
of business. Thus, the recordkeeping burden consists of the time 
required to identify and assemble the records for copying and holding 
and the reporting burden consists of the time required to assemble and 
provide records to the appropriate FSIS officials. FSIS estimates one 
hour of recordkeeping and one hour of recordkeeping burden for each 
newly required nutrient per manufacturer. If the rule is finalized as 
proposed, the declaration for added sugars, dietary fiber, soluble 
fiber, and insoluble fiber would be mandatory and 3,307 manufacturers 
for FSIS products would incur this burden. The declaration of Vitamin E 
and folate/folic acid is not mandatory unless accompanied with a 
nutrient claim. However, we estimate that roughly all 3,307 FSIS 
manufacturers will incur a one hour recordkeeping burden for the 
mandatory components and one hour record burden for vitamin E and folic 
acid. As shown in Table 26, the initial recordkeeping and reporting 
burden for covered respondents is 39,684 hours.

[[Page 6783]]



                          Table 27--Estimated Annual Reporting and Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
                                                                     Hours of        Hours of
                                                     Number of     recordkeeping     reporting     Total burden
               Type of declaration                  respondents     burden per      burden per         hours
                                                                    respondent      respondent
----------------------------------------------------------------------------------------------------------------
Added Sugars....................................           3,307               1               1           6,614
Dietary Fiber...................................           3,307               1               1           6,614
Soluble Fiber...................................           3,307               1               1           6,614
Insoluble Fiber.................................           3,307               1               1           6,614
Vitamin E.......................................           3,307               1               1           6,614
Folate/Folic Acid...............................           3,307               1               1           6,614
 
----------------------------------------------------------------------------------------------------------------
\2\ These estimates are likely to be large overestimates, as not all manufacturers will need to keep records for
  added sugars, dietary fiber, and soluble and insoluble fiber. Manufacturers will only need to keep records for
  products with both added and naturally occurring sugars and products with non-digestible carbohydrates
  (soluble or insoluble) that do and do not meet the definition of dietary fiber.
\3\ These estimates are likely to be large overestimates, as not all manufacturers will need to keep records for
  vitamin E and folate/folic acid. The declaration of vitamin E and folate/folic acid is not mandatory unless a
  health or nutrient content claim is being made or these nutrients are directly added to the food for
  enrichment purposes.

Third Party Disclosures Burden for Manufacturers

    FSIS estimated that the burden associated with the proposed changes 
would be a one-time burden for the food manufacturers to revise the 
nutrition labels. We estimate the one-time third party disclosure 
burden would be approximately two hours. Each label would require a 
respondent one hour of review to determine how to bring it into 
compliance with the proposed requirements. FSIS estimated each label 
redesign would require one additional hour per label, for a total of 
two hours per unique label for each respondent. Based on estimates from 
IRI scanner data, there are 50,110 unique nutrition labels under FSIS 
jurisdiction. Therefore, the estimated burden for this collection of 
information is 200,440 hours for respondents as shown in Table 27.

                                Table 28--Estimated Annual Third Party Disclosure
----------------------------------------------------------------------------------------------------------------
                                                                                   Average time
                             Action                                  Number of      burden per      Total hours
                                                                      labels        disclosure
----------------------------------------------------------------------------------------------------------------
Reviewing Labels................................................          50,110               2         100,220
Label Redesign..................................................          50,110               2         100,220
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total hours.................................................  ..............  ..............         200,440
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

Summary of Burden for Paperwork Reduction Act Section

    Estimate of Burden: FSIS estimates that it would take 2.00 hours 
per respondent for recordkeeping and record reporting. FSIS also 
estimates it will take a respondent 2 hours per label to review and 
redesign the label.
    Respondents: Manufacturers of FSIS products at the retail level.
    Estimated Number of respondents: 3,307.
    Estimated Number of FSIS labels: 50,110.
    Estimated Number of Responses per Respondent: about 73 hours.
    Estimated Total Annual Burden on Respondents: 241,411 hours.
    Copies of this information collection assessment can be obtained 
from Gina Kouba, Paperwork Reduction Act Coordinator, Food Safety and 
Inspection Service, USDA, 1400 Independence Avenue SW., Room 6065, 
South Building, Washington, DC 20250.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of FSIS's 
functions, including whether the information will have practical 
utility; (b) the accuracy of FSIS's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on those who 
are to respond, including through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology.
    Comments may be sent to both Gina Kouba, Paperwork Reduction Act 
Coordinator, at the address provided above, and the Desk Officer for 
Agriculture, Office of Information and Regulatory Affairs, Office of 
Management and Budget, Washington, DC 20253. To be most effective, 
comments should be sent to OMB.

VI. E-Government Act

    FSIS and USDA are committed to achieving the purposes of the E-
Government Act (44 U.S.C. 3601, et seq.) by, among other things, 
promoting the use of the Internet and other information technologies 
and providing increased opportunities for citizen access to government 
information and services, and for other purposes.

VII. Executive Order 12988, Civil Justice Reform

    This proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. Under this rule: (1) All State and local laws and 
regulations that are inconsistent with this rule will be preempted; (2) 
no retroactive effect will be given to this rule; and (3) no 
administrative proceedings will be required before parties may file 
suit in court challenging this rule.

[[Page 6784]]

VIII. Executive Order 13175

    This rule has been reviewed in accordance with the requirements of 
Executive Order 13175, ``Consultation and Coordination with Indian 
Tribal Governments.'' E.O. 13175 requires Federal agencies to consult 
and coordinate with tribes on a government-to-government basis on 
policies that have tribal implications, including regulations, 
legislative comments or proposed legislation, and other policy 
statements or actions that have substantial direct effects on one or 
more Indian tribes, on the relationship between the Federal Government 
and Indian tribes or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes.
    FSIS has assessed the impact of this rule on Indian tribes and 
determined that this rule does not, to our knowledge, have tribal 
implications that require tribal consultation under E.O. 13175. If a 
Tribe requests consultation, the Food Safety and Inspection Service 
will work with the Office of Tribal Relations to ensure meaningful 
consultation is provided where changes, additions and modifications 
identified herein are not expressly mandated by Congress.

IX. USDA Nondiscrimination Statement

    No agency, officer, or employee of the USDA shall, on the grounds 
of race, color, national origin, religion, sex, gender identity, sexual 
orientation, disability, age, marital status, family/parental status, 
income derived from a public assistance program, or political beliefs, 
exclude from participation in, deny the benefits of, or subject to 
discrimination any person in the United States under any program or 
activity conducted by the USDA.

How To File a Complaint of Discrimination

    To file a complaint of discrimination, complete the USDA Program 
Discrimination Complaint Form, which may be accessed online at http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your 
authorized representative.
    Send your completed complaint form or letter to USDA by mail, fax, 
or email:
    Mail: U.S. Department of Agriculture, Director, Office of 
Adjudication, 1400 Independence Avenue SW., Washington, DC 20250-9410.
    Fax: (202) 690-7442.
    Email: [email protected].
    Persons with disabilities who require alternative means for 
communication (Braille, large print, audiotape, etc.), should contact 
USDA's TARGET Center at (202) 720-2600 (voice and TDD).

X. Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, FSIS will announce this Federal 
Register publication on-line through the FSIS Web page located at: 
http://www.fsis.usda.gov/federal-register .
    FSIS also will make copies of this publication available through 
the FSIS Constituent Update, which is used to provide information 
regarding FSIS policies, procedures, regulations, Federal Register 
notices, FSIS public meetings, and other types of information that 
could affect or would be of interest to our constituents and 
stakeholders. The Update is available on the FSIS Web page. Through the 
Web page, FSIS is able to provide information to a much broader, more 
diverse audience. In addition, FSIS offers an email subscription 
service which provides automatic and customized access to selected food 
safety news and information. This service is available at: http://www.fsis.usda.gov/subscribe . Options range from recalls to export 
information, regulations, directives, and notices. Customers can add or 
delete subscriptions themselves, and have the option to password 
protect their accounts.

XI. Proposed Regulatory Amendments

List of Subjects

9 CFR Parts 301 and 304

    Meat inspection.

9 CFR Part 316

    Food labeling, Food packaging, Meat inspection.

9 CFR Part 317

    Food labeling, Food packaging, Meat inspection, Nutrition, 
Reporting and recordkeeping.

9 CFR Part 318

    Food additives, Food packaging, Laboratories, Meat inspection, 
Reporting and recordkeeping requirements, Signs and symbols.

9 CFR Part 319

    Food grades and standards, Food labeling, Frozen foods, Meat 
inspection, Oils and fats.

9 CFR Part 320

    Meat inspection, Reporting and recordkeeping.

9 CFR Part 327

    Food labeling, Food packaging, Imports, Meat inspection.

9 CFR Part 362

    Meat inspection, Poultry and poultry products, Reporting and 
recordkeeping.

9 CFR Part 381

    Administrative practice and procedure, Animal diseases, Crime, 
Exports, Food grades and standards, Food labeling, Food packaging, 
Government employees, Grant programs--agriculture, Imports, 
Intergovernmental relations, Laboratories, Meat inspection, Nutrition, 
Polychlorinated biphenyls (PCB's), Poultry and poultry products, 
Reporting and recordkeeping requirements, Seizures and forfeitures, 
Signs and symbols, Technical assistance, Transportation.

9 CFR Parts 412 and 413

    Food labeling, Food packaging, Meat inspection, Poultry and poultry 
products, Reporting and recordkeeping requirements.

    For the reasons discussed in the preamble, FSIS is proposing to 
amend 9 CFR Chapter III as follows:

PART 301--TERMINOLOGY; ADULTERATION AND MISBRANDING STANDARDS

0
1. The authority citation for part 301 continues to read as follows:

    Authority:  21 U.S.C. 601-695; 7 U.S.C. 138-138i, 450, 1901-
1906; 7 CFR 2.7, 2.18, 2.53.

0
2. Amend Sec.  301.2 by revising paragraph (10) under the definition of 
``Misbranded'' to read as follows:


Sec.  301.2  Definitions.

* * * * *
    (10) If it purports to be or is represented for special dietary 
uses, unless its label bears such information concerning its vitamin, 
mineral, and other dietary properties as is required by the regulations 
in part 317 of this subchapter and part 413 of subchapter E.
* * * * *

PART 304--APPLICATION FOR INSPECTION; GRANT OF INSPECTION

0
3. The authority citation for part 304 continues to read as follows:

    Authority:  21 U.S.C. 601-695; 7 CFR 2.18, 2.53.

0
4. Amend Sec.  304.2 by revising paragraph (b) to read as follows:


Sec.  304.2  Information to be furnished; grant or refusal of 
inspection.

* * * * *
    (b) The Administrator is authorized to grant inspection upon his or 
her

[[Page 6785]]

determination that the applicant and the establishment are eligible 
therefor and to refuse to grant inspection at any establishment if he 
or she determines that it does not meet the requirements of this part 
or the regulations in parts 305, 307, and part 416, Sec. Sec.  416.1 
through 416.6 of this chapter, or that the applicant has not received 
approval of labeling and containers to be used at the establishment as 
required by the regulations in parts 316 and 317 of this subchapter and 
part 412 of subchapter E. Any application for inspection may be refused 
in accordance with the rules of practice in part 500 of this chapter.
* * * * *

PART 316--MARKING PRODUCTS AND THEIR CONTAINERS

0
5. The authority citation for part 316 continues to read as follows:

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

0
6. Amend paragraph (b) of Sec.  316.8 by replacing the phrase ``this 
part and part 317 of this subchapter'' with ``this part, part 317 of 
this subchapter, and part 413 of subchapter E.''
0
7. Amend paragraph (e) of Sec.  316.11 by adding the phrase ``and part 
413 of subchapter E'' after ``in part 317 of this subchapter''.
0
8. Amend paragraph (b) of Sec.  316.13 by adding the phrase ``and part 
413 of subchapter E'' after ``part 317 of this subchapter''.

PART 317--LABELING, MARKING DEVICES, AND CONTAINERS

0
 9. The authority citation for part 317 continues to read as follows:

    Authority:  21 U.S.C. 601-695; 7 CFR 2.18, 2.53.

0
10. Amend Sec.  317.16 by replacing the phrase ``this part 317'' with 
``this part 317 or part 413 of subchapter E''.

Subpart B--[Removed and Reserved]

0
11. Remove and reserve subpart B, consisting of Sec. Sec.  317.300 
through 317.400.

PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND 
PREPARATION OF PRODUCTS

0
12. The authority citation for part 318 continues to read as follows:

    Authority:  7 U.S.C. 138f, 450, 1901-1906; 21 U.S.C. 601-695; 7 
CFR 2.18, 2.53.

0
13. Amend paragraph (b) of Sec.  318.10 by replacing the phrase ``part 
317 of the regulations in this subchapter'' with ``part 412 of 
subchapter E''.

PART 319--DEFINITIONS AND STANDARDS OF IDENTITY OR COMPOSITION

0
14. The authority citation for part 319 continues to read as follows:

    Authority:  7 U.S.C. 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR 
2.18, 2.53.

0
15. Amend paragraph (a) of Sec.  319.1 by adding the phrase ``and part 
413 of subchapter E'' after ``part 317 of this subchapter''.
0
16. Amend Sec.  319.10 by revising paragraph (a) to read as follows:


Sec.  319.10   Requirements for substitute standardized meat food 
products named by use of an expressed nutrition content claim and a 
standardized term.

    (a) Description. The meat food products prescribed by this general 
definition and standard of identity are those products that substitute, 
in accordance with Sec.  413.313(d), for a standardized product defined 
in this part and use the name of that standardized product in their 
statements of identity, but that do not comply with the established 
standard because of a compositional deviation that results from 
reduction of a constituent that is described by an expressed nutrient 
content claim that has been defined by regulation in part 413 of 
subchapter E. The expressed nutrient content claim shall comply with 
the requirements of Sec.  413.313 and with the requirements of part 
413, which define the particular nutrient content claim that is used. 
The meat food product shall comply with the relevant standard in this 
part in all other respects, except as provided in paragraphs (b) and 
(c) of this section.
* * * * *
0
17. Amend paragraph (b) of Sec.  319.10 by replacing the reference to 
``Sec.  317.313(d)(1) and (2)'' with ``Sec.  413.313(d)(1) and (2)''.

PART 320--RECORDS, REGISTRATION, AND REPORTS

0
18. The authority citation for part 320 continues to read as follows:

    Authority:  21 U.S.C. 601-695; 7 CFR 2.7, 2.18, 2.53.

0
19. Amend Sec.  320.1 by revising paragraph (b)(8) to read as follows:


Sec.  320.1   Records required to be kept.

* * * * *
    (b) * * *
    (8) Records of nutrition labeling as required by part 413 of 
subchapter E.
* * * * *

PART 327--IMPORTED PRODUCTS

0
20. The authority citation for part 327 continues to read as follows:

    Authority:  21 U.S.C. 601-695; 7 CFR 2.18, 2.53.

0
 21. Amend Sec.  327.15 by revising paragraph (b) to read as follows:


Sec.  327.15   Outside containers of foreign products; marking and 
labeling; application of official inspection legend.

* * * * *
    (b) All labeling used with an outside container of foreign product 
must be approved in accordance with part 317 of this subchapter and 
parts 412 and 413 of subchapter E.
* * * * *

PART 362--VOLUNTARY POULTRY INSPECTION REGULATIONS

0
22. The authority citation for part 362 continues to read as follows:

    Authority:  7 U.S.C. 1622; 7 CFR 2.18(g) and (i) and 2.53.

0
23. Amend paragraph (a) of Sec.  362.2 by replacing ``Part 381'' with 
``parts 381 and 413.''

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

0
24. The authority citation for part 381 continues to read as follows:

    Authority:  7 U.S.C. 138f, 450; 21 U.S.C. 451-470; 7 CFR 2.7, 
2.18, 2.53.


Sec.  381.172   [Amended]

0
25. Amend Sec.  381.172 by revising paragraphs (a) and (b) to read as 
follows:
    (a) Description. The poultry products prescribed by this general 
definition and standard of identity are those products that substitute, 
in accordance with Sec.  413.313(d), for a standardized product defined 
in this subpart and use the name of that standardized product in their 
statements of identity, but that do not comply with the established 
standard because of a compositional deviation that results from 
reduction of a constituent that is described by an expressed nutrient 
content claim that has been defined by regulation in this subpart. The 
expressed nutrient content claim shall comply with the requirements of 
Sec.  413.313 and with the requirements in part 413 which define the 
particular nutrient content claim that is used. The poultry product 
shall comply with the relevant standard in this part in all other 
respects, except as provided in paragraphs (b) and (c) of this section.
    (b) Performance characteristics. The performance characteristics, 
such as physical properties, functional properties, and shelf-life, of 
the poultry product shall be similar to those of the standardized 
poultry product produced under subpart P of this part. If there is

[[Page 6786]]

a significant difference in a performance characteristic that 
materially limits the use of the product compared to the use of the 
standardized product defined in subpart P of this part, the label shall 
include a statement in accordance with Sec.  413.313(d)(1) and (2) that 
informs the consumer of such differences (e.g., if appropriate, ``not 
recommended for frozen storage'' or ``not suitable for roller 
grilling''). Deviations from the ingredient provisions of the standard 
must be the minimum necessary to qualify for the nutrient content 
claim, while maintaining similar performance characteristics.
* * * * *
0
26. Amend Sec.  381.175 by revising paragraph (b)(5) to read as 
follows:


Sec.  381.175  Required records to be kept.

* * * * *
    (b) * * *
    (5) Records of nutrition labeling as required by part 413.
* * * * *

Subpart Y--[Removed and Reserved]

0
27. Remove and reserve subpart Y, consisting of Sec. Sec.  381.400 
through 381.500.

PART 412--LABEL APPROVAL

0
28. The authority citation for part 412 continues to read as follows:

    Authority:  21 U.S.C. 451-470, 601-695; 7 CFR 2.18, 2.53.

0
29. Amend Sec.  412.2 by revising paragraph (a)(1) to read as follows:


Sec.  412.2  Approval of generic labels.

    (a)(1) An official establishment, or an establishment certified 
under a foreign inspection system in accordance with part 327, or part 
381, subpart T of this chapter, is authorized to use generically 
approved labels, as defined in paragraph (b) of this section, and thus 
is free to use such labels without submitting them to the Food Safety 
and Inspection Service for approval, provided the label, in accordance 
with this section, displays all mandatory features in a prominent 
manner in compliance with parts 317, 381, and 413 and is not otherwise 
false or misleading in any particular.
* * * * *
0
30. Add part 413 to subchapter E to read as follows:

PART 413--NUTRITION LABELING

Sec.
413.1-413.299 [Reserved]
413.300 Nutrition labeling of meat, meat food products, and poultry 
products.
413.301 Required nutrition labeling of ground or chopped products.
413.302 Location of nutrition information.
413.303-413.307 [Reserved]
413.308 Labeling of products with number of servings.
413.309 Nutrition label content.
413.310-413.311 [Reserved]
413.312 Reference amounts customarily consumed per eating occasion.
413.313 Nutrient content claims; general principles.
413.314-413.343 [Reserved]
413.344 Identification of major cuts of meat products and poultry 
products.
413.345 Nutrition labeling of single-ingredient, raw meat or poultry 
products that are not ground or chopped products described in Sec.  
413.301.
413.346-413.353 [Reserved]
413.354 Nutrient content claims for ``good source,'' ``high,'' and 
``more''.
413.355 [Reserved]
413.356 Nutrient content claims for ``light'' or ``lite''.
413.357-413.359 [Reserved]
413.360 Nutrient content claims for calorie content.
413.361 Nutrient content claims for the sodium content.
413.362 Nutrient content claims for fat, fatty acids, and 
cholesterol content.
413.363 Nutrient content claims for ``healthy''.
413.364-413.368 [Reserved]
413.369 Labeling applications for nutrient content claims.
413.370-413.379 [Reserved]
413.380 Label statements relating to usefulness in reducing or 
maintaining body weight.
413.381-413.399 [Reserved]
413.400 Exemptions from nutrition labeling.

    Authority:  21 U.S.C. 451-470, 601-695; 7 CFR 2.7, 2.18, 2.53.


Sec.  413.300  Nutrition labeling of meat, meat food products, and 
poultry products.

    (a) Nutrition labeling must be provided for all meat, meat food 
products, and poultry products intended for human consumption and 
offered for sale, except single-ingredient, raw meat or poultry 
products that are not ground or chopped meat or poultry products 
described in Sec.  413.301 and are not major cuts of single-ingredient, 
raw meat or poultry products identified in Sec.  413.344, unless the 
product is exempted under Sec.  413.400. Nutrition labeling must be 
provided for the major cuts of single-ingredient, raw meat or poultry 
products identified in Sec.  413.344, either in accordance with the 
provisions of Sec.  413.309 for nutrition labels, or in accordance with 
the provisions of Sec.  413.345 for point-of-purchase materials, except 
as exempted under Sec.  413.400. For all other products for which 
nutrition labeling is required, including ground or chopped meat or 
poultry products described in Sec.  413.301, nutrition labeling must be 
provided in accordance with the provisions of Sec.  413.309, except as 
exempted under Sec.  413.400.
    (b) Nutrition labeling may be provided for single-ingredient, raw 
meat or poultry products that are not ground or chopped meat or poultry 
products described in Sec.  413.301 and that are not major cuts of 
single-ingredient, raw meat or poultry products identified in Sec.  
413.344, either in accordance with the provisions of Sec.  413.309 for 
nutrition labels, or in accordance with the provisions of Sec.  413.345 
for point-of-purchase materials.


Sec.  413.301  Required nutrition labeling of ground or chopped 
products.

    (a) Nutrition labels must be provided for all ground or chopped 
products (livestock species or kind) and hamburger with or without 
added seasonings (including, but not limited to, ground beef, ground 
beef patties, ground sirloin, ground pork, ground lamb, ground chicken, 
ground turkey, and (kind) burgers) that are intended for human 
consumption and offered for sale, in accordance with the provisions of 
Sec.  413.309, except as exempted under Sec.  413.400.
    (b) [Reserved]


Sec.  413.302  Location of nutrition information.

    (a) Nutrition information on a label of a packaged product shall 
appear on the label's principal display panel or on the information 
panel, except as provided in paragraphs (b) and (c) of this section.
    (b) Nutrition information for gift packs may be shown at a location 
other than on the product label, provided that the labels for these 
products bear no nutrition claim. In lieu of on the product label, 
nutrition information may be provided by alternate means such as 
product label inserts.
    (c) Products in packages that have a total surface area available 
to bear labeling greater than 40 square inches but whose principal 
display panel and information panel do not provide sufficient space to 
accommodate all required information may use any alternate panel that 
can be readily seen by consumers for the nutrition information. In 
determining the sufficiency of available space for the nutrition 
information, the space needed for vignettes, designs, and other 
nonmandatory label information on the principal display panel may be 
considered.

[[Page 6787]]

Sec. Sec.  413.303-413.307   [Reserved]


Sec.  413.308  Labeling of products with number of servings.

    The label of any package of a product that bears a representation 
as to the number of servings contained in such package shall meet the 
requirements of Sec.  317.2(h)(10) or Sec.  381.121(c)(7).


Sec.  413.309  Nutrition label content.

    (a) All nutrient and food component quantities shall be declared in 
relation to a serving as defined in this section.
    (b)(1) The term ``serving'' or ``serving size'' means an amount of 
food customarily consumed per eating occasion by persons 4 years of age 
or older, which is expressed in a common household measure that is 
appropriate to the product. When the product is specially formulated or 
processed for use by infants or by toddlers, a serving or serving size 
means an amount of food customarily consumed per eating occasion by 
infants up to 12 months of age or by children 1 through 3 years of age, 
respectively.
    (2) Except as provided in paragraphs (b)(8), (b)(12), and (b)(14) 
of this section and for products that are intended for weight control 
and are available only through a weight-control or weight-maintenance 
program, serving size declared on a product label shall be determined 
from the ``Reference Amounts Customarily Consumed Per Eating Occasion--
General Food Supply'' (Reference Amounts) that appear in Sec.  
413.312(b) using the procedures described in this paragraph (b). For 
products that are both intended for weight control and available only 
through a weight-control program, a manufacturer may determine the 
serving size that is consistent with the meal plan of the program. Such 
products must bear a statement, ``for sale only through the 
_______program'' (fill in the blank with the name of the appropriate 
weight-control program, e.g., Smith's Weight Control), on the principal 
display panel. However, the Reference Amounts in Sec.  413.312(b) shall 
be used for purposes of evaluating whether weight-control products that 
are available only through a weight-control program qualify for 
nutrition claims.
    (3) The declaration of nutrient and food component content shall be 
on the basis of the product ``as packaged'' for all products, except 
that single-ingredient, raw products that are not ground or chopped 
products described in Sec.  413.301 may be declared on the basis of the 
product ``as consumed''. For single-ingredient, raw products that are 
not ground or chopped products described in Sec.  413.301, if data are 
based on the product `as consumed,' the data must be presented in 
accordance with Sec.  413.345(d). In addition to the required 
declaration on the basis of ``as packaged'' for products other than 
single-ingredient, raw products that are not ground or chopped products 
described in Sec.  413.301, the declaration may also be made on the 
basis of ``as consumed,'' provided that preparation and cooking 
instructions are clearly stated.
    (4) For products in discrete units (e.g., hot dogs, chicken wings, 
and individually packaged products within a multi-serving package), and 
for products which consist of two or more foods packaged and presented 
to be consumed together where the ingredient represented as the main 
ingredient is in discrete units (e.g., beef fritters and barbecue 
sauce, chicken wings and barbecue sauce), the serving size shall be 
declared as follows:
    (i) If a unit weighs 50 percent or less of the Reference Amount, 
the serving size shall be the number of whole units that most closely 
approximates the Reference Amount for the product category.
    (ii) If a unit weighs more than 50 percent but less than 67 percent 
of the Reference Amount, the manufacturer may declare one unit or two 
units as the serving size.
    (iii) If a unit weighs 67 percent or more but less than 200 percent 
of the Reference Amount, the serving size shall be one unit.
    (iv) If a unit weighs at least 200 percent and up to and including 
300 percent of the applicable reference amount, the serving size shall 
be the amount that approximates the reference amount. In addition to 
providing a column within the Nutrition Facts label that lists the 
quantitative amounts and percent Daily Values per serving size, the 
manufacturer shall provide a column within the Nutrition Facts label 
that lists the quantitative amounts and percent Daily Values per 
individual unit. The first column would be based on the serving size 
for the product and the second column would be based on the individual 
unit. The exemptions in paragraphs (b)(16)(i)(A), (B), and (C) of this 
section apply to this provision.
    (v) For products which consist of two or more foods packaged and 
presented to be consumed together where the ingredient represented as 
the main ingredient is in discrete units (e.g., beef fritters and 
barbecue sauce, chicken wings and barbecue sauce), the serving size may 
be the number of discrete units represented as the main ingredient plus 
proportioned minor ingredients used to make the Reference Amount for 
the combined product as determined in Sec.  413.312(c).
    (vi) For packages containing several individual single-serving 
containers, each of which is labeled with all required information 
including nutrition labeling as specified in this section (i.e., are 
labeled appropriately for individual sale as single-serving 
containers), the serving size shall be 1 unit.
    (vii) The serving size for products that naturally vary in size 
(e.g., chicken breast, poultry parts, pork chop) may be the amount in 
ounces that most closely approximates the reference amount for the 
product category. Manufacturers shall adhere to the requirements in 
paragraph (b)(7)(iii) of this section for expressing the serving size 
in ounces.
    (5) For products in large discrete units that are usually divided 
for consumption (e.g., pizza, pan of poultry lasagna), for unprepared 
products where the entire contents of the package is used to prepare 
large discrete units that are usually divided for consumption (e.g. 
pizza kit), and for products which consist of two or more foods 
packaged and presented to be consumed together where the ingredient 
represented as the main ingredient is a large discrete unit usually 
divided for consumption, the serving size shall be the fractional slice 
of the ready-to-eat product (e.g., \1/8\ quiche, \1/4\ pizza) that most 
closely approximates the Reference Amount for the product category. The 
serving size may be the fraction of the package used to make the 
Reference Amount for the unprepared product determined in Sec.  
413.312(d) or the fraction of the large discrete unit represented as 
the main ingredient plus proportioned minor ingredients used to make 
the Reference Amount of the combined product determined in Sec.  
413.312(c). In expressing the fractional slice, manufacturers shall use 
\1/2\, \1/3\, \1/4\, \1/5\, \1/6\, or smaller fractions that can be 
generated by further division by 2 or 3.
    (6) For nondiscrete bulk products (e.g., whole roast beef, 
marinated beef tenderloin, large can of chili, whole turkey, turkey 
breast, ground poultry), and for products which consist of two or more 
foods packaged and presented to be consumed together where the 
ingredient represented as the main ingredient is a bulk product (e.g., 
roast beef and gravy, turkey breast and gravy), the serving size shall 
be the amount in household measure that most closely approximates the 
Reference Amount for the product category and may be the amount of the 
bulk product represented as the main ingredient plus proportioned minor 
ingredients used to make the Reference Amount for the

[[Page 6788]]

combined product determined in Sec.  413.312(c).
    (7) For labeling purposes, the term ``common household measure'' or 
``common household unit'' means cup, tablespoon, teaspoon, piece, 
slice, fraction (e.g., \1/4\ pizza), ounce (oz), or other common 
household equipment used to package food products (e.g., jar or tray). 
In expressing serving size in household measures, except as specified 
in paragraphs (b)(7)(iv), (v), and (vi) of this section, the following 
rules shall be used:
    (i) Cups, tablespoons, or teaspoons shall be used wherever possible 
and appropriate. Cups shall be expressed in \1/4\- or \1/3\-cup 
increments, tablespoons in whole number of tablespoons for quantities 
less than \1/4\ cup but greater than or equal to 2 tablespoons (tbsp), 
1, 1\1/3\, 1\1/2\, or 1\1/2\ tbsp for quantities less than 2 tbsp but 
greater than or equal to 1 tbsp, and teaspoons in whole number of 
teaspoons for quantities less than 1 tbsp but greater than or equal to 
1 teaspoon (tsp), and in \1/4\-tsp increments for quantities less than 
1 tsp.
    (ii) If cups, tablespoons or teaspoons are not applicable, units 
such as piece, slice, tray, jar, and fraction shall be used.
    (iii) If cups, tablespoons and teaspoons, or units such as piece, 
slice, tray, jar, or fraction are not applicable, ounces may be used. 
Ounce measurements shall be expressed in 0.5-ounce increments most 
closely approximating the Reference Amount with rounding indicated by 
the use of the term ``about'' (e.g., about 2.5 ounces).
    (iv) A description of the individual container or package shall be 
used for single-serving containers and for individually packaged 
products within multi-serving containers (e.g., can, box, package, 
meal, or dinner). A description of the individual unit shall be used 
for other products in discrete units (e.g., chop, slice, link, or 
patty).
    (v) For unprepared products where the entire contents of the 
package is used to prepare large discrete units that are usually 
divided for consumption (e.g., pizza kit), the fraction or portion of 
the package may be used.
    (vi) For products that consist of two or more distinct ingredients 
or components packaged and presented to be consumed together (e.g., ham 
with a glaze packet, chicken wings with a glaze packet), the nutrition 
information may be declared for each component or as a composite. The 
serving size shall be provided in accordance with the provisions of 
paragraphs (b)(4), (b)(5), and (b)(6) of this section, whichever is 
applicable.
    (vii) For nutrition labeling purposes, a teaspoon means 5 
milliliters (mL), a tablespoon means 15 mL, a cup means 240 mL, and 1 
oz in weight means 28 grams (g).
    (viii) When a serving size, determined from the Reference Amount in 
Sec.  413.312(b) and the procedures described in this section, falls 
exactly half way between two serving sizes (e.g., 2.5 tbsp), 
manufacturers shall round the serving size up to the next incremental 
size.
    (8) A product that is packaged and sold individually that contains 
less than 200 percent of the applicable reference amount must be 
considered to be a single-serving container, and the entire content of 
the product must be labeled as one serving. In addition to providing a 
column within the Nutrition Facts label that lists the quantitative 
amounts and percent Daily Values per serving, for a product that is 
packaged and sold individually that contains more than 150 percent and 
less than 200 percent of the applicable reference amount, the Nutrition 
Facts label may voluntarily provide, to the left of the column that 
provides nutrition information per container (i.e., per serving), an 
additional column that lists the quantitative amounts and percent Daily 
Values per common household measure that most closely approximates the 
reference amount.
    (9) A label statement regarding a serving shall be the serving size 
expressed in common household measures as set forth in paragraphs 
(b)(2) through (b)(8) of this section and shall be followed by the 
equivalent metric quantity in parenthesis (fluids in milliliters and 
all other foods in grams), except for single-serving containers.
    (i) For a single-serving container, the parenthetical metric 
quantity, which will be presented as part of the net weight statement 
on the principal display panel, is not required except where nutrition 
information is required on a drained weight basis according to 
paragraph (b)(11) of this section. However, if a manufacturer 
voluntarily provides the metric quantity on products that can be sold 
as single servings, then the numerical value provided as part of the 
serving size declaration must be identical to the metric quantity 
declaration provided as part of the net quantity of contents statement.
    (ii) The gram or milliliter quantity equivalent to the household 
measure should be rounded to the nearest whole number except for 
quantities that are less than 5 g (mL). The gram (mL) quantity between 
2 and 5 g (mL) should be rounded to the nearest 0.5 g (mL) and the g 
(mL) quantity less than 2 g (mL) should be expressed in 0.1-g (mL) 
increments.
    (iii) In addition, serving size may be declared in ounce, in 
parenthesis, following the metric measure separated by a slash where 
other common household measures are used as the primary unit for 
serving size, e.g., 1 slice (28 g/1 oz) for sliced bologna or for 
sliced chicken roll. The ounce quantity equivalent to the metric 
quantity should be expressed in 0.1-oz increments.
    (iv) If a manufacturer elects to use abbreviations for units, the 
following abbreviations shall be used: tbsp for tablespoon, tsp for 
teaspoon, g for gram, mL for milliliter, and oz for ounce.
    (v) For products that only require the addition of water or another 
ingredient that contains insignificant amounts of nutrients in the 
amount added and that are prepared in such a way that there are no 
significant changes to the nutrient profile, the amount of the finished 
product may be declared in parentheses at the end of the serving size 
declaration (e.g., \1/2\ cup (120g) concentrated soup (makes 1 cup 
prepared)).
    (10) Determination of the number of servings per container shall be 
based on the serving size of the product determined by following the 
procedures described in this section.
    (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).
    (ii) When the serving size is required to be expressed on a drained 
solids basis and the number of servings varies because of a natural 
variation in unit size (e.g., pickled pigs feet), the manufacturer may 
state the typical number of servings per container (e.g., usually 5 
servings).
    (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)(7) of this section. Random weight products are foods such 
as meat roasts or whole turkeys that are sold as random weights that 
vary in size, such that the net contents for different containers would 
vary. The manufacturer may provide the typical number of servings in 
parentheses following the ``varied''

[[Page 6789]]

statement (e.g., varied (approximately 8 servings per pound)).
    (iv) For packages containing several individual single-serving 
containers, each of which is labeled with all required information 
including nutrition labeling as specified in this section (i.e., are 
labeled appropriately for individual sale as single-serving 
containers), the number of servings shall be the number of individual 
packages within the total package.
    (v) For packages containing several individually packaged multi-
serving units, the number of servings shall be determined by 
multiplying the number of individual multi-serving units in the total 
package by the number of servings in each individual unit. The 
declaration of the number of servings per container need not be 
included in nutrition labeling of single-ingredient, raw products that 
are not ground or chopped products described in Sec.  413.301, 
including those that have been previously frozen.
    (11) The declaration of nutrient and food component content shall 
be on the basis of product as packaged or purchased with the exception 
of single-ingredient, raw products that are not ground or chopped 
products described in Sec.  413.301 and products that are packed or 
canned in water, brine, or oil but whose liquid packing medium is not 
customarily consumed. Declaration of the nutrient and food component 
content of products that are packed in liquid which is not customarily 
consumed shall be based on the drained solids.
    (12) The serving size for meal-type products and main-dish products 
as defined in Sec.  413.313(l) and Sec.  413.313(m) in single-serving 
containers will be the entire edible content of the package. Serving 
size for meal-type products and main-dish products in multi-serve 
containers will be based on the reference amount applicable to the 
product in Sec.  413.312(b) if the product is listed in Sec.  
413.312(b). Serving size for meal-type products and main-dish products 
in multi-serve containers that are not listed in Sec.  413.312(b) will 
be based on the reference amount according to Sec.  413.312(c), (d), 
and (e).
    (13) Another column of figures may be used to declare the nutrient 
and food component information in the same format as required by Sec.  
413.309(e).
    (i) Per 100 grams, 100 milliliters, or 1 ounce of the product as 
packaged or purchased.
    (ii) Per one unit if the serving size of a product in discrete 
units in is more than one unit.
    (14) If a product consists of assortments of meat, meat food 
products, or poultry products (e.g., variety packs) in the same 
package, nutrient content shall be expressed on the entire package 
contents or on each individual product.
    (15) If a product is commonly combined with other ingredients or is 
cooked or otherwise prepared before eating, and directions for such 
combination or preparations are provided, another column of figures may 
be used to declare nutrition information on the basis of the product as 
consumed in the format required in paragraph (e) of this section (e.g., 
a cream soup mix may be labeled with the percent Daily Value and 
quantitative amounts for the dry mix alone (per serving), and the 
percent Daily Value and quantitative amounts for the serving of the 
final soup when prepared (e.g., per serving of cream soup mix and 1 cup 
of vitamin D fortified whole milk)): Provided, that the type and 
quantity of the other ingredients to be added to the product by the 
user and the specific method of cooking and other preparation shall be 
specified prominently on the label.
    (16)(i) Products that are packaged and sold individually and that 
contain at least 200 percent and up to and including 300 percent of the 
applicable reference amount must provide an additional column within 
the Nutrition Facts label that lists the quantitative amounts and 
percent Daily Values for the entire package, as well as a column 
listing the quantitative amounts and percent Daily Values for a serving 
that is less than the entire package (i.e., the serving size derived 
from the reference amount). The first column would be based on the 
serving size for the product and the second column would be based on 
the entire contents of the package.
    (A) This provision does not apply to products that meet the 
requirements to use the tabular display for small packages in paragraph 
(g)(1)(i)(A) of this section or to products that meet the requirements 
to use the linear format in paragraph (g)(1)(i)(B) of this section.
    (B) This provision does not apply to products that require further 
preparation and provide an additional column of nutrition information 
under paragraph (e) of this section, to products that are commonly 
consumed in combination with another food and provide an additional 
column of nutrition information under paragraph (e) of this section, to 
products that provide an additional column of nutrition information for 
two or more groups for which RDIs are established (e.g., both infants 
through 12 months and children 1 through 3 years of age), or to random-
weight products covered under paragraph (b)(10)(iii) of this section.
    (ii) When a nutrient content claim or health claim is made on the 
label of a product that uses a dual column in accordance with paragraph 
(b) of this section, the claim must be followed by a statement that 
sets forth the basis on which the claim is made, except that the 
statement is not required for products when the nutrient that is the 
subject of the claim meets the criteria for the claim based on the 
reference amount for the product and the entire container or the unit 
amount. When a nutrient content claim is made, the statement must 
express that the claim refers to the amount of the nutrient per serving 
(e.g., ``good source of calcium per serving'' or ``per X [insert unit] 
serving'' or per reference amount (e.g., ``good source of calcium per 
[insert reference amount (e.g., per 8 ounces)]), as required based on 
Sec.  413.313(p). When a health claim is made, the statement shall be 
``A serving of __ ounces of this product conforms to such a diet.''
    (c) The declaration of nutrition information on the label and in 
labeling of a meat or meat food product or poultry product shall 
contain information about the level of the following nutrients, except 
for those nutrients whose inclusion, and the declaration of the 
amounts, is voluntary as set forth in this paragraph. No nutrients or 
food components other than those listed in this paragraph as either 
mandatory or voluntary may be included within the nutrition label. 
Except as provided for in paragraphs (f) or (g) of this section, 
nutrient information shall be presented using the nutrient names 
specified and in the following order in the formats specified in 
paragraphs (d) or (e) of this section.
    (1) ``Calories, total,'' ``Total calories,'' or ``Calories'': A 
statement of the caloric content per serving, expressed to the nearest 
5-calorie increment up to and including 50 calories, and 10-calorie 
increment above 50 calories, except that amounts less than 5 calories 
may be expressed as zero. Energy content per serving may also be 
expressed in kilojoule units, added in parenthesis immediately 
following the statement of the caloric content.
    (i) Caloric content may be calculated by the following methods. 
Where either specific or general food factors are used, the factors 
shall be applied to the actual amount (i.e., before rounding) of food 
components (e.g., fat, carbohydrate, protein, or ingredients with 
specific food factors) present per serving.
    (A) Using specific Atwater factors (i.e., the Atwater method) given 
in Table

[[Page 6790]]

13, USDA Handbook No. 74 (slightly revised, 1973);
    (B) Using the general factors of 4, 4, and 9 calories per gram for 
protein, total carbohydrate, and total fat, respectively, as described 
in USDA Handbook No. 74 (slightly revised, 1973) pp. 9-11;
    (C) Using the general factors of 4, 4, and 9 calories per gram for 
protein, total carbohydrate (less the amount of non-digestible 
carbohydrates and sugar alcohols), and total fat, respectively, as 
described in USDA Handbook No. 74 (slightly revised, 1973) pp. 9-11. A 
general factor of 2 calories per gram for soluble non-digestible 
carbohydrates shall be used. The general factors for caloric value of 
sugar alcohols provided in paragraph (c)(1)(i)(F) of this section shall 
be used;
    (D) Using data for specific food factors for particular foods or 
ingredients approved by the Food and Drug Administration (FDA) and 
provided in parts 172 or 184 of 21 CFR, or by other means, as 
appropriate;
    (E) Using bomb calorimetry data subtracting 1.25 calories per gram 
protein to correct for incomplete digestibility, as described in USDA 
Handbook No. 74 (slightly revised, 1973) p. 10; or
    (F) Using the following general factors for caloric value of sugar 
alcohols: Isomalt--2.0 calories per gram, lactitol--2.0 calories per 
gram, xylitol--2.4 calories per gram, maltitol--2.1 calories per gram, 
sorbitol--2.6 calories per gram, hydrogenated starch hydrolysates--3.0 
calories per gram, mannitol--1.6 calories per gram, and erythritol--0 
calories per gram.
    (ii) ``Calories from saturated fat'' or ``Calories from saturated'' 
(VOLUNTARY): A statement of the caloric content derived from saturated 
fat as defined in paragraph (c)(2)(i) of this section per serving may 
be declared voluntarily, expressed to the nearest 5-calorie increment, 
up to and including 50 calories, and the nearest 10-calorie increment 
above 50 calories, except that amounts less than 5 calories may be 
expressed as zero. This statement shall be indented under the statement 
of calories as provided in paragraph (d)(5) of this section.
    (2) ``Fat, total'' or ``Total fat'': A statement of the number of 
grams of total fat per serving defined as total lipid fatty acids and 
expressed as triglycerides where fatty acids are aliphatic carboxylic 
acids consisting of a chain of alkyl groups and characterized by a 
terminal carboxyl group. Amounts shall be expressed to the nearest 0.5 
(\1/2\)-gram increment below 5 grams and to the nearest gram increment 
above 5 grams. If the serving contains less than 0.5 gram, the content 
shall be expressed as zero.
    (i) ``Saturated fat'' or ``Saturated'': A statement of the number 
of grams of saturated fat per serving defined as the sum of all fatty 
acids containing no double bonds, except that label declaration of 
saturated fat content information is not required for products that 
contain less than 0.5 gram of total fat per serving if no claims are 
made about fat, fatty acid, or cholesterol content, and if ``calories 
from saturated fat'' is not declared. Saturated fat content shall be 
indented and expressed as grams per serving to the nearest 0.5 (\1/2\)-
gram increment below 5 grams and to the nearest gram increment above 5 
grams. If the serving contains less than 0.5 gram, the content shall be 
expressed as zero.
    (A) [Reserved]
    (B) [Reserved]
    (ii) ``Trans Fat'' or ``Trans'': A statement of the number of grams 
of trans fat in a serving, defined as the sum of all unsaturated fatty 
acids that contain one or more isolated (i.e., nonconjugated) double 
bonds in a trans configuration. The word ``trans'' may be italicized to 
indicate its Latin origin. Trans fat content shall be indented and 
expressed as grams per serving to the nearest 0.5 (\1/2\)-gram 
increment below 5 grams and to the nearest gram increment above 5 
grams. If the serving contains less than 0.5 gram, the content, when 
declared, shall be expressed as zero.
    (iii) ``Polyunsaturated fat'' or ``Polyunsaturated'' (VOLUNTARY): A 
statement of the number of grams of polyunsaturated fat per serving 
defined as cis, cis-methylene-interrupted polyunsaturated fatty acids 
may be declared voluntarily, except that when monounsaturated fat is 
declared, or when a claim about fatty acids or cholesterol is made on 
the label or in labeling of a product other than one that meets the 
criteria in Sec.  413.362(b)(1) for a claim for ``fat free,'' label 
declaration of polyunsaturated fat is required. Polyunsaturated fat 
content shall be indented and expressed as grams per serving to the 
nearest 0.5 (\1/2\)-gram increment below 5 grams and to the nearest 
gram increment above 5 grams. If the serving contains less than 0.5 
gram, the content shall be expressed as zero.
    (iv) ``Monounsaturated fat'' or ``Monounsaturated'' (VOLUNTARY): A 
statement of the number of grams of monounsaturated fat per serving 
defined as cis-monounsaturated fatty acids may be declared voluntarily, 
except that when polyunsaturated fat is declared, or when a claim about 
fatty acids or cholesterol is made on the label or in labeling of a 
product other than one that meets the criteria in Sec.  413.362(b)(1) 
for a claim for ``fat free,'' label declaration of monounsaturated fat 
is required. Monounsaturated fat content shall be indented and 
expressed as grams per serving to the nearest 0.5 (\1/2\)-gram 
increment below 5 grams and to the nearest gram increment above 5 
grams. If the serving contains less than 0.5 gram, the content shall be 
expressed as zero.
    (3) ``Cholesterol'': A statement of the cholesterol content per 
serving expressed in milligrams to the nearest 5-milligram increment, 
except that label declaration of cholesterol information is not 
required for products that contain less than 2 milligrams of 
cholesterol per serving and make no claim about fat, fatty acids, or 
cholesterol content, or such products may state the cholesterol content 
as zero. If the product contains 2 to 5 milligrams of cholesterol per 
serving, the content may be stated as ``less than 5 milligrams.''
    (4) ``Sodium'': A statement of the number of milligrams of sodium 
per serving expressed as zero when the serving contains less than 5 
milligrams of sodium, to the nearest 5-milligram increment when the 
serving contains 5 to 140 milligrams of sodium, and to the nearest 10-
milligram increment when the serving contains greater than 140 
milligrams.
    (5) ``Fluoride'' (VOLUNTARY): A statement of the number of 
milligrams of fluoride in a specified serving of food may be declared 
voluntarily, except that when a claim is made about fluoride content, 
label declaration shall be required. Fluoride content shall be 
expressed as zero when the serving contains less than 0.1 milligrams of 
fluoride, to the nearest 0.1-milligram increment when the serving 
contains less than or equal to 0.8 milligrams of fluoride, and the 
nearest 0.2 milligram-increment when a serving contains more than 0.8 
milligrams of fluoride.
    (6) ``Carbohydrate, total'' or ``Total carbohydrate'': A statement 
of the number of grams of total carbohydrate per serving expressed to 
the nearest gram, except that if a serving contains less than 1 gram, 
the statement ``Contains less than 1 gram'' or ``less than 1 gram'' may 
be used as an alternative, or, if the serving contains less than 0.5 
gram, the content may be expressed as zero. Total carbohydrate content 
shall be calculated by subtraction of the sum of the crude protein, 
total fat, moisture, and ash from the total weight of the product. This 
calculation method is described in USDA Handbook No. 74 (slightly 
revised, 1973), pp. 2-3.

[[Page 6791]]

    (i) ``Dietary fiber'': A statement of the number of grams of total 
dietary fiber per serving, indented and expressed to the nearest gram, 
except that if a serving contains less than 1 gram, declaration of 
dietary fiber is not required, or, alternatively, the statement 
``Contains less than 1 gram'' or ``less than 1 gram'' may be used, and 
if the serving contains less than 0.5 gram, the content may be 
expressed as zero. Dietary fiber is defined as non-digestible soluble 
and insoluble carbohydrates (with 3 or more monomeric units) and lignin 
that are intrinsic and intact in plants; isolated or synthetic non-
digestible carbohydrates (with 3 or more monomeric units) determined by 
FDA to have physiological effects that are beneficial to human health. 
Except as provided for in paragraph (f) of this section, if dietary 
fiber content is not required, and as a result not declared, the 
statement ``Not a significant source of dietary fiber'' shall be placed 
at the bottom of the table of nutrient values in the same type size. 
The following isolated or synthetic non-digestible carbohydrate(s) have 
been determined by FDA to have physiological effects that are 
beneficial to human health and, therefore, shall be included in the 
calculation of the amount of dietary fiber: [beta]-glucan soluble fiber 
(as described in 21 CFR 101.81(c)(2)(ii)(A)), psyllium husk (as 
described in 21 CFR 101.81(c)(2)(ii)(A)(6)), cellulose, guar gum, 
pectin, locust bean gum, and hydroxypropylmethylcellulose. The 
manufacturer must make and keep records in accordance with paragraphs 
(h) of this section to verify the declared amount of dietary fiber in 
the label and labeling of food when a mixture of dietary fiber, and 
added non-digestible carbohydrate(s) that does not meet the definition 
of dietary fiber, is present in the food.
    (A) ``Soluble fiber'' (VOLUNTARY): A statement of the number of 
grams of soluble dietary fiber per serving may be declared voluntarily 
except when a claim is made on the label or in labeling about soluble 
fiber, label declaration shall be required. Soluble fiber must meet the 
definition of dietary fiber in this paragraph (c)(6)(i). The 
manufacturer must maintain records in accordance with paragraph (h)(8) 
of this section to verify the declared amount of soluble fiber in the 
label and labeling of food when a mixture of soluble fiber and added 
non-digestible carbohydrate(s) that does not meet the definition of 
dietary fiber, is present in the food. Soluble fiber content shall be 
indented under dietary fiber and expressed to the nearest gram, except 
that if a serving contains less than 1 gram, the statement ``Contains 
less than 1 gram'' or ``less than 1 gram'' may be used as an 
alternative, and if the serving contains less than 0.5 gram, the 
content may be expressed as zero.
    (B) ``Insoluble fiber'' (VOLUNTARY): A statement of the number of 
grams of insoluble dietary fiber per serving may be declared 
voluntarily except when a claim is made on the label or in labeling 
about insoluble fiber, label declaration shall be required. Insoluble 
fiber must meet the definition of dietary fiber in this paragraph 
(c)(6)(i). The manufacturer must make and keep records in accordance 
with paragraph (h)(8) of this section to verify the declared amount of 
insoluble fiber in the label and labeling of food when a mixture of 
insoluble and added non-digestible carbohydrate(s) that does not meet 
the definition of dietary fiber is present in the food. Insoluble fiber 
content shall be indented under dietary fiber and expressed to the 
nearest gram, except that if a serving contains less than 1 gram, the 
statement ``Contains less than 1 gram'' or ``less than 1 gram'' may be 
used as an alternative, and if the serving contains less than 0.5 gram, 
the content may be expressed as zero.
    (ii) ``Total Sugars'': A statement of the number of grams of sugars 
per serving, except that the label declaration of sugars content is not 
required for products that contain less than 1 gram of sugars per 
serving if no claims are made about sweeteners, sugars, or sugar 
alcohol content. Total sugars shall be defined as the sum of all free 
mono- and disaccharides (such as glucose, fructose, lactose, and 
sucrose). Total sugars content shall be indented and expressed to the 
nearest gram, except that if a serving contains less than 1 gram, the 
statement ``Contains less than 1 gram'' or ``less than 1 gram'' may be 
used as an alternative, and if the serving contains less than 0.5 gram, 
the content may be expressed as zero.
    (iii) ``Added Sugars'': A statement of the number of grams of added 
sugars in a serving, except that label declaration of added sugars 
content is not required for products that contain less than 1 gram of 
added sugars in a serving if no claims are made about sweeteners, 
sugars, added sugars, or sugar alcohol content. If a statement of the 
added sugars content is not required and, as a result, not declared, 
the statement ``Not a significant source of added sugars'' shall be 
placed at the bottom of the table of nutrient values in the same type 
size. Added sugars are either added during the processing of foods, or 
are packaged as such, and include sugars (free, mono- and 
disaccharides), sugars from syrups and honey, and sugars from 
concentrated fruit or vegetable juices that are in excess of what would 
be expected from the same volume of 100 percent fruit or vegetable 
juice of the same type. Added sugars content shall be indented under 
Total Sugars and shall be prefaced with the word ``Includes'' followed 
by the amount (in grams) ``Added Sugars'' (``Includes `X' g Added 
Sugars''). It shall be expressed to the nearest gram, except that if a 
serving contains less than 1 gram, the statement ``Contains less than 1 
gram'' or ``less than 1 gram'' may be used as an alternative, and if 
the serving contains less than 0.5 gram, the content may be expressed 
as zero. When a mixture of naturally occurring and added sugars is 
present in the food, and for specific foods containing added sugars, 
alone or in combination with naturally occurring sugars, where the 
added sugars are subject to fermentation and/or non-enzymatic browning, 
the manufacturer must maintain records in accordance with paragraph 
(h)(8) of this section to verify the declared amount of added sugars in 
the label and labeling of food.
    (iv) ``Sugar alcohol'' (VOLUNTARY): A statement of the number of 
grams of sugar alcohols per serving may be declared voluntarily on the 
label, except that when a claim is made on the label or in labeling 
about sugar alcohol, total sugars, or added sugars when sugar alcohols 
are present in the product, sugar alcohol content shall be declared. 
For nutrition labeling purposes, sugar alcohols are defined as the sum 
of saccharide derivatives in which a hydroxyl group replaces a ketone 
or aldehyde group and whose use in the food is listed by FDA (e.g., 
mannitol or xylitol) or is generally recognized as safe (e.g., 
sorbitol). In lieu of the term ``sugar alcohol,'' the name of the 
specific sugar alcohol (e.g., ``xylitol'') present in the product may 
be used in the nutrition label, provided that only one sugar alcohol is 
present in the product. Sugar alcohol content shall be indented and 
expressed to the nearest gram, except that if a serving contains less 
than 1 gram, the statement ``Contains less than 1 gram'' or ``less than 
1 gram'' may be used as an alternative, and if the serving contains 
less than 0.5 gram, the content may be expressed as zero.
    (7) ``Protein'': A statement of the number of grams of protein per 
serving, expressed to the nearest gram, except that if a serving 
contains less than 1 gram, the statement ``Contains less than 1 gram'' 
or ``less than 1 gram'' may be used as an alternative, and if the 
serving contains less than 0.5 gram, the content may be expressed as 
zero. When the protein in products represented or

[[Page 6792]]

purported to be for adults and children 4 or more years of age has a 
protein quality value that is a protein digestibility-corrected amino 
acid score of less than 20 expressed as a percent, or when the protein 
in a product represented or purported to be for children greater than 1 
but less than 4 years of age has a protein quality value that is a 
protein digestibility-corrected amino acid score of less than 40 
expressed as a percent, either of the following shall be placed 
adjacent to the declaration of protein content by weight: The statement 
``not a significant source of protein,'' or a listing aligned under the 
column headed ``%Daily Value'' of the corrected amount of protein per 
serving, as determined in paragraph (c)(7)(ii) of this section, 
calculated as a percentage of the Daily Reference Value (DRV) or 
Reference Daily Intake (RDI), as appropriate, for protein and expressed 
as percent of Daily Value. When the protein quality in a product as 
measured by the Protein Efficiency Ratio (PER) is less than 40 percent 
of the reference standard (casein) for a product represented or 
purported to be specifically for infants through 12 months, the 
statement ``not a significant source of protein'' shall be placed 
adjacent to the declaration of protein content. Protein content may be 
calculated on the basis of the factor of 6.25 times the nitrogen 
content of the food as determined by appropriate methods of analysis in 
accordance with Sec.  413.309(h), except when the procedure for a 
specific food requires a specific factor other than 6.25, that factor 
shall be used.
    (i) A statement of the corrected amount of protein per serving, as 
determined in paragraph (c)(7)(ii) of this section, calculated as a 
percentage of the RDI or DRV for protein, as appropriate, and expressed 
as percent of Daily Value, may be placed on the label, except that such 
a statement shall be given if a protein claim is made for the product, 
or if the product is represented or purported to be specifically for 
infants through 12 months of age or children 1 through 3 years of age. 
When such a declaration is provided, it shall be placed on the label 
adjacent to the statement of grams of protein and aligned under the 
column headed ``%Daily Value,'' and expressed to the nearest whole 
percent. However, the percentage of the RDI for protein shall not be 
declared if the product is represented or purported to be specifically 
for infants through 12 months and the protein quality value is less 
than 40 percent of the reference standard.
    (ii) The ``corrected amount of protein (grams) per serving'' for 
products represented or purported to be for adults and children 1 or 
more years of age is equal to the actual amount of protein (grams) per 
serving multiplied by the amino acid score corrected for protein 
digestibility. If the corrected score is above 1.00, then it shall be 
set at 1.00. The protein digestibility-corrected amino acid score shall 
be determined by methods given in sections 5.4.1, 7.2.1, and 8.00 in 
``Report of the Joint FAO/WHO Expert Consultation on Protein Quality 
Evaluation,'' except that when official AOAC procedures described in 
paragraph (c)(7) of this section require a specific factor other than 
6.25, that specific factor shall be used.
    For products represented or purported to be specifically for 
infants through 12 months, the corrected amount of protein (grams) per 
serving is equal to the actual amount of protein (grams) per serving 
multiplied by the relative protein quality value. The relative protein 
quality value shall be determined by dividing the subject product's 
protein PER value by the PER value for casein. If the relative protein 
value is above 1.00, it shall be set at 1.00.
    (iii) For the purpose of labeling with a percent of the DRV or RDI, 
a value of 50 grams of protein shall be the DRV for adults and children 
4 or more years of age, a value of 11 grams of protein shall be the RDI 
for infants through 12 months, a value of 13 grams shall be the DRV for 
children 1 through 3 years of age, and a value of 71 grams of protein 
shall be the RDI for pregnant women and lactating women.
    (8) Vitamins and minerals: The requirements related to including a 
statement of the amount per serving of vitamins and minerals are 
described in this paragraph (c)(8).
    (i) For purposes of declaration of percent of Daily Value as 
provided for in paragraphs (d) through (g) of this section, products 
represented or purported to be specifically for infants through 12 
months, children 1 through 3 years, pregnant women and lactating women 
shall use the RDIs that are specified for the intended group. For 
products represented or purported to be specifically for both infants 
through 12 months and children 1 through 3 years of age, the percent of 
Daily Value shall be presented by separate declarations according to 
paragraph (e) of this section based on the RDI values for infants 
through 12 months and for children 1 through 3 years of age. When such 
dual declaration is used on any label, it shall be included in all 
labeling, and equal prominence shall be given to both values in all 
such labeling. The percent Daily Value based on the RDI values for 
pregnant women and lactating women shall be declared on food 
represented or purported to be specifically for pregnant women and 
lactating women. All other products shall use the RDI for adults and 
children 4 or more years of age.
    (ii) The declaration of vitamins and minerals as a quantitative 
amount by weight and percent of the RDI shall include vitamin D, 
calcium, iron, and potassium in that order, for infants through 12 
months, children 1 through 3 years of age, pregnant women, lactating 
women, and adults and children 4 or more years of age. The declaration 
of folic acid shall be included as a quantitative amount by weight when 
added or a claim is made about the nutrient. The declaration of 
vitamins and minerals in a food as a quantitative amount by weight and 
percent of the RDI, may include any of the other vitamins and minerals 
listed in paragraph (c)(8)(iv) of this section. The declaration of 
vitamins and minerals shall include any of the other vitamins and 
minerals listed in paragraph (c)(8)(iv) of this section as a statement 
of the amount per serving of the vitamins and minerals as described in 
this paragraph, calculated as a percent of the RDI and expressed as a 
percent of the Daily Value, when they are added, or when a claim is 
made about them, unless otherwise stated as quantitative amount by 
weight and percent of the Daily Value. Other vitamins and minerals need 
not be declared if neither the nutrient nor the component is otherwise 
referred to on the label or in labeling and the vitamins and minerals 
are:
    (A) Required or permitted in a standardized food (e.g., thiamin, 
riboflavin, and niacin in enriched flour) and that standardized food is 
included as an ingredient (i.e., component) in another product; or
    (B) Included in a product solely for technological purposes and 
declared only in the ingredients statement. The declaration may also 
include any of the other vitamins and minerals listed in paragraph 
(c)(8)(iv) of this section when they are naturally occurring in the 
food. The additional vitamins and minerals shall be listed in the order 
established in paragraph (c)(8)(iv) of this section.
    (iii) The percentages for vitamins and minerals shall be expressed 
to the nearest 2-percent increment up to and including the 10-percent 
level, the nearest 5-percent increment above 10 percent and up to and 
including the 50-percent level, and the nearest 10-percent increment 
above the 50-percent level. Quantitative amounts and percentages

[[Page 6793]]

of vitamins and minerals present at less than 2 percent of the RDI are 
not required to be declared in nutrition labeling but may be declared 
by a zero or by the use of an asterisk (or other symbol) that refers to 
another asterisk (or symbol) that is placed at the bottom of the table 
and that is followed by the statement ``Contains less than 2 percent of 
the Daily Value of this (these) nutrient (nutrients) or ``Contains <2 
percent of the Daily Value of this (these) nutrients.'' Alternatively, 
except as provided for in paragraph (f) of this section, if vitamin D, 
calcium, iron, or potassium is present in amounts less than 2 percent 
of the RDI, label declaration of the nutrient(s) is not required if the 
statement ``Not a significant source of __ (listing the vitamins or 
minerals omitted)'' is placed at the bottom of the table of nutrient 
values. Either statement shall be in the same type size as nutrients 
that are indented. The quantitative amounts of vitamins and minerals, 
excluding sodium, shall be the amount of the vitamin or mineral 
included in one serving of the product, using the units of measurement 
and the levels of significance given in paragraph (c)(8)(iv) of this 
section, except that zeros following decimal points may be dropped, and 
additional levels of significance may be used when the number of 
decimal places indicated is not sufficient to express lower amounts 
(e.g., the RDI for zinc is given in whole milligrams, but the 
quantitative amount may be declared in tenths of a milligram).
    (iv) The following RDIs, nomenclature, and units of measure are 
established for the following vitamins and minerals which are essential 
in human nutrition:

----------------------------------------------------------------------------------------------------------------
                                                                                RDI
                                                 ---------------------------------------------------------------
           Nutrient              Unit of measure    Adults and      Infants \1\     Children 1    Pregnant women
                                                   children >=4     through 12       through 3     and lactating
                                                       years          months           years           women
----------------------------------------------------------------------------------------------------------------
Vitamin A.....................  Micrograms RAE               900             500             300           1,300
                                 \2\ (mcg).
Vitamin C.....................  Milligrams (mg).              90              50              15             120
Calcium.......................  Milligrams (mg).           1,300             260             700           1,300
Iron..........................  Milligrams (mg).              18              11               7              27
Vitamin D.....................  Micrograms (mcg)              20              10              15              15
                                 \3\.
Vitamin E.....................  Milligrams (mg)               15               5               6              19
                                 \4\.
Vitamin K.....................  Micrograms (mcg)             120             2.5              30              90
Thiamin.......................  Milligrams (mg).             1.2             0.3             0.5             1.4
Riboflavin....................  Milligrams (mg).             1.3             0.4             0.5             1.6
Niacin........................  Milligrams NE                 16               4               6              18
                                 \5\ (mg).
Vitamin B6....................  Milligrams (mg).             1.7             0.3             0.5             2.0
Folate \6\....................  Micrograms DFE               400              80             150             600
                                 \7\ (mcg).
Vitamin B12...................  Micrograms (mcg)             2.4             0.5             0.9             2.8
Biotin........................  Micrograms (mcg)              30               6               8              35
Pantothenic acid..............  Milligrams (mg).               5             1.8               2               7
Phosphorus....................  Milligrams (mg).           1,250             275             460           1,250
Iodine........................  Micrograms (mcg)             150             130              90             290
Magnesium.....................  Milligrams (mg).             420              75              80             400
Zinc..........................  Milligrams (mg).              11               3               3              13
Selenium......................  Micrograms (mcg)              55              20              20              70
Copper........................  Milligrams (mg).             0.9             0.2             0.3             1.3
Manganese.....................  Milligrams (mg).             2.3             0.6             1.2             2.6
Chromium......................  Micrograms (mcg)              35             5.5              11              45
Molybdenum....................  Micrograms (mcg)              45               3              17              50
Chloride......................  Milligrams (mg).           2,300             570           1,500           2,300
Potassium.....................  Milligrams (mg).           4,700             700           3,000           5,100
Choline.......................  Milligrams (mg).             550             150             200             550
Protein.......................  Grams (g).......             N/A              11             N/A          \8\ 71
----------------------------------------------------------------------------------------------------------------
\1\ RDIs are based on dietary reference intake recommendations for infants through 12 months of age.
\2\ RAE = Retinol activity equivalents; 1 microgram RAE = 1 microgram retinol, 2 micrograms supplemental [beta]-
  carotene, 12 micrograms [beta]-carotene, or 24 micrograms [alpha]-carotene, or 24 micrograms [beta]-
  cryptoxanthin.
\3\ The amount of vitamin D may, but is not required to, be expressed in international units (IU), in additional
  to the mandatory declaration in mcg. Any declaration of the amount of vitamin D in IU must appear in
  parentheses after the declaration of the amount of vitamin D in mcg.
\4\ 1 mg [alpha]-tocopherol (label claim) = 1 mg [alpha]-tocopherol = 1 mg RRR- [alpha]-tocopherol = 2 mg all
  rac-[alpha]-tocopherol.
\5\ NE = Niacin equivalents, 1 mg NE = 1 mg niacin = 60 milligrams tryptophan.
\6\ ``Folate'' and ``Folic Acid'' must be used for purposes of declaration in the labeling of conventional foods
  and dietary supplements. The declaration for folate must be in mcg DFE (when expressed as a quantitative
  amount by weight in a conventional food or a dietary supplement), and percent DV based on folate in mcg DFE.
  Folate may be expressed as a percent DV in conventional foods. When folic acid is added or when a claim is
  made about the nutrient, folic acid must be declared in parentheses, as mcg of folic acid.
\7\ DFE = Dietary Folate Equivalents; 1 DFE = 1 mcg naturally-occurring folate = 0.6 mcg folic acid.
\8\ Based on the reference caloric intake of 2,000 calories for adults and children aged 4 years and older, and
  for pregnant women and lactating women.

    (v) The following synonyms may be added in parenthesis immediately 
following the name of the nutrient or dietary component:

Calories--Energy
Vitamin C--Ascorbic acid
Thiamin--Vitamin B1
Riboflavin--Vitamin B2

    (vi) A statement of the percent of vitamin A that is present as 
beta-carotene may be declared voluntarily. When the vitamins and 
minerals are listed in a single column, the statement shall be indented 
under the information on vitamin A. When vitamins and minerals are 
arrayed horizontally, the statement of percent shall be presented in 
parenthesis following the declaration

[[Page 6794]]

of vitamin A and the percent of Daily Value of vitamin A in the product 
(e.g., ``Percent Daily Value: Vitamin A 50 (90 percent as beta-
carotene)''). When declared, the percentages shall be expressed in the 
same increments as are provided for vitamins and minerals in paragraph 
(c)(8)(iii) of this section.
    (vii) When the amount of folate is declared in the labeling of a 
product the nutrient name ``folate'' shall be listed for products 
containing folate (natural folate, and/or synthetic folate), folic 
acid, or a mixture of folate and folic acid. The name of the synthetic 
form of the nutrient ``folic acid'', when added or a claim is made 
about the nutrient, shall be included in parentheses after this 
declaration with the amount of folic acid. The declaration must be 
folate in mcg DFE (when expressed as a quantitative amount by weight) 
and the percent Daily Value based on folate in mcg DFE, or may be 
expressed as folate and the percent DV based on folate in mcg DFE. When 
declared, folic acid must be in parentheses, mcg of folic acid as shown 
in paragraph (d)(12) of this section in the display that illustrates 
voluntary declaration of nutrition information.
    (9) The following DRVs, nomenclature, and units of measure are 
established for the following food components:

----------------------------------------------------------------------------------------------------------------
                                                                                DRV
                                                 ---------------------------------------------------------------
        Food component               Unit of        Adults and        Infants       Children 1    Pregnant women
                                   measurement     children >=4     through 12       through 3     and lactating
                                                       years          months           years           women
----------------------------------------------------------------------------------------------------------------
Fat...........................  Grams (g).......          \1\ 78              30          \2\ 39          \1\ 78
Saturated fatty acids.........  Grams (g).......          \1\ 20             N/A          \2\ 10          \1\ 20
Cholesterol...................  Milligrams (mg).             300             N/A             300             300
Total carbohydrate............  Grams (g).......         \1\ 275              95         \2\ 150         \1\ 275
Sodium........................  Milligrams (mg).           2,300             N/A           1,500           2,300
Dietary fiber.................  Grams (g).......          \1\ 28             N/A          \2\ 14          \1\ 28
Protein.......................  Grams (g).......          \1\ 50             N/A          \2\ 13             N/A
Added Sugars..................  Grams (g).......          \1\ 50             N/A          \2\ 25          \1\ 50
----------------------------------------------------------------------------------------------------------------
\1\ Based on the reference caloric intake of 2,000 calories for adults and children aged 4 years and older, and
  for pregnant women and lactating women.
\2\ Based on the reference caloric intake of 1,000 calories for children 1 through 3 years of age.

    (d)(1) Nutrient information specified in paragraph (c) of this 
section shall be presented on products in the following format, as 
shown in paragraph (d)(12) of this section, except on foods where the 
horizontal display is permitted as provided for in paragraph (d)(11) of 
this section, on which dual columns of nutrition information are 
declared as provided for in paragraph (e) of this section, on those 
food products on which the simplified format is permitted to be used as 
provided for in paragraph (f) of this section, on foods for infants 
through 12 months of age and children 1 through 3 years of age as 
provided for in Sec.  413.400(c), and on foods in small or 
intermediate-sized packages as provided for in paragraph (g) of this 
section.
    (i) The nutrition information shall be set off in a box by use of 
hairlines and shall be all black or one color type, printed on a white 
or other neutral contrasting background whenever practical.
    (ii) All information within the nutrition label shall utilize:
    (A) A single easy-to-read type style,
    (B) Upper and lower case letters,
    (C) At least one point leading (i.e., space between two lines of 
text) except that at least four points leading shall be utilized for 
the information required by paragraphs (d)(7) and (d)(8) of this 
section, and
    (D) Letters should never touch.
    (iii) Information required in paragraphs (d)(7) and (d)(8) of this 
section shall be in type size no smaller than 8 point. Information 
required in paragraph (d)(5) of this section for the ``Calories'' 
declaration shall be highlighted in bold or extra bold and shall be in 
a type size no smaller than 16 point except the type size for this 
information required in the tabular displays as shown in paragraphs 
(d)(11)(iii), (e)(6)(ii), and (g)(1)(i)(A) of this section, and the 
linear display for small packages as shown in paragraph (g)(1)(i)(B) of 
this section shall be in a type size no smaller than 10 point. The 
numeric amount for the information required in paragraph (d)(5) of this 
section shall also be highlighted in bold or extra bold type and shall 
be in a type size no smaller than 22 point, except the type size for 
this information required for the tabular display for small packages as 
shown in paragraph (g)(1)(i)(A) of this section, and for the linear 
display for small packages as shown in paragraph (g)(1)(i)(B) of this 
section no smaller than 14 point. The information required in paragraph 
(d)(9) of this section shall be in a type size no smaller than 6 point. 
When provided, the information described in paragraph (d)(10) of this 
section shall be in a type size no smaller than 6 point.
    (iv) The headings required by paragraphs (d)(2), (d)(3)(ii), 
(d)(4), and (d)(6) of this section (i.e., ``Nutrition Facts,'' 
``Serving Size,'' ``Amount per serving,'' and ``% Daily Value*''), the 
names of all nutrients that are not indented according to requirements 
of paragraph (c) of this section (i.e., ``Calories,'' ``Total Fat,'' 
``Cholesterol,'' ``Sodium,'' ``Total Carbohydrate'' and ``Protein''), 
and the percentage amounts required by paragraph (d)(7)(ii) of this 
section shall be highlighted in bold or extra bold type or other 
highlighting (reverse printing is not permitted as a form of 
highlighting) that prominently distinguishes it from other information. 
No other information shall be highlighted.
    (v) A hairline rule that is centered between the lines of text 
shall separate ``Nutrition Facts'' from the servings per container 
statement required in paragraph (d)(3)(i) of this section, and shall 
separate each nutrient and its corresponding percent of Daily Value 
required in paragraphs (d)(7)(i) and (d)(7)(ii) of this section from 
the nutrient and percent of Daily Value above and below it, as shown in 
paragraph (d)(12) of this section.
    (2) The information shall be presented under the identifying 
heading of ``Nutrition Facts'' which shall be set in a type size no 
smaller than all other print size in the nutrition label except for the 
numerical information for ``Calories'' required in paragraph (d)(5) of 
this section, and except for labels presented according to the format 
provided for in paragraphs (d)(11)(iii),

[[Page 6795]]

(d)(13)(ii), (e)(6)(ii), (g)(1)(i)(A) and (g)(1)(i)(B) of this section, 
unless impractical, shall be set the full width of the information 
provided under paragraph (d)(7) of this section, as shown in paragraph 
(d)(12) of this section.
    (3) Information on servings per container and serving size shall 
immediately follow the heading as shown in paragraph (d)(12) of this 
section. Such information shall include:
    (i) ``__ servings per container'': The number of servings per 
container, except that this statement is not required on single-serving 
containers as defined in paragraph (b)(8) of this section or on single-
ingredient, raw products that are not ground or chopped products 
described in Sec.  413.301. The information required in this paragraph 
shall be located immediately after the ``Nutrition Facts'' heading and 
shall be in a type size no smaller than 10 point, except the type size 
for this information shall be no smaller than 9 point in the tabular 
display for small packages as shown in paragraph (g)(1)(i)(A) of this 
section and the linear display for small packages as shown in paragraph 
(g)(1)(i)(B) of this section. For the linear display for small packages 
as shown in paragraph (g)(1)(i)(B) of this section, the actual number 
of servings may be listed after the servings per container declaration.
    (ii) ``Serving size'': A statement of the serving size as specified 
in paragraph (b)(9) of this section shall immediately follow the ``__ 
servings per container'' declaration. The information required in this 
paragraph shall be highlighted in bold or extra bold and be in a type 
size no smaller than 10 point except the type size shall be no smaller 
than 9 point for this information in the tabular displays as shown in 
paragraphs (d)(11) and (e)(6)(ii) of this section, the tabular display 
for small packages as shown in (g)(1)(i)(A) of this section, and the 
linear display for small packages as shown in paragraph (g)(1)(i)(B) of 
this section. The serving size amount must be right justified if 
adequate space is available. If the ``Serving size'' declaration does 
not fit in the allocated space a type size of no smaller than 8 point 
may be used on packages of any size.
    (4) A subheading ``Amount per serving'' shall be separated from 
serving size information by a bar as shown in paragraph (d)(12) of this 
section, except this information is not required for the dual column 
formats shown in paragraphs (e)(5), (e)(6)(i), and (e)(6)(ii) of this 
section. ``Per__'' (e.g., per \1/2\ a burrito)'' is required for dual 
column formats.
    (5) Information on calories shall immediately follow the subheading 
``Amount per serving'' and shall be declared in one line. If ``Calories 
from saturated fat'' is declared, it shall be indented under 
``Calories'' and shall be in a type size no smaller than 8 point.
    (6) The column heading ``% Daily Value,'' followed by an asterisk 
(e.g., ``% Daily Value*''), shall be separated from information on 
calories by a bar as shown in paragraph (d)(12) of this section. The 
position of this column heading shall allow for a list of nutrient 
names and amounts as described in paragraph (d)(7) of this section to 
be to the left of, and below, this column heading. The column headings 
``Percent Daily Value,'' ``Percent DV,'' or ``% DV'' may be substituted 
for ``% Daily Value.''
    (7) Except as provided for in paragraph (g)(1)(i)(B) of this 
section, and except as permitted by Sec.  413.400(d)(2), nutrient 
information for both mandatory and any voluntary nutrients listed in 
paragraph (c) of this section that are to be declared in the nutrition 
label, except for folic acid in conventional food and voluntarily 
declared vitamins and minerals expressed as a statement of the amount 
per serving calculated as a percent of the RDI and expressed as a 
percent Daily Value, shall be declared as follows:
    (i) The name of each nutrient, as specified in paragraph (c) of 
this section, shall be given in a column and followed immediately by 
the quantitative amount by weight for that nutrient appended with a 
``g'' for grams or ``mg'' for milligrams, or ``mcg'' for micrograms as 
shown in paragraph (d)(12) of this section. The symbol ``<'' may be 
used in place of ``less than''.
    (ii) A listing of the percent of the DRV as established in 
paragraphs (c)(7)(iii) and (c)(9) of this section shall be given in a 
column aligned under the heading ``% Daily Value'' established in 
paragraph (d)(6) of this section with the percent expressed to the 
nearest whole percent for each nutrient declared in the column 
described in paragraph (d)(7)(i) of this section for which a DRV has 
been established, except that the percent for protein may be omitted as 
provided in paragraph (c)(7) of this section. The percent shall be 
calculated by dividing either the amount declared on the label for each 
nutrient or the actual amount of each nutrient (i.e., before rounding) 
by the DRV for the nutrient, except that the percent for protein shall 
be calculated as specified in paragraph (c)(7)(ii) of this section. The 
numerical value shall be followed by the symbol for percent (i.e., %).
    (8) Nutrient information for vitamins and minerals (except sodium) 
shall be separated from information on other nutrients by a bar and 
shall be arrayed vertically as shown in paragraph (d)(12) of this 
section (e.g., Vitamin D 2 mcg 10%, Calcium 260 mg 20%, Iron 8 mg 45%, 
Potassium 235 mg 6%) or may be listed horizontally. When listed 
horizontally in two columns, vitamin D and calcium should be listed on 
the first line and iron and potassium should be listed on the second 
line as shown in paragraph (d)(12) of this section in the side-by-side 
display. When more than four vitamins and minerals are declared 
voluntarily as shown in paragraph (d)(12) of this section in the label 
which illustrates the mandatory plus voluntary provisions of paragraph 
(d) of this section, they may be declared vertically with percentage 
listed under the column headed ``% Daily Value.''
    (9) A footnote, preceded by an asterisk, shall be placed beneath 
the list of vitamins and minerals and shall be separated from the list 
by a bar, except that the footnote may be omitted from foods that can 
use the terms ``calorie free,'' ``free of calories,'' ``no calories,'' 
``zero calories,'' ``without calories,'' ``trivial source of 
calories,'' ``negligible source of calories,'' or ``dietarily 
insignificant source of calories'' on the label or in the labeling of 
foods as defined in 9 CFR 413.360(b). The first sentence of the 
footnote: ``The % Daily Value tells you how much a nutrient in a 
serving of food contributes to a daily diet'' may be used on foods than 
can use the terms ``calorie free,'' ``free of calories,'' ``no 
calories,'' ``zero calories,'' ``without calories,'' ``trivial source 
of calories,'' ``negligible source of calories,'' or ``dietarily 
insignificant source of calories'' on the label or in the labeling of 
foods as defined in 9 CFR 413.360(b). The footnote shall state: ``*The 
% Daily Value tells you how much a nutrient in a serving of food 
contributes to a daily diet. 2,000 calories a day is used for general 
nutrition advice.'' If the food product is represented or purported to 
be for children 1 through 3 years of age, the second sentence of the 
footnote shall substitute ``1,000 calories'' for ``2,000 calories''.
    (10) Caloric conversion information on a per gram basis for fat, 
carbohydrate, and protein may be presented beneath the information 
required in paragraph (d)(9), separated from that information by a 
hairline. This information may be presented horizontally (i.e. 
``Calories per gram: Fat 9, Carbohydrate 4, Protein 4'') or vertically 
in columns.
    (11)(i) If the space beneath the information on vitamins and 
minerals is not adequate to accommodate the information required in 
paragraph (d)(9)

[[Page 6796]]

of this section, the information required in paragraph (d)(9) may be 
moved to the right of the column required in paragraph (d)(7)(ii) of 
this section and set off by a line that distinguishes it and sets it 
apart from the percent of Daily Value information. The caloric 
conversion information provided for in paragraph (d)(10) of this 
section may be presented beneath either side or along the full length 
of the nutrition label.
    (ii) If the space beneath the mandatory declaration of potassium is 
not adequate to accommodate any remaining vitamins and minerals to be 
declared or the information required in paragraph (d)(9) of this 
section, the remaining information may be moved to the right and set 
off by a line that distinguishes it and sets it apart from the 
nutrients and the percent of DV information given to the left. The 
caloric conversion information provided for in paragraph (d)(10) of 
this section may be presented beneath either side or along the full 
length of the nutrition label.
    (iii) If there is not sufficient continuous vertical space (i.e., 
approximately 3 inches) to accommodate the required components of the 
nutrition label up to and including the mandatory declaration of 
potassium, the nutrition label may be presented in a horizontal display 
as shown in the following sample label.
[GRAPHIC] [TIFF OMITTED] TP19JA17.002

    (12) The following sample labels illustrate the mandatory 
provisions and mandatory plus voluntary provisions of paragraph (d) of 
this section and the side-by-side display:

[[Page 6797]]

[GRAPHIC] [TIFF OMITTED] TP19JA17.003

    (13)(i) Nutrition labeling on the outer label of packages of 
products that contain two or more products in the same packages (e.g., 
variety packs) or of packages that are used interchangeably for the 
same type of food (e.g., meat salad containers, poultry salad 
containers) may use an aggregate display.
    (ii) Aggregate displays shall comply with format requirements of 
paragraph (d) of this section to the maximum extent possible, except 
that the identity of each food shall be specified to the right of the 
``Nutrition Facts'' heading, and both the quantitative amount by weight 
(i.e., g/mg/mcg amounts) and the percent Daily Value for each nutrient 
shall be listed in separate columns under the name of each food. The 
following sample label illustrates an aggregate display.

[[Page 6798]]

[GRAPHIC] [TIFF OMITTED] TP19JA17.004

    (14) When nutrition labeling appears in a second language, the 
nutrition information may be presented in a separate nutrition label 
for each language or in one nutrition label with the information in the 
second language following that in English. Numeric characters that are 
identical in both languages need not be repeated (e.g., ``Protein/
Proteinas 2 g''). All required information must be included in both 
languages.
    (e) Nutrition information may be presented for two or more forms of 
the same product (e.g., both ``as purchased'' and ``as prepared'') or 
for common combinations of foods as provided for in paragraph (b) of 
this section, for different units (e.g., per nugget or per 100 grams) 
as provided for in paragraph (b) of this section, or for two or more 
groups for which RDIs are established (e.g., both infants through 12 
months of age and children 1 through 3 years of age) as shown in 
paragraph (c)(8)(i) of this section. When such dual labeling is 
provided, equal prominence shall be given to both sets of values. 
Information shall be presented in a format consistent with paragraph 
(d) of this section, except that:
    (1) Following the serving size information there shall be two or 
more column headings accurately describing the amount per serving size 
of the form of the same product (e.g., ``raw'' and ``roasted''), the 
combinations of foods, the units, or the RDI groups that are being 
declared as shown in paragraph (e)(5) of this section.
    (2) The quantitative information by weight as required in paragraph 
(d)(7)(i) and the information required in (d)(7)(ii) of this section 
shall be presented for the form of the product as packaged and for any 
other form of the product (e.g., ``as prepared'' or combined with 
another ingredient as shown in paragraph (e)(5) of this section) but 
may be on the basis of 'as consumed' for single-ingredient, raw 
products that are not ground or chopped products described in Sec.  
413.301, and according to the label serving size based on the Reference 
Amount in Sec.  413.312(b).
    (3) When the dual labeling is presented for two or more forms of 
the same food, for combinations of food, for different units, or for 
two or more groups for which RDIs are established, quantitative 
information by weight and the percent Daily Value shall be presented in 
two columns and the columns shall be separated by vertical lines as 
shown in paragraph (e)(5) of this section.
    (4) Nutrient information for vitamins and minerals (except sodium) 
shall be separated from information on other nutrients by a bar and 
shall be arrayed vertically in the following order: Vitamin D, calcium, 
iron, potassium as shown in paragraph (e)(5) of this section.
    (5) The following sample label illustrates the provisions of 
paragraph (e) of this section:

[[Page 6799]]

[GRAPHIC] [TIFF OMITTED] TP19JA17.005

    (6) When dual labeling is presented for a food on a per serving 
basis and per container basis as required in paragraph (b)(16)(i) of 
this section or on a per serving basis and per unit basis as required 
in paragraph (b)(4)(iv) of this section, the quantitative information 
by weight as required in (d)(7)(i) and the percent Daily Value as 
required in paragraph (d)(7)(ii) shall be presented in two columns, and 
the columns shall be separated by vertical lines as shown in the 
displays in paragraph (e)(6)(i) of this section.
    (i) Nutrient information for vitamins and minerals shall be 
separated from information on other nutrients by a bar and shall be 
arrayed vertically in the following order: Vitamin D, calcium, iron, 
and potassium as shown in the following sample labels.
[GRAPHIC] [TIFF OMITTED] TP19JA17.006

    (ii) The following sample label illustrates the provisions of 
paragraphs (b)(4)(iv) and (b)(16)(i) of this section for labels that 
use the dual column format in the horizontal display.

[[Page 6800]]

[GRAPHIC] [TIFF OMITTED] TP19JA17.007

    (f)(1) The declaration of nutrition information may be presented in 
the simplified format as set forth herein when any required nutrients, 
other than the core nutrients (i.e., calories, total fat, sodium, total 
carbohydrate, and protein), are present in insignificant amounts. An 
insignificant amount shall be defined as that amount that may be 
rounded to zero in nutrition labeling, except that for total 
carbohydrate, dietary fiber, total sugars, added sugars, and protein, 
it shall be an amount less than 1 gram.
    (2) The simplified format shall include information on the 
following nutrients:
    (i) Total calories, total fat, sodium, total carbohydrate, and 
protein;
    (ii) Any of the following that are present in more than 
insignificant amounts: saturated fat, trans fat, cholesterol, dietary 
fiber, total sugars, added sugars, vitamin D, calcium, iron, and 
potassium; and
    (iii) Any vitamins and minerals listed in paragraph (c)(8)(iv) of 
this section when they are added in fortified or fabricated foods.
    (3) Other nutrients that are naturally present in the product in 
more than insignificant amounts may be voluntarily declared as part of 
the simplified format.
    (4) Any required nutrient, other than a core nutrient, that is 
present in an insignificant amount may be omitted from the columnar 
listing, provided that the following statement is included at the 
bottom of the nutrition label, ``Not a significant source of __.'' The 
blank shall be filled in with the appropriate nutrient or food 
component. Alternatively, amounts of vitamins and minerals present in 
insignificant amounts may be declared by the use of an asterisk (or 
symbol) that is placed at the bottom of the table of nutrient values 
and that is followed by the statement ``Contains less than 2 percent of 
the Daily Value of this (these) nutrient (nutrients).''
    (5) Except as provided for in paragraph (g) of this section and in 
Sec.  413.400(c) and (d), nutrient information declared in the 
simplified format shall be presented in the same manner as specified in 
paragraphs (d) or (e) of this section, except that the footnote 
required in paragraph (d)(9) of this section is not required, and an 
asterisk shall be placed at the bottom of the label followed by the 
statement ``%DV = %Daily Value'' when ``Daily Value'' is not spelled 
out in the heading, as shown in the following example that illustrates 
the simplified display
[GRAPHIC] [TIFF OMITTED] TP19JA17.008

    (g) Foods in packages that have a total surface area available to 
bear labeling of 40 or less square inches may modify the requirements 
of paragraphs (c) through (f) of this section and Sec.  413.302(a) by 
one or more of the following means:
    (1)(i) Presenting the required nutrition information in a tabular 
or linear fashion, rather than in vertical columns if the product has a 
total surface area available to bear labeling of less than 12 square 
inches, or if the product has a total surface area available to bear 
labeling of 40 or less square inches and the package shape or size 
cannot accommodate a standard vertical column or tabular display on any 
label panel. Nutrition information may be given in a linear fashion 
only if the package shape or size will not accommodate a tabular 
display.
    (A) The following sample label illustrates the tabular display for 
small packages.

[[Page 6801]]

[GRAPHIC] [TIFF OMITTED] TP19JA17.009

    (B) The following sample label illustrates the linear display.
    [GRAPHIC] [TIFF OMITTED] TP19JA17.010
    
    (2) Using any of the following abbreviations:

Serving size--Serv size
Servings per container--Servings
Calories from saturated fat--Sat fat cal
Saturated fat--Sat fat
Monounsaturated fat--Monounsat fat
Polyunsaturated fat--Polyunsat fat
Cholesterol--Cholest

    Total carbohydrate--Total carb. This abbreviation can also be used 
on dual column displays as shown in paragraphs (e)(5), (e)(6)(i), and 
(e)(6)(ii).

Dietary fiber--Fiber
Soluble fiber--Sol fiber
Insoluble fiber--Insol fiber
Sugar alcohol--Sugar alc
Vitamin--Vit
Potassium--Potas

Includes--Incl. This abbreviation can also be used on dual column 
displays as shown in paragraphs (e)(5), (e)(6)(i), and (e)(6)(ii) of 
this section
    (3) Omitting the footnote statement and placing another asterisk at 
the bottom of the label followed by the statement ``%DV=%Daily Value.''
    (4) Presenting the required nutrition information on any other 
label panel.
    (h) Compliance with this section shall be determined as follows:
    (1) A production lot is a set of food production consumer units 
that are from one production shift. Alternatively, a collection of 
consumer units of the same size, type, and style produced under 
conditions as nearly uniform as possible, designated by a common 
container code or marking, constitutes a production lot.
    (2) The sample for nutrient analysis shall consist of a composite 
of a minimum of six consumer units, each from a production lot. 
Alternatively, the sample for nutrient analysis shall consist of a 
composite of a minimum of six consumer units, each randomly chosen to 
be representative of a production lot. In each case, the units may be 
individually analyzed and the results of the analyses averaged, or the 
units would be composited and the composite analyzed. In both cases, 
the results, whether an average or a single result from a composite, 
will be considered by the Agency to be the nutrient content of a 
composite. All analyses shall be performed by appropriate methods and 
procedures used by the Department for each nutrient in accordance with 
the ``Chemistry Laboratory Guidebook,'' or, if no USDA method is 
available and appropriate for the nutrient, by appropriate methods for 
the nutrient in accordance with the 2016 edition of the ``Official 
Methods of Analysis'' of the AOAC International, unless a particular 
method of analysis is specified in Sec.  413.309(c), or, if no USDA, 
AOAC, or specified method is available and appropriate, by other 
reliable and appropriate analytical procedures as so determined by the 
Agency.
    (3) Two classes of nutrients are defined for purposes of 
compliance:
    (i) Class I. Added nutrients in fortified or fabricated foods; and
    (ii) Class II. Naturally occurring (indigenous) nutrients. When a 
nutrient is naturally occurring (indigenous) in a food or an ingredient 
that is added to a food, the total amount of such nutrient in the final 
food product is subject to Class II requirements, except that when an 
exogenous source of the nutrient is also added to the final food 
product, the total amount of the nutrient in the final food product 
(indigenous and exogenous) is subject to Class I requirements.
    (4) A product with a label declaration of a vitamin, mineral, 
protein, total carbohydrate, dietary fiber, soluble fiber, insoluble 
fiber, polyunsaturated or monounsaturated fat shall be deemed to be 
misbranded under section 1(n) of the Federal Meat Inspection Act (21 
U.S.C. 601(n)(1)) or 4(h) of the Poultry Products Inspection Act (21 
U.S.C. 453(h)) unless it meets the following requirements:
    (i) When a vitamin, mineral, protein, or dietary fiber meets the 
definition of a Class I nutrient, the nutrient content of the composite 
must be formulated to be at least equal to the value for that nutrient 
declared on the label.
    (ii) When a vitamin, mineral, protein, total carbohydrate, 
polyunsaturated or monounsaturated fat, dietary fiber meets the 
definition of a Class II nutrient, the nutrient content of the 
composite must be at least equal to 80 percent of the value for that 
nutrient declared on the label. Provided, that no regulatory action 
will be based on a determination of a nutrient value that falls below 
this level by a factor less than the variability generally recognized 
for the analytical method used in that product at the level involved.
    (5) A product with a label declaration of calories, total sugars, 
added sugars (when the only source of sugars in the food is added 
sugars), total fat, saturated fat, trans fat, cholesterol, or sodium 
shall be deemed to be misbranded under section 1(n) of the Federal Meat 
Inspection Act (21 U.S.C. 601(n)(1)) or 4(h) of the Poultry Products 
Inspection

[[Page 6802]]

Act (21 U.S.C. 453(h)) if the nutrient content of the composite is 
greater than 20 percent in excess of the value for that nutrient 
declared on the label. Provided, that no regulatory action will be 
based on a determination of a nutrient value that falls above this 
level by a factor less than the variability generally recognized for 
the analytical method used in that product at the level involved, and 
inherent nutrient variation in a product.
    (6) The amount of vitamins, minerals, protein, total carbohydrate, 
dietary fiber, soluble fiber, insoluble fiber, sugar alcohols, 
polyunsaturated or monounsaturated fat may vary over labeled amounts 
within good manufacturing practice. The amount of calories, sugars, 
added sugars, total fat, saturated fat, trans fat, cholesterol, or 
sodium may vary under labeled amounts within good manufacturing 
practice.
    (7) Compliance will be based on the metric measure specified in the 
label statement of the serving size.
    (8) The management of the official establishment or establishment 
certified under a foreign inspection system, in accordance with parts 
327 and 381, subpart T, of this chapter must maintain records in 
accordance with parts 320 and 381, subpart Q, of this chapter to 
support the validity of nutrient declarations contained on product 
labels including the records in subparagraphs (h)(8)(i)-(vii) of this 
section for documenting the amount of dietary fiber, soluble fiber, 
insoluble fiber, added sugars, tocopherol, folate, and folic acid. Such 
records shall be made available to the inspector or any duly authorized 
representative of the Agency upon request.
    (i) When a mixture of dietary fiber, and added non-digestible 
carbohydrate(s) that does not meet the definition of dietary fiber, is 
present in the food, a manufacturer must maintain records of the amount 
of non-digestible carbohydrate(s) added to the food that does not meet 
the definition of dietary fiber.
    (ii) When a mixture of soluble fiber and added non-digestible 
carbohydrate(s) that does not meet the definition of dietary fiber is 
present in the food, a manufacturer must maintain records necessary to 
verify the amount of the non-digestible carbohydrate(s) added to the 
food that does not meet the definition of dietary fiber.
    (iii) When a mixture of insoluble fiber and added non-digestible 
carbohydrate(s) that does not meet the definition of dietary fiber is 
present in the food, a manufacturer must maintain records necessary to 
verify the amount of the non-digestible carbohydrate(s) added to the 
food that does not meet the definition of dietary fiber.
    (iv) When a mixture of naturally occurring and added sugars is 
present in the food, a manufacturer must maintain records of the amount 
of added sugars added to the food during the processing of the food, 
and if packaged as a separate ingredient, as packaged (whether as part 
of a package containing one or more ingredients or packaged as a single 
ingredient).
    (v) When the amount of sugars added to food products is reduced 
through the process of yeast-leavening, non-enzymatic browning or 
fermentation, manufacturers must:
    (A) Maintain records of all relevant scientific data and 
information relied upon by the manufacturer that demonstrates the 
amount of added sugars in the food after the process of non-enzymatic 
browning, yeast-leavening, fermentation, or the manufacture of reaction 
flavors and a narrative explaining why the data and information are 
sufficient to demonstrate the amount of added sugars declared in the 
finished food, provided the data and information used is specific to 
the type of food that is subject to non-enzymatic browning or 
fermentation; or
    (B) Maintain records of the amount of added sugars added to the 
food before and during the processing of the food, and if packaged as a 
separate ingredient, as packaged (whether as part of a package 
containing one or more ingredients or packaged as a single ingredient) 
and in no event shall the amount of added sugars declared exceed the 
amount of total sugars on the label; or
    (C) Submit a request to FSIS to use an alternative means of 
compliance. The request must provide scientific data or other 
information for why the amount of added sugars in a serving of product 
is likely to have a significant reduction in added sugars compared to 
the amount added prior to non-enzymatic browning and/or fermentation. A 
significant reduction would be where reduction in added sugars after 
non-enzymatic browning or fermentation may be significant enough to 
impact the label declaration for added sugars by an amount that exceeds 
the reasonable deficiency acceptable within good manufacturing practice 
under Sec.  413.309(h)(6). In addition, the scientific data or other 
information must include the reason that the manufacturer is unable to 
determine a reasonable approximation of the amount of added sugars in a 
serving of their finished product and a description of the process that 
they used to come to that conclusion.
    (vi) When a mixture of all rac-[alpha]-tocopherol and RRR-[alpha]-
tocopherol is present in a food, manufacturers must maintain records of 
the amount of all rac-[alpha]-tocopherol added to the food and RRR-
[alpha]-tocopherol in the finished food.
    (vii) When a mixture of folate and folic acid is present in a food, 
manufacturers must maintain records of the amount of synthetic folate 
and/or folic acid added to the food and the amount of naturally-
occurring folate in the finished food.
    (9) The compliance provisions set forth in paragraph (h)(1) through 
(8) of this section shall not apply to single-ingredient, raw products 
that are not ground or chopped products described in Sec.  413.301, 
including those that have been previously frozen, when nutrition 
labeling is based on the most current representative data base values 
contained in USDA's National Nutrient Data Bank or its released form, 
the USDA National Nutrient Database for Standard Reference as provided 
in Sec.  413.345(e) and (f).
    (i) The standards required in this section are incorporated by 
reference into this section with the approval of the Director of the 
Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved 
material is available for inspection at the office of the FSIS Docket 
Clerk, Room 8-164A, Patriots Plaza 3, 355 E Street SW., Washington, DC, 
and is available from the sources indicated below. It is also available 
for inspection at the National Archives and Records Administration 
(NARA), call 202-741-6030, or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
    (1) AOAC Reseller. Techstreet, 6300 Interfirst Dr., Ann Arbor, MI 
48108, Toll free in United States: 1-800-699-9277, Outside United 
States: 1-734-780-8000, Fax: 1-734-780-2046, www.techstreet.com, 
[email protected]. FSIS does not endorse any 
particular reseller and notes that other resellers also may have the 
reference for sale.
    (i) ``Official Methods of Analysis of the AOAC INTERNATIONAL,'' 
20th Edition, Volumes 1 and 2, 2016.
    (ii) [Reserved]
    (2) Food and Agriculture Organization of the United Nations/World 
Health Organization (FAO/WHO), Publications Division, Viale delle Terme 
di Caracalla, 00100 Rome, Italy.
    (i) FAO Food and Nutrition Paper 51,''Report of the Joint FAO/WHO 
Expert Consultation on Protein Quality Evaluation,'' Rome, 1991. http:/
/

[[Page 6803]]

apps.who.int/iris/bitstream/10665/38133/1/9251030979_eng.pdf.
    (ii) [Reserved]
    (3) United States Department of Agriculture (USDA), Agricultural 
Research Service, Washington, DC, Nutrient Data Laboratory, Bldg. 005, 
Room 105 BARC--West, Beltsville, MD 20705, 301-504-0630. http://www.ars.usda.gov/News/docs.htm?docid=9447.
    (i) USDA Handbook No. 74, Energy Value of Foods--basis and 
derivation, by A. L. Merrill and B. K. Watt, (slightly revised, 1973) 
http://www.ars.usda.gov/SP2UserFiles/Place/80400525/Data/Classics/ah74.pdf.
    (ii) [Reserved]


Sec. Sec.  413.310-413.311   [Reserved]


Sec.  413.312  Reference amounts customarily consumed per eating 
occasion.

    (a) The general principles followed in arriving at the reference 
amounts customarily consumed per eating occasion (Reference Amounts), 
as set forth in paragraph (b) of this section, are:
    (1) The Reference Amounts are calculated for persons 4 years of age 
or older to reflect the amount of food customarily consumed per eating 
occasion by persons in this population group. These Reference Amounts 
are based on data set forth in appropriate national food consumption 
surveys.
    (2) The Reference Amounts are calculated for an infant or child 
under 4 years of age to reflect the amount of food customarily consumed 
per eating occasion by infants through 12 months of age or by children 
1 through 3 years of age, respectively. These Reference Amounts are 
based on data set forth in appropriate national food consumption 
surveys. Such Reference Amounts are to be used only when the product is 
specially formulated or processed for use by an infant through 12 
months of age or by a child under 4 years of age.
    (3) An appropriate national food consumption survey includes a 
large sample size representative of the demographic and socioeconomic 
characteristics of the relevant population group and must be based on 
consumption data under actual conditions of use.
    (4) To determine the amount of food customarily consumed per eating 
occasion, the mean, median, and mode of the consumed amount per eating 
occasion were considered.
    (5) When survey data were insufficient, FSIS took various other 
sources of information on serving sizes of food into consideration. 
These other sources of information included:
    (i) Serving sizes used in dietary guidance recommendations or 
recommended by other authoritative systems or organizations;
    (ii) Serving sizes recommended in comments;
    (iii) Serving sizes used by manufacturers and grocers; and
    (iv) Serving sizes used by other countries.
    (6) Because they reflect the amount customarily consumed, the 
Reference Amount and, in turn, the serving size declared on the product 
label are based on only the edible portion of food, and not bone, seed, 
shell, or other inedible components.
    (7) The Reference Amount is based on the major intended use of the 
product (e.g., a mixed dish measurable with a cup as a main dish and 
not as a side dish).
    (8) The Reference Amounts for products that are consumed as an 
ingredient of other products, but that may also be consumed in the form 
in which they are purchased (e.g., ground beef), are based on use in 
the form purchased.
    (9) FSIS sought to ensure that foods that have similar dietary 
usage, product characteristics, and customarily consumed amounts have a 
uniform Reference Amount.
    (b) The following Product Categories and Reference Amounts shall be 
used as the basis for determining serving sizes for specific products:

 Table 1--Meat and Poultry Product Reference Amounts Customarily Consumed per Eating Occasion: Foods for Infants
                                and Young Children 1 Through 3 Years of Age 1 2 3
----------------------------------------------------------------------------------------------------------------
                                              Reference
             Product category                amount (g)                     Label statement \4\
----------------------------------------------------------------------------------------------------------------
Infant and Toddler Foods:
    Dinner Dry Mix.......................              15  _tbsp(s) (_g); cup(s) (_g).
    Dinner, ready-to-serve, strained type             110  _cup(s) (_g);_cup(s) (mL).
    Dinner, soups, ready-to-serve, junior             110  _cup(s) (_g); cup(s) (_mL).
     type.
    Dinner, stew or soup, ready-to-serve              170  _cup(s) (_g); cup(s) (_mL).
     young children.
    Plain meats, plain poultry, meat                   55  2 oz (56g); _link(s) (_g).
     sticks, poultry sticks, ready to
     serve.
----------------------------------------------------------------------------------------------------------------
\1\ These values represent the amount of food customarily consumed per eating occasion and were primarily
  derived from the 1977-1978 and the 1987-1988 Nationwide Food Consumption Surveys conducted by the U.S.
  Department of Agriculture and updated by the U.S. Department of Agriculture based on data from the National
  Health and Nutrition Examination Survey, 2003-2004, 2005-2006, and 2007-2008 conducted by the Centers for
  Disease Control and Prevention, in the U.S. Department of Health and Human Services.
\2\ Unless otherwise noted in the Reference Amount column, the Reference Amounts are for the ready-to-serve or
  almost ready-to-serve form of the product (e.g., heat and serve, brown and serve). If not listed separately,
  the Reference Amount for the unprepared form (e.g., dehydrated cereal) is the amount required to make one
  Reference Amount of the prepared form. Prepared means prepared for consumption (e.g., ready to serve).
\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 established by the regulation.
\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., patty for patties, link for links, etc.).


[[Page 6804]]


   Table 2--Meat and Poultry Product Reference Amounts Customarily Consumed per Eating Occasion: General Food
                                                Supply 1 2 3 4 5
----------------------------------------------------------------------------------------------------------------
                                           Reference amount         Reference amount
           Product category           --------------------------------------------------   Label statement \6\
                                            Ready-to-serve           Ready-to-cook
----------------------------------------------------------------------------------------------------------------
Egg mixtures with meat or poultry;     110 g..................  n/a....................  4 oz (112g); _piece(s)
 e.g., western style omelet,                                                              (_g).
 souffl[eacute], egg foo young.
Lard, margarine, shortening..........  1 tbsp.................  n/a....................  1 tbsp (_g).
Salad and potato toppers; e.g., bacon  7 g....................  n/a....................  _tbsp (_g).
 bits, poultry bacon bits.
Bacon; e.g., bacon, beef breakfast     15 g...................  54 g = bacon, pork       _piece(s) (_g) _pieces
 strips, pork breakfast strips, pork                             rinds, pork back fat;    pan fried (_g).
 rinds, pork back fat.                                           30 g = meat breakfast
                                                                 strips.
Poultry bacon, poultry breakfast       15 g...................  26 g = poultry bacon;    _piece(s) (_g); _pieces
 strips.                                                         18 g = poultry           pan fried (_g).
                                                                 breakfast strips.
Dried meat or poultry products; e.g.,  30 g...................  n/a....................  _piece(s) (_g);
 jerky, dried beef or poultry, Parma                                                      _slice(s) (_g); 2 oz
 ham, meat or poultry sausage                                                             (28g).
 products with a moisture/protein
 ratio of less than 2:1; e.g.,
 pepperoni.
Snacks; e.g., meat or poultry snack    30 g...................  n/a....................  _piece(s) (_g); 2 oz
 food sticks.                                                                             (28g).
Luncheon products, luncheon meat,      55 g...................  n/a....................  _slice(s) (_g);
 bologna, poultry bologna, Canadian                                                       _piece(s) (_g); _cup
 style bacon, poultry Canadian style                                                      (_g); 2 oz (56g).
 bacon, meat or poultry pattie
 crumbles, blood pudding, meat or
 poultry luncheon loaf, old fashioned
 loaf, berlinger, bangers, minced
 luncheon roll, thuringer, liver
 sausage, mortadella, uncured sausage
 (franks), ham and cheese loaf, P&P
 loaf, scrapple souse, head cheese,
 pizza loaf, olive loaf, pate,
 deviled ham, sandwich spread,
 teawurst, cervelat, Lebanon bologna,
 potted meat or poultry food product,
 taco fillings, pie fillings.
Linked meat or poultry sausage         55 g...................  n/a....................  _slice(s) (_g);
 products, Vienna sausage,                                      75 g = uncooked meat      _piece(s) (_g); _oz
 frankfurters, poultry franks, pork                              sausage; 69 g =          (_g).
 sausage, imitation frankfurters,                                uncooked poultry
 bratwurst, kielbasa, Polish sausage,                            sausage.
 poultry Polish sausage, summer
 sausage, mettwurst, smoked country
 sausage, smoked sausage, poultry
 smoked sausage, smoked pickled meat
 or poultry meat, pickled pigs feet.
Entrees without sauce; e.g., cuts of   85 g...................  114 g..................  _piece(s) (_g);
 meat or poultry including marinated,                                                     _slice(s) (_g); _oz
 tenderized, injected cuts of meat or                                                     (_g); _cup (_g).
 poultry, patties, corn dogs,
 croquettes, fritters, cured ham, dry
 cured ham, dry cured cappicola,
 cured poultry ham products, corned
 beef, pastrami, country ham, pork
 shoulder picnic, meatballs, pureed
 adult foods.
Appetizers, hors d'oeuvres--Mini       85 g (add 35 g for       n/a....................  _piece(s) (_g);
 mixed dishes with meat or poultry;     products with gravy or                            _piece(s) plus sauce
 e.g., mini bagel pizzas, mini egg      sauce toppings).                                  (_g).
 rolls, dumplings, mini pizza rolls,
 mini quesadilla, mini quiche.
Appetizers, hors d'oeuvres--Dips with  2 tbsp.................  n/a....................  2 tbsp (_g).
 meat or poultry; e.g., chicken dip,
 chicken and cheese dip, meat dip.
Canned meats (e.g., canned beef,       85 g...................  n/a....................  _cup (_g); 3 oz (84g).
 canned pork) and Canned Poultry
 (e.g., canned chicken, canned
 turkey).
Entrees with sauce; e.g., barbecued    140 g..................  n/a....................  _cup (_g); 2 oz (56g).
 meat or poultry in sauce, meat or
 poultry and gravy.
Mixed dishes NOT measurable with a     140 g (add 55 g for      n/a....................  _piece(s) (_g);
 cup; e.g., burrito, egg roll,          products with gravy or                            _piece(s) plus sauce
 enchilada, pizza, pizza roll,          sauce toppings).                                  (_g); 5 oz (140g); _oz
 quiche, all types of sandwiches with                                                     (_g).
 meat or poultry, cracker and meat/
 poultry lunch type packages, gyro,
 Stromboli, burger on a bun, poultry
 burger on a bun, frank on a bun,
 poultry frank on a bun, calzone,
 taco, stuffed pockets, foldovers,
 stuffed vegetables with meat or
 poultry, shish kabobs, empanada,
 chicken cordon bleu.

[[Page 6805]]

 
Mixed dishes measurable with a cup;    1 cup..................  n/a....................  1 cup (_g).
 e.g., casserole, macaroni and cheese
 with meat or poultry, pot pie,
 spaghetti with sauce, poultry
 spaghetti with sauce, meat or
 poultry chili, meat or poultry chili
 with beans, hash, creamed chipped
 beef, creamed dried poultry, ravioli
 in sauce, stroganoff, Brunswick
 stew, goulash, poultry a la king,
 meat or poultry stew, ragout, meat
 or poultry lasagna, meat or poultry
 filled pasta.
Salads--pasta or potato, potato salad  140 g..................  n/a....................  _cup (_g).
 with bacon, potato salad with
 poultry, macaroni and meat or
 poultry salad.
Salads--all other meat salads, all     100 g..................  n/a....................  _cup (_g).
 other poultry salads; e.g., chicken
 salad, ham salad, turkey salad.
Soups with meat or poultry--all        245 g..................  n/a....................  _cup (_g).
 varieties.
Major main entr[eacute]e type sauce;   125 g..................  n/a....................  _cup (_g); _meatballs
 e.g., spaghetti sauce with meat or                                                       plus _cup sauce (_g).
 poultry, spaghetti sauce with
 meatballs, spaghetti sauce with
 poultry meatballs.
Minor main entr[eacute]e sauce; e.g.,  1/4 c..................  n/a....................  1/4 c (_g).
 pizza sauce with meat or poultry,
 gravy.
Seasoning mixes dry, bases, extracts,
 dried broths and stock/juice, freeze
 dry trail mix products with meat or
 poultry.
As reconstituted:
    Amount to make one Reference
     Amount of the final dish; e.g.,.
        Gravy........................  \1/4\ c................  n/a....................  \1/4\ c (_g);
        Major main entr[eacute]e type  125 g..................  n/a....................  _cup (125 g);
         sauce.
        Soup.........................  245 g..................  n/a....................  _cup (245 g);
        Entr[eacute]e measurable with  1 cup..................  n/a....................  1 cup (_g).
         a cup.
Candies with meat or poultry; e.g.,    30 g...................  n/a....................  _squares (_g); _pieces
 chocolate with bacon, chocolate                                                          (_g); 1 oz (28g).
 dipped bacon, chocolate with salami.
----------------------------------------------------------------------------------------------------------------
\1\ These values represent the amount (edible portion) of food customarily consumed per eating occasion and were
  primarily derived from the 1977-1978 and the 1987-1988 Nationwide Food Consumption Surveys conducted by the
  U.S. Department of Agriculture and updated by U.S. Department of Agriculture based on data from the National
  Health and Nutrition Examination Survey, 2003-2004, 2005-2006 and 2007-2008 conducted by the Centers for
  Diseases Control and Prevention, in the Department of Health and Human Services.
\2\ Manufacturers are required to convert the Reference Amounts to the label serving size in a household measure
  most appropriate to their specific product using the procedures established by regulation.
\3\ Examples listed under Product Category are not all inclusive or exclusive. Examples are provided to assist
  manufacturers in identifying appropriate product Reference.
\4\ If packed or canned in liquid, the reference amount is for the drained solids, except for products in which
  both the solids and liquids are customarily consumed (e.g., canned chicken with broth).
\5\ Pizza sauce is part of the pizza and is not considered to be a sauce topping.
\6\ The 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. 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., patty for patties, meatballs for meatballs, link for links,
  etc.). The guidance provided is for the label statement of products in ready-to-serve or almost ready-to-serve
  form. The guidance does not apply to the products which require further preparation for consumption (e.g., dry
  mixes, concentrates) unless specifically stated in the product category, reference amount, or label statement
  column that it is for these forms of the product. For products that require further preparation, manufacturers
  must determine the label statement following the rules in Sec.   413.309(b) using the reference amount
  determined according to Sec.   413.412(b).

    (c) For products that have no Reference Amount listed in paragraph 
(b) of this section for the unprepared or the prepared form of the 
product and that consist of two or more foods packaged and presented to 
be consumed together (e.g., lunch meat with cheese and crackers), the 
Reference Amount for the combined product shall be determined using the 
following rules:
    (1) The reference amount for the combined product must be the 
reference amount, as established in paragraph (b) of this section, for 
the ingredient that is represented as the main ingredient (e.g., 
lunchmeat) plus proportioned amounts of all minor ingredients.
    (2) If the Reference Amounts are in compatible units, the weights 
or volumes must be summed (e.g., ingredients in equal volumes such as 
tablespoons). If the Reference Amounts are in incompatible units, all 
amounts must be converted to weights and summed (e.g., grams of one 
ingredient plus gram weight of tablespoons of a second ingredient).
    (d) 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

[[Page 6806]]

established in paragraph (b) of this section.
    (e) The Reference Amount for an imitation or substitute product or 
altered product as defined in Sec.  413.313(d), such as a ``low 
calorie'' version, shall be the same as for the product for which it is 
offered as a substitute.
    (f) The Reference Amounts set forth in paragraphs (b) through (e) 
of this section shall be used in determining whether a product meets 
the criteria for nutritional claims. If the serving size declared on 
the product label differs from the Reference Amount, and the product 
meets the criteria for the claim only on the basis of the Reference 
Amount, the claim shall be followed by a statement that sets forth the 
basis on which the claim is made. That statement shall include the 
Reference Amount as it appears in paragraph (b) of this section 
followed, in parentheses, by the amount in common household measure if 
the Reference Amount is expressed in measures other than common 
household measures.
    (g) The Administrator, on his or her own initiative or on behalf of 
any interested person who has submitted a labeling application, may 
issue a proposal to establish or amend a Product Category or Reference 
Amount identified in paragraph (b) of this section.
    (1) Labeling applications and supporting documentation to be filed 
under this section shall be submitted in quadruplicate, except that the 
supporting documentation may be submitted on a computer disc copy. If 
any part of the material submitted is in a foreign language, it shall 
be accompanied by an accurate and complete English translation. The 
labeling application shall state the applicant's post office address.
    (2) Pertinent information will be considered as part of an 
application on the basis of specific reference to such information 
submitted to and retained in the files of the Food Safety and 
Inspection Service. However, any reference to unpublished information 
furnished by a person other than the applicant will not be considered 
unless use of such information is authorized (with the understanding 
that such information may in whole or part be subject to release to the 
public) in a written statement signed by the person who submitted it. 
Any reference to published information should be accompanied by 
reprints or photostatic copies of such references.
    (3) The availability for public disclosure of labeling 
applications, along with supporting documentation, submitted to the 
Agency under this section will be governed by the rules specified in 
subchapter D, title 9.
    (4) Data accompanying the labeling application, such as food 
consumption data, shall be submitted on separate sheets, suitably 
identified. If such data has already been submitted with an earlier 
labeling application from the applicant, the present labeling 
application must provide the data.
    (5) The labeling application must be signed by the applicant or by 
his or her attorney or agent, or (if a corporation) by an authorized 
official.
    (6) The labeling application shall include a statement signed by 
the person responsible for the labeling application, that to the best 
of his or her knowledge, it is a representative and balanced submission 
that includes unfavorable information, as well as favorable 
information, known to him or her pertinent to the evaluation of the 
labeling application.
    (7) Labeling applications for a new Reference Amount and/or Product 
Category shall be accompanied by the following data which shall be 
submitted in the following form to the Director, Labeling and Program 
Delivery Staff, Office of Policy and Program Development, Food Safety 
and Inspection Service, Washington, DC 20250:

(Date)

    The undersigned, _____ submits this labeling application 
pursuant to 9 CFR 413.312 with respect to Reference Amount and/or 
Product Category.
    Attached hereto, in quadruplicate, or on a computer disc copy, 
and constituting a part of this labeling application, are the 
following:
    (i) A statement of the objective of the labeling application;
    (ii) A description of the product;
    (iii) A complete sample product label including nutrition label, 
using the format established by regulation;
    (iv) A description of the form in which the product will be 
marketed;
    (v) The intended dietary uses of the product with the major use 
identified (e.g., ham as a luncheon meat, turkey as a luncheon 
meat);
    (vi) If the intended use is primarily as an ingredient in other 
foods, list of foods or food categories in which the product will be 
used as an ingredient with information on the prioritization of the 
use;
    (vii) The population group for which the product will be offered 
for use (e.g., infants through 12 months, children under 4 years of 
age);
    (viii) The names of the most closely-related products (or in the 
case of foods for special dietary use and imitation or substitute 
foods, the names of the products for which they are offered as 
substitutes);
    (ix) The suggested Reference Amount (the amount of edible 
portion of food as consumed, excluding bone, skin or other inedible 
components) for the population group for which the product is 
intended with full description of the methodology and procedures 
that were used to determine the suggested Reference Amount. In 
determining the Reference Amount, general principles and factors in 
paragraph (a) of this section should be followed.
    (x) The suggested Reference Amount shall be expressed in metric 
units. Reference Amounts for foods shall be expressed in grams 
except when common household units such as cups, tablespoons, and 
teaspoons are more appropriate or are more likely to promote 
uniformity in serving sizes declared on product labels. For example, 
common household measures would be more appropriate if products 
within the same category differ substantially in density such as 
mixed dishes measurable with a cup.
    (A) In expressing the Reference Amount in grams, the following 
general rules shall be followed:
    (1) For quantities greater than 10 grams, the quantity shall be 
expressed in nearest 5 grams increment.
    (2) For quantities less than 10 grams, exact gram weights shall 
be used.
    (B) [Reserved]
    (xi) A labeling application for a new subcategory of food with 
its own Reference Amount shall include the following additional 
information:
    (A) Data that demonstrate that the new subcategory of food will 
be consumed in amounts that differ enough from the Reference Amount 
for the parent category to warrant a separate Reference Amount. Data 
must include sample size, and the mean, standard deviation, median, 
and modal consumed amount per eating occasion for the product 
identified in the labeling application and for other products in the 
category. All data must be derived from the same survey data.
    (B) Documentation supporting the difference in dietary usage and 
product characteristics that affect the consumption size that 
distinguishes the product identified in the labeling application 
from the rest of the products in the category.
    (xii) In conducting research to collect or process food 
consumption data in support of the labeling application, the 
following general guidelines should be followed.
    (A) Sampled population selected should be representative of the 
demographic and socioeconomic characteristics of the target 
population group for which the food is intended.
    (B) Sample size (i.e., number of eaters) should be large enough 
to give reliable estimates for customarily consumed amounts.
    (C) The study protocol should identify potential biases and 
describe how potential biases are controlled for or, if not possible 
to control, how they affect interpretation of results.
    (D) The methodology used to collect or process data including 
study design, sampling procedures, materials used (e.g., 
questionnaire, interviewer's manual), procedures used to collect or 
process data, methods or procedures used to control for unbiased 
estimates, and procedures used to

[[Page 6807]]

correct for nonresponse, should be fully documented.
    (xiii) A statement concerning the feasibility of convening 
associations, corporations, consumers, and other interested parties 
to engage in negotiated rulemaking to develop a proposed rule.

Yours very truly,

Applicant--------------------------------------------------------------

By---------------------------------------------------------------------

(Indicate authority)

    (8) Upon receipt of the labeling application and supporting 
documentation, the applicant shall be notified, in writing, of the date 
on which the labeling application was received. Such notice shall 
inform the applicant that the labeling application is undergoing Agency 
review and that the applicant shall subsequently be notified of the 
Agency's decision to consider for further review or deny the labeling 
application.
    (9) Upon review of the labeling application and supporting 
documentation, the Agency shall notify the applicant, in writing, that 
the labeling application is either being considered for further review 
or that it has been summarily denied by the Administrator.
    (10) If the labeling application is summarily denied by the 
Administrator, the written notification shall state the reasons 
therefor, including why the Agency has determined that the proposed 
Reference Amount or Product Category is false or misleading. The 
notification letter shall inform the applicant that the applicant may 
submit a written statement by way of answer to the notification, and 
that the applicant shall have the right to request a hearing with 
respect to the merits or validity of the Administrator's decision to 
deny the use of the proposed Reference Amount or Product Category.
    (i) If the applicant fails to accept the determination of the 
Administrator and files an answer and requests a hearing, and the 
Administrator, after review of the answer, determines the initial 
determination to be correct, the Administrator shall file with the 
Hearing Clerk of the Department the notification, answer, and the 
request for a hearing, which shall constitute the complaint and answer 
in the proceeding, which shall thereafter be conducted in accordance 
with the Department's Uniform Rules of Practice.
    (ii) The hearing shall be conducted before an administrative law 
judge with the opportunity for appeal to the Department's Judicial 
Officer, who shall make the final determination for the Secretary. Any 
such determination by the Secretary shall be conclusive unless, within 
30 days after receipt of notice of such final determination, the 
applicant appeals to the United States Court of Appeals for the circuit 
in which the applicant has its principal place of business or to the 
United States Court of Appeals for the District of Columbia Circuit.
    (11) If the labeling application is not summarily denied by the 
Administrator, the Administrator shall publish in the Federal Register 
a proposed rule to amend the regulations to authorize the use of the 
Reference Amount or Product Category. The proposal shall also summarize 
the labeling application, including where the supporting documentation 
can be reviewed. The Administrator's proposed rule shall seek comment 
from consumers, the industry, consumer and industry groups, and other 
interested persons on the labeling application and the use of the 
proposed Reference Amount or Product Category. After public comment has 
been received and reviewed by the Agency, the Administrator shall make 
a determination on whether the proposed Reference Amount or Product 
Category shall be approved for use on the labeling of meat food 
products or poultry food products.
    (i) If the Reference Amount or Product Category is denied by the 
Administrator, the Agency shall notify the applicant, in writing, of 
the basis for the denial, including the reason why the Reference Amount 
or Product Category on the labeling was determined by the Agency to be 
false or misleading. The notification letter shall also inform the 
applicant that the applicant may submit a written statement by way of 
answer to the notification, and that the applicant shall have the right 
to request a hearing with respect to the merits or validity of the 
Administrator's decision to deny the use of the proposed Reference 
Amount and/or Product Category.
    (A) If the applicant fails to accept the determination of the 
Administrator and files an answer and requests a hearing, and the 
Administrator, after review of an answer, determines the initial 
determination to be correct, the Administrator shall file with the 
Hearing Clerk of the Department the notification, answer, and the 
request for a hearing, which shall constitute the complaint and answer 
in the proceeding, which shall thereafter be conducted in accordance 
with the Department's Uniform Rules of Practice.
    (B) The hearing shall be conducted before an administrative law 
judge with the opportunity for appeal to the Department's Judicial 
Officer, who shall make the final determination for the Secretary. Any 
such determination by the Secretary shall be conclusive unless, within 
30 days after receipt of the notice of such final determination, the 
applicant appeals to the United States Court of Appeals for the circuit 
in which the applicant has its principal place of business or to the 
United States Court of Appeals for the District of Columbia Circuit.
    (ii) If the Reference Amount or Product Category is approved, the 
Agency shall notify the applicant, in writing, and shall also publish 
in the Federal Register a final rule amending the regulations to 
authorize the use of the Reference Amount or Product Category.


Sec.  413.313   Nutrient content claims; general principles.

    (a) This section applies to meat, meat food products, or poultry 
products that are intended for human consumption and that are offered 
for sale.
    (b) A claim which, expressly or by implication, characterizes the 
level of a nutrient (nutrient content claim) of the type required in 
nutrition labeling pursuant to Sec.  413.309, may not be made on a 
label or in labeling of that product unless the claim is made in 
accordance with the applicable provisions in this part.
    (1) An expressed nutrient content claim is any direct statement 
about the level (or range) of a nutrient in the product, e.g., ``low 
sodium'' or ``contains 100 calories.''
    (2) An implied nutrient content claim is any claim that:
    (i) Describes the product or an ingredient therein in a manner that 
suggests that a nutrient is absent or present in a certain amount 
(e.g., ``high in oat bran''); or
    (ii) Suggests that the product, because of its nutrient content, 
may be useful in maintaining healthy dietary practices and is made in 
association with an explicit claim or statement about a nutrient (e.g., 
``healthy, contains 3 grams (g) of fat'').
    (3) Except for claims regarding vitamins and minerals described in 
paragraph (q)(3) of this section, no nutrient content claims may be 
made on products intended specifically for use by infants through 12 
months and children less than 2 years of age unless the claim is 
specifically provided for in this part.
    (4) Reasonable variations in the spelling of the terms defined in 
applicable provisions in this part and their synonyms are permitted 
provided these variations are not misleading (e.g., ``hi'' or ``lo'').
    (c) Information that is required or permitted by Sec.  413.309 to 
be declared in nutrition labeling, and that appears as

[[Page 6808]]

part of the nutrition label, is not a nutrient content claim and is not 
subject to the requirements of this section. If such information is 
declared elsewhere on the label or in labeling, it is a nutrient 
content claim and is subject to the requirements for nutrient content 
claims.
    (d) A ``substitute'' product is one that may be used 
interchangeably with another product that it resembles, i.e., that it 
is organoleptically, physically, and functionally (including shelf 
life) similar to, and that it is not nutritionally inferior to unless 
it is labeled as an ``imitation.''
    (1) If there is a difference in performance characteristics that 
materially limits the use of the product, the product may still be 
considered a substitute if the label includes a disclaimer adjacent to 
the most prominent claim as defined in paragraph (j)(2)(iii) of this 
section, informing the consumer of such difference (e.g., ``not 
recommended for frying'').
    (2) This disclaimer shall be in easily legible print or type and in 
a size no less than that required by Sec.  317.2(h) or Sec.  381.121(c) 
for the net quantity of contents statement, except where the size of 
the claim is less than two times the required size of the net quantity 
of contents statement, in which case the disclaimer statement shall be 
no less than one-half the size of the claim but no smaller than \1/16\-
inch minimum height, except as permitted by Sec.  413.400(d)(2).
    (e)(1) Because the use of a ``free'' or ``low'' claim before the 
name of a product implies that the product differs from other products 
of the same type by virtue of its having a lower amount of the 
nutrient, only products that have been specially processed, altered, 
formulated, or reformulated so as to lower the amount of the nutrient 
in the product, remove the nutrient from the product, or not include 
the nutrient in the product, may bear such a claim (e.g., ``low sodium 
beef noodle soup'', ``low sodium chicken noodle soup'').
    (2) Any claim for the absence of a nutrient in a product, or that a 
product is low in a nutrient when the product has not been specially 
processed, altered, formulated, or reformulated to qualify for that 
claim shall indicate that the product inherently meets the criteria and 
shall clearly refer to all products of that type and not merely to the 
particular brand to which the labeling attaches (e.g., ``lard, a sodium 
free food'', ``chicken breast meat, a low sodium food'').
    (f) A nutrient content claim shall be in type size and style no 
larger than two times that of the statement of identity and shall not 
be unduly prominent in type style compared to the statement of 
identity.
    (g) Labeling information required in Sec. Sec.  413.313, 413.354, 
413.356, 413.360, 413.361, 413.362, and 413.380, whose type size is not 
otherwise specified, is required to be in letters and/or numbers no 
less than \1/16\ inch in height, except as permitted by Sec.  
413.400(d)(2).
    (h) [Reserved]
    (i) Except as provided in Sec.  413.309 or in paragraph (q)(3) of 
this section, the label or labeling of a product may contain a 
statement about the amount or percentage of a nutrient if:
    (1) The use of the statement on the product implicitly 
characterizes the level of the nutrient in the product and is 
consistent with a definition for a claim, as provided in this part, for 
the nutrient that the label addresses. Such a claim might be, ``less 
than 10 g of fat per serving;''
    (2) The use of the statement on the product implicitly 
characterizes the level of the nutrient in the product and is not 
consistent with such a definition, but the label carries a disclaimer 
adjacent to the statement that the product is not ``low'' in or a 
``good source'' of the nutrient, such as ``only 200 milligrams (mg) 
sodium per serving, not a low sodium product.'' The disclaimer must be 
in easily legible print or type and in a size no less than required by 
Sec.  317.2(h) or Sec.  381.121(c) for the net quantity of contents, 
except where the size of the claim is less than two times the required 
size of the net quantity of contents statement, in which case the 
disclaimer statement shall be no less than one-half the size of the 
claim but no smaller than \1/16\-inch minimum height, except as 
permitted by Sec.  413.400(d)(2);
    (3) The statement does not in any way implicitly characterize the 
level of the nutrient in the product and it is not false or misleading 
in any respect (e.g., ``100 calories'' or ``5 grams of fat''), in which 
case no disclaimer is required.
    (4) ``Percent fat free'' claims are not authorized by this 
paragraph. Such claims shall comply with Sec.  413.362(b)(6).
    (j) A product may bear a statement that compares the level of a 
nutrient in the product with the level of a nutrient in a reference 
product. These statements shall be known as ``relative claims'' and 
include ``light,'' ``reduced,'' ``less'' (or ``fewer''), and ``more'' 
claims.
    (1) To bear a relative claim about the level of a nutrient, the 
amount of that nutrient in the product must be compared to an amount of 
nutrient in an appropriate reference product as specified in this 
paragraph (j).
    (i)(A) For ``less'' (or ``fewer'') and ``more'' claims, the 
reference product may be a dissimilar product within a product category 
that can generally be substituted for one another in the diet or a 
similar product.
    (B) For ``light,'' ``reduced,'' and ``added'' claims, the reference 
product shall be a similar product, and
    (ii)(A) For ``light'' claims, the reference product shall be 
representative of the type of product that includes the product that 
bears the claim. The nutrient value for the reference product shall be 
representative of a broad base of products of that type; e.g., a value 
in a representative, valid data base; an average value determined from 
the top three national (or regional) brands, a market basket norm; or, 
where its nutrient value is representative of the product type, a 
market leader. Firms using such a reference nutrient value as a basis 
for a claim, are required to provide specific information upon which 
the nutrient value was derived, on request, to consumers and 
appropriate regulatory officials.
    (B) For relative claims other than ``light,'' including ``less'' 
and ``more'' claims, the reference product may be the same as that 
provided for ``light'' in paragraph (j)(1)(ii)(A) of this section or it 
may be the manufacturer's regular product, or that of another 
manufacturer, that has been offered for sale to the public on a regular 
basis for a substantial period of time in the same geographic area by 
the same business entity or by one entitled to use its trade name, 
provided the name of the competitor is not used on the labeling of the 
product. The nutrient values used to determine the claim when comparing 
a single manufacturer's product to the labeled product shall be either 
the values declared in nutrition labeling or the actual nutrient 
values, provided that the resulting labeling is internally consistent 
(i.e., that the values stated in the nutrition information, the 
nutrient values in the accompanying information, and the declaration of 
the percentage of nutrient by which the product has been modified are 
consistent and will not cause consumer confusion when compared), and 
that the actual modification is at least equal to the percentage 
specified in the definition of the claim.
    (2) For products bearing relative claims:
    (i) The label or labeling must state the identity of the reference 
product and the percent (or fraction) of the amount of the nutrient in 
the reference product by

[[Page 6809]]

which the nutrient has been modified, (e.g., ``50 percent less fat than 
`reference product' '' or ``\1/3\ fewer calories than `reference 
product' ''); and
    (ii) This information shall be immediately adjacent to the most 
prominent claim in easily legible boldface print or type, in distinct 
contrast to other printed or graphic matter, that is no less than that 
required by Sec.  317.2(h) or Sec.  381.121(c) for net quantity of 
contents, except where the size of the claim is less than two times the 
required size of the net quantity of contents statement, in which case 
the referral statement shall be no less than one-half the size of the 
claim, but no smaller than \1/16\-inch minimum height, except as 
permitted by Sec.  413.400(d)(2).
    (iii) The determination of which use of the claim is in the most 
prominent location on the label or labeling will be made based on the 
following factors, considered in order:
    (A) A claim on the principal display panel adjacent to the 
statement of identity;
    (B) A claim elsewhere on the principal display panel;
    (C) A claim on the information panel; or
    (D) A claim elsewhere on the label or labeling.
    (iv) The label or labeling must also bear:
    (A) Clear and concise quantitative information comparing the amount 
of the subject nutrient in the product per labeled serving size with 
that in the reference product; and
    (B) This statement shall appear adjacent to the most prominent 
claim or to the nutrition information.
    (3) A relative claim for decreased levels of a nutrient may not be 
made on the label or in labeling of a product if the nutrient content 
of the reference product meets the requirement for a ``low'' claim for 
that nutrient.
    (k) The term ``modified'' may be used in the statement of identity 
of a product that bears a relative claim that complies with the 
requirements of this part, followed immediately by the name of the 
nutrient whose content has been altered (e.g., ``modified fat `product' 
''). This statement of identity must be immediately followed by the 
comparative statement such as ``contains 35 percent less fat than 
`reference product.' '' The label or labeling must also bear the 
information required by paragraph (j)(2) of this section in the manner 
prescribed.
    (l) For purposes of making a claim, a ``meal-type'' product will be 
defined as a product that:
    (1) Makes a major contribution to the diet by:
    (i) Weighing at least 10 ounces per labeled serving; and
    (ii) Containing not less than three 40 gram portions of food, or 
combinations of foods, from two or more of the following four food 
groups, except as noted in paragraph (l)(1)(ii)(E) of this section:
    (A) Bread, cereal, rice, and pasta;
    (B) Fruits and vegetables;
    (C) Milk, yogurt, and cheese;
    (D) Meat, poultry, fish, dry beans, eggs, and nuts; except that:
    (E) These foods will not be sauces (except for foods in the four 
food groups in paragraph (l)(1)(ii)(A) through (D) of this section, 
that are in the sauces), gravies, condiments, relishes, pickles, 
olives, jams, jellies, syrups, breadings, or garnishes; and
    (2) Is represented as, or is in the form commonly understood to be, 
a breakfast, lunch, dinner, meal, or entree. Such representations may 
be made by statements, photographs, or vignettes.
    (m) For purposes of making a claim, a main-dish product will be 
defined as a food that:
    (1) Makes a major contribution to the meal by:
    (i) Weighing at least 6 ounces per labeled serving; and
    (ii) Containing not less than 40 grams of food, or combinations of 
foods, from two or more of the following four food groups, except as 
noted in paragraph (m)(1)(ii)(E) of this section.
    (A) Bread, cereal, rice, and pasta;
    (B) Fruits and vegetables;
    (C) Milk, yogurt, and cheese;
    (D) Meat, poultry, fish, dry beans, eggs, and nuts; except that:
    (E) These foods will not be sauces (except for foods in the four 
food groups in paragraph (m)(l)(ii)(A) through (D) of this section, 
that are in the sauces), gravies, condiments, relishes, pickles, 
olives, jams, jellies, syrups, breadings, or garnishes; and
    (3) Is represented as, or is in a form commonly understood to be, a 
main dish (e.g., not a beverage or dessert). Such representations may 
be made by statements, photographs, or vignettes.
    (n) Nutrition labeling in accordance with Sec.  413.309, shall be 
provided for any food for which a nutrient content claim is made.
    (o) Compliance with requirements for nutrient content claims shall 
be in accordance with Sec.  413.309(h).
    (p)(1) Unless otherwise specified, the reference amount customarily 
consumed set forth in Sec.  413.312(b) through (e) shall be used in 
determining whether a product meets the criteria for a nutrient content 
claim. If the serving size declared on the product label differs from 
the reference amount customarily consumed, 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 shall be followed by the criteria for the claim as 
required by Sec.  413.312(f) (e.g., ``very low sodium, 35 mg or less 
per 55 grams'').
    (2) The criteria for the claim shall be immediately adjacent to the 
most prominent claim in easily legible print or type and in a size that 
is no less than that required by Sec.  317.2(h) or Sec.  381.121(c) for 
net quantity of contents, except where the size of the claim is less 
than two times the required size of the net quantity of contents 
statement, in which case the criteria statement shall be no less than 
one-half the size of the claim but no smaller than \1/16\-inch minimum 
height, except as permitted by Sec.  413.400(d)(2).
    (q) The following exemptions apply:
    (1) Nutrient content claims that have not been defined by 
regulation and that appear as part of a brand name that was in use 
prior to November 27, 1991, may continue to be used as part of that 
brand name, provided they are not false or misleading under section 
1(n) of the Federal Meat Inspection Act (21 U.S.C. 601(n)(1)) or 4(h) 
of the Poultry Products Inspection Act (21 U.S.C. 453(h)).
    (2) [Reserved]
    (3) A statement that describes the percentage of a vitamin or 
mineral in the food, including foods intended specifically for use by 
infants through 12 months and children less than 2 years of age, in 
relation to a Reference Daily Intake (RDI) as defined in Sec.  413.309 
may be made on the label or in the labeling of a food without a 
regulation authorizing such a claim for a specific vitamin or mineral.
    (4) The requirements of this section do not apply to infant 
formulas and medical foods, as described in 21 CFR 101.13(q)(4).
    (5) [Reserved]
    (6) Nutrient content claims that were part of the name of a product 
that was subject to a standard of identity as of November 27, 1991, are 
not subject to the requirements of paragraph (b) of this section 
whether or not they meet the definition of the descriptive term.
    (7) Implied nutrient content claims may be used as part of a brand 
name, provided that the use of the claim has been authorized by FSIS. 
Labeling applications requesting approval of such a claim may be 
submitted pursuant to Sec.  413.369.

[[Page 6810]]

Sec. Sec.  413.314-413.343  [Reserved]


Sec.  413.344  Identification of major cuts of meat products and 
poultry products.

    (a) The major cuts of single-ingredient, raw meat products are: 
Beef chuck blade roast, beef loin top loin steak, beef rib roast large 
end, beef round eye round steak, beef round top round steak, beef round 
tip roast, beef chuck arm pot roast, beef loin sirloin steak, beef 
round bottom round steak, beef brisket (whole, flat half, or point 
half), beef rib steak small end, beef loin tenderloin steak, pork loin 
chop, pork loin country style ribs, pork loin top loin chop boneless, 
pork loin rib chop, pork spareribs, pork loin tenderloin, pork loin 
sirloin roast, pork shoulder blade steak, pork loin top roast boneless, 
ground pork, lamb shank, lamb shoulder arm chop, lamb shoulder blade 
chop, lamb rib roast, lamb loin chop, lamb leg (whole, sirloin half, or 
shank half), veal shoulder arm steak, veal shoulder blade steak, veal 
rib roast, veal loin chop, and veal cutlets.
    (b) The major cuts of single-ingredient, raw poultry products are: 
Whole chicken (without neck and giblets), chicken breast, chicken wing, 
chicken drumstick, chicken thigh, whole turkey (without necks and 
giblets; separate nutrient panels for white and dark meat permitted as 
an option), turkey breast, turkey wing, turkey drumstick, and turkey 
thigh.


Sec.  413.345  Nutrition labeling of single-ingredient, raw meat or 
poultry products that are not ground or chopped products described in 
Sec.  413.301.

    (a)(1) Nutrition information on the major cuts of single-
ingredient, raw meat or poultry products identified in Sec.  413.344, 
including those that have been previously frozen, is required, either 
on their label or at their point-of-purchase, unless exempted under 
Sec.  413.400. If nutrition information is presented on the label, it 
must be provided in accordance with Sec.  413.309. If nutrition 
information is presented at the point-of-purchase, it must be provided 
in accordance with the provisions of this section.
    (2) Nutrition information on single-ingredient, raw products that 
are not ground or chopped products described in Sec.  413.301 and are 
not major cuts of single-ingredient, raw products identified in Sec.  
413.344, including those that have been previously frozen, may be 
provided at their point-of-purchase in accordance with the provisions 
of this section or on their label, in accordance with the provisions of 
Sec.  413.309.
    (3) A retailer may provide nutrition information at the point-of-
purchase by various methods, such as by posting a sign or by making the 
information readily available in brochures, notebooks, or leaflet form 
in close proximity to the food. The nutrition labeling information may 
also be supplemented by a video, live demonstration, or other media. If 
a nutrition claim is made on point-of-purchase materials, all of the 
format and content requirements of Sec.  413.309 apply. However, if 
only nutrition information--and not a nutrition claim--is supplied on 
point-of-purchase materials, the requirements of Sec.  413.309 apply, 
provided, however:
    (i) The listing of percent of Daily Value for the nutrients (except 
vitamins and minerals specified in Sec.  413.309(c)(8)) and footnote 
required by Sec.  413.309(d)(9) may be omitted; and
    (ii) The point-of-purchase materials are not subject to any of the 
format requirements.
    (b) [Reserved]
    (c) For the point-of-purchase materials, the declaration of 
nutrition information may be presented in a simplified format as 
specified in Sec.  413.309(f).
    (d) The nutrition label data for products covered in paragraphs 
(a)(1) and (a)(2) must be based on either the raw or cooked edible 
portions of meat cuts with external cover fat at trim levels reflecting 
current marketing practices or the raw or cooked edible portions of 
poultry cuts with skin. If data are based on cooked portions, the 
methods used to cook the products must be specified and should be those 
which do not add nutrients from other ingredients such as flour, 
breading, and salt. Additional nutritional data may be presented on an 
optional basis for the raw or cooked edible portions of the separable 
lean of meat cuts or the raw or cooked edible portions of the skinless 
poultry meat.
    (e) Nutrient data that are the most current representative data 
base values contained in USDA's National Nutrient Data Bank or its 
released form, the USDA National Nutrient Database for Standard 
Reference, may be used for nutrition labeling of single-ingredient, raw 
products, including those that have been previously frozen. These data 
may be composite data that reflect different quality grades of beef or 
different classes of turkey or other variables affecting nutrient 
content. Alternatively, data that reflect specific grades or specific 
classes or other variables may be used, except that if data are used on 
labels attached to a product which is labeled as to grade of meat or 
class of poultry or other variables, the data must represent the 
product in the package when such data are contained in the 
representative data base. When data are used on labels attached to a 
product, the data must represent the edible meat tissues or the edible 
poultry tissues present in the package.
    (f) If the nutrition information is provided in accordance with 
paragraph (e) of this section, a nutrition label or labeling will not 
be subject to the Agency compliance review under Sec.  413.309(h), 
unless a nutrition claim is made on the basis of the representative 
data base values.
    (g) Retailers may use data bases that they believe reflect the 
nutrient content of single-ingredient, raw products, including those 
that have been previously frozen; however, such labeling shall be 
subject to the compliance procedures of paragraph (e) of this section 
and the requirements specified in this part for the mandatory nutrition 
labeling program.


Sec. Sec.  413.346-413.353   [Reserved]


Sec.  413.354   Nutrient content claims for ``good source,'' ``high,'' 
and ``more.''

    (a) General requirements. Except as provided in paragraph (e) of 
this section, a claim about the level of a nutrient in a product in 
relation to the Reference Daily Intake (RDI) or Daily Reference Value 
(DRV) established for that nutrient (excluding total carbohydrate) in 
Sec.  413.309(c), may only be made on the label or in labeling of the 
product if:
    (1) The claim uses one of the terms defined in this section in 
accordance with the definition for that term;
    (2) The claim is made in accordance with the general requirements 
for nutrient content claims in Sec.  413.313; and
    (3) The product for which the claim is made is labeled in 
accordance with Sec.  413.309.
    (b) ``High'' claims. (1) The terms ``high,'' ``rich in,'' or 
``excellent source of'' may be used on the label or in labeling of 
products, except meal-type products as defined in Sec.  413.313(l), and 
main-dish products as defined in Sec.  413.313(m) provided that the 
product contains 20 percent or more of the RDI or the DRV per reference 
amount customarily consumed.
    (2) The terms defined in paragraph (b)(1) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec.  413.313(l), and main-dish product as defined in Sec.  413.313(m) 
provided that:
    (i) The product contains a food that meets the definition of 
``high'' in paragraph (b)(1) of this section; and
    (ii) The label or labeling clearly identifies the food that is the 
subject of

[[Page 6811]]

the claim (e.g., ``the serving of broccoli in this meal is high in 
vitamin C'').
    (c) ``Good Source'' claims. (1) The terms ``good source,'' 
``contains,'' or ``provides'' may be used on the label or in labeling 
of products, except meal-type products as described in Sec.  
413.313(l), and main-dish products as defined in Sec.  413.313(m) 
provided that the product contains 10 to 19 percent of the RDI or the 
DRV per reference amount customarily consumed.
    (2) The terms defined in paragraph (c)(1) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec.  413.313(l), and main-dish product as defined in Sec.  413.313(m) 
provided that:
    (i) The product contains a food that meets the definition of ``good 
source'' in paragraph (c)(1) of this section; and
    (ii) The label or labeling clearly identifies the food that is the 
subject of the claim (e.g., ``the serving of sweet potatoes in this 
meal is a good source of fiber'').
    (d) Fiber claims. (1) If a nutrient content claim is made with 
respect to the level of dietary fiber, i.e., that the product is high 
in fiber, a good source of fiber, or that the product contains ``more'' 
fiber, and the product is not ``low'' in total fat as defined in Sec.  
413.362(b)(2) or, in the case of a meal-type product or a main-dish 
product, is not ``low'' in total fat as defined in Sec.  413.362(b)(3), 
then the labeling shall disclose the level of total fat per labeled 
serving size (e.g., ``contains 12 grams (g) of fat per serving''); and
    (2) The disclosure shall appear in immediate proximity to such 
claim and be in a type size no less than one-half the size of the 
claim.
    (e) ``More'' claims. (1) A relative claim using the terms ``more'' 
and ``added'' may be used on the label or in labeling to describe the 
level of protein, vitamins, minerals, dietary fiber, or potassium in a 
product, except meal-type products as defined in Sec.  413.313(l), and 
main-dish products as defined in Sec.  413.313(m) provided that:
    (i) The product contains at least 10 percent more of the RDI or the 
DRV for protein, vitamins, minerals, dietary fiber, or potassium 
(expressed as a percent of the Daily Value) per reference amount 
customarily consumed than an appropriate reference product as described 
in Sec.  413.313(j)(1); and
    (ii) As required in Sec.  413.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the nutrient is greater relative to the RDI or DRV are 
declared in immediate proximity to the most prominent such claim (e.g., 
``contains 10 percent more of the Daily Value for fiber than `reference 
product'''); and
    (B) Quantitative information comparing the level of the nutrient in 
the product per labeled serving size with that of the reference product 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``fiber content of `reference product' 
is 1 g per serving; `this product' contains 4 g per serving'').
    (2) A relative claim using the terms ``more'' and ``added'' may be 
used on the label or in labeling to describe the level of protein, 
vitamins, minerals, dietary fiber, or potassium in meal-type products 
as defined in Sec.  413.313(l), and main-dish products as defined in 
Sec.  413.313(m) provided that:
    (i) The product contains at least 10 percent more of the RDI or the 
DRV for protein, vitamins, minerals, dietary fiber, or potassium 
(expressed as a percent of the Daily Value) per 100 g of product than 
an appropriate reference product as described in Sec.  413.313(j)(1); 
and
    (ii) As required in Sec.  413.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the nutrient is greater relative to the RDI or DRV are 
declared in immediate proximity to the most prominent such claim (e.g., 
``contains 10 percent more of the Daily Value for fiber per 3 ounces 
(oz) than does `reference product'''), and
    (B) Quantitative information comparing the level of the nutrient in 
the meal-type product or a main-dish product per specified weight with 
that of the reference product that it replaces is declared adjacent to 
the most prominent claim or to the nutrition information (e.g., ``fiber 
content of `reference product' is 2 g per 3 oz; `this product' contains 
5 g per 3 oz'').


Sec.  413.355   [Reserved]


Sec.  413.356  Nutrient content claims for ``light'' or ``lite.''

    (a) General requirements. A claim using the terms ``light'' or 
``lite'' to describe a product may only be made on the label or in 
labeling of the product if:
    (1) The claim uses one of the terms defined in this section in 
accordance with the definition for that term;
    (2) The claim is made in accordance with the general requirements 
for nutrient content claims in Sec.  413.313; and
    (3) The product for which the claim is made is labeled in 
accordance with Sec.  413.309.
    (b) ``Light'' claims. The terms ``light'' or ``lite'' may be used 
on the label or in labeling of products, except meal-type products as 
defined in Sec.  413.313(l) and main-dish products as defined in Sec.  
413.313(m), without further qualification, provided that:
    (1) If the product derives 50 percent or more of its calories from 
fat, its fat content is reduced by 50 percent or more per reference 
amount customarily consumed compared to an appropriate reference 
product as described in Sec.  413.313(j)(1); or
    (2) If the product derives less than 50 percent of its calories 
from fat:
    (i) The number of calories is reduced by at least one-third (33 \1/
3\ percent) per reference amount customarily consumed compared to an 
appropriate reference product as described in Sec.  413.313(j)(1); or
    (ii) Its fat content is reduced by 50 percent or more per reference 
amount customarily consumed compared to the appropriate reference 
product as described in Sec.  413.313(j)(1); and
    (3) As required in Sec.  413.313(j)(2) for relative claims:
    (i) The identity of the reference product and the percent (or 
fraction) that the calories and the fat were reduced are declared in 
immediate proximity to the most prominent such claim (e.g., ``\1/3\ 
fewer calories and 50 percent less fat than the market leader''); and
    (ii) Quantitative information comparing the level of calories and 
fat content in the product per labeled serving size with that of the 
reference product that it replaces is declared adjacent to the most 
prominent claim or to the nutrition information (e.g., ``lite `this 
product'--200 calories, 4 grams (g) fat; regular `reference product'--
300 calories, 8 g fat per serving''); and
    (iii) If the labeled product contains less than 40 calories or less 
than 3 g fat per reference amount customarily consumed, the percentage 
reduction for that nutrient need not be declared.
    (4) A ``light'' claim may not be made on a product for which the 
reference product meets the definition of ``low fat'' and ``low 
calorie.''
    (c)(1)(i) A product for which the reference product contains 40 
calories or less and 3 g fat or less per reference amount customarily 
consumed may use the terms ``light'' or ``lite'' without further 
qualification if it is reduced by 50 percent or more in sodium content 
compared to the reference product; and
    (ii) As required in Sec.  413.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the sodium was reduced are declared in immediate 
proximity to the most prominent such claim (e.g., ``50

[[Page 6812]]

percent less sodium than the market leader''); and
    (B) Quantitative information comparing the level of sodium per 
labeled serving size with that of the reference product it replaces is 
declared adjacent to the most prominent claim or to the nutrition 
information (e.g., ``lite `this product'--500 milligrams (mg) sodium 
per serving; regular `reference product'--1,000 mg sodium per 
serving'').
    (2)(i) A product for which the reference product contains more than 
40 calories or more than 3 g fat per reference amount customarily 
consumed may use the terms ``light in sodium'' or ``lite in sodium'' if 
it is reduced by 50 percent or more in sodium content compared to the 
reference product, provided that ``light'' or ``lite'' is presented in 
immediate proximity with ``in sodium'' and the entire term is presented 
in uniform type size, style, color, and prominence; and
    (ii) As required in Sec.  413.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the sodium was reduced are declared in immediate 
proximity to the most prominent such claim (e.g., ``50 percent less 
sodium than the market leader''); and
    (B) Quantitative information comparing the level of sodium per 
labeled serving size with that of the reference product it replaces is 
declared adjacent to the most prominent claim or to the nutrition 
information (e.g., or ``lite `this product'--170 mg sodium per serving; 
regular `reference product'--350 mg per serving'').
    (3) Except for meal-type products as defined in Sec.  413.313(l) 
and main-dish products as defined in Sec.  413.313(m), a ``light in 
sodium'' claim may not be made on a product for which the reference 
product meets the definition of ``low in sodium.''
    (d)(1) The terms ``light'' or ``lite'' may be used on the label or 
in labeling of a meal-type product as defined in Sec.  413.313(l) and 
main-dish product as defined in Sec.  413.313(m), provided that:
    (i) The product meets the definition of:
    (A) ``Low in calories'' as defined in Sec.  413.360(b)(3); or
    (B) ``Low in fat'' as defined in Sec.  413.362(b)(3); and
    (ii)(A) A statement appears on the principal display panel that 
explains whether ``light'' is used to mean ``low fat,'' ``low 
calories,'' or both (e.g., ``Light Delight, a low fat meal''); and
    (B) The accompanying statement is no less than one-half the type 
size of the ``light'' or ``lite'' claim.
    (2)(i) The terms ``light in sodium'' or ``lite in sodium'' may be 
used on the label or in labeling of a meal-type product as defined in 
Sec.  413.313(l) and main-dish product as defined in Sec.  413.313(m), 
provided that the product meets the definition of ``low in sodium'' as 
defined in Sec.  413.361(b)(5)(i); and
    (ii) ``Light'' or ``lite'' and ``in sodium'' are presented in 
uniform type size, style, color, and prominence.
    (3) The term ``light'' or ``lite'' may be used in the brand name of 
a product to describe the sodium content, provided that:
    (i) The product is reduced by 50 percent or more in sodium content 
compared to the reference product;
    (ii) A statement specifically stating that the product is ``light 
in sodium'' or ``lite in sodium'' appears:
    (A) Contiguous to the brand name; and
    (B) In uniform type size, style, color, and prominence as the 
product name; and
    (iii) As required in Sec.  413.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the sodium was reduced are declared in immediate 
proximity to the most prominent such claim; and
    (B) Quantitative information comparing the level of sodium per 
labeled serving size with that of the reference product it replaces is 
declared adjacent to the most prominent claim or to the nutrition 
information.
    (e) Except as provided in paragraphs (b) through (d) of this 
section, the terms ``light'' or ``lite'' may not be used to refer to a 
product that is not reduced in fat by 50 percent, or, if applicable, in 
calories by \1/3\ or, when properly qualified, in sodium by 50 percent 
unless:
    (1) It describes some physical or organoleptic attribute of the 
product such as texture or color and the information (e.g., ``light in 
color'' or ``light in texture'') so stated, clearly conveys the nature 
of the product; and
    (2) The attribute (e.g., ``color'' or ``texture'') is in the same 
style, color, and at least one-half the type size as the word ``light'' 
and in immediate proximity thereto.
    (f) If a manufacturer can demonstrate that the word ``light'' has 
been associated, through common use, with a particular product to 
reflect a physical or organoleptic attribute to the point where it has 
become part of the statement of identity, such use of the term 
``light'' shall not be considered a nutrient content claim subject to 
the requirements in this part.
    (g) The term ``lightly salted'' may be used on a product to which 
has been added 50 percent less sodium than is normally added to the 
reference product as described in Sec.  413.313(j)(1)(i)(B) and 
(j)(1)(ii)(B), provided that if the product is not ``low in sodium'' as 
defined in Sec.  413.361(b)(4), the statement ``not a low sodium 
food,'' shall appear adjacent to the nutrition information and the 
information required to accompany a relative claim shall appear on the 
label or labeling as specified in Sec.  413.313(j)(2).


Sec. Sec.  413.357-413.359   [Reserved]


Sec.  413.360  Nutrient content claims for calorie content.

    (a) General requirements. A claim about the calorie or sugar 
content of a product may only be made on the label or in labeling of 
the product if:
    (1) The claim uses one of the terms defined in this section in 
accordance with the definition for that term;
    (2) The claim is made in accordance with the general requirements 
for nutrient content claims in Sec.  413.313; and
    (3) The product for which the claim is made is labeled in 
accordance with Sec.  413.309.
    (b) Calorie content claims. (1) The terms ``calorie free,'' ``free 
of calories,'' ``no calories,'' ``zero calories,'' ``without 
calories,'' ``trivial source of calories,'' ``negligible source of 
calories,'' or ``dietarily insignificant source of calories'' may be 
used on the label or in labeling of products, provided that:
    (i) The product contains less than 5 calories per reference amount 
customarily consumed and per labeled serving size; and
    (ii) If the product meets this condition without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the caloric content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (2) The terms ``low calorie,'' ``few calories,'' ``contains a small 
amount of calories,'' ``low source of calories,'' or ``low in 
calories'' may be used on the label or in labeling of products, except 
meal-type products as defined in Sec.  413.313(l) and main-dish 
products as defined in Sec.  413.313(m), provided that:
    (i)(A) The product has a reference amount customarily consumed 
greater than 30 grams (g) or greater than 2 tablespoons (tbsp) and does 
not provide more than 40 calories per reference amount customarily 
consumed; or
    (B) The product has a reference amount customarily consumed of 30 g

[[Page 6813]]

or less or 2 tbsp or less and does not provide more than 40 calories 
per reference amount customarily consumed and per 50 g (for dehydrated 
products that must be reconstituted before typical consumption with 
water or a diluent containing an insignificant amount, as defined in 
Sec.  413.309(f)(1), of all nutrients per reference amount customarily 
consumed, the per-50-g criterion refers to the ``as prepared'' form).
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the caloric content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (3) The terms defined in paragraph (b)(2) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec.  413.313(l) and main-dish product as defined in Sec.  413.313(m), 
provided that:
    (i) The product contains 120 calories or less per 100 g of product; 
and (ii) If the product meets this condition without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the calorie content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which it attaches.
    (4) The terms ``reduced calorie,'' ``reduced in calories,'' 
``calorie reduced,'' ``fewer calories,'' ``lower calorie,'' or ``lower 
in calories'' may be used on the label or in labeling of products, 
except meal-type products as defined in Sec.  413.313(l) and main-dish 
products as defined in Sec.  413.313(m), provided that:
    (i) The product contains at least 25 percent fewer calories per 
reference amount customarily consumed than an appropriate reference 
product as described in Sec.  413.313(j)(1); and
    (ii) As required in Sec.  413.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the calories differ between the two products are 
declared in immediate proximity to the most prominent such claim (e.g., 
lower calorie `product'-- ``33\1/3\ percent fewer calories than our 
regular `product' ''); and
    (B) Quantitative information comparing the level of calories in the 
product per labeled serving size with that of the reference product 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``calorie content has been reduced 
from 150 to 100 calories per serving'').
    (iii) Claims described in paragraph (b)(4) of this section may not 
be made on the label or in labeling of products if the reference 
product meets the definition for ``low calorie.''
    (5) The terms defined in paragraph (b)(4) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec.  413.313(l) and main-dish product as defined in Sec.  413.313(m), 
provided that:
    (i) The product contains at least 25 percent fewer calories per 100 
g of product than an appropriate reference product as described in 
Sec.  413.313(j)(1); and
    (ii) As required in Sec.  413.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the calories differ between the two products are 
declared in immediate proximity to the most prominent such claim (e.g., 
``calorie reduced `product', 25% less calories per ounce (oz) (or 3 oz) 
than our regular `product' ''); and
    (B) Quantitative information comparing the level of calories in the 
product per specified weight with that of the reference product that it 
replaces is declared adjacent to the most prominent claim or to the 
nutrition information (e.g., ``calorie content has been reduced from 
110 calories per 3 oz to 80 calories per 3 oz'').
    (iii) Claims described in paragraph (b)(5) of this section may not 
be made on the label or in labeling of products if the reference 
product meets the definition for ``low calorie.''
    (c) Sugar content claims. (1) Terms such as ``sugar free,'' ``free 
of sugar,'' ``no sugar,'' ``zero sugar,'' ``without sugar,'' 
``sugarless,'' ``trivial source of sugar,'' ``negligible source of 
sugar,'' or ``dietarily insignificant source of sugar'' may reasonably 
be expected to be regarded by consumers as terms that represent that 
the product contains no sugars or sweeteners, e.g., ``sugar free,'' or 
``no sugar,'' as indicating a product which is low in calories or 
significantly reduced in calories. Consequently, except as provided in 
paragraph (c)(2) of this section, a product may not be labeled with 
such terms unless:
    (i) The product contains less than 0.5 g of sugars, as defined in 
Sec.  413.309(c)(6)(ii), per reference amount customarily consumed and 
per labeled serving size or, in the case of a meal-type product or a 
main-dish product, less than 0.5 g of sugars per labeled serving size;
    (ii) The product contains no ingredient that is a sugar or that is 
generally understood by consumers to contain sugars unless the listing 
of the ingredient in the ingredients statement is followed by an 
asterisk that refers to the statement below the list of ingredients, 
which states: ``Adds a trivial amount of sugar,'' ``adds a negligible 
amount of sugar,'' or ``adds a dietarily insignificant amount of 
sugar;'' and
    (iii)(A) It is labeled ``low calorie'' or ``reduced calorie'' or 
bears a relative claim of special dietary usefulness labeled in 
compliance with paragraphs (b)(2), (b)(3), (b)(4), or (b)(5) of this 
section; or
    (B) Such term is immediately accompanied, each time it is used, by 
either the statement ``not a reduced calorie product,'' ``not a low 
calorie product,'' or ``not for weight control.''
    (2) The terms ``no added sugar,'' ``without added sugar,'' or ``no 
sugar added'' may be used only if:
    (i) No amount of sugars, as defined in Sec.  413.309(c)(6)(ii), or 
any other ingredient that contains sugars that functionally substitute 
for added sugars is added during processing or packaging;
    (ii) The product does not contain an ingredient containing added 
sugars such as jam, jelly, or concentrated fruit juice;
    (iii) The sugars content has not been increased above the amount 
present in the ingredients by some means such as the use of enzymes, 
except where the intended functional effect of the process is not to 
increase the sugars content of a product, and a functionally 
insignificant increase in sugars results;
    (iv) The product that it resembles and for which it substitutes 
normally contains added sugars; and
    (v) The product bears a statement that the product is not ``low 
calorie'' or ``calorie reduced'' (unless the product meets the 
requirements for a ``low'' or ``reduced calorie'' product) and that 
directs consumers' attention to the nutrition panel for further 
information on sugar and calorie content.
    (3) Paragraph (c)(1) of this section shall not apply to a factual 
statement that a product, including products intended specifically for 
infants and children less than 2 years of age, is unsweetened or 
contains no added sweeteners in the case of a product that contains 
apparent substantial inherent sugar content, e.g., juices.
    (4) The terms ``reduced sugar,'' ``reduced in sugar,'' ``sugar 
reduced,'' ``less sugar,'' ``lower sugar,'' or ``lower in sugar'' may 
be used on the label or in labeling of products, except meal-type 
products as defined in Sec.  413.313(l) and main-dish products as 
defined in Sec.  413.313(m), provided that:
    (i) The product contains at least 25 percent less sugars per 
reference amount customarily consumed than an

[[Page 6814]]

appropriate reference product as described in Sec.  413.313(j)(1); and
    (ii) As required in Sec.  413.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the sugars differ between the two products are declared 
in immediate proximity to the most prominent such claim (e.g., ``this 
product contains 25 percent less sugar than our regular product''); and
    (B) Quantitative information comparing the level of the sugar in 
the product per labeled serving size with that of the reference product 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``sugar content has been lowered from 
8 g to 6 g per serving'').
    (5) The terms defined in paragraph (c)(4) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec.  413.313(l) and main-dish product as defined in Sec.  413.313(m), 
provided that:
    (i) The product contains at least 25 percent less sugars per 100 g 
of product than an appropriate reference product as described in Sec.  
413.313(j)(1); and
    (ii) As required in Sec.  413.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the sugars differ between the two products are declared 
in immediate proximity to the most prominent such claim (e.g., 
``reduced sugar `product'--25% less sugar than our regular `product' 
''); and
    (B) Quantitative information comparing the level of the nutrient in 
the product per specified weight with that of the reference product 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``sugar content has been reduced from 
17 g per 3 oz to 13 g per 3 oz'').


Sec.  413.361   Nutrient content claims for the sodium content.

    (a) General requirements. A claim about the level of sodium in a 
product may only be made on the label or in labeling of the product if:
    (1) The claim uses one of the terms defined in this section in 
accordance with the definition for that term;
    (2) The claim is made in accordance with the general requirements 
for nutrient content claims in Sec.  413.313; and
    (3) The product for which the claim is made is labeled in 
accordance with Sec.  413.309.
    (b) Sodium content claims. (1) The terms ``sodium free,'' ``free of 
sodium,'' ``no sodium,'' ``zero sodium,'' ``without sodium,'' ``trivial 
source of sodium,'' ``negligible source of sodium,'' or ``dietarily 
insignificant source of sodium'' may be used on the label or in 
labeling of products, provided that:
    (i) The product contains less than 5 milligrams (mg) of sodium per 
reference amount customarily consumed and per labeled serving size or, 
in the case of a meal-type product or a main-dish product, less than 5 
mg of sodium per labeled serving size;
    (ii) The product contains no ingredient that is sodium chloride or 
is generally understood by consumers to contain sodium unless the 
listing of the ingredient in the ingredients statement is followed by 
an asterisk that refers to the statement below the list of ingredients, 
which states: ``Adds a trivial amount of sodium,'' ``adds a negligible 
amount of sodium'' or ``adds a dietarily insignificant amount of 
sodium''; and
    (iii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the sodium content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (2) The terms ``very low sodium'' or ``very low in sodium'' may be 
used on the label or in labeling of products, except meal-type products 
as defined in Sec.  413.313(l) and main-dish products as defined in 
Sec.  413.313(m), provided that:
    (i)(A) The product has a reference amount customarily consumed 
greater than 30 grams (g) or greater than 2 tablespoons (tbsp) and 
contains 35 mg or less sodium per reference amount customarily 
consumed; or
    (B) The product has a reference amount customarily consumed of 30 g 
or less or 2 tbsp or less and contains 35 mg or less sodium per 
reference amount customarily consumed and per 50 g (for dehydrated 
products that must be reconstituted before typical consumption with 
water or a diluent containing an insignificant amount, as defined in 
Sec.  413.309(f)(1), of all nutrients per reference amount customarily 
consumed, the per-50-g criterion refers to the ``as prepared'' form); 
and
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the sodium content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (3) The terms defined in paragraph (b)(2) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec.  413.313(l) and main-dish product as defined in Sec.  413.313(m), 
provided that:
    (i) The product contains 35 mg or less of sodium per 100 g of 
product; and
    (ii) If the product meets this condition without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the sodium content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (4) The terms ``low sodium,'' ``low in sodium,'' ``little sodium,'' 
``contains a small amount of sodium,'' or ``low source of sodium'' may 
be used on the label and in labeling of products, except meal-type 
products as defined in Sec.  413.313(l) and main-dish products as 
defined in Sec.  413.313(m), provided that:
    (i)(A) The product has a reference amount customarily consumed 
greater than 30 g or greater than 2 tbsp and contains 140 mg or less 
sodium per reference amount customarily consumed; or
    (B) The product has a reference amount customarily consumed of 30 g 
or less or 2 tbsp or less and contains 140 mg or less sodium per 
reference amount customarily consumed and per 50 g (for dehydrated 
products that must be reconstituted before typical consumption with 
water or a diluent containing an insignificant amount, as defined in 
Sec.  413.309(f)(1), of all nutrients per reference amount customarily 
consumed, the per-50-g criterion refers to the ``as prepared'' form); 
and
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the sodium content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (5) The terms defined in paragraph (b)(4) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec.  413.313(l) and main-dish product as defined in Sec.  413.313(m), 
provided that:
    (i) The product contains 140 mg or less sodium per 100 g of 
product; and
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the sodium content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (6) The terms ``reduced sodium,'' ``reduced in sodium,'' ``sodium 
reduced,'' ``less sodium,'' ``lower

[[Page 6815]]

sodium,'' or ``lower in sodium'' may be used on the label or in 
labeling of products, except meal-type products as defined in Sec.  
413.313(l) and main-dish products as defined in Sec.  413.313(m), 
provided that:
    (i) The product contains at least 25 percent less sodium per 
reference amount customarily consumed than an appropriate reference 
product as described in Sec.  413.313(j)(1); and
    (ii) As required in Sec.  413.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the sodium differs between the two products are declared 
in immediate proximity to the most prominent such claim (e.g., 
``reduced sodium `product', 50 percent less sodium than regular 
`product' ''); and
    (B) Quantitative information comparing the level of sodium in the 
product per labeled serving size with that of the reference product 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``sodium content has been lowered from 
300 to 150 mg per serving'').
    (iii) Claims described in paragraph (b)(6) of this section may not 
be made on the label or in labeling of a product if the nutrient 
content of the reference product meets the definition for ``low 
sodium.''
    (7) The terms defined in paragraph (b)(6) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec.  413.313(l) and main-dish product as defined in Sec.  413.313(m), 
provided that:
    (i) The product contains at least 25 percent less sodium per 100 g 
of product than an appropriate reference product as described in Sec.  
413.313(j)(1); and
    (ii) As required in Sec.  413.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the sodium differs between the two products are declared 
in immediate proximity to the most prominent such claim (e.g., 
``reduced sodium `product'--30% less sodium per 3 oz than our `regular 
product' ''); and
    (B) Quantitative information comparing the level of sodium in the 
product per specified weight with that of the reference product that it 
replaces is declared adjacent to the most prominent claim or to the 
nutrition information (e.g., ``sodium content has been reduced from 220 
mg per 3 oz to 150 mg per 3 oz'').
    (iii) Claims described in paragraph (b)(7) of this section may not 
be made on the label or in labeling of products if the nutrient content 
of the reference product meets the definition for ``low sodium.''
    (c) The term ``salt'' is not synonymous with ``sodium.'' Salt 
refers to sodium chloride. However, references to salt content such as 
``unsalted,'' ``no salt,'' ``no salt added'' are potentially 
misleading.
    (1) The term ``salt free'' may be used on the label or in labeling 
of products only if the product is ``sodium free'' as defined in 
paragraph (b)(1) of this section.
    (2) The terms ``unsalted,'' ``without added salt,'' and ``no salt 
added'' may be used on the label or in labeling of products only if:
    (i) No salt is added during processing;
    (ii) The product that it resembles and for which it substitutes is 
normally processed with salt; and
    (iii) If the product is not sodium free, the statement, ``not a 
sodium free product'' or ``not for control of sodium in the diet'' 
appears adjacent to the nutrition information of the product bearing 
the claim.
    (3) Paragraph (c)(2) of this section shall not apply to a factual 
statement that a product intended specifically for infants and children 
less than 2 years of age is unsalted, provided such statement refers to 
the taste of the product and is not false or otherwise misleading.


Sec.  413.362  Nutrient content claims for fat, fatty acids, and 
cholesterol content.

    (a) General requirements. A claim about the level of fat, fatty 
acid, and cholesterol in a product may only be made on the label or in 
labeling of products if:
    (1) The claim uses one of the terms defined in this section in 
accordance with the definition for that term;
    (2) The claim is made in accordance with the general requirements 
for nutrient content claims in Sec.  413.313; and
    (3) The product for which the claim is made is labeled in 
accordance with Sec.  413.309.
    (b) Fat content claims. (1) The terms ``fat free,'' ``free of 
fat,'' ``no fat,'' ``zero fat,'' ``without fat,'' ``nonfat,'' ``trivial 
source of fat,'' ``negligible source of fat,'' or ``dietarily 
insignificant source of fat'' may be used on the label or in labeling 
of products, provided that:
    (i) The product contains less than 0.5 gram (g) of fat per 
reference amount customarily consumed and per labeled serving size or, 
in the case of a meal-type product or a main-dish product, less than 
0.5 g of fat per labeled serving size;
    (ii) The product contains no added ingredient that is a fat or is 
generally understood by consumers to contain fat unless the listing of 
the ingredient in the ingredients statement is followed by an asterisk 
that refers to the statement below the list of ingredients, which 
states: ``Adds a trivial amount of fat,'' ``adds a negligible amount of 
fat,'' or ``adds a dietarily insignificant amount of fat''; and
    (iii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the fat content, it is labeled to clearly refer to all products of its 
type and not merely to the particular brand to which the label 
attaches.
    (2) The terms ``low fat,'' ``low in fat,'' ``contains a small 
amount of fat,'' ``low source of fat,'' or ``little fat'' may be used 
on the label and in labeling of products, except meal-type products as 
defined in Sec.  413.313(l) and main-dish products as defined in Sec.  
413.313(m), provided that:
    (i)(A) The product has a reference amount customarily consumed 
greater than 30 g or greater than 2 tablespoons (tbsp) and contains 3 g 
or less of fat per reference amount customarily consumed; or
    (B) The product has a reference amount customarily consumed of 30 g 
or less or 2 tbsp or less and contains 3 g or less of fat per reference 
amount customarily consumed and per 50 g (for dehydrated products that 
must be reconstituted before typical consumption with water or a 
diluent containing an insignificant amount, as defined in Sec.  
413.309(f)(1), of all nutrients per reference amount customarily 
consumed, the per-50-g criterion refers to the ``as prepared'' form).
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the fat content, it is labeled to clearly refer to all products of its 
type and not merely to the particular brand to which the label 
attaches.
    (3) The terms defined in paragraph (b)(2) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec.  413.313(l) and main-dish product as defined in Sec.  413.313(m), 
provided that:
    (i) The product contains 3 g or less of total fat per 100 g of 
product and not more than 30 percent of calories from fat; and
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the fat content, it is labeled to clearly refer to all products of its 
type and not merely to the

[[Page 6816]]

particular brand to which the label attaches.
    (4) The terms ``reduced fat,'' ``reduced in fat,'' ``fat reduced,'' 
``less fat,'' ``lower fat,'' or ``lower in fat'' may be used on the 
label or in labeling of products, except meal-type products as defined 
in Sec.  413.313(l) and main-dish products as defined in Sec.  
413.313(m), provided that:
    (i) The product contains at least 25 percent less fat per reference 
amount customarily consumed than an appropriate reference product as 
described in Sec.  413.313(j)(1); and
    (ii) As required in Sec.  413.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the fat differs between the two products are declared in 
immediate proximity to the most prominent such claim (e.g., ``reduced 
fat--50 percent less fat than our regular `product' ''); and
    (B) Quantitative information comparing the level of fat in the 
product per labeled serving size with that of the reference product 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``fat content has been reduced from 8 
g to 4 g per serving'').
    (iii) Claims described in paragraph (b)(4) of this section may not 
be made on the label or in labeling of a product if the nutrient 
content of the reference product meets the definition for ``low fat.''
    (5) The terms defined in paragraph (b)(4) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec.  413.313(l) and main-dish product as defined in Sec.  413.313(m), 
provided that:
    (i) The product contains at least 25 percent less fat per 100 g of 
product than an appropriate reference product as described in Sec.  
413.313(j)(1); and
    (ii) As required in Sec.  413.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the fat differs between the two products are declared in 
immediate proximity to the most prominent such claim (e.g., ``reduced 
fat `product', 33 percent less fat per 3 oz than our regular `product' 
''); and
    (B) Quantitative information comparing the level of fat in the 
product per specified weight with that of the reference product that it 
replaces is declared adjacent to the most prominent such claim or to 
the nutrition information (e.g., ``fat content has been reduced from 8 
g per 3 oz to 5 g per 3 oz'').
    (iii) Claims described in paragraph (b)(5) of this section may not 
be made on the label or in labeling of a product if the nutrient 
content of the reference product meets the definition for ``low fat.''
    (6) The term ``__ percent fat free'' may be used on the label or in 
labeling of products, provided that:
    (i) The product meets the criteria for ``low fat'' in paragraph 
(b)(2) or (b)(3) of this section;
    (ii) The percent declared and the words ``fat free'' are in uniform 
type size; and
    (iii) A ``100 percent fat free'' claim may be made only on products 
that meet the criteria for ``fat free'' in paragraph (b)(1) of this 
section, that contain less than 0.5 g of fat per 100 g, and that 
contain no added fat.
    (iv) A synonym for ``__ percent fat free'' is ``__ percent lean.''
    (c) Fatty acid content claims. (1) The terms ``saturated fat 
free,'' ``free of saturated fat,'' ``no saturated fat,'' ``zero 
saturated fat,'' ``without saturated fat,'' ``trivial source of 
saturated fat,'' ``negligible source of saturated fat,'' or ``dietarily 
insignificant source of saturated fat'' may be used on the label or in 
labeling of products, provided that:
    (i) The product contains less than 0.5 g of saturated fat and less 
than 0.5 g trans fatty acids per reference amount customarily consumed 
and per labeled serving size or, in the case of a meal-type product or 
a main-dish product, less than 0.5 g of saturated fat and less than 0.5 
g trans fatty acids per labeled serving size;
    (ii) The product contains no ingredient that is generally 
understood by consumers to contain saturated fat unless the listing of 
the ingredient in the ingredients statement is followed by an asterisk 
that refers to the statement below the list of ingredients, which 
states: ``Adds a trivial amount of saturated fat,'' ``adds a negligible 
amount of saturated fat,'' or ``adds a dietarily insignificant amount 
of saturated fat;'' and
    (iii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
saturated fat content, it is labeled to clearly refer to all products 
of its type and not merely to the particular brand to which the label 
attaches.
    (2) The terms ``low in saturated fat,'' ``low saturated fat,'' 
``contains a small amount of saturated fat,'' ``low source of saturated 
fat,'' or ``a little saturated fat'' may be used on the label or in 
labeling of products, except meal-type products as defined in Sec.  
413.313(l) and main-dish products as defined in Sec.  413.313(m), 
provided that:
    (i) The product contains 1 g or less of saturated fat per reference 
amount customarily consumed and not more than 15 percent of calories 
from saturated fat; and
    (ii) If the product meets these conditions without benefit of 
special processing, alteration, formulation, or reformulation to lower 
saturated fat content, it is labeled to clearly refer to all products 
of its type and not merely to the particular brand to which the label 
attaches.
    (3) The terms defined in paragraph (c)(2) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec.  413.313(l) and main-dish product as defined in Sec.  413.313(m), 
provided that:
    (i) The product contains 1 g or less of saturated fat per 100 g and 
less than 10 percent calories from saturated fat; and
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
saturated fat content, it is labeled to clearly refer to all products 
of its type and not merely to the particular brand to which the label 
attaches.
    (4) The terms ``reduced saturated fat,'' ``reduced in saturated 
fat,'' ``saturated fat reduced,'' ``less saturated fat,'' ``lower 
saturated fat,'' or ``lower in saturated fat'' may be used on the label 
or in labeling of products, except meal-type products as defined in 
Sec.  413.313(l) and main-dish products as defined in Sec.  413.313(m), 
provided that:
    (i) The product contains at least 25 percent less saturated fat per 
reference amount customarily consumed than an appropriate reference 
product as described in Sec.  413.313(j)(1); and
    (ii) As required in Sec.  413.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the saturated fat differs between the two products are 
declared in immediate proximity to the most prominent such claim (e.g., 
``reduced saturated fat `product', contains 50 percent less saturated 
fat than the national average for `product' ''); and
    (B) Quantitative information comparing the level of saturated fat 
in the product per labeled serving size with that of the reference 
product that it replaces is declared adjacent to the most prominent 
claim or to the nutrition information (e.g., ``saturated fat reduced 
from 3 g to 1.5 g per serving'').
    (iii) Claims described in paragraph (c)(4) of this section may not 
be made on the label or in labeling of a product if the nutrient 
content of the reference product meets the definition for ``low 
saturated fat.''
    (5) The terms defined in paragraph (c)(4) of this section may be 
used on the

[[Page 6817]]

label or in labeling of a meal-type product as defined in Sec.  
413.313(l) and main-dish product as defined in Sec.  413.313(m), 
provided that:
    (i) The product contains at least 25 percent less saturated fat per 
100 g of product than an appropriate reference product as described in 
Sec.  413.313(j)(1); and
    (ii) As required in Sec.  413.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the saturated fat differs between the two products are 
declared in immediate proximity to the most prominent such claim (e.g., 
``reduced saturated fat `product','' ``50 percent less saturated fat 
than our regular `product' ''); and
    (B) Quantitative information comparing the level of saturated fat 
in the product per specified weight with that of the reference product 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``saturated fat content has been 
reduced from 2.5 g per 3 oz to 1.5 g per 3 oz'').
    (iii) Claims described in paragraph (c)(5) of this section may not 
be made on the label or in labeling of a product if the nutrient 
content of the reference product meets the definition for ``low 
saturated fat.''
    (d) Cholesterol content claims. (1) The terms ``cholesterol free,'' 
``free of cholesterol,'' ``zero cholesterol,'' ``without cholesterol,'' 
``no cholesterol,'' ``trivial source of cholesterol,'' ``negligible 
source of cholesterol,'' or ``dietarily insignificant source of 
cholesterol'' may be used on the label or in labeling of products, 
provided that:
    (i) The product contains less than 2 milligrams (mg) of cholesterol 
per reference amount customarily consumed and per labeled serving size 
or, in the case of a meal-type product as defined in Sec.  413.313(l) 
and main-dish product as defined in Sec.  413.313(m), less than 2 mg of 
cholesterol per labeled serving size;
    (ii) The product contains no ingredient that is generally 
understood by consumers to contain cholesterol, unless the listing of 
the ingredient in the ingredients statement is followed by an asterisk 
that refers to the statement below the list of ingredients, which 
states: ``Adds a trivial amount of cholesterol,'' ``adds a negligible 
amount of cholesterol,'' or ``adds a dietarily insignificant amount of 
cholesterol'';
    (iii) The product contains 2 g or less of saturated fat per 
reference amount customarily consumed or, in the case of a meal-type 
product as defined in Sec.  413.313(l) and main-dish product as defined 
in Sec.  413.313(m), 2 g or less of saturated fat per labeled serving 
size; and
    (iv) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
cholesterol content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which it attaches; 
or
    (v) If the product meets these conditions only as a result of 
special processing, alteration, formulation, or reformulation, the 
amount of cholesterol is reduced by 25 percent or more from the 
reference product it replaces as described in Sec.  413.313(j)(1) and 
for which it substitutes as described in Sec.  413.313(d) that has a 
significant (e.g., 5 percent or more of a national or regional market) 
market share. As required in Sec.  413.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the cholesterol was reduced are declared in immediate 
proximity to the most prominent such claim (e.g., ``cholesterol free 
`product', contains 100 percent less cholesterol than `reference 
product' ''); and
    (B) Quantitative information comparing the level of cholesterol in 
the product per labeled serving size with that of the reference product 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``contains no cholesterol compared 
with 30 mg in one serving of `reference product' '').
    (2) The terms ``low in cholesterol,'' ``low cholesterol,'' 
``contains a small amount of cholesterol,'' ``low source of 
cholesterol,'' or ``little cholesterol'' may be used on the label or in 
labeling of products, except meal-type products as defined in Sec.  
413.313(l) and main-dish products as defined in Sec.  413.313(m), 
provided that:
    (i)(A) If the product has a reference amount customarily consumed 
greater than 30 g or greater than 2 tbsp:
    (1) The product contains 20 mg or less of cholesterol per reference 
amount customarily consumed; and
    (2) The product contains 2 g or less of saturated fat per reference 
amount customarily consumed; or
    (B) If the product has a reference amount customarily consumed of 
30 g or less or 2 tbsp or less:
    (1) The product contains 20 mg or less of cholesterol per reference 
amount customarily consumed and per 50 g (for dehydrated products that 
must be reconstituted before typical consumption with water or a 
diluent containing an insignificant amount, as defined in Sec.  
413.309(f)(1), of all nutrients per reference amount customarily 
consumed, the per-50-g criterion refers to the ``as prepared'' form); 
and
    (2) The product contains 2 g or less of saturated fat per reference 
amount customarily consumed.
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
cholesterol content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches; or
    (iii) If the product contains 20 mg or less of cholesterol only as 
a result of special processing, alteration, formulation, or 
reformulation, the amount of cholesterol is reduced by 25 percent or 
more from the reference product it replaces as described in Sec.  
413.313(j)(1) and for which it substitutes as described in Sec.  
413.313(d) that has a significant (e.g., 5 percent or more of a 
national or regional market) market share. As required in Sec.  
413.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the cholesterol has been reduced are declared in 
immediate proximity to the most prominent such claim (e.g., ``low 
cholesterol `product', contains 85 percent less cholesterol than our 
regular `product' ''); and
    (B) Quantitative information comparing the level of cholesterol in 
the product per labeled serving size with that of the reference product 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``cholesterol lowered from 30 mg to 5 
mg per serving'').
    (3) The terms defined in paragraph (d)(2) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec.  413.313(l) and main-dish product as defined in Sec.  413.313(m), 
provided that:
    (i) The product contains 20 mg or less of cholesterol per 100 g of 
product;
    (ii) The product contains 2 g or less of saturated fat per 100 g of 
product; and
    (iii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
cholesterol content, it is labeled to clearly refer to all products of 
its type and not merely to the particular brand to which the label 
attaches.
    (4) The terms ``reduced cholesterol,'' ``reduced in cholesterol,'' 
``cholesterol reduced,'' ``less cholesterol,'' ``lower cholesterol,'' 
or ``lower in cholesterol'' may be used on the label or in labeling of 
products or products that substitute for those products as specified in

[[Page 6818]]

Sec.  413.313(d), excluding meal-type products as defined in Sec.  
413.313(l) and main-dish products as defined in Sec.  413.313(m), 
provided that:
    (i) The product has been specifically formulated, altered, or 
processed to reduce its cholesterol by 25 percent or more from the 
reference product it replaces as described in Sec.  413.313(j)(1) and 
for which it substitutes as described in Sec.  413.313(d) that has a 
significant (e.g., 5 percent or more of a national or regional market) 
market share;
    (ii) The product contains 2 g or less of saturated fat per 
reference amount customarily consumed; and
    (iii) As required in Sec.  413.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the cholesterol has been reduced are declared in 
immediate proximity to the most prominent such claim (e.g., ``25 
percent less cholesterol than `reference product' ''); and
    (B) Quantitative information comparing the level of cholesterol in 
the product per labeled serving size with that of the reference product 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``cholesterol lowered from 55 mg to 30 
mg per serving'').
    (iv) Claims described in paragraph (d)(4) of this section may not 
be made on the label or in labeling of a product if the nutrient 
content of the reference product meets the definition for ``low 
cholesterol.''
    (5) The terms defined in paragraph (d)(4) of this section may be 
used on the label or in labeling of a meal-type product as defined in 
Sec.  413.313(l) and main-dish product as defined in Sec.  413.313(m), 
provided that:
    (i) The product has been specifically formulated, altered, or 
processed to reduce its cholesterol by 25 percent or more from the 
reference product it replaces as described in Sec.  413.313(j)(1) and 
for which it substitutes as described in Sec.  413.313(d) that has a 
significant (e.g., 5 percent or more of a national or regional market) 
market share;
    (ii) The product contains 2 g or less of saturated fat per 100 g of 
product; and
    (iii) As required in Sec.  413.313(j)(2) for relative claims:
    (A) The identity of the reference product and the percent (or 
fraction) that the cholesterol has been reduced are declared in 
immediate proximity to the most prominent such claim (e.g., ``25% less 
cholesterol than `reference product' ''); and
    (B) Quantitative information comparing the level of cholesterol in 
the product per specified weight with that of the reference product 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``cholesterol content has been reduced 
from 35 mg per 3 oz to 25 mg per 3 oz'').
    (iv) Claims described in paragraph (d)(5) of this section may not 
be made on the label or in labeling of a product if the nutrient 
content of the reference product meets the definition for ``low 
cholesterol.''
    (e) ``Lean'' and ``Extra Lean'' claims.
    (1) The term ``lean'' may be used on the label or in labeling of a 
product, provided that the product contains less than 10 g of fat, 4.5 
g or less of saturated fat, and less than 95 mg of cholesterol per 100 
g of product and per reference amount customarily consumed for 
individual foods, and per 100 g of product and per labeled serving size 
for meal-type products as defined in Sec.  413.313(l) and main-dish 
products as defined in Sec.  413.313(m).
    (2) The term ``extra lean'' may be used on the label or in labeling 
of a product, provided that the product contains less than 5 g of fat, 
less than 2 g of saturated fat, and less than 95 mg of cholesterol per 
100 g of product and per reference amount customarily consumed for 
individual foods, and per 100 g of product and per labeled serving size 
for meal-type products as defined in Sec.  413.313(l) and main-dish 
products as defined in Sec.  413.313(m).
    (f) A statement of the lean percentage may be used on the label or 
in labeling of ground or chopped products described in Sec.  413.301 
when the product does not meet the criteria for ``low fat,'' defined in 
Sec.  413.362(b)(2), provided that a statement of the fat percentage is 
contiguous to and in lettering of the same color, size, type, and on 
the same color background, as the statement of the lean percentage.


Sec.  413.363  Nutrient content claims for ``healthy.''

    (a) The term ``healthy,'' or any other derivative of the term 
``health,'' may be used on the labeling of any meat, meat food product, 
or poultry product, provided that the product is labeled in accordance 
with Sec.  413.309 and Sec.  413.313.
    (b)(1) The product shall meet the requirements for ``low fat'' and 
``low saturated fat,'' as defined in Sec.  413.362, except that single-
ingredient, raw products may meet the total fat and saturated fat 
criteria for ``extra lean'' in Sec.  413.362.
    (2) The product shall not contain more than 60 milligrams (mg) of 
cholesterol per reference amount customarily consumed, per labeled 
serving size, and, only for foods with reference amounts customarily 
consumed of 30 grams (g) or less or 2 tablespoons (tbsp) or less, per 
50 g, and, for dehydrated products that must be reconstituted with 
water or a diluent containing an insignificant amount, as defined in 
Sec.  413.309(f)(1), of all nutrients, the per-50-g criterion refers to 
the prepared form, except that:
    (i) A main-dish product, as defined in Sec.  413.313(m), and a 
meal-type product, as defined in Sec.  413.313(l), and including meal-
type products that weigh more than 12 ounces (oz) per serving 
(container), shall not contain more than 90 mg of cholesterol per 
labeled serving size; and
    (ii) Single-ingredient, raw products may meet the cholesterol 
criterion for ``extra lean'' in Sec.  413.362.
    (3) The product shall not contain more than 480 mg of sodium per 
reference amount customarily consumed, per labeled serving size, and, 
only for foods with reference amounts customarily consumed of 30 g or 
less or 2 tbsp or less, per 50 g, and, for dehydrated products that 
must be reconstituted with water or a diluent containing an 
insignificant amount, as defined in Sec.  413.309(f)(1), of all 
nutrients, the per-50-g criterion refers to the prepared form, except 
that:
    (i) A main-dish product, as defined in Sec.  413.313(m), and a 
meal-type product, as defined in Sec.  413.313(l), and including meal-
type products that weigh more than 12 oz per serving (container), shall 
not contain more than 600 mg of sodium per labeled serving size; \1\ 
and
---------------------------------------------------------------------------

    \1\ This regulation previously provided that, after January 1, 
2006, individual meat and poultry products bearing the claim 
``healthy'' (or any derivative of the term ``health'') must contain 
no more than 360 mg of sodium and that meal-type products bearing 
the claim ``healthy'' (or any other derivative of the term 
``health'') must contain no more than 600 mg of sodium. 
Implementation of these sodium level requirements for products 
bearing the claim ``healthy'' (or any derivative of the term 
``health'') has been deferred indefinitely due to technological 
barriers and consumer preferences.
---------------------------------------------------------------------------

    (ii) The requirements of this paragraph (b)(3) do not apply to 
single-ingredient, raw products.
    (4) The product shall contain 10 percent or more of the Reference 
Daily Intake or Daily Reference Value as defined in Sec.  413.309 for 
vitamin A, vitamin C, calcium, iron, protein, or fiber per reference 
amount customarily consumed prior to any nutrient addition, except 
that:
    (i) A main-dish product, as defined in Sec.  413.313(m), and 
including main-dish products that weigh less than 10 oz per serving 
(container), shall meet the level for two of the nutrients per labeled 
serving size; and

[[Page 6819]]

    (ii) A meal-type product, as defined in Sec.  413.313(l), shall 
meet the level for three of the nutrients per labeled serving size.


Sec. Sec.  413.364-413.368   [Reserved]


Sec.  413.369  Labeling applications for nutrient content claims.

    (a) This section pertains to labeling applications for claims, 
express or implied, that characterize the level of any nutrient 
required to be on the label or in labeling of product by this part.
    (b) Labeling applications included in this section are:
    (1) Labeling applications for a new (heretofore unauthorized) 
nutrient content claim,
    (2) Labeling applications for a synonymous term (i.e., one that is 
consistent with a term defined by regulation) for characterizing the 
level of a nutrient, and
    (3) Labeling applications for the use of an implied claim in a 
brand name.
    (c) Labeling applications and supporting documentation to be filed 
under this section shall be submitted in quadruplicate, except that the 
supporting documentation may be submitted on a computer disc copy. If 
any part of the material submitted is in a foreign language, it shall 
be accompanied by an accurate and complete English translation. The 
labeling application shall state the applicant's post office address.
    (d) Pertinent information will be considered as part of an 
application on the basis of specific reference to such information 
submitted to and retained in the files of the Food Safety and 
Inspection Service. However, any reference to unpublished information 
furnished by a person other than the applicant will not be considered 
unless use of such information is authorized (with the understanding 
that such information may in whole or part be subject to release to the 
public) in a written statement signed by the person who submitted it. 
Any reference to published information should be accompanied by 
reprints or photostatic copies of such references.
    (e) If nonclinical laboratory studies accompany a labeling 
application, the applicant shall include, with respect to each 
nonclinical study included with the application, either a statement 
that the study has been, or will be, conducted in compliance with the 
good laboratory practice regulations as set forth in part 58 of chapter 
1, title 21, or, if any such study was not conducted in compliance with 
such regulations, a brief statement of the reason for the 
noncompliance.
    (f) If clinical investigations accompany a labeling application, 
the applicant shall include, with respect to each clinical 
investigation included with the application, either a statement that 
the investigation was conducted in compliance with the requirements for 
institutional review set forth in part 56 of chapter 1, title 21, or 
was not subject to such requirements in accordance with Sec.  56.194 or 
Sec.  56.105, and that it was conducted in compliance with the 
requirements for informed consents set forth in part 50 of chapter 1, 
title 21.
    (g) The availability for public disclosure of labeling 
applications, along with supporting documentation, submitted to the 
Agency under this section will be governed by the rules specified in 
subchapter D, title 9.
    (h) The data specified under this section to accompany a labeling 
application shall be submitted on separate sheets, suitably identified. 
If such data has already been submitted with an earlier labeling 
application from the applicant, the present labeling application must 
provide the data.
    (i) The labeling application must be signed by the applicant or by 
his or her attorney or agent, or (if a corporation) by an authorized 
official.
    (j) The labeling application shall include a statement signed by 
the person responsible for the labeling application, that to the best 
of his or her knowledge, it is a representative and balanced submission 
that includes unfavorable information, as well as favorable 
information, known to him or her pertinent to the evaluation of the 
labeling application.
    (k)(1) Labeling applications for a new nutrient content claim shall 
be accompanied by the following data which shall be submitted in the 
following form to the Director, Labeling and Program Delivery Staff, 
Office of Policy and Program Development, Food Safety and Inspection 
Service, Washington, DC 20250.

-----------------------------------------------------------------------
(Date)

    The undersigned, ___, submits this labeling application pursuant 
to 9 CFR 413.369 with respect to (statement of the claim and its 
proposed use). Attached hereto, in quadruplicate, or on a computer 
disc copy, and constituting a part of this labeling application, are 
the following:
    (i) A statement identifying the nutrient content claim and the 
nutrient that the term is intended to characterize with respect to 
the level of such nutrient. The statement shall address why the use 
of the term as proposed will not be misleading. The statement shall 
provide examples of the nutrient content claim as it will be used on 
labels or labeling, as well as the types of products on which the 
claim will be used. The statement shall also specify the level at 
which the nutrient must be present or what other conditions 
concerning the product must be met for the appropriate use of the 
term in labels or labeling, as well as any factors that would make 
the use of the term inappropriate.
    (ii) A detailed explanation supported by any necessary data of 
why use of the food component characterized by the claim is of 
importance in human nutrition by virtue of its presence or absence 
at the levels that such claim would describe. This explanation shall 
also state what nutritional benefit to the public will derive from 
use of the claim as proposed and why such benefit is not available 
through the use of existing terms defined by regulation. If the 
claim is intended for a specific group within the population, the 
analysis shall specifically address nutritional needs of such group, 
and scientific data sufficient for such purpose, and data and 
information to the extent necessary to demonstrate that consumers 
can be expected to understand the meaning of the term under the 
proposed conditions of use.
    (iii) Analytical data that demonstrates the amount of the 
nutrient that is present in the products for which the claim is 
intended. The assays should be performed on representative samples 
in accordance with Sec.  413.309(h). If no USDA or AOAC methods are 
available, the applicant shall submit the assay method used, and 
data establishing the validity of the method for assaying the 
nutrient in the particular food. The validation data shall include a 
statistical analysis of the analytical and product variability.
    (iv) A detailed analysis of the potential effect of the use of 
the proposed claim on food consumption, and any corresponding 
changes in nutrient intake. The analysis shall specifically address 
the intake of nutrients that have beneficial and negative 
consequences in the total diet. If the claim is intended for a 
specific group within the population, the analysis shall 
specifically address the dietary practices of such group, and shall 
include data sufficient to demonstrate that the dietary analysis is 
representative of such group.

    Yours very truly,

Applicant--------------------------------------------------------------

By---------------------------------------------------------------------

(Indicate authority)

    (2) Upon receipt of the labeling application and supporting 
documentation, the applicant shall be notified, in writing, of the date 
on which the labeling application was received. Such notice shall 
inform the applicant that the labeling application is undergoing Agency 
review and that the applicant shall subsequently be notified of the 
Agency's decision to consider for further review or deny the labeling 
application.
    (3) Upon review of the labeling application and supporting 
documentation, the Agency shall notify the applicant, in writing, that 
the labeling application is either being considered for further review 
or that it

[[Page 6820]]

has been summarily denied by the Administrator.
    (4) If the labeling application is summarily denied by the 
Administrator, the written notification shall state the reasons 
therefor, including why the Agency has determined that the proposed 
nutrient content claim is false or misleading. The notification letter 
shall inform the applicant that the applicant may submit a written 
statement by way of answer to the notification, and that the applicant 
shall have the right to request a hearing with respect to the merits or 
validity of the Administrator's decision to deny the use of the 
proposed nutrient content claim.
    (i) If the applicant fails to accept the determination of the 
Administrator and files an answer and requests a hearing, and the 
Administrator, after review of the answer, determines the initial 
determination to be correct, the Administrator shall file with the 
Hearing Clerk of the Department the notification, answer, and the 
request for a hearing, which shall constitute the complaint and answer 
in the proceeding, which shall thereafter be conducted in accordance 
with the Department's Uniform Rules of Practice.
    (ii) The hearing shall be conducted before an administrative law 
judge with the opportunity for appeal to the Department's Judicial 
Officer, who shall make the final determination for the Secretary. Any 
such determination by the Secretary shall be conclusive unless, within 
30 days after receipt of notice of such final determination, the 
applicant appeals to the United States Court of Appeals for the circuit 
in which the applicant has its principal place of business or to the 
United States Court of Appeals for the District of Columbia Circuit.
    (5) If the labeling application is not summarily denied by the 
Administrator, the Administrator shall publish in the Federal Register 
a proposed rule to amend the regulations to authorize the use of the 
nutrient content claim. The proposal shall also summarize the labeling 
application, including where the supporting documentation can be 
reviewed. The Administrator's proposed rule shall seek comment from 
consumers, the industry, consumer and industry groups, and other 
interested persons on the labeling application and the use of the 
proposed nutrient content claim. After public comment has been received 
and reviewed by the Agency, the Administrator shall make a 
determination on whether the proposed nutrient content claim shall be 
approved for use on the labeling of meat and meat food products and 
poultry products.
    (i) If the claim is denied by the Administrator, the Agency shall 
notify the applicant, in writing, of the basis for the denial, 
including the reason why the claim on the labeling was determined by 
the Agency to be false or misleading. The notification letter shall 
also inform the applicant that the applicant may submit a written 
statement by way of answer to the notification, and that the applicant 
shall have the right to request a hearing with respect to the merits or 
validity of the Administrator's decision to deny the use of the 
proposed nutrient content claim.
    (A) If the applicant fails to accept the determination of the 
Administrator and files an answer and requests a hearing, and the 
Administrator, after review of the answer, determines the initial 
determination to be correct, the Administrator shall file with the 
Hearing Clerk of the Department the notification, answer, and the 
request for a hearing, which shall constitute the complaint and answer 
in the proceeding, which shall thereafter be conducted in accordance 
with the Department's Uniform Rules of Practice.
    (B) The hearing shall be conducted before an administrative law 
judge with the opportunity for appeal to the Department's Judicial 
Officer, who shall make final determination for the Secretary. Any such 
determination by the Secretary shall be conclusive unless, within 30 
days after receipt of the notice of such final determination, the 
applicant appeals to the United States Court of Appeals for the circuit 
in which the applicant has its principal place of business or to the 
United States Court of Appeals for the District of Columbia Circuit.
    (ii) If the claim is approved, the Agency shall notify the 
applicant, in writing, and shall also publish in the Federal Register a 
final rule amending the regulations to authorize the use of the claim.
    (l)(1) Labeling applications for a synonymous term shall be 
accompanied by the following data which shall be submitted in the 
following form to the Director, Labeling and Program Delivery Staff, 
Office of Policy and Program Development, Food Safety and Inspection 
Service, Washington, DC 20250:

-----------------------------------------------------------------------
(Date)

The undersigned, ___ submits this labeling application pursuant to 9 
CFR 413.369 with respect to (statement of the synonymous term and 
its proposed use in a nutrient content claim that is consistent with 
an existing term that has been defined under part 413).
    Attached hereto, in quadruplicate, or on a computer disc copy, 
and constituting a part of this labeling application, are the 
following:
    (i) A statement identifying the synonymous term, the existing 
term defined by a regulation with which the synonymous term is 
claimed to be consistent, and the nutrient that the term is intended 
to characterize the level of. The statement shall address why the 
use of the synonymous term as proposed will not be misleading. The 
statement shall provide examples of the nutrient content claim as it 
will be used on labels or labeling, as well as the types of products 
on which the claim will be used. The statement shall also specify 
whether any limitations not applicable to the use of the defined 
term are intended to apply to the use of the synonymous term.
    (ii) A detailed explanation supported by any necessary data of 
why use of the proposed term is requested, including whether the 
existing defined term is inadequate for the purpose of effectively 
characterizing the level of a nutrient. This explanation shall also 
state what nutritional benefit to the public will derive from use of 
the claim as proposed, and why such benefit is not available through 
the use of existing terms defined by regulation. If the claim is 
intended for a specific group within the population, the analysis 
shall specifically address nutritional needs of such group, 
scientific data sufficient for such purpose, and data and 
information to the extent necessary to demonstrate that consumers 
can be expected to understand the meaning of the term under the 
proposed conditions of use.

    Yours very truly,

Applicant--------------------------------------------------------------

By---------------------------------------------------------------------

(Indicate authority)

    (2) Upon receipt of the labeling application and supporting 
documentation, the applicant shall be notified, in writing, of the date 
on which the labeling application was received. Such notice shall 
inform the applicant that the labeling application is undergoing Agency 
review and that the applicant shall subsequently be notified of the 
Agency's decision to consider for further review or deny the labeling 
application.
    (3) Upon review of the labeling application and supporting 
documentation, the Agency shall notify the applicant, in writing, that 
the labeling application is either being considered for further review 
or that it has been summarily denied by the Administrator.
    (4) If the labeling application is summarily denied by the 
Administrator, the written notification shall state the reasons 
therefor, including why the Agency has determined that the proposed 
synonymous term is false or misleading. The notification letter shall 
inform the applicant that the applicant may submit a written statement 
by way

[[Page 6821]]

of answer to the notification, and that the applicant shall have the 
right to request a hearing with respect to the merits or validity of 
the Administrator's decision to deny the use of the proposed synonymous 
term.
    (i) If the applicant fails to accept the determination of the 
Administrator and files an answer and requests a hearing, and the 
Administrator, after review of the answer, determines the initial 
determination to be correct, the Administrator shall file with the 
Hearing Clerk of the Department the notification, answer, and the 
request for a hearing, which shall constitute the complaint and answer 
in the proceeding, which shall thereafter be conducted in accordance 
with the Department's Uniform Rules of Practice.
    (ii) The hearing shall be conducted before an administrative law 
judge with the opportunity for appeal to the Department's Judicial 
Officer, who shall make the final determination for the Secretary. Any 
such determination by the Secretary shall be conclusive unless, within 
30 days after receipt of notice of such final determination, the 
applicant appeals to the United States Court of Appeals for the circuit 
in which the applicant has its principal place of business or to the 
United States Court of Appeals for the District of Columbia Circuit.
    (5) If the claim is approved, the Agency shall notify the 
applicant, in writing, and shall publish in the Federal Register a 
notice informing the public that the synonymous term has been approved 
for use.
    (m)(1) Labeling applications for the use of an implied nutrient 
content claim in a brand name shall be accompanied by the following 
data which shall be submitted in the following form to the Director, 
Labeling and Program Delivery Staff, Office of Policy and Program 
Development, Food Safety and Inspection Service, Washington, DC 20250:

-----------------------------------------------------------------------
(Date)

    The undersigned, ___ submits this labeling application pursuant 
to 9 CFR 413.369 with respect to (statement of the implied nutrient 
content claim and its proposed use in a brand name).
    Attached hereto, in quadruplicate, or on a computer disc copy, 
and constituting a part of this labeling application, are the 
following:
    (i) A statement identifying the implied nutrient content claim, 
the nutrient the claim is intended to characterize, the 
corresponding term for characterizing the level of such nutrient as 
defined by a regulation, and the brand name of which the implied 
claim is intended to be a part. The statement shall address why the 
use of the brand-name as proposed will not be misleading. The 
statement shall provide examples of the types of products on which 
the brand name will appear. It shall also include data showing that 
the actual level of the nutrient in the food would qualify the label 
of the product to bear the corresponding term defined by regulation. 
Assay methods used to determine the level of a nutrient shall meet 
the requirements stated under labeling application format in 
paragraph (k)(1)(iii) of this section.
    (ii) A detailed explanation supported by any necessary data of 
why use of the proposed brand name is requested. This explanation 
shall also state what nutritional benefit to the public will derive 
from use of the brand name as proposed. If the branded product is 
intended for a specific group within the population, the analysis 
shall specifically address nutritional needs of such group and 
scientific data sufficient for such purpose.

    Yours very truly,

Applicant--------------------------------------------------------------

By---------------------------------------------------------------------

    (2) Upon receipt of the labeling application and supporting 
documentation, the applicant shall be notified, in writing, of the date 
on which the labeling application was received. Such notice shall 
inform the applicant that the labeling application is undergoing Agency 
review and that the applicant shall subsequently be notified of the 
Agency's decision to consider for further review or deny the labeling 
application.
    (3) Upon review of the labeling application and supporting 
documentation, the Agency shall notify the applicant, in writing, that 
the labeling application is either being considered for further review 
or that it has been summarily denied by the Administrator.
    (4) If the labeling application is summarily denied by the 
Administrator, the written notification shall state the reasons 
therefor, including why the Agency has determined that the proposed 
implied nutrient content claim is false or misleading. The notification 
letter shall inform the applicant that the applicant may submit a 
written statement by way of answer to the notification, and that the 
applicant shall have the right to request a hearing with respect to the 
merits or validity of the Administrator's decision to deny the use of 
the proposed implied nutrient content claim.
    (i) If the applicant fails to accept the determination of the 
Administrator and files an answer and requests a hearing, and the 
Administrator, after review of the answer, determines the initial 
determination to be correct, the Administrator shall file with the 
Hearing Clerk of the Department the notification, answer, and the 
request for a hearing, which shall constitute the complaint and answer 
in the proceeding, which shall thereafter be conducted in accordance 
with the Department's Uniform Rules of Practice.
    (ii) The hearing shall be conducted before an administrative law 
judge with the opportunity for appeal to the Department's Judicial 
Officer, who shall make the final determination for the Secretary. Any 
such determination by the Secretary shall be conclusive unless, within 
30 days after receipt of notice of such final determination, the 
applicant appeals to the United States Court of Appeals for the circuit 
in which the applicant has its principal place of business or to the 
United States Court of Appeals for the District of Columbia Circuit.
    (5) If the labeling application is not summarily denied by the 
Administrator, the Administrator shall publish a notice of the labeling 
application in the Federal Register seeking comment on the use of the 
implied nutrient content claim. The notice shall also summarize the 
labeling application, including where the supporting documentation can 
be reviewed. The Administrator's notice shall seek comment from 
consumers, the industry, consumer and industry groups, and other 
interested persons on the labeling application and the use of the 
implied nutrient content claim. After public comment has been received 
and reviewed by the Agency, the Administrator shall make a 
determination on whether the implied nutrient content claim shall be 
approved for use on the labeling of meat food products or for poultry 
products.
    (i) If the claim is denied by the Administrator, the Agency shall 
notify the applicant, in writing, of the basis for the denial, 
including the reason why the claim on the labeling was determined by 
the Agency to be false or misleading. The notification letter shall 
also inform the applicant that the applicant may submit a written 
statement by way of answer to the notification, and that the applicant 
shall have the right to request a hearing with respect to the merits or 
validity of the Administrator's decision to deny the use of the 
proposed implied nutrient content claim.
    (A) If the applicant fails to accept the determination of the 
Administrator and files an answer and requests a hearing, and the 
Administrator, after review of the answer, determines the initial 
determination to be correct, the Administrator shall file with the 
Hearing Clerk of the Department the notification, answer, and the 
request for a hearing, which shall thereafter be conducted in 
accordance with the Department's Uniform Rules of Practice.

[[Page 6822]]

    (B) The hearing shall be conducted before an administrative law 
judge with the opportunity for appeal to the Department's Judicial 
Officer, who shall make the final determination for the Secretary. Any 
such determination by the Secretary shall be conclusive unless, within 
30 days after receipt of the notice of such final determination, the 
applicant appeals to the United States Court of Appeals for the circuit 
in which the applicant has its principal place of business or to the 
United States Court of Appeals for the District of Columbia Circuit.
    (ii) If the claim is approved, the Agency shall notify the 
applicant, in writing, and shall also publish in the Federal Register a 
notice informing the public that the implied nutrient content claim has 
been approved for use.


Sec. Sec.  413.370-413.379   [Reserved]


Sec.  413.380  Label statements relating to usefulness in reducing or 
maintaining body weight.

    (a) General requirements. Any product that purports to be or is 
represented for special dietary use because of usefulness in reducing 
body weight shall bear:
    (1) Nutrition labeling in conformity with Sec.  413.309 of this 
part, unless exempt under that section, and
    (2) A conspicuous statement of the basis upon which the product 
claims to be of special dietary usefulness.
    (b) Nonnutritive ingredients. (1) Any product subject to paragraph 
(a) of this section that achieves its special dietary usefulness by use 
of a nonnutritive ingredient (i.e., one not utilized in normal 
metabolism) shall bear on its label a statement that it contains a 
nonnutritive ingredient and the percentage by weight of the 
nonnutritive ingredient.
    (2) A special dietary product may contain a nonnutritive sweetener 
or other ingredient only if the ingredient is safe for use in the 
product under the applicable law and regulations of this chapter. Any 
product that achieves its special dietary usefulness in reducing or 
maintaining body weight through the use of a nonnutritive sweetener 
shall bear on its label the statement required by paragraph (b)(1) of 
this section, but need not state the percentage by weight of the 
nonnutritive sweetener. If nutritive sweeteners as well as nonnutritive 
sweeteners are added, the statement shall indicate the presence of both 
types of sweetener; e.g., ``Sweetened with nutritive sweeteners and 
nonnutritive sweeteners.''
    (c) ``Low calorie'' foods. A product purporting to be ``low 
calorie'' must comply with the criteria set forth for such foods in 
Sec.  413.360.
    (d) ``Reduced calorie'' foods and other comparative claims. A 
product purporting to be ``reduced calorie'' or otherwise containing 
fewer calories than a reference food must comply with the criteria set 
forth for such foods in Sec.  413.360(b) (4) and (5).
    (e) ``Label terms suggesting usefulness as low calorie or reduced 
calorie foods''.
    (1) Except as provided in paragraphs (e)(2) and (e)(3) of this 
section, a product may be labeled with terms such as ``diet,'' 
``dietetic,'' ``artificially sweetened,'' or ``sweetened with 
nonnutritive sweetener'' only if the claim is not false or misleading, 
and the product is labeled ``low calorie'' or ``reduced calorie'' or 
bears another comparative calorie claim in compliance with the 
applicable provisions in this part.
    (2) Paragraph (e)(1) of this section shall not apply to any use of 
such terms that is specifically authorized by regulation governing a 
particular food, or, unless otherwise restricted by regulation, to any 
use of the term ``diet'' that clearly shows that the product is offered 
solely for a dietary use other than regulating body weight, e.g., ``for 
low sodium diets.''
    (3) Paragraph (e)(1) of this section shall not apply to any use of 
such terms on a formulated meal replacement or other product that is 
represented to be of special dietary use as a whole meal, pending the 
issuance of a regulation governing the use of such terms on foods.
    (f) ``Sugar free'' and ``no added sugar''. Criteria for the use of 
the terms ``sugar free'' and ``no added sugar'' are provided for in 
Sec.  413.360(c).


Sec. Sec.  413.381-413.399   [Reserved]


Sec.  413.400  Exemptions from nutrition labeling.

    (a) The following products are exempt from nutrition labeling:
    (1) Food products produced by small businesses, other than the 
major cuts of single-ingredient, raw products identified in Sec.  
413.344 produced by small businesses, provided that the labels for 
these products bear no nutrition claims or nutrition information, and 
ground or chopped products described in Sec.  413.301 produced by small 
businesses that bear a statement of the lean percentage and fat 
percentage on the label or in labeling in accordance with Sec.  
413.362(f), provided that labels or labeling for these products bear no 
other nutrition claims or nutrition information,
    (i) A food product, for the purposes of the small business 
exemption, is defined as a formulation, not including distinct flavors 
which do not significantly alter the nutritional profile, sold in any 
size package in commerce.
    (ii) For purposes of this paragraph, a small business is any 
single-plant facility, including a single retail store, or multi-plant 
company/firm, including a multi-retail store operation, that employs 
500 or fewer people and produces no more than 100,000 pounds of the 
product qualifying the firm for exemption from this part.
    (iii) For purposes of this paragraph, calculation of the amount of 
pounds shall be based on the most recent 2-year average of business 
activity. Where firms have been in business less than 2 years or where 
products have been produced for less than 2 years, reasonable estimates 
must indicate that the annual pounds produced will not exceed the 
amounts specified.
    (2) Products intended for further processing, provided that the 
labels for these products bear no nutrition claim or nutrition 
information,
    (3) Products that are not for sale to consumers, provided that the 
labels for these products bear no nutrition claims or nutrition 
information,
    (4) Products in small packages that are individually wrapped 
packages of less than \1/2\ ounce net weight, provided that the labels 
for these products bear no nutrition claims or nutrition information,
    (5) Products custom slaughtered or prepared,
    (6) Products intended for export, and
    (7) The following products prepared and served or sold at retail 
provided that the labels or the labeling of these products bear no 
nutrition claims or nutrition information:
    (i) Ready-to-eat products that are packaged or portioned at a 
retail store or similar retail-type establishment, provided, however, 
that this exemption does not apply to ready-to-eat ground or chopped 
products described in Sec.  413.301 that are packaged or portioned at a 
retail establishment, unless the establishment qualifies for an 
exemption under (a)(1) of this section;
    (ii) Multi-ingredient products (e.g., sausage) processed at a 
retail store or similar retail-type establishment, provided, however, 
that this exemption does not apply to multi-ingredient ground or 
chopped products described in Sec.  413.301 that are processed at a 
retail establishment, unless the establishment qualifies for an 
exemption under (a)(1) of this section; and
    (iii) Products that are ground or chopped at an individual 
customer's request.

[[Page 6823]]

    (b) Restaurant menus generally do not constitute labeling or fall 
within the scope of these regulations.
    (c)(1) Foods represented or purported to be specifically for 
infants through 12 months of age and children 1 through 3 years of age 
shall bear nutrition labeling. The nutrients declared for infants 
through 12 months of age and children 1 through 3 years of age shall 
include calories, total fat, saturated fat, trans fat, cholesterol, 
sodium, total carbohydrate, dietary fiber, total sugars, added sugars, 
protein, and the following vitamins and minerals: Vitamin D, calcium, 
iron, and potassium.
    (2) Foods represented or purported to be specifically for infants 
through 12 months of age shall bear nutrition labeling, except that:
    (i) Such labeling shall not declare a percent of Daily Value for 
saturated fat, trans fat, cholesterol, sodium, dietary fiber, total 
sugars, or added sugars and shall not include a footnote.
    (ii) The following sample label illustrates the provisions of 
paragraph (c)(2) of this section.
[GRAPHIC] [TIFF OMITTED] TP19JA17.011

    (3) Foods represented or purported to be specifically for children 
1 through 3 years of age shall include a footnote that states: `` * The 
%Daily Value tells you how much a nutrient in a serving of food 
contributes to a daily diet. 1,000 calories a day is used for general 
nutrition advice.''
    (i) The following sample label illustrates the provisions of 
paragraph (c)(3) of this section.
[GRAPHIC] [TIFF OMITTED] TP19JA17.012

    (ii) [Reserved]
    (d)(1) Products in packages that have a total surface area 
available to bear labeling of less than 12 square inches are exempt 
from nutrition labeling, provided that the labeling for these products 
bear no nutrition claims or other nutrition information, except that 
this exemption does not apply to the major cuts of single-ingredient, 
raw products identified in Sec.  413.344. The manufacturer, packer, or 
distributor shall provide, on the label of packages that qualify for 
and use this exemption, an address or telephone number that a consumer 
can use to obtain the required nutrition information (e.g., ``For 
nutrition information call 1-800-123-4567'').
    (2) When products bear nutrition labeling, either voluntarily or 
because nutrition claims or other nutrition information is provided, 
all required information shall be provided in accordance with 9 CFR 
413.309(d) for the linear nutrition display as shown in 9 CFR 
413.309(g)(1)(i)(B).

    Done at Washington, DC, on: November 28, 2016.
Alfred V. Almanza,
Acting Administrator.
[FR Doc. 2016-29272 Filed 1-18-17; 8:45 am]
 BILLING CODE 3410-DM-P