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

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.

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”

(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.

EP19JA17.000

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.

Table 1—Summary of Costs and Benefits

Costs

Benefits

Net benefits

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

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

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.

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.

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

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

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 α-tocopherol (label claim) = 1 mg α-tocopherol = 1 mg RRR- α-tocopherol = 2 mg

all rac

-α-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

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,

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 × 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

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

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 × 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

Toldrá, et al., “Handbook of Fermented Meat and Poultry,” Wiley Blackwell; 2015; Chapters1-2.

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

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, β-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

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 B

6

, vitamin B

12

, 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),

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 B

6

, vitamin B

12

, 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, B

6

, B

12

, 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 B

6

2.0 milligrams

1.7 milligrams.

Vitamin B

12

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 β-carotene, 12 micrograms β-carotene, or 24 micrograms α- carotene, or 24 micrograms β-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 α-tocopherol (label claim) = 1 mg α-tocopherol = 1 mg RRR- α-tocopherol = 2 mg

all rac

-α-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.

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)).

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

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

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

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).

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 B

6

, vitamin B

12

, 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 B

6

, vitamin B

12

, 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

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 B

12

, folate, choline, riboflavin, niacin, vitamin B

6

, 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

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 × .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)).

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 B

12

, folate, choline, riboflavin, niacin, vitamin B

6

, 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

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 B

12

, folate, choline, riboflavin, niacin, vitamin B

6

, 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

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

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