Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 11 and 101

[Docket No. FDA-2011-F-0172]

RIN 0910-AG57

Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

To implement the nutrition labeling provisions of the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act or ACA), the Food and Drug Administration (FDA or we) is requiring disclosure of certain nutrition information for standard menu items in certain restaurants and retail food establishments. The ACA, in part, amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act), among other things, to require 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 to provide calorie and other nutrition information for standard menu items, including food on display and self-service food. Under provisions of the ACA, restaurants and similar retail food establishments not otherwise covered by the law may elect to become subject to these Federal requirements by registering every other year with FDA. Providing accurate, clear, and consistent nutrition information, including the calorie content of foods, in restaurants and similar retail food establishments will make such nutrition information available to consumers in a direct and accessible manner to enable consumers to make informed and healthful dietary choices.

DATES:

Effective date:

December 1, 2015.

Compliance date:

Covered establishments must comply with the rule by December 1, 2015. See section XXIII for more information on the effective and compliance dates.

Comment Date:

Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by December 31, 2014 (see section XXVI, the “Paperwork Reduction Act of 1995” section of this document).

ADDRESSES:

To ensure that comments on the information collection are received, the Office of Management and Budget (OMB) recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to

oira_submission@omb.eop.gov.

All comments should be identified with the OMB control number 0910-New and title “Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments.” Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Daniel Y. Reese, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2371, email:

Daniel.Reese@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

Executive Summary

Purpose and Coverage of the Final Rule

Summary of the Major Provisions of the Final Rule

Costs and Benefits

I. Background

II. Legal Authority

III. General Comments on the Proposed Rule

A. Introduction

B. Description of General Comments and FDA Response

IV. Comments and FDA Response on Proposed Conforming Amendments

A. Section 11.1(g)—Electronic Signatures

B. Sections 101.9(j)(1)(i), (j)(2), and (j)(3)—Nutrition Labeling of Food

C. Section 101.10—Nutrition Labeling of Restaurant Foods Whose Labels or Labeling Bear Nutrient Content Claims or Health Claims

V. Key Terms That FDA Proposed to Define (Proposed § 101.11(a))

VI. Comments and FDA Response on the Proposed Definitions of Terms Related to the Scope of Establishments Covered by the Rule (Proposed § 101.11(a))

A. Introduction

B. Restaurant or Similar Retail Food Establishment

C. Restaurant Food and Restaurant-Type Food

D. Part of a Chain With 20 or More Locations

E. Doing Business Under the Same Name

F. Offering for Sale Substantially the Same Menu Items

G. Authorized Official of a Restaurant or Similar Retail Food Establishment

H. Covered Establishment

I. Revisions to Several Provisions to Clarify the Applicability of the Rule to Those Restaurants and Similar Retail Food Establishments That Are Covered Establishments

VII. Comments and FDA Response on the Proposed Definition of Menu or Menu Board (Proposed § 101.11(a))

VIII. Comments and FDA Response on the Proposed Definition of Terms Related to Foods Covered by the Rule (Proposed § 101.11(a))

A. Restaurant Food and Restaurant-Type Food

B. Standard Menu Item

C. Combination Meal

D. Variable Menu Item

E. Food on Display

F. Self-Service Food

G. Custom Order

H. Daily Special

I. Food That Is Part of a Customary Market Test

J. Temporary Menu Item

IX. Comments and FDA Response on Proposed § 101.11(b)(1)(i)—Food Subject to the Labeling Requirements

X. Comments and FDA Response on Proposed § 101.11(b)(1)(ii)—Food Not Subject to the Labeling Requirements

A. The Proposed Requirements

B. Alcohol

C. Condiments

D. Daily Specials, Temporary Menu Items, Custom Orders, and Food That Is Part of a Customary Market Test

E. Additional Comments on Food That Is Part of a Customary Market Test

XI. Comments and FDA Response on Proposed § 101.11(b)(2)(i)(A)(

1

) to (b)(2)(i)(A)(

3

)—General Requirements for Calorie Declaration on Menus and Menu Boards

XII. Additional Format Requirements That Apply When Declaring Calories on Menus and Menu Boards for Variable Menu Items, Combination Meals, and Toppings (Final § 101.11(b)(2)(i)(A)(

4

) Through (b)(2)(i)(A)(

8

))

A. Proposed Format for Declaring Calories for Variable Menu Items

B. Decision To Require Option 4

C. Requirements That Apply to Individual Variable Menu Items (Final § 101.11(b)(2)(i)(A)(

4

))

D. Requirements That Apply to a Variable Menu Item That Is Offered for Sale With the Option of Adding Toppings Listed on the Menu or Menu Board (Final § 101.11(b)(2)(i)(A)(

5

))

E. Requirements That Apply to a Combination Meal (Final § 101.11(b)(2)(i)(A)(

6

))

F. Format Requirements for Declaring Calories for an Individual Variable Menu Item, a Combination Meal, and Toppings as a Range, if Applicable (Final § 101.11(b)(2)(i)(A)(

7

))

G. Exception for a Variable Menu Item When There Is No Clearly Identifiable Upper Bound to the Range of Calories (Final § 101.11(b)(2)(i)(A)(

8

))

H. Declaring Calories Using Interactive Menus or New Technology

XIII. Additional Requirements That Apply to Beverages That Are Not Self-Service or on Display (Final § 101.11(b)(2)(i)(A)(

9

))

XIV. Comments and FDA Response on Proposed § 101.11(b)(2)(i)(B)—Succinct Statement That Must Be on Menus and Menu Boards To Provide Context About Calories in a Daily Diet

A. The Proposed Requirements

B. Principles for Establishing the Succinct Statement

C. Wording of the Succinct Statement

D. Succinct Statement on Menus Targeted to Children

E. Requirements for the Succinct Statement To Be Prominent, Clear, and Conspicuous

F. Placement of the Succinct Statement on Menus and Menu Boards

XV. Comments and FDA Response on Proposed § 101.11(b)(2)(i)(C)—Statement That Must Be on Menus and Menu Boards About Availability of Written Nutrition Information

A. Proposed Wording of the Statement of Availability

B. Requirements for the Statement of Availability To Be Prominent and Conspicuous

C. Placement of the Statement of Availability

XVI. Comments and FDA Response on Proposed § 101.11(b)(2)(ii)—Nutrition Information That Must Be Made Available in Written Form

A. Required Nutrients

B. Manner of Presentation of the Written Nutrition Information

C. Nutrients in Insignificant Amounts

D. Variable Menu Items

E. Form of the Written Nutrition Information

XVII. Comments and FDA Response on Proposed § 101.11(b)(2)(iii)—Requirements for Food That Is Self-Service or on Display

A. Applicability of § 101.11(b)(2)(i) to Food That Is Self-Service or on Display

B. Placement of Calories for Self-Service Foods and Foods on Display

C. Declaring Calories “Per Item” or “Per Serving”

D. Declaring Calories “Per Serving” for Self-Service Beverages

E. Manner of Declaring Calories for Self-Service Foods and Foods on Display

F. Applicability of Requirements for Written Nutrition Information, Succinct Statement, and Statement of Availability to Self-Service Foods and Foods on Display

G. Succinct Statement and Statement of Availability for Self-Service Foods and Foods on Display

H. The Written Nutrition Information That Must Be Provided for Food That Is Self-Service or on Display

XVIII. Comments and FDA Response on Proposed § 101.11(c)(1) to (c)(5)—Determination of Nutrient Content (Final § 101.11(c)(1) to (c)(2))

XIX. Comments and FDA Response on Proposed § 101.11(c)(6)—Substantiation Documentation (Final 101.11(c)(3))

XX. Comments and FDA Response on Proposed § 101.11(d)—Voluntary Registration to Elect To Be Subject to the Rule

XXI. Comments and FDA Response on Proposed § 101.11(e)—Signatures

XXII. Comments and FDA Response on Proposed § 101.11(f)—Misbranding

XXIII. Comments and FDA Response on Effective Date

A. Proposed Effective Date and Request for Comment

B. Comments on Proposed Effective Date

C. Effective Date and Compliance Date for This Rule

XXIV. Comments and FDA Response on Compliance

XXV. Final Regulatory Impact Analysis

XXVI. Paperwork Reduction Act of 1995

XXVII. Federalism

XXVIII. Environmental Impact

XXIX. References

Executive Summary

Purpose and Coverage of the Final Rule

More than two thirds of adults and about a third of children in the United States are overweight or obese. Overconsumption of calories is one of the primary risk factors for overweight and obesity. About half of consumers' annual food dollars are spent on, and a third of total calories come from, foods prepared outside the home, including foods from restaurants and similar retail food establishments. Many people do not know, or underestimate, the calorie and nutrient content of these foods. To help make nutrition information for these foods available to consumers in a direct, accessible, and consistent manner to enable consumers to make informed and healthful dietary choices, section 4205 of the ACA requires that calorie and other nutrition information be provided to consumers in 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 (chain retail food establishment). Section 4205 of the ACA also provides that a restaurant or similar retail food establishment that is not a chain retail food establishment may elect to be subject to section 4205's nutrition labeling requirements by registering every other year with FDA.

To be covered by this rule, an establishment must satisfy several criteria. First, the establishment must be a restaurant or similar retail food establishment. Under this rule, that means a retail establishment that offers for sale restaurant-type food, except if it is a school as defined in 7 CFR 210.2 or 220.2. Restaurants and similar retail food establishments include bakeries, cafeterias, coffee shops, convenience stores, delicatessens, food service facilities located within entertainment venues (such as amusement parks, bowling alleys, and movie theatres), food service vendors (

e.g.,

ice cream shops and mall cookie counters), food take-out and/or delivery establishments (such as pizza take-out and delivery establishments), grocery stores, retail confectionary stores, superstores, quick service restaurants, and table service restaurants.

The rule defines “restaurant-type food” in a way that both focuses on the food most like the food offered for sale in restaurants and reflects the statutory context of section 4205 of the ACA. The table that follows provides examples of foods that generally would be considered restaurant-type food (

e.g.,

foods that are usually eaten on the premises, while walking away, or soon after arriving at another location), as well as examples of foods that generally would be not be considered restaurant-type food (

e.g.,

foods that are grocery-type items that consumers often store for use at a later time or customarily further prepare), for the purposes of this rule.

Examples of Foods That Generally Would or Would Not Be Considered Restaurant-Type Food

Examples of foods that generally would be considered

restaurant-type food

Examples of foods that generally would not be considered

restaurant-type food

• Food for immediate consumption at a sit-down or quick service restaurant

• Food purchased at a drive-through establishment

• Food purchased at a drive-through establishment

• Take-out and delivery pizza; hot pizza at grocery and convenience stores that is ready to eat; pizza slice from a movie theater

• Hot buffet food, hot soup at a soup bar, and food from a salad bar

• Foods ordered from a menu/menu board at a grocery store intended for individual consumption (e.g., soups, sandwiches, and salads)

• Self-service foods and foods on display that are intended for individual consumption (e.g., sandwiches, wraps, and paninis at a deli counter; salads plated by the consumer at a salad bar; cookies from a mall cookie counter; bagels, donuts, rolls offered for individual sale)

• Certain foods bought from bulk bins or cases (e.g., dried fruit, nuts) in grocery stores

• Foods to be eaten over several eating occasions or stored for later use (e.g., loaves of bread, bags or boxes of dinner rolls, whole cakes, and bags or boxes of candy or cookies)

• Foods that are usually further prepared before consuming (e.g., deli meats and cheeses)

• Foods sold by weight that are not self-serve and are not intended solely for individual consumption (e.g., deli salads sold by unit of weight such as potato salad, chicken salad), either prepacked or packed upon consumer request

Consistent with the statute, to be covered by the rule, a restaurant or similar retail establishment must be “part of a chain with 20 or more locations doing business under the same name (regardless of the type of ownership of the locations) and offering for sale substantially the same menu items.” A restaurant or similar retail food establishment that does not satisfy these criteria may choose to be covered by the rule by registering with FDA using a process established in the rule.

Under the rule, “location” means a fixed position or site. Transportation venues such as trains and airplanes are not covered by the rule because they do not have a fixed position or site. “Doing business under the same name” means a restaurant or similar retail food establishment must share the same name as other establishments in the chain (regardless of the type of ownership of the locations,

e.g.,

individual franchises). The term “name” refers to either the name of the establishment presented to the public or, if there is no name of the establishment presented to the public (

e.g.,

an establishment with the generic descriptor “concession stand”), the name of the parent entity of the establishment. “Offering for sale substantially the same menu items” means offering for sale a significant proportion of menu items that use the same general recipe and are prepared in substantially the same way with substantially the same food components, even if the name of the menu item varies.

The nutrition labeling requirements of the rule apply to standard menu items offered for sale in covered establishments. “Standard menu item” means a restaurant-type food that is routinely included on a menu or menu board or routinely offered as a self-service food or food on display. The nutrition labeling requirements are not applicable to certain foods, including foods that are not standard menu items, such as condiments, daily specials, temporary menu items, custom orders, and food that is part of a customary market test; and self-service food and food on display that is offered for sale for less than a total of 60 days per calendar year or fewer than 90 consecutive days in order to test consumer acceptance. In addition, the rule exempts alcohol beverages that are food on display and are not self-service food (

e.g.,

bottles of liquor behind the bar used to prepare mixed drinks) from the labeling requirements that apply to food on display.

Summary of the Major Provisions of the Final Rule

The rule includes provisions that:

• Define terms, including terms that describe criteria for determining whether an establishment is subject to the rule;

• Establish which foods are subject to the nutrition labeling requirements and which foods are not subject to these requirements;

• Require that calories for standard menu items be declared on menus and menu boards that list such foods for sale;

• Require that calories for standard menu items that are self-service or on display be declared on signs adjacent to such foods;

• Require that written nutrition information for standard menu items be available to consumers who ask to see it;

• Require, on menus and menu boards, a succinct statement concerning suggested daily caloric intake (succinct statement), designed to help the public understand the significance of the calorie declarations;

• Require, on menus and menu boards, a statement regarding the availability of the written nutrition information (statement of availability);

• Establish requirements for determination of nutrient content of standard menu items;

• Establish requirements for substantiation of nutrient content determined for standard menu items, including requirements for records that a covered establishment must make available to FDA within a reasonable period of time upon request; and

• Establish terms and conditions under which restaurants and similar retail food establishments not otherwise subject to the rule could elect to be subject to the requirements by registering with FDA.

Costs and Benefits

The statute requires nutrition labeling for standard menu items on menus and menu boards for certain restaurants and similar retail food establishments and calorie labeling for food sold from certain vending machines. FDA is issuing two separate final rules (one for menu labeling and one for vending machine labeling) to implement those labeling requirements. Taken together the labeling requirements (of the menu labeling and vending machine labeling rules combined) are estimated to have benefits exceeding costs by $477.9 million on an annualized basis (over 20 years discounted at 7 percent).

Summary of Costs and Benefits of Menu Labeling and Vending Machine Rules

[In millions]

Rate

Potential benefits

Estimated costs

Net benefits

Total for Labeling (menu and vending rules) over 20 years*

3

$9,221.3

$1,697.9

$7,523.4

7

6,752.8

1,333.9

5,418.9

Annualized for Labeling (menu and vending rules) over 20 years*

3

601.9

110.8

491.1

7

595.5

117.6

477.9

Total for Menu Labeling over 20 years

3

9,221.3

1,166.8

8,054.5

7

6,752.8

932.8

5,820.0

Annualized for Menu Labeling over 20 years

3

601.9

76.9

525.01

7

595.5

84.5

510.99

* Benefits for the vending machine labeling rule are not quantified and are not counted in these values.

I. Background

More than two thirds of adults and about a third of children in the United States are overweight or obese (Refs. 1 and 2). Overconsumption of calories is one of the primary risk factors for overweight and obesity (Ref. 3). About half of consumers' annual food dollars are spent on, and a third of total calories come from, foods prepared outside the home, including foods from restaurants and similar retail food establishments (Refs. 4 to 6). Research indicates that many people do not know, or underestimate, the calorie and nutrient content of these foods (Ref. 7).

Since the early 1990s, the Nutrition Labeling and Education Act of 1990 (NLEA) and our regulations in § 101.9 (21 CFR 101.9) implementing the NLEA have required that the labeling for many foods bear nutrition information, including calorie information. However, as we noted in the proposed rule (76 FR 19192 at 19193; April 6, 2011), the NLEA left a gap in the Federal requirements for nutrition labeling through certain exemptions. The NLEA included an exemption for nutrition labeling for food that is “served in restaurants or other establishments in which food is served for immediate human consumption” or “sold for sale or use in such establishments” (section 403(q)(5)(A)(i) of the FD&C Act) (21 U.S.C. 343(q)(5)(A)(i)). The NLEA also included an exemption for food of the type described in section 403(q)(5)(A)(i) that is primarily processed and prepared in a retail establishment, ready for human consumption, “offered for sale to consumers but not for immediate human consumption in such establishment and which is not offered for sale outside such establishment” (section 403(q)(5)(A)(ii) of the FD&C Act). However, these exemptions were contingent on there being no nutrient content claims or health claims made on the label or labeling, or in the advertising, for the food. Current provisions in § 101.10 (21 CFR 101.10) require restaurants and other establishments in which food is offered for human consumption that make either a nutrient content claim (defined in § 101.13 (21 CFR 101.13)) or health claim (defined in 21 CFR 101.14) to provide certain nutrition information upon request. For example, if a menu lists an entree as being low in fat, information about the amount of fat in the entree must be available upon request (§ 101.10).

Section 101.9(j)(2) of our regulations implementing the NLEA includes examples of restaurants or other establishments in which food sold for immediate human consumption generally was exempted from nutrition labeling requirements under the NLEA. Section 101.9(j)(3) of these regulations includes examples of food sold in establishments in which food is processed and prepared, ready for human consumption, offered for sale to consumers but not for immediate consumption, and not offered for sale outside of the establishments.

Several State and local governments enacted their own laws requiring nutrition labeling on menus and menu boards to fill the gap in the Federal requirements. However, these State and local requirements vary significantly in their substantive requirements and the set of establishments to which they apply.

On March 23, 2010, the ACA (Pub. L. 111-148) was signed into law. Section 4205 of the ACA amends section 403(q) of the FD&C Act, which governs nutrition labeling requirements, and section 403A of the FD&C Act (21 U.S.C. 343-1), which governs Federal preemption of State and local food labeling requirements. As amended, section 403(q)(5)(H) of the FD&C Act requires chain retail food establishments with 20 or more locations to provide calorie information for standard menu items, including food on display and self-service food, and to provide, upon consumer request, additional written nutrition information for standard menu items (21 U.S.C. 343(q)(5)(H)(i) to (iii)). Section 403(q)(5)(H) of the FD&C Act also provides that a restaurant or similar retail food establishment not otherwise subject to the requirements of section 403(q)(5)(H) (

e.g.,

a restaurant that is not part of a chain with 20 or more locations) may elect to be subject to the requirements of section 403(q)(5)(H) by registering every other year with FDA (21 U.S.C. 343(q)(5)(H)(ix)). Thus, “covered establishments” include both chain retail food establishments and other restaurants or similar retail food establishments that voluntarily register to be subject to the rule. A standard menu item offered for sale in a covered establishment is deemed to be misbranded if the requirements of section 403(q)(5)(H) are not met.

Section 4205 of the ACA became effective on the date the law was signed, March 23, 2010; however, FDA must issue rules before some provisions can be required. On July 7, 2010, we published a notice in the

Federal Register

to solicit comments and suggestions on the new law (2010 docket notice) (75 FR 39026). On August 25, 2010, we published for public comment a draft guidance entitled “Draft Guidance for Industry: Questions and Answers Regarding Implementation of the Menu Labeling Provisions of Section 4205 of the Patient Protection and Affordable Care Act of 2010” (draft implementation guidance) (Ref. 8) (75 FR 52426), describing which provisions became requirements upon enactment of the law, which provisions we would implement through rulemaking, and draft interpretations of certain provisions, including a broad interpretation of the scope of establishments covered. On January 25, 2011, we published in the

Federal Register

a notice withdrawing the draft implementation guidance (76 FR 4360) and announcing our intent to exercise our enforcement discretion until we

complete the notice and comment rulemaking process.

In the

Federal Register

of April 6, 2011 (76 FR 19192), we issued a proposed rule (proposed rule) to implement the requirements of section 4205 of the ACA for the nutrition labeling of standard menu items in certain restaurants and similar retail food establishments. We requested public comments on the proposed requirements and some alternatives by June 6, 2011. In the

Federal Register

of May 24, 2011 (76 FR 30050), we issued a document (correction document) correcting errors in the proposed rule, including errors in cross-references, an incomplete address, and a typographical error in the codified section of the document. In the

Federal Register

of May 24, 2011 (76 FR 30051), we extended the comment period until July 5, 2011.

In the proposed rule, we described both the provisions that became requirements upon enactment (

i.e.,

they are self-executing) and the provisions that depend on FDA to issue rules before they can become effective (76 FR 19192 at 19194). We also noted that we had published the draft implementation guidance and described the issues addressed by the draft implementation guidance. In the proposed rule, we reiterated that we intended to exercise enforcement discretion for the self-executing provisions of section 4205 of the ACA and described our reasons for doing so (76 FR 19192 at 19194).

After considering comments to the proposed rule, we are issuing this final rule to implement the requirements of section 4205 of the ACA for the nutrition labeling of standard menu items in certain chain restaurants and similar retail food establishments.

In addition to the nutrition labeling requirements for standard menu items, other amendments made by section 4205 of the ACA to the FD&C Act (specifically, section 403(q)(5)(H)(viii)(I)) establish calorie disclosure requirements for certain articles of food sold from vending machines. We published a proposed rule to implement the vending machine provisions of section 403(q) of the FD&C Act on April 6, 2011 (76 FR 19238; the proposed vending machine rule). Elsewhere in this issue of the

Federal Register

, we are issuing a final rule to implement the vending machine provisions of section 403(q)(5)(H)(viii)(I) of the FD&C Act.

II. Legal Authority

On March 23, 2010, the ACA was signed into law. Section 4205 of the ACA amended section 403(q)(5) of the FD&C Act by amending section 403(q)(5)(A) and by creating new clause (H), which requires, in relevant part, covered establishments to provide certain nutrient declarations for standard menu items in the labeling for such foods. Under section 403(f) of the FD&C Act, any word, statement, or other information required by or under authority of the FD&C Act to appear on the label or labeling of a food is required to be prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. Under section 403(a)(1) of the FD&C Act, food labeling must be truthful and non-misleading. Because food that is not in compliance with section 403 is deemed misbranded, food to which these requirements apply is deemed misbranded if these requirements are not met. In addition, under section 201(n) of the FD&C Act (21 U.S.C. 321(n)), the labeling of a food is misleading if it fails to reveal facts that are material in light of representations made in the labeling or with respect to consequences that may result from use. Section 403(q)(5)(H)(x) of the FD&C Act requires that the Secretary of Health and Human Services (Secretary) issue regulations to carry out requirements in section 403(q)(5)(H). Section 701(a) of the FD&C Act (21 U.S.C. 371(a)) vests the Secretary with the authority to issue regulations for the efficient enforcement of the FD&C Act. Thus, we have the authority to issue this final rule under sections 201(n), 403(a)(1), 403(f), 403(q)(5)(H), and 701(a) of the FD&C Act.

We have revised our labeling regulations by adding new § 101.11 to require that covered establishments provide calorie and other nutrition information for standard menu items, including food on display and self-service food. Also, we are establishing the terms and conditions for voluntary registration by establishments that are not otherwise subject to the requirements of section 4205 of the ACA but elect to become subject to such requirements.

III. General Comments on the Proposed Rule

A. Introduction

We received approximately 900 submissions on the proposed rule by the close of the comment period, each containing one or more comments. We received submissions from consumers; consumer groups; trade organizations; industry (including restaurants, entertainment venues, food service operations, and grocery stores); public health organizations; public advocacy groups; contractors; Congress; Federal, State, and local Government Agencies; and other organizations.

We describe and respond to the comments in sections III, IV, VI through XXIV, and XXVII of this document. To make it easier to identify comments and our responses, the word “Comment,” in parentheses, appears before the comment's description, and the word “Response,” in parentheses, appears before our response. We have also numbered each comment and response to help distinguish between different comments and responses. The number assigned to each comment is purely for organizational purposes and does not signify the comment's value or importance or the order in which it was received.

B. Description of General Comments and FDA Response

Many comments made general remarks supporting or opposing the rule and did not focus on a particular section of the rule. The majority of these comments expressed general support for nutrition labeling of standard menu items in covered establishments, and we do not discuss them in detail. In the following paragraphs, we discuss general comments that did not support the rule as proposed.

(Comment 1) Some comments stated that people do not need to be told what to eat. Some comments asserted that calorie disclosure on menus will either cause eating disorders or affect those with eating disorders. Other comments asserted that the menu labeling requirements will not affect consumer behavior, there will be information overload, and people will ignore the information. Some comments considered that the menu labeling requirements will promote healthier choices, whereas other comments considered that the menu labeling requirements will not promote healthier choices. Some comments supported the menu labeling requirements but considered that education is needed to fight obesity.

(Response 1) The rule does not tell consumers what they should or should not eat. The nutrition labeling required by section 4205 of the ACA will provide nutrition information to consumers in covered establishments in a direct, accessible, and consistent manner to enable consumers to make informed choices about the foods they purchase in such establishments.

About half of consumers' annual food dollars are spent on, and a third of total calories come from, foods prepared outside of the home, including foods from restaurants or similar retail food establishments (Refs. 4 to 6). Further, research indicates that many people do not know, or underestimate, the calorie and nutrient content of these foods (Ref. 7). Accordingly, providing direct access to nutrition information for these foods will enable consumers to make informed decisions within the context of nutrition regarding the foods they purchase in restaurants or similar retail food establishments. Providing nutrition information to consumers for standard menu items offered for sale in covered establishments will give consumers much needed access to essential nutrition information for a large and growing number of the foods they purchase and consume. In addition, it will allow consumers to make informed nutritional comparisons between different foods and informed purchase decisions. Further, section 4205 of the ACA and this rule require covered establishments to post, on menus and menu boards, a succinct statement concerning suggested daily caloric intake designed to enable consumers to understand, in the context of a total daily diet, the significance of the calorie information provided on menus and menu boards. This statement, along with the required calorie information, will enable consumers to better understand the significance of the calorie information provided on menus and menu boards and the potential impacts of overconsumption of calories. As a result, the information will enable consumers to assess their calorie intake during short- or long-term settings and better understand how the foods that they purchase at covered establishments fit within their daily caloric and other nutritional needs.

The comments provided no evidence that the provision of nutrition labeling at the point of purchase causes or adversely affects those with eating disorders. For nearly two decades, consumers have had access to this type of information on the labels of packaged foods that bear the Nutrition Facts label in accordance with § 101.9. We are not aware of data or other information demonstrating that the availability of nutrition information through the Nutrition Facts Panel has either caused eating disorders or negatively impacted persons with eating disorders. In addition, Congress, through section 4205 of the ACA, requires covered establishments to provide calorie and other nutrition information for standard menu items. This rulemaking implements that Congressional mandate.

(Comment 2) Some comments considered that the requirements are unnecessary because most “fast food” restaurants have the information already. One comment considered that the proposed requirements constitute a tax increase designed to relieve the individual of personal responsibility.

(Response 2) Section 4205 of the ACA requires covered establishments to provide calorie and other information for standard menu items on menus, menu boards, signs adjacent to self-service foods and foods on display and additional nutrition information for standard menu items in written form, available on the premises, to consumers on request. Therefore, section 4205 of the ACA requires covered establishments to provide nutrition information to consumers in a direct, accessible, and consistent manner, typically at points of purchase, where consumers make order selections. While some “fast food” establishments may already have some nutrition information available to consumers in some fashion, these establishments are a subset of the establishments required to comply with the requirements of this rule, and these establishments may not be providing nutrition information to consumers in the manner required by section 4205 of the ACA.

Regarding the comment asserting that the proposed requirements somehow negate personal responsibility, we reiterate that the requirements do not tell consumers what they should or should not eat or otherwise interfere with a consumer's ability to purchase foods. In fact, as we noted previously, this rule requires covered establishments to provide accurate nutrition information to consumers in a direct and accessible manner to enable consumers to make informed and healthful dietary choices.

(Comment 3) Some comments addressed concerns related to enforcement. One comment expressed concern that the proposed rule did not set forth a clear “chain of liability” for food that is misbranded under the rule and related provisions of the FD&C Act, specifically sections 201(n), 403(a), or 403(q) of the FD&C Act. The comment stated that it is unclear whether FDA might impose vicarious liability on the franchisor or licensor of a restaurant for such misbranded food, particularly where the franchisor or licensor retains power over the menus and menu boards used by the restaurants. The comment also expressed concern that restaurants that “unwittingly 'misbrand' their menu offerings” will be held liable for their food that is misbranded under this rule and related provisions of the FD&C Act.

(Response 3) Persons exercising authority and supervisory responsibility over a restaurant or similar retail food establishment can be held responsible for violations under the FD&C Act. See

United States

v.

Park,

421 U.S. 658, 659 (1978). (“The Act imposes upon persons exercising authority and supervisory responsibility reposed in them by a business organization not only a positive duty to seek out and remedy violations but also, and primarily, a duty to implement measures that will insure that violations will not occur . . . .”) (citing

United States

v.

Dotterweich,

320 U.S. 277 (1943)). Agency decisions regarding enforcement actions will be determined on a case by case basis.

(Comment 4) Some comments addressed issues unrelated to the specific nutrition labeling requirements of section 4205 of the ACA, such as labeling of genetically engineered foods, allergens, gluten, food additives (including preservatives), artificial sweeteners, ingredients, pesticides, and organic foods; labeling to indicate whether a food has been irradiated; labeling of alcohol as a toxin; labeling the country of origin; and labeling the “gender of meat products.”

(Response 4) Section 4205 of the ACA requires covered establishments to provide certain nutrition information for standard menu items. It does not address the labeling issues raised in these comments. Therefore, we do not address these issues in this document.

(Comment 5) Some comments directed to what establishments would be covered by the rule pointed to a report submitted by a U.S. House of Representatives Appropriations Committee explaining an appropriations bill for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies for fiscal year 2012 (Ref. 9). The comments quoted an excerpt from the report (“. . . and the Committee believes that the FDA should define the term restaurant to mean only restaurants doing business marketed under the same name or retail establishments where the primary business is the selling of food for immediate consumption . . .”) to signify Congressional intent on the scope of establishments subject to section 4205 of the ACA or as evidence supporting their own recommendations regarding the establishments that should be covered by the rule. (We note that some comments reported the date of the report as June 3, 2011, and one comment reported the date of the report

as May 27, 2011. We identified a report dated June 3, 2011 (Ref. 9), but did not identify a report dated May 27, 2011. For the purpose of this document, we assume that the comments are referring to the report dated June 3, 2011.)

(Response 5) We disagree that an Appropriations Committee report from a Congress subsequent to the Congress that passed section 4205 of the ACA can be used as evidence of the intent of the previous Congress that passed section 4205. The Appropriations Committee report cited by the comments is dated after the ACA was passed, so it is not part of the relevant legislative history and carries no interpretive weight on this issue (see,

e.g., Bruesewitz

v.

Wyeth,

131 U.S. 1068, 1081 (2011)).

IV. Comments and FDA Response on Proposed Conforming Amendments

A. Section 11.1(g)—Electronic Signatures

Proposed § 11.1(g) (21 CFR 11.1(g)) would provide that 21 CFR part 11 regarding electronic signatures does not apply to electronic signatures obtained under the voluntary registration provision for covered restaurants and similar retail food establishments at proposed § 101.11(d).

We received no comments on this proposed provision and are finalizing it without change.

B. Sections 101.9(j)(1)(i), (j)(2) and (j)(3)—Nutrition Labeling of Food

Our proposed amendment to § 101.9(j)(1)(i) would specify that claims or other nutrition information subject the food to the nutrition labeling provisions of § 101.11 as well as § 101.9 or § 101.10 (nutrition labeling of restaurant foods), as applicable.

Our proposed amendments to § 101.9(j)(2) and (j)(3) would change the introductory text of paragraphs (j)(2) and (j)(3) to add the phrase “Except as provided in § 101.11, food products that are:”.

We received no comments on these proposed provisions and are finalizing them without change. However, we also are adding a conforming amendment to add the phrase “Except as provided in § 101.11” to the beginning of the first sentence in § 101.9(j)(4). As with § 101.9(j)(2) and (j)(3), § 101.9(j)(4) needs to be revised to exclude standard menu items sold in covered establishments and reference the special labeling requirements for those foods in § 101.11 (see § 101.11(b)(2)(ii)(B)).

C. Section 101.10—Nutrition Labeling of Restaurant Foods Whose Labels or Labeling Bear Nutrient Content Claims or Health Claims

Our proposed amendment to § 101.10 would provide that the information in the written nutrition information required by § 101.11(b)(2)(ii)(A) for standard menu items that are offered for sale in covered establishments (as defined in § 101.11(a)) will serve to meet the requirements of § 101.10.

We received no comments on this proposed provision. Given our removal of the term “restaurant food” and our revision of the term “restaurant-type food” in § 101.11, we are adding a conforming amendment to ensure that the use of the term “restaurant foods” in § 101.10, which predates the ACA, is not confusing. We are inserting three sentences between the current first and second sentences of § 101.10, to clarify that the scope of § 101.10 includes those foods described in section 403(q)(5)(A)(i) and (ii) of the FD&C Act. These sentences describe that, for the purposes of § 101.10, restaurant food includes two categories of food. The first category of food is that which is served in restaurants or other establishments in which food is served for immediate human consumption or which is sold for sale or use in such establishments. The second category of food is that which is processed and prepared primarily in a retail establishment, which is ready for human consumption, which is of the type described in the first category, and which is offered for sale to consumers but not for immediate consumption in such establishment and which is not offered for sale outside such establishment. This scope is reflected in numerous prior Agency statements, including in the preamble to our final rule entitled “Food Labeling: Nutrient Content Claims, General Principles, Petitions, Definition of Terms; Definitions of Nutrient Content Claims for the Fat, Fatty Acid, and Cholesterol Content of Food” (58 FR 2302, 2386, January 6, 1993), and in our 2008 “Guidance for Industry: A Labeling Guide for Restaurants and Other Retail Establishments Selling Away-From-Home Foods” (Ref. 10). This change does not alter the meaning or applicability of § 101.10.

V. Key Terms That FDA Proposed To Define (Proposed § 101.11(a))

To establish the scope of establishments, labeling, and food covered by section 4205 of the ACA, we proposed to define key terms (proposed § 101.11(a)). We also proposed to establish that the definitions in section 201 of the FD&C Act apply when used in § 101.11 (proposed § 101.11(a)). We received no comments regarding the use of statutory definitions in section 201 of the FD&C Act, and we are finalizing that provision without change.

In the next section of this document, we discuss the final definitions and related comments, organized into three categories: (1) Terms related to the scope of establishments covered by the rule, (2) the terms menu and menu board, and (3) terms related to foods covered. This organization is consistent with our discussion of our proposed terms in the preamble to the proposed rule.

VI. Comments and FDA Response on the Proposed Definitions of Terms Related to the Scope of Establishments Covered by the Rule (Proposed § 101.11(a))

A. Introduction

To specify establishments that would be subject to the nutrition labeling requirements of section 4205 of the ACA, we proposed to define “covered establishment” to mean a

restaurant or similar retail food establishment

that is a part of a chain with 20 or more

locations doing business under the same name

(regardless of the type of ownership,

e.g.,

individual franchises) and

offering for sale substantially the same menu items,

as well as a restaurant or similar retail food establishment that is registered to be covered under section 403(q)(5)(H)(ix) of the FD&C Act. (Emphasis added).

Importantly, the definition of “covered establishment” includes several terms, identified in italics, that are defined in the rule. In addition, the proposed definition of one of these terms—

i.e.,

“restaurant or similar retail food establishment”—includes other terms we proposed to define—

i.e.,

“restaurant food” and “restaurant-type food.” Thus, any revisions we make to the proposed definitions of any of these terms may affect whether a particular establishment is a “covered establishment” for the purposes of this rule. As discussed more fully in sections VI.B, VI.C, VI.D, VI.E, and VI.F:

• We have revised the definition of “restaurant or similar retail food establishment” to mean a retail establishment that offers for sale restaurant-type food, except if it is a school as defined in 7 CFR 210.1 or 220.2;

• We have revised the definition of the term “restaurant-type food” to focus on the food most like the food offered for sale in restaurants;

• We are adding a definition of “locations” to clarify our interpretation of “part of a chain with 20 or more locations”;

• We have revised the definition of “doing business under the same name” so that the term “name” refers to either (1) the name of the establishment presented to the public or (2), if there is no name of the establishment presented to the public (

e.g.,

an establishment with the generic descriptor “concession stand”), the name of the parent entity of the establishment; and

• We have revised the definition of “offering for sale substantially the same menu items” to add a qualitative description of the number of menu items that must be shared in order for the criterion of “offering for sale substantially the same menu items” to be met.

We proposed to define the term “gross floor area” because we proposed that it be used in the definition of restaurant or similar retail food establishment. While we received comments on this proposed definition, as discussed in section VI.B.2 the definition of restaurant or similar retail food establishment in this rule no longer considers gross floor area. Therefore, we are deleting the proposed definition of “gross floor area” because it is no longer relevant to the scope of establishments covered by this rule.

B. Restaurant or Similar Retail Food Establishment

1. The Proposed Definition

Proposed § 101.11(a) would define “restaurant or similar retail food establishment” as a retail establishment that offers for sale restaurant or restaurant-type food, where the sale of food is the primary business activity of that establishment. Proposed § 101.11(a) would provide that the sale of food is the retail establishment's primary business activity if the establishment presents itself, or has presented itself publicly as a restaurant (primary purpose 1), or a total of more than 50 percent of that retail establishment's gross floor area is used for the preparation, purchase, service, consumption, or storage of food (primary purpose 2). (See Figure 1 in the proposed rule (76 FR 19192 at 19201), in which we coined the terms “primary purpose 1” and “primary purpose 2.” We did not include these coined terms in the regulatory text of the definition. In this document, we are using these coined terms to simplify the discussion. We also are coining the term “primary business test” to simplify the discussion of the criterion for the primary business activity of the establishment.) Under an alternative approach we discussed in the proposed rule (76 FR 19192 at 19197) (the alternative revenue approach), “primary purpose 2” would be that more than 50 percent of the retail establishment's gross revenues are generated by the sale of food rather than that more than 50 percent of the retail establishment's gross floor area is used for the preparation, purchase, service, consumption, or storage of food.

In the proposed rule (76 FR 19192 at 19198), we also discussed an alternative (the restaurant-type food alternative) in which the sale of restaurant or restaurant-type food (rather than the sale of food in general) would be the primary business activity of the establishment. Under the restaurant-type food alternative, “primary purpose 2” would be that a total of more than 50 percent of a retail establishment's gross floor area is used for the preparation, purchase, service, consumption, or storage of restaurant or restaurant-type food or its ingredients.

In the proposed rule (76 FR 19192 at 19198), we acknowledged that many facilities that sell restaurant or restaurant-type food are located within larger retail establishments, such as coffee shops in bookstores or concession stands in movie theaters. We considered that some of these facilities would be separate retail establishments, while others would be part of their larger retail establishments. We explained that if a facility that is inside a larger establishment is part of a chain with locations outside of the chain of the larger establishment, the facility would be considered a separate establishment. For example, if a coffee shop in a bookstore is part of a chain of coffee shops with locations outside of the chain of bookstores, the coffee shop would be considered a separate retail establishment. By contrast, if a facility is not part of a chain with locations outside of the chain of the larger establishment, the facility would be considered part of the larger establishment. Thus, a movie theater concession stand that appears only in other movie theaters in that particular chain of movie theaters would not be considered a separate establishment for the purposes of this proposed rule.

As an example of how all of the elements of the proposed definition of restaurant or similar retail food establishment fit together, movie theaters would not have met the proposed definition of restaurant or similar retail food establishment. Movie theaters usually do not present themselves as restaurants. In addition, movie theaters usually neither dedicate more than 50 percent of their gross floor area to the sale of food, nor generate more than 50 percent of their gross revenues from the sale of food. Thus, under the proposed definition of “restaurant or similar retail food establishment,” movie theater concession stands generally would not have been covered regardless of whether “primary purpose 2” is based on the percent of gross floor area dedicated to the sale of food or on the alternative revenue approach based on the percent of gross revenues from the sale of food.

In the proposed rule (76 FR 19192 at 19197 to 19199), we acknowledged that the statutory language is ambiguous with respect to the scope of establishments covered by section 4205 of the ACA, and asked for comments on:

• Whether we should use “primary business activity,” or a different test, as a basis for determining whether an establishment is a restaurant or similar retail food establishment;

• Whether we should use the sale of food in general, or the sale of restaurant-type food, as the criterion for “primary business activity”;

• Whether we should use the alternative revenue approach, rather than a floor space approach, in “primary purpose 2”;

• Whether we should choose a different number for the cutoff for the percent of gross floor area for determining the primary business activity of the retail establishment;

• Whether we should choose a different criteria for determining primary business activity, such as whether the consumer pays for admission to the establishment; and

• Whether a facility selling restaurant or restaurant-type food that is not part of a chain with locations outside of the chain of a larger retail establishment should be included within the definition of restaurant or similar retail food establishment. We particularly requested comment on this approach with respect to larger retail establishments such as movie theaters, other entertainment-type venues, and superstores that offer restaurant or restaurant-type food.

In the following paragraphs, we discuss comments on the proposed definition of “restaurant or similar retail food establishment.” After considering these comments, we have revised the proposed definition to eliminate the primary business test.

Importantly, the proposed definition of “restaurant or similar retail food establishment” included the terms “restaurant and restaurant-type food” and, thus, revisions to those terms also may affect whether a particular establishment is a “restaurant or similar

retail food establishment” for the purposes of this rule. As discussed more fully in section VI.C, we are deleting the term “restaurant food” throughout the rule and establishing a revised definition of “restaurant-type food” that better reflects the food most like the food offered for sale in restaurants.

With these changes, in this rule “restaurant or similar retail food establishment” means a retail establishment that offers for sale restaurant-type food, except if it is a school as defined in 7 CFR 210.2 or 220.2. Establishments such as bakeries, cafeterias, coffee shops, convenience stores, delicatessens, food service facilities located within entertainment venues (such as amusement parks, bowling alleys, and movie theatres), food service vendors (

e.g.,

ice cream shops and mall cookie counters), food take-out and/or delivery establishments (such as pizza take-out and delivery establishments), grocery stores, retail confectionary stores, superstores, quick service restaurants, and table service restaurants would be restaurants or similar retail food establishments if they sell restaurant-type food.

2. Primary Business Test

(Comment 6) A few comments generally opposed having any primary business test within the definition of “restaurant or similar retail food establishment.” One of these comments recommended that the primary purpose of the definition be related to “whether the establishment optimizes the nation's health through their food distribution channels, rather than a profit/commerce approach.” This comment acknowledged that a “profit/commerce approach” may be more tangibly measured but believed that the definition of restaurant or similar retail food establishment should reflect what the comment considered to be the purpose of the ACA: To inform consumers on healthy food choices. Another comment considered that the floor space test we proposed as “primary purpose 2” is not a rational basis for defining a restaurant or similar retail food establishment. Another comment asserted that both the proposed definition of “restaurant or similar retail food establishment” and the “alternative revenue approach” would have covered grocery stores but not superstores, putting grocery stores at a competitive disadvantage.

One comment recommended that we define a restaurant or similar retail food establishment as any chain establishment selling restaurant or restaurant-type food. The comment asserted that this broader interpretation is consistent with the language in the statute. The comment pointed out that the statute does not include text to suggest that in order to qualify as a retail food establishment, an entity must have the sale of food as its primary business activity.

One comment recommended that the definition cover all of the establishments exempted from nutrition labeling by the NLEA. Some comments referred to examples of covered establishments that we had included in our draft implementation guidance (which we withdrew on January 25, 2011) and agreed that these types of establishments should be covered by the rule. The examples in the draft implementation guidance included table service restaurants, quick service restaurants, coffee shops, delicatessens, food take-out and/or delivery establishments (

e.g.,

pizza take-out and delivery establishments), grocery stores, convenience stores, movie theaters, cafeterias, bakeries/retail confectionary stores, food service vendors (

e.g.,

lunch wagons, ice cream shops, mall cookie counters, and sidewalk carts), and transportation carriers (

e.g.,

airlines and trains). These examples reflected the establishments that sell certain food previously exempted from nutrition labeling by the NLEA under sections 403(q)(5)(A)(i) and (ii) of the FD&C Act, including those mentioned in § 101.9(j)(2) and (j)(3) as well as some additional examples (

i.e.,

similar food served in coffee shops, grocery stores, and movie theaters). Some of the establishments that would have been covered under the draft implementation guidance (such as transportation carriers and facilities located within movie theaters) would be excluded under a definition that includes any primary business test presented in the proposed rule (

i.e.,

regardless of whether the criterion is the proposed criterion based on the sale of food in general or the restaurant-type food alternative based on the sale of restaurant-type food, and regardless of whether “primary purpose 2” relates to gross floor area or gross revenue). Other examples (such as grocery stores and convenience stores) would be excluded from coverage under the restaurant-type food alternative but not under the proposed criterion based on the sale of food in general.

Several comments recommended that we define a restaurant or similar retail food establishment using the restaurant-type food alternative. Some comments that opposed coverage of grocery and convenience stores asserted that selling prepared foods does not make grocery stores similar to restaurants or food court facilities that have on-premises consumption. According to some of these comments, the primary purpose of grocery stores is to sell packaged food, which is already labeled with nutrition information. One comment that opposed covering convenience stores considered that the proposed criterion for a primary business activity based on the sale of food in general, including prepackaged food, is an activity in which restaurants do not engage. The comment recommended that we view the phrase “similar retail food establishment” as a single cohesive term and define those that are in fact similar to restaurants.

Some comments opposed “primary purpose 1” of the proposed primary business test because it would be difficult to enforce. One comment asserted that some bowling alleys list themselves as restaurants in the phone book or have signs indicating that they serve as a restaurant, whereas others do not. The comments maintained that FDA and State and local inspectors would have to determine how many establishments in the chain present themselves as restaurants, which would make enforcement difficult.

One comment agreed with the proposed criterion for “primary purpose 2”—

i.e.,

that greater than 50 percent of a retail establishment's gross floor area is used for the preparation, purchase, service, consumption, or storage of food. One comment asserted that the amount of floor space used for the preparation, purchase, service, consumption, or storage of food would be difficult to determine. Another comment considered that “primary purpose 1” is sufficient for determining whether an establishment is covered, but considered that the floor space criterion would be a more accurate approach than the alternative revenue approach if a second approach for “primary business activity” is needed. One comment asked us to clarify that “gross floor area” includes outdoor space for parks as part of the calculation of the percentage of gross floor area used for the preparation, purchase, service, consumption, or storage of food. A few comments recommended that seating areas, including outside seating, be included in the floor space.

A few comments preferred the alternative revenue approach for “primary purpose 2.” One comment reported that the Internal Revenue Service uses revenue to determine a business's primary activity. One comment suggested that we add to the proposed definition “or a total of more than 50 percent of that retail establishment's revenues are generated by the sale of food.”

A few comments opposed the alternative revenue approach for “primary purpose 2.” These comments considered that it would be difficult for FDA and the States to ascertain the revenue of a restaurant or similar retail food establishment and the revenue may change from day to day. One comment noted that the proposed rule did not include a defined time period for revenue. Another comment asserted that basing “primary purpose 2” on revenue would be complicated when a primary non-food related service or good is paired with an ancillary service such as the sale of food in one price. The comment asserted that it would be difficult to distinguish or separate the percentage of the fee for the non-food related service or good from the percentage of the fee for the food.

A few comments suggested a lower cutoff (20 to 25 percent) for the alternative revenue approach but provided no rationale for the lower cutoff. One comment, which also supported the coverage of movie theaters, stated that movie theaters derive much of their revenue from food in concession stands.

Some comments agreed with our discussion in the proposed rule that a facility within a larger facility should not be considered to be a separate establishment if it is not part of a chain outside that establishment. Some comments specifically agreed that facilities located within movie theaters and other entertainment venues should not be covered by the provisions of section 4205 of the ACA. However, many comments opposed a definition of “restaurant or similar retail food establishment” that would exclude facilities located within a larger facility, specifically facilities in movie theaters and other entertainment venues. Some of these comments provided the following reasons for including such facilities:

• Excluding facilities located within movie theaters removes information from consumers, which defeats the very purpose of the law.

• Food in entertainment venues is high in calories and some of these venues cater to children and have many less healthy options (

e.g.,

fries, ice cream, cotton candy).

• Covering facilities located within movie theaters would not be burdensome for them because they have limited menu options and many packaged foods that have Nutrition Facts.

• Movie theaters derive large revenue from the sale of food; some much more than chain restaurants. It is irresponsible to send the message that consumption of calories in popcorn offered for sale at movie theaters is not as important as consumption of calories in menu items offered for sale at drive-through restaurants.

• Movies attract sedentary people.

• Congress intended that the law apply to movie theaters, bowling alleys, bookstore cafes, and other establishments; the phrase “and similar retail establishments” was used to reach beyond restaurants.

• Excluding facilities located within movies theatres and other entertainment venues is unfair to competing venues.

• Providing other services or entertainment does not affect the need for nutrition information.

• Menu labeling is feasible in venues not covered by the proposed rule. Movie theaters in California, New York City, and counties in New York are providing this information with no problem. To capriciously exempt movie theaters defeats the purpose of the law. One comment asserted that there is 98 percent compliance for menu labeling by movie theaters in New York City.

• Excluding such venues raises equal protection concerns (U.S. Const. 14 Amend. section 1 for similarly situated entities).

One comment considered that we would have to broaden the scope of covered establishments to include other places (such as bowling alleys, airlines, trains, and hotels), regardless of whether they fit the proposed definition of a restaurant or similar retail food establishment, if the rule covered establishments such as facilities located within movie theaters. This comment argued that there is no mention in the legislative history, committee reports, or Congressional floor debates of facilities located within movie theaters being covered. The comment considered that no one would associate “chain retail food establishment” with movie theaters because the primary purpose of going to movies or other entertainment venues is not to eat food and noted that many States and localities do not include these establishments in their laws. Another comment suggested that we add the following statement to our proposed definition: “This definition does not include businesses or establishments that sell food incidental to their primary purpose of providing or hosting entertainment at venues such as movie and live theaters, arenas, amusement parks, sports facilities, concert venues, and other similar establishments.”

(Response 6) We have revised the definition of “restaurant or similar retail food establishment” to eliminate the primary business test. Most of the comments opposed one or more aspects associated with our proposal to include a primary business test, and we are persuaded by them. The comments we received were diverse and raised important considerations, including issues related to fairness; public health impact; accessibility of nutrition information; enabling informed decision-making; statutory purpose and Congressional intent; enforcement challenges; and feasibility of complying with the rule. We are convinced that any primary purpose test presented in the proposed rule will be problematic.

Congress did not define the term “restaurant or similar retail food establishment” in section 4205 of the ACA or elsewhere in the FD&C Act. As we stated in the proposed rule, we look to statutory context as a starting point for the regulatory definition of “restaurant or similar retail food establishment.” As we noted, the 1990 NLEA amendments exempted two categories of food relevant for this discussion: (1) Food “which is served in restaurants or other establishments in which food is served for immediate human consumption or which is sold for sale or use in such establishments,” (termed “restaurant food” in the proposed rule); and (2) food “which is processed and prepared primarily in a retail establishment, which is ready for human consumption, which is of the type described in [(1)] and which is offered for sale to consumers but not for immediate human consumption in such establishment and which is not offered for sale outside such establishment” (termed “restaurant-type food” in the proposed rule). Section 4205 of the ACA amended both of these statutory exemptions. In determining the scope of section 4205 of the ACA, we must determine which of these foods should remain wholly exempt from Federal nutrition labeling requirements and which should be covered by the new nutrition labeling requirements in this rule.

Instead of using a primary purpose test within the definition of restaurant or similar retail food establishment to set the scope of the new law, we are finalizing a broader definition of restaurant or similar retail food establishment, consistent with many of the comments. In response to concerns about overreaching in establishments that sell a significant amount of food that is not typical of food sold in restaurants, such as grocery and convenience stores (see also discussion in section VI.B.3), we are narrowing the set of food covered by removing the term “restaurant food” from this rule and redefining “restaurant-type food” to

include only the set of food described in sections 403(q)(5)(A)(i) and (ii) of the FD&C Act that is most like the food served in restaurants (see discussion in section VI.C). Retail food establishments that offer for sale this type of food are either restaurants or are relevantly similar to restaurants in that they offer for sale the kind of food that restaurants do. Therefore, the final definition focuses on those establishments that offer for sale food that is most like food served in restaurants; overall, it is generally broader than the definition provided in the proposed rule, but narrower than what we put forward in the draft implementation guidance.

Most of the comments that addressed the floor space approach or the alternative revenue approach to “primary purpose 2” expressed a preference for one or the other without providing strong and convincing arguments as to why their preferred alternative is superior to the alternative that they opposed. Several comments identified challenges to enforcing the rule if the definition of “restaurant or similar retail food establishment” included either the floor space approach or the alternative revenue approach.

We agree with several points made by the comments about facilities within entertainment venues such as movie theaters and amusement parks—

e.g.,

that providing nutrition information to consumers at such venues will make such nutrition information available to consumers in a direct and accessible manner to enable consumers to make informed and healthful dietary choices; food in entertainment venues is similar to food offered for sale in other restaurants or similar retail food establishments; and covering entertainment venues would create a level playing field. Under the revised definition of “restaurant or similar retail food establishment,” such facilities in entertainment venues will be covered by the rule if they offer for sale restaurant-type food and satisfy the other criteria in the definition of “covered establishment”—

i.e.,

part of a chain with 20 or more locations, doing business under the same name, and offering for sale substantially the same menu items. Similarly, some superstores that may not have been covered under the proposed definition likewise may be considered a “restaurant or similar retail food establishment” under the final definition established in the rule. Under the definition of “restaurant or similar retail food establishment” in this rule, a superstore, like a grocery store, would be covered if it sells restaurant-type food and is part of a chain with 20 or more locations, doing business under the same name, and offering for sale substantially the same menu items. Hotel restaurants are another type of establishment that we stated generally would not have been covered under the proposed rule (76 FR 19192 at 19198), but would be covered under the final rule if they sell restaurant-type food and are part of a chain of hotel restaurants with 20 or more fixed locations, doing business under the same name, and offering for sale substantially the same menu items.

We disagree that the legislative history of section 4205 of the ACA demonstrates any express intent of Congress to exclude facilities located within entertainment venues such as movie theaters and bowling alleys from the rule. The legislative history of section 4205 of the ACA is very sparse; the section was discussed on few occasions, and when it was discussed, few specifics were mentioned, including specifics about the scope of the law.

We discuss transportation venues later in this document (see Response 27).

(Comment 7) One comment considered the proposed requirement that the sale of food be the retail establishment's primary business to be at odds with the approach taken in the proposed vending machine rule. The comment pointed out that we concluded that only 5,000 of 10,000 vending machine operators operate vending machines as their primary business, yet the proposed vending machine rule would apply to those with 20 or more machines, which includes all 10,000 of the vending machine operators.

(Response 7) The provisions of the proposed vending machine rule, including criteria for determining coverage of that rule, are not relevant to the criteria for determining coverage of this rule. Regardless, this comment is moot because the definition of “restaurant or similar retail food establishment” established in this rule no longer includes a primary business test.

(Comment 8) A few comments recommended that we separately define “restaurant” and “similar retail food establishment.” One of these comments recommended that we define “restaurant” separately from “similar retail food establishment” because Congress uses the word “or” in the phrase “restaurant or similar retail food establishment,” and thus “restaurants” and “similar retail food establishments” are clearly two separate things. Another comment recommended that we define a restaurant as one that uses greater than 50 percent gross floor space for preparation, purchase, service, consumption of restaurant food and a similar retail food establishment as an establishment that meets the same standard but does not present itself as a restaurant.

(Response 8) We disagree that we should separately define “restaurant” and “similar retail food establishment.” As an initial matter, while Congress does use the word “or” between “restaurant” and “similar retail food establishment” in some places, it also uses the word “and” between them in others. For example, section 403(q)(5)(H)(i) of the FD&C Act contains both constructions (“General requirements for restaurants and similar retail food establishments” and “the restaurant or similar retail food establishment shall disclose”). We interpret the choice of the words “and” and “or” in section 403(q)(5)(H) of the FD&C Act to be a function of appropriate grammar, not to indicate Congressional intent to conceptualize “restaurants” separately from “similar retail food establishments.” Moreover, given that the requirements in section 403(q)(5)(H) of the FD&C Act are the same for restaurants and similar retail food establishments, we see no practical reason to create separate regulatory definitions.

(Comment 9) One comment recommended that we include as part of the regulation table 1 from the proposed rule to help the public interpret the regulation.

(Response 9) In the proposed rule (77 FR 19192 at 19198 and 19199), tables 1 and 2 identify establishments that generally would, or would not, be a “restaurant or similar retail food establishment” for the purposes of this rule. We included these tables to demonstrate the likely impact for many establishments of the proposed and alternative criteria for a “primary business test” within the definition of “restaurant or similar retail food establishment.” The definition of “restaurant or similar retail food establishment” established in this rule no longer has a primary business test. Any establishment that sells restaurant-type food is a “restaurant or similar retail food establishment” for the purposes of this rule. Therefore, we see no value added in including such tables in this final rule.

3. Coverage of Grocery Stores and Convenience Stores

(Comment 10) Several comments recommended that grocery stores be covered. Some of these comments considered that grocery stores should be covered because they sell a great deal of food for immediate consumption. One

of these comments referred to the “Food Marketing Institute's 2010 U.S. Grocery Shopper Trends” (Ref. 11) as evidence that the number of consumers who express interest in supermarket ready-to-eat food is at its highest point in 4 years. One comment asserted that the law does not exempt grocery stores or take-out food.

(Response 10) We agree with these comments. Grocery stores that sell restaurant-type food and 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 are covered by the rule.

(Comment 11) One comment argued that the plain meaning of section 4205 of the ACA precludes including grocery stores as “restaurants and similar retail food establishments.” The comment stated that Congress used other words elsewhere in the FD&C Act to refer to the set of establishments that include grocery stores, such as “food retailer” and “retail establishment” in section 403(q) of the FD&C Act. In addition, our regulation at 21 CFR 1.227 defines “retail food establishment” to include grocery stores for the purposes of food facility registration. Given that Congress chose a different term here, the comment argued that we must assume “similar retail food establishments” has a different meaning.

(Response 11) We disagree with this comment. We do interpret the phrase “similar retail food establishment” to have a different meaning than the terms “food retailer” and “retail establishment” that appear elsewhere in section 403(q) of the FD&C Act or “retail food establishment” in 21 CFR 1.227. Both our proposed and final definitions are different from the definitions of these other terms. If a retail food establishment does not offer for sale restaurant-type food, it would not be a “restaurant or similar retail food establishment” for the purposes of section 403(q)(5)(H) of the FD&C Act, even though it could be a “food retailer” or a “retail establishment” or “retail food establishment.”

(Comment 12) One comment argues that the heading of section 4205 of the ACA, “Nutrition Labeling of Standard Menu Items at Chain Restaurants,” indicates that “restaurants or similar retail food establishments” is an ambiguous term, and should be interpreted narrowly to exclude grocery stores.

(Response 12) We disagree with this comment. First, while we recognize that the heading of a statute may be considered part of a section's legislative history, the heading is not part of the law itself (Ref. 12). Second, it is clear that the heading is not meant to describe the scope of the requirements in section 4205 of the ACA, given that section 4205 includes requirements for “restaurants and similar retail food establishments” and requirements for vending machine operators.

(Comment 13) One comment argued that the legislative history of section 4205 of the ACA demonstrates that grocery stores should not be included in the menu labeling requirements. The comment cited a floor speech by Senator Harkin where he favorably compares the nutrition information available in grocery stores to the lack of nutrition information available at restaurants. For example, “It makes no sense that American consumers can go to a grocery store and find nutrition information on just about anything, but then they are totally in the dark when they go to a restaurant for dinner.” (Ref. 13) The comment also argued that the legislative history does not include any hearing or debate indicating that we were being given authority to regulate chain grocery stores through section 4205 of the ACA.

Some comments stated that some State and local jurisdictions did not cover grocery stores. One comment remarked that State and local laws related to menu labeling referred to in the legislative history of section 4205 of the ACA did not cover grocery stores. Specifically, the comment mentions that the New York City Health Code provisions on menu labeling, which the comment characterizes as the first and most extensively discussed law cited by Senator Harkin, does not regulate supermarkets.

(Response 13) We disagree that the legislative history demonstrates that grocery stores should not be included in the nutrition labeling requirements of this rule. First, the most straightforward interpretation of Senator Harkin's statements is that the food in grocery stores he had in mind was packaged food already required to bear nutrition information under Federal law.

Second, the fact that none of the State or local jurisdictions with menu labeling requirements explicitly covered grocery stores does not mean that Congress did not intend to cover grocery stores under the Federal law. Many State and local jurisdictions with menu labeling requirements predating the ACA did not cover self-service food or food on display, which is most likely to be the type of food in grocery stores covered by this rule. However, it is clear that Congress intended for self-service food and food on display to be covered, because section 403(q)(5)(H)(iii) explicitly establishes statutory requirements specific to self-service food and food on display. In addition, for at least some local governments, including New York City, the regulation of grocery stores fell outside of their jurisdiction (Ref. 14). So, the fact that grocery stores were not covered by New York City cannot be assumed to be a choice by local authorities.

Finally, we recognize that the legislative history of section 4205 of the ACA does not include any hearing or debate indicating specifically mentioning chain grocery stores. However, this does not imply that Congress intended for grocery stores to be excluded. As already noted, the legislative history of section 4205 of the ACA is very sparse; the section was discussed on few occasions, and when it was discussed, few specifics were raised, including specifics about the scope of the law. The comment does not provide evidence to the contrary. Our final rule represents a reasonable interpretation of the statute, given the language of section 4205 of the ACA and the scant legislative history.

(Comment 14) Some comments asserted that if Congress had intended broad application, it would have overhauled 21 U.S.C. 343(q)(5)(A)(i) and (ii) of the FD&C Act rather than letting those stand and adding 21 U.S.C. 343(q)(5)(H). Further, these comments stated that if Congress had wanted to include all establishments exempted by the NLEA, it would have cross-referenced to the NLEA exemption or just removed the exemption.

(Response 14) We agree with some of these comments and disagree with others. We agree that Congress did not intend for all establishments exempted by the NLEA to be covered by section 4205 of the ACA. Under the rule, there are many establishments, including establishments that meet the regulatory definition of restaurant or similar retail food establishment, that will not be covered. For example, food described in section 403(q)(5)(A)(i) of the FD&C Act served in certain sit-down restaurants that are not part of a chain of 20 or more locations will continue to be exempt from the Federal nutrition labeling requirements in sections 403(q)(1) to (4). In addition, section 403(q)(5)(A)(i) and (ii) of the FD&C Act continue to exempt all food that is described in sections 403(q)(5)(A)(i) and (ii), including food offered for sale in restaurants and similar retail food establishments, from the nutrition labeling requirements in sections 403(q)(3) and (4). Therefore, irrespective of the breadth of section 403(q)(5)(H) of the FD&C Act, Congress's amendment to sections 403(q)(5)(A)(i) and (ii) leaves a large portion of the exemption intact. Congress could not

have removed the exemption in sections 403(q)(5)(A)(i) and (ii) of the FD&C Act and achieved the same result.

Instead, Congress amended sections 403(q)(5)(A)(i) and (ii) of the FD&C Act to cross-reference section 403(q)(5)(H). The cross-references to section 403(q)(5)(H) of the FD&C Act in sections 403(q)(5)(A)(i) and (ii) indicate that the requirements in 403(q)(5)(H) must apply to at least a subset of those foods described in both sections 403(q)(5)(A)(i) and (ii). Congress did not provide a statutory definition of “restaurant or similar retail food establishment” in section 403(q)(5)(H) of the FD&C Act, leaving ambiguity in the statute as to the breadth of the set of establishments covered. Our definition of restaurant or similar retail food establishment is a reasonable interpretation of this ambiguous term, and is consistent with section 4205's amendments to section 403(q)(5)(A)(i) and (ii) of the FD&C Act.

(Comment 15) One comment argued that the restaurant industry supported section 4205 of the ACA, because the law would provide them with a nationally uniform regulatory scheme. The comment asserted that grocery stores “did not ask for this law,” and should therefore not be covered.

(Response 15) In general, whether an industry asks to be regulated is not determinative of whether that industry should be regulated. In addition, grocery stores are increasingly offering for sale restaurant-type food, including food for immediate consumption that is prepared and processed on the premises.

(Comment 16) A few comments maintained that there is too much variability in grocery store food because food is seasonal and grocery stores make prepared food from food in the store. Some comments also noted that some grocery stores offer unique menu items, such as a unique chicken salad based on the personal recipe of a chef at a particular grocery store's location, that are not available at all grocery stores in the chain. These comments asserted that it would be difficult to calculate the nutrient information if grocery stores were covered under the final rule.

(Response 16) A grocery store is required to make calorie declarations for its standard menu items if it meets the definition of “covered establishment” in this rule; including, in relevant part, that the grocery store is “offering for sale substantially the same menu items” as other grocery stores in the chain (see section VI.F for discussion on “offering for sale substantially the same menu items”). However, if a food is not routinely included on a menu or menu board or routinely offered as a self-service food or food on display at a covered establishment, it is not a standard menu item at that establishment and therefore not covered by this rule (see section VIII.B for discussion on the definition of standard menu item). For example, if a food's ingredients and recipe changes daily based on food available in the store, it is likely that such food would not be a standard menu item. However, for food offerings that are standard menu items, even if unique to only one location in the chain, a covered establishment has many options for determining nutrient content, including, for example, calculating the required nutrient information from the recipe for the food offering using nutrient databases (see § 101.11(c)). Per the statute, in those cases where seasonal availability is limited to less than 60 days, the food offering may be exempt from the nutrition labeling requirements of this rule as a temporary menu item or a self-service food and food on display that is offered for sale for less than a total of 60 days per calendar year.

(Comment 17) One comment maintained that menu labeling is needed in small grocery stores and convenience stores because of the disparity in low-income neighborhoods that do not have many large grocery stores or superstores but do have small grocery stores and convenience stores. According to the comment, grocery stores, convenience stores, and drug store chains have expanded their businesses to include ready-to-eat food offerings. The comment maintained that these establishments are in direct competition with restaurants and have grown so rapidly over the past decade that some are being called “grocerants.”

(Response 17) Small grocery stores and convenience stores are covered by the rule if they sell restaurant-type food and 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.

(Comment 18) One comment considered that grocery stores should not be covered by the menu labeling requirements because they do not have menus and menu boards.

(Response 18) We disagree with this comment. First, the comment suggests that no grocery stores have menus or menu boards. However, some grocery stores do have menus and menu boards, including for example, menus and menu boards for sandwiches that are prepared upon the consumer's request. Second, the comment implies that a restaurant or similar retail food establishment must have a menu or menu board in order to be covered by this rule. This is not the case. Consistent with section 403(q)(5)(H) of the FD&C Act, this rule requires that covered establishments provide certain nutrition information for standard menu items, even the standard menu items that do not appear on menus or menu boards. For example, section 403(q)(5)(H)(iii) of the FD&C Act requires nutrition labeling for standard menu items that are self-service foods and foods on display, irrespective of whether they are listed on a menu or menu board.

4. Confectionery Stores

(Comment 19) A few comments recommended that confectionery stores not be covered because they do not sell restaurant food. According to one of these comments, most candy sold in retail confectionery stores is not generally consumed immediately where purchased or while walking away. Instead, the comment stated, most candy sold in retail confectionery stores is either prepackaged (

e.g.,

boxed chocolates) or selected by the consumer and placed in a box or other packaging for consumption at a later time. Thus, according to this comment, food served in retail confectionery stores without facilities for consumption on the premises would continue to be covered by the nutrition labeling requirements in § 101.9. Another comment acknowledged that some confectionary stores do sell some restaurant-type foods, such as chocolate from display cases, shakes, and specialty items dipped in chocolate, but that the primary focus of the business was the sale of packaged food such as “gift box” packaged chocolates.

(Response 19) We disagree that confectionery stores, as a class of retail food establishments, should not be covered. Based on these comments, some foods sold in some confectionery stores are restaurant-type foods. As discussed in section VI.C, we are establishing a revised definition of “restaurant-type food” that would cover food that is usually eaten on the premises, while walking away, or soon after arriving at another location (see Response 24). A prepackaged box of candy sold in a confectionery store is not likely to be a restaurant-type food, because a box of candy is not usually eaten on the premises, while walking away, or soon after arriving at another location. However, individual pieces of candy sold to a consumer from a display case, shakes, and specialty items dipped in chocolate likely would be restaurant-type foods, because they are generally consumed on the premises, while walking away, or soon after arriving at

another location. Under this rule, a confectionery store that sells restaurant-type food would be covered if it is part of a chain with 20 or more locations doing business under the same name and offering for sale substantially the same menu items. We note that the only foods covered by this rule in a covered establishment are restaurant-type foods that are standard menu items.

5. Facilities Within Facilities

(Comment 20) One comment asked us to clarify that the independent franchise restaurant that operates within an amusement park is liable for adherence to the final regulation, not the park. The comment maintained that the park would have no way of knowing if the franchisee is compliant.

(Response 20) The covered establishment bears the responsibility to comply with the rule. In addition, see Response 3.

6. Schools

(Comment 21) One comment asked us to clarify whether a school food service contractor that uses a central kitchen or cooks the same food for 20 schools would be covered. One comment stated that these establishments should provide calories on menu boards, online menus, and menus sent home to parents.

(Response 21) We have decided not to include schools in the definition of “restaurant or similar retail food establishment” for the purposes of this rule. As previously discussed (see Response 6) Congress did not define the term “restaurant or similar retail food establishment” in section 4205 of the ACA or elsewhere in the FD&C Act. The term is ambiguous, and we look to statutory context as a starting point for our regulatory definition. As discussed in section I of this document, while the NLEA required that the labeling of many foods bear nutrition information, it exempted certain food from such nutrition labeling requirements, including food that is “served in restaurants or other establishments in which food is served for immediate human consumption” (section 403(q)(5)(A)(i) of the FD&C Act). In FDA's regulations implementing the NLEA, we included schools among the list of examples of “other establishments in which food is served for immediate human consumption” (§ 101.9(j)(2)) Section 4205 of the ACA amended this statutory exemption, among others, to account for new nutrition labeling requirements for standard menu items in restaurants and similar retail food establishments. Therefore, we must determine whether standard menu items in schools should remain wholly exempt from FDA nutrition labeling requirements or whether they should be eligible to be covered by the new nutrition labeling requirements in this rule.

Traditionally, the U.S. Department of Agriculture (USDA) has exercised a primary role in setting the standards for foods served in schools through school lunch and breakfast programs. USDA regulates such foods, under various Federal statutes, including the Child Nutrition Act of 1996 and the Richard B. Russell National School Lunch Act. Given the traditional and long-standing role of USDA in setting standards, including nutrition requirements, for foods served in schools through school lunch and breakfast programs, as established by Federal legislation and implemented by Federal Agencies, we conclude that it is reasonable to interpret the term “restaurant or similar retail food establishment” to not include schools. Therefore, we have revised the definition “restaurant or similar retail food establishment” to mean a retail establishment that offers for sale restaurant-type food, except if it is a school as defined in 7 CFR 210.2 or 220.2.

C. Restaurant Food and Restaurant-Type Food

A key term in the final definition of “restaurant or similar retail food establishment” is the term “restaurant-type food.” The terms “restaurant food” and “restaurant-type food” also were important to the proposed definition of “restaurant or similar retail food establishment.” Proposed § 101.11(a) would define “restaurant food” as food that is served in restaurants or other establishments in which food is served for immediate human consumption,

i.e.,

to be consumed either on the premises where that food is purchased or while walking away; or which is sold for sale or use in such establishments. (As a typographical error, the proposed rule incorrectly stated “where that the food is purchased” rather than “where that food is purchased.”) Proposed § 101.11(a) would define “restaurant-type food” as food of the type described in the definition of “restaurant food” that is ready for human consumption, offered for sale to consumers but not for immediate consumption, processed and prepared primarily in a retail establishment, and not offered for sale outside of that establishment.

In the following paragraphs, we discuss comments on these proposed definitions. After considering comments, we are deleting the proposed definition of “restaurant food” and establishing a revised definition of “restaurant-type food” that better reflects the food most like the food offered for sale in restaurants. As conforming amendments, we are deleting the term “restaurant food” from other proposed definitions that had included this term—

i.e.,

the proposed definitions for “food on display,” “restaurant or similar retail food establishment,” “self-service food,” and “standard menu item.”

(Comment 22) One comment recommended that food be covered if prepared for immediate human consumption regardless of whether consumers choose to consume on or off the premises. The comment recommended that we remove the term “walking away” from the definition of restaurant food because it would be clearer to state simply that foods that are served in restaurants or similar retail food establishments and are prepared for immediate human consumption are covered, whether customers choose to consume them on or off the premises. The comment considered that whether foods are actually consumed on or off the premises should not be a determining factor as to whether a food or facility is covered by the rule. The comment asked us to clarify that food from facilities serving take-away food that meet the other criteria are covered.

(Response 22) We decline the specific suggestion that we replace our proposed criterion that food may be “consumed either on the premises where the food is purchased or while walking away” with a criterion mentioning that consumers may consume the food “on or off the premises.” The comment did not disagree that restaurant food should include food that is consumed while walking away but rather suggested communicating this differently.

While restaurants do offer for sale food that is consumed off the premises, in general that food is consumed while walking away or upon arriving at another location. Other foods, like groceries, are also consumed “off the premises” of the store that sells them (

e.g.,

a grocery or convenience store), but they are often consumed at a later time or over a period of days. Our aim is to cover the food most like the food offered for sale in restaurants, and not food that is more similar to food traditionally thought of as groceries. Therefore, the phrase “on or off the premises” is too broad for our final definition of restaurant-type food.

In general, take-away food is consumed while walking away or upon arriving at another location. Therefore, take-away food is likely to be “restaurant-type food,” and retail

establishments that offer for sale take-away food are likely to meet the definition of restaurant or similar retail food establishment. Take-away food that satisfies the definition of “restaurant-type food” established in this rule would be subject to the nutrition labeling requirements of this rule if it is a standard menu item that is offered for sale in a covered establishment.

(Comment 23) One comment recommended that the phrase “not offered for sale outside that establishment” be deleted from the definition of restaurant food because some restaurants market frozen meals from their restaurants.

(Response 23) We are retaining the phrase “not offered for sale outside such establishment” in the definition of restaurant-type food. This phrase comes from section 403(q)(5)(A)(ii) of the FD&C Act. FDA previously has interpreted this phrase (see 58 FR 2079 at 2146 (January 6, 1993)). The frozen meals described by the comment appear to be packaged foods. Most packaged foods are subject to the labeling requirements of § 101.9. The sale of such packaged, frozen food outside of a restaurant,

e.g.,

in a grocery store, will not affect whether the food in a restaurant is covered by this rule.

(Comment 24) One comment urged us to remove the term “restaurant-type food” from the rule and recognize that the sale of food to consumers for immediate consumption is a primary distinguishing factor of a restaurant. The comment contended that our definition of restaurant or similar retail food establishment is overly broad because it includes an establishment that sells not only restaurant food but also restaurant-type food. The comment maintained that we did not explain our rationale for including restaurant-type food in the proposed rule, especially when our existing regulation on restaurants refers only to restaurant food.

A few comments were concerned that because of the definition of restaurant-type food grocery stores would have to label prepared foods for immediate consumption as well as every loaf of bread, roll, cookie and deli item except cold cuts; these comments estimated that approximately 6,400 service deli, prepared foods, and bakery items would be included, which would be very costly. One comment contended that the increase in cost may limit the items that grocery stores would carry, which would limit sales growth. According to a few comments 95 percent of items in grocery stores have Nutrition Facts and the costs to cover the remaining 5 percent vastly outweighs benefits.

(Response 24) We agree that sale of food to consumers for immediate consumption is a common characteristic of restaurants but disagree that it follows that only “restaurant food” is relevant to this rulemaking. In the proposed rule, we explained that section 4205 of the ACA amended both sections 403(q)(5)(A)(i) and (ii) of the FDA&C Act. Under section 403(q)(5)(A)(ii) of the FD&C Act, except as provided in section 403(q)(5)(H)(ii)(III) of the FD&C Act (

i.e.,

the requirement for written nutrition information for food covered by this rule) the nutrition labeling requirements of section 403(q)(1), (2), (3), and (4) of the FD&C Act shall not apply to food which is processed and prepared primarily in a retail establishment, which is ready for human consumption, which is of the type described in section 403(q)(5)(A)(i), and which is offered for sale to consumers

but not for immediate human consumption

in such establishment and which is not offered for sale outside such establishment (emphasis added). To implement the phrase “except as provided in section 403(q)(5)(H)(ii)(III)” of the FD&C Act, some set of food described in section 403(q)(5)(A)(ii)—that is not for immediate consumption—is covered by this rule.

We acknowledge that the proposed definition of restaurant-type food includes some foods that are sold in grocery or convenience stores that are not generally offered for sale in restaurants, foods that are more like groceries, and we have amended that definition in the final rule. After considering all of the comments directed to the proposed definitions of “restaurant food” or “restaurant-type food,” in addition to the comments related to the scope of the rule more generally, given the relationship between these terms and the definition of restaurant or similar retail food establishment, we are convinced that this rule should cover only those foods described in sections 403(q)(5)(A)(i) and (ii) of the FD&C Act that are most like the food sold in restaurants and should not cover foods that are more commonly considered to be groceries. Therefore, we are deleting the proposed definition of “restaurant food” and establishing a revised definition of “restaurant-type food” that reflects the food most like the food offered for sale in restaurants. Under that new definition, restaurant-type food means food that is (1) usually eaten on the premises, while walking away, or soon after arriving at another location; and (2) either (i) served in restaurants or other establishments in which food is served for immediate human consumption or which is sold for sale or use in such establishments; or (ii) processed and prepared primarily in a retail establishment, ready for human consumption, of the type described in (i), and offered for sale to consumers but not for immediate human consumption in such establishment and which is not offered for sale outside such establishment. The first part of this definition focuses on the food most like the food offered for sale in restaurants, while the second part of this definition reflects the statutory context of sections 403(q)(5)(A)(i) and (ii) of the FD&C Act. The new definition includes food for immediate consumption at a sit-down or quick service restaurant; food purchased at a drive-through establishment; take-out and delivery pizza; hot pizza at grocery and convenience stores that is ready to eat; pizza slice from a movie theater; hot buffet food, hot soup at a soup bar, and food from a salad bar; foods ordered from a menu/menu board at a grocery store intended for individual consumption (

e.g.,

soups, sandwiches, and salads); and self-service foods and foods on display that are intended for individual consumption (

e.g.,

sandwiches, wraps, and paninis at a deli counter; salads plated by the consumer at a salad bar; cookies from a mall cookie counter; bagels, donuts, rolls offered for individual sale). Foods that are similar to grocery items that may be ready for immediate consumption but that consumers usually store for use at a later time or customarily further prepare would not be included within the meaning of “restaurant-type food.” Foods that we therefore would not consider to be within the meaning of “restaurant-type food” include foods to be eaten over several eating occasions or stored for later use (

e.g.,

loaves of bread, bags or boxes of dinner rolls, whole cakes, and bags or boxes of candy or cookies); foods sold by weight that are not self-serve and are not intended solely for individual consumption (

e.g.,

deli salads sold by unit of weight such as potato salad, chicken salad), either prepacked or packed upon consumer request; and foods that are usually further prepared before consuming (

e.g.,

deli meats and cheeses).

(Comment 25) One comment asked us to clarify that only food offered “for sale” in a restaurant or similar retail food establishment should be considered in determining whether an establishment is a covered establishment. The comment noted that the statute expressly limits the

application of food labeling to items that are “offered for sale,” and considered that the menu labeling regulations should adopt a similar limitation.

(Response 25) The rule only applies to food offered for sale.

D. Part of a Chain With 20 or More Locations

In the proposed rule (76 FR 19192 at 19195), we noted that we did not propose a definition of the statutory criterion “part of a chain with 20 or more locations” and that we were assuming the common meaning of the words in the phrase. However, we requested comment on whether the phrase should be defined in the final rule, and particularly on whether the terms “chain” and “location” should be defined in context of the various types of corporate or other business arrangements that may be relevant, including contracting arrangements.

In the following paragraphs, we discuss comments on the terms “chain” and “location.” After considering these comments, we are adding a definition of “locations” to clarify our interpretation of “part of a chain with 20 or more locations.”

(Comment 26) A few comments responded to our request for comment on the term “chain.” One comment recommended that we define “chain” as a covered establishment doing business under the same name as those that share the same name under the ownership, control, and operation of a single corporate entity. This comment considered that this is consistent with the commonly accepted dictionary definition of a chain as “a group of enterprises or institutions of the same kind or function under a single ownership, management, or control.” Another comment cited the following dictionary definition for “chain”: “A range of retail outlets which share a brand and central management, usually with standardized business methods”. This comment also cited the following dictionary definition for “restaurant chain”: “A set of restaurants, usually with the same name in many different locations either under shared corporate ownership or franchising agreements. Typically, the restaurants within a chain are built to a standard format and offer a standard menu.”

(Response 26) Section 4205 of the ACA covers restaurants or similar retail food establishments that are part of a chain with 20 or more locations doing business under the same name “regardless of the type of ownership of the locations.” Both definitions suggested by comments refer to management structure, corporate control, and/or ownership. Because the statute directs us to disregard the type of ownership of the locations when determining whether an establishment is “part of a chain with 20 or more locations doing business under the same name,” neither of these definitions for the word “chain” is appropriate.

According to the dictionary definitions, the word “chain” means, among other things, “a group of enterprises, establishments, institution, or constructions of the same kind or function linked together into a single system” (Ref. 15), a “series or group of things or people that are connected to each other in some way” (Ref. 15), and “a series of closely linked or connected things” (Ref. 16). In section 403(q)(5)(H)(i) of the FD&C Act, Congress provides the ways in which restaurants or similar retail food establishments must be connected to or linked to each other in order to be covered by the new law: They must be doing business under the same name and offering for sale substantially the same menu items, and there must be 20 or more locations of them. Therefore, we continue to use the common meaning of the word “chain” and do not consider an additional regulatory definition necessary for this broad term. The statute specifies the particular criteria for the set of chains that are relevant for this rulemaking, and we provide regulatory definitions for those criteria specifically.

(Comment 27) One comment recommended that we not rely solely on the terms “chain” and “location” because some restaurants and food establishments have locations at the same address, such as a mall. The comment asked us to either use the term “selling post” or to clarify that the location includes chains with restaurants in the same physical building. Another comment asked us to clarify that mobile facilities (such as food trucks) are covered. Some comments noted that transportation venues have menus that look like those in sandwich shops. Other comments noted that it is feasible for transportation venues to comply with the rule.

(Response 27) We disagree that we should add the term “selling post” to the definition to specify restaurants and similar retail food establishments that are part of the same chain and are located in the same shopping mall or otherwise in the same physical building. However, this comment demonstrates that there is a need to define the term “locations,” even assuming its common meaning. Unlike “chain,” where a definition is unnecessary given that we are establishing definitions for more specific, relevant criteria, we are convinced that establishing a regulatory definition of “locations” would provide clarity and facilitate a better understanding of regulatory expectations.

The dictionaries define “location” to mean, among other things, “a position or site occupied . . . a tract of land designated for a purpose” (Ref. 17); “an area or tract of land” (Ref. 18); “a place where something is or could be located; a site . . . a tract of land that has been surveyed and marked off” (Ref. 19). This evidences that the common meaning of the word “location” involves a specific or fixed position on land or portion of land. For clarity, we are defining “location” to mean “a fixed position or site.” Therefore, for the purposes of determining whether an establishment is part of a chain with “20 or more locations,” we would consider each of the establishments occupying separate fixed positions or sites within the same shopping mall or physical building as separate establishments. One result of this definition of “location” is to exclude food facilities that do not have a fixed position or site, such as trains and airplanes. Additionally, mobile food operations such as food trucks without a fixed position or site are not covered by the rule.

E. Doing Business Under the Same Name

Proposed § 101.11(a) would define “doing business under the same name” as sharing the same name, where “same name” would include names that are either exactly the same, or are slight variations of each other, for example, due to the region, location, or size (

e.g.,

“New York Ave. Burgers” and “Pennsylvania Ave. Burgers” or “ABC” and “ABC Express”). In the proposed rule (76 FR 19192 at 19199), we requested comment on whether the term should be understood to refer to the underlying name of ownership such as the name of the parent company, or the name of the entity conducting corporate business on behalf of the establishment,

e.g.,

the name of a contractor operating the establishment, regardless of the public name used by the individual establishment.

In the following paragraphs, we discuss comments on this proposed definition. After considering comments, we have revised the definition to clarify that the term “name” refers to either (a) the name of the establishment presented to the public or (b), if there is no name of the establishment presented to the public (

e.g.,

an establishment with the generic descriptor “concession stand”),

the name of the parent entity of the establishment.

(Comment 28) Several comments supported the proposed definition. One comment recommended that the definition be broadened to include those with the same underlying name of ownership (parent company or contractor). A few comments recommended that the definition not be based on the underlying name of ownership. Based on the language of the statute, the comments considered that “regardless of . . . ownership” means that the ownership is not determinative and, therefore, the term should refer to the name used when doing business with the public and not the parent company, franchise owner, or other ownership entity. One comment argued that the phrase “regardless of . . . ownership” means that the corporate structure should not be considered when determining coverage; instead, the determining factor should be whether the name of the restaurant is the same. Another comment maintained that to include the underlying name of ownership in the definition would stifle investment in smaller locally based restaurants,

i.e.,

it would place a cap on the number of restaurants an investor or entity could have before subjecting them to menu labeling.

One comment recommended that the definition not be based on the name of the parent company because the name of the parent company has no bearing on the similarity of menu offerings. The comment argued that to do so would ignore the plain language of the statute, which clearly meant the public name of the location. One comment asserted that our proposed definition would expand the definition beyond the statutory language and Congress' express intent by covering smaller restaurant chains that offer creative menus and, thus, thwart the purpose and intent behind thoughtfully designed restaurants.

(Response 28) We agree with comments that considered that the statutory phrase “regardless of the type of ownership of the locations” means that the type of ownership is not determinative. We also agree that “doing business under the same name” should, in general, refer to the name used when doing business with the public (

e.g.,

the branded name that appears on the establishment's signage) rather than the name of the person or legal entity that owns the establishment. However, we are aware that some establishments have no specific name presented to the public. For example, concession stands in entertainment venues or cafeterias in office buildings may simply have a sign with a general descriptor, such as “Hot Dogs” or “Concession Stand” or “Building 1 Café,” or they may have no sign at all. In instances where there is no specific name presented to the public, we find it reasonable to conclude that the name under which they are doing business is the name of the parent entity of the facility. Consequently, we have revised the definition of the term “doing business under the same name” in § 101.11(a) to add that the term “name” refers to the name of the facility presented to the public or, if there is no name of the facility presented to the public (

e.g.,

a facility with the generic descriptor “concession stand”), the name of the parent entity of the facility.

(Comment 29) One comment addressed the examples we included in the proposed definition of establishments doing business under the same name. As discussed in the proposed rule (76 FR 19192 at 19199), these examples include names that are slight variations on each other due, for example, to the region, location, or size. The comment asserted that it is inappropriate to imply that same name means slight variation. Another comment recommended that the rule apply to facilities in grocery stores with 20 or more locations even if the facilities' names vary from store to store.

(Response 29) We disagree that the examples we included in the proposed definition of establishments doing business under the same name are inappropriate. Establishments that are part of large chains have slight variations in the name,

e.g.,

to reflect a limited menu based on the space that the establishment occupies. For example, “XYZ” chain may have “XYZ” restaurant in a free-standing store and “XYZ Express” in an airline terminal, food court in a shopping mall, or grocery store. Even though the names are slight variations of each other, they are sufficiently similar that it is clear that the establishments are affiliated with one another. Generally, these establishments also have the same trade dress (

e.g.,

trade name, logo, graphics and other distinctive elements of a brand) as the other establishments in the chain.

(Comment 30) One comment recommended that we require that a chain remain covered if it initially is subject to the rule but the parent company changes the name of some locations to get below 20.

(Response 30) Individual restaurants and similar retail food establishments would be subject to the rule if they satisfy the criteria for a “covered establishment.” If a restaurant or similar retail food establishment satisfies all the criteria for a covered establishment, and subsequently changes its name, it must reconsider whether it continues to satisfy all the criteria for a covered establishment, including whether it “is part of a chain with 20 or more locations doing business under the same name.” We anticipate that the benefits to an establishment to continue to do business under the same name as other establishments in the chain will keep establishments from changing their names in order to avoid being covered by this rule.

F. Offering for Sale Substantially the Same Menu Items

Proposed § 101.11(a) would define “offering for sale substantially the same menu items” as offering for sale menu items that use the same general recipe and are prepared in substantially the same way with substantially the same food components, even if the name of the menu item varies (

e.g.

“Bay View Crab Cake” and “Ocean View Crab Cake”). Under the proposed definition, “menu items” would refer to food items that are listed on a menu or menu board or that are offered as self-service food or food on display. The proposed definition would also provide that restaurants and similar retail food establishments that are part of a chain can still be offering for sale substantially the same menu items if the availability of some menu items varies within the chain.

In the following paragraphs, we discuss comments on this proposed definition. After considering comments, we have revised the definition to:

• Add a qualitative description of the number of menu items that must be shared in order for the criterion of “offering for sale substantially the same menu items” to be met; and

• Add a statement that having the same name may indicate, but does not necessarily guarantee, that menu items are substantially the same.

(Comment 31) Several comments supported the definition. One comment asserted that the proposed rule was not clear on what “substantially” the same menu items means quantitatively and suggested that it could mean anywhere between 51 and 99 percent. Another comment asked us to clarify what constitutes “offering for sale menu items that use the same general recipe and are prepared with substantially the same food components even if the name varies.” This comment pointed out that some restaurants in a chain may have some unique items or may vary the recipes and therefore, it is not clear if the restaurant is “offering for sale substantially the same menu items.”

The comment gave as an example a kosher restaurant that uses the same name as non-kosher restaurants that are part of the same chain. The comment noted that due to the kosher restaurant's following of the kosher laws, the kosher restaurant may offer for sale some menu items that vary from the menu items offered for sale in a non-kosher restaurant in the chain. In addition, the comment noted that the kosher restaurant may offer for sale unique menu items, such as schwarma, that are not offered for sale in the non-kosher restaurants in the chain. This comment requested an exemption for franchise restaurants that offer specialty menu items or items altered to accommodate a specific dietary practice (

e.g.,

kosher).

One comment pointed out that menu items in chain restaurants and similar retail food establishments vary between States and within States to accommodate local tastes, even if the menu items have the same name. The comment cited chili as an example, stating that in Cincinnati it is common for chili to be made with cocoa and cinnamon thinned out with finely ground meat over spaghetti, whereas in Texas, chili is made with large chunks of meat, often with beans, served alone in a bowl.

One comment stated that some food service contractors provide clients with menus that may change daily, weekly, or monthly and with rotating cycle menus that can use up to several hundred recipes with cycle menus that vary from 3, 4, or 5 week cycles and from 5, 6, or 7 day service weeks. Due to the variability in menus in locations that rely on contract food services, the comment recommended that the definition of “offering for sale substantially the same menu item” be changed to “establishments in a chain that offer standard menus comprised of menu items that use the same general recipes and are prepared in substantially the same ways with substantially the same food components, even if the name of the menu item varies.”

(Response 31) We decline to name a proportion or percentage of menu items that must be shared between establishments. Restaurants and similar retail food establishments regularly offer new and reformulated menu items in their establishments. It would be burdensome and impractical for establishments and inspectors to continually evaluate all of the establishments in the chain to count the numbers of standard menu items in common in order to determine whether a given establishment is covered. In addition, some establishments that are part of a large chain may not offer for sale all of the standard menu items offered in other locations of that chain. For example, some chains have a handful of locations in airports or other venues notated by the term “Express” added to the name, that sell a subset of the foods that are carried by the larger establishments in the chain. Finally, as the comments point out, some restaurants that are part of large chains have some unique or regional items or may vary recipes in a unique way. These types of minor variations should not exclude establishments from the requirements of this rule.

Based on the comments and on the considerations discussed previously in this document, we are not finalizing a specific proportion or percentage of menu items that covered establishments within a chain must share. However, we understand from the comments that our definition should speak to the number of menu items that must be shared more clearly. Therefore, we are adding a qualitative, not quantitative, description of the number of menu items that must be shared in order for the criterion of “offering for sale substantially the same menu items” to be met. Given the statutory language, along with the practicalities of and variations within the industry, we are adding “offering for sale a significant proportion of menu items” to the definition of “offering for sale substantially the same menu items.” For example, if establishments only share one or two menu items, those establishments would not meet the criterion of “offering for sale substantially the same menu items.”

We recognize that some establishments in a chain may have some menu items with ingredients that vary based on regional taste or source. Some menu items may be designed or prepared to meet certain dietary practices (

e.g.,

Kosher or Halal) or contain a “secret ingredient.” This is why our definition of “offering for sale substantially the same menu items” includes the criteria “us[ing] the same general recipe, prepared in substantially the same way, with substantially the same food components.” By “the same general recipe,” we mean that the establishments share a recipe, even if one establishment subsequently tweaks that recipe due to regional tastes or dietary practices. By “prepared in substantially the same way,” we mean to include slight deviations from the recipe, because of, for example, food service worker variability. By “with substantially the same food components,” we mean to include situations where ingredients may vary based on local availability or sourcing, including those used to conform to certain dietary practices (

e.g.,

Kosher meat).

We also agree with comments that having the same name may indicate that the menu items are substantially the same, but it does not always do so. As comments pointed out, menu items that reflect regional differences may be so different that the name of the menu item sheds little light on whether the menu items use the same general recipe and are prepared in substantially the same way with substantially the same food components. For example, in some regions of the United States a menu item named “barbecue” may refer to a food prepared from pulled pork, whereas in other regions a menu item named “barbecue” may refer to a food prepared from beef ribs. Therefore, we have revised the definition to add a new sentence stating that having the same name may indicate, but does not necessarily guarantee, that menu items are substantially the same.

The definition for “substantially the same menu items” would also apply to establishments relying on food contractors. If such an arrangement caused menu rotations, the relevant question would still be whether those establishments are offering for sale substantially the same menu items, including whether they are selling a significant proportion of menu items that use the same general recipe and are prepared in substantially the same way with substantially the same food components, even if not necessarily at the same time. In other words, the focus is on whether the menu items are substantially the same, not on whether the menus or menu boards are substantially the same. We decline to accept the suggestion from the comment to revise the definition to include “establishments in a chain that offer standard menus comprised of menu items that . . .” because it reflects a misunderstanding that an establishment needs to have a menu, or a “standard menu” more specifically, to be covered by the new law.

(Comment 32) One comment maintained that convenience stores in a chain do not have identical business plans and the same food; the food varies per establishment and is not prepared to corporate policy as it is in restaurants.

(Response 32) As explained previously in this document, establishments can be “offering for sale substantially the same menu items” even if not all of their menu items are exactly the same. Depending on the extent to which the menu items vary, a convenience store may or may not meet the criterion of offering for sale

substantially the same menu items as defined in the rule.

(Comment 33) One comment described itself as a family-owned restaurant operator with 25 restaurants located entirely within a single State. Two of its restaurants also contain sushi operations, each under a different name and with entirely different menus than the larger establishment. The comment asked us to confirm that the rule would not apply to these sushi operations.

(Response 33) Based on the information in the comment, the two sushi operations do not appear to be covered by the rule because they are neither doing business under the same name (see section VI.E) nor offering for sale substantially the same menu items as 18 other establishments.

G. Authorized Official of a Restaurant or Similar Retail Food Establishment

Proposed § 101.11(a) would define “Authorized official of a restaurant or similar retail food establishment” as the owner, operator, agent in charge, or other person authorized by the owner, operator, or agent in charge to register the restaurant or similar retail food establishment, which is not otherwise subject to section 403(q)(5)(H) of the FD&C Act, with FDA for the purposes of § 101.11(d). (Section 101.11(d) pertains to voluntary registration to become subject to the requirements of section 403(q)(5)(H) of the FD&C Act.)

We received no comments on the proposed definition and are finalizing it without change.

H. Covered Establishment

As already noted in section VI.A, proposed § 101.11(a) would define “covered establishment” as a

restaurant or similar retail food establishment

that is a part of a chain with 20 or more

locations doing business under the same name

(regardless of the type of ownership,

e.g.,

individual franchises) and

offering for sale substantially the same menu items,

as well as a restaurant or similar retail food establishment that is registered to be covered under section 403(q)(5)(H)(ix) of the FD&C Act. (Emphasis added).

In the following paragraphs, we discuss general comments on this proposed definition. We are finalizing the definition of “covered establishment” without change, except to refer to § 101.11(d) instead of section 403(q)(5)(H)(ix) of the FD&C Act. However, as already discussed (see sections VI.B, VI.C, VI.D, VI.E, and VI.F), changes we are making to other terms (

i.e.,

adding a definition of “location,” revising the definition of “restaurant or similar retail food establishment,” revising the definition of “restaurant-type food,” revising the definition of “doing business under the same name,” and revising the definition of “offering for sale substantially the same menu items”) affect the overall set of covered establishments.

1. General Comments on the Definition of Covered Establishment

(Comment 34) One comment considered that our proposed definition would make it conceivable for the requirements to apply to a single, completely unique “restaurant concept” that is owned by a chain with 20 or more other restaurants. The comment described a “restaurant concept” as separate and distinct operations by virtue of the individual restaurant's menu offerings or recipes, name, decor, and other distinguishing characteristics such as different dining experiences with higher quality food and different menu items that may be unrecognizable to the average diner as being operated by the larger chain. This comment also considered that applying the menu labeling requirements to these individual “restaurant concepts” would not be consistent with the statute or intent of Congress. Another comment expressed concern that a person who operates more than 20 chain retail food establishments and wants to start a “new concept” would be required to provide nutrition information if this “new concept” is only in one location.

(Response 34) We disagree that we need to revise the definition of a covered establishment to prevent a misinterpretation that a single, completely unique “restaurant concept” that is owned by a chain with 20 or more other restaurants generally would be covered by the rule. An establishment that is “single” and a “completely unique restaurant concept” is unlikely to have “20 or more locations” and be “offering for sale substantially the same menu items” as 20 or more other restaurants. Thus, such an establishment is unlikely to satisfy the criteria in the proposed definition to be a “covered establishment” as it is currently written. Likewise, if a person operates more than 20 chain retail food establishments and starts a “new concept,” that “new concept” establishment would not be a covered establishment unless it is part of a chain with 20 or more locations doing business under the same name and offering for sale substantially the same menu items. We are retaining our definition, which, as we described in the proposed rule, is derived from sections 403(q)(5)(H)(i) and (xi)(I) of the FD&C Act (76 FR 19192 at 19195).

(Comment 35) One comment recommended that we revise the definition of covered establishment to use the following language from its State's regulation: “A food establishment that: (1) Is engaged in the business of preparing and selling food items for immediate human consumption on the premises or off the premises, . . . and (2) offers for sale substantially the same menu items, utilizing menus, menu boards or food item tags, in servings that are standardized for portion size and content, and (3) is one of a group of . . . food establishments . . . that (a) operates under common ownership or control, or (b) operates as franchised outlets of a parent business, or (c) does business under the same name.” The comment cited only those portions of its regulation relevant to the questions raised by the definition of covered establishment in our proposed rule, and used ellipses to indicate text that was in the State regulation but not being offered as part of the definition of “covered establishment” in this rule.

(Response 35) We disagree with this comment and are not revising the definition of “covered establishment” to incorporate its suggestions. Our definition of covered establishment is derived from the Federal statutory language. The only basis offered by the comment was that the suggestions are used in a State law; the comment did not state why these changes were necessary from a policy perspective or legally justified under the Federal law.

(Comment 36) One comment recommended that the rule apply to most restaurants, and not just those with more than 20 locations, possibly excluding only establishments with a very small seating capacity. The comment contended that consumers already know that fast food is “bad for you” and they need to know the nutrition information about the food in other restaurants.

(Response 36) This rule implements section 4205 of the ACA, which, in general, covers only restaurants and similar retail food establishments that are part of a chain with 20 or more locations. Section 4205 of the ACA allows other restaurants and similar retail food establishments to register with FDA to become subject to the Federal requirements, but it does not require them to do so.

(Comment 37) One comment asked us to clarify whether the rule would apply to foreign establishments of a particular chain that has 20 or more establishments in the United States, and also has an establishment located in a foreign location, such as Italy.

(Response 37) The rule applies to locations in the United States, including any State or Territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico. This geographic scope is consistent with the definitions of “State” and “Territory” in section 201(a) of the FD&C Act.

(Comment 38) A few comments asked us to clarify that contractors and managed food service operations would be covered if they offer for sale substantially the same menu items.

(Response 38) Whether any other specific contractor or managed food service would be subject to the rule would depend on whether it satisfied all criteria established within the definition of “covered establishment.” Thus, to be a covered establishment, an establishment operated by a contractor or managed food service must be a restaurant or similar retail food establishment that is a part of a chain with 20 or more locations doing business under the same name and offering for sale substantially the same menu items. We expect that some establishments operated by contractors and managed food services will satisfy all of these criteria.

2. Cooperatives

(Comment 39) Some comments addressed cooperatives and discussed multiple aspects related to the definition of “covered establishment,” including “part of a chain,” “doing business under the same name,” and “offering for sale substantially the same menu items.” One comment considered that cooperatives should not be exempt because the law expressly states “regardless of . . . ownership.” One comment considered that the type of ownership of grocery stores, such as a cooperative, is irrelevant to whether a store is part of a chain. This comment maintained that the law clearly requires chains operating under the same name to disclose calories, regardless of the type of ownership. This comment also maintained that grocery store cooperatives face a similar situation as that faced by independent franchise owners of chain restaurants.

Other comments generally expressed the view that cooperatives should not be covered by the rule. One comment asserted that establishments associated with the same wholesaler or cooperative should not be considered “part of a chain” regardless of whether they operate under the same “banner” or under a different “banner.” The comment considered that cooperatives are the opposite of chains because they are owned by individual members, operate independently, and are not bound by franchise agreements, whereas chains are centrally controlled with little say or choice by participants. The comment asked us to recognize that independent grocers are not part of a chain of 20, doing business under same name and selling the same items, even if we believe cooperatives are similar retail food establishments.

A few comments maintained that the definition for “doing business under the same name” does not apply to cooperatives because they are independent and exercise their independence more than franchised restaurants. According to one comment, independent retailers own, control, and operate their stores independently as customers of voluntary wholesalers and members of cooperatives. The comment explained that the food distribution system allows independent retailers to take advantage of economies of scale when procuring goods and services, as well as marketing and advertising, thus helping independent operators effectively compete with large national chain stores. The comment also explained that these entities are independently owned and operated businesses that often compete with other stores under the same banner name, and that menu items can have different general recipes and be prepared in substantially different ways with substantially different food components.

One comment asked us to recognize that members of cooperatives are not “doing business under the same name.” For example, the comment considered that “Fred's Thriftway” is not the same as “Bob's Thriftway.” The comment considered that “Thriftway” signals that these establishments are part of a cooperative but maintained that they are two different stores.

One comment contended that the term “offering for sale substantially the same menu items” may not apply to some foods, such as brownies or potato salad, made in grocery store cooperatives, although those foods may be offered for sale under the same name in those stores. According to the comment, “Bob's Thriftway” and “Mike's Thriftway” may both sell brownies made from the same general recipe, (

e.g.,

flour, sugar, eggs, chocolate and butter); however, because independent grocers compete with each other, each is likely to include a secret ingredient, and as a result, the brownies are not the same.

(Response 39) We agree with some comments that the type of ownership of an establishment is not relevant to whether it is covered. To be subject to the rule, a cooperative must satisfy all the criteria in the definition of “covered establishment.” In other words, to be subject to the rule a cooperative must be a restaurant or similar retail food establishment that sells restaurant-type food and is a part of a chain with 20 or more locations doing business under the same name (regardless of the type of ownership,

e.g.,

individual franchises) and offering for sale substantially the same menu items. As we explain in section VI.D., we are not defining the term “chain” in this rulemaking. In addition, for the reasons we provide in section VI.E., we continue to define doing business under the same name to include names that are slight variations of each other. Independent businesses that are cooperatives, even those that are similarly named, are not covered establishments if, for example, they are only connected insofar as they take advantage of economies of scale when procuring goods and services, or for marketing and advertising purposes, but are not “offering for sale substantially the same menu items.”

However, given the way cooperatives generally are structured, we do not expect that two cooperatives would be offering for sale substantially the same menu items. Unless a food such as a brownie offered for sale in Bob's Thriftway has the same general recipe, prepared in substantially the same way, with substantially the same food components as a brownie offered for sale in Mike's Thriftway, the two cooperatives' brownies would not be “substantially the same.” However, if Bob's Thriftway and Mike's Thriftway share a recipe such as a brownie recipe, and the only difference between the two brownie recipes is that Mike's Thriftway has added a “secret ingredient,” the brownies could be considered substantially the same menu item, depending on the importance of that ingredient. Note that even in this circumstance, Bob's Thriftway and Mike's Thriftway would not be “offering for sale substantially the same menu items” if the brownie is the only menu item that the two cooperatives share.

In addition, we note that a cooperative that is a restaurant or similar retail food establishment and does not satisfy all of the criteria to be a covered establishment, but voluntarily registers to be covered in accordance with § 101.11(d), would be subject to the rule.

I. Revisions to Several Provisions To Clarify the Applicability of the Rule to Those Restaurants and Similar Retail Food Establishments That Are Covered Establishments

This rule applies to restaurants and similar retail food establishments that satisfy the definition of “covered establishment” in this rule. Several provisions of the proposed rule that would apply to “covered establishments” used the term “restaurant or similar retail food establishment” rather than “covered establishment.” To make clear that those provisions only apply to those restaurants and similar retail food establishments that satisfy the definition of “covered establishment,” we are replacing the term “restaurant or similar retail food establishment” with “covered establishment” in those provisions. The affected provisions are:

• The definition of “custom order” (§ 101.11(a));

• The definition of “menu or menu board” (§ 101.11(a));

• The introductory text of § 101.11(b)(2)(ii) regarding nutrition information for a standard menu item that must be available in written form;

• The introductory paragraph of proposed § 101.11(c)(6) (which we are establishing in § 101.11(c)(3)) regarding information that must be provided to FDA substantiating nutrient information; and

• A subparagraph of proposed § 101.11(c)(6) regarding specific substantiation documentation (

i.e.,

proposed paragraph (c)(6)(ii)(D), which we are establishing as paragraph (c)(3)(ii)(D)).

We note these changes in our discussion of each of these specific provisions.

VII. Comments and FDA Response on the Proposed Definition of Menu or Menu Board (Proposed § 101.11(a))

Proposed § 101.11(a) would define “menu or menu board” as the primary writing of the restaurant or similar retail food establishment from which a customer makes an order selection, including, but not limited to, breakfast, lunch, and dinner menus; dessert menus; beverage menus; children's menus; other specialty menus; electronic menus; and menus on the Internet. The proposed definition would also provide that menus may be in different forms,

e.g.,

booklets, pamphlets, or single sheets of paper and that menu boards include those inside a restaurant or similar retail food establishment as well as drive-through menu boards at restaurants or similar retail food establishments.

In the proposed rule, we stated that given the importance for all consumers to have access to nutrition information when making order selections, “primary writing” should be interpreted from a consumer's vantage point (76 FR 19192 at 19202). For example, while a printed menu may be the “primary writing” of a restaurant used by a customer ordering food while dining inside the restaurant itself, a menu mailed as a flyer to another customer's home could be the “primary writing” of the restaurant used by that customer ordering take-out or delivery from the same restaurant. Both the printed menu and the menu flyer would meet the definition of “menu” or “menu board” under proposed § 101.11(a).

In the following paragraphs, we discuss comments on this proposed definition. We have revised the definition by replacing the term “restaurant or similar retail food establishment” with “covered establishment” in three locations in the definitions for clarity (see explanation in section VI.I). We are also including factors used to determine whether a writing is or is part of the primary writing from which a consumer makes an order selection.

(Comment 40) Many comments supported the proposed definition and agreed that “primary writing” should be interpreted from the perspective of consumers, so that each writing of the establishment that is the primary writing used by consumers in making order selections would be considered a menu or menu board. Several comments asserted that consumers need to see calorie information when making order selections in order for the information to be useful to them. One comment noted that Congress did not intend for covered establishments to only provide calorie declarations on a single medium in each establishment, as evidenced by the fact that section 4205 of the ACA requires calorie declarations on drive-through menu boards and menus and menu boards located inside establishments. Another comment suggested that we emphasize that any list or display of a standard menu item that is primary to the consumer placing an order would constitute a menu or menu board.

One comment considered that a single store that has multiple menus or menu boards should be able to select the menu on which the calories must be disclosed. For example, a single store might have more than one menu board—with one such board being handwritten and highlighting specific special options. As long as every food offered for sale in the establishment is listed on one menu board and that menu board includes the necessary information, the comment considered that requiring calories on that one menu board should be sufficient. Alternatively, the comment suggested that the calorie declaration be required on the “menu board of prominence,” which the comment considered to be the menu board from which the order is placed.

Another comment similarly asserted that covered establishments must post the required information on the menu used most often rather than on all menus. Alternatively, the comment suggested that we provide an exemption for menus not commonly used by customers. In support of its suggestion, the comment pointed out that the statute uses the singular term “writing” and not a plural term. The comment stated that 90 percent of pizza customers order over the phone or the Internet or may order from memory. The comment asserted that to require nutrient information on every menu, menu board, Internet menu, or other writing is expensive, time consuming, and burdensome. The comment stated that it already uses in-store brochures to provide nutrition information to the small percentage of in-store customers. Although each franchisee in the applicable chain is required to carry certain menu items, the comment considered that each franchisee has the latitude to add items to the menu. Because the franchisee can add menu items to its menu, the comment asserted that it would be costly to a franchisee to change menu boards, because the franchisee will be required to order new menu boards and request calorie information for the new menu items.

One comment referred to an “industry proposal” for posting calories only on menus and menu boards that have the highest percentage of sales for that particular establishment,

e.g.,

Web sites used for Internet ordering and paper menus for phone ordering. This comment was opposed to any such proposal. The comment asserted that this approach would be an unfair business advantage for certain restaurants because it would allow some restaurants to provide calorie declarations on less expensive menus such as paper take-out menus or Internet Web sites while others would have to provide calorie declarations for more expensive in-restaurant menus and menu boards. The comment also expressed concern that any requirement for a covered establishment to declare calories on only the menus that listed substantially all menu items would exclude children's menus and dessert menus.

(Response 40) We agree with the comments in support of the proposed definition. We disagree that the required information should only be posted on the menu or menu board most often used by consumers in a covered establishment, the “menu board of prominence,” or only on the menus and menu boards that have the highest percentage of sales for a particular covered establishment. The critical factor is whether written material is or is part of the primary writing of a covered establishment from which a customer makes an order selection. It is not a matter of physical prominence of a menu, or the proportion of customers who order from a menu. Some consumers may want to select from a subset of standard menu items sold in the covered establishment. For example, if a consumer wanted to order only a dessert, he or she may ask for a dessert menu. As raised by one comment, if calorie information is listed only on the dinner menu, the consumer would not have access to the calorie information for the desserts if he or she is ordering from the dessert menu. As we stated in the proposed rule, given the importance for all consumers to have access to nutrition information when making order selections, we believe that the term “primary writing” should be interpreted from a consumer's vantage point (76 FR 19192 at 19202).

In addition, in the proposed rule, we tentatively concluded that a “menu” or “menu board” includes any writing of the covered establishment that is the primary writing from which a consumer makes an order selection (76 FR 19192 at 19201). We affirm this conclusion. The “primary writing” of an establishment can include more than one form of written material, such as a paper menu, a delivery menu, and a menu board; the critical factor is whether the written material is or is part of the primary writing of a covered establishment from which a customer makes an order selection. Further, we clarify that determining whether a writing is or is part of the primary writing from which a consumer makes an order selection depends on a number of factors, including whether the writing, such as a paper menu, delivery menu, or sign, lists the name of a standard menu item (or an image depicting the standard menu item) and the price of the standard menu item, and whether the writing can be used by a consumer to make an order selection at the time the consumer is viewing the writing (

e.g.,

the writing is posted at the cash register in a covered establishment, or the writing lists the phone number or email address of a covered establishment for purposes of placing an order).

Accordingly, a writing of a covered establishment that contains the name (or image) and price of a standard menu item, and that can be used by a consumer to make an order selection from the establishment at the time the consumer is viewing the writing would be a menu or menu board regardless of whether, for example, the writing is not the menu used most often by consumers. Another writing, such as a poster on a storefront, a banner or billboard located along a road or highway, or a tray-liner or table-tent at a quick-service restaurant, could be considered a “secondary” writing within this context and would not meet the definition of a “menu or menu board,” provided that such writing does not contain the name (or image) and price of a standard menu item, and cannot be used by a consumer to make an order selection at the time the consumer is viewing the writing.

We interpret the comment asserting that section 403(q)(5)(H)(xi) of the FD&C Act uses the singular term “writing” in defining the term “menu or menu board” as raising the question of what Congress intended “primary writing” to mean within the context of section 403(q)(5)(H)(xi) of the FD&C Act. In construing section 403(q)(5)(H)(xi) of the FD&C Act, FDA is confronted with two questions. First, has Congress directly spoken to the precise question presented (Chevron step one)? (

Chevron, U.S.A., Inc.

v.

NRDC, Inc.,

467 U.S. 837, 842 (1984).) If the “intent of Congress is clear,” an Agency “must give effect to the unambiguously expressed intent of Congress.” (

Id.

at 843.) However, if “Congress has not directly addressed the precise question at issue,” and the statute is “silent or ambiguous with respect to the specific issue,” then our interpretation of the term “primary writing” will be upheld as long as it is based on a “permissible construction of the statute (Chevron step two). (

Chevron,

467 U.S. at 842-43;

FDA

v.

Brown & Williamson Tobacco Corp,

529 U.S. 120, 132 (2000).) To find no ambiguity, Congress must have clearly manifested its intention with respect to the particular issue. (See

e.g., Young

v.

Community Nutrition Institute,

476 U.S. 974, 980 (1986).)

We have determined that, in enacting section 403(q)(5)(H)(xi) of the FD&C Act, Congress did not speak directly and precisely to the meaning of “primary writing” within the definition of “menu or menu board.” In conducting the Chevron step one analysis, we began with the language of section 403(q)(5)(H)(xi) of the FD&C Act. (See

e.g., Touche Ross & Co.

v.

Redington,

442 U.S. 560, 568 (“[A]s with any case involving the interpretation of a statute, our analysis must begin with the language of the statute itself.”).) The term “primary writing” is not defined in section 403(q)(5)(H) of the FD&C Act or elsewhere in the FD&C Act. In general, a term that is undefined in a statute carries its ordinary meaning. (See

e.g., Perrin

v.

United States,

444 U.S. 37, 42 (1979) (“A fundamental canon of statutory construction is that, unless otherwise defined, words will be interpreted as taking their ordinary contemporary, common meaning.”).) One common definition of the term “writing” is “something written, especially (a) meaningful letters or characters that constitute readable matter . . . (b) a written work, especially a literary composition” (Ref. 20). Similarly, another common definition of the term “writing” is “something written: As (a) letters or characters that serve as visible signs of ideas, words, or symbols; (b) a letter, note, or notice used to communicate or record; (c) a written composition.” (Ref. 21; see also Ref. 22).

One common definition of the term “primary” is “first or highest in rank or importance; principal” (Ref. 23; see also Refs. 24 and 25). Another common definition of the term “primary” is “functioning or transmitting without intermediary: Direct” (Ref. 25; see also Ref. 24).

Where, as here, the statutory language on its face does not clearly establish Congressional intent, it is appropriate to also consider other traditional tools of statutory construction, including other language in the section, the language, design, and purpose of the statute as whole, and legislative history. (See

e.g., Pharmaceutical Research & Manufacturers of America

v.

Thompson,

251 F.3d 219, 224 (D.C. Cir. 2001);

Davis

v.

Michigan Department of Treasury,

489 U.S. 803, 809 (1989);

Martini

v.

Federal National Mortgage Association,

178 F.3d 1336, 1345 (D.C. Cir. 1999).) The other language in section 403(q)(5)(H)(xi) of the FD&C Act indicates that the writing at issue is writing of the establishment “from which a consumer makes an order selection.” Further, other provisions within section 403(q)(5)(H) of the FD&C Act indicate that requirements apply to more than one form of writing within a covered establishment. (See sections 403(q)(5)(H)(ii)(I) and (II) of the FD&C Act.) In addition, a general purpose of section 4205 of the ACA is to make calorie and other nutrition information available to consumers in a direct and

accessible manner to enable consumers to make informed and healthful dietary choices. Lastly, the legislative history does not suggest that Congress intended to limit the term to only one writing of the establishment.

Having determined that the meaning of “primary writing” in section 403(q)(5)(H)(xi) of the FD&C Act is ambiguous, we have determined that the final rule's interpretation of “primary writing” is a permissible construction of the s

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