80_FR_39807 80 FR 39675 - Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Compliance Date

80 FR 39675 - Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Compliance Date

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 132 (July 10, 2015)

Page Range39675-39676
FR Document2015-16865

The Food and Drug Administration (FDA or we) is extending the compliance date for the final rule requiring disclosure of certain nutrition information for standard menu items in certain restaurants and retail food establishments. The final rule appeared in the Federal Register of December 1, 2014. We are taking this action in response to requests for an extension and for further clarification of the rule's requirements.

Federal Register, Volume 80 Issue 132 (Friday, July 10, 2015) 
[Federal Register Volume 80, Number 132 (Friday, July 10, 2015)]
[Rules and Regulations]
[Pages 39675-39676]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-16865]


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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; Extension of 
Compliance Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; extension of compliance date.

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

SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
compliance date for the final rule requiring disclosure of certain 
nutrition information for standard menu items in certain restaurants 
and retail food establishments. The final rule appeared in the Federal 
Register of December 1, 2014. We are taking this action in response to 
requests for an extension and for further clarification of the rule's 
requirements.

DATES: 
    Effective date: This final rule is effective December 1, 2015.
    Compliance date: Covered establishments must comply with the rule 
published December 1, 2014 (79 FR 71156) by December 1, 2016.

FOR FURTHER INFORMATION CONTACT: Ashley Rulffes, 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: 
ashley.rulffes@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 1, 2014 (79 FR 71156), we 
published a final rule requiring disclosure of certain nutrition 
information for standard menu items in certain restaurants and retail 
food establishments. The final rule implements provisions of section 
403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
343(q)(5)(H)) and:
     Defines terms, including terms that describe criteria for 
determining whether an establishment is subject to the rule;
     establishes which foods are subject to the nutrition 
labeling requirements and which foods are not subject to these 
requirements;
     requires that calories for standard menu items be declared 
on menus and menu boards that list such foods for sale;
     requires that calories for standard menu items that are 
self-service or on display be declared on signs adjacent to such foods;
     requires that written nutrition information for standard 
menu items be available to consumers who ask to see it;
     requires, 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;
     requires, on menus and menu boards, a statement regarding 
the availability of the written nutrition information (statement of 
availability);
     establishes requirements for determination of nutrient 
content of standard menu items;
     establishes 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
     establishes 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.
    In the preamble to the final rule (79 FR 71156 at 71239 through 
71241), we stated that the rule would be effective on December 1, 2015, 
and also provided a compliance date of December 1, 2015, for covered 
establishments. The final rule (at 21 CFR 101.11(a)) defines ``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 voluntarily registered to be covered under 21 CFR 
101.11(d).

II. Extending the Compliance Date

    Since we published the final rule in the Federal Register, we have 
received numerous requests asking us to further

[[Page 39676]]

interpret portions of the final rule or to respond to questions asking 
whether specific practices would be acceptable for purposes of 
complying with the rule. We issued a document in the Federal Register 
(80 FR 13225, March 13, 2015) announcing the availability of a ``Small 
Entity Compliance Guide'' for the rule, and are considering what 
additional guidance might be helpful.
    Since February 2015, we have received four requests asking us to 
extend the compliance date of the final rule based on concerns that 
covered establishments do not have adequate time to fully implement the 
requirements of the rule by the compliance date. These requests were 
submitted by a large retailer and trade and other associations, and 
they provide information regarding steps involved in implementation of 
the requirements. More specifically, the requests describe steps 
involved in developing software, information systems, and other 
technologies for providing nutrition information in ways that better 
correspond to how foods are offered for sale in covered establishments 
and allow for more efficient and product-specific nutrition labeling. 
In addition, the requests describe steps involved in training staff, 
implementing standard operating procedures, and developing and 
installing updated and consistent menu boards across all locations 
within a chain. Most requests sought to extend the compliance date by 1 
year.
    In light of these requests, we have decided to extend the 
compliance date for the final rule to December 1, 2016. The final rule 
requirements are intended to ensure that consumers are provided 
accurate, clear, and consistent nutrition information for foods sold in 
covered establishments in a direct and accessible manner to enable 
consumers to make informed and healthful dietary choices. Therefore, 
allowing adequate time for covered establishments to fully implement 
the final rule's requirements, as described in the requests, helps 
accomplish the primary objective of the final rule and is in the public 
interest.

III. Economic Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). FDA has developed a regulatory impact analysis that presents 
the benefits and costs of this final rule (Ref. 1). The Agency believes 
that this final rule is not a significant regulatory action under 
Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because the final rule changes the compliance date 
from December 1, 2015, to December 1, 2016, the Agency certifies that 
the final rule will not have a significant economic impact on a 
substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $144 million, using the most current (2014) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
final rule to result in any 1-year expenditure that would meet or 
exceed this amount.

IV. Paperwork Reduction Act

    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

V. Environmental Impact

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

VI. Reference

    The following reference has been placed on display in the Division 
of Dockets Management (see ADDRESSES) and may be seen by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday, and is 
available electronically at http://www.regulations.gov. (FDA has 
verified the Web site address in this reference section, but we are not 
responsible for any subsequent changes to the Web site after this 
document publishes in the Federal Register.)

    1. FDA, ``Food Labeling; Nutrition Labeling of Standard Menu 
Items in Restaurants and Similar Retail Food Establishments; 
Extension of Compliance Date,'' 2015. Available at: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/.

    Dated: July 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-16865 Filed 7-9-15; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 132 / Friday, July 10, 2015 / Rules and Regulations 39675 safety data, go to Done in Washington, DC, this 6th day of • Defines terms, including terms that productdata.aphis.usda.gov. July 2015. describe criteria for determining * * * * * Kevin Shea, whether an establishment is subject to Administrator, Animal and Plant Health the rule; ■ 3. Section 112.5 is amended as Inspection Service. • establishes which foods are subject follows: [FR Doc. 2015–16898 Filed 7–9–15; 8:45 am] to the nutrition labeling requirements ■ a. In the introductory text, by BILLING CODE 3410–34–P and which foods are not subject to these removing the words ‘‘paragraph (c) of requirements; this section and under the master label • requires that calories for standard system provided in paragraph (d)’’ and DEPARTMENT OF HEALTH AND menu items be declared on menus and adding the words ‘‘paragraph (d) of this HUMAN SERVICES menu boards that list such foods for section and under the master label sale; system provided in paragraph (e)’’ in Food and Drug Administration • requires that calories for standard their place. menu items that are self-service or on 21 CFR Parts 11 and 101 display be declared on signs adjacent to ■ b. In paragraph (a), by removing the such foods; words ‘‘(http://www.aphis.usda.gov/ [Docket No. FDA–2011–F–0172] • requires that written nutrition animal_health/vet_biologics/vb_ information for standard menu items be RIN 0910–AG57 forms.shtml)’’ and adding the words available to consumers who ask to see ‘‘(productdata.aphis.usda.gov)’’ in their Food Labeling; Nutrition Labeling of it; place. Standard Menu Items in Restaurants • requires, on menus and menu ■ c. By redesignating paragraphs (b) and Similar Retail Food boards, a succinct statement concerning through (g) as paragraphs (c) through Establishments; Extension of suggested daily caloric intake (succinct (h). Compliance Date statement), designed to help the public ■ d. By adding a new paragraph (b). understand the significance of the AGENCY: Food and Drug Administration, calorie declarations; ■ e. In newly redesignated paragraph HHS. • requires, on menus and menu (d)(1), by removing the citation ACTION:Final rule; extension of boards, a statement regarding the ‘‘§ 112.5(d)’’ and adding the words compliance date. availability of the written nutrition ‘‘paragraph (e) of this section’’ in its information (statement of availability); SUMMARY: The Food and Drug place. Administration (FDA or we) is • establishes requirements for ■ f. In newly redesignated paragraph extending the compliance date for the determination of nutrient content of (e)(1)(ii), by removing the citation final rule requiring disclosure of certain standard menu items; ‘‘§ 112.5(d)(1)(iii)’’ and adding the • establishes requirements for nutrition information for standard menu words ‘‘paragraph (e)(1)(iii) of this substantiation of nutrient content items in certain restaurants and retail section’’ in its place. determined for standard menu items, food establishments. The final rule including requirements for records that ■ g. In newly redesignated paragraph appeared in the Federal Register of a covered establishment must make (e)(1)(iii), by removing the citation December 1, 2014. We are taking this available to FDA within a reasonable ‘‘§ 112.5(d)(1)(i)’’ and adding the words action in response to requests for an period of time upon request; and ‘‘paragraph (e)(1)(i) of this section’’ in extension and for further clarification of • establishes terms and conditions its place. the rule’s requirements. under which restaurants and similar ■ h. In newly redesignated paragraph DATES: retail food establishments not otherwise (e)(1)(iv), by removing the citation Effective date: This final rule is subject to the rule could elect to be ‘‘§ 112.5(d)(1)(ii)’’ and adding the words effective December 1, 2015. subject to the requirements by ‘‘paragraph (e)(1)(ii) of this section’’ in Compliance date: Covered registering with FDA. its place. establishments must comply with the In the preamble to the final rule (79 rule published December 1, 2014 (79 FR FR 71156 at 71239 through 71241), we ■ i. In newly redesignated paragraph (h), 71156) by December 1, 2016. by removing the citation ‘‘§ 112.5(c)’’ stated that the rule would be effective FOR FURTHER INFORMATION CONTACT: on December 1, 2015, and also provided and adding the words ‘‘paragraph (d) of Ashley Rulffes, Center for Food Safety a compliance date of December 1, 2015, this section’’ in its place. and Applied Nutrition (HFS–820), Food for covered establishments. The final The addition reads as follows: and Drug Administration, 5100 Paint rule (at 21 CFR 101.11(a)) defines Branch Pkwy., College Park, MD 20740, ‘‘covered establishment’’ as a restaurant § 112.5 Review and approval of labeling. 240–402–2371, email: ashley.rulffes@ or similar retail food establishment that * * * * * fda.hhs.gov. is a part of a chain with 20 or more (b) A data summary, available on the SUPPLEMENTARY INFORMATION: locations doing business under the same Internet at productdata.aphis.usda.gov, name (regardless of the type of shall be used with each submission of I. Background ownership, e.g., individual franchises) efficacy and safety data in support of a In the Federal Register of December 1, and offering for sale substantially the label claim. Manufacturers will submit 2014 (79 FR 71156), we published a same menu items, as well as a restaurant the efficacy and safety data information final rule requiring disclosure of certain or similar retail food establishment that mstockstill on DSK4VPTVN1PROD with RULES with either the efficacy and safety nutrition information for standard menu is voluntarily registered to be covered studies or at the time of label items in certain restaurants and retail under 21 CFR 101.11(d). submission. This information will be food establishments. The final rule posted at productdata.aphis.usda.gov to implements provisions of section II. Extending the Compliance Date allow public disclosure of product 403(q)(5)(H) of the Federal Food, Drug, Since we published the final rule in performance. and Cosmetic Act (21 U.S.C. the Federal Register, we have received * * * * * 343(q)(5)(H)) and: numerous requests asking us to further VerDate Sep<11>2014 16:28 Jul 09, 2015 Jkt 235001 PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 E:\FR\FM\10JYR1.SGM 10JYR1

39676 Federal Register / Vol. 80, No. 132 / Friday, July 10, 2015 / Rules and Regulations interpret portions of the final rule or to and safety, and other advantages; 1. FDA, ‘‘Food Labeling; Nutrition Labeling respond to questions asking whether distributive impacts; and equity). FDA of Standard Menu Items in Restaurants and specific practices would be acceptable has developed a regulatory impact Similar Retail Food Establishments; for purposes of complying with the rule. analysis that presents the benefits and Extension of Compliance Date,’’ 2015. Available at: http://www.fda.gov/AboutFDA/ We issued a document in the Federal costs of this final rule (Ref. 1). The ReportsManualsForms/Reports/ Register (80 FR 13225, March 13, 2015) Agency believes that this final rule is EconomicAnalyses/. announcing the availability of a ‘‘Small not a significant regulatory action under Entity Compliance Guide’’ for the rule, Executive Order 12866. Dated: July 6, 2015. and are considering what additional The Regulatory Flexibility Act Leslie Kux, guidance might be helpful. requires Agencies to analyze regulatory Associate Commissioner for Policy. Since February 2015, we have options that would minimize any [FR Doc. 2015–16865 Filed 7–9–15; 8:45 am] received four requests asking us to significant impact of a rule on small BILLING CODE 4164–01–P extend the compliance date of the final entities. Because the final rule changes rule based on concerns that covered the compliance date from December 1, establishments do not have adequate 2015, to December 1, 2016, the Agency time to fully implement the certifies that the final rule will not have DEPARTMENT OF THE TREASURY requirements of the rule by the a significant economic impact on a compliance date. These requests were substantial number of small entities. Office of Foreign Assets Control submitted by a large retailer and trade Section 202(a) of the Unfunded and other associations, and they provide Mandates Reform Act of 1995 requires 31 CFR Part 591 information regarding steps involved in that Agencies prepare a written implementation of the requirements. statement, which includes an Venezuela Sanctions Regulations More specifically, the requests describe assessment of anticipated costs and AGENCY: Office of Foreign Assets steps involved in developing software, benefits, before proposing ‘‘any rule that Control, Treasury. information systems, and other includes any Federal mandate that may technologies for providing nutrition result in the expenditure by State, local, ACTION: Final rule. information in ways that better and tribal governments, in the aggregate, correspond to how foods are offered for SUMMARY: The Department of the or by the private sector, of $100,000,000 Treasury’s Office of Foreign Assets sale in covered establishments and or more (adjusted annually for inflation) allow for more efficient and product- Control (OFAC) is issuing regulations to in any one year.’’ The current threshold implement the Venezuela Defense of specific nutrition labeling. In addition, after adjustment for inflation is $144 the requests describe steps involved in Human Rights and Civil Society Act of million, using the most current (2014) 2014 (Pub. L. 113–278) and Executive training staff, implementing standard Implicit Price Deflator for the Gross operating procedures, and developing Order 13692 of March 8, 2015 Domestic Product. FDA does not expect (‘‘Blocking Property and Suspending and installing updated and consistent this final rule to result in any 1-year menu boards across all locations within Entry of Certain Persons Contributing to expenditure that would meet or exceed the Situation in Venezuela’’). OFAC a chain. Most requests sought to extend this amount. the compliance date by 1 year. intends to supplement this part 591 In light of these requests, we have IV. Paperwork Reduction Act with a more comprehensive set of decided to extend the compliance date This final rule contains no collection regulations, which may include for the final rule to December 1, 2016. of information. Therefore, clearance by additional interpretive and definitional The final rule requirements are intended the Office of Management and Budget guidance and additional general to ensure that consumers are provided under the Paperwork Reduction Act of licenses and statements of licensing accurate, clear, and consistent nutrition 1995 is not required. policy. information for foods sold in covered DATES: Effective: July 10, 2015. establishments in a direct and accessible V. Environmental Impact FOR FURTHER INFORMATION CONTACT: manner to enable consumers to make We have determined under 21 CFR informed and healthful dietary choices. 25.30(k) that this action is of a type that Assistant Director for Licensing, tel.: Therefore, allowing adequate time for does not individually or cumulatively 202/622–2480, Assistant Director for covered establishments to fully have a significant effect on the human Policy, tel.: 202/622–6746, Assistant implement the final rule’s requirements, environment. Therefore, neither an Director for Regulatory Affairs, tel.: 202/ as described in the requests, helps environmental assessment nor an 622–4855, Assistant Director for accomplish the primary objective of the environmental impact statement is Sanctions Compliance & Evaluation, final rule and is in the public interest. required. tel.: 202/622–2490, OFAC, or Chief Counsel (Foreign Assets Control), tel.: III. Economic Analysis of Impacts VI. Reference 202/622–2410, Office of the General FDA has examined the impacts of the The following reference has been Counsel, Department of the Treasury final rule under Executive Order 12866, placed on display in the Division of (not toll free numbers). Executive Order 13563, the Regulatory Dockets Management (see ADDRESSES) SUPPLEMENTARY INFORMATION: Flexibility Act (5 U.S.C. 601–612), and and may be seen by interested persons Electronic and Facsimile Availability the Unfunded Mandates Reform Act of between 9 a.m. and 4 p.m., Monday 1995 (Pub. L. 104–4). Executive Orders through Friday, and is available This document and additional mstockstill on DSK4VPTVN1PROD with RULES 12866 and 13563 direct Agencies to electronically at http:// information concerning OFAC are assess all costs and benefits of available www.regulations.gov. (FDA has verified available from OFAC’s Web site regulatory alternatives and, when the Web site address in this reference (www.treasury.gov/ofac). Certain general regulation is necessary, to select section, but we are not responsible for information pertaining to OFAC’s regulatory approaches that maximize any subsequent changes to the Web site sanctions programs also is available via net benefits (including potential after this document publishes in the facsimile through a 24-hour fax-on- economic, environmental, public health Federal Register.) demand service, tel.: 202/622–0077. VerDate Sep<11>2014 16:28 Jul 09, 2015 Jkt 235001 PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 E:\FR\FM\10JYR1.SGM 10JYR1


Document Created: 2018-02-23 09:15:23
Document Modified: 2018-02-23 09:15:23
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule; extension of compliance date.
DatesEffective date: This final rule is effective December 1, 2015.
ContactAshley Rulffes, 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: [email protected]
FR Citation80 FR 39675 
RIN Number0910-AG57
CFR Citation21 CFR 101
21 CFR 11
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