
[Federal Register Volume 81, Number 251 (Friday, December 30, 2016)]
[Rules and Regulations]
[Pages 96364-96366]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31597]


=======================================================================
-----------------------------------------------------------------------

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, and on May 5, 2016, we stated in the 
Federal Register that the enforcement of the final rule would begin on 
May 5, 2017. We are taking this action to clarify and confirm that the 
compliance date for the final rule is May 5, 2017.

DATES: Effective date: This final rule is effective December 30, 2016. 
Compliance date: Covered establishments must comply with the rule 
published December 1, 2014 (79 FR 71156) by May 5, 2017.

FOR FURTHER INFORMATION CONTACT: Ashley Rulffes, Center for Food Safety 
and Applied Nutrition (HFS-820), Food and Drug Administration, 5001 
Campus Dr., 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

[[Page 96365]]

items in certain restaurants and retail food establishments. The final 
rule, which is now codified at Sec.  101.11 (21 CFR 101.11), 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 Sec.  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 Sec.  
101.11(d).

II. Extending the Compliance Date

    In the Federal Register of July 10, 2015 (80 FR 39675), in response 
to requests from affected entities, we announced our decision 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. We stated in 
that extension that allowing adequate time for covered establishments 
to fully implement the final rule's requirements, as described in the 
requests, would help accomplish the primary objective of the final rule 
and is in the public interest.
    On December 18, 2015, the President signed the Consolidated 
Appropriations Act, 2016 (Pub. L. 114-113). Section 747 of the 
Consolidated Appropriations Act states that none of the funds made 
available under the Consolidated Appropriations Act may be used to 
implement, administer, or enforce the final rule entitled ``Food 
Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and 
Similar Retail Food Establishments'' until 1 year after the date we 
publish a Level 1 guidance with respect to nutrition labeling of 
standard menu items in restaurants and similar retail food 
establishments.
    In the Federal Register of May 5, 2016 (81 FR 27067), we announced 
the availability of the Level 1 guidance document and stated that 
enforcement of the final rule published December 1, 2014, would 
commence on May 5, 2017 (81 FR 27067 at 27068). While FDA made clear 
that we would not begin enforcing menu labeling requirements prior to 
May 5, 2017, we did not at that time formally make a change to the 
compliance date through rulemaking.
    Therefore, through this final rule, we are clarifying and 
confirming that the compliance date for the final rule entitled ``Food 
Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and 
Similar Retail Food Establishments,'' codified at Sec.  101.11, is May 
5, 2017.

III. Economic Analysis of Impacts

    We have 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 us to assess all costs 
and benefits of available regulatory alternatives and, when regulation 
is necessary, to select regulatory approaches that maximize net 
benefits (including potential economic, environmental, public health 
and safety, and other advantages; distributive impacts; and equity). We 
have developed a comprehensive Economic Analysis of Impacts that 
assesses the impacts of the final rule. We believe that this final rule 
is not a significant regulatory action as defined by 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 this rule provides more flexibility by 
further extending the compliance date for the ``Food Labeling: 
Nutrition Labeling of Standard Menu Items in Restaurants and Similar 
Retail Food Establishments'' final rule (79 FR 71156) (menu labeling 
final rule), we certify that the final rule will not have a significant 
economic impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before issuing ``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 $146 
million, using the most current (2015) Implicit Price Deflator for the 
Gross Domestic Product. This final rule would not result in an 
expenditure in any year that meets or exceeds this amount.
    This rule extends the compliance date of the menu labeling final 
rule by approximately 5 months: From December 1, 2016, to May 5, 2017. 
The estimated costs and benefits accrued in any given year that the 
menu labeling rule is in effect, relative to the first year of 
compliance, does not change; however, because the compliance date is 
being extended by 5 months, the discounted value of both total costs 
and total benefits decreases. The principal benefit of this final rule 
will be the reduction in costs associated with extending the compliance 
date by 5 months. The principal cost of this final rule will be the 
reduction in benefits associated with extending the compliance date by 
5 months. Extending the compliance date of the menu labeling final rule 
by 5 months reduces the annualized net benefits (discounted at 3 
percent) approximately 3 percent, from $457 million to $442

[[Page 96366]]

million. While average annualized net benefits decrease by $15 million, 
they are still positive. We note that this extension of the compliance 
date will not have an actual effect on the cost or benefits of the menu 
labeling rule, because, under section 747 of the Consolidated 
Appropriations Act, 2016, FDA was not authorized to spend funds to 
``implement, administer, or enforce'' the rule until May 5, 2017, a 
year after the date on which published a Level 1 guidance with respect 
to nutrition labeling of standard menu items in restaurants and similar 
retail food establishments. We are presenting the benefits and costs of 
the menu labeling final rule, which takes effect according to the dates 
in this rule.
    The full analysis of economic impacts is available in the docket 
for this final rule (Ref. 1) and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

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. Analysis of 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 is on display in the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, and is available for viewing by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday; it 
is also available electronically at https://www.regulations.gov. FDA 
has verified the Web site addresses, as of the date this document 
publishes in the Federal Register, but Web sites are subject to change 
over time.

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: December 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31597 Filed 12-29-16; 8:45 am]
 BILLING CODE 4164-01-P


