
[Federal Register Volume 80, Number 132 (Friday, July 10, 2015)]
[Rules and Regulations]
[Pages 39675-39676]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

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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


