[Federal Register Volume 82, Number 85 (Thursday, May 4, 2017)]
[Rules and Regulations]
[Pages 20825-20829]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-09029]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 11 and 101

[Docket No. FDA-2011-F-0172]
RIN 0910-ZA48


Food Labeling; Nutrition Labeling of Standard Menu Items in 
Restaurants and Similar Retail Food Establishments; Extension of 
Compliance Date; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Interim final rule; extension of compliance date; request for 
comments.

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

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. In the Federal Register of December 30, 
2016, we stated that the compliance date for the final rule would be 
May 5, 2017. We are extending the compliance date to May 7, 2018. We 
are taking this action to enable us to consider how we might further 
reduce the regulatory burden or increase

[[Page 20826]]

flexibility while continuing to achieve our regulatory objectives, in 
keeping with the Administration's policies.

DATES: Compliance date: As of May 4, 2017, the compliance date for 
covered establishments set out in the final rule published December 1, 
2014 (79 FR 71156), and extended in final rules published on July 10, 
2015 (80 FR 39675) and December 30, 2016 (81 FR 96364), is further 
extended. Covered establishments must comply with the rule published 
December 1, 2014 (79 FR 71156), by May 7, 2018.
    Comment date: Submit either electronic or written comments 
regarding this compliance date extension, implementation of the 
December 2014 final rule, and the various topics flagged in the 
SUPPLEMENTARY INFORMATION section of this document, by July 3, 2017.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of July 3, 2017. Comments received by 
mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2011-F-0172 for ``Food Labeling; Nutrition Labeling of Standard 
Menu Items in Restaurants and Similar Retail Food Establishments; 
Extension of Compliance Date; Request for Comments.'' Received 
comments, those filed in a timely manner (see DATES), will be placed in 
the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review 
this copy, including the claimed confidential information, in our 
consideration of comments. The second copy, which will have the claimed 
confidential information redacted/blacked out, will be available for 
public viewing and posted on https://www.regulations.gov. Submit both 
copies to the Division of Dockets Management. If you do not wish your 
name and contact information to be made publicly available, you can 
provide this information on the cover sheet and not in the body of your 
comments and you must identify this information as ``confidential.'' 
Any information marked as ``confidential'' will not be disclosed except 
in accordance with 21 CFR 10.20 and other applicable disclosure law. 
For more information about FDA's posting of comments to public dockets, 
see 80 FR 56469, September 18, 2015, or access the information at: 
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Felicia B. Billingslea, Center for 
Food Safety and Applied Nutrition (HFS-820), Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2371.

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, 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

[[Page 20827]]

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. Extension of the Compliance Date and Request for Comments

    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.
    On December 18, 2015, the President signed the Consolidated 
Appropriations Act, 2016 (Pub. L. 114-113). Section 747 of that law 
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 the later of December 1, 2016 or 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). In the Federal Register 
of December 30, 2016 (81 FR 96364), we confirmed that the compliance 
date would be May 5, 2017.
    This interim final rule extends the compliance date to May 7, 2018. 
We are taking this action consistent with Executive Orders 13777, 
13771, and 13563, as well as in response to the diverse and complex set 
of stakeholders affected by the rule and continued, numerous, and 
fundamental questions they raise regarding the final rule and its 
implementation. The continued, fundamental questions and concerns with 
the final rule suggest that critical implementation issues, including 
some related to scope, may not have been fully understood and the 
agency does not want to proceed if we do not have all of the relevant 
facts on these matters. Retailers with many different and diverse 
business models have raised concerns about how the rule lacks 
flexibility to permit them to provide meaningful nutrition information 
to consumers given their type of business and different operations. 
Moreover, we continue to receive many questions about calorie 
disclosure signage for self-service foods, including buffets and grab-
and-go foods. We do not want to proceed with a rule that might turn out 
to be too inflexible to support innovation in delivering information to 
consumers. In addition, we have received questions regarding how to 
distinguish a menu, which requires the posting of calorie information, 
from advertisements and other marketing pieces, which do not require 
calorie information. Many of these menu questions are complex and have 
highlighted for the agency the need for further consideration and 
clarification. How to address the natural calorie variations for foods 
has also been raised by stakeholders as an issue that needs additional 
guidance and clarity. Finally, some entities with certain business 
models have stated that they continue to have questions about what 
provisions of the final rule are applicable to them. We believe 
questions like this still need to be addressed.
    The previous extensions, as well as Congressional concern regarding 
implementation expressed through letters and appropriations law, are a 
reflection of the challenge in implementing this rule for a diverse 
industry of approximately 298,600 covered establishments, organized 
under 2,130 chains, that we estimated to be covered by the 2014 final 
rule. Executive Order 13777, ``Enforcing the Regulatory Reform Agenda'' 
(82 FR 12285, March 1, 2017), sets forth a policy to alleviate 
unnecessary regulatory burdens. Given the principles and policies set 
forth in these executive orders, particularly with respect to reducing 
burdens, reducing costs, maintaining flexibility, and improving 
effectiveness, we have decided to extend the compliance date to May 7, 
2018. The additional time will allow us to consider what opportunities 
there may be to address these fundamental and complex questions and 
reduce the cost and enhance the flexibility of these requirements 
beyond those reflected in the final rule. Given our decision to 
reconsider the rule consistent with these Executive Orders, it would 
not make sense to require establishments covered by our final rule to 
come into compliance with the rule (for which compliance is not yet 
required), as well as incur additional ongoing costs to maintain or 
update compliance, when these requirements may change as a result of 
our reconsideration of the rule. We solicit comment on the extension of 
the compliance date.
    To assist us in our review, we invite interested parties to submit 
comments on how we might further reduce the regulatory burden or 
increase flexibility while continuing to achieve our regulatory 
objectives to provide consumers with nutrition information so that they 
can make informed choices for themselves and their families. In 
particular, and in light of the issues we have noted above, we are 
interested in hearing about approaches to reduce the regulatory burden 
or increase flexibility with respect to:
    (1) Calorie disclosure signage for self-service foods, including 
buffets and grab-and-go foods;
    (2) methods for providing calorie disclosure information other than 
on the menu itself, including how different kinds of retailers might 
use different methods; and
    (3) criteria for distinguishing between menus and other information 
presented to the consumer. (See ADDRESSES for instructions on 
submitting comments.) These questions have been identified by 
stakeholders as among the fundamental issues that continue to pose 
significant implementation challenges. As of April 7, 2017, we have 
received five requests for an extension of the compliance period, which 
we will add to the docket. In addition, on April 5, 2017, a request to 
stay the effective date was submitted to FDA (see Docket No. FDA-2017-
P-2164); this request is currently under consideration.
    To the extent that 5 U.S.C. 553 applies to this extension of the 
compliance date, the action is exempt from notice and comment because 
it constitutes a rule of procedure under 5 U.S.C. 553(b)(A). 
Alternatively, to the extent that the notice-and-comment and delayed 
effective date requirements set forth in 5 U.S.C. 553 applies to this 
action, the implementation of this action without opportunity for 
public comment, effective immediately upon publication today in the 
Federal Register, is based

[[Page 20828]]

on the good cause exceptions in 5 U.S.C. 553(b)(B) and (d)(3). Given 
the imminence of the compliance date (May 5, 2017), and the fact that, 
as discussed above, a number of regulated establishments continue to 
raise numerous, complex questions about applicability of the menu 
labeling requirements and about how to implement them, we have decided 
that providing an opportunity for public comment would be impracticable 
and contrary to the public interest. This is because providing 
immediate notice to covered establishments of the additional time to 
come into compliance allows for more efficient planning and accounting 
for implementation of requirements, thus reducing regulatory burden and 
costs on affected entities. In addition, providing immediate notice 
that there will be additional time to comply is necessary so that 
affected entities can avoid incurring immediate costs and efficiently 
plan and account for implementation of the requirements by the imminent 
compliance date. Good cause exists to delay the compliance date without 
comment and effective immediately. In accordance with 21 CFR 
10.40(e)(1), however, we note that interested parties may provide 
comment on the compliance date extension, including whether it should 
be modified or revoked. In addition, interested parties may submit 
comments on how we might further reduce the regulatory burden or 
increase flexibility while continuing to achieve our regulatory 
objectives with respect to providing consumers with nutrition 
information so that they can make informed choices for themselves and 
their families. In addition, as we have done throughout this complex 
rulemaking process, we will continue to work with stakeholders as we go 
forward.

III. Economic Analysis of Impacts

    We have examined the impacts of the interim final rule under 
Executive Order 12866, Executive Order 13563, Executive Order 13771, 
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). Executive Order 13771 
requires that the costs associated with new regulations shall ``be 
offset by the elimination of existing costs associated with at least 
two prior regulations.'' We have developed an Economic Analysis of 
Impacts that assesses the impacts of the interim final rule, including 
cost savings to industry and foregone benefits to consumers. We 
estimate at least one type of impact in at least one year to be greater 
than $100 million. Thus, we believe that this interim final rule is an 
economically 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 reduces the burden on covered 
establishments 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, December 
1, 2014 (final rule); 80 FR 39675, July 10, 2015 (extending the 
compliance date to December 1, 2016); 81 FR 96364, December 30, 2016 
(clarifying extension of the compliance date to May 5, 2017)), we 
certify the interim 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 $148 
million, using the most current (2016) Implicit Price Deflator for the 
Gross Domestic Product. This interim final rule would not result in an 
expenditure by industry in any year that meets or exceeds this amount.
    This interim final rule extends the compliance date to May 7, 2018, 
for the final rule requiring disclosure of certain nutrition 
information for standard menu items in certain restaurants and similar 
retail food establishments. The principal benefit of this interim final 
rule will be the reduction in costs to covered establishments 
associated with extending the compliance date by one year. The total 
annualized benefit (i.e., cost savings) of this interim final rule, 
using a 3-percent discount rate over 20 years, would be from $2 to $6 
million; with a 7-percent discount rate, the annualized benefit would 
be $3 to $8 million. The principal cost of this interim final rule will 
be the reduction in benefits to consumers associated with extending the 
compliance date by one year. The total annualized cost (i.e., foregone 
benefits) of this interim final rule, using a 3-percent discount rate 
over 20 years, would be from $5 to $15 million; with a 7-percent 
discount rate, the annualized cost would be $6 to $19 million. 
Extending the compliance date of the ``Food Labeling: Nutrition 
Labeling of Standard Menu Items in Restaurants and Similar Retail Food 
Establishments'' final rule by one year reduces the annualized net 
benefits (discounted at 3 percent) approximately 1 percent, from $506 
million to $501 million. While average annualized net benefits decrease 
by $5 million, they are still positive. We recognize that there may be 
additional costs and benefits to both consumers and covered 
establishments that we do not have the data to quantify here. We are 
presenting the estimated benefits and costs of the menu labeling final 
rule, which takes effect according to the dates in this interim final 
rule. These quantitative estimates reflect an assumed baseline in which 
the menu labeling regulation eventually goes fully into effect. If 
statutory or other changes that are separate from FDA rulemaking were 
to impact full implementation, the quantitative benefits estimates 
would be lower and the quantitative cost estimates higher than shown 
here. We invite comment on both this Regulatory Impact Analysis and the 
Regulatory Impact Analysis for the December 2014 final rule.
    The full analysis of economic impacts is available in the docket 
for this interim final rule (Ref. 1) and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

IV. Paperwork Reduction Act

    This interim 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 (see ADDRESSES) and is available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also 
available electronically

[[Page 20829]]

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, interim economic impact analysis for ``Food Labeling; 
Nutrition Labeling of Standard Menu Items in Restaurants and Similar 
Retail Food Establishments; Extension of Compliance Date; Request 
for Comment,'' April 2017. Available at: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses.

    Dated: May 1, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-09029 Filed 5-1-17; 4:15 pm]
 BILLING CODE 4164-01-P