[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:
[email protected].
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