for menu item nutrient analysis and redesigning menu boards will
skyrocket upon publication of the final rule, thereby overwhelming
testing laboratories and companies that design menus and menu boards.
    (Response 143) We agree that covered establishments will need more
than 6 months to come into compliance with the rule, including making
changes to menus and menus boards. While some establishments already
are subject to State or local nutrition labeling requirements for foods
sold in such establishments, others are not. Moreover, even those
establishments that already are subject to State or local requirements
nutrition labeling requirements may not be required to disclose such
nutrition information in the format and manner specified in section
403(q)(5)(H) of the FD&C Act and this rule. We carefully considered the
activities and associated time frames identified by the comments,
including the comment from national organizations representing
restaurants, and we agree that the rule should provide for an effective
date of 1 year to comply with the Federal requirements. Most comments,
even the comment noting that one State and one local

government provided more than 1 year for full implementation, requested
an effective date of ``at least 1 year.''
    We also agree that a time frame that enables establishments to make
changes to menus and menu boards during a time period that coincides
with their regular menu replacement cycles would save time and
resources. In addition, we acknowledge that companies that design and
produce menu boards will receive many orders to update menu boards to
comply with the rule. We note that a covered establishment that
experiences difficulty obtaining new menus or menu boards as a result
of increased demand as the effective date draws near will have other
ways to comply with the rule without replacing the menus or menu
boards. For example, we would not object if a covered establishment
declares calorie information by applying stickers or pieces of paper to
menus or menu boards. For packaged foods, we have taken the position
for some time that the Nutrition Facts label may be printed on a
sticker and affixed to a package, as long as the sticker adheres to the
product under the intended storage conditions (Ref. 38; see L16). We
also have long taken the position that stickers may be used to make
changes in labeling such as correcting label mistakes provided that the
final label is correct and complies with all regulations at the time of
retail sale, the stickers do not cover other mandatory labeling, and
the stickers adhere tightly (Ref. 38, see L55).
    Likewise, we acknowledge that there could be some increased demand
for nutrient analysis by testing laboratories as the effective date
draws near. Importantly, the rule does not require analytical testing
of standard menu items; analytical testing is merely one option
available to a covered establishment to determine nutrient values.
Other options include use of nutrient databases, cookbooks, or other
reasonable means, including the use of Nutrition Facts on labels on
packaged foods that comply with the nutrition labeling requirements of
section 403(q)(1) of the FD&C Act and Sec.  101.9, FDA nutrient values
for raw fruits and vegetables in Appendix C of part 101, or FDA
nutrient values for cooked fish in Appendix D (see Sec.  101.11(c)(1)).
In addition, as noted by the comments, many establishments that are
part of large chains have already determined nutrient values for their
menu items. As discussed in Response 138 and Response 139, this rule
provides that corporate headquarters or a parent entity, rather than
each individual covered establishment, may determine and certify
nutrient values, as requested by comments. Thus, to the extent
establishments' corporate headquarters or parent entity have determined
nutrient values for standard menu items offered for sale in such
establishments, individual covered establishments can come into
compliance with this rule without significantly overwhelming testing
laboratories, even if such establishments choose analytical testing as
the means to determine nutrient values.
    For all of these reasons, and as discussed in more detail in
section XXIII.C, we have established an effective date for this rule
that is 1 year from the date of publication of this document. Thus, the
final rule is effective on December 1, 2015.
    (Comment 144) One comment that recommended a minimum of 12 to 18
months for establishments to comply with the rule provided information
about its experience from a 2010 rollout of new menu boards for all its
domestic stores. This comment identified the following steps and
corresponding time frames for this 2010 rollout:
     2 months to develop new menu board templates for the seven
types of menu boards for its various types of store locations (mall
stores, mall kiosks, mall carts, stadium stores, stadium carts, etc.);
     8 months to develop, program, and test an ordering site to
accommodate more than 850 individual store menus;
     2 months to receive the orders and lay out all custom menu
boards; and
     2 months to produce and ship new menu boards to its
stores.
    (Response 144) We appreciate that this comment provided its
specific experience from a company-wide rollout of new menu boards. The
steps identified by this comment are similar to the steps identified by
the comment from national associations representing restaurants,
although with longer timeframes. However, as discussed in Comment 143
these national associations also noted that extending the time period
to 1 year would allow most restaurants to incorporate adding calorie
declarations to menus and associated menu redesigns with regular menu
replacement cycles. We therefore disagree that the time frames
experienced by one entity during a company-initiated rollout of new
menu boards should determine the time frame for compliance by all
covered establishments.
    (Comment 145) Some comments requested an effective date of more
than 12 months. One comment requested an 18-month effective date
because it considered that many requirements are still unclear. Another
comment requested an 18-month to 2-year effective date for similar
retail food establishments, even if there is a shorter time for
restaurants. According to this comment, establishments need time to
comply properly with the requirements and rushing through compliance
could result in mistakes that may be confusing to consumers and would
require additional industry resources to correct.
    A few comments requested a 2-year effective date. One comment
asserted that there will be a steep learning curve and time is needed
to train employees and develop and print display materials. A few
comments maintained that a 2-year compliance period is appropriate
because, according to one comment, we used a 2-year uniform compliance
period when implementing the NLEA. According to another comment, a 2-
year timeframe is reasonable as long as nutrition information is
available in brochures and online.
    (Response 145) We disagree that an effective date over 1 year (such
as 18 months or 2 years, as suggested by the comments) is necessary.
Many comments seeking a longer effective date focused on the need to
train employees. Such training does not need to wait until all
implementation activities are complete--e.g., such training can begin
while an establishment is waiting for delivery of its revised menus and
menu boards.
    We also disagree with the comment asserting that similar retail
food establishments need more time than restaurants to comply with the
rule. The comment provided no basis for why similar retail food
establishments should be treated differently from restaurants or why
such establishments would need more time for compliance than
restaurants.
    We discuss the applicability of the uniform compliance date in
section XXIII.C.
    (Comment 146) One comment asserted that there will be an unfair
competitive advantage for larger companies because of the ability of
larger companies to leverage their market position with the menu board
producers. One comment requested a grace period to come into compliance
if a covered establishment has adopted and followed a reasonable
program to monitor changing nutrient values and update menus and menu
boards at reasonable intervals coinciding with typical cycles.
    (Response 146) In the proposed rule, we specifically requested that
comments about whether we should provide for staggered implementation
based on the size of a chain or of a specific franchisee be supported
by data. The comment

asserting that there will be an unfair competitive advantage for larger
companies (because of their ability to leverage their market position
with the menu board producers) provided no data for its assertion;
therefore we have no information that could assist us in considering
whether or how much additional time might be appropriate. Further, as
discussed in Response 143, covered establishments can use a number of
ways to comply with this rule without replacing menus or menu boards;
for example, they can apply stickers or pieces of paper to menus or
menu boards. For these reasons, we do not believe there is a sufficient
basis to establish a staggered implementation period based on the size
of the chain or of a specific franchise.
    Nevertheless, we can work with establishments that are not in
compliance by the effective date of this rule on a case-by-case basis,
taking into consideration a number of factors, including specific steps
an establishment has taken towards compliance.
    (Comment 147) One comment requested that we allow 1 year for
implementation, rather than 6 months, to provide covered establishments
with adequate time to come into compliance given contractual
requirements. For example, the comment said that it maintains a
database with over 35,000 recipes which, in turn, may be modified or
adapted by the specific restaurant or similar retail food establishment
for local needs and tastes, limitations of the establishment,
contractual specifications, and other restrictions (e.g., an
establishment's determinations as to types of offerings). In addition,
the comment stated that contractors rely on suppliers to provide
nutritional information and, therefore, we should allow adequate time
to retrieve data from these sources.
    (Response 147) As discussed in section XXIII.C, we are establishing
an effective date of 1 year from the date of publication of this rule.
We note that the comment refers to recipes that may be modified or
adapted by a specific restaurant or similar retail food establishment.
In section VI.F, we discuss how such modifications can affect whether
an establishment is offering for sale substantially the same menu items
(and, thus, satisfies this criterion in the definition of covered
establishment).

C. Effective Date and Compliance Date for This Rule

    We are establishing the effective date to be 1 year from the date
of publication of this document, i.e., the final rule is effective on
December 1, 2015, (see DATES). We believe that extending the effective
date from 6 months to 1 year provides sufficient time for covered
establishments to come into compliance with the requirements without a
significant negative impact on public health.
    We expect covered establishments to come into compliance with the
requirements of this rule by December 1, 2015, i.e., the same date as
the effective date of this rule. Although we are issuing this final
rule after January 1, 2013, there is sufficient justification for
establishing a compliance date of December 1, 2015, to enforce the
provisions of this final rule, rather than January 1, 2016, which FDA
has established as the next uniform compliance date for other food
labeling changes required by food labeling regulations that are issued
between January 1, 2013, and December 31, 2014 (77 FR 70885; November
28, 2012). Typically, our uniform compliance dates for food labeling
regulations focus on changes made to the requirements for labels of
packaged foods and seek to minimize the economic impact of such label
changes, in relevant part, by allowing manufacturers to come into
compliance with such regulations by one particular compliance date
rather than several different dates (e.g., 77 FR 70885; 75 FR 78155
(December 15, 2010)). By providing one uniform compliance date, we
enable manufacturers to avoid multiple short-term label revisions that
would otherwise occur if not for the uniform compliance date. However,
this rule does not establish requirements for the labels of packaged
foods, and therefore would not cause food label revisions comparable to
other food labeling regulations typically addressed by our uniform
compliance dates. In addition, standard menu items offered for sale in
covered establishments were not subject to Federal nutrition labeling
requirements before the enactment of section 4205 of the ACA. As a
result, unlike packaged foods, standard menu items currently are not
subject to several different Federal food labeling regulations that may
provide for different compliance dates. Further, a comment from
national associations representing restaurants reported that extending
the time period from the 6 months that we proposed, to 1 year, would
allow most restaurants to comply with the rule as part of regular menu
replacement cycles, thereby lessening costs. For these reasons, along
with the reasons discussed previously, we believe that 1 year is
sufficient time for covered establishments to come into compliance with
the requirements of this rule. Waiting until FDA's next uniform
compliance date of January 1, 2016, would create unnecessary delay in
the enforcement of this rule and could minimize public health benefits.

XXIV. Comments and FDA Response on Compliance

    In the proposed rule, we noted that some provisions of section 4205
of the ACA became requirements immediately upon enactment of the law
and that we intended to exercise enforcement discretion until after we
had completed notice and comment rulemaking. We encouraged our State
and local partners to proceed in a similar way. We requested comment on
how we should implement the rule, including whether specific provisions
of the rule can be more quickly implemented than others (76 FR 19192 at
19220).
    (Comment 148) One comment asked us to develop a protocol for
checking the accuracy of the nutritional information provided by
covered establishments. One comment recommended that we undertake
random testing as resources allow. Another comment recommended that
testing be done annually and kept on a public file to ensure that the
portions continue to be within 5 percent tolerance of the original
nutritional information. The comment suggested that if deviations are
found, the company would either retest in 30 days or pay a penalty fee
that would be passed to a childhood obesity campaign.
    (Response 148) The rule provides several options for how covered
establishments can determine nutrition information. While analytical
testing of standard menu items may be appropriate in some cases (e.g.,
when the reasonable basis that a covered establishment uses to
determine nutrient values is analytical testing), we expect our routine
approach to evaluating the accuracy of the nutrition information to be
based on the particular facts at issue, including the reasonable basis
used by the covered establishment, which may be means other than
analytical testing. Consistent with our approach to inspection of food
processing facilities, we do not expect to establish a public file with
the results of any testing we conduct. Under the Freedom of Information
Act and our regulations in part 20, a person who wishes to see the
results of our inspections may submit a request to do so.
    Regarding the comment suggesting that we develop a protocol for
checking the accuracy of the nutritional

information provided by covered establishments, we decline to include
such a protocol for checking the accuracy of the nutritional
information in the rule at this time. Section 101.11(c) includes
requirements for determining nutrient content and section XVII further
discusses such requirements, including the requirement that nutrient
declarations be accurate and consistent with the specific basis used to
determine nutrient values. After we have had experience in evaluating
compliance with the rule, we will consider whether to develop such a
protocol.
    (Comment 149) A few comments asked us to clarify our enforcement
strategy and quickly establish an enforcement protocol. One comment
stated that the proposed rule is virtually silent on how the menu
labeling requirements will be enforced and encouraged us to permit the
industry to comment on our enforcement strategy before it is included
in the rule. One comment recommended that we issue guidance documents
to the industry to better clarify matters of uncertainty that will
persist following issuance of the rule.
    One comment asked us to provide details on the penalties for
noncompliance. Another comment recommended that we issue warning
letters prior to instituting civil penalties against a covered
establishment, particularly if the proposed rule's ambiguities are not
clarified in the final rule. The comment maintained that a covered
establishment may have made a good faith effort to comply and that
warning letters will encourage compliance and inform establishments how
they have fallen short of compliance. The comment recommended that we
use a tiered penalty structure, whereby minor violations (e.g.,
inadequate font size of nutrition information) are treated less harshly
than more serious violations (e.g., a clear lack of effort to place
calorie information on printed menus). The comment also encouraged us
to have a progressive penalty system for violations, whereby first
violations are treated less harshly (e.g., a warning letter) than
repeated violations. The comment maintained that this is especially
crucial in the first few years the rules are being implemented as
covered establishments familiarize themselves with the new
requirements.
    (Response 149) We are establishing these regulations under sections
201(n), 403(a)(1), 403(f), and 403(q)(5)(H) of the FD&C Act, as well as
under section 701(a) of the FD&C Act. As discussed in the proposed rule
and in section XXII, failure to comply with the rule will render the
food misbranded under section(s) 201(n), 403(a), 403(f), or 403(q) of
the FD&C Act (76 FR 19192 at 19219). Penalties are already set forth in
the FD&C Act, and violations of Sec.  101.11 may result in enforcement
action consistent with those penalties. For example, introducing,
delivering for introduction, or receiving a misbranded food in
interstate commerce, or misbranding a food while it is in interstate
commerce or being held for sale after shipment in interstate commerce,
are prohibited acts under section 301 of the FD&C Act (21 U.S.C. 331),
carrying criminal penalties under section 303 of the FD&C Act (21
U.S.C. 333). In addition, under section 302 of the FD&C Act (21 U.S.C.
332), the United States can bring a civil action in Federal court to
enjoin a person who commits a prohibited action. Under section
304(a)(1) of the FD&C Act (21 U.S.C. 334(a)(1)), a food that is
misbranded when introduced into or while in interstate commerce or
while held for sale after shipment in interstate commerce may be seized
by order of a Federal court. We expect to issue guidance to help
covered establishments with compliance.
    The tiered enforcement approach described by the comment is similar
to the approach we currently take for other misbranded food, and we
generally expect our enforcement approach to misbranding violations of
this rule to be similar to that for other misbranded food.
Nevertheless, enforcement will be considered on a case-by-case basis
depending on the specific facts and circumstances.
    (Comment 150) One comment asked us to focus our enforcement actions
on helping with compliance, rather than seeking monetary penalties, at
least until establishments have an opportunity to fully adopt the
requirements. This comment maintained that flexibility is needed in the
initial phases of implementation for facilities that operate under
Federal Government contracts so that they can continue to comply with
requirements mandated by specific Government Agencies. As a result, the
comment recommended that we provide flexibility for contract food
providers that provide services to Government facilities under a
specified program.
    (Response 150) We recognize that covered establishments will need
time to comply with the nutrition labeling requirements of this rule
during the initial phase of implementation. To provide more time to do
so, this rule is not becoming effective until 1 year after the date of
publication of this document (see the discussion in section XXIII.C of
this document).
    A covered establishment has responsibility to comply with all
requirements of the rule. We acknowledge that a covered establishment
may need to update its business and contractual relationships with its
suppliers in order to do so.
    (Comment 151) One comment asked us to permit stores to register
points of contact to which we will address enforcement because
experience shows that involving ``corporate parents'' of individual
franchises or the owner of multi-store chains is the most effective way
to manage enforcement issues. The comment recommended that we notify
these contacts in the event of an enforcement action. Similarly, the
comment recommended that we designate specific contacts for informal
guidance and advice and develop a menu labeling hotline telephone
number or email address to which store operators can ask specific
questions. The comment considered that doing so would increase
compliance and ease the administrative burden on its members.
    (Response 151) Each individual restaurant or similar retail food
establishment is responsible for disclosing the required nutrition
information for its standard menu items and otherwise complying with
the requirements of sections 403(q)(5)(H), 403(a)(1), and 403(f) of the
FD&C Act and Sec.  101.11. Persons exercising authority and supervisory
responsibility over such establishments may also be held liable for
violations of the FD&C Act. See Response 3. Our decisions regarding
enforcement actions will be determined on a case by case basis. In
general, we intend to notify a ``corporate parent'' as appropriate (see
e.g., Refs. 39 and 40). Although Sec.  101.11(d) provides for voluntary
registration for restaurants and similar retail food establishments
that are not subject to the nutrition labeling requirements of section
403(q)(5)(H) of the FD&C Act, and requires contact information, these
requirements only apply to such establishments that would not be
subject to the rule without registering.
    We already maintain a telephone hotline where industry may contact
us for questions about compliance with our regulations (1-888-SAFEFOOD
(1-888-723-3366)). Staff who are assigned to the hotline will have or
obtain the information to answer questions about this rule. In
addition, a covered establishment may direct questions to the contact
person identified in this document (see FOR FURTHER INFORMATION
CONTACT), to the contact telephone number provided in any subsequent

guidance, and to a general email mailbox for industry questions
(industry@fda.gov). A covered establishment also may send written
inquiries to Center for Food Safety and Applied Nutrition (HFS-009),
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD
20740.
    (Comment 152) A few comments recommended that we preapprove menus
and menu boards. One of these comments recommended that we do so even
if a fee was required. The comment maintained that an approval process
would alleviate covered establishments from having to pay the costs to
replace menus that they thought met the menu labeling requirements.
    (Response 152) We decline the request of these comments. Section
403(q)(5)(H) of the FD&C Act does not require that we preapprove menus
and menu boards, nor do we have the resources to do so at this time.
Section 403(q)(5)(H) of the FD&C Act and this rule set forth and
specify the requirements for menus and menu boards such that a covered
establishment should be able to determine whether its menu or menu
board meets the applicable requirements. Further, a covered
establishment may contact us with questions about compliance, as
discussed previously in Response 151.
    (Comment 153) One comment asked us to clarify that compliance is
the responsibility of each establishment and that if someone fails to
comply, only that standard menu item in the particular establishment is
misbranded. The comment expressed concern that without clarity on this
point, States and localities may cite franchisors for violations by
franchisees, and plaintiffs' attorneys may sue franchisors for
violations by franchisees under consumer protection laws.
    (Response 153) With regard to what food is misbranded if there is a
failure to comply with the regulations, this would be determined based
on the particular facts of the situation (see also Response 3).
    (Comment 154) Some comments asked us to allow flexibility for when
a covered establishment must update menus to reflect changes in
nutrient content. One of these comments asked us to clarify that any
temporary inconsistencies resulting from periodic updating will not
result in a violation of the law. The comment expressed concern that
nutrient values may change because of ingredient changes, use of
different suppliers, suppliers updating nutritional analysis with no
changes in formulation, and reformulation of menu items based on
consumer feedback. The comment asked us to state that values found not
current will not raise a compliance issue if the covered establishment
can demonstrate that it has adopted a reasonable program to monitor
changing values and that it updates materials at reasonable intervals
based on the manner and frequency in which it changes menus and other
labeling. The comment also recommended that covered establishments be
able to update their menus and menu boards at reasonable intervals
coinciding with typical cycles to change menus and, at a maximum,
values that require updating be updated at least once a year. One
comment asked that the final rule clearly state that covered
establishments are responsible for maintaining the accuracy of their
nutrient declarations, including keeping this information up-to-date as
their menus change.
    (Response 154) Nutrition labeling for a standard menu item must be
truthful and not misleading, consistent with the specific basis used to
determine nutrient values, and otherwise in compliance with the
requirements of sections 403(a)(1), 403(f), and 403(q)(5)(H) of the
FD&C Act and Sec.  101.11. We recognize that changes in nutrition
information for standard menu items could cause a covered establishment
to change a menu or menu board even if the list of menu items has not
changed. In general, revised nutrition must be posted before serving
the food. Compliance will be determined on a case-by-case basis
depending on the specific facts and circumstances. We recommend that a
covered establishment coordinate changes in menu items that are
significant enough to affect nutrient content with the introduction of
new items that also require updating a menu or menu board to help
minimize costs. As discussed in Response 143, covered establishment may
also use measures such as stickers to update nutrient content on menus
or menu boards.
    (Comment 155) Several comments requested clarification on who would
enforce the rule. One comment asked that delegation of inspection
authority to the States be explicit, and asserted that the provision in
21 U.S.C. 337 authorizing States to enforce Federal law has rarely been
used. This comment stated that we could use 21 U.S.C 372(a)(1)(A) to
provide technical assistance and funding to States and locals for
enforcement. The comment suggested that we set up a simple process for
local health inspectors to report violations to us, e.g., a postcard to
be filled in and sent to us with a tear off receipt to be left with the
restaurant manager. The comment also suggested that we develop a system
to collect and store reports of violations in a database. A few
comments recommended that the final rule specify that enforcement
procedures of States are not affected by section 4205 of the ACA.
    One comment recommended that we work with headquarters of chain
restaurants and similar retail food establishments to ensure compliance
and then have our District Offices assess compliance in the States.
    One comment stated that States and locals cannot be expected to
enforce the Federal menu labeling requirements without significant
funding. The comment stated that the enforcement process in its State
is already overburdened and, therefore, the Federal Government should
enforce the requirements. Other comments recommended that we rely on
States and localities and provide training and funding. A few comments
stated that historically restaurant inspections are done by the States
and localities, and one comment recommended that we use the contractual
regime of food safety inspections used with the enforcement of the
NLEA. One comment stated that local restaurant inspectors can add the
enforcement of menu labeling to their current inspections. One comment
recommended that we enforce fines and penalties for noncompliance and
direct any resulting funds to inspection programs enforcing the menu
labeling requirements.
    One comment stated that it is not always practical for States and
locals to enforce section 4205 of the ACA as delegates of FDA; rather
we should encourage and support enactment of identical requirements
that fit into local and State food codes.
    One comment suggested that the rule include specific provisions
that would be binding on State and local jurisdictions relative to
enforcing the rule. The comment stated that the right to a notice of a
violation, the opportunity to cure a violation, and the opportunity to
have a re-inspection before an adverse decision by the enforcing agent,
e.g. a citation, vary enormously from jurisdiction to jurisdiction, at
the State and at the local level. The comment suggested that we include
specifics such as:
     The enforcement agency at initial inspection provides
written notice of violations;
     The enforcement agency gives the establishment a period of
time to cure the violations (e.g., 15-30 days);
     The enforcement agency would re-inspect after cure period;
and
     If violations are not cured, the enforcement agency would
issue

adverse decision applying fine or other action that would apply under
the enforcement agency's regulations or applicable State or local laws.
    The comment stated that these actions would only apply to calorie
labeling and not to other violations related to safety.
    (Response 155) Collectively, these comments address three
mechanisms by which States (and, in some cases, local jurisdictions)
could have a role in enforcing the provisions of section 403(q)(5)(H)
of the FD&C Act and this rule:
     In general, a State or political subdivision of a State
may establish food nutrition labeling requirements that are identical
to applicable Federal requirements, including the requirements of this
rule. In this case, the State or local jurisdiction would act on its
own behalf to enforce its own requirements, albeit requirements that
are identical to the Federal requirements.
     Under 702(a)(1)(A) of the FD&C Act (21 U.S.C.
372(a)(1)(A)), FDA is authorized to conduct examinations and
investigations for the purposes of the FD&C Act through any health,
food, or drug officer or employee of any State, Territory, or political
subdivision thereof (such as a locality), duly commissioned to act on
behalf of FDA. In this case, the State or local representative would
act on our behalf to enforce the Federal requirements.
     In general, under section 310(b) of the FD&C Act (21
U.S.C. 337(b)), a State may bring in its own name and within its
jurisdiction proceedings for the civil enforcement, or to restrain
violations, of section 403(q) of the FD&C Act, including the nutrition
labeling requirements for standard menu items under section
403(q)(5)(H) of the FD&C Act, if the food that is the subject of the
proceedings is located in the State provided that other requirements
and conditions are met. In this case, the State acts on its own behalf
to enforce the Federal requirements.
    We have successfully partnered with States to conduct examinations
and inspections in other contexts, including inspections of food
processing facilities on our behalf (Ref. 41). We expect to continue to
cooperatively leverage the resources of Federal, State, and local
Government Agencies as we strive to obtain industry-wide compliance
with this rule.

XXV. Final Regulatory Impact Analysis

    FDA has examined the impacts of this 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). We have developed a detailed Regulatory Impact Analysis (RIA)
that presents the benefits and costs of this final rule (Ref. 42) which
is available at http://www.regulations.gov (enter Docket No. FDA-2011-
F-0172). The full economic impact analyses of FDA regulations are no
longer (as of April 2012) published in the Federal Register but are
submitted to the docket and are available at http://www.regulations.gov. We also post the full economic impact analyses of
FDA regulations at the following Web site: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
    This rule is designated an ``economically'' significant rule, under
section 3(f)(1) of Executive Order 12866. Accordingly, the rule was
reviewed by OMB. In particular, Executive Order 12866 directs each
Agency engaged in rulemaking to ``identify the problem that it intends
to address''--that is, the essential purpose of the rule. As a separate
step in its rulemaking, Executive Order 12866 directs the Agency to
``assess both the costs and the benefits of the intended regulation . .
. , recognizing that some costs and benefits are difficult to
quantify.''
    Executive Order 13563 confirms that ``each agency is directed to
use the best available techniques to quantify anticipated present and
future benefits and costs as accurately as possible. Where appropriate
and permitted by law, each Agency may consider (and discuss
qualitatively) values that are difficult or impossible to quantify.''
Here, the essential purpose of the rule is to make nutrition
information for certain foods available to consumers in a direct,
accessible, and consistent manner to enable consumers to make informed
and healthful dietary choices. The full analysis--contained in the
RIA--of anticipated and quantifiable costs and benefits from the
promulgation of the rule does not alter this fundamental purpose. Nor
does it fully capture the unquantifiable benefits of greater consumer
understanding regarding dietary choices and their impact on health.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. According to our analysis, we believe that the final
rule will have a significant economic impact on a substantial number of
small entities, and we have accordingly analyzed regulatory options
that would minimize the economic impact of the rule on small entities
consistent with statutory objectives. We have crafted the final rule to
provide flexibility for compliance.
    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 $141 million, using the most current (2013) Implicit
Price Deflator for the Gross Domestic Product. FDA has determined that
this final rule has met the threshold under the Unfunded Mandates
Reform Act.
    The analyses that we have performed to examine the impacts of this
final rule under Executive Order 12866, Executive Order 13563, the
Regulatory Flexibility Act, and the Unfunded Mandates Reform Act of
1995 are included in the RIA (Ref. 42).
    We had prepared a ``Preliminary Regulatory Impact Analysis'' (Ref.
43) in connection with the proposed rule. We also included sections
titled ``Summary of Preliminary Regulatory Impact Analysis'' and
``Initial Regulatory Flexibility Analysis'' in the preamble to the
proposed rule (76 FR 19192 at 19220 through 19225). We received
comments on our analysis of the impacts presented in those sections,
and the RIA (Ref. 42) contains our responses to those comments.

XXVI. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are
subject to review by OMB under the Paperwork Reduction Act of 1995 (the
PRA) (44 U.S.C. 3501-3520). A description of these provisions is given
in this section of the document with estimates of the annual reporting,
recordkeeping, and third-party disclosure burden. Included in each
burden estimate is the time for reviewing instructions, searching
existing data sources, gathering and maintaining the data needed, and
completing and reviewing each collection of information.

    We had included a section titled ``Paperwork Reduction Act of
1995'' in the preamble to the proposed rule (76 FR 19192 at 19225
through 19229). We received one comment on our analysis of the burdens
presented in that section.
    (Comment 156) One comment stated that the recordkeeping burdens of
the proposed rule would impose millions of dollars in cost per year.
The comment stated that these burdens are needless.
    (Response 156) We disagree that the burdens are needless. Providing
accurate, clear, and consistent nutrition information, including the
calorie content of foods, in restaurants and similar retail food
establishments will make such nutrition information available to
consumers in a direct and accessible manner to enable consumers to make
informed and healthful dietary choices.
    We invite comments on these topics: (1) Whether the proposed
collection of information is necessary for the proper performance of
FDA's functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Title: Information Collection Provisions of the Final Rule on Food
Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and
Similar Retail Food Establishments

A. Reporting Requirements
    Description of Respondents: The likely respondents to this
information collection are restaurants and similar retail food
establishments that voluntarily elect to be subject to the Federal
requirements of this rule by registering with FDA. These establishments
include chain retail food establishments and eating and drinking places
such as full- and limited-service restaurants, snack bars (including,
for example, ice cream, donut, and bagel shops and similar
establishments), cafeterias and drinking places, managed food service
facilities, grocery stores, supermarkets, convenience stores, general
merchandise stores, lodging facilities, recreational venues, sports
venues, performing arts venues, and movie theaters.
    Description: Restaurants and similar retail food establishments not
subject to the ACA's requirements may voluntarily elect to be subject
to the Federal requirements by registering with FDA. Authorized
officials for restaurants and similar retail food establishments must
provide FDA with the following information on Form FDA 3757: Their
contact information including name, address, phone number, and email
address for their authorized official; the contact information
including name, address, phone number, and email address for each
restaurant or similar retail food establishment being registered, as
well as the name and contact information for an official onsite, such
as the owner or manager, for each specific restaurant or similar retail
food establishment; all trade names the restaurant or similar retail
food establishment uses; preferred mailing address, if different from
location address for each establishment; and certification that the
information submitted is true and accurate, that the person submitting
it is authorized to do so, and that each registered restaurant or
similar retail food establishment will be subject to the requirements
of section 403(q)(5)(H) of the FD&C Act and Sec.  101.11 of the final
rule.
    To keep the establishment's registration active, the authorized
official of the restaurant or similar retail food establishment must
register every other year within 60 days prior to the expiration of the
establishment's current registration with FDA. Registration will
automatically expire if not renewed.

                                     Table 1--Estimated Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
                                   Number of     responses per   Total annual    Average burden
        21 CFR part 101           respondents   respondent per     responses    per response (in    Total hours
                                                     year                            hours)
----------------------------------------------------------------------------------------------------------------
Initial Burden (annualized
 over 3 years):
    Sec.   101.11(d) Initial             3,559               1           3,559  2...............           7,118
     Registration.
Annual Burden:
    Sec.   101.11(d)                     5,340               1           5,340  0.5 (30 minutes)           2,670
     Registration Renewal.
                               ------------------------------------------------                  ---------------
    Total Burden Hours........  ..............  ..............  ..............  ................           9,788
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We lack data on the number of restaurants and similar retail food
establishments that might voluntarily register to comply with this
final rule. We do not expect the net benefit for voluntary registration
for many non-covered establishments to be positive and in the RIA (Ref.
42) we indicate that as of the conducting of this analysis, no
establishments have voluntarily registered with FDA. Therefore we did
not estimate a significant burden in the RIA. However, in the event
that a few register anyway, or find positive incentive to do so, for
the purposes of this PRA analysis, we estimate the burden such
establishments will face. We believe that implementation of the final
rule, and the resulting attention to the nutrition content of standard
menu items, may give non-covered establishments an incentive to
voluntarily disclose calorie and other nutrition information. We
believe that the only types of establishments that would likely face a
positive incentive to voluntarily register are some restaurants and
some grocery, convenience, and general merchandise stores that do not
already provide this information in some form or another at the point
of purchase. We estimate that 5 percent of these establishments may
register, or 10,678 [(5% volunteer x 47% no nutrition info x 348,200
non-covered restaurants) + (5% volunteer x 49,900 non-covered grocery,
convenience, and general merchandise stores)] (Refs. 44 and 45). We
estimate it will require approximately 2 hours per initial
registration. Given 10,678 establishments and one initial registration
per establishment at 2 hours per registration, we estimate the initial
hourly burden for these establishments is 21,356 hours (10,678
establishments x 1 initial registration per establishment x 2 hours per
registration). Annualizing

this value over 3 years yields 7,118 hours per year (10,678
establishments/3 years x 1 initial registration per establishment x 2
hours per registration). (10,678 establishments/3 years = 3,559
establishments per year.)
    We expect that renewal registrations will require substantially
less time because establishments are expected to be able to affirm or
update the existing information in an online account in a way similar
to other FDA firm registration systems. We estimate that re-
registration will take 30 minutes (0.5 hours) for each registrant. This
would indicate that biennial registration would impose a burden of
5,340 hours (10,678 establishments x 0.5 hours) every 2 years, or 2,670
hours every year (10,678 establishments/2 years x 0.5 hours).
B. Recordkeeping Requirements
    The preamble to the proposed rule provided an estimate of the
recordkeeping burden, which consisted of the burden associated with
nutrition analysis and the burden associated with generating,
providing, or maintaining records. Upon further consideration, we have
omitted the burden estimate associated with generating or maintaining
records previously estimated in the proposed rule because the rule does
not require restaurants and similar retail food establishments to
generate or maintain records. This section now includes only the burden
estimate associated with providing information substantiating nutrient
values of standard menu items to FDA as required by the final rule.
Further, as discussed in section C of this analysis, we have included a
burden estimate for nutrition analysis as part of the third party
disclosure burden, since the total time, effort, or financial resources
expended by covered establishments to declare nutrition information
likely includes time, effort, or financial resources to determine the
nutrition content of covered menu items.
Description of Respondents
    The likely respondents to this information collection are
restaurants and similar retail food establishments that are subject to
the Federal requirements of this rule or that volunteer to be subject
to the rule. These establishments include chain retail food
establishments and eating and drinking places such as full- and
limited-service restaurants, snack bars (including, for example, ice
cream, donut, and bagel shops and similar establishments), cafeterias
and drinking places, and managed food service facilities. Chain retail
food establishments would also include some grocery stores,
supermarkets, convenience stores, general merchandise stores, lodging
facilities, recreational venues, sports venues, performing arts venues,
and movie theaters (Ref. 46).
Description
    The paperwork burden for the recordkeeping requirements of the
final rule is to provide substantiation of the nutrient values of
standard menu items to FDA. The likely respondents for the nutrition
analysis are restaurants and similar retail food establishments that
are subject to the Federal requirements of this rule or that volunteer
to be subject to the rule. These establishments must produce records
with information substantiating nutrient values for their standard menu
items.
    The likely respondents are the universe of retail food
establishments and retail chains that are covered by the final rule.
Our estimate includes eating and drinking places such as full- and
limited-service restaurants, snack bars including, for example, ice
cream, donut, and bagel shops and similar establishments, cafeterias
and drinking places, and managed food service facilities. Covered
establishments also include some grocery stores, supermarkets,
convenience stores, general merchandise stores, lodging facilities,
recreational venues, sports venues, performing arts venues, and movie
theaters.

                                                       Table 2--Estimated Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Annual
                21 CFR part 101                     Number       frequency per   Total annual               Hours per record                Total hours
                                                 recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                        Initial Burden (Annualized over 3 years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   101.8(c)(2)(i)(A) Initial Nutrition              69,017               1          69,017  0.25 (15 minutes).......................          17,254
 Analysis Records.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      Annual Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   101.8(c)(2)(i)(A) Recurring Nutrition            30,059               1          30,059  0.25 (15 minutes).......................           7,515
 Analysis Records.
                                               ------------------------------------------------                                          ---------------
    Total Burden Hours........................  ..............  ..............  ..............  ........................................          24,769
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

Initial Nutrition Analysis
    We estimate the annual number of the largest restaurant chains that
will need to produce substantiation of their standard menu items to be
541 (503 covered restaurant chains + 38 voluntary restaurant chains)
with an average of 117 unique menu items that will require an initial
nutrition analysis. This leads to 63,297 (541 chains x 117 items)
individual chains-specific restaurant records. In addition to chain-
level nutrition analysis, each individual restaurant establishment will
likely have a small variety of standard menu items that are unique to
the individual establishment. We estimate there are 11,684 restaurants
establishments (10,866 covered + 818 voluntary) with establishment-
specific items. Each of these restaurant establishments has an average
of five establishment-specific menu items. This leads to 58,420 (11,684
establishments x 5 items) individual establishment-specific restaurant
records.
    In addition to restaurants, other similar retail food
establishments have both chain-specific and establishment-specific menu
items. Other covered retail food establishments include: Grocery
stores, supermarkets, convenience stores, general merchandise stores,
lodging facilities, recreational venues, sports venues, performing arts
venues, and movie theaters. We estimate there are 691 grocery,
convenience, and general merchandise (GCGM) store chains (660 covered +
31 voluntary) with an average of 40 menu items each (= 27,640 records);
5,309 GCGM establishments

(5,060 covered + 249 voluntary) with an average of 5 establishment-
specific menu items each (= 26,545 records); 50 managed food service
(MFS) chains with an average of 80 menu items (= 4,000 records); 450
MFS establishments with an average of 5 establishment-specific menu
items (= 2,250 records); 100 lodging chains with an average of 40 menu
items (= 4,000 records); 620 lodging establishments with an average of
5 establishment-specific menu items (= 3,100 records); 250 sports,
recreation and entertainment (SRE) chains with an average of 59 menu
items (= 14,750 records); and 610 SRE establishments with an average of
5 establishment-specific menu times (= 3,050 records). In total, we
estimate there are 207,052 records (63,297 restaurant chain-level +
58,420 restaurant establishment-level + 27,640 GCGM chain-level +
26,545 GCGM establishment-level + 4,000 MFS chain-level + 2,250 MFS
establishment-level + 4,000 lodging chain-level + 3,100 lodging
establishment-level + 14,750 SRE chain-level + 3,050 SRE establishment-
level). Annualized over 3 years, this value yields 69,017 (= 207,052
records/3 years) per year. We estimate that each nutrition analysis
will require a burden of 15 minutes to produce each record. We estimate
the total recordkeeping burden for the initial nutrition analysis to be
17,254.25 hours (= 69,017 records x 0.25 hours per record).
Recurring Nutrition Analysis
    From Mintel Menu Insights data, we estimate that restaurant chains
introduced, on average, 24 new menu items in 2009 (Ref. 47). Because
the final requirements do not apply to temporary menu items, daily
specials, and foods that are part of a customary market test, only a
fraction of these items will need nutrition analysis. We estimate that
existing restaurant chains or individual establishments would need new
nutrition analysis for 25 percent of new standard menu items, or six
new standard menu items per year. If in addition to these new standard
menu items, chains need nutrition analysis on 6 reformulated standard
menu items, there would be a total of 12 nutrition analyses per chain
needed on an annual basis. Thus we estimate there will be 26,904 annual
records associated with new or reformulated items of covered chains [=
(1,151 restaurant chains + 691 GCGM chains + 50 MFS chains + 100
lodging chains + 250 SRE chains) x 12 menus items].
    In addition we estimate that each year there will be the number of
covered chains to increase in each category as companies expand. As
discussed in the final RIA, each year there will be some existing non-
covered chains that, through expansion of their business, will become
subject to the rule's requirements (for example, a chain expanding from
19 to 20 locations). We estimate there will be 20 new restaurant
chains, each with an average of 117 menu items; 5 new GCGM chains each
with an average of 40 menu items; 3 new MFS chains each with an average
of 80 menu items; 2 new lodging chains each with an average of 40 menu
items; 5 new SRE chains each with an average of 59 menu items. Thus we
estimate there will be 3,155 annual records [= (20 restaurants x 117
items) + (5 GCGM x 40 items) + (3 MFS x 80 items) + (2 lodging x 40
items) + (5 SRE x 59 items] associated with nutrition analysis for new
covered chains.
    Based on data from FDA's Recordkeeping Cost Model, we estimate that
it will take approximately 15 minutes per standard menu item for
providing the information of nutrition analysis to FDA (Ref. 48). We
estimate the total recurring recordkeeping burden for the nutrition
analysis to be 7,515 hours [(26,899 records for new/reformulated
standard menu items under existing chains + 3,155 records for items
under new chains) x 0.25 hours per record)].

C. Third-Party Disclosure Requirements

    Description of Respondents: Restaurants and similar retail food
establishments that are subject to statutory menu labeling requirements
or that voluntarily elect to be subject to the Federal requirements by
registering with FDA.
    Description: There will be five types of third-party disclosure
burdens under the rule related to: Initial nutrition analysis, initial
menu replacement, chain-level written nutrition information,
establishment-level nutrition information, recurring nutrition
analysis, and recurring menu replacement.

                                                    Table 3--Estimated Third Party Disclosure Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Number of                                                                   Total operating
            21 CFR Part 101                 Number of      disclosures    Total annual     Average burden per disclosure      Total     and maintenance
                                           respondents   per respondent    disclosures                                        hours          costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                        Initial Burden (Annualized over 3 years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   101.8(c)(2)(i)(A) Initial                 69,017               1          69,017  4................................    276,068  .................
 Nutrition Analysis.
Sec.   101.8(c)(2)(i)(A) Initial Menu           106,168               1         106,168  0.5 (30 minutes).................     53,084       $248,767,000
 Replacement.
Sec.   101.8(c)(2)(i)(A) Written                  1,632               1           1,632  3................................      4,896  .................
 Nutrition Information Chain-level.
Sec.   101.8(c)(2)(i)(A) Written                 18,673               1          18,673  0.5 (30 minutes).................      9,337  .................
 Nutrition Information Establishment-
 level.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      Annual Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   101.8(c)(2)(i)(A) Recurring               30,054               1          30,054  4................................    120,216  .................
 Nutrition Analysis.
Sec.   101.8(c)(2)(i)(A) Recurring Menu             700               1             700  0.5 (30 minutes).................        350           $529,000
 Replacement.
                                        ----------------------------------------------------------------------------------------------------------------
    Total..............................  ..............  ..............  ..............  .................................    463,951       $249,296,000
--------------------------------------------------------------------------------------------------------------------------------------------------------

Initial Nutrition Analysis
    The first burden is the time and effort expended by restaurants and
other retail food establishments to determine the nutrition content of
their covered menu items, which we refer to as ``Nutrition Analysis.''
A nutrition analysis entails the burden of determining nutrition
content for covered and voluntary establishment menus by analyzing the
food product and summarizing the nutritional information results. Note
that the recordkeeping portion of this burden was estimated in the
previous subsection.
    Our estimate for the annual number of the restaurant and similar
retail food chains and individual establishments that will be burdened
with initial nutrition analysis is identical to our estimate for the
chains and establishments under the recordkeeping subsection. The total
number of respondents estimated for the third-party disclosure burden
of initial nutrition analysis is 207,052. Annualized over 3 years, this
value becomes 69,017. We estimate that each nutrition analysis will
require a burden of 4 hours (this estimate of 4 hours was used in the
final RIA (Ref. 42)), thus total burden for the initial nutrition
analysis is 276,068 hours (207,052 records/3 years x 4 hours per
record).
Recurring Nutrition Analysis
    The second burden is the time and effort expended by restaurants
and other retail food establishments in recurring nutrition analysis.
As discussed in the recordkeeping subsection of this PRA, recurring
nutrition analysis will be required for new and reformulated standard
menu items. Our estimate for the annual number of the restaurant and
similar retail food chains and individual establishments that will be
burdened with recurring nutrition analysis is identical to our estimate
for the chains and establishments under the recordkeeping subsection.
The total number of respondents estimated for the third-party
disclosure burden of recurring nutrition analysis is 30,054. We
estimate that each nutrition analysis will require a burden of 4 hours
(this estimate of 4 hours was used in the final RIA (Ref. 42)), thus
total third party disclosure burden recurring nutrition analysis is
120,216 hours (30,054 records x 4 hours per record).
Initial Menu Replacement
    The third burden is for the time expended by restaurants and
similar retail food establishments to physically produce and install
the menus, menu boards that include the new calorie declarations, which
we refer to as ``Calorie Declaration Signs.'' As described in the final
RIA (Ref. 42), chain retail food establishments will need to redesign
and replace their existing menus and menu boards in order to comply
with the final requirements. For full service restaurants and drinking
places with only personal menus and no menu boards, this burden will be
relatively low. Most menus are replaced frequently anyway as they wear
out, are lost, or as prices and menu items change. For many of these
establishments, the burden of updating menus to comply with the final
requirements would be limited to design and associated administrative
hours.
    The longer lifespan of menu boards in limited-service eating places
would likely require the redesign of menu/menu boards and the
replacement of one or more menu boards. In addition, some chains would
need to update self-serve and display signs. The number of menus that
an establishment will keep on hand is highly variable. A full-service
restaurant, where each order is placed using a menu, will need more
than a quick-service establishment that uses menus just for takeout
orders. The number of menus is also tied to the seating capacity of the
restaurant, and whether the menu is laminated or paper. Because paper
menus are more fragile and cheaper to print in bulk, an establishment
may keep a large reserve in stock, whereas establishments using more
durable and expensive laminated menus may only keep a few extra on
hand. Estimates for the burden of updating menu boards, other major
displays that serve as menus, such as electronic displays, or major
materials needed to disclose calories for self-serve or displayed foods
to comply with the final requirements, will vary widely across chains
and establishments because of different menu board and display types.
    As described in the RIA, we estimate that the average full-service
restaurant establishment must discard and reprint one menu for each
seat, plus 10 extra, for a total of 91 menus per restaurant each year.
We estimate that GCGM stores have an average of two menu boards per
establishment based on public comments that we received. We estimate
that MFS and SRE establishments will each have an average of one menu
board. Lodging establishments generally have menus instead of menu
boards, and we estimate the menu replacement burden for establishments
in the lodging sector to be 87 menu replacements per establishment.
Since each covered and voluntarily registered establishment will need
to replace menus and/or menu boards, we estimate this total value to be
318,505 (= 248,610 restaurants + 53,095 GCGM + 4,500 MFS + 6,200
lodging + 6,100 SRE). (In the previous calculation, 248,610 restaurants
= 231,200 covered restaurants + 17,410 voluntary; and 53,095 GCGM =
50,600 covered + 2,495 voluntary.) Annualized over 3 years, this value
becomes 106,168 (= 318,505/3 years). We estimate the labor burden for
ordering new menus and menu boards to be 30 minutes (0.5 hours) per
establishment. Thus the total burden for initial menu replacement is
53,084 hours per year. At an average wage (which includes an extra 50
percent to account for overhead costs and employee benefits) of $30 per
hour for managers across the covered industries, the labor burden comes
to $1,593,000 (= 53,084 hours x $30 per hour). In the final RIA (Ref.
42), we estimated the total average costs associated with initial menu
replacement to be $250.36 million. This value takes into consideration
costs of menu/menu board design, printing, and installation.
Subtracting the labor costs of ordering new menus, $1,593,000, from the
total costs for initial menu replacement, $250,360,000, yields total
initial operating and maintenance costs of $248,767,000.
Recurring Menu Replacement for New Chains
    The fourth burden is for the time expended by new restaurants and
similar retail food establishments to physically replace menus and menu
boards that include the new calorie declarations. All restaurants and
similar retail food chains that become covered as the number of their
associated establishments grows beyond the coverage threshold of 20
will need to replace their menus and menu boards. We estimated in the
final RIA (Ref. 42) that the annual number of new covered restaurants
and similar retail food establishments is 700. Again, we estimate the
labor burden for ordering new menus and menu boards to be 30 minutes
(0.5 hours) per establishment. Thus the total annual burden for
recurring menu replacement is 350 hours per year. At an average wage
(which includes an extra 50 percent in overhead costs and employee
benefits) of $30 per hour for managers across the covered industries,
the recurring labor burden comes to $11,000 (= 350 hours x $30 per
hour). In the final RIA, we estimated the total average annual
operating and maintenance costs associated with recurring menu
replacement to be $540,000. This value

takes into consideration costs of menu/menu board design, printing, and
installation. Subtracting the recurring labor costs of ordering new
menus, $11,000, from the total costs for recurring menu replacement of
$540,000, yields total recurring operating and maintenance costs of
$529,000.
Written Nutrition Information
    The fifth burden is for the time expended by restaurants and
similar retail food establishments to make written nutrition
information available to customers upon request. The number of chains
(and associated establishments) that do not already provide this
information was estimated in the recordkeeping subsection under initial
nutrition analysis, or 1,632 chains (503 covered restaurant + 38
voluntary restaurant + 660 covered GCGM + 31 voluntary GCGM + 50
covered MFS + 100 covered lodging + 250 covered SRE) and 18,673
establishments with establishment specific-menu items (10,866 covered
restaurant + 818 voluntary restaurant + 5,060 covered GCGM + 249
voluntary GCGM + 450 covered MFS + 620 covered lodging + 610 covered
SRE). We estimate the time it takes to provide written nutrition
information at the chain level to be 3 hours per respondent. Since the
average number of establishment-specific menu items is only five per
establishment, we estimate the time it takes to provide written
nutrition information at the establishment level (for those menu items
that are specific only to the establishment) to be 30 minutes per
respondent. Thus the total burden hours for chain-level and
establishment level written nutrition information disclosure are 4,896
and 9,336.5 hours, respectively. Therefore the total third party
disclosure burden for the rule is 463,950.5 hours with total operating
and maintenance costs of $249,296,000.
    To ensure that comments on information collection are received, OMB
recommends that written comments be faxed to the Office of Information
and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX:<PHONE_NUMBER>,
or emailed to<EMAIL_ADDRESS>All comments should be
identified with the OMB Control Number 0910-NEW, and title
``Information Collection Provisions of the Final Rule on Food Labeling:
Nutrition Labeling of Standard Menu Items in Restaurants and Similar
Retail Food Establishments.'' Also include the FDA docket number found
in brackets in the heading of this document.
    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3507(d)), we have resubmitted the information collection provisions of
this final rule to OMB for review, because the final rule provides
additional modifications to Sec.  101.11. These requirements will not
be effective until we obtain OMB approval. Interested persons are
requested to submit comments regarding information collection to OMB
(see DATES and ADDRESSES).
    Prior to the effective and compliance date of this final rule, we
will publish a notice in the Federal Register announcing OMB's decision
to approve, modify, or disapprove the information collection provisions
in this final rule. An Agency may not conduct or sponsor, and a person
is not required to respond to, a collection of information unless it
displays a currently valid OMB control number.

XXVII. Federalism

    We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. Section 4(a) of the Executive order
requires Agencies to ``construe . . . a Federal statute to preempt
State law only where the statute contains an express preemption
provision or there is some other clear evidence that the Congress
intended preemption of State law, or where the exercise of State
authority conflicts with the exercise of Federal authority under the
Federal statute.'' Federal law includes an express preemption provision
that preempts ``any requirement for nutrition labeling of food that is
not identical to the requirement of section 403(q) [of the FD&C Act]
[21 U.S.C. 343(q)]'', except that this provision does not apply ``to
food that is offered for sale in a restaurant or similar retail food
establishment that is not part of a chain with 20 or more locations
doing business under the same name (regardless of the type of ownership
of the locations) and offering for sale substantially the same menu
items unless such restaurant or similar retail food establishment
complies with the voluntary provision of nutrition information
requirements under section 403(q)(5)(H)(ix) [of the FD&C Act].'' In the
proposed rule, we provided an interpretation of the preemptive
provisions of section 4205 of the ACA, as well as an alternative
interpretation (76 FR 19192 at 19203). (21 U.S.C. 343-1(a)(4)). The
final rule creates requirements for nutrition labeling of food under
section 403(q) of the FD&C Act that would preempt certain non-identical
State and local nutrition labeling requirements.
    Section 4205 of the ACA also includes a Rule of Construction
providing that ``Nothing in the amendments made by [section 4205] shall
be construed--(1) to preempt any provision of State or local law,
unless such provision establishes or continues into effect nutrient
content disclosures of the type required under section 403(q)(5)(H) of
the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(q)(5)(H)] (as
added by subsection(b)) and is expressly preempted under subsection
(a)(4) of such section; (2) to apply to any State or local requirement
respecting a statement in the labeling of food that provides for a
warning concerning the safety of the food or component of the food; or
(3) except as provided in section 403(q)(5)(H)(ix) of the Federal Food,
Drug, and Cosmetic Act [21 U.S.C. 343(q)(5)(H)(ix)] (as added by
subsection (b)), to apply to any restaurant or similar retail food
establishment other than a restaurant or similar retail food
establishment described in section 403(q)(5)(H)(i) of such Act.'' (See
Pub. L. 111-148, Sec. 4205(d), 124 Stat. 119, 576 (2010).)
    We interpret the provisions of section 4205 of the ACA related to
preemption to mean that States and local governments may not impose
nutrition labeling requirements for food sold in a covered
establishment, as defined in Sec.  101.11(a), unless the State or local
requirements are identical to the Federal requirements. In other words,
States and localities cannot have additional or different nutrition
labeling requirements for food sold either in (1) chain retail food
establishments or (2) restaurants and similar retail food
establishments not subject to the requirements of section 403(q)(5)(H)
of the FD&C Act that voluntarily elect to be subject to the
requirements by registering biannually under section 403(q)(5)(H)(ix).
    Otherwise, for certain food that is not subject to the nutrition
labeling requirements of section 403(q)(5)(H) of the FD&C Act, States
and localities may establish or continue to impose nutrition labeling
requirements. First, States and localities can have nutrition labeling
requirements for food sold in restaurants or similar retail food
establishments that are not part of a chain with 20 or more locations
doing business under the same name and offering for sale substantially
the same menu items that have not voluntarily registered under section
403(q)(5)(H)(ix) of the FD&C Act.
    Second, States and localities can have nutrition labeling
requirements for foods offered for sale in other establishments
described in sections

403(q)(5)(A)(i) or (ii) of the FD&C Act that are exempt from the
nutrition labeling requirements of sections 403(q)(1) to (q)(4) of the
FD&C Act under section 403(q)(5)(A)(i) or (ii) of the FD&C Act,
provided that such food is not required to have nutrition labeling
under section 403(q)(5)(H) of the FD&C Act. For example, certain foods
sold in schools and transportation carriers would not be required to
have nutrition labeling under sections 403(q)(1) to (q)(4) of the FD&C
Act (see section 403(q)(5)(A)(i) and (ii) of the FD&C Act and Sec.
101.9(j)(2) and (j)(3)), or under section 403(q)(5)(H) of the FD&C Act
because these establishments are not covered establishments within the
meaning of Sec.  101.11(a). Under our interpretation of the Rule of
Construction in section 4205(d)(1) of the ACA, nutrition labeling for
food sold from such establishments would not be ``nutrient content
disclosures of the type required under section 403(q)(5)(H)(viii) [of
the FD&C Act]'' and, therefore, would not be preempted. As a result,
States and localities would be able to continue to require nutrition
labeling for foods sold from establishments that are exempt from the
nutrition labeling requirements of section 403(q)(1) to (q)(4) of the
FD&C Act and not subject to nutrition labeling requirements of section
403(q)(5)(H) of the FD&C Act.
    In addition, the express preemption provisions of section
403(A)(a)(4) of the FD&C Act do not preempt any State or local
requirement respecting a statement in the labeling of food that
provides for a warning concerning the safety of the food or component
of the food.
    The preamble to the proposed rule (76 FR 19192 at 19229 to 19230)
described an alternative interpretation of the preemption provisions of
section 4205 of the ACA that could leave less room for States and
localities to require nutrition labeling for food sold in restaurants
or similar retail food establishments. Under this alternative
interpretation, State or local nutrition labeling requirements for food
sold in establishments that are not ``restaurants or similar retail
food establishments,'' would be ineligible for the exception to the
preemption in section 403(A)(a)(4) of the FD&C Act, because that
exception by its literal terms only covers nutrition labeling
requirements for food offered for sale in certain restaurants or
similar retail food establishments, specifically those not subject to
the nutrition labeling requirements of section 403(q)(5)(H) of the FD&C
Act. Under this alternative interpretation, States and localities could
not have nutrition labeling requirements for certain foods offered for
sale in non-restaurants and similar retail food establishments unless
they successfully petitioned us. Federal law provides that, upon
petition, FDA may exempt State or local requirements from the express
preemption provisions of section 403A(a)(4) of the FD&C Act under
certain conditions. (See 21 U.S.C. 343-1(b).) We have issued
regulations at Sec.  100.1 (21 CFR 100.1) describing the petition
process that is available to State and local governments to request
such exemptions from preemption.
    In addition, under this alternative interpretation, there would be
foods in certain establishments for which the Federal Government has
not required nutrition labeling and for which States and localities
would also be precluded from establishing such labeling requirements
unless they successfully petitioned us and a rulemaking was completed.
This approach would risk creating a regulatory gap that would be
inconsistent with the purposes of section 4205 of the ACA. It would
also impose a restriction and burden on the States and localities that
is inconsistent with the Federalism principles expressed in Executive
Order 13132, as well as a substantial administrative burden on FDA in
the event States petition for exemption.
    We requested comment on our interpretation of section 4025 of the
ACA related to preemption, as well as the alternative interpretation.
We also requested comment on the use of the petition process in this
context and on other potential interpretations that interested persons
could identify as appropriate given both the preemption-related
language of section 4205 of the ACA and the statutory goals.
    (Comment 157) Several comments agreed with our interpretation of
the preemption provisions of section 4205 of the ACA. A few of these
comments recommended that the final rule include an explicit statement
that the scope of the law's preemptive effect is coextensive with the
law's nutrition labeling requirements; that is, the only State and
local provisions that are preempted are those that explicitly require
the type of menu labeling set forth in section 4205 of the ACA at a
covered establishment. For example, the comments stated that if we
decide not to cover movie theaters, hospitals, and other establishments
or decide to exempt alcohol beverages from menu labeling in the final
rule, then States and localities can enact laws to cover them. Another
comment stated that an express statement about preemption will
encourage States and localities to pass laws that fill in the gaps and
to pass identical laws.
    One comment disagreed with our proposed interpretation of the
preemption provisions and its outcome. The comment stated that
narrowing the exception for preemption is consistent with Congress'
purpose to preempt the growing patchwork of State and local menu
labeling laws. In addition, the comment stated that, while the
alternative interpretation would result in a ``regulatory gap'' with
some establishments not covered by Federal, State, and local menu
labeling laws, Congress could amend the FD&C Act, if it chose to do so.
    (Response 157) We agree with the comments asserting that the
preemptive effect of the Federal menu labeling requirements of section
4205 of the ACA is limited to State and local requirements that impose
additional or different nutrition labeling requirements for food that
is covered by the Federal requirements of section 403(q)(5)(H) of the
FD&C Act and Sec.  101.11. We also agree that the alternative
interpretation described in the proposed rule (76 FR 19192 at 19230)
would restrict State and local authorities and create a regulatory gap
that would be inconsistent with the purposes and language of section
4205 of the ACA and the Federalism principles expressed in Executive
Order 13132.
    We disagree with the comment that suggested that the alternative
interpretation is more consistent with congressional intent to preempt
the ``patchwork'' of State and local laws on menu labeling and that the
solution for the ``regulatory gap'' under that interpretation would be
for Congress to amend the FD&C Act again. Congress did create a uniform
national menu labeling scheme for certain foods in certain facilities
described in section 4205 of the ACA. However, nothing in the
legislative history suggests that Congress intended to create a
category of foods in establishments for which neither the Federal
Government nor State or local governments could require menu labeling.
We think it is more consistent with the purposes of section 4205 of the
ACA, which provides valuable nutrition information to consumers, to
allow State and local governments to require menu labeling for food not
covered by Federal law. The language of section 4205(c) of the ACA
amending section 403A of the FD&C Act is consistent with our final
interpretation. This amendment includes an exception from preemption
for food sold in restaurants or similar retail food establishments that
are not restaurants or establishments subject to the requirements of
403(q)(5)(H) of the FD&C Act.

    For these reasons, we interpret the provisions of section 4205 of
the ACA related to preemption to mean that State and local governments
may not establish or continue in effect nutrition labeling requirements
for food covered by the Federal requirements of section 403(q)(5)(H) of
the FD&C Act and Sec.  101.11, unless the State or local requirements
are identical to the Federal requirements of section 403(q)(5)(H) of
the FD&C Act and Sec.  101.11. In other words, States and localities
cannot have additional or different nutrition labeling requirements for
food sold either from: (1) Chain retail food establishments; or (2)
restaurants and similar retail food establishments not otherwise
subject to the requirements of section 403(q)(5)(H) and Sec.  101.11
who voluntarily elect to be subject to those requirements by
registering biannually with FDA in accordance with section
403(q)(5)(H)(ix) of the FD&C Act and Sec.  101.11(d). For food sold in
restaurants and similar retail establishments not subject to the
nutrition labeling requirements of section 403(q)(5)(H) of the FD&C
Act, States and localities may impose nutrition labeling requirements.
    (Comment 158) Several comments agreed with our interpretation of
the Rule of Construction. One comment agreed that warning statements
are not preempted but asked us to clarify that this does not mean just
microbiological hazards.
    A few comments recommended that we codify the Rule of Construction.
The comments asserted that the absence of codified provisions in the
rule regarding the Rule of Construction could lead to confusion in
properly interpreting the statute. The comments maintained that the
lack of codified provisions in the rule for a similar Rule of
Construction in the NLEA (see 21 U.S.C. 343-1 note) has led to
confusion and to court decisions that have not taken that rule into
account. The comments maintained that ensuring that the Rule of
Construction is explicitly set out in Title 21 of the Code of Federal
Regulations could help to avoid similar problems with the menu labeling
law.
    (Response 158) With respect to our interpretation of the Rule of
Construction in section 4205(d) of the ACA, we reiterate that State or
local requirements for statements in food labeling providing for
warnings concerning food safety are not preempted. We agree with the
comment that food safety in this context is not limited to
microbiological hazards. We are not persuaded by the comments
suggesting that we add a codified statement to Sec.  101.11 restating
the Rule of Construction at section 4205(d) of the ACA. We have
highlighted the existence of the Rule of Construction and have
explained our interpretation of section 4205(d) of the ACA both in the
preamble to the proposed rule and in the preamble to this final rule.
We do not think that codifying the Rule of Construction in section
4205(d) in our regulations is needed either to prevent confusion in
interpreting the statute or to assure that courts consider section
4205(d) when appropriate.
    (Comment 159) Some comments asked us to address the meaning of
``identical'' in section 403A(a)(4) of the FD&C Act, which excludes
from preemption State and local requirements that are identical to
Federal requirements under section 403(q) of the FD&C Act. The comments
recommended that the final rule explicitly state that ``identical''
refers to the effect of the law and does not mean that a State or local
requirement must be identical in wording of the law.
    (Response 159) In response to the comments asserting that we revise
the rule to clarify the meaning of ``identical'' within the context of
section 403A(a)(4) of the FD&C Act, we note that we have already issued
a regulation at Sec.  100.1 that explains the meaning of ``not
identical to'' in the context of section 403A of the FD&C Act in
describing the petition process available to State and local
governments to request an exemption from the express preemption
provisions of section 403A of the FD&C Act under section 403A(b).
Section 100.1(c)(4) provides in relevant part that, within the context
of section 403A of FD&C Act, ``not identical to'' does not refer to the
specific words in the State or local requirement but instead means that
the State or local requirement directly or indirectly imposes
obligations or contains provisions concerning the labeling of food
that: (1) Are not imposed by or contained in the applicable provision
(including any implementing regulation) of section 403 of the FD&C Act;
or (2) differ from those specifically imposed by or contained in the
applicable provision (including any implementing regulation) of section
403 of the FD&C Act.
    Accordingly, a State or local nutrition labeling requirement for
food covered by the requirements of section 403(q)(5)(H) of the FD&C
Act and Sec.  101.11 that directly or indirectly imposes obligations or
contains labeling provisions that: (1) Are not imposed by or contained
in section 403(q) of the FD&C Act and Sec.  101.11; or (2) differ from
those specifically imposed by or contained in section 403(q) of the
FD&C Act and Sec.  101.11 would be ``not identical to'' the Federal
requirements and therefore would be preempted under section 403A(a)(4)
of the FD&C Act. Because the meaning of the phrase ``not identical
to,'' within the context of section 403A of the FD&C Act, is already
described in Sec.  100.1 and is further explained here, we decline to
revise the rule to clarify the meaning of ``identical'' as suggested by
the comments.
    (Comment 160) A few comments recommended that we support
development of State and local laws that are identical. The comments
recommended that we help the States and localities by making staff
available to help assess the proposed language of State or local law
for potential conflicts with Federal law and providing model
legislation, which should be made part of the Model Food Code.
    (Response 160) As discussed in section XXIV, a State or local
jurisdiction may establish requirements, identical to those established
in this rule, in its own food codes and then enforce its own food
codes. Whether we can help States and localities assess the proposed
language of State or local law for potential conflicts with Federal law
will depend on resources available at the time of any requests for such
assistance. However, at this time, we do not expect to have resources
to provide model legislation for use by States and localities. We
recommend that States and localities who wish to establish
requirements, in their own food codes, identical to those established
in this rule adapt Sec.  101.11 for their own use.
    (Comment 161) One comment asked us to describe the basis on which
establishments that opt into the program can be assured that preemption
applies. The comment asserted that if a facility complies with the
Federal requirements under its food service contract as agreed to by
the Federal Government, that establishment must be fully protected from
State and local menu labeling action. The comment also stated that a
facility's compliance with the terms of a Federal Government contract
must suffice as certification that the facility is in compliance with
all FDA menu labeling provisions and the facility should be permitted
to opt into our program without any additional requirements.
    (Response 161) As provided in 403(q)(5)(H)(ix) of the FD&C Act,
authorized officials of restaurants and similar retail establishments
that are not subject to the requirements of section 403(q)(5)(H) may
elect to be subject to those requirements by registering biannually
with FDA, as specified in Sec.  101.11(d). Under section 403A(a)(4) of

the FD&C Act, an establishment that ``complies with the voluntary
provision of nutrition information requirements of 403(q)(5)(H)(ix)''
brings itself within the scope of Federal preemption of State and local
laws. The comment appears essentially to be seeking FDA's assurances
that a facility's compliance with the terms of a Federal contract to
provide food services would (1) suffice for ``opting in'' to the
voluntary program and (2) guarantee that State and local menu labeling
action against the facility is prohibited. We decline to provide such
assurances. The requirements for voluntarily ``opting in'' to be
subject to the Federal menu labeling requirements are set forth in
Sec.  101.11(d). Preemption of certain State and local requirements
follows from voluntarily becoming subject to the requirements of Sec.
101.11. The effects of following the terms of Federal contracts to
procure food services are outside the scope of this rulemaking.

XXVIII. 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.

XXIX. References

    The following references have been placed on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov. (FDA
has verified all the Web site addresses in this reference section, but
FDA is not responsible for any subsequent changes to the Web sites
after this document publishes in the Federal Register).

1. Flegal, K.M., M.D. Carroll, C.L. Ogden, et al., ``Prevalence and
Trends in Obesity Among U.S. Adults 1999-2008,'' Journal of the
American Medical Association, 303:235-241, 2010.
2. Ogden, C.L., M.D. Carroll, L.R. Curtin, et al., ``Prevalence of
High Body Mass Index in U.S. Children and Adolescents, 2007-2008,''
Journal of the American Medical Association, 303:242-249, 2010.
3. U.S. Department of Health and Human Services (DHHS) and USDA,
``2010 Dietary Guidelines for Americans,'' 7th ed., Washington DC:
U.S. Government Printing Office, 2010. Available at http://www.cnpp.usda.gov/DGAs2010-PolicyDocument.htm. Accessed on November
3, 2014.
4. Lin, B.H., J. Guthrie, and E. Fraz[atilde]o. ``Nutrient
Contribution of Food Away From Home,'' America's Eating Habits:
Changes and Consequences, chapter 12, Elizabeth Fraz[atilde]o (ed.),
USDA Agriculture Information Bulletin No. (AIB-750), pp. 213-242,
May 1999.
5. FDA Reports & Research Internet Web page: ``Backgrounder--
Keystone Forum on Away-From-Home Foods: Opportunities for Preventing
Weight Gain and Obesity Report,'' Keystone Center, June 2006.
6. USDA, Economic Research Service, ``Table 10: Food Away From Home
as a Share of Food Expenditures,'' Food CPI and Expenditures: Food
Expenditure Tables. Available at http://www.ers.usda.gov/data-products/food-expenditures.aspx. Accessed on November 3, 2014.
7. Burton, S., E.H. Creyer, J. Kees, et al., ``Attacking the Obesity
Epidemic: The Potential Health Benefits of Providing Nutrition
Information in Restaurants,'' American Journal of Public Health,
96(9):1669-1675, September 2006.
8. FDA, ``Draft Guidance for Industry: Questions and Answers
Regarding Implementation of the Menu Labeling Provisions of Section
4205 of the Patient Protection and Affordable Care Act of 2010,''
2010.
9. 112th Congress, House of Representatives, H. Rept. 112-101,
``Agriculture, Rural Development, Food and Drug Administration, and
Related Agencies Appropriations Bill, 2012,'' June 3, 2011.
10. FDA, ``Guidance for Industry: A Labeling Guide for Restaurants
and Other Retail Establishments Selling Away-From-Home Foods,''
April 2008.
11. Food Marketing Trends. ``U.S. Grocery Shopper Trends'', 2010.
12. Sutherland Statutes 21.4, 7th ed., 2009.
13. 155 Cong. Rec. S5522 (May 14, 2009) (statement of Senator
Harkin).
14. Commissioner, New York State Department of Agriculture and
Markets and Commissioner, New York State Department of Health.
``Memorandum of Understanding Between the New York State Department
of Health and the New York State Department of Agriculture and
Markets Concerning the Inspection of Food Service Establishments and
Food Processing Establishments'', 2010.
15. Webster's Third New International Dictionary, p. 369, 2002.
16. The American Heritage Online Dictionary. Available at http://ahdictionary.com/word/search.html?q=chain. Accessed on November 3,
2014.
17. Merriam-Webster Dictionary. Available at http://www.merriam-webster.com/dictionary/chain. Accessed on November 3, 2014.
18. Webster's Third New International Dictionary, pp. 1327-1328,
2002.
19. The American Heritage Online Dictionary. Available at http://ahdictionary.com/word/search.html?q=location. Accessed on November
3, 2014.
20. The American Heritage Online Dictionary. Available at http://ahdictionary.com/word/search.html?q=writing. Accessed on November 3,
2014.
21. Merriam-Webster Dictionary. Available at http://www.merriam-webster.com/dictionary/writing. Accessed on November 3, 2014.
22. Webster's Third New International Dictionary, p. 2641, 2002.
23. Merriam-Webster Dictionary. Available at http://www.merriam-webster.com/dictionary/primary. Accessed on November 3, 2014.
24. The American Heritage Online Dictionary. Available at http://ahdictionary.com/word/search.html?q=primary. Accessed on November 3,
2014.
25. Webster's Third New International Dictionary, p. 1800, 2002.
26. 2A Sutherland Statutory Construction 137, 7th ed., 2009.
27. McDonald's and North America Consumer and Business Insights,
``Drive-Thru Caloric Information Online Customer Satisfaction
Survey'', 2011.
28. FDA Memorandum, Chung-Tung Jordan Lin, to the File, ``Review of
Comment Submitted by McDonald's USA to Docket No. FDA-2011-F-0172,
on the Use of Stanchions at Drive-Through Windows to Disclose
Calories in Standard Menu Items in Restaurants and Similar Retail
Food Establishments,'' January 27, 2012.
29. Harkin, DeLauro Respond to Proposed Menu Labeling Rules. April
1, 2011. Available at http://www.harkin.senate.gov/press/release.cfm?i=332329. Accessed on November 3, 2014.
30. U.S. Department of the Treasury, Alcohol and Tobacco Tax and
Trade Bureau. TTB Ruling Number: 2013-2, May 28, 2013.
31. Cunningham, S.K., The Bartender's Black Book, 10th ed., 2011.
32. Comment from Hyman, Phelps, and McNamara on behalf of Dominoes,
Appendix 3, 2011.
33. FDA Memorandum, Chung-Tung Jordan Lin, to the File, ``Review of
Comment Submitted by Culver Franchising Systems, Inc,. to Docket No.
FDA-2011-F-0172, on the Calorie Declaration Option of Not Using
Caloric Ranges for Combination Meals and Variable Menu Items,''
February 29, 2012.
34. California Health and Safety Code, Section 114377.
35. New York City Health Code, Section 81.08.
36. Baltimore City Health Code Section 6-507.
37. County Council for Montgomery County Maryland, Resolution No.
16-134, 2007.
38. FDA, ``Guidance for Industry: A Food Labeling Guide,'' 2008.
39. FDA, ``Regulatory Procedures Manual,'' chapter 4.
40 FDA, ``Regulatory Procedures Manual,'' chapter 6, section 5.
41. FDA, ``State Contracts,'' available at http://www.fda.gov/ForFederalStateandLocalOfficials/PartnershipsContracts/StateContracts/default.htm, 2012.
42. FDA, ``Food Labeling: Nutrition Labeling of Standard Menu Items
in Restaurants

and Similar Retail Food Establishments. Final Regulatory Impact
Analysis,'' Docket No. FDA-2011-F-0172, 2014.
43. ``Food Labeling: Nutrition Labeling of Standard Menu Items in
Restaurants and Similar Retail Food Establishments. Notice of
Proposed Rulemaking,'' Docket No. FDA-2011-F-0172, Preliminary
Regulatory Impact Analysis, 2011.
44. U.S. Census Bureau. County Business Patterns, United States
NAICS 2000-2008. October 18, 2010.
45. Wootan, M.G., M. Osborn. ``Availability of Nutrition Information
From Chain Restaurants in the United States. American Journal of
Preventive Medicine, 30(3):266-268, 2006.
46. U.S. Census Bureau. North American Industry Classification
System. 2007. October 18, 2010.
47. Mintel Menu Insights. New Menu Items at Restaurants. 2010.
48. Eastern Research Group I. Evaluation of Recordkeeping Costs for
Food Manufacturers, Final Report. Sertkaya, A, A. Berlind, S. Erdem,
editors. Contract No. 223-01-2461, Task Order Number 5. 2007.

List of Subjects

21 CFR Part 11

    Administrative practice and procedure, Computer technology,
Reporting and recordkeeping requirements.

21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
11 and 101 are amended as follows:

PART 11--ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

0
1. The authority citation for 21 CFR part 11 continues to read as
follows:

    Authority:  21 U.S.C. 321-393; 42 U.S.C. 262.

0
2. Section 11.1 is amended by adding paragraph (g) to read as follows:

Sec.  11.1  Scope.

* * * * *
    (g) This part does not apply to electronic signatures obtained
under Sec.  101.11(d) of this chapter.

PART 101--FOOD LABELING

0
3. The authority citation for 21 CFR part 101 continues to read as
follows:

    Authority:  15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,
343, 348, 371; 42 U.S.C. 243, 264, 271.

0
4. Section 101.9 is amended by revising paragraph (j)(1)(i), the
introductory text of paragraphs (j)(2) and (3), and the first sentence
of paragraph (j)(4) to read as follows:

Sec.  101.9  Nutrition labeling of food.

* * * * *
    (j) * * *
    (1)(i) Food offered for sale by a person who makes direct sales to
consumers (e.g., a retailer) who has annual gross sales made or
business done in sales to consumers that is not more than $500,000 or
has annual gross sales made or business done in sales of food to
consumers of not more than $50,000, Provided, That the food bears no
nutrition claims or other nutrition information in any context on the
label or in labeling or advertising. Claims or other nutrition
information subject the food to the provisions of this section, Sec.
101.10, or Sec.  101.11, as applicable.
* * * * *
    (2) Except as provided in Sec.  101.11, food products that are:
* * * * *
    (3) Except as provided in Sec.  101.11, food products that are:
* * * * *
    (4) Except as provided in Sec.  101.11, foods that contain
insignificant amounts of all of the nutrients and food components
required to be included in the declaration of nutrition information
under paragraph (c) of this section, Provided, That the food bears no
nutrition claims or other nutrition information in any context on the
label or in labeling or advertising. * * *
* * * * *

0
5. Section 101.10 is revised to read as follows:

Sec.  101.10  Nutrition labeling of restaurant foods whose labels or
labeling bear nutrient content claims or health claims.

    Nutrition labeling in accordance with Sec.  101.9 shall be provided
upon request for any restaurant food or meal for which a nutrient
content claim (as defined in Sec.  101.13 or in subpart D of this part)
or a health claim (as defined in Sec.  101.14 and permitted by a
regulation in subpart E of this part) is made, except that information
on the nutrient amounts that are the basis for the claim (e.g., ``low
fat, this meal provides less than 10 grams of fat'') may serve as the
functional equivalent of complete nutrition information as described in
Sec.  101.9. For the purposes of this section, restaurant food includes
two categories of food. It includes food which is served in restaurants
or other establishments in which food is served for immediate human
consumption or which is sold for sale or use in such establishments. It
also includes food which is processed and prepared primarily in a
retail establishment, which is ready for human consumption, which is of
the type described in the previous sentence, and which is offered for
sale to consumers but not for immediate human consumption in such
establishment and which is not offered for sale outside such
establishment. For standard menu items that are offered for sale in
covered establishments (as defined in Sec.  101.11(a)), the information
in the written nutrition information required by Sec.
101.11(b)(2)(ii)(A) will serve to meet the requirements of this
section. Nutrient levels may be determined by nutrient databases,
cookbooks, or analyses or by other reasonable bases that provide
assurance that the food or meal meets the nutrient requirements for the
claim. Presentation of nutrition labeling may be in various forms,
including those provided in Sec.  101.45 and other reasonable means.

0
6. Section 101.11 is added to subpart A to read as follows:

Sec.  101.11  Nutrition labeling of standard menu items in covered
establishments.

    (a) Definitions. The definitions of terms in section 201 of the
Federal Food, Drug, and Cosmetic Act apply to such terms when used in
this section. In addition, for purposes of this section:
    Authorized official of a restaurant or similar retail food
establishment means the owner, operator, agent in charge, or other
person authorized by the owner, operator, or agent in charge to
register the restaurant or similar retail food establishment, which is
not otherwise subject to section 403(q)(5)(H) of the Federal Food,
Drug, and Cosmetic Act, with FDA for the purposes of paragraph (d) of
this section.
    Combination meal means a standard menu item that consists of more
than one food item, for example a meal that includes a sandwich, a side
dish, and a drink. A combination meal may be represented on the menu or
menu board in narrative form, numerically, or pictorially. Some
combination meals may include a variable menu item or be a variable
menu item as defined in this paragraph where the components may vary.
For example, the side dish may vary among several options (e.g., fries,
salad, or onion rings) or the drinks may vary (e.g., soft drinks, milk,
or juice) and the customer selects which of these items will be
included in the meal.
    Covered establishment means 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 registered to be covered under paragraph (d) of this section.
    Custom order means a food order that is prepared in a specific
manner based on an individual customer's request, which requires the
covered establishment to deviate from its usual preparation of a
standard menu item, e.g., a club sandwich without the bacon if the
establishment usually includes bacon in its club sandwich.
    Daily special means a menu item that is prepared and offered for
sale on a particular day, that is not routinely listed on a menu or
menu board or offered by the covered establishment, and that is
promoted by the covered establishment as a special menu item for that
particular day.
    Doing business under the same name means sharing the same name. The
term ``name'' refers to either:
    (i) The name of the establishment presented to the public; or
    (ii) If there is no name of the establishment presented to the
public (e.g., an establishment with the generic descriptor ``concession
stand''), the name of the parent entity of the establishment. When the
term ``name'' refers to the name of the establishment presented to the
public under paragraph (i) of this definition, the term ``same''
includes names that are slight variations of each other, for example,
due to the region, location, or size (e.g., ``New York Ave. Burgers''
and ``Pennsylvania Ave. Burgers'' or ``ABC'' and ``ABC Express'').
    Food on display means restaurant-type food that is visible to the
customer before the customer makes a selection, so long as there is not
an ordinary expectation of further preparation by the consumer before
consumption.
    Food that is part of a customary market test means food that
appears on a menu or menu board for less than 90 consecutive days in
order to test consumer acceptance of the product.
    Location means a fixed position or site.
    Menu or menu board means the primary writing of the covered
establishment from which a customer makes an order selection,
including, but not limited to, breakfast, lunch, and dinner menus;
dessert menus; beverage menus; children's menus; other specialty menus;
electronic menus; and menus on the Internet. Determining whether a
writing is or is part of the primary writing of the covered
establishment from which a customer makes an order selection depends on
a number of factors, including whether the writing lists the name of a
standard menu item (or an image depicting the standard menu item) and
the price of the standard menu item, and whether the writing can be
used by a customer to make an order selection at the time the customer
is viewing the writing. The menus may be in different forms, e.g.,
booklets, pamphlets, or single sheets of paper. Menu boards include
those inside a covered establishment as well as drive-through menu
boards at covered establishments.
    Offering for sale substantially the same menu items means offering
for sale a significant proportion of menu items that use the same
general recipe and are prepared in substantially the same way with
substantially the same food components, even if the name of the menu
item varies, (e.g. ``Bay View Crab Cake'' and ``Ocean View Crab
Cake''). ``Menu items'' in this definition refers to food items that
are listed on a menu or menu board or that are offered as self-service
food or food on display. Restaurants and similar retail food
establishments that are part of a chain can still be offering for sale
substantially the same menu items if the availability of some menu
items varies within the chain. Having the same name may indicate, but
does not necessarily guarantee, that menu items are substantially the
same.
    Restaurant or similar retail food establishment means a retail
establishment that offers for sale restaurant-type food, except if it
is a school as defined by 7 CFR 210.2 or 220.2.
    Restaurant-type food means food that is:
    (i) Usually eaten on the premises, while walking away, or soon
after arriving at another location; and
    (ii) Either:
    (A) Served in restaurants or other establishments in which food is
served for immediate human consumption or which is sold for sale or use
in such establishments; or
    (B) Processed and prepared primarily in a retail establishment,
ready for human consumption, of the type described in paragraph (ii)(A)
of this definition, and offered for sale to consumers but not for
immediate human consumption in such establishment and which is not
offered for sale outside such establishment.
    Self-service food means restaurant-type food that is available at a
salad bar, buffet line, cafeteria line, or similar self-service
facility and that is served by the customers themselves. Self-service
food also includes self-service beverages.
    Standard menu item means a restaurant-type food that is routinely
included on a menu or menu board or routinely offered as a self-service
food or food on display.
    Temporary menu item means a food that appears on a menu or menu
board for less than a total of 60 days per calendar year. The 60 days
includes the total of consecutive and non-consecutive days the item
appears on the menu.
    Variable menu item means a standard menu item that comes in
different flavors, varieties, or combinations, and is listed as a
single menu item.
    (b) Requirements for nutrition labeling for food sold in covered
establishments--(1) Applicability. (i) The labeling requirements in
this paragraph (b) apply to standard menu items offered for sale in
covered establishments.
    (ii)(A) The labeling requirements in this paragraph (b) do not
apply to foods that are not standard menu items, including:
    (1) Items such as condiments that are for general use, including
those placed on the table or on or behind the counter; daily specials;
temporary menu items; custom orders; food that is part of a customary
market test; and
    (2) Self-service food and food on display that is offered for sale
for less than a total of 60 days per calendar year or fewer than 90
consecutive days in order to test consumer acceptance.
    (B) The labeling requirements of paragraph (b)(2)(iii) of this
section do not apply to alcoholic beverages that are foods on display
and are not self-service foods.
    (2) Nutrition information. (i) Except as provided by paragraph
(b)(2)(i)(A)(8) of this section, the following must be provided on
menus and menu boards:
    (A) The number of calories contained in each standard menu item
listed on the menu or menu board, as usually prepared and offered for
sale. In the case of multiple-serving standard menu items, this means
the calories declared must be for the whole menu item listed on the
menu or menu board as usually prepared and offered for sale (e.g.,
``pizza pie: 1600 cal''); or per discrete serving unit as long as the
discrete serving unit (e.g., pizza slice) and total number of discrete
serving units contained in the menu item are declared on the menu or
menu board, and the menu item is usually prepared and offered for sale
divided in discrete serving units (e.g., ``pizza pie: 200 cal/slice, 8
slices''). The calories must be declared in the following manner:
    (1) The number of calories must be listed adjacent to the name or
the price of the associated standard menu item, in a type size no
smaller than the type size of the name or the price of the

associated standard menu item, whichever is smaller, in the same color,
or a color at least as conspicuous as that used for the name of the
associated standard menu item, and with the same contrasting background
or a background at least as contrasting as that used for the name of
the associated standard menu item.
    (2) To the nearest 5-calorie increment up to and including 50
calories and to the nearest 10-calorie increment above 50 calories,
except that amounts less than 5 calories may be expressed as zero.
    (3) The term ``Calories'' or ``Cal'' must appear as a heading above
a column listing the number of calories for each standard menu item or
adjacent to the number of calories for each standard menu item. If the
term ``Calories'' or ``Cal'' appears as a heading above a column of
calorie declarations, the term must be in a type size no smaller than
the smallest type size of the name or price of any menu item on that
menu or menu board in the same color or a color at least as conspicuous
as that used for that name or price and in the same contrasting
background or a background at least as contrasting as that used for
that name or price. If the term ``Calories'' or ``Cal'' appears
adjacent to the number of calories for the standard menu item, the term
``Calories'' or ``Cal'' must appear in the same type size and in the
same color and contrasting background as the number of calories.
    (4) Additional requirements that apply to each individual variable
menu item:
    (i) When the menu or menu board lists flavors or varieties of an
entire individual variable menu item (such as soft drinks, ice cream,
doughnuts, dips, and chicken that can be grilled or fried), the
calories must be declared separately for each listed flavor or variety.
Where flavors or varieties have the same calorie amounts (after
rounding in accordance with paragraph (b)(2)(i)(A)(2) of this section),
the calorie declaration for such flavors or varieties can be listed as
a single calorie declaration adjacent to the flavors or varieties,
provided that the calorie declaration specifies that the calorie amount
listed represents the calorie amounts for each individual flavor or
variety.
    (ii) When the menu or menu board does not list flavors or varieties
for an entire individual variable menu item, and only includes a
general description of the variable menu item (e.g. ``soft drinks''),
the calories must be declared for each option with a slash between the
two calorie declarations where only two options are available (e.g.,
``150/250 calories'') or as a range in accordance with the requirements
of paragraph (b)(2)(i)(A)(7) of this section where more than two
options are available (e.g., ``100-250 calories'').
    (iii) When the menu or menu board describes flavors or varieties
for only part of an individual variable menu item (such as different
types of cheese offered in a grilled cheese sandwich (e.g., ``Grilled
Cheese (Cheddar or Swiss)''), the calories must be declared for each
option with a slash between the two calorie declarations where only two
options are available (e.g., ``450/500 calories'') or as a range in
accordance with the requirements of paragraph (b)(2)(i)(A)(7) of this
section where more than two options are available (e.g., ``450-550
calories'').
    (5) Additional requirements that apply to a variable menu item that
is offered for sale with the option of adding toppings listed on the
menu or menu board. When the menu or menu board lists toppings that can
be added to a menu item (such as pizza or ice cream):
    (i) The calories must be declared for the basic preparation of the
menu item as listed (e.g., ``small pizza pie,'' ``single scoop ice
cream'').
    (ii) The calories must be separately declared for each topping
listed on the menu or menu board (e.g., pepperoni, sausage, green
peppers, onions on pizza; fudge, almonds, sprinkles on ice cream),
specifying that the calories are added to the calories contained in the
basic preparation of the menu item. Where toppings have the same
calorie amounts (after rounding in accordance with paragraph
(b)(2)(i)(A)(2) of this section), the calorie declaration for such
toppings can be listed as a single calorie declaration adjacent to the
toppings, provided that the calorie declaration specifies that the
calorie amount listed represents the calorie amount for each individual
topping.
    (iii) The calories for the basic preparation of the menu item must
be declared for each size of the menu item. The calories for each
topping listed on the menu or menu board must be declared for each size
of the menu item, or declared using a slash between the two calorie
declarations for each topping where only two sizes of the menu item are
available (e.g., ``adds 150/250 cal'') or as a range for each topping
in accordance with the requirements of paragraph (b)(2)(i)(A)(7) of
this section where more than two sizes of the menu item are available
(e.g., ``adds 100-250 cal''). If a slash between two calorie
declarations or a range of calorie declarations is used, the menu or
menu board must indicate that the variation in calories for each
topping arises from the size of the menu item to which the toppings are
added.
    (iv) If the amount of the topping included on the basic preparation
of the menu item decreases based on the total number of toppings
ordered for the menu item (such as is sometimes the case with pizza
toppings), the calories for each topping must be declared as single
values representing the calories for each topping when added to a one-
topping menu item, specifying that the calorie declaration is for the
topping when added to a one-topping menu item.
    (6) Additional requirements that apply to a combination meal.
Except as provided in paragraph (b)(2)(i)(A)(6)(iv) of this section:
    (i) When the menu or menu board lists two options for menu items in
a combination meal (e.g., a sandwich with a side salad or chips), the
calories must be declared for each option with a slash between the two
calorie declarations (e.g., ``350/450 calories'').
    (ii) When the menu or menu board lists three or more options for
menu items in a combination meal (e.g., a sandwich with chips, a side
salad, or fruit), the calories must be declared as a range in
accordance with the requirements of paragraph (b)(2)(i)(A)(7) of this
section (e.g., ``350-500 calories'').
    (iii) When the menu or menu board includes a choice to increase or
decrease the size of a combination meal, the calorie difference must be
declared for the increased or decreased size with a slash between two
calorie declarations (e.g., ``Adds 100/150 calories,'' ``Subtracts 100/
150 calories'') if the menu or menu board lists two options for menu
items in the combination meal, or as a range in accordance with the
requirements of paragraph (b)(2)(i)(A)(7) of this section (e.g., ``Adds
100-250 calories,'' ``Subtracts 100-250 calories'') if the menu or menu
board lists three or more options for menu items in the combination
meal.
    (iv) Where the menu or menu board describes an opportunity for a
consumer to combine standard menu items for a special price (e.g.,
``Combine Any Sandwich with Any Soup or Any Salad for $8.99''), and the
calories for each standard menu item, including each size option as
described in paragraph (b)(2)(i)(A)(6)(iii) of this section if
applicable, available for the consumer to combine are declared
elsewhere on the menu or menu board, the requirements of paragraphs
(b)(2)(i)(A)(6)(i), (ii), and (iii) of this section do not apply.
    (7) Additional format requirements for declaring calories for an
individual variable menu item, a combination meal, and toppings as a
range, if

applicable. Calories declared as a range must be in the format ``xx-
yy,'' where ``xx'' is the caloric content of the lowest calorie
variety, flavor, or combination, and ``yy'' is the caloric content of
the highest calorie variety, flavor, or combination.
    (8) Exception for a variable menu item that has no clearly
identifiable upper bound to the range of calories: If the variable menu
item appears on the menu or menu board and is a self-service food or
food on display, and there is no clearly identifiable upper bound to
the range, e.g., all-you-can-eat buffet, then the menu or menu board
must include a statement, adjacent to the name or price of the item,
referring customers to the self-service facility for calorie
information, e.g., ``See buffet for calorie declarations.'' This
statement must appear in a type size no smaller than the type size of
the name or price of the variable menu item, whichever is smaller, and
in the same color or a color at least as conspicuous as that used for
that name or price, with the same contrasting background or a
background at least as contrasting as that used for that name or price.
    (9) Additional requirements that apply to beverages that are not
self-service. For beverages that are not self-service, calories must be
declared based on the full volume of the cup served without ice, unless
the covered establishment ordinarily dispenses and offers for sale a
standard beverage fill (i.e., a fixed amount that is less than the full
volume of the cup per cup size) or dispenses a standard ice fill (i.e.,
a fixed amount of ice per cup size). If the covered establishment
ordinarily dispenses and offers for sale a standard beverage fill or
dispenses a standard ice fill, the covered establishment must declare
calories based on such standard beverage fill or standard ice fill.
    (B) The following statement designed to enable consumers to
understand, in the context of a total daily diet, the significance of
the calorie information provided on menus and menu boards: ``2,000
calories a day is used for general nutrition advice, but calorie needs
vary.'' For menus and menu boards targeted to children, the following
options may be used as a substitute for or in addition to the succinct
statement: ``1,200 to 1,400 calories a day is used for general
nutrition advice for children ages 4 to 8 years, but calorie needs
vary.''; or ``1,200 to 1,400 calories a day is used for general
nutrition advice for children ages 4 to 8 years and 1,400 to 2,000
calories a day for children ages 9 to 13 years, but calorie needs
vary.''
    (1) This statement must be posted prominently and in a clear and
conspicuous manner in a type size no smaller than the smallest type
size of any calorie declaration appearing on the same menu or menu
board and in the same color or in a color at least as conspicuous as
that used for the calorie declarations and with the same contrasting
background or a background at least as contrasting as that used for the
calorie declarations.
    (2) For menus, this statement must appear on the bottom of each
page of the menu. On menu pages that also bear the statement required
by paragraph (b)(2)(i)(C) of this section, this statement must appear
immediately above, below, or beside the statement required by paragraph
(b)(2)(i)(C) of this section.
    (3) For menu boards, this statement must appear on the bottom of
the menu board, immediately above, below, or beside the statement
required by paragraph (b)(2)(i)(C) of this section.
    (C) The following statement regarding the availability of the
additional written nutrition information required in paragraph
(b)(2)(ii) of this section must be on all forms of the menu or menu
board: ``Additional nutrition information available upon request.''
    (1) This statement must be posted prominently and in a clear and
conspicuous manner in a type size no smaller than the smallest type
size of any calorie declaration appearing on the same menu or menu
board and in the same color or in a color at least as conspicuous as
that used for the caloric declarations, and with the same contrasting
background or a background at least as contrasting as that used for the
caloric declarations.
    (2) For menus, the statement must appear on the bottom of the first
page with menu items immediately above, below, or beside the succinct
statement required by paragraph (b)(2)(i)(B) of this section.
    (3) For menu boards, the statement must appear on the bottom of the
menu board immediately above, below, or beside the succinct statement
required by paragraph (b)(2)(i)(B) of this section.
    (ii) The following nutrition information for a standard menu item
must be available in written form on the premises of the covered
establishment and provided to the customer upon request. This nutrition
information must be presented in the order listed and using the
measurements listed, except as provided in paragraph (b)(2)(ii)(B) of
this section. Rounding of these nutrients must be in compliance with
Sec.  101.9(c). The information must be presented in a clear and
conspicuous manner, including using a color, type size, and contrasting
background that render the information likely to be read and understood
by the ordinary individual under customary conditions of purchase and
use. Covered establishments may use the abbreviations allowed for
Nutrition Facts for certain packaged foods in Sec.
101.9(j)(13)(ii)(B):
    (A)(1) Total calories (cal);
    (2) Calories from fat (fat cal);
    (3) Total fat (g);
    (4) Saturated fat (g);
    (5) Trans fat (g);
    (6) Cholesterol (mg);
    (7) Sodium (mg);
    (8) Total carbohydrate (g);
    (9) Dietary fiber (g);
    (10) Sugars (g); and
    (11) Protein (g).
    (B) If a standard menu item contains insignificant amounts of all
the nutrients required to be disclosed in paragraph (b)(2)(ii)(A) of
this section, the establishment is not required to include nutrition
information regarding the standard menu item in the written form.