81_FR_50450 81 FR 50303 - Food Labeling; Calorie Labeling of Articles of Food in Vending Machines; Extension of Compliance Date

81 FR 50303 - Food Labeling; Calorie Labeling of Articles of Food in Vending Machines; Extension of Compliance Date

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 147 (August 1, 2016)

Page Range50303-50306
FR Document2016-18140

The Food and Drug Administration (FDA or we) is extending the compliance date for certain requirements in the final rule requiring disclosure of calorie declarations for food sold from certain vending machines. The final rule appeared in the Federal Register of December 1, 2014. We are taking this action in response to requests for an extension and for reconsideration of the rule's requirements pertaining to the size of calorie disclosures on front-of-package labeling.

Federal Register, Volume 81 Issue 147 (Monday, August 1, 2016)
[Federal Register Volume 81, Number 147 (Monday, August 1, 2016)]
[Rules and Regulations]
[Pages 50303-50306]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-18140]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 11 and 101

[Docket No. FDA-2011-F-0171]
RIN 0910-AG56


Food Labeling; Calorie Labeling of Articles of Food in Vending 
Machines; Extension of Compliance Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; extension of compliance date.

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

SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
compliance date for certain requirements in the final rule requiring 
disclosure of calorie declarations for food sold from certain vending 
machines. The final rule appeared in the Federal Register of December 
1, 2014. We are taking this action in response to requests for an 
extension and for reconsideration of the rule's requirements pertaining 
to the size of calorie disclosures on front-of-package labeling.

DATES: Effective date: This final rule is effective December 1, 2016.
    Compliance date: The compliance date for type size front-of-pack 
labeling requirements (Sec.  101.8(b)(2) (21 CFR 101.8(b)(2))) and 
calorie disclosure requirements (Sec.  101.8(c)(2)) for certain gums, 
mints, and roll candy products in glass-front machines in the final 
rule published December 1, 2014 (79 FR 71259) is extended to July 26, 
2018. The compliance date for all other requirements in the final rule 
(79 FR 71259) remains December 1, 2016.

FOR FURTHER INFORMATION CONTACT: April Kates, Center for Food Safety 
and Applied Nutrition (HFS-820), Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740, 240-402-2371, email: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 1, 2014 (79 FR 71259), we 
published a final rule establishing requirements for providing calorie 
declarations for food sold from certain vending machines. The final 
rule, which is codified primarily at Sec.  101.8, will ensure that 
calorie information is available for certain food sold from a vending 
machine that does not permit a prospective purchaser to examine the 
Nutrition Facts Panel before purchasing the article, or does not 
otherwise provide visible nutrition information at the point of 
purchase. The declaration of accurate and clear calorie information for 
food sold from vending machines will make calorie information available 
to consumers in a direct and accessible manner to enable consumers to 
make informed and healthful dietary choices. The final rule applies to 
certain food from vending machines operated by a person engaged in the 
business of owning or operating 20 or more vending machines. Vending 
machine operators not subject to the rules may elect to be subject to 
the Federal requirements by registering with FDA.
    The final rule also specifies how calories must be declared. In 
brief,
     Vending machine operators do not have to declare calorie 
information for a food if a prospective purchaser can view certain 
calorie information on the front of the package, in the Nutrition Facts 
label on the food, or in a reproduction of the Nutrition Facts label on 
the food subject to certain requirements, or if the vending machine 
operator does not own or operate 20 or more vending machines.
     Calorie declarations must be clear and conspicuous and 
placed prominently, and may be placed on a sign in, on, or adjacent to 
the vending machine, so long as the sign is in close proximity to the 
article of food or selection button.
     The final rule establishes type size, color, and contrast 
requirements for calorie declarations in or on the vending machines, 
and for calorie declarations on signs adjacent to the vending machines.
     The final rule establishes requirements for calorie 
declarations on electronic vending machines, those vending machines 
with only pictures or names of the food items, and those vending 
machines with few choices (e.g., popcorn machines).
    The final rule also requires vending machine operator contact 
information to be displayed for enforcement purposes.
    The final rule implements provisions of section 403(q)(5)(H) of the 
Federal

[[Page 50304]]

Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 343(q)(5)(H)).
    In the preamble to the final rule (79 FR 71259 at 71282 through 
71283), we stated that all covered vending machine operators must come 
into compliance with the rule's requirements no later than December 1, 
2016.

II. Extending the Compliance Date

A. Introduction

    Since we published the final rule in the Federal Register, several 
trade associations have contacted us to state that the type size 
requirement for calorie information on the package, often referred to 
as ``front-of-pack'' or FOP labeling, presents significant technical 
challenges to the packaged food industry. The trade associations asked 
us to amend the type size requirement for FOP labeling and to provide 
additional flexibility for providing calorie information for gums, 
mints, and roll candy (see Refs. 1 and 2).

B. Type Size Requirement for ``Articles of Food Not Covered'' (Sec.  
101.8(b)(2))

    With respect to FOP labeling, Sec.  101.8(b)(2), states that 
articles of food sold from a vending machine are not ``covered vending 
machine food'' if the prospective purchaser can otherwise view visible 
nutrition information, including, at a minimum the total number of 
calories for the article of food as sold at the point of purchase. The 
visible nutrition information must appear on the food label itself, be 
clear and conspicuous and able to be easily read on the article of food 
while in the vending machine, and be in a type size at least 50 percent 
of the size of the largest printed matter on the label and with 
sufficient color and contrasting background to other print on the label 
to permit the perspective purchaser to clearly distinguish the 
information.
    In the preamble to the final rule (79 FR 71259 at 71269 (see 
comment 16 and our response)), we discussed how FOP labeling could be a 
way to provide visible nutrition information for articles of food that 
are sold from a vending machine that are not ``covered vending machine 
food'' as interpreted by Sec.  101.8(c). We also noted how some 
comments felt that the rule's type size requirement was too large, 
whereas others stated that the type size would be too small (79 FR 
71259 at 71269). We explained that specifying the minimum type size for 
calorie information on vending machine food labels will provide greater 
clarity for both compliance and enforcement (id.).
    Since the publication of the final rule, several trade associations 
indicated that the type size requirement would make the calorie 
declaration very large on some products and would make label redesign 
difficult and/or not practical. They noted the existence of voluntary 
FOP labeling programs whereby calorie information is presented in a FOP 
type size that ranges from 100 to 150 percent of the size of the ``net 
quantity of contents'' statement on the principal display panel. They 
also asked us to align the compliance date with that for the Nutrition 
Facts labeling rule (81 FR 33742, May 27, 2016) so that food companies 
can ``make all changes to their food labels, including adding FOP 
calorie information, at the same time'' (see Ref. 2). The compliance 
date for the Nutrition Facts label rule is July 26, 2018, for 
manufacturers with $10 million or more in annual food sales.
    Consequently, with respect to Sec.  101.8(b)(2), we have decided to 
extend the compliance date for certain food products sold from a glass-
front vending machine that allow prospective purchasers to view 
packaged foods offered for sale. Specifically, if the food is:
     Sold from a glass-front vending machine that allows 
prospective purchasers to view packaged foods offered for sale;
     not a covered vending machine food within Sec.  
101.8(b)(2); and
     the label for such packaged foods provides front-of-
package calorie disclosures that complies with all aspects of the final 
vending machine labeling rule except that the disclosure is not 50 
percent of the size of the largest print on the label,

then the compliance date for Sec.  101.8(b)(2) is extended to July 26, 
2018. This extension of the compliance date will give us time to 
consider whether a revision to Sec.  101.8(b)(2) is necessary and also 
give packaged food manufacturers more time to consider label redesign 
issues or, in the case of products without FOP calorie labeling, to 
consider whether to add such labeling. We emphasize that this extension 
is limited to vending machine operators whose glass-front vending 
machines are subject to Sec.  101.8(b)(2) and where the packaged food 
has FOP calorie disclosures that complies with all aspects of the final 
vending machine labeling rule except that the disclosure is not 50 
percent of the size of the largest print on the label. Thus, a vending 
machine operator whose vending machines dispense packaged food without 
FOP labeling or use electronic displays is not affected by the 
extension. Similarly, a vending machine operator whose vending machines 
sell unpackaged food (such as fruit) is not affected by the extension.

C. Signage for Gums, Mints, and Roll Candy

    With respect to providing calorie information for gums, mints, and 
roll candy, our regulations, at Sec.  101.8(c), establishes 
requirements for calorie labeling for certain food sold from vending 
machines. Under Sec.  101.8(c)(2)(i)(C), the calorie declaration for 
covered vending machine food must include the total calories present in 
the packaged food, regardless of whether the packaged food contains a 
single serving or multiple servings. Under Sec.  101.8(c)(2)(ii)(A), 
the calorie declarations for covered vending machine food must be clear 
and conspicuous and placed prominently on a sign in close proximity to 
the article of food or selection button so long as the calorie 
declaration is visible at the same time as the food, its name, price, 
selection button, or selection number is visible.
    Several trade associations have disagreed with Sec.  101.8(c)(2) 
insofar as it would apply to gums, mints, and roll candy. The trade 
associations contend that gums, mints, and roll candy suitable for 
vending machines are not typically amenable to FOP labeling due to the 
limited size of the principal display panel, and as a result, there are 
few options for compliance for these products. They also describe that 
in glass-front vending machines, these items are often placed together 
at the bottom of the machine with limited space for signage. In 
addition, the trade associations have asserted that providing calories 
declarations ``per serving'' for these items is preferable to providing 
calories ``per container'', because consumers typically do not consume 
the entire packaged product at one time, and providing calorie 
declarations on a ``per serving'' basis would be consistent with our 
serving size requirements at 21 CFR 101.9. The trade associations also 
explained that these items typically contain insignificant amounts of 
all nutrients and are otherwise exempt from packaged food nutrition 
labeling, and that providing a sign with a range of 0 to 25 calories 
``per serving'' for these items is sufficient for consumers to make 
informed choices (Ref. 1). Based on these distinct challenges, the 
trade associations also suggested that we amend Sec.  101.8(c)(2) by 
adding a new paragraph that would, in effect, provide an exception for 
gums, mints, and roll candies that would allow the use of a range of 
calories (such as ``25 calories or

[[Page 50305]]

less/serving'') and the covered vending machine food:
     Contains at least three servings per package;
     has a ``reference amount customarily consumed'' (the 
portion size based on the amount the average person is likely to eat at 
one time) of 5 grams or less; and
     contains 25 calories or less per serving.

The trade associations indicated that the extension would only be for 
vending machine operators who, by December 1, 2016, have ``interim 
calorie signage'' that would consist of a single sign in close 
proximity to the article of food or selection button or inside the 
vending machine, where the sign states that gum, mint, and roll candies 
provide 25 calories or less/serving.
    We addressed a similar issue in the preamble to the final rule (see 
79 FR 71259 at 71276 through 71277 (see comment 24 and our response)) 
and explained why the calorie declaration requirement applies to the 
entire package rather than to a serving in the package. We disagree 
with the trade associations' suggestion that the final vending machine 
rule's serving size requirement should be consistent with that in our 
serving size rule. The vending machine rule applies to certain vending 
machine operators, whereas the serving size rule applies to food 
manufacturers. The statutory authority behind each regulation also 
differs; the vending machine label requirement is found in section 
403(q)(5)(H) of the FD&C Act, which requires, generally, that food sold 
in certain vending machines disclose the number of calories contained 
in food, whereas section 403(q)(1)(A)(i) of the FD&C Act requires, with 
certain exceptions, that food that is intended for human consumption 
and offered for sale bear nutrition information that provides a serving 
size that reflects the amount of food customarily consumed and is 
expressed in a common household measure that is appropriate to the 
food. Section 2(b)(1)(B) of the Nutrition Labeling and Education Act 
further requires the Secretary of Health and Human Services to issue 
regulations to establish standards to define serving size. 
Nevertheless, we note that, in the preamble to the final vending 
machine rule, we said we would allow, in addition to the total calorie 
declaration for the food as vended, the voluntary declaration of 
calories per serving for covered vending machine foods (see 79 FR 71259 
at 71277). The voluntary declaration of calories per serving, in 
addition to declaration of calories per container (required by Sec.  
101.8(c)(2)), should accommodate the trade associations' desire to 
disclose the number of calories per serving.
    However, we also are mindful that the gums, mints, and roll candies 
mentioned by the trade associations tend to be sold in small packages 
that do not lend themselves to FOP labeling and often are located or 
placed in a small space in glass-front vending machines; the small 
space may limit the size of any sign(s) that would disclose calorie 
information for each gum, mint, or roll candy. For example, we are 
aware that some glass-front vending machines may have trays that are 
different sizes; the tray width for bags of potato chips is larger than 
the tray width for a roll of mints or hard candies or for a small 
package of gum. The smaller tray size for gums, mints, and roll candy 
may make it difficult to add information, inside the vending machine, 
beyond the product's price and selection number. Therefore, we are 
extending the compliance date for Sec.  101.8(c)(2) to July 26, 2018, 
so that we may consider this issue further. This extension of the 
compliance date is limited to:
     Gums, mints, and roll candy sold in packages that are too 
small to bear FOP labeling and where the gums, mints, and roll candy 
are located in a small space within a glass-front vending machine that 
allows prospective purchasers to view packaged foods offered for sale;
     the space within the glass-front vending machine holding 
the gum, mints, and roll candy is so small such that it is not 
practicable to provide calorie information under each gum, mint, or 
roll candy; and
     the glass-front vending machine also does not or is not 
capable of providing calorie information electronically.
    This limited change in the compliance date for Sec.  101.8(c)(2) 
will give us time to consider issues relating to signage and vending 
machine design and give vending machine operators some flexibility in 
their disclosure of calorie information for gums, mints, and roll 
candies in small packages. In the interim, so consumers can make 
informed choices, we encourage vending machine operators to provide 
calorie information through a sign in close proximity to the gums, 
mints, and roll candy inside the vending machine that states the gums, 
mints, and roll candies provide ``X'' calories or less/serving, where X 
represents the value of the largest number of calories per serving for 
the gums, mints, and roll candies. We emphasize that this extension 
does not extend to other products in glass-front vending machines or 
glass-front vending machines that are capable of providing information 
electronically, nor does it extend to other types of vending machines. 
We also emphasize that the limited compliance date extension for Sec.  
101.8(c)(2) is intended to give vending machine operators more 
flexibility in providing calorie information for gums, mints, and roll 
candy in glass-front vending machines where those gums, mints, and roll 
candy are located or placed in a small space such that it is not 
practicable to provide calorie information under each gum, mint, or 
roll candy. Our final rule already gives vending machine operators 
other ways to comply with the calorie disclosure requirement; for 
example, vending machine operators can provide calorie declarations on 
a sign adjacent to the vending machine (see Sec.  101.8(c)(2)(ii)(C)).

III. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct us to assess all costs 
and benefits of available regulatory alternatives and, when regulation 
is necessary, to select regulatory approaches that maximize net 
benefits (including potential economic, environmental, public health 
and safety, and other advantages; distributive impacts; and equity). We 
have developed a comprehensive Economic Analysis of Impacts that 
assesses the impacts of this final rule (Ref. 3). We believe that this 
final rule is not a significant regulatory action as defined by 
Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because the final rule changes the compliance date for Sec.  
101.8(b)(2) and (c)(2), under the limited circumstances described in 
this document, from December 1, 2016, to July 26, 2018, we certify that 
the final rule will not have a significant economic impact on a 
substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before issuing ``any rule that includes 
any Federal mandate that may result in the expenditure by State, local, 
and tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted

[[Page 50306]]

annually for inflation) in any one year.'' The current threshold after 
adjustment for inflation is $146 million, using the most current (2015) 
Implicit Price Deflator for the Gross Domestic Product. This final rule 
would not result in an expenditure in any year that meets or exceeds 
this amount.

IV. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

V. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(k) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VI. References

    The following references are on display in the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, and are available for viewing by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday; 
they are also available electronically at http://www.regulations.gov.

1. Letter from Karin F. R. Moore, Vice President and General 
Counsel, Grocery Manufacturers Association, to Susan Mayne, Ph.D., 
Director, Center for Food Safety and Applied Nutrition, dated March 
31, 2016.
2. Letter from Karin Moore, Senior Vice President and General 
Counsel, Grocery Manufacturers Association, to Susan Mayne, Ph.D., 
Director, Center for Food Safety and Applied Nutrition, dated June 
26, 2016.
3. Economics Staff, Office of Planning, Office of Policy, Planning, 
Legislation, and Analysis, Office of the Commissioner, Food and Drug 
Administration, ``Food Labeling; Calorie Labeling of Articles of 
Food in Vending Machines; Extension of Compliance Date,'' dated July 
2016.

    Dated: July 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18140 Filed 7-29-16; 8:45 am]
 BILLING CODE 4164-01-P



                                                                 Federal Register / Vol. 81, No. 147 / Monday, August 1, 2016 / Rules and Regulations                                          50303

                                              for whom suitable work, as defined in                    Secretary of Labor is satisfied that there            I. Background
                                              State law, as defined in § 620.2, is only                is no longer any such failure. Until the                 In the Federal Register of December 1,
                                              available in an occupation that regularly                Secretary of Labor is so satisfied, the               2014 (79 FR 71259), we published a
                                              conducts drug testing under § 620.3.                     Department of Labor will not make                     final rule establishing requirements for
                                              Drug testing is permitted only of an                     further payments to such State.                       providing calorie declarations for food
                                              applicant, and not of an individual                                                                            sold from certain vending machines.
                                                                                                       Portia Wu,
                                              filing a continued claim for                                                                                   The final rule, which is codified
                                              unemployment compensation after                          Assistant Secretary for Employment and
                                                                                                       Training, Labor.                                      primarily at § 101.8, will ensure that
                                              initially being determined eligible. No                                                                        calorie information is available for
                                                                                                       [FR Doc. 2016–17738 Filed 7–29–16; 8:45 am]
                                              State is required to apply drug testing to                                                                     certain food sold from a vending
                                              UC applicants under this part 620.                       BILLING CODE 4510–FN–P
                                                                                                                                                             machine that does not permit a
                                                 (b) A State conducting drug testing as                                                                      prospective purchaser to examine the
                                              a condition of unemployment                                                                                    Nutrition Facts Panel before purchasing
                                              compensation eligibility as provided in                                                                        the article, or does not otherwise
                                                                                                       DEPARTMENT OF HEALTH AND
                                              paragraph (a) of this section may apply                                                                        provide visible nutrition information at
                                                                                                       HUMAN SERVICES
                                              drug testing only to the occupations                                                                           the point of purchase. The declaration
                                              listed under § 620.3, but is not required                Food and Drug Administration                          of accurate and clear calorie information
                                              to apply drug testing to any of them.                                                                          for food sold from vending machines
                                                 (c) State standards governing drug                    21 CFR Parts 11 and 101                               will make calorie information available
                                              testing of UC applicants must be in
                                                                                                                                                             to consumers in a direct and accessible
                                              accordance with guidance, in the form                    [Docket No. FDA–2011–F–0171]                          manner to enable consumers to make
                                              of program letters or other issuances,
                                                                                                                                                             informed and healthful dietary choices.
                                              issued by the Department of Labor.                       RIN 0910–AG56                                         The final rule applies to certain food
                                              § 620.5 Conformity and substantial                                                                             from vending machines operated by a
                                              compliance.                                              Food Labeling; Calorie Labeling of                    person engaged in the business of
                                                 (a) In general. A State law                           Articles of Food in Vending Machines;                 owning or operating 20 or more vending
                                              implementing the drug testing of                         Extension of Compliance Date                          machines. Vending machine operators
                                              applicants for unemployment                              AGENCY:    Food and Drug Administration,              not subject to the rules may elect to be
                                              compensation must conform with, and                      HHS.                                                  subject to the Federal requirements by
                                              the law’s administration must                                                                                  registering with FDA.
                                                                                                       ACTION:Final rule; extension of
                                              substantially comply with, the                                                                                    The final rule also specifies how
                                                                                                       compliance date.
                                              requirements of this part 620 for                                                                              calories must be declared. In brief,
                                              purposes of certification under Section                  SUMMARY:   The Food and Drug                             • Vending machine operators do not
                                              302 of the SSA (42 U.S.C. 502), of                       Administration (FDA or we) is                         have to declare calorie information for
                                              whether a State is eligible to receive                   extending the compliance date for                     a food if a prospective purchaser can
                                              Federal grants for the administration of                 certain requirements in the final rule                view certain calorie information on the
                                              its UC program.                                          requiring disclosure of calorie                       front of the package, in the Nutrition
                                                 (b) Resolving issues of conformity and                declarations for food sold from certain               Facts label on the food, or in a
                                              substantial compliance. For the                          vending machines. The final rule                      reproduction of the Nutrition Facts label
                                              purposes of resolving issues of                          appeared in the Federal Register of                   on the food subject to certain
                                              conformity and substantial compliance                    December 1, 2014. We are taking this                  requirements, or if the vending machine
                                              with the requirements of this part 620,                  action in response to requests for an                 operator does not own or operate 20 or
                                              the following provisions of 20 CFR                       extension and for reconsideration of the              more vending machines.
                                              601.5 apply:                                             rule’s requirements pertaining to the                    • Calorie declarations must be clear
                                                 (1) Paragraph (b) of 20 CFR 601.5,                    size of calorie disclosures on front-of-              and conspicuous and placed
                                              pertaining to informal discussions with                  package labeling.                                     prominently, and may be placed on a
                                              the Department of Labor to resolve                                                                             sign in, on, or adjacent to the vending
                                                                                                       DATES: Effective date: This final rule is
                                              conformity and substantial compliance                                                                          machine, so long as the sign is in close
                                                                                                       effective December 1, 2016.
                                              issues, and                                                                                                    proximity to the article of food or
                                                                                                          Compliance date: The compliance
                                                 (2) Paragraph (d) of 20 CFR 601.5,                                                                          selection button.
                                                                                                       date for type size front-of-pack labeling
                                              pertaining to the Secretary of Labor’s                                                                            • The final rule establishes type size,
                                                                                                       requirements (§ 101.8(b)(2) (21 CFR
                                              hearing and decision on conformity and                                                                         color, and contrast requirements for
                                                                                                       101.8(b)(2))) and calorie disclosure
                                              substantial compliance.                                                                                        calorie declarations in or on the vending
                                                 (c) Result of failure to conform or                   requirements (§ 101.8(c)(2)) for certain
                                                                                                                                                             machines, and for calorie declarations
                                              substantially comply. Whenever the                       gums, mints, and roll candy products in
                                                                                                                                                             on signs adjacent to the vending
                                              Secretary of Labor, after reasonable                     glass-front machines in the final rule
                                                                                                                                                             machines.
                                              notice and opportunity for a hearing to                  published December 1, 2014 (79 FR                        • The final rule establishes
                                              the State UC agency, finds that the State                71259) is extended to July 26, 2018. The              requirements for calorie declarations on
                                              UC law fails to conform, or that the                     compliance date for all other                         electronic vending machines, those
                                              State or State UC agency fails to comply                 requirements in the final rule (79 FR                 vending machines with only pictures or
                                              substantially, with the requirements of                  71259) remains December 1, 2016.                      names of the food items, and those
sradovich on DSK3GMQ082PROD with RULES




                                              title III, SSA (42 U.S.C. 501–504), as                   FOR FURTHER INFORMATION CONTACT:                      vending machines with few choices
                                              implemented in this part 620, then the                   April Kates, Center for Food Safety and               (e.g., popcorn machines).
                                              Secretary of Labor must notify the                       Applied Nutrition (HFS–820), Food and                    The final rule also requires vending
                                              Governor of the State and such State UC                  Drug Administration, 5001 Campus Dr.,                 machine operator contact information to
                                              agency that further payments for the                     College Park, MD 20740, 240–402–2371,                 be displayed for enforcement purposes.
                                              administration of the State UC law will                  email: april.kates@fda.hhs.gov.                          The final rule implements provisions
                                              not be made to the State until the                       SUPPLEMENTARY INFORMATION:                            of section 403(q)(5)(H) of the Federal


                                         VerDate Sep<11>2014   17:30 Jul 29, 2016   Jkt 238001   PO 00000   Frm 00021   Fmt 4700   Sfmt 4700   E:\FR\FM\01AUR1.SGM   01AUR1


                                              50304              Federal Register / Vol. 81, No. 147 / Monday, August 1, 2016 / Rules and Regulations

                                              Food, Drug, and Cosmetic Act (the                        the type size requirement would make                  unpackaged food (such as fruit) is not
                                              FD&C Act) (21 U.S.C. 343(q)(5)(H)).                      the calorie declaration very large on                 affected by the extension.
                                                In the preamble to the final rule (79                  some products and would make label
                                                                                                                                                             C. Signage for Gums, Mints, and Roll
                                              FR 71259 at 71282 through 71283), we                     redesign difficult and/or not practical.
                                                                                                                                                             Candy
                                              stated that all covered vending machine                  They noted the existence of voluntary
                                              operators must come into compliance                      FOP labeling programs whereby calorie                    With respect to providing calorie
                                              with the rule’s requirements no later                    information is presented in a FOP type                information for gums, mints, and roll
                                              than December 1, 2016.                                   size that ranges from 100 to 150 percent              candy, our regulations, at § 101.8(c),
                                                                                                       of the size of the ‘‘net quantity of                  establishes requirements for calorie
                                              II. Extending the Compliance Date
                                                                                                       contents’’ statement on the principal                 labeling for certain food sold from
                                              A. Introduction                                          display panel. They also asked us to                  vending machines. Under
                                                Since we published the final rule in                   align the compliance date with that for               § 101.8(c)(2)(i)(C), the calorie
                                              the Federal Register, several trade                      the Nutrition Facts labeling rule (81 FR              declaration for covered vending
                                              associations have contacted us to state                  33742, May 27, 2016) so that food                     machine food must include the total
                                              that the type size requirement for calorie               companies can ‘‘make all changes to                   calories present in the packaged food,
                                              information on the package, often                        their food labels, including adding FOP               regardless of whether the packaged food
                                              referred to as ‘‘front-of-pack’’ or FOP                  calorie information, at the same time’’               contains a single serving or multiple
                                              labeling, presents significant technical                 (see Ref. 2). The compliance date for the             servings. Under § 101.8(c)(2)(ii)(A), the
                                              challenges to the packaged food                          Nutrition Facts label rule is July 26,                calorie declarations for covered vending
                                              industry. The trade associations asked                   2018, for manufacturers with $10                      machine food must be clear and
                                              us to amend the type size requirement                    million or more in annual food sales.                 conspicuous and placed prominently on
                                              for FOP labeling and to provide                             Consequently, with respect to                      a sign in close proximity to the article
                                              additional flexibility for providing                     § 101.8(b)(2), we have decided to extend              of food or selection button so long as the
                                              calorie information for gums, mints, and                 the compliance date for certain food                  calorie declaration is visible at the same
                                              roll candy (see Refs. 1 and 2).                          products sold from a glass-front vending              time as the food, its name, price,
                                                                                                       machine that allow prospective                        selection button, or selection number is
                                              B. Type Size Requirement for ‘‘Articles                  purchasers to view packaged foods                     visible.
                                              of Food Not Covered’’ (§ 101.8(b)(2))                    offered for sale. Specifically, if the food              Several trade associations have
                                                 With respect to FOP labeling,                         is:                                                   disagreed with § 101.8(c)(2) insofar as it
                                              § 101.8(b)(2), states that articles of food                 • Sold from a glass-front vending                  would apply to gums, mints, and roll
                                              sold from a vending machine are not                      machine that allows prospective                       candy. The trade associations contend
                                              ‘‘covered vending machine food’’ if the                  purchasers to view packaged foods                     that gums, mints, and roll candy
                                              prospective purchaser can otherwise                      offered for sale;                                     suitable for vending machines are not
                                              view visible nutrition information,                         • not a covered vending machine                    typically amenable to FOP labeling due
                                              including, at a minimum the total                        food within § 101.8(b)(2); and                        to the limited size of the principal
                                              number of calories for the article of food                  • the label for such packaged foods                display panel, and as a result, there are
                                              as sold at the point of purchase. The                    provides front-of-package calorie                     few options for compliance for these
                                              visible nutrition information must                       disclosures that complies with all                    products. They also describe that in
                                              appear on the food label itself, be clear                aspects of the final vending machine                  glass-front vending machines, these
                                              and conspicuous and able to be easily                    labeling rule except that the disclosure              items are often placed together at the
                                              read on the article of food while in the                 is not 50 percent of the size of the                  bottom of the machine with limited
                                              vending machine, and be in a type size                   largest print on the label,                           space for signage. In addition, the trade
                                              at least 50 percent of the size of the                   then the compliance date for                          associations have asserted that
                                              largest printed matter on the label and                  § 101.8(b)(2) is extended to July 26,                 providing calories declarations ‘‘per
                                              with sufficient color and contrasting                    2018. This extension of the compliance                serving’’ for these items is preferable to
                                              background to other print on the label                   date will give us time to consider                    providing calories ‘‘per container’’,
                                              to permit the perspective purchaser to                   whether a revision to § 101.8(b)(2) is                because consumers typically do not
                                              clearly distinguish the information.                     necessary and also give packaged food                 consume the entire packaged product at
                                                 In the preamble to the final rule (79                 manufacturers more time to consider                   one time, and providing calorie
                                              FR 71259 at 71269 (see comment 16 and                    label redesign issues or, in the case of              declarations on a ‘‘per serving’’ basis
                                              our response)), we discussed how FOP                     products without FOP calorie labeling,                would be consistent with our serving
                                              labeling could be a way to provide                       to consider whether to add such                       size requirements at 21 CFR 101.9. The
                                              visible nutrition information for articles               labeling. We emphasize that this                      trade associations also explained that
                                              of food that are sold from a vending                     extension is limited to vending machine               these items typically contain
                                              machine that are not ‘‘covered vending                   operators whose glass-front vending                   insignificant amounts of all nutrients
                                              machine food’’ as interpreted by                         machines are subject to § 101.8(b)(2) and             and are otherwise exempt from
                                              § 101.8(c). We also noted how some                       where the packaged food has FOP                       packaged food nutrition labeling, and
                                              comments felt that the rule’s type size                  calorie disclosures that complies with                that providing a sign with a range of 0
                                              requirement was too large, whereas                       all aspects of the final vending machine              to 25 calories ‘‘per serving’’ for these
                                              others stated that the type size would be                labeling rule except that the disclosure              items is sufficient for consumers to
                                              too small (79 FR 71259 at 71269). We                     is not 50 percent of the size of the                  make informed choices (Ref. 1). Based
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                                              explained that specifying the minimum                    largest print on the label. Thus, a                   on these distinct challenges, the trade
                                              type size for calorie information on                     vending machine operator whose                        associations also suggested that we
                                              vending machine food labels will                         vending machines dispense packaged                    amend § 101.8(c)(2) by adding a new
                                              provide greater clarity for both                         food without FOP labeling or use                      paragraph that would, in effect, provide
                                              compliance and enforcement (id.).                        electronic displays is not affected by the            an exception for gums, mints, and roll
                                                 Since the publication of the final rule,              extension. Similarly, a vending machine               candies that would allow the use of a
                                              several trade associations indicated that                operator whose vending machines sell                  range of calories (such as ‘‘25 calories or


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                                                                 Federal Register / Vol. 81, No. 147 / Monday, August 1, 2016 / Rules and Regulations                                           50305

                                              less/serving’’) and the covered vending                  container (required by § 101.8(c)(2)),                products in glass-front vending
                                              machine food:                                            should accommodate the trade                          machines or glass-front vending
                                                • Contains at least three servings per                 associations’ desire to disclose the                  machines that are capable of providing
                                              package;                                                 number of calories per serving.                       information electronically, nor does it
                                                • has a ‘‘reference amount                               However, we also are mindful that the               extend to other types of vending
                                              customarily consumed’’ (the portion                      gums, mints, and roll candies                         machines. We also emphasize that the
                                              size based on the amount the average                     mentioned by the trade associations                   limited compliance date extension for
                                              person is likely to eat at one time) of 5                tend to be sold in small packages that                § 101.8(c)(2) is intended to give vending
                                              grams or less; and                                       do not lend themselves to FOP labeling                machine operators more flexibility in
                                                • contains 25 calories or less per                     and often are located or placed in a                  providing calorie information for gums,
                                              serving.                                                 small space in glass-front vending                    mints, and roll candy in glass-front
                                              The trade associations indicated that the                machines; the small space may limit the               vending machines where those gums,
                                              extension would only be for vending                      size of any sign(s) that would disclose               mints, and roll candy are located or
                                              machine operators who, by December 1,                    calorie information for each gum, mint,               placed in a small space such that it is
                                              2016, have ‘‘interim calorie signage’’                   or roll candy. For example, we are                    not practicable to provide calorie
                                              that would consist of a single sign in                   aware that some glass-front vending                   information under each gum, mint, or
                                              close proximity to the article of food or                machines may have trays that are                      roll candy. Our final rule already gives
                                              selection button or inside the vending                   different sizes; the tray width for bags of           vending machine operators other ways
                                                                                                       potato chips is larger than the tray                  to comply with the calorie disclosure
                                              machine, where the sign states that gum,
                                                                                                       width for a roll of mints or hard candies             requirement; for example, vending
                                              mint, and roll candies provide 25
                                                                                                       or for a small package of gum. The                    machine operators can provide calorie
                                              calories or less/serving.
                                                                                                       smaller tray size for gums, mints, and                declarations on a sign adjacent to the
                                                We addressed a similar issue in the
                                                                                                       roll candy may make it difficult to add               vending machine (see
                                              preamble to the final rule (see 79 FR
                                                                                                       information, inside the vending                       § 101.8(c)(2)(ii)(C)).
                                              71259 at 71276 through 71277 (see
                                                                                                       machine, beyond the product’s price
                                              comment 24 and our response)) and                                                                              III. Economic Analysis of Impacts
                                                                                                       and selection number. Therefore, we are
                                              explained why the calorie declaration                                                                             We have examined the impacts of the
                                                                                                       extending the compliance date for
                                              requirement applies to the entire                                                                              final rule under Executive Order 12866,
                                                                                                       § 101.8(c)(2) to July 26, 2018, so that we
                                              package rather than to a serving in the                  may consider this issue further. This                 Executive Order 13563, the Regulatory
                                              package. We disagree with the trade                      extension of the compliance date is                   Flexibility Act (5 U.S.C. 601–612), and
                                              associations’ suggestion that the final                  limited to:                                           the Unfunded Mandates Reform Act of
                                              vending machine rule’s serving size                        • Gums, mints, and roll candy sold in               1995 (Pub. L. 104–4). Executive Orders
                                              requirement should be consistent with                    packages that are too small to bear FOP               12866 and 13563 direct us to assess all
                                              that in our serving size rule. The                       labeling and where the gums, mints, and               costs and benefits of available regulatory
                                              vending machine rule applies to certain                  roll candy are located in a small space               alternatives and, when regulation is
                                              vending machine operators, whereas the                   within a glass-front vending machine                  necessary, to select regulatory
                                              serving size rule applies to food                        that allows prospective purchasers to                 approaches that maximize net benefits
                                              manufacturers. The statutory authority                   view packaged foods offered for sale;                 (including potential economic,
                                              behind each regulation also differs; the                   • the space within the glass-front                  environmental, public health and safety,
                                              vending machine label requirement is                     vending machine holding the gum,                      and other advantages; distributive
                                              found in section 403(q)(5)(H) of the                     mints, and roll candy is so small such                impacts; and equity). We have
                                              FD&C Act, which requires, generally,                     that it is not practicable to provide                 developed a comprehensive Economic
                                              that food sold in certain vending                        calorie information under each gum,                   Analysis of Impacts that assesses the
                                              machines disclose the number of                          mint, or roll candy; and                              impacts of this final rule (Ref. 3). We
                                              calories contained in food, whereas                        • the glass-front vending machine                   believe that this final rule is not a
                                              section 403(q)(1)(A)(i) of the FD&C Act                  also does not or is not capable of                    significant regulatory action as defined
                                              requires, with certain exceptions, that                  providing calorie information                         by Executive Order 12866.
                                              food that is intended for human                          electronically.                                          The Regulatory Flexibility Act
                                              consumption and offered for sale bear                      This limited change in the                          requires us to analyze regulatory options
                                              nutrition information that provides a                    compliance date for § 101.8(c)(2) will                that would minimize any significant
                                              serving size that reflects the amount of                 give us time to consider issues relating              impact of a rule on small entities.
                                              food customarily consumed and is                         to signage and vending machine design                 Because the final rule changes the
                                              expressed in a common household                          and give vending machine operators                    compliance date for § 101.8(b)(2) and
                                              measure that is appropriate to the food.                 some flexibility in their disclosure of               (c)(2), under the limited circumstances
                                              Section 2(b)(1)(B) of the Nutrition                      calorie information for gums, mints, and              described in this document, from
                                              Labeling and Education Act further                       roll candies in small packages. In the                December 1, 2016, to July 26, 2018, we
                                              requires the Secretary of Health and                     interim, so consumers can make                        certify that the final rule will not have
                                              Human Services to issue regulations to                   informed choices, we encourage                        a significant economic impact on a
                                              establish standards to define serving                    vending machine operators to provide                  substantial number of small entities.
                                              size. Nevertheless, we note that, in the                 calorie information through a sign in                    The Unfunded Mandates Reform Act
                                              preamble to the final vending machine                    close proximity to the gums, mints, and               of 1995 (section 202(a)) requires us to
                                              rule, we said we would allow, in                         roll candy inside the vending machine                 prepare a written statement, which
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                                              addition to the total calorie declaration                that states the gums, mints, and roll                 includes an assessment of anticipated
                                              for the food as vended, the voluntary                    candies provide ‘‘X’’ calories or less/               costs and benefits, before issuing ‘‘any
                                              declaration of calories per serving for                  serving, where X represents the value of              rule that includes any Federal mandate
                                              covered vending machine foods (see 79                    the largest number of calories per                    that may result in the expenditure by
                                              FR 71259 at 71277). The voluntary                        serving for the gums, mints, and roll                 State, local, and tribal governments, in
                                              declaration of calories per serving, in                  candies. We emphasize that this                       the aggregate, or by the private sector, of
                                              addition to declaration of calories per                  extension does not extend to other                    $100,000,000 or more (adjusted


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                                              50306              Federal Register / Vol. 81, No. 147 / Monday, August 1, 2016 / Rules and Regulations

                                              annually for inflation) in any one year.’’               DEPARTMENT OF THE INTERIOR                            MMS’s MRM to ONRR and transferred
                                              The current threshold after adjustment                                                                         it to the Assistant Secretary of Policy,
                                              for inflation is $146 million, using the                 Office of Natural Resources Revenue                   Management and Budget. This change
                                              most current (2015) Implicit Price                                                                             required the reorganization of title 30 of
                                              Deflator for the Gross Domestic Product.                 30 CFR Part 1241                                      the Code of Federal Regulations (30
                                              This final rule would not result in an                   [Docket No. ONRR–2012–0005; DS63644000                CFR). In response, ONRR published a
                                              expenditure in any year that meets or                    DR2PS0000.CH7000 167D0102R2]                          direct final rule on October 4, 2010 (75
                                              exceeds this amount.                                                                                           FR 61051), to establish a new chapter
                                                                                                       RIN 1012–AA05                                         XII in 30 CFR; to remove certain
                                              IV. Paperwork Reduction Act of 1995                                                                            regulations from Chapter II; and to
                                                                                                       Amendments to Civil Penalty                           recodify these regulations in the new
                                                This final rule contains no collection                 Regulations                                           Chapter XII. Therefore, all references to
                                              of information. Therefore, clearance by                  AGENCY:  Office of the Secretary, Office              ONRR in this rule include its
                                              the Office of Management and Budget                      of Natural Resources Revenue, Interior.               predecessor MRM, and all references to
                                              under the Paperwork Reduction Act of                                                                           30 CFR part 1241 in this rule include
                                                                                                       ACTION: Final rule.
                                              1995 is not required.                                                                                          former 30 CFR part 241.
                                              V. Analysis of Environmental Impact                      SUMMARY:   This rule amends the Office of             II. Notice of and Comments on the
                                                                                                       Natural Resources Revenue (ONRR)                      Proposed Amendments
                                                We have determined under 21 CFR                        civil penalty regulations by expanding
                                              25.30(k) that this action is of a type that              the regulations to all Federal mineral                   On May 20, 2014, ONRR published a
                                                                                                       leases onshore and on the Outer                       Notice of Proposed Rulemaking (79 FR
                                              does not individually or cumulatively
                                                                                                       Continental Shelf (OCS), to all                       28862) to amend ONRR’s civil penalty
                                              have a significant effect on the human                                                                         regulations. In the preamble of the
                                              environment. Therefore, neither an                       Federally-administered mineral leases
                                                                                                       on Indian Tribal and individual Indian                proposed rule, ONRR invited comments
                                              environmental assessment nor an                                                                                on all aspects of the proposed rule,
                                              environmental impact statement is                        mineral owners’ lands, and to all
                                                                                                       easements, rights of way, and other                   including (1) the amount of the
                                              required.                                                                                                      proposed processing fee for a hearing
                                                                                                       agreements on the OCS; incorporating
                                              VI. References                                           the civil penalty inflation adjustments               request, payment by Electronic Funds
                                                                                                       pursuant to the Federal Civil Penalties               Transfer, and the form of identification
                                                The following references are on                        Inflation Adjustment Act Improvements                 to include with the fee; (2) the effect
                                              display in the Division of Dockets                       Act of 2015 (the 2015 Act); clarifying                that the proposed processing fee could
                                              Management (HFA–305), Food and Drug                      and simplifying existing regulations for              have on the filing of hearing requests;
                                              Administration, 5630 Fishers Lane, Rm.                   issuing a Notice of Noncompliance                     (3) the procedure to allow a motion for
                                              1061, Rockville, MD 20852, and are                       (NONC), Failure to Correct Civil Penalty              summary decision to be filed at any
                                              available for viewing by interested                      Notice (FCCP), and Immediate Liability                time after the case is referred to the
                                              persons between 9 a.m. and 4 p.m.,                       Civil Penalty Notice (ILCP); and                      Departmental Cases Hearings Division
                                              Monday through Friday; they are also                     providing notice that ONRR will post                  (DCHD), including before discovery
                                                                                                       matrices for civil penalty assessments                commences; (4) whether industry
                                              available electronically at http://
                                                                                                       on its Web site.                                      should have the burden of showing by
                                              www.regulations.gov.
                                                                                                                                                             a preponderance of the evidence that it
                                              1. Letter from Karin F. R. Moore, Vice                   DATES: Effective Date: August 31, 2016.
                                                                                                                                                             is not liable or that the penalty amount
                                                   President and General Counsel, Grocery              FOR FURTHER INFORMATION CONTACT: For                  should be reduced; (5) whether the
                                                   Manufacturers Association, to Susan                 comments or questions on procedural                   accrual of a penalty during the hearing
                                                   Mayne, Ph.D., Director, Center for Food             issues, contact Armand Southall,                      process could be stayed; and (6) the
                                                   Safety and Applied Nutrition, dated                 Regulatory Specialist, by telephone at                definition of the term ‘‘knowingly or
                                                   March 31, 2016.                                     (303) 231–3221 or email to                            willfully.’’
                                              2. Letter from Karin Moore, Senior Vice                  armand.southall@onrr.gov. For                            The proposed rulemaking provided
                                                   President and General Counsel, Grocery              questions on technical issues, contact                for a 60-day comment period, which
                                                   Manufacturers Association, to Susan                 Geary Keeton, ONRR Chief of                           ended on July 21, 2014. During the
                                                   Mayne, Ph.D., Director, Center for Food             Enforcement, by telephone at (303) 231–               public comment period, ONRR received
                                                   Safety and Applied Nutrition, dated June            3096 or email to geary.keeton@onrr.gov.               19 written comments: 11 responses from
                                                   26, 2016.                                           SUPPLEMENTARY INFORMATION:                            members of industry, 7 responses from
                                              3. Economics Staff, Office of Planning, Office                                                                 industry trade groups or associations,
                                                   of Policy, Planning, Legislation, and               I. Background
                                                                                                                                                             and 1 response from the Jicarilla Apache
                                                   Analysis, Office of the Commissioner,                  ONRR is amending its civil penalty                 Nation.
                                                   Food and Drug Administration, ‘‘Food                regulations.                                             ONRR has carefully considered all of
                                                   Labeling; Calorie Labeling of Articles of              On May 13, 1999, the Department of                 the public comments that we received
                                                   Food in Vending Machines; Extension of              the Interior (Department) published a                 during the rulemaking process. We
                                                   Compliance Date,’’ dated July 2016.                 final rule (64 FR 26240) in the Federal               hereby adopt final regulations governing
                                                Dated: July 27, 2016.                                  Register (FR) governing Minerals                      the application, assessment, and
                                              Leslie Kux,                                              Management Service (MMS) Minerals                     issuance of and request for hearing on
                                                                                                       Revenue Management (MRM) issuance                     a NONC, FCCP, and ILCP. These
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                                              Associate Commissioner for Policy.
                                                                                                       of notices of noncompliance and civil                 regulations will apply prospectively to a
                                              [FR Doc. 2016–18140 Filed 7–29–16; 8:45 am]
                                                                                                       penalties.                                            NONC, FCCP or ILCP issued on or after
                                              BILLING CODE 4164–01–P                                      On May 19, 2010, the Secretary of the              the effective date that we specify in the
                                                                                                       Department (Secretary) reassigned                     DATES section of this preamble.
                                                                                                       MMS’s responsibilities to three separate                 This final rule reflects revisions to the
                                                                                                       organizations. As part of this                        proposed rule. Also, consistent with the
                                                                                                       reorganization, the Secretary renamed                 proposed rule, it amends the current


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Document Created: 2016-07-30 06:25:58
Document Modified: 2016-07-30 06:25:58
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule; extension of compliance date.
ContactApril Kates, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2371, email: [email protected]
FR Citation81 FR 50303 
RIN Number0910-AG56
CFR Citation21 CFR 101
21 CFR 11

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