Federal Register, Volume 76 Issue 66 (Wednesday, April 6, 2011)

[Federal Register Volume 76, Number 66 (Wednesday, April 6, 2011)]
[Proposed Rules]
[Pages 19238-19255]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8037]

[[Page 19237]]

Vol. 76

Wednesday,

No. 66

April 6, 2011

Part III

Department of Health and Human Services

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Food and Drug Administration

21 CFR Parts 11 and 101

Food Labeling; Calorie Labeling of Articles of Food in Vending
Machines; Proposed Rule

Federal Register / Vol. 76, No. 66 / Wednesday, April 6, 2011 /
Proposed Rules

[[Page 19238]]

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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

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: To implement the vending machine labeling provisions of the
Patient Protection and Affordable Care Act of 2010 (Affordable Care
Act), the Food and Drug Administration (FDA) is proposing requirements
for providing calorie information for certain articles of food sold
from vending machines. The Affordable Care Act, in part, amended the
Federal Food, Drug and Cosmetic Act (FD&C Act) to, among other things,
require that for an article of 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, and is operated
by a person engaged in the business of owning or operating 20 or more
vending machines, the vending machine operator must disclose the number
of calories for the article of food. Vending machine operators not
subject to the requirements of the Affordable Care Act may elect to be
subject to the Federal requirements by registering with FDA. Providing
calorie disclosures for food sold from vending machines would assist
consumers in making healthier dietary choices.

DATES: Submit either written or electronic comments on the proposed
rule by July 5, 2011. Submit comments on the information collection
issues under the Paperwork Reduction Act of 1995 by May 6, 2011, (see
the ``Paperwork Reduction Act of 1995'' section of this document).

ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-
F-0171 and/or RIN 0910-AG56, by any of the following methods, except
that comments on information collection issues under the Paperwork
Reduction Act of 1995 must be submitted to the Office of Regulatory
Affairs, Office of Management and Budget (OMB) (see the ``Paperwork
Reduction Act of 1995'' section of this document).

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov. Follow the
instructions for submitting comments.

Written Submissions

Submit written submissions in the following ways:
FAX: 301-827-6870.
Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Agency name
and docket number and Regulatory Information Number (RIN) for this
rulemaking. All comments received may be posted without change to
http://www.regulations.gov, including any personal information
provided. For additional information on submitting comments, see the
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this
document.
Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Daniel Y. Reese, Center for Food
Safety and Applied Nutrition (HFS-820), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2371.

SUPPLEMENTARY INFORMATION:

I. Background

A. Nutrition Labeling Requirements That Currently Apply to Packaged
Foods

The Nutrition Labeling and Education Act of 1990 (NLEA) amended the
FD&C Act, in part, by adding section 403(q) (21 U.S.C. 343(q)), which
specifies, in pertinent part and with certain exceptions, that a food
is considered to be misbranded unless its label or labeling bears
nutrition information. See 21 U.S.C. 343(q)(1). When a food is in
package form, the required nutrition information generally must appear
on the label of the food. FDA's final regulations establishing
nutrition labeling requirements were published in 1993 (58 FR 2079,
January 6, 1993) and are found at Title 21 of the Code of Federal
Regulations (21 CFR) section 101.9. Regulations implementing the NLEA
require nutrition information for a food product intended for human
consumption and offered for sale unless an exemption is provided for
the product (Sec. 101.9(a)). The declaration of nutrition information
on the label and labeling of food generally must include information
about the following nutrients: Total calories, calories from fat
(unless the product contains less than 0.5 g of fat), total fat,
saturated fat, trans fat, cholesterol, sodium, total carbohydrate,
dietary fiber, sugars, protein, and certain vitamins and minerals
(Sec. 101.9).
The NLEA amendments to the FD&C Act included an exemption from
nutrition labeling for food that is served in restaurants or other
establishments in which food is served for immediate human consumption
or sold for sale or use in such establishments (21 U.S.C. 343
(q)(5)(A)(i)). The NLEA amendments to the FD&C Act also included an
exemption from nutrition labeling for food that is processed and
prepared primarily in a retail establishment, ready for human
consumption, of the type of food described in section 403(q)(5)(A)(i)
of the FD&C Act, offered for sale to consumers but not for immediate
human consumption in such establishment, and not offered for sale
outside such establishment (21 U.S.C. 343(q)(5)(A)(ii)). However, these
exemptions were contingent on there being no nutrient content claims or
health claims made on the label or labeling, or in the advertising, for
the food. In our regulations implementing these exemptions, we included
vending machines among the examples of establishments in which food is
served for immediate human consumption that generally are exempt from
nutrition labeling requirements because like the other examples,
vending machines offer food products that are generally consumed
immediately where purchased or while the consumer is walking away. See
Sec. 101.9(j)(2).

B. Requirements of Section 4205 of the Affordable Care Act

On March 23, 2010, the Affordable Care Act (Pub. L. 111-148) was
signed into law. Section 4205 of the Affordable Care Act (section
4205), amends section 403(q) of the FD&C Act, which governs nutrition
labeling requirements, and section 403A of the FD&C Act (21 U.S.C. 343-
1), which governs Federal preemption of State and local food labeling
requirements. The Affordable Care Act requires FDA to issue proposed
regulations to carry out section 403(q)(5)(H) of the FD&C Act no later

[[Page 19239]]

than one year from the date of enactment. As amended, section
403(q)(5)(H)(viii) of the FD&C Act requires that if an article of food
is sold from a vending machine that does not permit a prospective
purchaser to examine the Nutrition Facts Panel before purchasing the
food or does not otherwise provide visible nutrition information at the
point of purchase and the vending machine is operated by a person who
is engaged in the business of owning or operating 20 or more vending
machines, the vending machine operator must provide calorie information
for the food. Specifically, the vending machine operator must ``provide
a sign in close proximity to each article of food or the selection
button that includes a clear and conspicuous statement disclosing the
number of calories contained in the article.''
Section 403(q)(5)(H)(ix) of the FD&C Act allows vending machine
operators not subject to the requirements of section 4205 of the
Affordable Care Act to voluntarily register with FDA to become subject
to the Federal requirements. In the Federal Register of July 23, 2010,
(75 FR 43182), FDA published a notice in the Federal Register
specifying the terms and conditions for implementation of voluntary
registration, pending promulgation of final regulations. See 75 FR
43182.

C. FDA Activities Related to Implementation of Section 4205 of the
Affordable Care Act

Section 4205 of the Affordable Care Act also requires certain
restaurants and similar retail food establishments to provide calorie
and other nutrition information for standard menu items, including food
on display and self-service food. Elsewhere in this issue of the
Federal Register, FDA is proposing requirements to implement the menu
labeling provisions of section 4205. As discussed in that proposal, FDA
has published in the Federal Register a number of documents concerning
section 4205. On July 7, 2010, FDA published a notice entitled
``Disclosure of Nutrient Content Information for Standard Menu Items
Offered for Sale at Chain Restaurants or Similar Retail Food
Establishments and for Articles of Food Sold from Vending Machines''
(``docket notice'') (75 FR 39026, July 7, 2010) to solicit comments and
suggestions on the new law. In response to this notice, FDA received
approximately 875 letters and e-mails. Of those, approximately 60
contained one or more comments pertaining to vending machine calorie
labeling. Many of these comments were general comments on the law
itself and either supported or opposed the requirement in section
403(q)(5)(H)(viii) of the FD&C Act that calorie information be provided
for foods sold from vending machines. Comments in opposition stated
that providing calorie information for foods sold from vending machines
would be overly burdensome to the industry. FDA describes these
comments in more detail and responds to those comments in this
proposal.
On July 23, 2010, FDA published the Federal Register notice
entitled ``Voluntary Registration by Authorized Officials of Non-
Covered Retail Food Establishments and Vending Machine Operators
Electing to be Subject to the Menu and Vending Machine Labeling
Requirements Established by Section 4205 of the Patient Protection and
Affordable Care Act of 2010'' (``registration notice'') (75 FR 43182).
FDA issued this registration notice to provide assistance for voluntary
registration for restaurants, similar retail establishments, and
vending machine operators that are not subject to the nutrition
labeling requirements of section 4205 (e.g., restaurants and similar
retail food establishments with fewer than 20 locations, and vending
machine operators with fewer than 20 machines). In the registration
notice, FDA specified the terms and conditions for implementation of
voluntary registration, pending promulgation of regulations. In
response to the notice, FDA received 7 comments, none of which
addressed registration.
On August 25, 2010, FDA published a ``Guidance for Industry:
Questions and Answers Regarding the Effect of Section 4205 of the
Patient Protection and Affordable Care Act of 2010 on State and Local
Menu and Vending Machine Labeling Laws'' (``preemption guidance'') (75
FR 52427, August 25, 2010). The preemption guidance discusses the
preemptive effect of section 4205 and identifies the provisions of
amended section 403(q) of the FD&C Act that became requirements upon
enactment. Our current thinking on the preemptive effect of section
4205 is set out in section VII of this document.
Also on August 25, 2010, FDA published a ``Draft Guidance for
Industry: Questions and Answers Regarding the Menu Labeling Provisions
of Section 4205 of the Patient Protection and Affordable Care Act of
2010; Availability'' (``draft implementation guidance'') (75 FR 52426,
August 25, 2010). This draft guidance addressed only the menu labeling
provisions of section 4205. It did not address the calorie labeling
requirements for vending machine operators in section 4205. FDA
subsequently withdrew the draft implementation guidance (76 FR 4360,
January 25, 2011).

II. Legal Authority

As stated in section I.C. of this document, on March 23, 2010, the
Affordable Care Act was signed into law. Section 4205 of the Affordable
Care Act amended 403(q)(5) of the FD&C Act (21 U.S.C. 343(q)(5)) by
amending section 403(q)(5)(A) and by creating new clause (H) to
require, in relevant part, that vending machine operators provide
calorie information for certain articles of food sold from vending
machines. Under section 403(a)(1), such information must be truthful
and nonmisleading. Food to which these requirements apply is deemed
misbranded if these requirements are not met. In addition, under
section 201(n) of the FD&C Act (21 U.S.C. 321(n)), the labeling of food
is misleading if it fails to reveal facts that are material in light of
representations actually made in the labeling. Section 403(q)(5)(H)(x)
requires the Secretary of Health and Human Services (Secretary) to
issue proposed regulations no later than 1 year after enactment . Thus,
FDA has the authority to issue this proposed rule under sections
201(n), 403(a)(1), and 403(q)(5)(H), as well as under section 701(a) of
the FD&C Act (21 U.S.C. 371(a)), which vests the Secretary with the
authority to issue regulations for the efficient enforcement of the
FD&C Act.
FDA is proposing requirements that vending machine operators
provide calorie information for certain articles of food sold from
vending machines. FDA is also proposing the terms and conditions for
voluntary registration by vending machine operators not subject to the
requirements of section 4205 of the Affordable Care Act that elect to
become subject the requirements. FDA is proposing to set out these
provisions in new Sec. 101.8.

III. The Proposal

A. Definitions

We are proposing in the introductory paragraph of Sec. 101.8(a)
that the terms defined in section 201 of the FD&C Act are applicable
when these terms are used. Additional terms are defined alphabetically
in the proposed codified and are discussed in alphabetical order in
this section. ``Act'' is defined as the Federal Food, Drug, and
Cosmetic Act.

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1. Authorized Official of a Vending Machine Operator
We are proposing in Sec. 101.8(a) that the term ``authorized
official of a vending machine operator'' means the owner, operator, or
agent in charge of a vending machine, or any other person authorized by
a vending machine operator not subject to the requirements of section
4205 of the Affordable Care Act to voluntarily register the vending
machine operator with FDA to become subject to the requirements. For
the purposes of this definition, the agent in charge would not be the
person who is only in charge or in control of the location where the
vending machine is located.
2. Vending Machine Operator
We are proposing in Sec. 101.8(a) that the term ``vending machine
operator'' means a person that controls or directs the function of the
vending machine, including deciding which articles of food are sold
from the vending machine or the placement of the articles of food
within the vending machine, and is compensated for the control or
direction of the function of the vending machine. Section 201(e) of the
FD&C Act defines ``person'' to include an individual, partnership,
corporation, and association. For example, a vending machine operator
could be a corporation that manufacturers beverages and sells these
products in its machines. A vending machine operator also could be an
individual or a business that only operates and stocks vending
machines, such as a private company with onsite vending machines.
3. Vending Machine
Section 403(q)(5)(H)(viii) of the FD&C Act sets forth labeling
requirements for certain vending machine food but does not define the
term ``vending machine.'' We are proposing in Sec. 101.8(a) that the
term ``vending machine'' means a self-service device that, upon
insertion of a coin, paper currency, token, card, or key, or by
optional manual operation, dispenses servings of food in bulk, in
packages, or prepared by the machine, without the necessity of
replenishing the device between each vending operation. This definition
is almost identical to the definition of ``vending machine'' in the FDA
Food Code 2009.\1\ Examples of food dispensed from vending machines may
include prepackaged foods (e.g., candy, snacks, gum, bottled or canned
soft drinks), unpackaged bulk foods (e.g., handful of gum, candy, or
mixed nuts), prepared foods (e.g., sandwiches or fresh fruit), multi-
serving foods (e.g., gallon of milk), or foods prepared in the machine
and dispensed in bulk (e.g., coffee, soup, or popcorn).
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\1\ FDA regularly publishes the Food Code, which provides
guidance on food safety, sanitation, and fair dealing that can be
uniformly adopted by State and local governments for the retail
segment of the food industry. The Food Code provisions are not
Federal requirements; however, they are designed to be consistent
with Federal food laws and regulations. The 2009 Food Code defined
the term ``vending machine'' to mean a ``self-service device that,
upon insertion of a coin, paper currency, token, card, or key, or by
optional manual operation, dispenses unit servings of food in bulk
or in packages without the necessity of replenishing the device
between each vending operation.'' (U.S. Public Health Service, FDA,
2009 Food Code, U.S. Department of Health and Human Services, Public
Health Service, Food and Drug Administration, College Park, MD
20740, chapter 1, section 1-201.) http://www.fda.gov/Food/FoodSafety/RetailFoodProtection/FoodCode/FoodCode2009/ucm186464.htm.
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B. Who Must Comply With This Rule

Section 4205 of the Affordable Care Act provides that ``in the case
of an article of 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, and is operated by a person
engaged in the business of owning or operating 20 or more vending
machines, the vending machine operator shall provide a sign in close
proximity to each article of food or the selection button that includes
a clear and conspicuous statement disclosing the number of calories
contained in the article of food.'' Consistent with the requirements of
section 4205, all vending machine operators with 20 or more vending
machines, as defined in section III.A.3. of this document, will be
subject to these requirements. Therefore, FDA is proposing in Sec.
101.8(c)(1)(i)(A) and (B) that the labeling requirements of this
proposed rule apply to vending machine operators that own or operate 20
or more vending machines that do not allow a prospective purchaser to
examine the Nutrition Facts Panel prior to purchase or do not otherwise
provide visible nutrition information at the point of purchase. As
discussed in below in section III.D. of this document, vending machine
operators that are not subject to the requirements of the law may elect
to be subject to the Federal requirements by voluntarily registering
with FDA.
Several comments requested that FDA apply the small business
nutrition labeling exemption (Sec. 101.9(j)(1)) to vending machine
operators. The comments said that: (1) 90-95 percent of vending machine
operators have 20 or more machines, and therefore, would be covered by
section 403(q)(5)(H) of the FD&C Act and (2) 70 percent of vending
machine operators have three or fewer employees, and would likely be
generating sales less than $500,000.
FDA is not proposing an exemption from the vending machine
nutrition labeling requirements for small businesses. FDA notes that
section 403(q)(5)(H) of the FD&C Act does not include an exemption from
the vending machine nutrition labeling requirements for small
businesses. Section 403(q)(5)(D) includes an exemption from the
nutrition labeling requirements in sections 403(q)(1) through (q)(4)
for small businesses. The requirement that vending machine operators
disclose calories for covered vending machine food is not found in
sections 403(q)(1) through (q)(4); instead, it is found in section
403(q)(5)(H)(viii). Therefore, the small business exemption in
403(q)(5)(D) does not apply. We believe that the proposed rule provides
adequate flexibility to allow these small businesses to comply with the
proposed requirements in a cost-effective and equitable way. For
example, the proposed requirements allow vending machine operators to
choose from various approaches for compliance, including adopting less
expensive measures as discussed below in section III.E. and section IV.
of this document. We request comment on additional ways that FDA can
make the requirements of this rule less burdensome on small businesses,
while still meeting the requirements of section 403(q)(5)(H).
The Agency also received comments regarding operators of vending
machines who are blind and operate vending machines through the Vending
Facility Program operated by the U.S. Department of Education under the
Randolph-Sheppard Act of 1936, 20 U.S.C. 107 et seq. These comments
suggested that regardless of the number of machines that were operated
by an operator, all operators of vending machines under the Randolph-
Sheppard Act would be covered.
The Agency wishes to clarify its interpretation of the
applicability of section 4205 of the Affordable Care Act to vending
machine operators who fall under the Randolph-Sheppard Act. Section
403(q)(5)(H)(viii) of the FD&C Act sets forth requirements for vending
machine operators based on the number of machines that they operate.
Thus, as with other operators, Randolph-Sheppard Act operators would
only be covered by the disclosure requirements if they operate 20 or
more vending

[[Page 19241]]

machines that dispense food or if they voluntarily register to be
covered.
These comments also stated that operators of vending machines who
are blind ``may place different products in the same row due to limited
visual recognition and the similarity of product packaging.'' These
comments requested flexibility for posting calorie information.
Specifically, the comments requested that the calorie disclosure
requirements permit the ``stacking of multiple products in the same
coil.''
FDA is proposing requirements that provide flexibility for vending
machine operators to comply with the labeling requirements for covered
vending machine food. As discussed later in this document, the required
calorie information may be posted on a sign adjacent to the vending
machine, so long as the sign is visible to the prospective purchaser at
the same time as the food, its description, or its selection button is
visible.

C. Who Is Not Required to Comply With This Rule

FDA is aware that many vending machine operators operate machines
that dispense a variety of articles other than articles of food. For
example, some vending machines may dispense detergent, compact discs,
gift cards or toiletries. If a vending machine operator operated a
total of 50 vending machines, only 15 of which sell articles of food,
the vending machine operator would not be subject to the requirements
of 403(q)(5)(H)(viii) of the FD&C Act because the vending machine
operator operates fewer than 20 vending machines that sell articles of
food.
Further, FDA tentatively concludes that vending machines that may
dispense food as part of a game or other non-food related activity are
not covered by 403(q)(5)(H) of the FD&C Act. For example, a vending
machine may contain a variety of items ranging from small toys, coins,
or individually wrapped candies that can be picked up by maneuvering a
large claw arm. In this instance, the vending machine does not sell
articles of food, even though in the course of maneuvering the arm,
candies could be dispensed. The vending machine is selling the
opportunity to play the game. FDA seeks comment on this tentative
conclusion.
Bulk vending machines dispense unpackaged articles of food in
preselected amounts (e.g. gumball machines, mixed nut machines). FDA
received a few comments suggesting that bulk vending machines are
different from ``more modern types of vending machines,'' and therefore
should be exempt from these disclosure requirements. The comments
argued that bulk vending machines should be distinguished from other
vending machines for three reasons. First, they noted that these
machines do not have selection buttons, and as a result a vending
machine operator could not place a sign ``in close proximity to * * *
the selection button'' that includes the calorie information required
by section 403(a)(5)(H)(viii)(I) of the FD&C Act. Second, they argued
that food sold from bulk vending machines represents only a small
fraction of overall market sales of the vending machine industry.
Finally, the comments stated that there is no reported association
between foods sold from bulk vending machines and obesity.
FDA notes that section 403(q)(5)(H)(viii) of the FD&C Act does not
limit its applicability to vending machines for which there has been a
reported association between the food vended by the machine and
obesity. However, section 403(q)(5)(H)(viii) provides that for covered
vending machine food, the vending machine operator must provide a sign
disclosing the number of calories contained in the food ``in close
proximity to each article of food or the selection button.'' FDA
tentatively concludes that the reference to ``selection button'' in the
statute can be read to mean that the types of vending machines subject
to requirements in section 403(q)(5)(H)(viii) are those with selection
buttons. FDA is not aware of vending machines without selection buttons
other than bulk vending machines that dispense, by use of a crank,
single types of unpackaged articles of food in preselected amounts
(e.g., a single piece of gum or a handful of candy or nuts). FDA
tentatively concludes that vending machines, including bulk vending
machines, without any type of selection button are not covered by
section 403(q)(5)(H)(viii). However, FDA tentatively concludes that a
bulk vending machine that has a selection button, regardless of the
type of food it dispenses, e.g., unpackaged articles of food such as
soup, popcorn, or hot or cold beverages, is covered under section
403(q)(5)(H)(viii), if it meets the other statutory criteria. FDA is
proposing in Sec. 101.8(c)(1)(i)(C) that the nutrition labeling
requirements of Sec. 101.8 apply to an article of food sold from a
vending machine that, among other things, has a selection button. FDA
seeks comment on these tentative conclusions. FDA is also interested in
comments demonstrating any unintended adverse effect resulting from the
exclusion of vending machines without selection buttons from the
calorie labeling requirements.

D. Voluntary Registration by a Vending Machine Operator That Is Not
Subject to the Requirements of Section 4205 of the Affordable Care Act
That Elects To Be Subject to the Requirements

Section 4205 of the Affordable Care Act provides that vending
machine operators not subject to the requirements of section
403(q)(5)(H)(viii) \2\ of the FD&C Act may elect to become subject to
the requirements by registering ``biannually'' with FDA (21 U.S.C.
343(q)(5)(H)(ix)). As discussed below, operators that choose to be
subject to the Federal requirements would not be subject to non-
identical state or local nutrition labeling laws for food sold from
vending machines. In the proposed rule entitled: Food Labeling;
Nutrition Labeling of Standard Menu Items in Restaurants and Similar
Retail Food Establishments, published elsewhere in this issue of the
Federal Register, FDA explains that ``biannual'' can be defined as
occurring twice every year or as occurring every other year. (Ref. 1).
FDA tentatively concludes that registration every other year is a more
reasonable interpretation, because it does not seem warranted or
necessary for a vending machine operator to tell FDA every 6 months
that the operator wants to be subject to Federal requirements. FDA
began accepting registrations on July 21, 2010, and will continue to
accept them on a continuous basis. FDA is proposing in Sec. 101.8(d)
that an authorized official for a vending machine operator that is not
subject to the Federal requirements may register with FDA every other
year by providing FDA the following information:
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\2\ As discussed in section I.B. of this document, vending
machine operators that own or operate fewer than 20 vending machines
could elect to be subject to the requirements of 403(q)(5)(H)(viii)
of the FD&C Act by voluntarily registering with FDA.
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The contact information (including name, address, phone
number, e-mail address), for the vending machine operator;
The address of the location of each vending machine owned
or operated by the vending machine operator that is being registered;
Preferred mailing address (if different from the vending
machine operator address), for purposes of receiving correspondence;
and
Certification that the information submitted is true and
accurate, that the person or firm submitting it is authorized to do so,
and that each registered vending machine will be subject to the
requirements of Sec. 101.8.

[[Page 19242]]

An authorized official of a vending machine operator who elects to
be subject to the Federal requirements can register by visiting http://www.fda.gov/menulabeling. FDA has created a form that contains fields
requesting the information in Sec. 101.8(d) and made the form
available at this Web site. Registrants must use this form to ensure
that complete information is submitted.

E. Requirements for Vending Machine Operators Subject to This Rule and
Operators That Elect To Be Subject to the Rule When Calorie
Declarations Are Required

Calorie Declaration for a Covered Vending Machine Food
a. Calorie declaration. Section 403(q)(5)(H)(viii) of the FD&C Act
provides that, for a covered vending machine food, the vending machine
operator must ``provide a sign in close proximity to the article of
food or the selection button that includes a clear and conspicuous
statement disclosing the number of calories contained in the article.''
FDA is proposing in Sec. 101.8(c)(2)(i)(A) to require that for a
covered vending machine food, the statement of the number of calories
in the food must be expressed to the nearest 5-calorie increment up to
and including 50 calories, and 10-calorie increment above 50 calories.
For a covered vending machine food that has fewer than 5 calories, the
calorie declaration may be expressed as zero. These rounding rules are
consistent with the declaration of calories for packaged foods as
provided in Sec. 101.9(c)(1).
In addition, FDA tentatively concludes that the number of calories
must be accompanied by a term, e.g., ``calories,'' to make clear what
that number refers to. Consequently, FDA is proposing in Sec.
101.8(c)(2)(i)(B) that the term ``Calories'' or ``Cal'' must appear
adjacent to the number of calories for the covered vending machine
food. This is the ``calorie declaration.'' We tentatively conclude that
permitting the use of the abbreviation ``Cal'' will provide flexibility
for vending machine operators, especially those that have limited space
on their machines, in meeting the proposed requirements.
Because section 403(q)(5)(H)(viii) of the FD&C Act refers to ``an
article of food sold from a vending machine,'' FDA tentatively
concludes that calorie information must include the total calories
present in the covered vending machine food as it is vended. For
example, if a covered vending machine food, such as a sandwich, is
dispensed with a single serving unit of a condiment, such as
mayonnaise, the calorie declaration must include the number of calories
contained in the sandwich and the package of mayonnaise. FDA also
tentatively concludes that the number of calories declared for the
article of food must be identical to the number of calories that are
declared in the Nutrition Facts, if present. If the food contains
multiple servings and bears a Nutrition Facts Panel, FDA tentatively
concludes that the number of calories declared must be equal to the
total number of calories contained in the food item as dispensed. The
total number of calories can be determined by multiplying the number of
calories per serving by the number of servings in the package. For
example, if the Nutrition Facts states 80 calories per serving and 3
servings per container, the total number of calories in the entire
package would be 240 calories. FDA tentatively concludes that for a
covered vending machine food that contains multiple servings, a vending
machine operator may voluntarily disclose calories per serving in
addition to total calories for the food.
Several comments requested that FDA permit the use of calorie
ranges, similar to those provided for restaurants and similar retail
food establishments under section 403(q)(5)(H)(v) of the FD&C Act, in
declaring calorie information for covered vending machine foods that
come in different flavors and varieties, e.g., coffee which comes in
different flavors, brew strength, serving size, sweeteners or different
types of sandwiches or fruit. The comments discussed the need for
flexibility to provide calorie ranges for such items.
FDA acknowledges that some articles of food sold from vending
machines come in varieties, such as different flavors and types of hot
beverages (e.g., coffee or hot chocolate). For some of these varieties,
there could be a large range for calories. For example, calories for
coffee could range from zero calories for a plain brewed coffee to over
400 calories for a large mocha coffee with whole milk and whipped
cream. We point out, however, that a vending machine operator could
post a calorie declaration in close proximity to the selection button
for a food that comes in different varieties and flavors that is sold
in a vending machine that has selection buttons corresponding to the
different options. For example, if there is a button to select cream
for a coffee, a vending machine operator would be able to post a
calorie declaration for that cream item in close proximity to the
selection button. FDA has considered vending machines that typically
dispense fresh sandwiches and fruit (often these machines are turnstile
type). FDA believes that such machines do not present a unique
situation where the proposed options for declaring calorie information
would not be appropriate. FDA tentatively concludes, therefore, that
calorie ranges are not necessary within the context of vending machines
because a vending machine operator would be able to disclose calorie
information under other options, as explained below (e.g., use of signs
including posters).
b. Determination of calorie content. If a covered vending machine
food does not bear Nutrition Facts, FDA anticipates that the
manufacturer or supplier of the food may provide the number of total
calories for the food to the vending machine operator so that the
operator has the necessary calorie information to meet the calorie
disclosure requirements of section 403(q)(5)(H)(viii) of the FD&C Act.
FDA notes that covered vending machine operators must ensure that the
calorie declaration is truthful and not misleading in accordance with
section 403(a)(1) of the FD&C Act. In the event the calorie information
is not available from the manufacturer of the food, FDA seeks comments
on whether a vending machine operator may use nutrient databases,
cookbooks, laboratory analyses, and other reasonable means. FDA notes
that such flexibility is provided in Sec. 101.10 and section
403(q)(5)(H)(iv). Further, FDA seeks comment on whether vending machine
operators should be required to provide FDA the information on which
they relied to determine the total calories posted for the vending
machine food.
c. Placement and prominence of calorie declarations. Section
403(q)(5)(H)(viii) of the FD&C Act provides that for a covered vending
machine food, the vending machine operator must provide a sign in close
proximity to the article of food or the selection button that includes
a clear and conspicuous statement disclosing the number of calories
contained in the food. FDA is interpreting the requirement that a sign
be placed in close proximity to the article to mean that the sign is
placed either in or on the vending machine itself or adjacent to the
vending machine and near the food, its price, its selection number, or
its selection button.
Section 403(q)(5)(H)(viii) also requires that the calorie
declaration be clear and conspicuous. FDA notes that to be clear and
conspicuous the calorie declaration must be in a font size large enough
to be seen and easily readable. However, FDA recognizes that vending
machines come in a variety of sizes, shapes, and

[[Page 19243]]

styles. We also understand that vending machines will often have
limited space. We think that it is important to provide businesses with
flexibility while, at the same time, fulfilling the requirements of the
statute. Therefore, we think it would not be appropriate to require one
specific type size and font for calorie declarations for all covered
vending machine food. Generally, if a calorie declaration is in a
similar color as and a type size no smaller than the name \3\ of the
food, price of the food, or the selection number (e.g., A9 or E4),
consumers should be able to read the calories in the same manner as
they read the name and price of the food item. Therefore, FDA is
proposing in Sec. 101.8(c)(2)(i)(C) that if the calorie declaration is
in or on the vending machine itself, the calorie declaration for a
covered vending machine food must be in a type size no smaller than the
name, selection number, or price of the food as displayed on the
vending machine, whichever is smallest. In addition, to help ensure
that the calorie declaration is clear and conspicuous, FDA is proposing
in Sec. 101.8(c)(2)(i)(B) and Sec. 101.8(c)(2)(i)(C) that the calorie
declaration be made in the same color, or in a color at least as
conspicuous, as the color of the name, price, or selection number of
the food. Further, FDA proposes that the calorie declaration on the
machine must have the same contrasting background as the name or price
or selection number it is in closest proximity to. FDA notes that if a
calorie declaration is presented in a color that is not sufficiently
contrasted with its background or the declaration is in a type size
that is too small to be read by a prospective purchaser, FDA
tentatively concludes that the calorie declaration for a covered
vending machine food is not disclosed in a clear and conspicuous
manner, and the declaration would not be in compliance with the
requirements of section 403(q)(5)(H)(viii)(I). FDA requests comment on
whether these requirements meet the conditions for ``clear and
conspicuous'' or whether the requirements should be more or less
prescriptive.
---------------------------------------------------------------------------

\3\ Here the discussion of ``name'' refers to the name of the
food on or in the vending machine and not the name of the food on
the label of the food package.
---------------------------------------------------------------------------

A number of comments suggested that calorie information be provided
on a poster or sign near the machine, such as for a bank of several
vending machines that may use a common singular payment acceptor.
However, several comments noted a concern that calorie information
would not be read by the consumer unless the calorie information were
posted immediately next to each food item. The comments stated that
``vending menus'' (such as a menu poster for a bank of vending
machines) would not provide the buyer with easy access to the calorie
information.
FDA agrees with the comments that a sign that is a poster may be an
appropriate medium to convey the required calorie declarations, so long
as the sign is in close proximity to the covered vending machine food
or selection button. The Agency tentatively concludes that ``close
proximity'' could mean adjacent to the vending machine, but not
necessarily attached, so long as the sign adjacent to the machine is
clear and conspicuous at the same time as the food, its name, or its
selection button or selection number is visible. The Agency requests
comments on this tentative conclusion. FDA is also proposing in Sec.
101.8(c)(2)(ii)(B) that if the sign required by section
403(q)(5)(H)(viii) of the FD&C Act is placed adjacent to the vending
machine, the calorie declaration must be in type that is all black or
one color printed on a white or other neutral background that contrasts
with the type color. The Agency is not proposing a minimum type size
for the calorie declaration, but we request comment on this tentative
decision. Comments should provide a rationale supporting their position
and any supporting data, including consumer research. Where the vending
machine only displays a vignette (i.e., picture of the food) or name of
the food item, FDA is proposing in Sec. 101.8(c)(2)(ii)(D) that the
calorie disclosure sign must be in close proximity to the vignette or
name or in close proximity to the selection button.
For electronic vending machines (e.g., machines with digital or
electronic or liquid crystal display (LCD) displays), FDA tentatively
concludes that the calorie disclosure sign required by the statute may
be displayed when the selection numbers are entered but before the
selection is confirmed, as proposed in Sec. 101.8(c)(2)(ii)(E).
FDA tentatively concludes, that for certain types of vending
machines with a limited number of selections, (e.g., popcorn with or
without added butter), the sign with the statement of calories may
appear anywhere on the front (or face) of the vending machine. A sign
may consist of a handwritten sticker in permanent marking that is
affixed to the machine, provided that the statement is prominent, not
crowded by other labeling on the machine and in a type size reasonably
related to the largest print on the vending machine.

F. When Calorie Declaration Is Not Required

1. Examination of the Nutrition Facts Panel
If the Nutrition Facts Panel of an article of food sold from a
vending machine may be examined by a prospective purchaser before
purchasing the article, the vending machine operator is not required to
provide the calorie information. FDA is interpreting the term
``Nutrition Facts Panel'' to mean the nutrition information in the
format required in Sec. 101.9(c) and (d) on the label of the food. FDA
tentatively concludes in order for the Nutrition Facts Panel to be
examined, it must be visible in full, without obstruction, before
purchase. For example, a vending machine's automatic dispensing coil
that holds the food in place or the placement of the package in the
machine must not obscure, cover, or cause to be covered any portion of
the Nutrition Facts Panel. To enable the prospective buyer to obtain
the total number of calories of the article of food, the information
that would be required to be made available on a sign by the vending
machine operator if the provisions of section 403(q)(5)(H)(viii)(I)(aa)
are not met, the agency notes that, in most cases, the prospective
purchaser must use several parts of the panel to determine the total
number of calories for the article of food. This is one reason that it
is critical that no portion of the Nutrition Facts Panel be obscured.
In addition, the Nutrition Facts Panel must be in a size that
permits the prospective purchaser to easily read the nutrition
information while the food is in the vending machine. FDA regulations
allow certain foods to bear Nutrition Facts in a modified or smaller
format based on the composition of the food, the size of the food
package or other factors (see Sec. 101.9(d), (e), (f), (h) and (j)).
Where the Nutrition Facts Panel is in a smaller format consistent with
the regulations, a prospective purchaser is unlikely to be able to
easily read it on the label of the article of food in the vending
machine prior to purchase. In such cases, the Agency tentatively
concludes that the prospective purchaser is not able to examine the
Nutrition Facts Panel prior to purchase. FDA requests comment on these
tentative conclusions.
FDA recognizes that ordinarily the vending machine operator is not
responsible for the printing of the Nutrition Facts Panel. Nor is the
vending machine operator required by section 403(q)(5)(H)(viii)(I) to
make examination of the Nutrition Facts

[[Page 19244]]

possible by the prospective purchaser prior to purchase. However, food
manufacturers may have an incentive to work with vending machine
operators to find ways to have their packaged food displayed with the
Nutrition Facts easily readable in the vending machine. In this way,
potential purchasers would have more information about the
manufacturers' food than just calories.
2. Visible Nutrition Information at the Point of Purchase
The second prong of section 403(q)(5)(H)(viii)(I)(aa) specifies
that if a vending machine ``otherwise provide[s] visible nutrition
information at the point of purchase'' for an article of food sold from
the machine, the vending machine operator is not required to provide
the calorie information. As with the Nutrition Facts Panel this
alternative means of satisfying the requirement of section
403(q)(5)(H)(viii) is optional for vending machine operators.
The terms ``visible nutrition information'' and ``point of
purchase'' in section 403(q)(5)(H)(viii)(I)(aa) are not defined in the
statute. FDA sees two possible ways to understand and apply the terms.
One approach is to conclude that (1) ``nutrition information'' in this
context means total calories in the article of food, because this is
the information that the vending machine operator must provide by sign
if the provisions in section 403(q)(5)(H)(viii)(I)(aa) are not met; and
(2) ``otherwise provide[d] * * * at the point of purchase'' suggests,
in the context of the provision as a whole, that the information, like
the Nutrition Facts Panel, should be on the article of food itself. FDA
proposes this approach in proposed Sec. 101.8(b).
FDA received several comments supporting the use of ``front of
package'' nutrition information contained on the food label as a means
of ``providing visible nutrition information at the point of
purchase.'' For example, some packaged food manufacturers voluntarily
place certain nutrition information on the principal display panel that
includes calorie and other nutrition information about the product.
This type of nutrition information is sometimes referred to as ``front
of package'' by industry, whereas Nutrition Facts typically appear on
the information panel of a food label. FDA tentatively concludes that
``front of package'' nutrition information could be a way to provide
visible nutrition information, so long as the criteria for color, font
and type size are met and total calories in the article of food are
included. If a nutrient content claim or a health claim for the article
of food also is included on the front of the package, the claim must
comply with relevant FDA regulations authorizing nutrient content
claims (a claim on food labeling regarding the level of a nutrient,
e.g., low fat) or health claims (a claim on food labeling regarding the
relationship between a substance and a disease, e.g., calcium and
osteoporosis), as applicable.
FDA also received a few comments stating that the Nutrition Facts
Panel and any ``front of package'' nutrition information may be small
and difficult to read in a vending machine. FDA recognizes that a
consumer may not be able to easily read some nutrition information in a
vending machine and therefore this information may not inform the
consumer about the number of total calories in the article of food.
Section 101.8(b) of this proposed rule sets out the provisions
regarding ``visible nutrition information at the point of purchase''
discussed above.
Under proposed Sec. 101.8(b), for the nutrition information on the
label to be considered ``visible,'' it must be clear and conspicuous.
To ensure that it is clear and conspicuous, it must be both (1) in a
type size easily readable from the distance between the prospective
purchaser and the label and (2) in print with sufficient color and
contrasting background to be readily distinguishable from other types
of information on the label. FDA tentatively concludes that the visible
nutrition information presented on the label of the food at the point
of purchase must be in a type size reasonably related to the most
prominent printed matter on the label and in a color that sufficiently
contrasts with the background, such that a prospective purchaser is
able to notice and read the information. Generally, FDA has considered
``reasonably related'' to mean a type size that is at least 50 percent
of the size of the largest print on the label. (Ref. 2).
The alternative approach is to interpret the words ``otherwise
provide visible nutrition information at the point of purchase'' by
concluding that (1) ``nutrition information'' means something more than
total calories, and (2) ``point of purchase'' means something more than
on the package of the food itself. Under this interpretation, the non-
Nutrition Facts Panel option in the statute would include information
in addition to total calories because the broader term ``nutrition
information'' was used instead of ``calories.'' Just as the Nutrition
Facts Panel contains more than calorie information, so too, would
``visible nutrition information at the point of purchase.'' This could
include, in addition to total calories in the food, information such as
serving size information or information on the nutrients that are
required to be disclosed in the Nutrition Facts as described in Sec.
101.9 or 21 U.S.C. 343(q)(1)(D) and (E). FDA seeks comment on what
other nutrition information, if any, should be required if this
alternative interpretation were adopted. FDA also notes that under this
alternative interpretation, the vending machine operator could rely on
any ``visible nutrition information at the point of purchase'' that
included total calories in addition to other nutrition information
regardless of what entity supplied the information.
Likewise, under the alternative approach, ``point of purchase''
would be read to mean that the ``visible nutrition information'' could
be provided in places other than on the package of the food in the
vending machine, such as on the vending machine itself.
In the case of the alternative interpretation, in which the
``visible nutrition information at the point of purchase'' appears
other than on the label of the article of food, there are also the
questions of where and through what means the information may be
provided. The agency specifically requests comment on whether, under
this alternative interpretation, signs (including posters) or booklets
would be sufficient in providing ``otherwise visible nutrition
information at the point of purchase'' and we especially request any
consumer studies or social scientific data on this issue.
Regardless of the precise location or means of providing the
nutrition information, under the alternative interpretation there would
also be a question of ensuring that the information is adequately
``visible.'' At a minimum, the nutrition information should be clear
and conspicuous and noticeable at the point of purchase, in the context
of the surroundings. One way to ensure this visibility if the nutrition
information is not on the label of the article of food would be to
provide the information in type that is all black or one color, printed
on a white or other neutral background that contrasts with the type
color. Another way would be to also provide the information using a
minimum type size. The agency requests comments on these and other ways
to determine if the information is ``visible.''
Another aspect of whether information that is not on the food
itself is visible to the consumer is where the information is placed
relative to the ``point of purchase.'' FDA requests comment on the
meaning of ``the point of purchase'' in this context and on all

[[Page 19245]]

aspects of the alternative interpretation of ``visible nutrition
information at the point of purchase.''
FDA seeks comment on the alternative approaches to interpreting and
applying ``otherwise provide visible nutrition information at the point
of purchase.''

G. Conforming Amendment

FDA is proposing to exempt electronic signatures submitted to
satisfy the requirements of this proposed section from the requirement
to comply with Part 11--Electronic Records; Electronic Signatures (21
CFR part 11) and proposing to amend part 11 to reflect this exemption.
We expect this exemption to facilitate the registration process for
those vending machine operators who voluntarily choose to register
under section 403(q)(5)(H)(ix) of the FD&C Act.

H. Effective Date

FDA received a few comments regarding the effective date of the
final rule that would issue based on this proposal. These comments
suggested that vending machine operators would need 2 years to
implement the requirements for calorie labeling for vending machines
due to the costs of producing posters and driving to each site to post
the information.
FDA is proposing that the final rule become effective one year from
the date of its publication. Because FDA is proposing flexibility for
compliance, i.e., the use of signs in, on, or adjacent to vending
machines, vending machine operators would be able to choose among a
wide variety of less expensive avenues to achieve compliance, depending
on their situation. Many foods sold from vending machines are packaged
and have Nutrition Facts. Therefore, vending machine operators have the
opportunity of orienting the food in the vending machine such that the
prospective customer may examine the Nutrition Facts Panel. In this
case, the operators would not need to provide calorie information
required by 403(q)(5)(H)(viii)(I) of the FD&C Act. If the operator
chooses not to orient the food such that the prospective customer may
examine the Nutrition Facts Panel, or if it is not practicable to do so
because the vending machine is not of the type where the food is
visible, the operator may obtain the calorie information from the
Nutrition Facts to place on the signs. Further, the proposed rule, if
finalized, does not require any particular manner of obtaining calorie
information. As discussed above in this document, FDA anticipates that,
if a covered vending machine food does not bear Nutrition Facts because
it falls under an exemption, the manufacturer or supplier of the food
may provide the number of total calories for the food to the vending
machine operator so that the operator has the necessary calorie
information to meet the calorie disclosure requirements of section
403(q)(5)(H)(viii)(I). Because of the flexibility provided in this
proposed rule, the Agency finds that it is reasonable to make the
requirements effective in 1 year. Based on the comments and on what
vending machine operators will need to do to come into compliance, the
Agency tentatively finds that making the final rule effective 1 year
after publication is practicable. The Agency seeks comment on the
appropriateness of this timeframe.

IV. Summary Preliminary Regulatory Impact Analysis

The summary analysis of benefits and costs included in this
document is drawn from the detailed Preliminary Regulatory Impact
Analysis which is available at http://www.regulations.gov, Docket No.
FDA-2011-F-0171, and is also available on FDA's Web site at http://www.fda.gov/Food/LabelingNutrition/ucm217762.htm.

A. Introduction

FDA has examined the impacts of the proposed rule under Executive
Orders 13563 and 12866, the Regulatory Flexibility Act (5 U.S.C. 601-
612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).
Executive Orders 13563 and 12866 direct agencies to assess all costs
and benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety
effects, distributive impacts, and equity). Executive Order 13563
emphasizes the importance of quantifying both costs and benefits, of
reducing costs, of harmonizing rules, and of promoting flexibility.
This proposed rule has been designated an ``economically'' significant
rule, under section 3(f)(1) of Executive Order 12866. Accordingly, the
proposed rule has been reviewed by the Office of Management and Budget
(OMB).
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Using the Small Business Administration (SBA)
definition of small vending machine operators as classified by the
North American Industry Classification System (NAICS 45421), FDA
estimates that a significant number of operators impacted by this
proposed rule are small businesses. As directed by statute, the
requirements of the proposed rule only apply to vending machine
operators that own or operate 20 or more vending machines. However,
according to data from the Vending Times Census and from the National
Automatic Merchandising Association (NAMA), the average annual revenue
per machine is less than $7,000 (Refs. 3 and 4). An operator with only
20 machines may have vending machine revenue of less than $140,000. In
order to exceed the SBA's definition of a small vending machine
operator, a firm would need at least $10 million in annual revenue
(Ref. 5). This suggests that a firm with revenue exclusively from
vending machine sales would need more than 1,400 machines to exceed the
definition of small business. Based on the latest available U.S.
Economic Census data that breaks down establishments by revenue, we
project that 97 percent of firms selling covered vending machine food,
as that term is used in this document, that identify primarily as
vending machine operators that are engaged in the business of owning or
operating 20 or more vending machines would be small businesses as
defined by SBA. Therefore, the Agency believes that the proposed rule
would have a significant economic impact on a substantial number of
small entities. This impact is discussed further in section V of this
document.
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 $135 million, using the most current (2009) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.

B. Need for This Regulation

This proposed rule is necessary to implement section 4205 of the
Affordable Care Act, which principally amends sections 403 and 403A of
the FD&C Act, and requires operators of 20 or more vending machines to
disclose calorie information for covered vending machine food. The
provision of calorie information for covered vending

[[Page 19246]]

machine food may help consumers make better informed dietary choices.
Economic justifications for regulatory interventions in private
markets rely on the presence of some market failure. In the case of
food sold from a vending machine, the private market is particularly
robust and competitive. Thousands of individual firms vie for consumer
dollars in millions of vending machines across the United States (Ref.
3). Low entry costs for firms and low switching costs for customers
suggest that if a sizable fraction of consumers were willing to pay
for--and discriminate based on--the visible calorie information at the
point of purchase then the industry would provide it to them. In fact,
some vending machine operators are voluntarily providing more healthful
choices and additional information on machines (Refs. 4 and 6).
Although many of the usual market failures that justify regulatory
action, such as the existence of market power or of ill-defined
property rights, do not apply here (Refs. 7 and 8), the primary support
for regulatory intervention is that there are systematic biases in how
consumers process information and weigh current benefits (from
consuming higher calorie foods) against future costs (higher
probability of obesity and its comorbidities).
The bias is more directly related to the requirements of this
proposed rule: Consumer demand for calorie information does not create
incentives for the provision of calorie information at the vending
machine. This market failure occurs because at the time of purchase,
consumers do not value calorie information as much as they do later,
when the effects of excess calorie consumption are evident. Studies
have shown that consumers have present-based preferences, meaning that
they are continually optimistic about the healthfulness of their future
choices (Ref. 9, 10 and 11).
These studies suggest that calorie information often lacks
salience, or relevance, for consumers at the time of purchase and
consumption, even though they may experience regret about their
decisions at a later date. This tendency may explain why consumers have
not generally demanded calorie and other nutrition information for food
sold from vending machines before, or at, the point of purchase, even
if they may, at a later point in time, value that information. Because
of competition for consumer time and attention vending machine
operators have limited time and space in which to convey information to
consumers. These limits mean that there is a substantial opportunity
cost to the operator of providing calorie information. That is, just as
an operator may have to decide which possible foods to leave out of a
vending machine with limited space (thus giving up the opportunity to
sell those items), it must choose which pieces of information about its
foods it wants to convey. Adding an additional piece of information
means that an operator may need to downplay or remove some other piece
of information. This opportunity cost of information holds true whether
the calorie information is displayed on the machine or, as with an
increasing number of packaged foods, on the principal display panel of
the package.
The proposed requirements mitigate the apparent market failure in
information provision stemming from present-biased preferences,
although not necessarily the tendency of consumers to underutilize that
information. Specifically, for a covered vending machine food, this
proposed rule requires that the vending machine operator provide a sign
in close proximity to the food or the selection button, i.e. in, on, or
adjacent to the vending machine, but not necessarily attached to the
vending machine, so long as the sign is visible at the same time as the
food, its name, price, or selection number. This information must be
presented in a color that is sufficiently contrasted with the
background, must be in close proximity to the vignette or name or in
close proximity to the selection button when a name or vignette is
displayed, and, for electronic vending machines, the calorie
information may be displayed when the selection numbers are entered but
before the selection is confirmed. These requirements are designed so
that the calorie information is made available to consumers before they
purchase such food. Providing the information will likely increase
consumer awareness regarding the calorie content in covered vending
machine food and increase the perceived relevance of that information
to their decision making. Providing the information may serve to
highlight the potential future costs of additional calorie consumption.
This increased attention to the caloric content of covered vending
machine food may then result in an increased availability of lower
calorie options, and an increased demand for these options.

C. Summary of Costs and Benefits of the Proposed Requirements and
Regulatory Options

In this section FDA describes the bases of benefits and costs of
the proposed requirements and summarizes the results of the detailed
Preliminary Regulatory Impact Analysis (PRIA).
Benefits in response to the proposed requirements Obesity is a
major public health concern in the United States and one of the top
leading health indicators addressed by the United States Healthy People
2020 goals. Nationally representative data indicate an increase in the
prevalence of obesity over the past three decades (Ref. 12). The 2007-
2008 National Health and Nutrition Examination Survey (NHANES) data
showed that 34 percent of the adult U.S. population is obese and 34
percent are overweight (Ref. 13).
Excess body weight has many health (Ref. 14), social (Refs. 15 and
16), psychological (Refs. 17 and 18), and economic consequences (Ref.
19) for the affected individuals. Lower life expectancy, elevated risk
of diabetes, hypertension, stroke and other cardiovascular diseases
have been documented to rise simultaneously with the increased
prevalence of obesity (Ref. 14). The economic impact is especially
evident in health-care costs in terms of greater health-care
utilization and higher medical expenditures (Ref. 20). More
specifically, medical expenditures attributable to overweight and
obesity accounted for more than 9 percent of the total U.S. medical
expenditures in 1998, or between $85.7 billion and $147 billion (Ref.
20). Researchers have proposed various factors to explain this dramatic
rise in obesity including declining food prices and physical
requirements of labor (Refs. 21 and 22), declining time costs of food
preparation (Ref. 23), fast-food restaurant density (Ref. 24) and
social interactions (Refs. 25).
Although the relationship between obesity and poor dietary choices
is multi-faceted, there is a general agreement in the literature that
reduction in excess calories is helpful in preventing or delaying the
onset of excess weight gain (Ref. 26). Vending machines are a likely
source of high-calorie snack or discretionary foods, as well as some
high-calorie meal items. Industry data indicate that there is
approximately one vending machine for every 40 adults in the United
States, and that up to 5 percent of the money consumers spend on food
away from home is spent on vending machine food (Ref. 27). This
suggests that providing calorie information for covered vending machine
food to consumers may have a significant effect on calorie intake, the
prevalence of obesity, and thus the cost of health care and lost
productivity.
To the extent that the proposed requirements mitigate the increase
in the prevalence of obesity and the

[[Page 19247]]

prevalence of these costly co-morbidities such as hypertension and
diabetes, society gains the opportunity cost of the averted medical
expenditures and an increase in productivity from averted debilitation
and death. In addition to educating consumers about calorie content,
major predicted elements of the consumer and industry response to this
proposed rule are:
1. Increased awareness regarding the caloric content in covered
vending machine foods, and the perceived relevance of that information
to decision making, which may help reduce the present-bias in
preferences, and thus encourage the consumption of lower calorie
options.
2. Increased consumer interest in lower calorie options, and
greater transparency in the caloric content of foods sold in vending
machines, which may give manufacturers an incentive to:
a. Reduce the calorie content of foods sold in vending machines
through reformulation or by decreasing portion size.
b. Provide additional items with lower calorie formulations.
These changes may reduce consumers' caloric intake from food sold
in vending machines. Note that any reduction in calorie intake in these
settings may be at least partially offset by increases in calorie
intake during other meals or snacks. Because FDA lacks data on how
consumers will substitute among caloric sources, the benefit
estimations given here may be higher or lower than those that will be
realized if the rule is finalized as proposed.
Coverage of the proposed rule and industry overview. The proposed
rule covers certain vending machine operators that are engaged in the
business of owning or operating 20 or more vending machines and those
vending machine operators that voluntarily register with FDA to become
subject to the Federal requirements. The proposed rule does not cover
vending machines without a selection button, including bulk vending
machines that dispense gum, candy and nuts. Vending machines are
operated both by food service firms and by firms in other businesses
that operate machines for the benefit of their customers or employees
and do not identify as vending machine operators. Because this latter
group cannot be accurately counted, published estimates of the number
of vending machine operators will generally undercount the number of
covered operators under the proposed rule. For the purposes of this
preliminary regulatory impact analysis, we will use the term ``covered
operators'' or ``covered vending machines'' to refer to operators or
machines that sell covered vending machine foods. According to the
NAMA, there are approximately 13,500 companies that operate vending
machines in the United States (Ref. 4). Other estimates put the total
closer to 10,000 (Ref. 3). This total includes 5,000 firms whose
primary business identification is as vending machine operators (NAICS
4542), plus a variety of other firms that operate vending machines, but
do not primarily identify as such. These other companies include, for
example, beverage manufacturers and food service contractors. Because
of the difficulty in determining which firms are covered, and because
FDA has no data on the potentially significant number of covered
vending machine operators that self-identify as businesses outside the
food industry, we take NAMA's higher estimate of 13,500 firms as the
number of covered firms.
FDA estimates that 97 percent of firms selling covered vending
machine food that identify primarily as vending machine operators that
are engaged in the business of owning or operating 20 or more vending
machines are small businesses as defined by the SBA. Other estimates
indicate that more than 90 percent of the firms covered by the proposed
rule are defined as small businesses (Ref. 3). This percentage may be
lower for firms that have primary business identification other than as
vending machine operators, but the majority of covered businesses will
likely still be defined as small businesses. Because very small,
informal businesses that are not captured by economic census data might
operate 20 or more machines, these figures may underestimate the number
of affected small businesses. Conversely, approximately 72 percent of
industry revenue--and thus a comparably large fraction of consumption--
comes from firms with more than $10 million in annual sales, and 85
percent comes from firms with more than $5 million in revenue (Ref. 3).
Vending machine operators together operate an estimated 5 to 7
million machines (Refs. 3 and 4) in at least 1.5 million locations
(Ref. 3). Approximately 70 percent of these machines sell packaged
food, including beverages, that are required to bear nutrition labeling
under section 403(q)(1) of the FD&C Act and FDA regulations at Sec.
101.9, and thus have Nutrition Facts. This 70 percent is comprised
mostly of packaged beverage machines, which account for more than 50
percent of all vending machines, with the remainder--approximately 20
percent of all machines--selling packaged confections or snacks. Ten
percent sell a variety of hot and cold cup beverages, frozen or fresh
food products and miscellaneous other food products. The final 20
percent of machines are bulk candy, nut or gum machines that are not
covered by section 403(q)(5)(H)(viii) and the proposed requirements
because they lack selection buttons. While these bulk machines form a
large percentage of vending machines, they account for less than 0.5
percent of vending machine sales (Ref. 4).
Summary of costs and benefits of the proposed rule and regulatory
options In this section we briefly summarize the costs and benefits of
the proposed rule that are analyzed in the detailed PRIA. These
estimates are collected in table 1. Costs of complying with the
proposed requirements have been estimated for three major areas: Cost
of nutrition analysis, cost of new signs, including posters, and labor
costs. In the case of the proposed rule, FDA estimates that there would
be approximately 10,800 operators under the proposed requirements,
controlling between 4 million and 5.6 million machines that sell
covered vending machine foods. The initial mean estimated cost of
complying with the proposed requirements is $25.8 million, with an
estimated mean ongoing cost of $24.0 million. Mean annualized costs are
$24.5 million at a 7 percent discount rate, and $24.2 million at 3
percent discount rate. Per operator costs are estimated to be $2,400.
FDA estimates that average per machine costs are less than $10
annually.
FDA has not estimated the actual benefits associated with proposed
requirements. Food choice and consumption decisions are complex and FDA
is unaware of any comprehensive data allowing accurate predictions of
the effect of the proposed requirements on consumer choice and vended
foods. Therefore, FDA has constructed a plausible individual effect of
the proposed rule, and has conducted a break-even analysis in order to
determine the proportion of the U.S. obese adult population that would
need to attain this minimal response in order for the proposed
requirement to yield a positive net benefit. Using a 100 calorie per
week reduction in intake as the benchmark effect, FDA estimates that at
least 0.02 percent of the adult obese population would need to reach
this benchmark in order for the rule to break even on the initial total
cost. On an ongoing basis, again, at least 0.02 percent of the adult
obese population would need to reach this benchmark in

[[Page 19248]]

order for the rule to break even on the recurring annual costs. These
effects are summarized in table 1 of this document.
Finally, although registration by firms wishing to register with
FDA in order to come under the proposed requirements and the associated
preemption from State or local regulations is voluntary, and will only
occur to the extent that the costs of registration and compliance with
Federal regulation is lower than that of State or local laws, this
registration constitutes a collection of information under the
Paperwork Reduction Act of 1995. Therefore, FDA has also estimated the
burden associated with this collection of information in the detailed
analysis.

Table 1--Accounting Statement: Annualized Cost and Break-Even Benefit Point for the Proposed Requirements
----------------------------------------------------------------------------------------------------------------
Primary Low High Year Discount Period
estimate estimate estimate dollar rate covered
----------------------------------------------------------------------------------------------------------------
Benefits
----------------------------------------------------------------------------------------------------------------
Annualized Monetized ($millions/
year)............................ Not Quantified
-----------------------------------
Annualized Quantified:
----------------------------------------------------------------------------------------------------------------
Qualitative: FDA estimates that at least 0.02 percent of the adult obese population would need to reduce caloric
intake by at least 100 calories per week in order for benefits from the proposed requirements to reach a break
even point on annualized costs (at either 3% or 7%)
----------------------------------------------------------------------------------------------------------------
Costs
----------------------------------------------------------------------------------------------------------------
Annualized Monetized ($millions/ $24.5 $12.5 $39.8 2009 7% 10
year)............................
24.2 12.1 39.6 2009 3% 10
----------------------------------------------------------------------------------------------------------------

Regulatory Options In addition to a baseline, FDA has identified
four regulatory options for this proposed rule. The costs and benefits
of these options are summarized in table 2 of this document.
(0) Baseline for the purpose of analysis--No new Federal regulatory
action.
(1) Option 1, the proposed rule, allowing a sign in close proximity
to the article of food or selection button, i.e. in, on, or adjacent to
the vending machine, but not necessarily attached to the vending
machine, so long as the sign is visible at the same time as the food,
its name, price, or selection number, and with an effective date of 1
year after publication of the final rule.
(2) Option 2, similar to the proposed rule, but requiring that
calorie declarations be immediately adjacent to the article of food or
selection button for all calorie disclosures. For this option, FDA
estimates the cost of individual signs for each article of food or
selection button.
(3) Option 3, Similar to the proposed rule, but with an additional
year in compliance period for vendors with less than $500,000 in annual
revenue from vending machines.
(4) Option 4, similar to the proposed rule, but with coverage
extended to bulk vending machines without selection buttons.

Table 2--Summary of Estimated Annualized Compliance Costs for Each Option
--------------------------------------------------------------------------------------------------------------------------------------------------------
Proportional
Proportional dollar sales
Percent cost relative of restaurant
Primary Low estimate High estimate discount rate to primary food relative
Summary of options estimate (in (in millions) (in millions) (10 year estimate of to primary
millions) horizon) the proposed estimate of
requirements the proposed
requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
(Baseline).............................................. N/A N/A N/A N/A N/A
Option 1: the Proposed Rule............................. $24.2 $12.1 $39.6 3% 0.0% 0.0%
24.5 12.5 39.8 7%
Option 2: Individual Signs.............................. 81.8 36.1 140.4 3% +229.2% 0.0%
82.5 36.6 141.1 7%
Option 3: Longer Compliance Time for Small Businesses... 24.2 12.1 39.6 3% 0.0% 0.0%
24.5 12.5 39.8 7%
Option 4: Extended Scope to Include Bulk Machines....... 30.2 15.1 49.4 3% +25.6% +0.5%
31.0 15.8 50.3 7%
--------------------------------------------------------------------------------------------------------------------------------------------------------

FDA estimates that Option 2, which would require individual signs
or labels for each covered vended food, has a ten-year annualized costs
of between $36.1 million per year and $140.4 million per year at a 3
percent discount rate, with a primary estimate of $81.8 million.
Averaged over primary, low and high estimates, the costs of Option 2
are 229.2 percent higher than those of the proposed requirements. These
changes are discussed more fully in the detailed analysis.
Option 3 which considers a longer compliance time for small
businesses represents only a delay in the costs. This delay has a small
positive impact on the annualized cost, but one that does not change
the (rounded) estimate of costs for Option 3 from the estimate,

[[Page 19249]]

of costs for Option 1. Option 4, expands the scope of the requirements
to include foods in bulk vending machines without selection buttons,
has costs that are 25.6 percent higher than the proposed option, and
covers an additional 0.5 percent of sales of vended foods.
For full documentation and discussion of these estimated costs and
benefits see the detailed Preliminary Regulatory Impact Analysis,
available at http://www.regulations.gov, Docket No. FDA-2011-F-0171,
and is also available on FDA's Web site at http://www.fda.gov/Food/LabelingNutrition/ucm217762.htm.

V. Initial Regulatory Flexibility Analysis

FDA has examined the economic implications of this proposed rule as
required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a
rule has a significant economic impact on a substantial number of small
entities, the Regulatory Flexibility Act requires agencies to analyze
regulatory options that would lessen the economic effect of the rule on
small entities consistent with statutory objectives. FDA tentatively
concludes that this proposed rule will have a significant economic
impact on a substantial number of small entities.
However, FDA has built flexibility into the proposed rule. The
proposed rule does not mandate a particular method for determining
calorie disclosure; instead, the proposed rule provides options for how
vending machine operators can determine calorie information for covered
vending machine food. Further, the proposed rule does not prescribe the
materials that may be used by vending machine operators in disclosing
calorie information; instead, the proposed rule provides options for
how vending machine operators can disclose calorie information for
covered vending machine food. Therefore, vending machine operators may
choose among a wide variety of less, or more, expensive avenues to
achieve compliance, depending on their situation. Because no particular
method for compliance is mandated, the proposed rule gives small
businesses the leeway to use cheaper solutions that meet the
requirements of the proposed rule (e.g., stickers).
A general way to add flexibility for small firms during a
rulemaking is to lengthen the time for these firms to comply with the
rule. An example of a delayed compliance time for small businesses
applied to this proposed rule is the option for vendors with less than
$500,000 in annual revenue from vending machine food sales to have an
additional year to comply. Generally, FDA uses the SBA's definition of
``small business'' as it applies to the relevant economic sector, in
this case, NAICS 4542. However, as noted in the detailed Preliminary
Regulatory Impact Analysis, available at http://www.regulations.gov,
Docket No. FDA-2011-F-0171, and is also available on FDA's Web site at
http://www.fda.gov/Food/LabelingNutrition/ucm217762.htm, SBA defines a
small vending machine operator as one with annual revenue less than $10
million, and this definition would cover at least 97 percent of the
industry. Adding flexibility--such as a longer time to come into
compliance--specifically for small firms would mean that most vending
machine operators would be given that added flexibility. Therefore FDA
has taken the approach of building substantial flexibility into the
proposed rule for most vending machine operators in order to give the
entire industry the opportunity to comply in the most cost-effective
way.

VI. Paperwork Reduction Act

This proposed rule contains information collection provisions that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). A
description of these provisions is given in the following paragraphs
with an estimate of the annual reporting and recordkeeping burden.
Included in the 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.
The information collection provisions for all provisions of this
proposed rule have been submitted to OMB for review as revisions of
collections approved under OMB control numbers 0910-0664 and 0910-0665.
Interested persons are requested to fax comments regarding information
collection by May 6, 2011, to the Office of Information and Regulatory
Affairs, OMB. 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: 202-395-5806.
FDA invites comments on: (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.

Vending Machine Labeling: Recordkeeping and Mandatory Third Party
Disclosure Under Section 4205 of the Patient Protection and Affordable
Care Act of 2010--(OMB Control Number 0910-0665)--Revision

Section 4205 of the Affordable Care Act, which amends sections
403(q)(5) and 403A of the FD&C Act, requires disclosure of calorie and
other nutrition information by restaurants and vending machine
operators. Section 4205 became effective on the date the law was
signed, March 23, 2010. Restaurants and vending machine operators not
subject to the requirements of section 403(q)(5)(H) may elect to become
subject to the requirements of section 403(q)(5)(H) by registering
biannually with FDA. Section 4205 required FDA to publish a notice in
the Federal Register within 120 days of the date of enactment of
section 4205, providing information on the terms and conditions for
persons who voluntarily elect to be subject to nutrition disclosure
requirements specified in the law.

A. Statutory Compliance

To comply with the PRA and with the statutory deadline under the
provisions of section 4205 for publication of registration information,
FDA initially obtained a 6-month OMB approval of the collection of
information requirements under the emergency processing provisions of
the PRA. With OMB approval of the collection of information
requirements of section 4205, FDA took several actions: (1) Developed
an electronic form, ``Menu And Vending Machine Labeling Voluntary
Registration,'' Form FDA 3757, (2) as required by section 4205,
published a notice in the Federal Register of July 23, 2010 (75 FR
43182) (the July 23, 2010, notice) to explain how retail food
establishments and vending machine operators not otherwise subject to
the provisions of section 4205 may voluntarily elect to become subject
to them, and (3) developed and implemented the guidance entitled,
``Guidance for Industry: Questions and Answers Regarding the Effect of
Section 4205 of the Patient Protection and Affordable Care Act of 2010
on State and Local Menu and Vending Machine Labeling

[[Page 19250]]

Laws.'' This guidance among other things clarified section 4205's
effect on State and local menu and vending machine labeling laws, to
ensure that industry and State and local government understood the
immediate effects of the law. FDA's current thinking on the preemptive
effects of section 4205 is set out in the Federalism sections of the
preamble to the proposed rule implementing menu labeling and this
proposed rule.
FDA has requested a 3-year approval of the information collection
requirements under the same assigned OMB Control Nos. 0910-0664 and
0910-0665. In the Federal Register of January 31, 2011, FDA published
two notices announcing the submission to OMB of the information
collection requests for No. 0910-0664 (76 FR 5384) and No. 0910-0665
(76 FR 5380). Elsewhere in this Federal Register, FDA published a
proposed rule entitled ``Food Labeling; Nutrition labeling of standard
menu items in restaurants and similar retail food establishments'' (the
Menu Labeling proposed rule). As noted, the information collection
requests previously submitted sought OMB approval of the reporting,
recordkeeping, and third party disclosure burdens of section 4205, not
the provisions of the Menu Labeling proposed rule. With that proposed
rule, FDA submitted a revised information collection request seeking
OMB approval of the changes caused by the Menu Labeling proposed rule
to the collections approved under OMB Control Nos. 0910-0664 and 0910-
0665. This proposed rule seeks further revision of those information
collections with regard to the recordkeeping and third party disclosure
burdens for vending machine operators caused by this proposed rule.

B. Revision of OMB Control No. 0910-0665 by the Proposed Rule

These estimated annual recordkeeping burdens have changed from the
burdens estimated for the OMB control number 0910-0665 30 day notice
(76 FR 5380, January 31, 2011). Total initial hours have risen by 1,920
due to an increase in the estimated number of recordkeepers from 600 to
915 and an increase in the number of hours per record from 2 hours to 4
hours. The estimated burden of recurring hours increased by 8 hours to
128 hours. This estimate of third party disclosure hours has decreased
by approximately 13.2 million hours, from the 14 million hours estimate
given in the 30-day notice.

C. Consolidation of OMB Control No. 0910-0664 Under 0910-0665

The Menu Labeling proposed rule contains a revision request in
which the burden hours for the information collection request under OMB
control number 0910-0664, ``Restaurant Menu and Vending Machine
Labeling: Registration for Small Chains Under Section 4205 of the
Patient Protection and Affordable Care Act of 2010'' are being
consolidated under the information collection request assigned OMB
control number 0910-0665,''Restaurant Menu and Vending Machine
Labeling: Recordkeeping and Mandatory Third Party Disclosure Under
Section 4205 of the Patient Protection and Affordable Care Act of
2010.'' In addition, this proposed rule is a revision request in which
these two information collection requests will be further revised with
regard to the estimated burden of the proposed rule on vending machine
operators. The revised information collection request for 0910-0665
will be renamed ``Restaurant Menu and Vending Machine Labeling:
Registration, Recordkeeping and Mandatory Third Party Disclosure Under
Section 4205 of the Patient Protection and Affordable Care Act of
2010.'' Upon approval of this revision request, the information
collection request for OMB control number 0910-0664 will be
discontinued.

D. Analysis of Changes in Burden Estimates Caused by the Proposed Rule

Description of Respondents: The likely respondents to this
information collection are operators of 20 or more vending machines.
The following analysis provides FDA's estimate of the changes caused by
this proposed rule to the previously approved recordkeeping and third
party disclosure burdens for vending machine operators. The analysis of
burden included in this document is drawn from the detailed Preliminary
Regulatory Impact Analysis which is available at http://www.regulations.gov, Docket No. FDA-2011-F-0171, and is also available
on FDA's Web site at http://www.fda.gov/Food/LabelingNutrition/ucm217762.htm.
Most food sold from vending machines is subject to nutrition
labeling requirements under section 403(q) of the FD&C Act and Sec.
101.9, which means that calorie content is already collected. A likely
scenario in response to vending machine labeling is that food
manufacturers will include a set of calorie label stickers in each case
of product. This would be efficient both because most manufacturers
will already have the calorie information available, and because
economies of scale exist for the manufacturer. In this case, vending
machine operators will not need to keep a record of calorie content.
Instead, the burden for most operators will be limited to that of
creating records and passing the existing information on to consumers.
FDA estimates that there is an average of 600,000 machines that
sell unpackaged products. FDA tentatively estimates that between 5 and
10 percent of all operators of vending machines with covered vending
machine food, or an average of 810 operators, will need to acquire
nutrition information for at least some covered vending machine food.
FDA tentatively estimates that there are between 5 to 10 covered
vending machine foods that do not include nutrition information per
operator, so that the average number of possible new calorie analyses
would be 6,480 (8 items/firm x 810 firms). FDA requests comment on
these estimates. Based on data from FDA's Recordkeeping Cost Model
(Ref. 28), we estimate approximately 4 hours as the time per covered
vending machine food for creating the record of nutritional
information. Although the proposed rule does not mandate recordkeeping,
vending machine operators will likely need to be able to ensure that
calorie disclosures for covered vending machine foods are accurate and
consistent without needing to re-analyze these foods. The estimated
number of hours required for new calorie analysis in the first year is
then 25,920 hours. This number is displayed in the first row of table 3
of this document.
FDA believes that the subgroup of covered vending machine foods
sold in these vending machines is approximately constant. If there is
0.5 percent growth or turnover in the number of firms providing these
unpackaged foods, then approximately four new firms will become subject
to section 4205 of the Affordable Care Act and the proposed
requirements in a given year. The burden associated with these firms
would be 128 hours (4 firms x 8 items/firm x 4 hours/item). This amount
is given in second row of table 7 of this document.
These estimated annual recordkeeping burdens have changed from the
burdens estimated for the OMB control number 0910-0665 30-day notice
(76 FR 5380, January 31, 2011). Total initial hours have risen by 1,920
due to an increase in the estimated number of recordkeepers from 600 to
915 and an increase in the number of hours per record from 2 hours to 4
hours. The estimated burden of

[[Page 19251]]

recurring hours increased by 8 hours to 128 hours. This change is due
to an increase in the estimated number of new operators (which stems
from the increase in the number of initial recordkeepers), and the
increase in the number of hours per record. These changes are due to
additional data and analysis that FDA was able to collect in the
interim.

Table 3--Estimated Annual Recordkeeping Burden: Calorie Analysis and Recording
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average burden
Number of Number of Total annual per Total capital costs for
Type of response recordkeepers records per records recordkeeping Total hours recordkeeping
recordkeeper (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Initial hours for vending operators.... 810 8 6,480 4 25,920 $1.3 million.
Recurring hours for vending operators.. 4 8 32 4 128 $6,400.
----------------------------------------------------------------------------------------------------------------
Total.............................. .............. .............. .............. .............. 26,048 ...............................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.

The third party disclosure burden for vending machine operators is
the time necessary to install calorie displays on their vending
machines. In the PRIA, FDA estimates an average, recurring hourly
burden of 0.17 hours per machine per year to install and maintain the
displays. FDA estimates an average of 4.8 million machines are serviced
by 10,800 operators, for an average number of machines per operator of
444 machines. The estimated recurring hours needed for third party
disclosure is then 816,000 hours (10,800 firms x 444 machines/firm x
0.17 hours/display). This amount is recurring in every year, and is
given in table 4 of this document.
These estimated annual third party disclosure burdens have changed
from the burdens estimated for the OMB Control Number 0910-0665 30-day
notice (76 FR 5380, (Jan. 31, 2011)). This estimate of third party
disclosure hours has decreased by approximately 13.2 million hours,
from the 14 million hours estimate given in the 30-day notice. In
addition, we no longer estimate any growth in the number of hours,
given that data shows no significant increase in the number of vending
machines over the last several years. These changes are due to
additional data and analysis that FDA was able to collect in the
interim.

Table 4--Estimated Annual Third Party Disclosure Burden: Calorie Content
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total annual burden per Total operating
Type of respondent respondents disclosures disclosures disclosure Total hours Total capital costs costs
per respondent (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recurring burden for vending 10,800 444 4,800,000 0.17 816,000 $4.8 million........ $19.2 million.
operators.
--------------------------------------------------------------------------------------------------------------------------------------------------------

The current total reporting burden for menu labeling and vending
machine operator registration as required by section 4205, now under
review at OMB under No. 0910-0664, is 820 hours. The estimated
reporting burden under the Menu Labeling proposed rule is 2,190 hours,
an increase of 1,370 hours. As described in the paperwork analysis in
that proposed rule, this increase is due to an increase in the
estimated number of respondents. This proposed rule does not further
revise those estimates.
In compliance with the PRA, the agency has submitted the
information collection provisions of this proposed rule to OMB for
review. Interested persons are requested to send comments regarding the
information collection to OMB (see DATES and ADDRESSES sections of this
document).

VII. Federalism

FDA has analyzed this proposed 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 [21 U.S.C.
343(q)]'' (21 U.S.C. 343-1(a)(4)), 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 [21 U.S.C. 343(q)(5)(H)(ix)].'' (21
U.S.C. 343-1(a)(4)). If this proposed rule is made final, the final
rule would create requirements for nutrition labeling of food under 21
U.S.C. 343(q) that would preempt certain non-identical State and local
nutrition labeling requirements.
Section 4205 of the Affordable Care Act also included 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

[[Page 19252]]

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 [21 U.S.C. 343(q)(5)(H)(i)].'' (Pub. L.
111-148, Sec. 4205(d), 124 Stat. 119, 576 (2010)0.
FDA interprets the provisions of Section 4205 of the Affordable
Care Act related to preemption to mean that States and local
governments may not impose nutrition labeling requirements for food
sold in vending machines that must comply with the Federal requirements
of 21 U.S.C. 343(q)(5)(H), 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 (1) from vending machines that are
operated by a person engaged in the business of owning or operating 20
or more vending machines subject to the requirements of 21 U.S.C.
343(q)(5)(H)(viii) or (2) from vending machines operated by a person
not subject to the requirements of 21 U.S.C. 343(q)(5)(H)(viii) who
voluntarily elects to be subject to those requirements by registering
biannually under 21 U.S.C. 343(q)(5)(H)(ix).
Otherwise, for food sold from vending machines not subject to the
nutrition labeling requirements of 21 U.S.C. 343(q)(5)(H)(viiii),
States and localities may impose nutrition labeling requirements. Under
FDA's interpretation of the Rule of Construction in section 4205(d)(1)
of the Affordable Care Act, nutrition labeling for food sold from these
vending machines would not be ``nutrient content disclosures of the
type required under [21 U.S.C. 343(q)(5)(H)]'' and, therefore, would
not be preempted. Under this interpretation, States and localities
would be able to continue to require nutrition labeling for food sold
from vending machines which are exempt from nutrition labeling under 21
U.S.C. 343(q)(5). This interpretation is consistent with the fact that
Congress included vending machine operators in the voluntary
registration provision of 21 U.S.C. 343(q)(5)(H)(ix). There would have
been no need to include vending machine operators in the provision that
allows opting into the Federal requirements if States and localities
could not otherwise require non-identical nutrition labeling for food
sold from any vending machines.
An alternative to FDA's interpretation of the provisions of section
4205 of the Affordable Care Act related to preemption could leave less
room for States and localities to require nutrition labeling for food
sold from vending machines. Under this alternative interpretation,
State or local nutrition labeling requirements for food sold from
vending machines would be preempted because such nutrition labeling
requirements would be ``nutrition content disclosures of the type
required under [21 U.S.C. 343(q)(5)(H)]'' and would not fall within the
exception to preemption in 21 U.S.C. 343-1(a)(4) (``except that this
paragraph 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 * * *'').
Under this alternative interpretation, States and localities could
not have nutrition labeling requirements for vending machines that were
not identical to the Federal requirements, unless they successfully
petitioned FDA. The position that no State or locality may have a
vending machine nutrition labeling requirement not identical to the
Federal requirements, regardless of how many vending machines the
operator owns or operates, was the position in the guidance issued by
FDA on August 25, 2010 (``Guidance for Industry: Questions and Answers
Regarding the Effect of Section 4205 of the Patient Protection and
Affordable Care Act of 2010 on State and Local Menu and Vending Machine
Labeling Laws'' (75 FR 52427)). Federal law provides that, upon
petition, FDA may exempt State or local requirements from the express
preemption provisions of 21 U.S.C. 343-1(a) under certain conditions.
21 U.S.C. 343-1(b). FDA has promulgated regulations at 21 CFR 100.1
describing the petition process that is available to State and local
governments to request such exemptions from preemption. Under the
interpretation being proposed by FDA, for food sold from vending
machines that is not subject to the nutrition labeling requirements of
21 U.S.C. 343(q)(5)(H), States and localities may establish or continue
to impose nutrition labeling requirements. Under the alternative
interpretation described above, there would be vending machines 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 FDA and a rulemaking was completed. This approach would risk
creating a regulatory gap that would be inconsistent with the purposes
of section 4205. 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.
FDA requests comments on the Agency's interpretation of the
provisions of section 4205 of the Affordable Care Act related to
preemption, as well as on the alternative interpretation described in
the Federalism section. FDA also requests comments on the use of the
petition process in the context. In addition, the Agency requests
comments on other potential interpretations that interested persons
identify as appropriate given both the preemption-related language of
section 4205 and the statutory goals.
In addition, the express preemption provisions of 21 U.S.C. 343-
1(a)(4) 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. This is
clear from both the literal language of 21 U.S.C. 343-1(a)(4) with
respect to the scope of preemption and from the Rule of Construction at
section 4205(d)(2) of the Affordable Care Act.

VIII. Environmental Impact

The Agency has 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.

IX. Comments

Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

X. References

The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the

[[Page 19253]]

Web site addresses, but FDA is not responsible for any subsequent
changes to the Web sites after this document publishes in the Federal
Register.)

1. Merriam Webster Collegiate Dictionary, Tenth Edition, 1993.
2. Food and Drug Administration, Food Labeling Guide, pg. 7, 2009.
http://www.fda.gov/FoodLabelingGuide/accessed, March 28, 2011.
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Report.'' http://www.vendingmarketwatch.com/content/reports/
accessed, November 09, 2010.
4. National Automatic Merchandising Association. ``Comments of: The
National Automatic Merchandising Association.'' Docket No. FDA-2010-
N-0298 2010.
5. U.S. Small Business Administration. ``Table of Small Business
Size Standards Matched to North American Industry Classification
System Codes,'' Effective November 5, 2010. http://www.sba.gov/idc/groups/public/documents/sba_homepage/serv_sstd_tablepdf.pdf,
accessed 12/10/2010.
6. Jed, E. ``Operators Find Today's Patrons Favor `Better-For-You'
Food Selections In Vending,'' Vending Times, 41:8, 2001.
7. Finkelstein, E.A. and K.L. Strombotne. ``The Economics of
Obesity.'' American Journal of Clinical Nutrition, 91(5): 1520S-
1524S, May 2010.
8. Philipson, T. and R. Posner. ``Is the Obesity Epidemic a Public
Health Problem? A Decade of Research on the Economics of Obesity.''
NBER Working Paper Series, 14010, May 2008.
9. Downs, J.S., G. Loewenstein and J. Wisdom. ``Strategies for
Promoting Healthier Food Choices.'' American Economic Review: Papers
and Proceedings, 99(2): 1-10, 2009.
10. O'Donoghue, T. and M. Rabin. ``The Economics of Immediate
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250, 2000.
11. O'Donoghue, T. and M. Rabin. ``Doing it Now or Later.'' American
Economic Review, 89(1): 103-124, 1999.
12. Wang, Y., M.A. Beydoun, L. Liang, B. Cabellero and S.K.
Kumanyika, ``Will all Americans Become Overweight or Obese?
Estimating the Progression and Cost of the US Obesity Epidemic.''
Obesity, 16(10): 2323-2330, 2008.
13. Ogden, C.L. and M.D. Carroll. ``Prevalence of Overweight,
Obesity, and Extreme Obesity Among Adults: United States, Trends
1976-1980 Through 2007-2008.'' National Center for Health
Statistics, June 2010.
14. Sullivan, P.W., V. Ghusheyan, and R.H. Ben-Joseph. ``The Effect
of Obesity and Cardiometabolic Risk Factor on Expenditures and
Productivity in the US.'' Obesity, 16: 2155-2162, 2008.
15. Ali, M.M., A. Amialchuk, and F. Renna. ``Social Network and
Weight Misperception Among Adolescents''. Southern Economic Journal,
Forthcoming, (2010a).
16. Cawley, J., K. Joyner, and J. Sobal. ``Size Matters: The
Influence of Adolescent's Weight and Height on Dating and Sex.''
Rationality and Society, 18(1): 67-94, 2006.
17. Ali, M.M., H. Fang, and J. Rizzo. (2010b). ``Body Weight, Self-
Perception and Mental Health among Adolescents.'' Journal of Mental
Health Policy and Economics, 13(2): 53-63 (2010b).
18. Puhl, R., and K.D. Brownell. ``Bias, Discrimination, and
Obesity.'' Obesity Research, 9(12): 788-805, 2001.
19. Cawley, J. ``The Impact of Obesity on Wages.'' Journal of Human
Resources, 39(2): 451-474, 2004.
20. Finkelstein, E.A., J.G. Trogdon, J.W. Cohen and W. Dietz.
``Annual Medical Spending Attributable to Obesity: Payer- and
Service-Specific Estimates.'' Health Affairs, 28(5): w822-w831,
2009.
21. Lakdawalla, D. and T.J. Philipson. ``The Growth of Obesity and
Technological Change: A Theoretical and Empirical Examination,''
NBER Working Paper No. 8946, 2002.
22. Philipson, T.J. and R.A. Posner, ``The Long-Run Growth in
Obesity as a Function of Technological Change.'' NBER Working Paper
No. 7423, 1999.
23. Cutler, D.M., E.L. Glaeser, and J.M. Shapiro, ``Why Have
Americans Become More Obese?'' Journal of Economic Perspectives, 17:
93-118, 2003.
24. Chou, S-Y., M. Grossman, and H. Saffer. ``An Economic Analysis
of Adult Obesity: Results from the Behavioral Risk Factor
Surveillance System.'' Journal of Health Economics, 23: 565-587,
2004.
25. Burke, M. and F. Heiland. ``Social Dynamics of Obesity.''
Economic Inquiry, 45(3), 571-591, 2007.
26. French, S.A., R.W. Jeffery, M. Story, P. Hannan, and P. Snyder.
``A Pricing Strategy to Promote Low-Fat Snack Choices through
Vending Machines''. American Journal of Public Health, 87: 849-851,
1997.
27. U.S. Department of Agriculture Economic Research Service.
``Table 15: Sales of meals and snacks away from home by type of
outlet.'' Food CPI and Expenditures: Food Expenditure Tables. http://www.ers.usda.gov/Briefing/CPIFoodAndExpenditures/Data/ Accessed 10/
8/2010.
28. Eastern Research Group, Inc. ``Evaluation of Recordkeeping Costs
for Food Manufacturers, Final Report.'' Prepared for Andy Estrin and
Cristina McLaughlin of FDA's Center for Food Safety and Applied
Nutrition. Prepared by Aylin Sertkaya, Ayesha Berlind and Seda
Erdem. Contract No. 223-01-2461, Task Order Number 5, February 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, it is
proposed that 21 CFR parts 11 and 101 be amended as follows:

PART 11--ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

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.

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

Sec. 11.1 Scope.

* * * * *
(h) This part does not apply to electronic signatures obtained
under Sec. 101.8(d) of this chapter.

PART 101--FOOD LABELING

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.

4. Section 101.8 is added to subpart A to read as follows:

Sec. 101.8 Vending machines.

(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 the purposes of this section:
Authorized official of a vending machine operator means the owner,
operator, or agent in charge or any other person authorized by the
vending machine operator to register the vending machine operator,
which is not otherwise subject to the requirements of section
403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
343(q)(5)(H)) with FDA for purposes of paragraph (d) of this section.
Vending machine means a self-service device that, upon insertion of
a coin, paper currency, token, card, or key, or by optional manual
operation, dispenses servings of food in bulk or in packages, or
prepared by the machine, without the necessity of replenishing the
device between each vending operation.
Vending machine operator means a person(s) or entity that controls
or directs the function of the vending machine, including deciding
which articles of food are sold from the machine or the placement of
the articles of food within the vending machine, and is compensated for
the control or direction of the function of the vending machine.

[[Page 19254]]

(b) Articles of food not covered. Articles of food dispensed from a
vending machine are not covered vending machine food if:
(1) The prospective purchaser can view the entire Nutrition Facts
Panel on the label of the vended food without an obstruction. The
Nutrition Facts Panel must be the information in the format required in
Sec. 101.9(c) and (d). The Nutrition Facts Panel must be in a size
that permits the prospective purchaser to be able to easily read the
nutrition information contained in the Nutrition Facts Panel on the
label of the article of food in the vending machine. Smaller formats
allowed for nutrition facts for certain food labeling under FDA
regulation at Sec. 101.9 are not considered to be a size that a
prospective purchaser is able to easily read.
(2) An article of food sold from a vending machine provides visible
nutrition information at the point of purchase. The visible nutrition
information at the point of purchase includes the total number of
calories for the article of food, as dispensed, at the point of
purchase. This visible nutrition information must appear on the food
label itself. This visible nutrition information must be clear and
conspicuous and easily read on the article of food while in the vending
machine, in a type size reasonably related to the largest printed
matter on the label and with sufficient color and contrasting
background to other print on the label to permit the prospective
purchaser to clearly distinguish the information.
(c) Requirements for calorie labeling for certain food sold from
vending machines.
(1) Applicability; covered vending machine food. For the purposes
of this section, the term ``covered vending machine food'' means an
article of food that is:
(i) Sold from a vending machine that:
(A) Does not permit the consumer to examine the Nutrition Facts
Panel prior to purchase as provided in paragraph (b) of this section,
or otherwise provide visible nutrition information at the point of
purchase as provided in paragraph (b);
(B) Is operated by a person engaged in the business of owning or
operating 20 or more vending machines; and
(C) Is a vending machine with a selection button; or
(ii) Sold from a vending machine that is operated by a vending
machine operator that has voluntarily elected to be subject to the
requirements of this section by registering with the FDA under the
provisions of paragraph (d) of this section.
(2) Calorie declaration. (i) The number of calories must be clear
and conspicuous for a covered vending machine food and declared in the
following manner:
(A) To the nearest 5-calorie increment up to and including 50
calories and 10-calorie increment above 50 calories, except that
amounts less than 5 calories may be expressed as zero.
(B) The term ``Calories'' or ``Cal'' must appear adjacent to the
caloric content value for each food in the vending machine.
(C) For calorie declarations in or on the vending machine, the
declaration of calories must be in a type size no smaller than the name
of the food on the machine, not the label, selection number, or price
of the food as displayed on the vending machine, whichever is smallest,
with the same prominence, i.e., the same color, or in a color at least
as conspicuous, as the color of the name, if applicable, or price of
the food or selection number, and the same contrasting background, as
the item it is in closest proximity to, i.e., name, selection number,
or price of the food item as displayed on the machine.
(D) The number of calories for single-serving packaged food
declared on the sign must be identical to the number of calories that
are declared in the Nutrition Facts, if applicable.
(E) The number of calories for packaged foods that contain multiple
servings must include the total calories present in the covered vending
machine food. The vending machine operator may voluntarily disclose
calories per serving in addition to the total calories for the food.
(ii) Calorie information for covered vending machine food must be
placed prominently in the following manner:
(A) This calorie information may be placed on a sign in close
proximity to the article of food or selection button, i.e., in, on, or
adjacent to the vending machine, but not necessarily attached to the
vending machine, so long as the sign is visible at the same time as the
food, its name, price, or selection button or selection number is
visible.
(B) When the calorie information is in or on the vending machine,
the calorie declaration must be in the same color or a color at least
as conspicuous as the color of the name or the price of the food or
selection number.
(C) When the calorie information is declared on a sign adjacent to
the vending machine, the calorie declaration must be in type that is
all black or one color printed on a white or other neutral background
that contrasts with the type color.
(D) Where the vending machine only displays a vignette or name of
the food item, the calorie information must be in close proximity to
the vignette or name or in close proximity to the selection button.
(E) For electronic vending machines (e.g., machines with digital or
electronic or liquid crystal display (LCD) displays), the calorie
information may be displayed when the selection numbers are entered but
before the selection is confirmed.
(F) For vending machines with limited choices, e.g., popcorn, the
declaration of calories may appear on the face of the machine so long
as the declaration is prominent, not crowded by other labeling on the
machine, and the type size is reasonably related to the largest print
on the vending machine.
(d) Voluntary provision of calorie labeling for foods sold from
vending machines.
(1) Applicability. An authorized official of a vending machine
operator that is not subject to the requirements of section
403(q)(5)(H)(viii) of the Federal Food, Drug, and Cosmetic Act may
voluntarily register with FDA to be subject to the requirements
established in paragraph (c)(2) of this section. An authorized official
of a vending machine operator that voluntarily registers cannot be
subject to any State or local nutrition labeling requirements that are
not identical to the requirements in 403(q)(5)(H) of the Federal Food,
Drug, and Cosmetic Act.
(2) Who may register? A vending machine operator that is not
otherwise subject to the requirements of section 403(q)(5)(H) of the
Federal Food, Drug, and Cosmetic Act may register with FDA.
(3) What information is required? The vending machine operator must
provide FDA with the following information:
(i) The contact information (including name, address, phone number,
e-mail address), for the vending machine operator;
(ii) The address of the location of each vending machine owned or
operated by the vending machine operator that is being registered.
(iii) Preferred mailing address (if different from the vending
machine operator address), for purposes of receiving correspondence;
and
(iv) Certification that the information submitted is true and
accurate, that the person or firm submitting it is authorized to do so,
and that each registered vending machine will be subject to the
requirements of this section.
(v) Information should be submitted by e-mail by typing complete

[[Page 19255]]

information into the portable document format (PDF) form, saving it on
the registrant's computer, and sending it by e-mail to
[email protected]. If e-mail is not available, the registrant
can either fill in the PDF form and print it out (or print out the
blank PDF and fill in the information by hand or typewriter), and
either fax the completed form to 301-436-2804 or mail it to FDA, White
Oak Building 22, Rm. 0209, 10903 New Hampshire Ave., Silver Spring, MD
20993.
(vi) Authorized officials of a vending machine operator who elects
to be subject to the Federal requirements can register by visiting
http://www.fda.gov/menulabeling. FDA has created a form that contains
fields requesting the information in paragraph (d) of this section and
made the form available at this Web site. Registrants must use this
form to ensure that complete information is submitted.
(vii) To keep the establishment's registration active, the
authorized official of the vending machine operator must register every
other year within 60 days prior to the expiration of the vending
machine operator's current registration with FDA. Registration will
automatically expire if not renewed.
(e) Signatures. Signatures obtained under paragraph (d) of this
section that meet the definition of electronic signatures in Sec.
11.3(b)(7) of this chapter are exempt from the requirements of part 11
of this chapter.

Dated: March 28, 2011.
Margaret A. Hamburg,
Commissioner of Food and Drugs.
Kathleen Sebelius,
Secretary of Health and Human Services.
[FR Doc. 2011-8037 Filed 4-1-11; 4:15 pm]
BILLING CODE 4160-01-P