[Federal Register Volume 75, Number 141 (Friday, July 23, 2010)]
[Notices]
[Pages 43182-43184]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-18123]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0371]
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 the Patient Protection and Affordable Care Act of 2010
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: Section 4205 of the Patient Protection and Affordable Care
Act of 2010 (Affordable Care Act) established requirements for
nutrition labeling of standard menu items for restaurants and similar
retail food establishments with 20 or more locations doing business
under the same name and offering for sale substantially the same menu
items (hereinafter ``chain retail food establishments''), and for
certain foods sold in vending machines operated by an operator that
owns or operates 20 or more vending machines (hereinafter ``chain
vending machine operators''). Under the Affordable Care Act, retail
food establishments and vending machine operators not covered by
section 4205 of the Affordable Care Act may elect to become subject to
its requirements by registering biannually with FDA. Congress required
that, within 120 days of enactment of the Affordable Care Act (March
23, 2010), FDA issue a Federal Register notice specifying the terms and
conditions for implementation of voluntary registration, pending
promulgation of regulations. FDA is issuing this notice to assist
restaurants and similar retail food establishments and vending machine
[[Page 43183]]
operators that are not subject to the menu labeling requirements of
section 4205 of the Affordable Care Act, but choose to register to
become subject to them, in voluntarily registering with FDA, pending
promulgation of regulations.
DATES: Submit electronic or written comments by October 21, 2010.
ADDRESSES: Submit electronic comments on the notice to http://www.regulations.gov. Submit written comments on the notice to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Kathleen Lewis, Center for Food
Safety and Applied Nutrition (HFS-608), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2148.
SUPPLEMENTARY INFORMATION:
I. Background
Section 4205 of the Affordable Care Act (Public Law 111-148)
requires restaurants and similar retail food establishments with 20 or
more locations doing business under the same name and offering for sale
substantially the same menu items (hereinafter ``chain retail food
establishments'') to disclose specific nutrition information about
certain food items offered for sale. Section 4205 also requires that
calorie information be disclosed for certain food articles sold in
vending machines operated by an operator that owns or operates 20 or
more vending machines (hereinafter ``chain vending machine
operators''). For chain retail food establishments, as that term is
used in this notice, and for vending machines regardless of how many
vending machines the operator owns or operates, section 4205 preempts
State and local nutrition labeling laws unless they are ``identical``
to the requirements imposed by section 4205.
This notice is 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. In future
actions, FDA will provide information to the public and the regulated
communities about the new requirements in section 4205.
II. Terms and Conditions for Implementation of Voluntary Registration
A. Why is the section 4205 voluntary registration program being
established?
Congress provided in section 4205 of the Affordable Care Act that
restaurants and similar retail food establishments and vending machine
operators not covered by section 4205 may elect to become subject to
its requirements by registering biannually (every other year) with FDA.
Congress required FDA to publish a notice in the Federal Register,
within 120 days of enactment of the Affordable Care Act (March 23,
2010), specifying the terms and conditions for implementation of
voluntary registration, pending promulgation of regulations.
B. What is the effect of voluntary registration under section 4205?
Unlike chain retail food establishments (as that term is used in
this document), restaurants and similar retail food establishments that
are not covered by section 4205 can still be regulated under State and
local nutrition labeling laws that are not ``identical to'' the Federal
requirements. If these restaurants and similar retail food
establishments voluntarily register, they will no longer be subject to
State or local nutrition labeling requirements unless those
requirements are identical to Federal requirements. Vending machine
operators are in a different position; under section 4205, no State or
locality may have a requirement concerning vending machines that is not
``identical to'' the Federal requirements, regardless of how many
vending machines the operator owns or operates (section 403A(a)(4) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343-1(a)(4))).
Therefore, whether a vending machine operator has or has not
registered, it cannot be subject to State or local nutrition labeling
requirements that are not identical to the Federal requirements.
However, Congress expressly provided in section 4205 that vending
machine operators not subject to the requirements of the law might
elect to be subject to them by registering with FDA.
C. Who must register?
No restaurant or similar retail food establishment, or vending
machine operator, is required to register under section 4205. However,
if a restaurant or similar retail food establishment, or vending
machine operator not otherwise subject to the provisions of section
4205 elects to be subject to the Federal requirements of that section,
registration must be by an authorized official.
D. Who is an authorized official of a restaurant or similar retail food
establishment, or of a vending machine operator?
The authorized official of a restaurant or similar retail food
establishment or of a vending machine operator may be the owner,
operator, agent in charge, or any other person authorized by the
restaurant or similar retail food establishment or vending machine
operator to register the restaurant, similar retail food establishment
and/or vending machine operator with FDA under section 4205.
E. Should a separate registration be submitted for every location at
which a restaurant or similar retail food establishment is operating?
Section 4205 applies to restaurants or similar retail food
establishments that are part of a chain with 20 or more locations,
doing business under the same name (regardless of the type of ownership
of the locations, e.g., individual franchisees), and offering for sale
substantially the same menu items.
Restaurants, similar retail food establishments, and operators of
vending machines doing business at one or more but fewer than 20
locations can register to be subject to section 4205. If a restaurant
or similar retail food establishment has more than one but fewer than
20 locations that are doing business under the same name, regardless of
the type of ownership of the locations, which offer for sale
substantially the same menu items, an authorized official may register
multiple locations within the group of restaurants or retail food
establishments on a single registration form. Alternatively, an
authorized official of an individual restaurant or retail food
establishment may register just that restaurant or retail food
establishment.
F. When will the registration process begin and how often must the
authorized official register?
FDA will accept registrations beginning July 21, 2010, on a
continuous basis. The authorized official must register every other
year with FDA, and the registration will automatically expire if not
renewed.
G. What information must be provided for the registration of
restaurants or similar retail food establishments?
Authorized officials for restaurants and similar retail food
establishments must provide FDA with the following information:
[[Page 43184]]
The name, address, phone number, e-mail address, and
contact information for the authorized official;
The name, address, and e-mail address of each restaurant
or similar retail food establishment being registered, as well as the
name and contact information for an official onsite, such as the owner
or manager, for each specific restaurant or similar retail food
establishment;
All trade names the restaurant or similar retail food
establishment uses;
Preferred mailing address (if different from location
address for each establishment) 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 restaurant or similar retail food
establishment will be subject to the requirements of section 4205.
As described in section II.I of this document, FDA has created and
made available at a Web site, http://www.fda.gov/menulabeling, a form
that contains fields requesting this information. Registrants must use
this form to ensure that complete information is submitted.
H. What information must be provided for the registration of vending
machine operators?
Authorized officials for vending machine operators must provide FDA
with the following information:
The name, address, phone number, e-mail address, and
contact information for the vending machine operator;
The address of each vending machine owned or operated by
the vending machine operator, and the name and contact information,
including e-mail address, of the location in which each vending machine
is located;
Preferred mailing address (if different from location
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 restaurant or similar retail food
establishment will be subject to the requirements of section 4205.
As described in section II.I of this document, FDA has created and
made available at a Web site, http://www.fda.gov/menulabeling, a form
that contains fields requesting this information. Registrants must use
this form to ensure that complete information is submitted.
I. How do authorized officials of restaurants, similar retail food
establishments, and vending machine operators register?
Authorized officials of restaurants, similar retail food
establishments, and/or vending machine operators electing to be subject
to the section 4205 requirements can register by visiting http://www.fda.gov/menulabeling. FDA prefers that the information be submitted
by e-mail by typing complete information into the form (PDF), saving it
on the registrant's computer, and sending it by e-mail to http://[email protected]. If e-mail is not available, the
registrant can either fill in the form (PDF) and print it out (or print
out the blank PDF and fill in the information by hand or typewriter),
and send it to FDA either by faxing the completed form to 301-436-2804
or mailing it to the Center for Food Safety and Applied Nutrition,
Compliance Information Branch (HFS-681), 5600 Fishers Lane, Rockville,
MD 20857.
J. Will each registrant receive a confirmation of the registration?
Initially, FDA will not provide automatic confirmation of
registrations. We recommend that registrants save a copy of the
completed form and evidence that it has been transmitted to FDA
electronically, by fax, or by mail.
K. What does it mean to be ``registered''?
Pending promulgation of regulations, FDA considers that an
authorized official of any restaurant or similar retail food
establishment, or of any vending machine operator, that completely and
accurately provides the information described in response to sections
II.G and II.H of this document, has registered the restaurant or
similar retail food establishment, or vending machine operator.
L. How will future changes to the voluntary registration program be
announced?
FDA is required to propose regulations implementing the provisions
of section 4205. We intend to include in those proposed regulations
further specifications about the voluntary biannual registration of
restaurants, similar retail food establishments, and vending machine
operators that are not otherwise subject to the requirements of section
4205.
III. Paperwork Reduction Act of 1995
This notice refers to previously approved collections of
information found in the Federal Food, Drug and Cosmetic Act and
established by section 4205 of the Affordable Care Act. These
collections of information 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). The collections of information in section 4205
of the Affordable Care Act have been approved under OMB control number
0910-0664.
IV. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
notice. 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.
Dated: July 20, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-18123 Filed 7-21-10; 11:15 am]
BILLING CODE 4160-01-S