[Federal Register Volume 77, Number 229 (Wednesday, November 28, 2012)]
[Rules and Regulations]
[Pages 70885-70886]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-28817]



 ========================================================================
 Rules and Regulations
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains regulatory documents 
 having general applicability and legal effect, most of which are keyed 
 to and codified in the Code of Federal Regulations, which is published 
 under 50 titles pursuant to 44 U.S.C. 1510.
 
 The Code of Federal Regulations is sold by the Superintendent of Documents. 
 Prices of new books are listed in the first FEDERAL REGISTER issue of each 
 week.
 
 ========================================================================
 

  Federal Register / Vol. 77, No. 229 / Wednesday, November 28, 2012 / 
Rules and Regulations  

[[Page 70885]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2000-N-0011]


Uniform Compliance Date for Food Labeling Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA or we) is establishing 
January 1, 2016, as the uniform compliance date for food labeling 
regulations that are issued between January 1, 2013, and December 31, 
2014. We periodically announce uniform compliance dates for new food 
labeling requirements to minimize the economic impact of label changes. 
On December 15, 2010, we established January 1, 2014, as the uniform 
compliance date for food labeling regulations issued between January 1, 
2011, and December 31, 2012.

DATES: This rule is effective November 28, 2012. Submit electronic or 
written comments by January 28, 2013.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2000-
N-0011, by any of the following methods:

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 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 No. FDA-2000-N-0011 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: Paul L. Ferrari, Center for Food 
Safety and Applied Nutrition (HFS-24), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1722.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA periodically issues regulations requiring changes in the 
labeling of food. If the effective dates of these labeling changes were 
not coordinated, the cumulative economic impact on the food industry of 
having to respond separately to each change would be substantial. 
Therefore, we periodically have announced uniform compliance dates for 
new food labeling requirements (see, e.g., the Federal Register of 
October 19, 1984 (49 FR 41019); December 24, 1996 (61 FR 67710); 
December 27, 1996 (61 FR 68145); December 23, 1998 (63 FR 71015); 
November 20, 2000 (65 FR 69666); December 31, 2002 (67 FR 79851); 
December 21, 2006 (71 FR 76599); December 8, 2008 (73 FR 74349); and 
December 15, 2010 (75 FR 78155). Use of a uniform compliance date 
provides for an orderly and economical industry adjustment to new 
labeling requirements by allowing sufficient lead time to plan for the 
use of existing label inventories and the development of new labeling 
materials. This policy serves consumers' interests as well because the 
cost of multiple short-term label revisions that would otherwise occur 
would likely be passed on to consumers in the form of higher prices.
    We have determined under 21 CFR 25.30(k) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.
    This final rule contains no collections of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.
    We have examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). We believe that this final rule is not a significant 
regulatory action under Executive Order 12866.
    The establishment of a uniform compliance date does not in itself 
lead to costs or benefits. We will assess the costs and benefits of the 
uniform compliance date in the regulatory impact analyses of the 
labeling rules that take effect at that date.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant economic impact 
of a rule on small entities. Because the final rule does not impose 
compliance costs on small entities, FDA certifies that the final rule 
will not have a significant economic impact on a substantial number of 
small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000

[[Page 70886]]

or more (adjusted annually for inflation) in any one year.'' The 
current threshold after adjustment for inflation is $139 million, using 
the most current (2011) Implicit Price Deflator for the Gross Domestic 
Product. We do not expect this final rule to result in any 1-year 
expenditure that would meet or exceed this amount.
    We have analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. We have determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, we have concluded that the 
rule does not contain policies that have federalism implications as 
defined in the Executive Order and, consequently, a federalism summary 
impact statement is not required.
    This action is not intended to change existing requirements for 
compliance dates contained in final rules published before January 1, 
2013. Therefore, all final rules published by FDA in the Federal 
Register before January 1, 2013, will still go into effect on the date 
stated in the respective final rule.
    We generally encourage industry to comply with new labeling 
regulations as quickly as feasible, however. Thus, when industry 
members voluntarily change their labels, it is appropriate that they 
incorporate any new requirements that have been published as final 
regulations up to that time.
    In rulemaking that began with publication of a proposed rule on 
April 15, 1996 (61 FR 16422), and ended with a final rule on December 
24, 1996, we provided notice and an opportunity for comment on the 
practice of establishing uniform compliance dates by issuance of a 
final rule announcing the date. Receiving no comments objecting to this 
practice, we find any further rulemaking unnecessary for establishment 
of the uniform compliance date. Nonetheless, under 21 CFR 10.40(e)(1), 
we are providing an opportunity for comment on whether this uniform 
compliance date should be modified or revoked.
    The new uniform compliance date will apply only to final FDA food 
labeling regulations that require changes in the labeling of food 
products and that publish after January 1, 2013, and before December 
31, 2014. Those regulations will specifically identify January 1, 2016, 
as their compliance date. All food products subject to the January 1, 
2016, compliance date must comply with the appropriate regulations when 
initially introduced into interstate commerce on or after January 1, 
2016. If any food labeling regulation involves special circumstances 
that justify a compliance date other than January 1, 2016, we will 
determine for that regulation an appropriate compliance date, which 
will be specified when the final regulation is published.

II. Comments

    Interested persons may submit either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. It is only necessary 
to send one set of 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, and will be posted to the docket at http://www.regulations.gov.

    Dated: November 20, 2012.
 Leslie Kux,
 Assistant Commissioner for Policy.
[FR Doc. 2012-28817 Filed 11-27-12; 8:45 am]
BILLING CODE 4160-01-P