
[Federal Register Volume 79, Number 237 (Wednesday, December 10, 2014)]
[Rules and Regulations]
[Pages 73201-73202]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28829]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2000-N-0011 (Formerly Docket No. 2000N-1596)]


Uniform Compliance Date for Food Labeling Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is establishing 
January 1, 2018, as the uniform compliance date for food labeling 
regulations that are issued between January 1, 2015, and December 31, 
2016. We periodically announce uniform compliance dates for new food 
labeling requirements to minimize the economic impact of label changes. 
On November 28, 2012, we established January 1, 2016, as the uniform 
compliance date for food labeling regulations issued between January 1, 
2013, and December 31, 2014.

DATES: This rule is effective December 10, 2014. Submit electronic or 
written comments by February 9, 2015.

ADDRESSES: You may submit comments 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:
     Mail/Hand delivery/Courier (for paper 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 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: Michael Ellison, Center for Food 
Safety and Applied Nutrition (HFS-24), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2093.

SUPPLEMENTARY INFORMATION:

I. Background

    We periodically issue 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

[[Page 73202]]

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); December 15, 2010 (75 FR 
78155); and November 28, 2012 (77 FR 70885)). 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.
    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 (Public 
Law 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, we certify 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 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $141 million, using the most current (2013) Implicit 
Price Deflator for the Gross Domestic Product. 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, 
2015. Therefore, all final rules published by FDA in the Federal 
Register before January 1, 2015, 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, FDA finds any further advance notice and opportunity for 
comment or delayed effective date unnecessary for establishment of the 
uniform compliance date. We have previously invited comment on the 
practice of establishing uniform compliance dates by issuing a final 
rule, and interested parties will have an opportunity to comment on the 
compliance date for each individual food labeling regulation as part of 
the rulemaking process for that regulation. Nonetheless, under 21 CFR 
10.40(e)(1), we are providing an opportunity for comment on whether the 
uniform compliance date established by this final rule 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, 2015, and before December 
31, 2016. Those regulations will specifically identify January 1, 2018, 
as their compliance date. All food products subject to the January 1, 
2018, compliance date must comply with the appropriate regulations when 
initially introduced into interstate commerce on or after January 1, 
2018. If any food labeling regulation involves special circumstances 
that justify a compliance date other than January 1, 2018, 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 electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). 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: December 4, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28829 Filed 12-9-14; 8:45 am]
BILLING CODE 4164-01-P


