[Federal Register Volume 75, Number 240 (Wednesday, December 15, 2010)]
[Rules and Regulations]
[Pages 78155-78156]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-31382]


=======================================================================
-----------------------------------------------------------------------

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) is establishing January 
1, 2014, as the uniform compliance date for food labeling regulations 
that are issued between January 1, 2011, and December 31, 2012. FDA 
periodically announces uniform compliance dates for new food labeling 
requirements to minimize the economic impact of label changes. On 
December 8, 2008, FDA established January 2, 2012, as the uniform 
compliance date for food labeling regulations issued between January 1, 
2009, and December 31, 2010 (January 1, 2012 fell on a Sunday; 
therefore the uniform compliance date was January 2, 2012).

DATES: This rule is effective December 15, 2010. Submit either 
electronic or written comments by February 14, 2011.

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:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
    <bullet> FAX: 301-827-6870.
    <bullet> 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 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'' paragraph of the SUPPLEMENTARY 
INFORMATION section of this document.
    Docket: For access to the docket to read background documents or

[[Page 78156]]

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: Louis B. Brock, Center for Food Safety 
and Applied Nutrition (HFS-24), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 301-436-2378.

SUPPLEMENTARY INFORMATION: 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, the Agency periodically has 
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), and 
December 8, 2008 (73 FR 74349). 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.
    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.
    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.
    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and 
the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive 
Order 12866 directs 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). The Agency believes that 
this final rule is not a significant regulatory action under the 
Executive order.
    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, the Agency 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 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 
final rule to result in any 1-year expenditure that would meet or 
exceed this amount.
    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has 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, the Agency has 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, 
2011. Therefore, all final FDA regulations published in the Federal 
Register before January 1, 2011, will still go into effect on the date 
stated in the respective final rule.
    The Agency generally encourages 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, FDA 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 rulemaking unnecessary for 
establishment of the uniform compliance date. Nonetheless, under 21 CFR 
10.40(e)(1), FDA is providing an opportunity for comment on whether 
this uniform compliance date should be modified or revoked.
    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.
    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, 2011, and before December 
31, 2012. Those regulations will specifically identify January 1, 2014, 
as their compliance date. All food products subject to the January 1, 
2014, compliance date must comply with the appropriate regulations when 
initially introduced into interstate commerce on or after January 1, 
2014. If any food labeling regulation involves special circumstances 
that justify a compliance date other than January 1, 2014, the Agency 
will determine for that regulation an appropriate compliance date, 
which will be specified when the final regulation is published.

    Dated: December 9, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-31382 Filed 12-14-10; 8:45 am]
BILLING CODE 4160-01-P