[Federal Register Volume 73, Number 236 (Monday, December 8, 2008)]
[Rules and Regulations]
[Pages 74349-74350]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-28920]


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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) is establishing January 
2, 2012, as the uniform compliance date for food labeling regulations 
that are issued between January 1, 2009, and December 31, 2010. 
(January 1, 2012, falls on a Sunday; therefore, the uniform compliance 
date will be January 2, 2012). FDA periodically announces uniform 
compliance dates for new food labeling requirements to minimize the 
economic impact of label changes. On December 21, 2006, FDA established 
January 1, 2010, as the uniform compliance date for food labeling 
regulations issued between January 1, 2007, and December 31, 2008.

DATES: This rule is effective December 8, 2008. Submit written or 
electronic comments by February 23, 2009.

ADDRESSES:  You may submit comments, identified by Docket No. FDA-2000-
N-0011, formerly Docket No. 2000N-1596, 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, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal, as described previously, in the ADDRESSES portion 
of this document under Electronic Submissions.
    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'' paragraphs 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: 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 Registers of October 19, 1984

[[Page 74350]]

(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), and December 31, 2002 (67 FR 79851), and December 21, 2006 (71 
FR 76599)). 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 (Public Law 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 $130 million, using the most current (2007) 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, 
2009. Therefore, all final FDA regulations published in the Federal 
Register before January 1, 2009, 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 proposal 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) written or electronic comments regarding 
this document. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified 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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.
    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, 2009, and before December 
31, 2010. Those regulations will specifically identify January 1, 2012, 
as their compliance date. All food products subject to the January 1, 
2012, compliance date must comply with the appropriate regulations when 
initially introduced into interstate commerce on or after January 1, 
2012. If any food labeling regulation involves special circumstances 
that justify a compliance date other than January 1, 2012, the agency 
will determine for that regulation an appropriate compliance date, 
which will be specified when the final regulation is published.

    Dated: December 1, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-28920 Filed 12-5-08; 8:45 am]
BILLING CODE 4160-01-S