[Federal Register Volume 70, Number 48 (Monday, March 14, 2005)]
[Rules and Regulations]
[Pages 12414-12416]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-4956]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 2000N-1596] (formerly 00N-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 
1, 2008, as the uniform compliance date for food labeling regulations 
that are issued between March 14, 2005, and December 31, 2006. FDA 
periodically announces uniform compliance dates for new food labeling 
requirements to minimize the economic impact of label changes. On 
December 31, 2002, FDA established January 1, 2006, as the uniform 
compliance date for food labeling regulations that issued between 
January 1, 2003, and December 31, 2004.

DATES: This rule is effective March 14, 2005. Submit written or 
electronic comments May 31, 2005.

ADDRESSES: You may submit comments, identified by Docket No. 2000N-
1596, by any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: http://www.fda.gov/dockets/ecomments. 
Follow the instructions for submitting comments on the agency Web site.
     E-mail: [email protected]. Include Docket No. 00N-1596 
in the subject line of your e-mail message.
     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.
    Instructions: All submissions received must include the agency name 
and

[[Page 12415]]

Docket No. 2000N-1596 for this rulemaking. All comments received will 
be posted without change to http://www.fda.gov/ohrms/dockets/default.htm, including any personal information provided. For detailed 
instructions on submitting comments and additional information on the 
rulemaking process, see the Comments discussion 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.fda.gov/ohrms/dockets/default.htm 
and insert the docket number 2000N-1596, 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 (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)). 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 (OMB) 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 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 $115 million, using the most current (2003) 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 March 14, 
2005. Therefore, all final FDA regulations published in the Federal 
Register before March 14, 2005, 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. After its review of any comments received to this final 
rule, FDA will either publish a document providing its conclusions 
concerning the comments or will initiate notice and comment rulemaking 
to modify or revoke the uniform compliance date established by this 
final rule.
    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 March 14, 2005, and before December 31, 
2006. Those regulations will specifically identify January 1, 2008, as 
their compliance date. All food

[[Page 12416]]

products subject to the January 1, 2008, compliance date must comply 
with the appropriate regulations when initially introduced into 
interstate commerce on or after January 1, 2008. If any food labeling 
regulation involves special circumstances that justify a compliance 
date other than January 1, 2008, the agency will determine for that 
regulation an appropriate compliance date, which will be specified when 
the final regulation is published.

    Dated: March 8, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-4956 Filed 3-11-05; 8:45 am]
BILLING CODE 4160-01-S