[Federal Register: March 14, 2005 (Volume 70, Number 48)]
[Rules and Regulations]
[Page 12414-12416]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14mr05-11]
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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: fdadockets@oc.fda.gov. 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