[Federal Register Volume 79, Number 237 (Wednesday, December 10, 2014)]
[Rules and Regulations]
[Pages 73201-73202]
From the Federal Register Online via the Government Publishing 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