
[Federal Register Volume 81, Number 227 (Friday, November 25, 2016)]
[Rules and Regulations]
[Pages 85156-85157]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28333]


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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.

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SUMMARY: The Food and Drug Administration (FDA or we) is establishing 
January 1, 2020, as the uniform compliance date for food labeling 
regulations that are issued between January 1, 2017, and December 31, 
2018. We periodically announce uniform compliance dates for new food 
labeling requirements to minimize the economic impact of label changes.

DATES: This rule is effective November 25, 2016. Submit electronic or 
written comments by January 24, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov/. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov/ 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov/.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2000-N-0011 for ``Uniform Compliance Date for Food Labeling 
Regulations.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov/ or at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov/. Submit both copies to the Division of Dockets 
Management. If you do not wish your name and contact information to be 
made publicly available, you can provide this information on the cover 
sheet and not in the body of your comments and you must identify this 
information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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: Philip L. Chao, Center for Food Safety 
and Applied Nutrition (HFS-24), Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740, 240-402-2112.

SUPPLEMENTARY INFORMATION: 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 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); November 28, 2012 (77 FR

[[Page 85157]]

70885); and December 10, 2014 (79 FR 73201)). 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 (Pub. L. 
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 issuing ``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 $146 million, using the most current (2015) 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, 
2017. Therefore, all final rules published by FDA in the Federal 
Register before January 1, 2017, 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. 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. 
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.
    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, 2017, and before December 
31, 2018. Those regulations will specifically identify January 1, 2020, 
as their compliance date. All food products subject to the January 1, 
2020, compliance date must comply with the appropriate regulations when 
initially introduced into interstate commerce on or after January 1, 
2020. If any food labeling regulation involves special circumstances 
that justify a compliance date other than January 1, 2020, we will 
determine for that regulation an appropriate compliance date, which 
will be specified when the final regulation is published.

    Dated: November 18, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-28333 Filed 11-23-16; 8:45 am]
 BILLING CODE 4164-01-P


