[Federal Register Volume 83, Number 244 (Thursday, December 20, 2018)]
[Rules and Regulations]
[Pages 65294-65296]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27429]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is establishing
January 1, 2022, as the uniform compliance date for food labeling
regulations that are published on or after January 1, 2019, and on or
before December 31, 2020. We periodically announce uniform compliance
dates for new food labeling requirements to minimize the economic
impact of label changes.
DATES: This rule is effective December 20, 2018. Submit electronic or
written comments by February 19, 2019.
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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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.'' We will review
this copy, including the claimed confidential information, in our
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 Dockets Management Staff. 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:
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
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 Dockets Management
[[Page 65295]]
Staff, 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
70885); December 10, 2014 (79 FR 73201); and November 25, 2016 (81 FR
85156)). 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, Executive Order 13771, 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). Executive Order 13771
requires that the costs associated with significant new regulations
``shall, to the extent permitted by law, be offset by the elimination
of existing costs associated with at least two prior regulations.'' 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 $150 million, using the most current (2017) 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,
2019. Therefore, all final rules published by FDA in the Federal
Register before January 1, 2019, 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 (61 FR 67710) (together ``the 1996 rulemaking''), 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. We received no comments objecting to this practice during the
1996 rulemaking, nor have we received comments objecting to this
practice since we published a uniform compliance date on November 25,
2016 (81 FR 85156). Therefore, we find good cause to dispense with
issuance of a proposed rule inviting comment on the practice of
establishing the uniform compliance date because such prior notice and
comment are unnecessary. 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.
Consequently, FDA finds any further advance notice and opportunity for
comment 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.
In addition, we find good cause for this final rule to become
effective on the date of publication of this action. A delayed
effective date is unnecessary in this case because the establishment of
a uniform compliance date does not impose any new regulatory
requirements on affected parties. Instead, this final rule provides
affected parties with notice of our policy to identify January 1, 2022,
as the compliance date for final food labeling regulations that require
changes in the labeling of food products and that publish on or after
January 1, 2019, and on or before December 31, 2020, unless special
circumstances justify a different compliance date. Thus, affected
parties do not need time to prepare before the rule takes effect.
Therefore, we find good cause for this final rule to become effective
on the date of publication of this action.
The new uniform compliance date will apply only to final FDA food
labeling regulations that require changes
[[Page 65296]]
in the labeling of food products and that publish on or after January
1, 2019, and on or before December 31, 2020. Those regulations will
specifically identify January 1, 2022, as their compliance date. All
food products subject to the January 1, 2022, compliance date must
comply with the appropriate regulations when initially introduced into
interstate commerce on or after January 1, 2022. If any food labeling
regulation involves special circumstances that justify a compliance
date other than January 1, 2022, we will determine for that regulation
an appropriate compliance date, which will be specified when the final
regulation is published.
Dated: December 13, 2018.
Scott Gottlieb,
Commissioner of Food and Drugs.
[FR Doc. 2018-27429 Filed 12-19-18; 8:45 am]
BILLING CODE 4164-01-P