Uniform Compliance Date for Food Labeling Regulations, 65294-65296 [2018-27429]
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65294
Federal Register / Vol. 83, No. 244 / Thursday, December 20, 2018 / Rules and Regulations
Items Controlled), and ‘‘specially
designed’’ ‘‘parts’’ and ‘‘components’’
therefor.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
License Requirements
Reason for Control: MT, AT
21 CFR Part 101
Country chart
(See Supp. No. 1
to part 738)
Control(s)
MT applies to entire
entry.
AT applies to entire
entry.
MT Column 1
ACTION:
List of Items Controlled
Related Controls: (1) See also 7A005, 7A611
and 7A994. (2) See USML Category XII(d)
for GNSS receiving equipment subject to
the ITAR and USML Category XI(c)(10) for
antennae that are subject to the ITAR. (3)
Items that otherwise would be covered by
ECCN 7A105.b.2 are ‘‘subject to the ITAR’’
(see 22 CFR parts 120 through 130). (4) See
USML Category XII(d) for GPS receiving
equipment in 7A105.a, b.1 and b.3 that are
subject to the ITAR.
Related Definitions: ‘Navigation satellite
systems’ include Global Navigation
Satellite Systems (GNSS; e.g. GPS,
GLONASS, Galileo or BeiDou) and
Regional Navigation Satellite Systems
(RNSS; e.g. NavIC, QZSS).
Items:
a. Designed or modified for use in
‘‘missiles’’; or
b. Designed or modified for airborne
applications and having any of the following:
b.1. Capable of providing navigation
information at speeds in excess of 600 m/s;
b.2. Employing decryption, designed or
modified for military or governmental
services, to gain access to a ‘navigation
satellite system’ secure signal/data; or
b.3. Being ‘‘specially designed’’ to employ
anti-jam features (e.g., null steering antenna
or electronically steerable antenna) to
function in an environment of active or
passive countermeasures.
Note: 7A105.b.2 and 7A105.b.3 do not
control equipment designed for commercial,
civil or Safety of Life (e.g., data integrity,
flight safety) ‘navigation satellite system’
services.
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*
*
*
Dated: December 17, 2018.
Matthew S. Borman,
Deputy Assistant Secretary for Export
Administration.
[FR Doc. 2018–27542 Filed 12–19–18; 8:45 am]
BILLING CODE 3510–33–P
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Food and Drug Administration,
HHS.
LVS: N/A
GBS: N/A
CIV: N/A
*
Uniform Compliance Date for Food
Labeling Regulations
AGENCY:
AT Column 1
List Based License Exceptions (See Part 740
for a description of all license exceptions)
*
[Docket No. FDA–2000–N–0011]
Final rule.
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:
SUMMARY:
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
PO 00000
Frm 00012
Fmt 4700
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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/201523389.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
E:\FR\FM\20DER1.SGM
20DER1
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Federal Register / Vol. 83, No. 244 / Thursday, December 20, 2018 / Rules and Regulations
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
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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
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65295
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
E:\FR\FM\20DER1.SGM
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65296
Federal Register / Vol. 83, No. 244 / Thursday, December 20, 2018 / Rules and Regulations
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
EQUAL EMPLOYMENT OPPORTUNITY
COMMISSION
29 CFR Part 1630
[EEOC–2018–0004]
RIN 3046–AB01
Removal of Final ADA Wellness Rule
Vacated by Court
Equal Employment
Opportunity Commission.
ACTION: Final rule.
AGENCY:
This final rule removes from
the Code of Federal Regulations a
section of the final rule published on
May 17, 2016, entitled ‘‘Regulations
Under the Americans With Disabilities
Act.’’ This action responds to a decision
of the U.S. District Court for the District
of Columbia that vacated the incentive
section of the ADA rule effective
January 1, 2019.
DATES: The action is effective on January
1, 2019.
FOR FURTHER INFORMATION CONTACT:
Christopher J. Kuczynski, (202) 663–
4665 (voice), christopher.kuczynski@
eeoc.gov; or Joyce Walker-Jones, (202)
663–7031 (voice); joyce.walker-jones@
eeoc.gov; or (202) 663–7026 (TTY).
SUPPLEMENTARY INFORMATION: On May
17, 2016, the Equal Employment
Opportunity Commission (EEOC)
published a final rule entitled
‘‘Regulations Under the Americans With
Disabilities Act’’ under the authority of
Title I of the Americans with
Disabilities Act (ADA), 42 U.S.C.
12101–12117. 81 Federal Register
31126. The rule ‘‘provide[d] guidance
on the extent to which employers may
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SUMMARY:
VerDate Sep<11>2014
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Jkt 247001
use incentives to encourage employees
to participate in wellness programs that
ask them to respond to disability-related
inquiries and/or undergo medical
examinations.’’
On October 24, 2016, AARP filed a
complaint in the U.S. District Court for
the District of Columbia challenging the
incentive section of the ADA rule. On
August 22, 2017, the District Court
concluded that the Commission did not
provide sufficient reasoning to justify
the incentive limit adopted in the ADA
rule and remanded the rule to the EEOC
for reconsideration without vacating it.
Following a motion by AARP to alter or
amend the court’s summary judgment
order, the court issued an order vacating
the incentive section of the rule, 29 CFR
1630.14(d)(3), effective January 1, 2019.
AARP v. EEOC, D.D.C., No. 16–2113
(D.D.C. December 20, 2017). Consistent
with that decision, this rule removes the
incentive section of the ADA regulations
at 29 CFR 1630.14(d)(3).
This rule is not subject to the
requirement to provide public comment
because it falls under the good cause
exception at 5 U.S.C. 553(b)(B). The
good cause exception is satisfied when
notice and comment is ‘‘impracticable,
unnecessary, or contrary to the public
interest.’’ Id. This rule is an
administrative step that implements the
court’s order vacating the incentive
section of the ADA rule. Additionally,
because this rule implements a court
order already in effect, the Commission
has good cause to waive the 30-day
effective date under 5 U.S.C. 553(d)(3).
List of Subjects in 29 CFR Part 1630
Administrative practice and
procedure, Equal employment
opportunity.
For the reasons set forth in the
preamble, under the authority of 42
U.S.C. 12101–12117, the Commission
amends chapter XIV of title 29 of the
Code of Federal Regulations as follows:
PART 1630—REGULATIONS TO
IMPLEMENT THE EQUAL
EMPLOYMENT PROVISIONS OF THE
AMERICANS WITH DISABILITIES ACT
1. The authority citation for part 1630
continues to read as follows:
■
Authority: 42 U.S.C. 12116 and 12205a of
the Americans with Disabilities Act, as
amended.
§ 1630.14
[Amended]
2. Amend § 1630.14 by removing and
reserving paragraph (d)(3).
■
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Dated: December 14, 2018.
Victoria A. Lipnic,
Acting Chair, U.S. Equal Employment
Opportunity Commission.
[FR Doc. 2018–27539 Filed 12–19–18; 8:45 am]
BILLING CODE 6570–01–P
EQUAL EMPLOYMENT OPPORTUNITY
COMMISSION
29 CFR Part 1635
EEOC–2018–0005]
RIN 3046–AB02
Removal of Final GINA Wellness Rule
Vacated by Court
Equal Employment
Opportunity Commission.
ACTION: Final rule.
AGENCY:
This final rule removes from
the Code of Federal Regulations a
section of the final rule published on
May 17, 2016, entitled, ‘‘Genetic
Information Nondiscrimination Act.’’
This action responds to a decision of the
U.S. District Court for the District of
Columbia that vacated the incentive
section of the GINA rule effective
January 1, 2019.
DATES: The action is effective on January
1, 2019.
FOR FURTHER INFORMATION CONTACT:
Christopher J. Kuczynski, (202) 663–
4665 (voice), christopher.kuczynski@
eeoc.gov; or Kerry E. Leibig, (202) 663–
4516 (voice), kerry.leibig@eeoc.gov; or
(202) 663–7026 (TTY).
SUPPLEMENTARY INFORMATION: On May
17, 2016, the Equal Employment
Opportunity Commission (EEOC)
published a final rule entitled, ‘‘Genetic
Information Nondiscrimination Act’’
under the authority of Title II of the
Genetic Information Nondiscrimination
Act of 2008 (GINA), 42 U.S.C. 2000ff–
2000ff–11. 81 Federal Register 31143.
The rule ‘‘addressed the extent to which
an employer may offer an inducement to
an employee for the employee’s spouse
to provide his or her current health
status information as part of a health
risk assessment (HRA) administered in
connection with an employee-sponsored
wellness program.’’ Id.
On October 24, 2016, AARP filed a
complaint in the U.S. District Court for
the District of Columbia challenging the
incentive section of the GINA rule. On
August 22, 2017, the District Court
concluded that the Commission did not
provide sufficient reasoning to justify
the incentive limit adopted in the GINA
rule and remanded the rule to the EEOC
for further consideration without
vacating it. Following a motion by
SUMMARY:
E:\FR\FM\20DER1.SGM
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]]>Agencies
[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]
=======================================================================
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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.
-----------------------------------------------------------------------
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
