Crabmeat; Amendment of Common or Usual Name Regulation, 19429-19431 [2018-09371]
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Federal Register / Vol. 83, No. 86 / Thursday, May 3, 2018 / Rules and Regulations
previously issued. It is unlikely that
prior public comment would result in a
significant change from the subject
contained herein. Therefore, notice and
opportunity for prior public comment
hereon are unnecessary and the FAA
finds good cause, in accordance with 5
U.S.C. 553(b)(3)(B) and 553(d)(3),
making these special conditions
effective upon issuance. The FAA is
requesting comments to allow interested
persons to submit views that may not
have been submitted in response to the
prior opportunities for comment
described above.
List of Subjects in 14 CFR Part 23
Aircraft, Aviation safety, Signs and
symbols.
Citation
The authority citation for these
special conditions is as follows:
■
Authority: 49 U.S.C. 106(f), 106(g), 40113,
44701–44702, 44704; Pub. L. 113–53, 127
Stat 584 (49 U.S.C. 44704) note; 14 CFR 21.16
and 21.101; and 14 CFR 11.38 and 11.19.
The Special Conditions
Accordingly, pursuant to the authority
delegated to me by the Administrator,
the following special conditions are
issued as part of the type certification
basis for Textron Aviation B300, B300C,
B300C (MC–12W), and B300C (UC–
12W) airplanes modified by St. Louis
Helicopter, LLC.
■
sradovich on DSK3GMQ082PROD with RULES
1. Installation of Lithium Battery
The FAA adopts that the following
special conditions be applied to lithium
battery installations on the Textron
Aviation models B300, B300C, B300C
(MC–12W), and B300C (UC–12W)
airplanes in lieu of the requirements
§ 23.1353 (a), (b), (c), (d), and (e),
amendment 23–49.
Lithium battery installations on the
models B300, B300C, B300C (MC–12W),
and B300C (UC–12W) airplanes must be
designed and installed as follows:
(1) Safe cell temperatures and
pressures must be maintained during—
i. Normal operations;
ii. Any probable failure conditions of
charging or discharging or battery
monitoring system; and
iii. Any failure of the charging or
battery monitoring system not shown to
be extremely remote.
(2) The rechargeable lithium battery
installation must be designed to
preclude explosion or fire in the event
of 1(1)ii and 1(1)iii failures.
(3) Design of the rechargeable lithium
batteries must preclude the occurrence
of self-sustaining, uncontrolled
increases in temperature or pressure.
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(4) No explosive or toxic gasses
emitted by any rechargeable lithium
battery in normal operation or as the
result of any failure of the battery
charging system, monitoring system, or
battery installation, which is not shown
to be extremely remote, may accumulate
in hazardous quantities within the
airplane.
(5) Installations of rechargeable
lithium batteries must meet the
requirements of § 23.863(a) through (d),
amendment 23–34.
(6) No corrosive fluids or gases that
may escape from any rechargeable
lithium battery, may damage
surrounding structure or any adjacent
systems, equipment, electrical wiring, or
the airplane in such a way as to cause
a major or more severe failure condition,
in accordance with § 23.1309,
amendment 23–49, and applicable
regulatory guidance.
(7) Each rechargeable lithium battery
installation must have provisions to
prevent any hazardous effect on
structure or essential systems that may
be caused by the maximum amount of
heat the battery can generate during a
short circuit of the battery or of its
individual cells.
(8) Rechargeable lithium battery
installations must have—
i. A system to automatically control
the charging rate of the battery to
prevent battery overheating and
overcharging; and either
ii. A battery temperature sensing and
over-temperature warning system with a
means for automatically disconnecting
the battery from its charging source in
the event of an over-temperature
condition; or
iii. A battery failure sensing and
warning system with a means for
automatically disconnecting the battery
from its charging source in the event of
battery failure.
(9) Any rechargeable lithium battery
installation, the function of which is
required for safe operation of the
aircraft, must incorporate a monitoring
and warning feature that will provide an
indication to the appropriate flight
crewmembers whenever the state of
charge of the batteries has fallen below
levels considered acceptable for
dispatch (see note 1) of the aircraft.
19429
contain the rechargeable lithium battery
or rechargeable lithium battery system.
The lithium rechargeable batteries and
lithium rechargeable battery systems
must not degrade below specified
ampere-hour levels sufficient to power
the aircraft system. The ICA must also
contain procedures for the maintenance
of replacement batteries (see note 4) to
prevent the installation of batteries that
have degraded charge retention ability
or other damage due to prolonged
storage at a low state of charge.
Replacement batteries must be of the
same manufacturer and part number as
approved by the FAA.
Note 2: Maintenance requirements include
procedures that—
(a) Check battery capacity, charge
degradation at manufacturers recommended
inspection intervals; and
(b) Replace batteries at manufacturers
recommended replacement schedule/time to
prevent age related degradation.
Note 3: The term ‘‘sufficiently charged’’
means that the battery must retain enough
charge, expressed in ampere-hours, to ensure
that the battery cells will not be damaged.
A battery cell may be damaged by low
charge (i.e., below certain level),
resulting in a reduction in the ability to
charge and retain a full charge. This
reduction would be greater than the
reduction that may result from normal
operational degradation.
Note 4: Replacement battery in spares
storage may be subject to prolonged storage
at a low state of charge.
Issued in Kansas City, Missouri on April
23, 2018.
Pat Mullen,
Manager, Small Airplane Standards Branch,
Aircraft Certification Service.
[FR Doc. 2018–09350 Filed 5–2–18; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 102
[Docket No. FDA–2018–N–1438]
RIN 0910–AI04
Note 1: Reference § 23.1353(h) for dispatch
consideration.
Crabmeat; Amendment of Common or
Usual Name Regulation
(10) The Instructions for Continued
Airworthiness (ICA) required by
§ 23.1529 must contain maintenance
requirements (see note 2) to assure that
the battery has been sufficiently charged
(see note 3) at appropriate intervals
specified by the battery manufacturer
and the equipment manufacturer that
AGENCY:
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Fmt 4700
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Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
The Food and Drug
Administration (FDA or we) is
amending the common or usual name
SUMMARY:
E:\FR\FM\03MYR1.SGM
03MYR1
19430
Federal Register / Vol. 83, No. 86 / Thursday, May 3, 2018 / Rules and Regulations
regulation for crabmeat by replacing
‘‘brown king crabmeat’’ with ‘‘golden
king crabmeat’’ as the common or usual
name for crabmeat derived from the
species Lithodes aequispinus. We are
taking this action due to a recently
enacted law. We are also correcting an
error in the placement of a scientific
term, which is editorial in nature.
DATES: This rule is effective May 3,
2018. The compliance date for this rule
is January 1, 2020.
ADDRESSES: For access to the docket, go
to https://www.regulations.gov and
insert the docket number found in
brackets in the heading of this final rule
into the ‘‘Search’’ box and follow the
prompts, and/or go to the Dockets
Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Steven Bloodgood, Center for Food
Safety and Applied Nutrition, Food and
Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–5316,
Steven.Bloodgood@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. General Overview of Final Rule
II. Background and Legal Authority
III. Compliance Date
IV. Economic Analysis of Impacts
V. Analysis of Environmental Impact
VI. Paperwork Reduction Act of 1995
VII. Federalism
VIII. Consultation and Coordination With
Indian Tribal Governments
IX. References
sradovich on DSK3GMQ082PROD with RULES
I. General Overview of Final Rule
This rule amends § 102.50 (21 CFR
102.50) to designate ‘‘golden king
crabmeat’’ as the sole common or usual
name of crabmeat derived from the
species Lithodes aequispinus. The
regulation at § 102.50 currently lists
‘‘brown king crabmeat’’ as the common
or usual name of crabmeat derived from
the species Lithodes aequispina. In
addition to replacing the common or
usual name, we are revising the
scientific name to read as Lithodes
aequispinus, in accordance with a
recently enacted law designating the
acceptable market name of the species
as ‘‘golden king crab.’’ We are also
correcting § 102.50 so that Paralithodes
platypus appears under the ‘‘Scientific
name of crab’’ column for King
crabmeat.
II. Background and Legal Authority
In the Federal Register of July 3, 1995
(60 FR 34459), we published a final rule
amending the common or usual name
provisions for crabmeat, to provide that
the common or usual name of crabmeat
VerDate Sep<11>2014
15:59 May 02, 2018
Jkt 244001
derived from the species Lithodes
aequispina is ‘‘brown king crabmeat.’’
On May 5, 2017, the Consolidated
Appropriations Act, 2017 (Pub. L. 115–
31), was signed into law. Section 774 of
the Consolidated Appropriations Act,
2017, provides that, for purposes of
applying the Federal Food, Drug, and
Cosmetic Act (FD&C Act), the
acceptable market name of Lithodes
aequispinus is ‘‘golden king crab.’’
The final rule amends § 102.50 to
reflect the common or usual name of
crabmeat derived from Lithodes
aequispinus as provided by the
Consolidated Appropriations Act, 2017,
and to revise the scientific name of the
species. The final rule also corrects
§ 102.50 to move the scientific name for
King crabmeat, Paralithodes platypus,
from the ‘‘Common or usual name of
crabmeat’’ column to the ‘‘Scientific
name of crab’’ column.
FDA finds good cause for issuing this
amendment as a final rule without
notice and comment because this
amendment only updates the regulation
to align with the law enacted by the
Consolidated Appropriations Act, 2017
(5 U.S.C. 553(b)(B)). (‘‘[W]hen
regulations merely restate the statute
they implement, notice-and-comment
procedures are unnecessary.’’ Gray
Panthers Advocacy Committee v.
Sullivan, 936 F.2d 1284, 1291 (DC Cir.
1991); see also Komjathy v. Nat. Trans.
Safety Bd., 832 F.2d 1294, 1296 (DC Cir.
1987), cert. denied, 486 U.S. 1057 (1988)
(when a rule ‘‘does no more than repeat,
virtually verbatim, the statutory grant of
authority,’’ notice-and-comment
procedures are not required)).)
Therefore, we are issuing this
amendment as a final rule, and
publication of this document constitutes
final action under the Administrative
Procedure Act (APA) (5 U.S.C. 553).
In addition, we find good cause for
this amendment to become effective on
the date of publication of this action.
The APA allows an effective date less
than 30 days after publication as
‘‘provided by the agency for good cause
found and published with the rule’’ (5
U.S.C. 553(d)(3)). A delayed effective
date is unnecessary in this case because
the new requirements regarding golden
king crab are already effective as a
matter of law and because moving the
scientific name for King crabmeat is a
ministerial action. Therefore, we find
good cause for this amendment to
become effective on the date of
publication of this action.
III. Compliance Date
With respect to a compliance date, we
intend that any adjustments to a
product’s labeling occur in a manner
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Sfmt 4700
consistent with our uniform compliance
date (see 81 FR 85156, November 25,
2016). Thus, the compliance date is
January 1, 2020.
IV. Economic Analysis of Impacts
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 us 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
as defined by Executive Order 12866
and is not a deregulatory action for
purposes of Executive Order 13771.
The Regulatory Flexibility Act
requires us to analyze regulatory options
that would minimize any significant
impact of a rule on small entities. We
estimate that the mean cost per crab
covered by the final rule is $0.23
(2016$). We estimate that the revenue
per crab covered by the final rule ranges
from $17.65 to $99.42 (2016$). Because
the cost per crab covered by the final
rule as a percentage of the revenue per
crab covered by the final rule is small,
ranging from 0.2 percent to 1.3 percent,
we certify that the final rule will not
have a significant economic impact on
a substantial number of small entities.
The Unfunded Mandates Reform Act
of 1995 (section 202(a)) requires us to
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 $148 million, using the
most current (2016) Implicit Price
Deflator for the Gross Domestic Product.
This final rule would not result in an
expenditure in any year that meets or
exceeds this amount.
We have developed a comprehensive
Economic Analysis of Impacts that
assesses the impacts of the final rule.
E:\FR\FM\03MYR1.SGM
03MYR1
Federal Register / Vol. 83, No. 86 / Thursday, May 3, 2018 / Rules and Regulations
The full analysis of economic impacts is
available in the docket for this final rule
(Ref. 1).
V. Analysis of Environmental Impact
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.
VI. Paperwork Reduction Act of 1995
This final rule contains no collection
of information. Therefore, clearance by
the Office of Management and Budget
under the Paperwork Reduction Act of
1995 is not required.
VII. Federalism
We have 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, we
conclude 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.
VIII. Consultation and Coordination
With Indian Tribal Governments
We have analyzed this rule in
accordance with the principles set forth
in Executive Order 13175. We have
determined that the rule does not
contain policies that have substantial
direct effects on one or more Indian
Tribes, on the relationship between the
Federal Government and Indian Tribes,
or on the distribution of power and
responsibilities between the Federal
Government and Indian Tribes.
Accordingly, we conclude that the rule
does not contain policies that have
tribal implications as defined in the
Executive Order and, consequently, a
tribal summary impact statement is not
required.
in the Federal Register, but websites are
subject to change over time.
1. FDA, ‘‘Crabmeat; Amendment of Common
or Usual Name Regulation: Final
Regulatory Impact Analysis,’’ 2017. Also
available at https://www.fda.gov/
AboutFDA/ReportsManualsForms/
Reports/EconomicAnalyses/default.htm.
List of Subjects in 21 CFR Part 102
Beverages, Food grades and standards,
Food labeling, Frozen foods, Oils and
fats, Onions, Potatoes, Seafood.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 102 is
amended as follows:
PART 102—COMMON OR USUAL
NAME FOR NONSTANDARDIZED
FOODS
1. The authority citation for part 102
continues to read as follows:
■
Authority: 21 U.S.C. 321, 343, 371.
2. In § 102.50 revise the table to read
as follows:
■
§ 102.50
*
*
Crabmeat.
*
*
Scientific name of crab
Chionoecetes opilio,
Chionoecetes tanneri,
Chionoecetes bairdii,
and Chionoecetes
angulatus.
Erimacrus isenbeckii .......
Lithodes aequispinus ......
Paralithodes brevipes .....
Paralithodes
camtschaticus and
Paralithodes platypus.
*
Snow crabmeat.
Korean variety crabmeat
or Kegani crabmeat.
Golden King crabmeat.
King crabmeat or
Hanasaki crabmeat.
King crabmeat.
Dated: April 27, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–09371 Filed 5–2–18; 8:45 am]
sradovich on DSK3GMQ082PROD with RULES
IX. References
The following reference is on display
in the Dockets Management Staff (see
ADDRESSES) and is available for viewing
by interested persons between 9 a.m.
and 4 p.m., Monday through Friday.
FDA has verified the website addresses,
as of the date this document publishes
VerDate Sep<11>2014
15:59 May 02, 2018
Jkt 244001
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Fmt 4700
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DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 54
[TD 9744]
RIN 1545–BJ45, 1545–BJ50, 1545–BJ62,
1545–BJ57
DEPARTMENT OF LABOR
Employee Benefits Security
Administration
29 CFR Part 2590
RIN 1210–AB72
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
45 CFR Parts 144, 146, and 147
[CMS–9993–N]
RIN 0938–AS56
Clarification of Final Rules for
Grandfathered Plans, Preexisting
Condition Exclusions, Lifetime and
Annual Limits, Rescissions,
Dependent Coverage, Appeals, and
Patient Protections Under the
Affordable Care Act
Internal Revenue Service,
Department of the Treasury; Employee
Benefits Security Administration,
Department of Labor; and Centers for
Medicare & Medicaid Services,
Department of Health and Human
Services.
ACTION: Final rule; clarification.
AGENCY:
Common or usual name
of crabmeat
BILLING CODE 4164–01–P
19431
On November 18, 2015, the
Departments of Labor, Health and
Human Services, and the Treasury (the
Departments) published a final rule in
the Federal Register titled ‘‘Final Rules
for Grandfathered Plans, Preexisting
Condition Exclusions, Lifetime and
Annual Limits, Rescissions, Dependent
Coverage, Appeals, and Patient
Protections Under the Affordable Care
Act’’ (the November 2015 final rule),
regarding, in part, the coverage of
emergency services by nongrandfathered group health plans and
health insurance issuers offering nongrandfathered group or individual
health insurance coverage, including the
requirement that non-grandfathered
group health plans and health insurance
issuers offering non-grandfathered
group or individual health insurance
coverage limit cost-sharing for out-ofnetwork emergency services and, as part
of that rule, pay at least a minimum
amount for out-of-network emergency
services. The American College of
SUMMARY:
E:\FR\FM\03MYR1.SGM
03MYR1
Agencies
[Federal Register Volume 83, Number 86 (Thursday, May 3, 2018)]
[Rules and Regulations]
[Pages 19429-19431]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-09371]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 102
[Docket No. FDA-2018-N-1438]
RIN 0910-AI04
Crabmeat; Amendment of Common or Usual Name Regulation
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is amending the
common or usual name
[[Page 19430]]
regulation for crabmeat by replacing ``brown king crabmeat'' with
``golden king crabmeat'' as the common or usual name for crabmeat
derived from the species Lithodes aequispinus. We are taking this
action due to a recently enacted law. We are also correcting an error
in the placement of a scientific term, which is editorial in nature.
DATES: This rule is effective May 3, 2018. The compliance date for this
rule is January 1, 2020.
ADDRESSES: For access to the docket, go to https://www.regulations.gov
and insert the docket number found in brackets in the heading of this
final rule into the ``Search'' box and follow the prompts, and/or go to
the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT: Steven Bloodgood, Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240-402-5316,
[email protected].
SUPPLEMENTARY INFORMATION:
Table of Contents
I. General Overview of Final Rule
II. Background and Legal Authority
III. Compliance Date
IV. Economic Analysis of Impacts
V. Analysis of Environmental Impact
VI. Paperwork Reduction Act of 1995
VII. Federalism
VIII. Consultation and Coordination With Indian Tribal Governments
IX. References
I. General Overview of Final Rule
This rule amends Sec. 102.50 (21 CFR 102.50) to designate ``golden
king crabmeat'' as the sole common or usual name of crabmeat derived
from the species Lithodes aequispinus. The regulation at Sec. 102.50
currently lists ``brown king crabmeat'' as the common or usual name of
crabmeat derived from the species Lithodes aequispina. In addition to
replacing the common or usual name, we are revising the scientific name
to read as Lithodes aequispinus, in accordance with a recently enacted
law designating the acceptable market name of the species as ``golden
king crab.'' We are also correcting Sec. 102.50 so that Paralithodes
platypus appears under the ``Scientific name of crab'' column for King
crabmeat.
II. Background and Legal Authority
In the Federal Register of July 3, 1995 (60 FR 34459), we published
a final rule amending the common or usual name provisions for crabmeat,
to provide that the common or usual name of crabmeat derived from the
species Lithodes aequispina is ``brown king crabmeat.''
On May 5, 2017, the Consolidated Appropriations Act, 2017 (Pub. L.
115-31), was signed into law. Section 774 of the Consolidated
Appropriations Act, 2017, provides that, for purposes of applying the
Federal Food, Drug, and Cosmetic Act (FD&C Act), the acceptable market
name of Lithodes aequispinus is ``golden king crab.''
The final rule amends Sec. 102.50 to reflect the common or usual
name of crabmeat derived from Lithodes aequispinus as provided by the
Consolidated Appropriations Act, 2017, and to revise the scientific
name of the species. The final rule also corrects Sec. 102.50 to move
the scientific name for King crabmeat, Paralithodes platypus, from the
``Common or usual name of crabmeat'' column to the ``Scientific name of
crab'' column.
FDA finds good cause for issuing this amendment as a final rule
without notice and comment because this amendment only updates the
regulation to align with the law enacted by the Consolidated
Appropriations Act, 2017 (5 U.S.C. 553(b)(B)). (``[W]hen regulations
merely restate the statute they implement, notice-and-comment
procedures are unnecessary.'' Gray Panthers Advocacy Committee v.
Sullivan, 936 F.2d 1284, 1291 (DC Cir. 1991); see also Komjathy v. Nat.
Trans. Safety Bd., 832 F.2d 1294, 1296 (DC Cir. 1987), cert. denied,
486 U.S. 1057 (1988) (when a rule ``does no more than repeat, virtually
verbatim, the statutory grant of authority,'' notice-and-comment
procedures are not required)).) Therefore, we are issuing this
amendment as a final rule, and publication of this document constitutes
final action under the Administrative Procedure Act (APA) (5 U.S.C.
553).
In addition, we find good cause for this amendment to become
effective on the date of publication of this action. The APA allows an
effective date less than 30 days after publication as ``provided by the
agency for good cause found and published with the rule'' (5 U.S.C.
553(d)(3)). A delayed effective date is unnecessary in this case
because the new requirements regarding golden king crab are already
effective as a matter of law and because moving the scientific name for
King crabmeat is a ministerial action. Therefore, we find good cause
for this amendment to become effective on the date of publication of
this action.
III. Compliance Date
With respect to a compliance date, we intend that any adjustments
to a product's labeling occur in a manner consistent with our uniform
compliance date (see 81 FR 85156, November 25, 2016). Thus, the
compliance date is January 1, 2020.
IV. Economic Analysis of Impacts
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 us 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 as
defined by Executive Order 12866 and is not a deregulatory action for
purposes of Executive Order 13771.
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. We estimate that the mean cost per crab covered by the final
rule is $0.23 (2016$). We estimate that the revenue per crab covered by
the final rule ranges from $17.65 to $99.42 (2016$). Because the cost
per crab covered by the final rule as a percentage of the revenue per
crab covered by the final rule is small, ranging from 0.2 percent to
1.3 percent, we certify that the final rule will not have a significant
economic impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to 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 $148
million, using the most current (2016) Implicit Price Deflator for the
Gross Domestic Product. This final rule would not result in an
expenditure in any year that meets or exceeds this amount.
We have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of the final rule.
[[Page 19431]]
The full analysis of economic impacts is available in the docket for
this final rule (Ref. 1).
V. Analysis of Environmental Impact
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.
VI. Paperwork Reduction Act of 1995
This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
VII. Federalism
We have 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, we conclude 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.
VIII. Consultation and Coordination With Indian Tribal Governments
We have analyzed this rule in accordance with the principles set
forth in Executive Order 13175. We have determined that the rule does
not contain policies that have substantial direct effects on one or
more Indian Tribes, on the relationship between the Federal Government
and Indian Tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian Tribes. Accordingly, we
conclude that the rule does not contain policies that have tribal
implications as defined in the Executive Order and, consequently, a
tribal summary impact statement is not required.
IX. References
The following reference is on display in the Dockets Management
Staff (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.
1. FDA, ``Crabmeat; Amendment of Common or Usual Name Regulation:
Final Regulatory Impact Analysis,'' 2017. Also available at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
List of Subjects in 21 CFR Part 102
Beverages, Food grades and standards, Food labeling, Frozen foods,
Oils and fats, Onions, Potatoes, Seafood.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
102 is amended as follows:
PART 102--COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS
0
1. The authority citation for part 102 continues to read as follows:
Authority: 21 U.S.C. 321, 343, 371.
0
2. In Sec. 102.50 revise the table to read as follows:
Sec. 102.50 Crabmeat.
* * * * *
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Common or usual name of
Scientific name of crab crabmeat
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Chionoecetes opilio, Chionoecetes tanneri, Snow crabmeat.
Chionoecetes bairdii, and Chionoecetes
angulatus.
Erimacrus isenbeckii...................... Korean variety crabmeat or
Kegani crabmeat.
Lithodes aequispinus...................... Golden King crabmeat.
Paralithodes brevipes..................... King crabmeat or Hanasaki
crabmeat.
Paralithodes camtschaticus and King crabmeat.
Paralithodes platypus.
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Dated: April 27, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-09371 Filed 5-2-18; 8:45 am]
BILLING CODE 4164-01-P