83 FR 19429 - Crabmeat; Amendment of Common or Usual Name Regulation

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 86 (May 3, 2018)

Page Range		19429-19431
FR Document		2018-09371

The Food and Drug Administration (FDA or we) is amending the common or usual name 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.

Federal Register, Volume 83 Issue 86 (Thursday, May 3, 2018)

[Federal Register Volume 83, Number 86 (Thursday, May 3, 2018)]
[Rules and Regulations]
[Pages 19429-19431]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-09371]


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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.

* * * * *

------------------------------------------------------------------------
                                               Common or usual name of
          Scientific name of crab                     crabmeat
------------------------------------------------------------------------
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.
------------------------------------------------------------------------


    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

Federal Register / Vol. 83, No. 86 / Thursday, May 3, 2018 / Rules and Regulations 19429

previously issued. It is unlikely that (4) No explosive or toxic gasses contain the rechargeable lithium battery
prior public comment would result in a emitted by any rechargeable lithium or rechargeable lithium battery system.
significant change from the subject battery in normal operation or as the The lithium rechargeable batteries and
contained herein. Therefore, notice and result of any failure of the battery lithium rechargeable battery systems
opportunity for prior public comment charging system, monitoring system, or must not degrade below specified
hereon are unnecessary and the FAA battery installation, which is not shown ampere-hour levels sufficient to power
finds good cause, in accordance with 5 to be extremely remote, may accumulate the aircraft system. The ICA must also
U.S.C. 553(b)(3)(B) and 553(d)(3), in hazardous quantities within the contain procedures for the maintenance
making these special conditions airplane. of replacement batteries (see note 4) to
effective upon issuance. The FAA is (5) Installations of rechargeable prevent the installation of batteries that
requesting comments to allow interested lithium batteries must meet the have degraded charge retention ability
persons to submit views that may not requirements of § 23.863(a) through (d), or other damage due to prolonged
have been submitted in response to the amendment 23–34. storage at a low state of charge.
prior opportunities for comment (6) No corrosive fluids or gases that Replacement batteries must be of the
described above. may escape from any rechargeable same manufacturer and part number as
lithium battery, may damage approved by the FAA.
List of Subjects in 14 CFR Part 23 surrounding structure or any adjacent Note 2: Maintenance requirements include
Aircraft, Aviation safety, Signs and systems, equipment, electrical wiring, or procedures that—
symbols. the airplane in such a way as to cause (a) Check battery capacity, charge
a major or more severe failure condition, degradation at manufacturers recommended
Citation
in accordance with § 23.1309, inspection intervals; and
■ The authority citation for these amendment 23–49, and applicable (b) Replace batteries at manufacturers
special conditions is as follows: regulatory guidance. recommended replacement schedule/time to
(7) Each rechargeable lithium battery prevent age related degradation.
Authority: 49 U.S.C. 106(f), 106(g), 40113,
44701–44702, 44704; Pub. L. 113–53, 127 installation must have provisions to
Note 3: The term ‘‘sufficiently charged’’
Stat 584 (49 U.S.C. 44704) note; 14 CFR 21.16 prevent any hazardous effect on means that the battery must retain enough
and 21.101; and 14 CFR 11.38 and 11.19. structure or essential systems that may charge, expressed in ampere-hours, to ensure
be caused by the maximum amount of that the battery cells will not be damaged.
The Special Conditions heat the battery can generate during a
A battery cell may be damaged by low
■ Accordingly, pursuant to the authority short circuit of the battery or of its
charge (i.e., below certain level),
delegated to me by the Administrator, individual cells.
resulting in a reduction in the ability to
the following special conditions are (8) Rechargeable lithium battery
charge and retain a full charge. This
issued as part of the type certification installations must have—
i. A system to automatically control reduction would be greater than the
basis for Textron Aviation B300, B300C, reduction that may result from normal
B300C (MC–12W), and B300C (UC– the charging rate of the battery to
prevent battery overheating and operational degradation.
12W) airplanes modified by St. Louis
overcharging; and either Note 4: Replacement battery in spares
Helicopter, LLC. storage may be subject to prolonged storage
ii. A battery temperature sensing and
1. Installation of Lithium Battery over-temperature warning system with a at a low state of charge.

The FAA adopts that the following means for automatically disconnecting Issued in Kansas City, Missouri on April
special conditions be applied to lithium the battery from its charging source in 23, 2018.
battery installations on the Textron the event of an over-temperature Pat Mullen,
Aviation models B300, B300C, B300C condition; or
Manager, Small Airplane Standards Branch,
(MC–12W), and B300C (UC–12W) iii. A battery failure sensing and Aircraft Certification Service.
airplanes in lieu of the requirements warning system with a means for
[FR Doc. 2018–09350 Filed 5–2–18; 8:45 am]
§ 23.1353 (a), (b), (c), (d), and (e), automatically disconnecting the battery
BILLING CODE 4910–13–P
amendment 23–49. from its charging source in the event of
Lithium battery installations on the battery failure.
(9) Any rechargeable lithium battery
models B300, B300C, B300C (MC–12W), DEPARTMENT OF HEALTH AND
installation, the function of which is
and B300C (UC–12W) airplanes must be HUMAN SERVICES
required for safe operation of the
designed and installed as follows:
aircraft, must incorporate a monitoring
(1) Safe cell temperatures and Food and Drug Administration
and warning feature that will provide an
pressures must be maintained during—
indication to the appropriate flight
i. Normal operations; 21 CFR Part 102
crewmembers whenever the state of
ii. Any probable failure conditions of
charge of the batteries has fallen below [Docket No. FDA–2018–N–1438]
charging or discharging or battery
levels considered acceptable for
monitoring system; and RIN 0910–AI04
dispatch (see note 1) of the aircraft.
iii. Any failure of the charging or
battery monitoring system not shown to Note 1: Reference § 23.1353(h) for dispatch Crabmeat; Amendment of Common or
be extremely remote. consideration. Usual Name Regulation
(2) The rechargeable lithium battery (10) The Instructions for Continued AGENCY: Food and Drug Administration,
sradovich on DSK3GMQ082PROD with RULES

installation must be designed to Airworthiness (ICA) required by HHS.
preclude explosion or fire in the event § 23.1529 must contain maintenance Final rule; technical
ACTION:
of 1(1)ii and 1(1)iii failures. requirements (see note 2) to assure that amendment.
(3) Design of the rechargeable lithium the battery has been sufficiently charged
batteries must preclude the occurrence (see note 3) at appropriate intervals SUMMARY: The Food and Drug
of self-sustaining, uncontrolled specified by the battery manufacturer Administration (FDA or we) is
increases in temperature or pressure. and the equipment manufacturer that amending the common or usual name

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Federal Register / Vol. 83, No. 86 / Thursday, May 3, 2018 / Rules and Regulations 19431

The full analysis of economic impacts is in the Federal Register, but websites are DEPARTMENT OF THE TREASURY
available in the docket for this final rule subject to change over time.
(Ref. 1). Internal Revenue Service
1. FDA, ‘‘Crabmeat; Amendment of Common
V. Analysis of Environmental Impact or Usual Name Regulation: Final
26 CFR Part 54
Regulatory Impact Analysis,’’ 2017. Also
We have determined under 21 CFR available at https://www.fda.gov/ [TD 9744]
25.30(k) that this action is of a type that AboutFDA/ReportsManualsForms/
does not individually or cumulatively RIN 1545–BJ45, 1545–BJ50, 1545–BJ62,
Reports/EconomicAnalyses/default.htm.
have a significant effect on the human 1545–BJ57
environment. Therefore, neither an List of Subjects in 21 CFR Part 102
DEPARTMENT OF LABOR
environmental assessment nor an
environmental impact statement is Beverages, Food grades and standards,
Food labeling, Frozen foods, Oils and Employee Benefits Security
required.
fats, Onions, Potatoes, Seafood. Administration
VI. Paperwork Reduction Act of 1995
Therefore, under the Federal Food, 29 CFR Part 2590
This final rule contains no collection Drug, and Cosmetic Act and under
of information. Therefore, clearance by authority delegated to the Commissioner RIN 1210–AB72
the Office of Management and Budget of Food and Drugs, 21 CFR part 102 is
under the Paperwork Reduction Act of DEPARTMENT OF HEALTH AND
amended as follows:
1995 is not required. HUMAN SERVICES
VII. Federalism PART 102—COMMON OR USUAL
NAME FOR NONSTANDARDIZED 45 CFR Parts 144, 146, and 147
We have analyzed this final rule in FOODS [CMS–9993–N]
accordance with the principles set forth
in Executive Order 13132. FDA has RIN 0938–AS56
■ 1. The authority citation for part 102
determined that the rule does not continues to read as follows:
contain policies that have substantial Clarification of Final Rules for
direct effects on the States, on the Authority: 21 U.S.C. 321, 343, 371. Grandfathered Plans, Preexisting
relationship between the National Condition Exclusions, Lifetime and
■ 2. In § 102.50 revise the table to read Annual Limits, Rescissions,
Government and the States, or on the
as follows: Dependent Coverage, Appeals, and
distribution of power and
responsibilities among the various Patient Protections Under the
§ 102.50 Crabmeat. Affordable Care Act
levels of government. Accordingly, we
* * * * *
conclude that the rule does not contain AGENCY: Internal Revenue Service,
policies that have federalism Common or usual name Department of the Treasury; Employee
Scientific name of crab
implications as defined in the Executive of crabmeat Benefits Security Administration,
order and, consequently, a federalism Department of Labor; and Centers for
Chionoecetes opilio, Snow crabmeat.
summary impact statement is not Chionoecetes tanneri, Medicare & Medicaid Services,
required. Chionoecetes bairdii, Department of Health and Human
and Chionoecetes Services.
VIII. Consultation and Coordination angulatus.
With Indian Tribal Governments Erimacrus isenbeckii ....... Korean variety crabmeat ACTION: Final rule; clarification.
or Kegani crabmeat.
We have analyzed this rule in Lithodes aequispinus ...... Golden King crabmeat. SUMMARY: On November 18, 2015, the
accordance with the principles set forth Paralithodes brevipes ..... King crabmeat or Departments of Labor, Health and
in Executive Order 13175. We have Hanasaki crabmeat. Human Services, and the Treasury (the
determined that the rule does not Paralithodes King crabmeat. Departments) published a final rule in
camtschaticus and
contain policies that have substantial Paralithodes platypus.
the Federal Register titled ‘‘Final Rules
direct effects on one or more Indian for Grandfathered Plans, Preexisting
Tribes, on the relationship between the Condition Exclusions, Lifetime and
Federal Government and Indian Tribes, Dated: April 27, 2018. Annual Limits, Rescissions, Dependent
or on the distribution of power and Leslie Kux, Coverage, Appeals, and Patient
responsibilities between the Federal Associate Commissioner for Policy. Protections Under the Affordable Care
Government and Indian Tribes. [FR Doc. 2018–09371 Filed 5–2–18; 8:45 am] Act’’ (the November 2015 final rule),
Accordingly, we conclude that the rule BILLING CODE 4164–01–P regarding, in part, the coverage of
does not contain policies that have emergency services by non-
tribal implications as defined in the grandfathered group health plans and
Executive Order and, consequently, a health insurance issuers offering non-
tribal summary impact statement is not grandfathered group or individual
required. health insurance coverage, including the
requirement that non-grandfathered
IX. References
group health plans and health insurance
sradovich on DSK3GMQ082PROD with RULES

The following reference is on display issuers offering non-grandfathered
in the Dockets Management Staff (see group or individual health insurance
ADDRESSES) and is available for viewing coverage limit cost-sharing for out-of-
by interested persons between 9 a.m. network emergency services and, as part
and 4 p.m., Monday through Friday. of that rule, pay at least a minimum
FDA has verified the website addresses, amount for out-of-network emergency
as of the date this document publishes services. The American College of

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Document Created: 2018-05-02 23:48:36
Document Modified: 2018-05-02 23:48:36

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule; technical amendment.
Dates		This rule is effective May 3, 2018. The compliance date for this rule is January 1, 2020.
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]
FR Citation		83 FR 19429
RIN Number		0910-AI04
CFR Associated		Beverages; Food Grades and Standards; Food Labeling; Frozen Foods; Oils and Fats; Onions; Potatoes and Seafood

83 FR 19429 - Crabmeat; Amendment of Common or Usual Name Regulation

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 86 (May 3, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration