[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]


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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.

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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