美国修订蟹肉通用名称

      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 nameStart Printed Page 19430regulation 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

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 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 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. Start Printed Page 19431The 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

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	Common or usual name of crabmeat
Chionoecetes opilio, Chionoecetes tanneri, Chionoecetes bairdii, and Chionoecetes angulatus	Snow crabmeat.
Erimacrus isenbeckii	Korean variety crabmeat or Kegani crabmeat.
Lithodes aequispinus	Golden King crabmeat.
Paralithodes brevipes	King crabmeat or Hanasaki crabmeat.
Paralithodes camtschaticus and Paralithodes platypus	King crabmeat.

Dated: April 27, 2018.

Leslie Kux,

Associate Commissioner for Policy.