Comments Invited

The FAA invites you to send any written data, views, or arguments about this final rule. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2023-2142; Project Identifier MCAI-2023-01056-T” at the beginning of your comments. The most helpful comments reference a specific portion of the final rule, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this final rule because of those comments.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to regulations.gov, including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this final rule.

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this AD contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this AD, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this AD. Submissions containing CBI should be sent to Dat Le, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7317; email Dat.V.Le@faa.gov. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

The FAA issued AD 2023-04-12, Amendment 39-22359 (88 FR 12143, February 27, 2023) (AD 2023-04-12), for all Airbus SAS Model A350-941 and -1041 airplanes. AD 2023-04-12 was prompted by an MCAI originated by EASA, which is the Technical Agent for the Member States of the European Union. EASA issued AD 2023-0011, dated January 17, 2023 (EASA AD 2023-0011), to correct an unsafe condition.

EASA AD 2023-0011 stated that longitudinal sealing tape in the forward and aft cargo compartments had migrated from its original position, possibly due to relative movement between the cargo floor panels and the cargo loading system, combined with compression of the tape.

AD 2023-04-12 required repetitive detailed inspection of the affected parts ( i.e., cargo sealing tapes installed between the cargo floor panels and the cargo loading system in longitudinal direction, in the forward and aft cargo compartment area), and, depending on findings, accomplishment of applicable corrective action. The FAA issued AD 2023-04-12 to address migration of the tape, which can affect the tightness of the cargo compartment floor panels that provide an enclosed area to maintain halon concentration in the event of a fire. This condition, if not addressed, could affect the fire extinguishing system efficiency in the cargo compartments, possibly resulting in failure of the system to contain a cargo compartment fire or permanently extinguish a fire.

Since the FAA issued AD 2023-04-12, EASA issued AD 2023-0011R1, dated February 23, 2023 (EASA AD 2023-0011R1) to provide dispatch instructions under the Master Minimum Equipment List. EASA subsequently superseded EASA AD 2023-0011R1 and issued EASA AD 2023-0176, dated October 6, 2023 (EASA AD 2023-0176) (also referred to as the MCAI), to correct an unsafe condition for all Airbus SAS Model A350-941 and -1041 airplanes. The MCAI states that additional parts (cargo sealing tapes installed between the cargo floor panels and the floor structure in transversal direction in the bulk cargo compartment area at frame 82) have been identified as affected by the same potential unsafe condition.

The FAA is issuing this AD to address the unsafe condition on these products. You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2023-2142.

Although this AD does not explicitly restate the requirements of AD 2023-04-12, this AD retains all of the requirements of AD 2023-04-12. Those requirements are referenced in EASA AD 2023-0176, which, in turn, is referenced in paragraph (g) of this AD.

EASA AD 2023-0176 specifies procedures for the following actions:

• Repetitive detailed inspections to detect complete or partial migration of the cargo sealing tapes (including high speed tape and glass cloth tape) and existing repairs of affected parts ( i.e., cargo sealing tapes installed between the cargo floor panels and the cargo loading system in longitudinal direction, in the forward and aft cargo compartment area; and cargo sealing tapes installed between the cargo floor panels and the floor structure in transversal direction, in the bulk cargo compartment area at frame 82).

• Measurement of the maximum migration of partially migrated tape.

• Inspection for incorrect seating or sealant of repaired tape.

• Repair of discrepancies, including cargo sealing tape that has migrated more than 11 millimeters, complete migration of the tape, incorrect seating/condition of the tape in repaired areas, and incorrect sealant condition in repaired areas.

EASA AD 2023-0176 allows deferral of corrective actions through dispatch of the airplane under specified Airbus A350 Master Minimum Equipment List items.

This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

This product has been approved by the aviation authority of another country and is approved for operation in the United States. Pursuant to the FAA's bilateral agreement with this State of Design Authority, it has notified the FAA of the unsafe condition described in the MCAI referenced above. The FAA is issuing this AD after determining that the unsafe condition described previously is likely to exist or develop on other products of the same type design.

This AD requires accomplishing the actions specified in EASA AD 2023-0176 described previously, except for any differences identified as exceptions in the regulatory text of this AD.

In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA developed a process to use some civil aviation authority (CAA) ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has been coordinating this process with manufacturers and CAAs. As a result, EASA AD 2023-0176 is incorporated by reference in this AD. This AD requires compliance with EASA AD 2023-0176 in its entirety through that incorporation, except for any differences identified as exceptions in the regulatory text of this AD. Using common terms that are the same as the heading of a particular section in EASA AD 2023-0176 does not mean that operators need comply only with that section. For example, where the AD requirement refers to “all required actions and compliance times,” compliance with this AD requirement is not limited to the section titled “Required Action(s) and Compliance Time(s)” in EASA AD 2023-0176. Service information required by EASA AD 2023-0176 for compliance will be available at regulations.gov under Docket No. FAA-2023-2142 after this AD is published.

The FAA considers that this AD is an interim action. If final action is later identified, the FAA might consider further rulemaking then.

Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5 U.S.C. 551 et seq. ) authorizes agencies to dispense with notice and comment procedures for rules when the agency, for “good cause,” finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under this section, an agency, upon finding good cause, may issue a final rule without providing notice and seeking comment prior to issuance. Further, section 553(d) of the APA authorizes agencies to make rules effective in less than thirty days, upon a finding of good cause.

An unsafe condition exists that requires the immediate adoption of this AD without providing an opportunity for public comments prior to adoption. The FAA has found that the risk to the flying public justifies forgoing notice and comment prior to adoption of this rule because migration of the sealing tape can affect the tightness of the cargo compartment floor panels, which provide an enclosed area to maintain halon concentration in the event of a fire. Migration of the sealing tape in the forward and aft cargo compartments could affect the fire extinguishing system efficiency in the cargo compartments and possibly result in failure of the system to contain a cargo compartment fire or permanently extinguish the fire. The additional affected locations in the bulk cargo compartment further increase the effect on the fire extinguishing system efficiency by widening the area in which a halon concentration could perpetuate due to migration of the sealing tape and increasing the likelihood of a failure to contain a cargo compartment fire or permanently extinguish the fire. Accordingly, notice and opportunity for prior public comment are impracticable and contrary to the public interest pursuant to 5 U.S.C. 553(b)(3)(B).

In addition, the FAA finds that good cause exists pursuant to 5 U.S.C. 553(d) for making this amendment effective in less than 30 days, for the same reasons the FAA found good cause to forgo notice and comment.

The requirements of the RFA do not apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and comment. Because the FAA has determined that it has good cause to adopt this rule without notice and comment, RFA analysis is not required.

The FAA estimates that this AD affects 32 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

The FAA estimates the following costs to do any necessary on-condition actions that would be required based on the results of any required actions. The FAA has no way of determining the number of aircraft that might need these on-condition actions:

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect 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.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866, and

(2) Will not affect intrastate aviation in Alaska.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes Class E airspace to support IFR operations at Grand Coulee Dam Airport, Electric City, WA.

The FAA published an NPRM for Docket No. FAA-2023-1339 in the Federal Register (88 FR 39384; June 16, 2023), proposing to establish Class E airspace at Grand Coulee Dam Airport, Electric City, WA. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

The Class E5 airspace designation is published in paragraph 6005 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document amends the current version of that order, FAA Order JO 7400.11H, dated August 11, 2023, and effective September 15, 2023. FAA Order JO 7400.11H is publicly available as listed in the ADDRESSES section of this document. These amendments will be published in the next update to FAA Order JO 7400.11.

FAA Order JO 7400.11H lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This action amends 14 CFR part 71 to establish Class E airspace Grand Coulee Dam Airport, Electric City, WA, in support of the airport's transition from VFR to IFR operations.

The airspace design—which extends from the airport reference point (ARP) 10.2 miles east and 9.7 miles southwest—would fully contain departing and missed approach IFR operations until reaching 1,200 feet above the surface on the Area Navigation (RNAV) (Global Positioning System [GPS]) Z Runway (RWY) 22 missed approach and the SINGG (RNAV) obstacle departure procedure (ODP), and arriving IFR operations below 1,500 feet above the surface on the RNAV (GPS) Y RWY 22 and RNAV (GPS) Z RWY 22 approaches.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5.a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would modify the route structure as necessary to preserve the safe and efficient flow of air traffic within the National Airspace System (NAS).

The FAA published a notice of proposed rulemaking for Docket No. FAA 2023-0866 in the Federal Register (88 FR 21139; April 10, 2023), proposing to amend RNAV route Q-46. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

The NPRM published in the Federal Register (88 FR 21139, April 10, 2023) contained a typographical error in the proposed legal description. In the proposed legal description, the longitudinal geographical coordinate listed for Barrow, AK, Very High Frequency Omnidirectional Range/Distance Measuring Equipment (VOR/DME) was incorrect. The NPRM listed the longitudinal coordinate for Barrow, AK, VOR/DME as 156°47′18.90″ W. The final rule corrects this error by listing the longitudinal coordinate for Barrow, AK, VOR/DME as 156°47′17.22″ W.

United States Area Navigation Routes are published in paragraph 2006 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document amends the current version of that order, FAA Order JO 7400.11H, dated August 11, 2023, and effective September 15, 2023. FAA Order JO 7400.11H is publicly available as listed in the ADDRESSES section of this document. These amendments will be published in the next update to FAA Order JO 7400.11.

FAA Order JO 7400.11H lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This action amends 14 CFR part 71 by amending RNAV route Q-46 in the vicinity of Point Hope, AK due to the pending decommissioning of the Point Hope NDB. The RNAV route amendment action is described below.

Q-46: As amended, Q-46 extends between the VANTY, AK, waypoint (WP) and the Barrow, AK, VOR/DME.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

This action of amending RNAV Route Q-46 in the vicinity of Point Hope, AK due to the pending decommissioning of the Point Hope NDB qualifies for categorical exclusion under the National Environmental Policy Act (42 U.S.C. 4321 et seq. ) and its implementing regulations at 40 CFR part 1500, and in accordance with FAA Order 1050.1F, Environmental Impacts: Policies and Procedures, paragraph 5-6.5a, which categorically excludes from further environmental impact review rulemaking actions that designate or modify classes of airspace areas, airways, routes, and reporting points (see 14 CFR part 71, Designation of Class A, B, C, D, and E Airspace Areas; Air Traffic Service Routes; and Reporting Points); and paragraph 5-6.5.i., which categorically excludes from further environmental impact review the establishment of new or revised air traffic control procedures conducted at 3,000 feet or more above ground level (AGL); procedures conducted below 3,000 feet AGL that do not cause traffic to be routinely routed over noise sensitive areas; modifications to currently approved procedures conducted below 3,000 feet AGL that do not significantly increase noise over noise sensitive areas; and increases in minimum altitudes and landing minima. As such, this action is not expected to result in any potentially significant environmental impacts. In accordance with FAA Order 1050.1F, paragraph 5-2 regarding Extraordinary Circumstances, the FAA has reviewed this action for factors and circumstances in which a normally categorically excluded action may have a significant environmental impact requiring further analysis. Accordingly, the FAA has determined that no extraordinary circumstances exist that warrant preparation of an environmental assessment or environmental impact study.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code (U.S.C.). Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes Class E airspace to support IFR operations at Tununak Airport, Tununak, AK.

The FAA published an NPRM for Docket No. FAA-2023-1119 in the Federal Register (88 FR 37484; June 8, 2023), proposing to establish Class E airspace at Tununak Airport, AK. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

The Class E5 airspace designation is published in paragraph 6005 of FAA Order JO 7400.11, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document amends the current version of that order, FAA Order JO 7400.11H, dated August 11, 2023, and effective September 15, 2023. FAA Order JO 7400.11H is publicly available as listed in the ADDRESSES section of this document. These amendments will be published in the next update to FAA Order JO 7400.11.

FAA Order JO 7400.11H lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This action amends 14 CFR part 71 to establish Class E airspace at Tununak Airport, Tununak, AK, in support of the airport's transition from VFR to IFR operations.

The Class E airspace will extend upward from 700 feet above the surface and extends 7.4 miles from the airport reference point to both the north and south with a 3.4-mile western extension. This configuration is designed to fully contain arriving IFR operations below 1,500 feet above the surface on the Area Navigation (RNAV) Global Positioning System (GPS) RWY 34 approach, RNAV (GPS) Y RWY 16 approach, and the RNAV (GPS) Z RWY 16 approach, as well as departing IFR operations until they reach 1,200 feet above the surface on the EZEPU ONE (OBSTACLE) (RNAV) departure.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order (E.O.) 12866; (2) is not a “significant rule” under DOT regulatory policies and procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for a categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, Environmental Impacts: Policies and Procedures, paragraph 5-6.5.a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

In consideration of the foregoing, the FAA amends 14 CFR part 71 as follows:

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it modifies the Air Traffic Service (ATS) route structure as necessary to preserve the safe and efficient flow of air traffic within the National Airspace System.

The FAA published a notice of proposed rulemaking for Docket No. FAA-2023-1026 in the Federal Register (88 FR 29573; May 8, 2023), proposing to amend Jet Route J-84, United States RNAV route Q-42, and VOR Federal airways V-171 and V-251, and establish United States RNAV route T-478 due to the planned decommissioning of the VOR portion of the Danville, IL, VORTAC NAVAID. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal. No comments were received.

Concurrent with the NPRM, the FAA published a final rule for Docket No. FAA-2022-1586 in the Federal Register (88 FR 31607; May 18, 2023), amending VOR Federal airway V-171 by removing the airway segment between the Grand Forks, ND, VOR/Distance Measuring Equipment (VOR/DME) and the Roseau, MN, VOR/DME. That airway amendment, effective August 10, 2023, is included in this rule.

Additionally, subsequent to the NPRM, the FAA determined the STRUK, IL, waypoint (WP) listed in the Q-42 description is not required to be included in the part 71 description of Q-42. The WP is not a beginning or end point of Q-42, is not a point where the route changes one degree or more, is not used as a holding fix, and is not required as the maximum distance allowed between NAVAIDs, fixes, or WPs is not exceeded. As such, this rule removes the STRUK, IL, WP from the Q-42 part 71 description. This is an editorial change only and does not alter the alignment of the Q-42 route.

Finally, in the NPRM, the RIVRS, IL, route point listed in the T-478 description was incorrectly referenced and listed as a Fix. The RIVRS, IL, Fix was updated in the National Airspace System Resource (NASR) database prior to publication of the NPRM and is now described as a WP. This rule corrects that error and lists the RIVRS route point as a WP. This is an editorial change only to match the FAA's NASR database information and does not alter the alignment of the T-478 route.

Jet Routes are published in paragraph 2004, United States RNAV Routes (Q-routes) are published in paragraph 2006, VOR Federal airways are published in paragraph 6010(a), and United States RNAV Routes (T-routes) are published in paragraph 6011 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document amends the current version of that order, FAA Order JO 7400.11H, dated August 11, 2023, and effective September 15, 2023. FAA Order JO 7400.11H is publicly available as listed in the ADDRESSES section of this document. This amendment action will be published in the next update to FAA Order JO 7400.11.

FAA Order JO 7400.11H lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This action amends 14 CFR part 71 by amending Jet Route J-84, United States RNAV route Q-42, and VOR Federal airways V-171 and V-251, and establishing United States RNAV route T-478. This action is due to the planned decommissioning of the VOR portion of the Danville, IL, VORTAC. The ATS route actions are described below.

J-84: Prior to this final rule, J-84 extended between the Oakland, CA, VOR/DME and the Sidney, NE, VOR/DME; and between the Dubuque, IA, VORTAC and the Danville, IL, VORTAC. The route segment between the Northbrook, IL, VOR/DME and the Danville, IL, VORTAC is removed. As amended, the route now extends between the Oakland VOR/DME and the Sidney VOR/DME and between the Dubuque VORTAC and the Northbrook VOR/DME.

Q-42: Prior to this final rule, Q-42 extended between the Kirksville, MO, VORTAC and the ZIMMZ, PA, Fix. The Kirksville VORTAC route point is replaced with the LEWRP, MO, WP; the Danville, IL, VORTAC route point is replaced with the LCOLN, IL, WP; and the Muncie, IN, VOR/DME route point is replaced with the SNKPT, IN, WP. Editorial corrections are made to the state abbreviation and the type of route point for the ZIMMZ Fix to match the NASR database information. As amended, the route now extends between the LEWRP WP and the ZIMMZ Fix.

V-171: Prior to this final rule, V-171 extended between the Lexington, KY, VOR/DME and the Joliet, IL, VOR/DME; and between the Nodine, MN, VORTAC and the Grand Forks, ND, VOR/DME. The airway segment between the Terre Haute, IN, VORTAC and the Peotone, IL, VORTAC is removed. As amended, the airway now extends between the Lexington VOR/DME and the Terre Haute VORTAC, between the Peotone VORTAC and the Joliet VOR/DME, and between the Nodine VORTAC and the Grand Forks VOR/DME.

V-251: Prior to this final rule, V-251 extended between the Adders, IL, VORTAC and the Boiler, IN, VORTAC. The airway segment between the Champaign, IL, VORTAC and the Boiler, IN, VORTAC is removed. As amended, the airway now extends between the Adders VORTAC and the Champaign VORTAC.

T-478: T-478 is a new RNAV route established between the RIVRS, MO, WP located northeast of Bolling Green, MO, and the BOLRR, IN, WP located near the Boiler, IN, VORTAC. This new T-route mitigates the removal of the V-251 airway segment addressed above between the Champaign, IL, VORTAC and the Lafayette, IN, area to mitigate the removal of the V-251 airway segment addressed above and provides non-radar routing between the RIVRS WP and the Champaign VORTAC, when needed.

All NAVAID radials listed in the VOR Federal airway V-171 description below are unchanged and stated in degrees True north.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action of amending Jet Route J-84, United States RNAV route Q-42, and VOR Federal airways V-171 and V-251, and establishes United States RNAV route T-478, due to the planned decommissioning of the VOR portion of the Danville, IL, VOR/DME NAVAID, qualifies for categorical exclusion under the National Environmental Policy Act (42 U.S.C. 4321 et seq. ) and its implementing regulations at 40 CFR part 1500, and in accordance with FAA Order 1050.1F, Environmental Impacts: Policies and Procedures, paragraph 5-6.5a, which categorically excludes from further environmental impact review rulemaking actions that designate or modify classes of airspace areas, airways, routes, and reporting points (see 14 CFR part 71, Designation of Class A, B, C, D, and E Airspace Areas; Air Traffic Service Routes; and Reporting Points); and paragraph 5-6.5i, which categorically excludes from further environmental impact review the establishment of new or revised air traffic control procedures conducted at 3,000 feet or more above ground level (AGL); procedures conducted below 3,000 feet AGL that do not cause traffic to be routinely routed over noise sensitive areas; modifications to currently approved procedures conducted below 3,000 feet AGL that do not significantly increase noise over noise sensitive areas; and increases in minimum altitudes and landing minima. As such, this action is not expected to result in any potentially significant environmental impacts. In accordance with FAA Order 1050.1F, paragraph 5-2 regarding Extraordinary Circumstances, the FAA has reviewed this action for factors and circumstances in which a normally categorically excluded action may have a significant environmental impact requiring further analysis. The FAA has determined that no extraordinary circumstances exist that warrant preparation of an environmental assessment or environmental impact study.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it modifies the Air Traffic Service (ATS) route structure as necessary to preserve the safe and efficient flow of air traffic within the National Airspace System.

The FAA published a notice of proposed rulemaking for Docket No. FAA-2023-1014 in the Federal Register (88 FR 29580; May 8, 2023), proposing to amend VOR Federal airways V-14 and V-67, and United States RNAV route T-272 due to the planned decommissioning of the VOR portion of the Vandalia, IL, VOR/DME NAVAID. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal. No comments were received.

VOR Federal airways are published in paragraph 6010(a) and United States Area Navigation Routes (T-routes) are published in paragraph 6011 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document amends the current version of that order, FAA Order JO 7400.11H, dated August 11, 2023, and effective September 15, 2023. FAA Order JO 7400.11H is publicly available as listed in the ADDRESSES section of this document. This amendment action will be published in the next update to FAA Order JO 7400.11.

FAA Order JO 7400.11H lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This action amends 14 CFR part 71 by amending VOR Federal airways V-14 and V-67, and United States RNAV route T-272 due to the planned decommissioning of the VOR portion of the Vandalia, IL, VOR/DME. The Air Traffic Service (ATS) route actions are described below.

V-14: Prior to this final rule, V-14 extended between the Chisum, NM, VOR/Tactical Air Navigation (VORTAC) and the Tulsa, OK, VORTAC; and between the Springfield, MO, VORTAC and the Flag City, OH, VORTAC. The airway segment between the St. Louis, MO, VORTAC and the Terre Haute, IN, VORTAC is removed. As amended, the airway now extends between the Chisum VORTAC and the Tulsa VORTAC, between the Springfield VORTAC and the St. Louis VORTAC, and between the Terre Haute VORTAC and the Flag City VORTAC.

V-67: Prior to this final rule, V-67 extended between the intersection of the Centralia, IL, VORTAC 010° and Vandalia, IL, VOR/DME 162° radials (CORKI Fix) and the Rochester, MN, VOR/DME. The airway segment between the intersection of the Centralia VORTAC 010° and Vandalia VOR/DME 162° radials (CORKI Fix) and the Spinner, IL, VORTAC is removed. As amended, the airway now extends between the Spinner VORTAC and the Rochester VOR/DME.

T-272: Prior to this final rule, T-272 extended between the Hallsville, MO, VORTAC and the Vandalia, IL, VOR/DME. The Vandalia, IL, VOR/DME route point is changed to the TYMME, IL, waypoint (WP) which is located approximately 60 feet northeast of the Vandalia VOR/DME. As amended, the route now extends between the Hallsville VORTAC and the TYMME WP. Additionally, the Hallsville, MO, identifier is added to the first line of the route description and the geographic coordinates of each route point are updated to be expressed in degrees, minutes, seconds, and hundredths of a second.

The NAVAID radials contained in the V-14 description listed below in The Amendment section are unchanged and stated in degrees True north.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action of amending VOR Federal airways V-14 and V-67, and United States RNAV route T-272, due to the planned decommissioning of the VOR portion of the Vandalia, IL, VOR/DME NAVAID, qualifies for categorical exclusion under the National Environmental Policy Act (42 U.S.C. 4321 et seq. ) and its implementing regulations at 40 CFR part 1500, and in accordance with FAA Order 1050.1F, Environmental Impacts: Policies and Procedures, paragraph 5-6.5a, which categorically excludes from further environmental impact review rulemaking actions that designate or modify classes of airspace areas, airways, routes, and reporting points (see 14 CFR part 71, Designation of Class A, B, C, D, and E Airspace Areas; Air Traffic Service Routes; and Reporting Points); and paragraph 5-6.5k, which categorically excludes from further environmental impact review publication of existing air traffic control procedures that do not essentially change existing tracks, create new tracks, change altitude, or change concentration of aircraft on these tracks. As such, this action is not expected to result in any potentially significant environmental impacts. In accordance with FAA Order 1050.1F, paragraph 5-2 regarding Extraordinary Circumstances, the FAA has reviewed this action for factors and circumstances in which a normally categorically excluded action may have a significant environmental impact requiring further analysis. The FAA has determined that no extraordinary circumstances exist that warrant preparation of an environmental assessment or environmental impact study.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it modifies the Air Traffic Service (ATS) route structure as necessary to preserve the safe and efficient flow of air traffic within the National Airspace System (NAS).

The FAA published a notice of proposed rulemaking for Docket No. FAA-2023-0965 in the Federal Register (88 FR 23595; April 18, 2023), proposing to amend VOR Federal airways V-158 and V-172 due to the planned decommissioning of the VOR portion of the Polo, IL, VOR/DME NAVAID. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal. One comment was received.

The commenter stated the FAA should keep the Polo VOR and associated VOR Federal airways, V-158 and V-172, because decommissioning them represented an aeronautical navigation challenge to instrument flight rules (IFR) aircraft not yet equipped with an IFR suitable global positioning system (GPS) and as a backup to GPS navigation, since there is a lack of other suitable VOR navigational aids in the area.

The VOR MON is designed to enable aircraft, having lost Global Navigation Satellite System (GNSS) service, to revert to conventional navigation procedures and enable aircraft to proceed to a MON airport where an Instrument Landing System (ILS) or VOR approach procedure can be flown without the necessity of GPS.

In December 2011, the FAA published a notice of proposed policy and request for comments in the Federal Register (76 FR 77939). The notice addressed the FAA's proposed strategy for reducing the current VOR network to a Minimum Operational Network (MON) in support of transitioning the NAS to performance-based navigation (PBN) as part of the Next Generation Air Transportation System (NextGen). The FAA announced that, as part of a NAS Efficient Streamlined Services Initiative, the number of VORs would be reduced while more efficient Area Navigation (RNAV) routes and procedures would be implemented throughout the NAS. The notice stated that the FAA, with assistance of a work group, would develop a candidate list of VORs for discontinuance using relevant operational, safety, cost, and economic criteria.

In response to comments received to the notice of proposed policy, the FAA published a disposition of comments notice in the Federal Register (77 FR 50420; August 21, 2012), stating it would develop an initial VOR MON discontinuance plan which would be made publicly available. As a result, the FAA convened a working group for developing the objective criteria to be used to help identify those VORs that would remain operational. Stakeholders, aviation industry, and military services provided further input to the FAA for consideration in developing the criteria to select VORs that needed to be retained as a part of the MON. With this collective input, the FAA developed the criteria to determine which VORs would be retained. The VORs not meeting these criteria were considered discontinuance candidates.

As referenced in the NPRM, the FAA published its VOR MON final policy statement in the Federal Register (81 FR 48694; July 26, 2016). In that notice, the candidate list of VORs to be discontinued was announced. The Polo, MI, VOR was announced as a candidate VOR for discontinuance. The FAA remains committed to its final policy statement and plan to retain an optimized VOR MON that enables pilots to revert from PBN to conventional navigation for approach, terminal, and enroute operations in the event of a GPS outage. This action supports the NAS transition from ground-based to satellite-based navigation consistent with the FAA's NextGen goals and the NAS Efficient Streamlined Services Initiative.

The commenter also stated that if the Polo VOR is decommissioned, there will not be any usable NAVAID between the Moline, IL, VOR and the DuPage, IL, VOR (a distance of 108 nautical miles (NM)) which is outside of the current VOR service volume, nor would there be any usable VOR connecting the Dubuque, IA, VOR/Tactical Air Navigation (VORTAC) with the Chicago area DuPage, IL, and Joliet, IL, VORs. The commenter continued that flying between the Dubuque, IA, VORTAC and the Joliet, IL, VOR/DME would put pilots outside current VOR service volumes due to significant limitations imposed on the Dubuque VOR and the limited ranges of the Davenport and Moline VORs.

In response, the FAA offers that although the route between the Moline VOR/DME and the DuPage, IL, VOR/DME is approximately 108 NM, pilots flying direct between those two VORs today are required to have their aircraft RNAV equipped since the distance, as stated, is beyond the service volume of the two NAVAIDS. However, there are other VOR Federal airway alternatives in the area that allow pilots to navigate between the Moline and DuPage VORs. A pilot could choose to navigate between the Moline and DuPage VORs via V-63 between the Moline VOR/DME and the Davenport, IA, VORTAC, then via V-6 between the Davenport VORTAC and the DuPage VOR/DME.

Likewise, there will continue to be VOR Federal airway alternatives available for navigating between the Dubuque, IA, area and the Chicago area DuPage, IL, and Joliet, IL, VORs. To navigate between the Dubuque VORTAC and DuPage VOR/DME, pilots may navigate via V-129 between the Dubuque and Davenport VORTACs, then via V-6 between the Davenport VORTAC and the DuPage VOR/DME. Alternatively, a pilot could choose to navigate between the Dubuque VORTAC and the Joliet VOR/DME via V-129 between the Dubuque VORTAC and the GENSO Fix, then via V-8 between the GENSO Fix and the Joliet VOR/DME.

Additionally, pilots may continue to navigate between the Dubuque, IA, area and the Chicago area Northbrook, IL, VOR/DME via V-246 between the Dubuque VORTAC and the Janesville, IL, VOR/DME, then via V-24 between the Janesville VOR/DME and the Northbrook VOR/DME.

Finally, pilots, regardless of flying under instrument flight rules or visual flight rules, may always request radar vectors from air traffic control for navigation assistance in the area or file and fly point-to-point using the Fixes and waypoints that will remain in the area if their aircraft is RNAV equipped.

Lastly, the commenter stated that the FAA's plan to use VORs with the new VOR service volumes, labeled as VOR Low (VL) and VOR High (VH), as a backup plan in the event of a GPS outage did not provide sufficient coverage in the vicinity of the Polo VOR/DME due to the operational limitations imposed on the Dubuque VORTAC and the Northbrook VOR/DME. The commenter thought that the Polo VOR and associated V-158 and V-172 airways segments should be retained until the limitations currently being imposed on the Dubuque and Northbrook VORs can be removed and the service volumes of the Joliet VOR/DME and the Davenport VORTAC can be increased to ensure signal coverage throughout the entire area.

As stated previously, the FAA remains committed to its final policy statement and plan to retain an optimized VOR MON that enables pilots to revert from PBN to conventional navigation for approach, terminal, and enroute operations in the event of a GPS outage. The limitations with the four listed VORs, Dubuque, Northbrook, Joliet, and Davenport, exist today due to the VOR type, user retention requirements, or an increase in tree/terrain blockage occurring over time causing certain radials of the VORs to become unusable. The limitations imposed on these four VORs do not affect the normal operation of the VORs until exceeding 40 NM below 14,500 feet mean seal level (MSL). Whether the Polo VOR remains operational or is decommissioned does not change the existing limitations on the four VORs, nor would it effect the use of the VOR Federal airway alternatives identified for pilots to continue navigating through the affected area. The FAA has determined that with the planned decommissioning of the Polo VOR, there remains sufficient conventional navigation enroute structure in place to enable pilots to navigate from the Dubuque, IA; Cedar Rapids, IA; or Moline, IL, areas into the Chicago Metropolitan Area.

VOR Federal airways are published in paragraph 6010(a) of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document amends the current version of that order, FAA Order JO 7400.11H, dated August 11, 2023, and effective September 15, 2023. FAA Order JO 7400.11H is publicly available as listed in the ADDRESSES section of this document. This amendment action will be published in the next update to FAA Order JO 7400.11.

FAA Order JO 7400.11H lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This action amends 14 CFR part 71 by amending VOR Federal airways V-158 and V-172 due to the planned decommissioning of the VOR portion of the Polo, IL, VOR/DME. The airway actions are described below.

V-158: Prior to this final rule, V-158 extended between the Mason City, IA, VOR/DME and the intersection of the Polo, IL, VOR/DME 122° and Davenport, IA, VORTAC 087° radials (SHOOF Fix). The airway segment between the Dubuque, IA, VORTAC and the intersection of the Polo, IL, 122° and Davenport, IA, 087° radials (SHOOF Fix) is removed. As amended, the airway now extends between the Mason City VOR/DME and the Dubuque VORTAC.

V-172: Prior to this final rule, V-172 extended between the Columbus, NE, VOR/DME and the DuPage, IL, VOR/DME. The airway segment between the Cedar Rapids, IA, VOR/DME and the DuPage, IL, VOR/DME is removed. As amended, the airway now extends between the Columbus VOR/DME and the Cedar Rapids VOR/DME.

The NAVAID radials contained in the VOR Federal airway descriptions listed below in The Amendment section are unchanged and stated in degrees True north.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action of amending VOR Federal airways V-158 and V-172, due to the planned decommissioning of the VOR portion of the Polo, IL, VOR/DME NAVAID, qualifies for categorical exclusion under the National Environmental Policy Act (42 U.S.C. 4321 et seq. ) and its implementing regulations at 40 CFR part 1500, and in accordance with FAA Order 1050.1F, Environmental Impacts: Policies and Procedures, paragraph 5-6.5a, which categorically excludes from further environmental impact review rulemaking actions that designate or modify classes of airspace areas, airways, routes, and reporting points (see 14 CFR part 71, Designation of Class A, B, C, D, and E Airspace Areas; Air Traffic Service Routes; and Reporting Points); and paragraph 5-6.5i, which categorically excludes from further environmental impact review the establishment of new or revised air traffic control procedures conducted at 3,000 feet or more above ground level (AGL); procedures conducted below 3,000 feet AGL that do not cause traffic to be routinely routed over noise sensitive areas; modifications to currently approved procedures conducted below 3,000 feet AGL that do not significantly increase noise over noise sensitive areas; and increases in minimum altitudes and landing minima. As such, this action is not expected to result in any potentially significant environmental impacts. In accordance with FAA Order 1050.1F, paragraph 5-2 regarding Extraordinary Circumstances, the FAA has reviewed this action for factors and circumstances in which a normally categorically excluded action may have a significant environmental impact requiring further analysis. The FAA has determined that no extraordinary circumstances exist that warrant preparation of an environmental assessment or environmental impact study.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

I. Introduction

In a notification published in the Federal Register on November 20, 2020 (85 FR 74304), we announced that we filed a color additive petition (CAP 0C0317) submitted by Ecoflora SAS, c/o Exponent, Inc., 1150 Connecticut Ave. NW, Suite 1100, Washington, DC 20036. The petition proposed to amend the color additive regulations in part 73 (21 CFR part 73), “Listing of Color Additives Exempt from Certification,” to provide for the safe use of jagua (genipin-glycine) blue, derived from the pulp of the unripe jagua fruit ( Genipa americana ), as a color additive at levels consistent with GMP in flavored milk; dairy drinks and substitutes; dairy and dairy alternative yogurt; ice cream, frozen dairy and dairy alternative desserts, puddings, gelatins, ices, sorbets; ready-to-eat multicolored cereals; flavored potato chips, tortilla, corn, and other chips; candy and chewing gum; non-alcoholic fruit based/flavored drinks, nutritional beverages and smoothies; flavored cream cheese-based spreads; and icings, frostings, jams, syrups, and fruit toppings and fillings.

The color additive that is the subject of this petition is a dark blue liquid or powder produced by reacting genipin (CAS Reg. No. 6902-77-8) in the juice of the unripe fruit of Genipa americana with an equivalent amount of the amino acid glycine (CAS Reg. No. 56-40-6) using mild heat. The principal coloring component in jagua (genipin-glycine) blue is a genipin-glycine polymer (CAS Reg. No. 1314879-21-4) consisting of repeating dimeric units containing two genipin moieties reacted to add glycine units as side chains. We will subsequently refer to this principal coloring component as “the polymer.” Iridoids, of which genipin is an example, are found in a wide variety of plants, and glycine is a common building block of proteins. The color additive jagua (genipin-glycine) blue also contains three dimers as minor coloring components (CAS Reg. No. 1313734-13-2, CAS Reg. No. 104359-67-3, and CAS Reg. No. 1313734-14-3) that are structural units of the polymer.

The petitioner proposed the following specifications for jagua (genipin-glycine) blue: appearance, dark blue; color value (E10 percent), 240-280 for the powder form and 120-240 for the liquid form; polymer, 20 to 40 percent for the powder form and 10 to 35 percent for the liquid form; aflatoxins (B1, B2, G1, and G2), not more than 0.01 milligram per kilogram (mg/kg); fumonisine (B1, B2), not more than 0.5 mg/kg; Escherichia coli, negative in 1 gram (g); aerobic plate count, not more than 1,000 colony forming units per gram (cfu/g); yeast and mold, not more than 300 cfu/g, and Staphylococcus aureus, negative in 1 g.

FDA amended the proposed specifications to add the following: arsenic, not more than 1 mg/kg; cadmium, not more than 1 mg/kg; mercury, not more than 1 mg/kg; and lead, not more than 1 mg/kg (Ref. 1). We also amended the proposed specification for genipin, not more than 20 mg/kg, to be consistent with the petitioner's analytical results. Furthermore, we concluded that the petitioner's proposed specifications for appearance, color value, polymer, glycine, the minor coloring components, carbohydrate, modified starch, total fat, total protein, and ash content are not needed in the codified regulation (Ref. 1).

Under section 721(b)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379e(b)(4)), a color additive may not be listed for a proposed use unless the data and information available to FDA establish that the color additive is safe for that use. Our color additive regulations at 21 CFR 70.3(i) define “safe” to mean that there is convincing evidence establishing with reasonable certainty that no harm will result from the intended use of the color additive.

To determine whether a color additive is safe under the general safety clause, the FD&C Act requires FDA to conduct a fair evaluation of the available data and consider, among other relevant factors: (1) probable consumption of, or other relevant exposure from, the additive and of any substance formed in or on food, drugs, devices, or cosmetics because of the use of the additive; (2) cumulative effect, if any, of such additive in the diet of man or animals, taking into account chemically or pharmacologically related substance or substances in such diet; and (3) safety factors recognized by experts as appropriate for the use of animal experimentation data (see section 721(b)(5)(A)(i) through (iii) of the FD&C Act).

As part of our safety evaluation to establish with reasonable certainty that a color additive is not harmful under its intended conditions of use, we consider the additive's manufacturing and stability, the projected human dietary exposure to the additive and any impurities resulting from the petitioned use of the additive, the additive's toxicological data, and other relevant information (such as published literature) available to us.

The petitioner requested that jagua (genipin-glycine) blue be permitted at levels consistent with GMP and provided the representative maximum use levels for the color additive for each proposed food use. The petitioner used food consumption data from the 2013-2016 National Health and Nutrition Examination Survey (NHANES) to estimate the dietary exposure to jagua (genipin-glycine) blue and to the polymer from the proposed uses. The petitioner stated that the use of the liquid form of jagua (genipin-glycine) blue would be substitutional for the powder form and that, on the polymer basis, the use levels are the same for both forms.

The petitioner estimated the eaters-only ( i.e., only those individuals in the population that consume the foods of interest) dietary exposure to jagua (genipin-glycine) blue to be 34 mg/person/day (mg/p/d) at the mean and 78 mg/p/d at the 90th percentile for the U.S. population aged 2 years and older, and 34 mg/p/d at the mean and 76 mg/p/d at the 90th percentile for children aged 2 to 5 years.

The petitioner provided a specification limit of 20 to 40 percent for the polymer in jagua (genipin-glycine) blue powder. We estimated the eaters-only dietary exposure to the polymer to be 14 mg/p/d at the mean and 31 mg/p/d at the 90th percentile for the U.S. population aged 2 years and older, and 14 mg/p/d at the mean and 30 mg/p/d at the 90th percentile for children aged 2 to 5 years (Ref. 2).

To establish that jagua (genipin-glycine) blue is safe for consumption at the proposed levels, the petitioner used aqueous jagua (genipin-glycine) blue containing a specified percentage of the polymer to conduct the following studies: (1) bacterial reverse mutation assay, mouse lymphoma assay, and in vitro mouse micronucleus assay addressing potential mutagenicity and genotoxicity of the polymer; (2) studies conducted in rats to address the potential toxic effects of acute oral exposure to the polymer; (3) 28-day oral toxicity studies in rats and beagle dogs and 90-day repeated dose oral toxicity studies in rats and beagle dogs to address the potential toxic effects of subchronic oral exposure to the polymer; and (4) 12 months repeated dose toxicity study including in utero exposure in rats to address the potential toxic and/or reproductive effects of chronic oral exposure to the polymer. 1 FDA searched the publicly available literature to identify any new studies that might have examined toxicological effects of jagua (genipin-glycine) blue, or genipin or related compounds; however, no relevant studies were found.

We reviewed the mutagenicity and genotoxicity studies (a bacterial reverse mutation assay, an in vitro mouse lymphoma, and an in vivo mammalian micronucleus induction assay) and concluded that the polymer is not mutagenic or genotoxic under the experimental procedures and conditions applied (Ref. 3).

We reviewed the acute oral toxicity studies and concluded that the oral median lethal dose is greater than 661 mg/kg body weight (bw) of the polymer for the female rats used in the study (Ref. 3).

We reviewed the 28-day studies conducted in rats and in beagle dogs and consider these only as range-finding studies due to the limited number of animals tested per group and other study limitations, and thus not appropriate to establish a no-observed-effect-level (NOEL) or no-observed-adverse-effect-level (NOAEL). We reviewed the 90-day repeated dose oral toxicity study conducted in rats and concur with the study authors that the NOAEL for the rats under the conditions of the study was 330.5 mg/kg bw/d of the polymer for both sexes of the rats. We also reviewed the 90-day repeated dose oral toxicity study in dogs; however, due to the low number of dogs tested per group, and other inadequacies and limitations in the experimental design, we concluded that a NOAEL for the polymer could not be established from this study (Ref. 3).

We reviewed the 12-months repeated dose toxicity study including in utero exposure in rats. The lowest of all the NOAELs for F 0 (parental) generation male rats was 1,127 mg/kg bw/d of polymer  2 (Ref. 3).

The study chosen to establish an acceptable daily intake (ADI) for the polymer was the 12 months repeated dose toxicity study including in utero exposure to rats over the 90-day study in rats. This study combined the in utero phase and a 1-year chronic toxicity phase of sufficient length and overall complexity to produce information on chronic exposure to the polymer. Based on the NOAEL of the polymer (1,127 mg/kg bw/d)) in the 12 months repeated dose toxicity study in rats including in utero exposure, and applying a safety factor of 500 (10 to account for possible increased sensitivity of humans compared to test animals, 10 to account for sensitive individuals in determining safe intake for humans, and 5 for the lack of metabolism and pharmacokinetics and long-term chronic study), the ADI for the polymer is calculated as follows: 1,127 mg/kg bw/d (NOAEL)/500 = 2.3 mg/kg bw/d or 138 mg/p/d (based upon 60 kg bw/p) (Ref. 3). 3

The petitioner estimated the highest dietary exposure (37 mg/p/d at 90th percentile based on the polymer) for children aged 6-12 years as well as adolescents aged 13-18 years. The highest estimated dietary exposure value of 37 mg/p/d at the 90th percentile based on the polymer is lower than the ADI value of 138 mg/p/d polymer.

Therefore, we conclude that the proposed use of jagua (genipin-glycine) blue as a color additive at levels consistent with GMP is considered to have reasonable certainty of no harm (Ref. 3).

Based on the data and information in the petition and other available relevant information, we conclude that the petitioned use of jagua (genipin-glycine) blue as a color additive in flavored milk; dairy drinks and substitutes; dairy and dairy alternative yogurt; ice cream, frozen dairy and dairy alternative desserts, puddings, gelatins, ices, sorbets; ready-to-eat multicolored cereals, flavored potato chips, tortilla, corn, and other chips; candy and chewing gum; non-alcoholic fruit based/flavored drinks, nutritional beverages and smoothies; flavored cream cheese-based spreads; and icings, frostings, jams, syrups, and fruit toppings and fillings, provided the amount of jagua (genipin-glycine) blue does not exceed levels consistent with GMP.

We further conclude that this color additive will achieve its intended technical effect and is suitable for the petitioned use. Therefore, we are amending the color additive regulations in part 73 to provide for the safe use of this color additive as set forth in this document. In addition, based on the factors in 21 CFR 71.20(b), we conclude that batch certification of jagua (genipin-glycine) blue is not necessary to protect the public health.

In accordance with § 71.15 (21 CFR 71.15), the petition and the documents that we considered and relied upon in reaching our decision to approve the petition will be made available for public disclosure (see FOR FURTHER INFORMATION CONTACT ). As provided in § 71.15, we will delete from the documents any materials that are not available for public disclosure.

As stated in the November 20, 2020, Federal Register notice of filing, the petitioner claimed that this action is categorically excluded under § 25.32(k) (21 CFR 25.32(k)) because jagua (genipin-glycine) blue would be added directly to food and is intended to remain in the food through ingestion by consumers and is not intended to replace macronutrients in food. We further stated that if FDA determines a categorical exclusion applies, neither an environmental assessment nor an environmental impact statement is required. We did not receive any new information or comments regarding this claim of categorical exclusion. We considered the petitioner's claim of categorical exclusion and determined that this action is categorically excluded under § 25.32(k). Therefore, neither an environmental assessment nor an environmental impact statement is required.

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.

Our review of this petition was limited to section 721 of the FD&C Act. This final rule is not a statement regarding compliance with other sections of the FD&C Act. For example, section 301(ll) of the FD&C Act (21 U.S.C. 331(ll)) prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FD&C Act (21 U.S.C. 355), a biological product licensed under section 351 of the Public Health Service Act (42 U.S.C. 262), or a drug or biological product for which substantial clinical investigations have been instituted and their existence has been made public, unless one of the exemptions in section 301(ll)(1) to (4) of the FD&C Act applies. In our review of this petition, we did not consider whether section 301(ll) of the FD&C Act or any of its exemptions apply to food containing this color additive. Accordingly, this final rule should not be construed to be a statement that a food containing this color additive, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll) of the FD&C Act. Furthermore, this language is included in all color additive final rules that pertain to food and therefore should not be construed to be a statement of the likelihood that section 301(ll) of the FD&C Act applies.

This rule is effective as shown in the DATES section, except as to any provisions that may be stayed by the filing of proper objections. If you will be adversely affected by one or more provisions of this regulation, you may file with the Dockets Management Staff (see ADDRESSES ) either electronic or written objections. You must separately number each objection, and within each numbered objection you must specify with particularity the provision(s) to which you object, and the grounds for your objection. Within each numbered objection, you must specifically state whether you are requesting a hearing on the particular provision that you specify in that numbered objection. If you do not request a hearing for any particular objection, you waive the right to a hearing on that objection. If you request a hearing, your objection must include a detailed description and analysis of the specific factual information you intend to present in support of the objection in the event that a hearing is held. If you do not include such a description and analysis for any particular objection, you waive the right to a hearing on the objection.

Any objections received in response to the regulation may be seen in the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov. We will publish notice of the objections that we have received or lack thereof in the Federal Register .

The following references marked with an asterisk (*) are on display at the Dockets Management Staff (see ADDRESSES ) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public display at https://www.regulations.gov because they have copyright restriction. Some may be available at the website address, if listed. References without asterisks are available for viewing only at the Dockets Management Staff. 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.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under the authority delegated to the Commissioner of Food and Drugs, 21 CFR part 73 is amended as follows:

Electronic Availability

This document and additional information concerning OFAC are available on OFAC's website: https://ofac.treasury.gov.

On March 5, 2020, OFAC issued GLs 1 and 2 to authorize certain transactions otherwise prohibited by the Nicaragua Sanctions Regulations, 31 CFR part 582 (NSR). On March 25, 2020, OFAC issued GL 2A, which superseded GL 2, pursuant to the NSR and the Nicaragua Investment Conditionality Act of 2018 (50 U.S.C. 1701 note) (NICA Act), previously known as the “Nicaragua Human Rights and Anticorruption Act of 2018.” GL 2A expired on May 6, 2020. Also on March 25, 2020, OFAC issued GL 1A pursuant to the NSR and the NICA Act; GL 1A superseded GL 1 and was later incorporated into the NSR (85 FR 43436). Each GL was made available on OFAC's website ( https://ofac.treasury.gov ) when it was issued. The text of GLs 1, 2, and 2A is provided below.

(a) Except as provided in paragraph (b) of this general license, all transactions that are for the conduct of the official business of the United States Government by employees, grantees, or contractors thereof are authorized.

(b) This general license does not authorize any transaction that is prohibited by any part of 31 CFR chapter V other than part 582.

(a) Except as provided in paragraph (b) of this general license, all transactions and activities prohibited by the Nicaragua Sanctions Regulations, 31 CFR part 582 (the NSR), that are ordinarily incident and necessary to the wind down of transactions involving the Nicaraguan National Police (NNP), or any entity in which the NNP owns, directly or indirectly, a 50 percent or greater interest, including the processing of salary payments from the NNP, or any entity in which the NNP owns, directly or indirectly, a 50 percent or greater interest, to its employees, are authorized through 12:01 a.m. eastern daylight time, May 6, 2020.

(b) This general license does not authorize:

(1) Any debit to an account of the NNP, or any entity in which the NNP owns, directly or indirectly, a 50 percent or greater interest, on the books of a U.S. financial institution; or

(2) Any transactions or activities prohibited by any part of 31 CFR chapter V other than the NSR, or any transactions or activities with any blocked person other than the blocked persons identified in paragraph (a) of this general license.

(a) Except as provided in paragraph (b) of this general license, all transactions and activities prohibited by the Nicaragua Sanctions Regulations, 31 CFR part 582 (the NSR) or the Nicaragua Human Rights and Anticorruption Act of 2018 (NHRAA), that are ordinarily incident and necessary to the wind down of transactions involving the Nicaraguan National Police (NNP), or any entity in which the NNP owns, directly or indirectly, a 50 percent or greater interest, including the processing of salary payments from the NNP, or any entity in which the NNP owns, directly or indirectly, a 50 percent or greater interest, to its employees, are authorized through 12:01 a.m. eastern daylight time, May 6, 2020.

(b) This general license does not authorize:

(1) Any debit to an account of the NNP, or any entity in which the NNP owns, directly or indirectly, a 50 percent or greater interest, on the books of a U.S. financial institution; or

(2) Any transactions or activities prohibited by any part of 31 CFR chapter V other than the NSR, or any transactions or activities with any blocked person other than the blocked persons identified in paragraph (a) of this general license.

(c) Effective March 25, 2020, General License No. 2, dated March 5, 2020, is replaced and superseded in its entirety by this General License No. 2A.

I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background Information and Regulatory History

Virginia has the potential to be affected by hurricanes and tropical storms on a yearly basis, especially between the months of June and November. Additionally, severe storms generating high winds and rough seas are also common in the winter months. In response, on September 14, 2023, the Coast Guard published a notice of proposed rulemaking (NPRM) titled “Safety Zone; Hurricanes, Tropical Storms, and other Storms with High Winds; Captain of the Port Zone Virginia” (88 FR 63042). There, we stated why we issued the NPRM and invited comments on our proposed regulatory action related to this safety zone. During the comment period that ended October 16, 2023, we received one comment.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034. The Captain of the Port Sector Virginia (COTP) has determined that potential hazards associated with hurricanes, tropical storms, and other storms pose a safety concern to the maritime community. The purpose of this rule is to ensure safety of vessels and the navigable waters in the safety zone before, during, and after a hurricane, tropical storm, or other storm.

As noted above, we received one comment that concurred with the proposed rulemaking on our NPRM published September 14, 2023. The comment also addressed the need for Coast Guard Sector Virginia to maintain and update the Port Heavy Weather Plan. The comment is referring to the Maritime Severe Weather Contingency Plan, which advises the maritime community of the sequence and timing of COTP decisions and actions made pursuant to 33 CFR parts 160 and 165 that may be taken when there is the threat of a hurricane. The Plan also recommends actions to be taken to minimize storm related deaths, injury, damage, and threats to the environment. Coast Guard Sector Virginia will review and update the Maritime Severe Weather Contingency Plan as necessary to reflect the promulgation of this rule, and to provide guidance on advisable steps to take in addition to those required by the rule. Aside from adding the word “Sector” to the title of the regulation to conform to 33 CFR 3.25-10, there are no changes in the regulatory text of this rule from the proposed rule in the NPRM.

This rule establishes a safety zone on the navigable waters of the Sector Virginia COTP Zone during hurricanes, tropical storms, and other storms with high winds. This safety zone establishes actions to be completed by local industry and vessels in the COTP zone prior to landfall of hurricanes, tropical storms, and other storms with high winds threatening Virginia and in the aftermath of landfall. Port Conditions (WHISKEY, X-RAY, YANKEE, ZULU, and RECOVERY) are standardized terms for states of operation instituted by the COTP which are clearly communicated to port facilities, vessels, and members of the Marine Transportation System (MTS).

Ports and waterfront facilities are encouraged to take action when specific Port Conditions are declared. Under Port Condition WHISKEY, ports and waterfront facilities should remove all debris and secure potential flying hazards. Upon a declaration that Port Condition X-RAY is in effect, port facilities should ensure that potential flying debris and hazardous materials are removed, and that loose cargo and cargo equipment is secured. Upon a declaration of Port Condition YANKEE, terminal operators should terminate all cargo operations not associated with storm preparations. All facilities should continue to operate in accordance with approved Facility Security Plans (as defined at 33 CFR 101.105, and as further described in 33 CFR 105.400 to 105.415), and to comply with all applicable requirements of the Maritime Transportation Security Act of 2002 (46 U.S.C. chapter 701).

The COTP retains flexibility in controlling and reconstituting vessel traffic during periods of heavy weather, and it will allow for the expedited resumption of the MTS following such events. The safety zone consists of all waters of the territorial seas within the Sector Virginia COTP Zone, as defined in 33 CFR 3.25-10. Portions of the safety zone might be activated at different times, as conditions dictated. Notice of Port Conditions and their requirements will be given via Marine Safety Information Bulletins and Broadcast Notice to Mariners. The regulatory text appears at the end of this document.

We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This rule has not been designated a “significant regulatory action,” under section 3(f) of Executive Order 12866, as amended by Executive Order 14094 (Modernizing Regulatory Review). Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB).

This regulatory action determination is based on the size, location, duration, and time of day of the regulated area. This regulatory action determination is based on the necessity to protect life, port infrastructure, and the environment during hurricanes, tropical storms, and other storms with high winds. The scope of the regulation is narrow and will only apply when a hurricane, tropical storm, or other storm with high winds impacts the navigable waters of the Virginia COTP Zone. These events are infrequent and of short duration. Regulatory restrictions will be lifted as soon as practicable.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received no comments from the Small Business Administration on this rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule will affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the FOR FURTHER INFORMATION CONTACT section.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect 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. We have analyzed this rule under that order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect 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.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or Tribal Government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone that prohibits entry in certain waters of the Sector Virginia COTP Zone for the duration needed to ensure safe transit of vessels and industry before and after a hurricane, tropical storm, or other storm with high winds. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the ADDRESSES section of this preamble.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

On April 26, 2022, VA published an interim final rule at 87 FR 24421, to amend its adjudication regulations to establish presumptive service connection for nine rare respiratory cancers in association with presumed exposure to fine particulate matter. These presumptions apply to Veterans with a qualifying period of service, i.e., who served on active military, naval, or air service in the Southwest Asia theater of operations during the Gulf War, from August 2, 1990, onward, as well as in Afghanistan, Syria, Djibouti, or Uzbekistan, on or after September 19, 2001, during the Gulf War. The 60-day comment period ended on June 27, 2022.

VA received nine comments from interested individuals and organizations. The comments are discussed below under the appropriate headings. VA made no changes based on comments received. However, we note that changes made to § 3.320 in the final rule for RIN 2900-AR25 are carried forward here and continue to remain in effect. Based on the rationale set forth in the interim final rule and in this final rule, VA adopts the provisions of the interim final rule as a final rule without change.

VA received three comments that expressed confusion regarding whether service in the Southwest Asia theater of operations during the first Gulf War is included under the definition of the phrase qualifying period of service. VA agrees with these comments that the rulemaking could have caused some confusion, and acknowledges that additional clarity is needed. So, to clarify, as currently written, the rule applies to those who served in Desert Shield or Desert Storm as part of the Persian Gulf War from August 2,1990 to February 28, 1991. We note that the definition of qualifying period of service contained in paragraph (a)(5)(i) refers to § 3.2(i), which defines “Persian Gulf War” as: “August 2, 1990, through date to be prescribed by Presidential proclamation or law.” However, VA makes no changes based on these comments because this issue was addressed in the final rule for RIN 2900-AR25, which changes have been carried forward here and continue to remain in effect.

One commenter expressed general support for the rulemaking. VA thanks the commenter for their view. VA makes no changes based on this comment.

VA received two comments that addressed time frames and locations that qualify for the presumption of exposure contained in § 3.320. In particular, one commenter stated that he was on an aircraft carrier in the theater of Southwest Asia in July of 1987. He went on to state that “[a]ll Military Service-members should qualify for all exposures during active duty in this theater of operations.” Another commenter asked “is this related to burn pits? If so, why are you just making this available to only veterans who served for that time period?” The commenter went on to state that they served in Beirut, Lebanon in 1982-1983 and were exposed to burning human waste during that time. While VA sympathizes with these commenters, VA's rulemaking establishes presumptive service connection for nine rare respiratory cancers in association with presumed exposure to fine particulate matter; it does not address the locations or periods of service that qualify for the presumption of exposure to fine particulate matter. Thus, these comments are outside the scope of the present rulemaking.

Additionally, we note that the Secretary has made the decision to limit these presumptive conditions to a timeframe and locations during which VA has evidence of relevant levels of fine particulate matter in the air. When VA created the presumption of exposure to fine particulate matter in 38 CFR 3.320, it was based on scientific and medical studies that focused on the respiratory effects of fine particulate matter for Veterans who served in the Southwest Asia theater of operations, Afghanistan, Syria, Djibouti, and Uzbekistan during the Gulf War. Veterans began reporting a variety of respiratory health issues during and after the initial Gulf War conflict, and as a result, Congress mandated that VA study the health outcomes of veterans deployed to the Southwest Asia theater of operations. VA then requested the National Academies of Sciences, Engineering, and Medicine (NASEM) to study the evidence regarding respiratory health outcomes in veterans of the Southwest Asia conflicts. The results of that study formed the basis for this rulemaking. As service prior to the Gulf War was not considered in these studies, it cannot be included as part of the qualifying timeframe under 38 CFR 3.320.

While this rulemaking is based on current medical and scientific evidence related to the respiratory health effects of fine particulate matter on Veterans who served during the Gulf War, VA will continue to review new scientific evidence as it develops relating to other exposures and to all health effects resulting from exposure to fine particulate matter. This rulemaking does not limit the future establishment of presumptive service connection for conditions related to respiratory or other body systems, or the establishment of presumptions of exposure for service in other locations or during other time frames. Additionally, VA encourages all Veterans who believe that they are entitled to VA compensation to file a claim with their local VA regional office. VA makes no change to the final rule based on the comment.

One commenter reported that they had filed 3 intent letters and had not received a response. The commenter went on to report that they had been turned down for compensation in the past. VA's rulemaking establishes presumptive service connection for nine rare respiratory cancers in association with presumed exposure to fine particulate matter. This comment, which relates to an individual case, is outside the scope of the present rulemaking. However, VA encourages all Veterans who believe that they are entitled to VA compensation to file a claim with their local VA regional office. VA makes no change to the final rule based on the comment.

One commenter stated that her husband served in the US Army and while serving he died of squamous cell carcinoma of the larynx. While VA sympathizes with this commenter, VA's rulemaking establishes presumptive service connection for nine rare respiratory cancers in association with presumed exposure to fine particulate matter. This comment refers to a specific case, which is outside the scope of the present rulemaking. However, VA encourages all Veterans and dependents who believe that they are entitled to VA compensation to file a claim with their local VA regional office. VA makes no change to the final rule based on the comment.

Another commenter objected to the rulemaking because it did not cover all diseases and disabilities caused by open air burn pits or the chemical contamination in Gulf War I. Additionally, the commenter stated that the “interim final rule does not clearly define the provisions attaching to Gulf War I. Including coverage dates would eliminate any possible confusion.” As noted above, while this rulemaking is based on current medical and scientific evidence related to the respiratory health effects of fine particulate matter on Veterans who served during the Gulf War, VA will continue to review new scientific evidence as it develops relating to other exposures and to all health effects resulting from exposure to fine particulate matter. This rulemaking does not limit the future establishment of presumptive service connection for conditions related to respiratory or other body systems, or the establishment of presumptions of exposure for service in other locations or during other time frames. Also, the potential confusion regarding service during the first Gulf War was addressed in the final rule for RIN 2900-AR25, which changes have been carried forward here and continue to remain in effect. VA makes no change to the final rule based on the comment.

Further, we again note that changes made to § 3.320 in the final rule for RIN 2900-AR25 are carried forward here and continue to remain in effect. Additionally, provisions of the Sergeant First Class Heath Robinson Honoring our Promise to Address Comprehensive Toxics Act of 2022, Public Law 117-168, relevant to this regulation will be the subject of separate and future rulemaking.

This document affirms the amendment made by the interim final rule that is already in effect. The Secretary concluded that, pursuant to 5 U.S.C. 553(b)(B) and (d)(3), there was good cause to publish this rule without prior opportunity for public comment and good cause to publish this rule with an immediate effective date. Delay in the implementation of this rule would have been impracticable, unnecessary, and contrary to public interest, particularly to Veterans.

Executive Order 12866 (Regulatory Planning and Review) directs agencies to assess the 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 effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 14094 (Executive Order on Modernizing Regulatory Review) supplements and reaffirms the principles, structures, and definitions governing contemporary regulatory review established in Executive Order 12866 of September 30, 1993 (Regulatory Planning and Review), and Executive Order 13563 of January 18, 2011 (Improving Regulation and Regulatory Review). The Office of Information and Regulatory Affairs has determined that this rulemaking is not a significant regulatory action under Executive Order 12866, as amended by Executive Order 14094. The Regulatory Impact Analysis associated with this rulemaking can be found as a supporting document at www.regulations.gov.

The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act (5 U.S.C. 601-612). The certification is based on the fact that no small entities or businesses determine service connection or the rating criteria, or assign evaluations for disability claims. Therefore, pursuant to 5 U.S.C. 605(b), the initial and final regulatory flexibility analysis requirements of sections 603 and 604 do not apply.

The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This final rule will have no such effect on State, local, and tribal governments, or on the private sector.

This final rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).

The Assistance Listing numbers and titles for this rule are 64.101, Burial Expenses Allowance for Veterans; 64.102, Compensation for Service-Connected Deaths for Veterans' Dependents; 64.105, Pension to Veterans, Surviving Spouses, and Children; 64.109, Veterans Compensation for Service-Connected Disability; and 64.110, Veterans Dependency and Indemnity Compensation for Service-Connected Death.

Pursuant to Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (known as the Congressional Review Act) (5 U.S.C. 801 et seq. ), the Office of Information and Regulatory Affairs designated this rule as not a major rule, as defined by 5 U.S.C. 804(2).

Denis McDonough, Secretary of Veterans Affairs, signed and approved this document on August 24, 2023, and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs.

I. Overview

EPA is approving a SIP revision submitted by North Carolina on April 14, 2021, 1 seeking to amend various air quality rules and to remove one rule from the North Carolina SIP. 2 Specifically, the SIP revision addresses State regulations amended in 15A North Carolina Administrative Code (NCAC) Subchapter 02D. The submission includes changes to multiple rules in Sections .0400 and .0500 of Subchapter 02D and the removal of Rule 02D .0536, Particulate Emissions from Electric Utility Boilers. 3 To support the removal of Rule 02D .0536 from the SIP, the submission includes technical support materials to demonstrate that the removal of the rule would not interfere with any applicable requirement concerning attainment and reasonable further progress (RFP) or any other applicable requirement of the CAA. 4

Through a notice of proposed rulemaking (NPRM) published on September 1, 2023 (88 FR 60424), EPA proposed to approve the April 13, 2021, submission. The details of North Carolina's submission, which amends various air quality rules and removes Rule 02D .0536 from North Carolina's SIP, as well as EPA's rationale for approving the changes, are described in the September 1, 2023, NPRM. Comments on the September 1, 2023, NPRM were due on or before October 2, 2023. No comments were received on the September 1, 2023, NPRM, adverse or otherwise.

In this document, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with the requirements of 1 CFR 51.5, and as discussed in Section I of this preamble, EPA is finalizing the incorporation by reference of the following air quality rules under 15A NCAC Subchapter 02D, Air Pollution Control Requirements, state effective on November 1, 2020: 02D .0403, Total Suspended Particulates; 02D .0501, Compliance with Emission Control Standards; 02D .0504, Particulates from Wood Burning Indirect Heat Exchangers; 02D .0506, Particulates from Hot Mix Asphalt Plants;   5 02D .0507, Particulates from Chemical Fertilizer Manufacturing Plants; 02D .0508, Particulates from Pulp and Paper Mills; 02D .0509, Particulates from Mica and Feldspar Processing Plants; 02D .0510, Particulates from Sand, Gravel or Crushed Stone Processes; 02D .0511, Particulates from Lightweight Aggregate Processes; 02D .0513, Particulates from Portland Cement Plants; 02D .0514, Particulates from Ferrous Jobbing Foundries; and 02D .0515, Particulates from Miscellaneous Industrial Processes. Also in this document, EPA is finalizing the removal of Rule 02D .0536, Particulate Emissions from Electric Utility Boilers, from the North Carolina SIP, which is incorporated by reference in accordance with the requirements of 1 CFR part 51. EPA has made, and will continue to make, the SIP generally available at the EPA Region 4 office (please contact the person identified in the For Further Information Contact section of this preamble for more information). Therefore, the revised materials as stated above, have been approved by EPA for inclusion in the SIP, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference in the next update to the SIP compilation. 6

EPA is approving the aforementioned changes to the North Carolina SIP. Specifically, EPA is finalizing the approval of the April 13, 2021, SIP revision which amends various air quality rules under 15A NCAC 02D, Air Pollution Control Requirements, and removes Rule 02D .0536 from North Carolina's SIP.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. This action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 14094 (88 FR 21879, April 11, 2023);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. );

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. );

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it approves a state program;

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); and

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA.

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

Executive Order 12898 (Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations, 59 FR 7629, February 16, 1994) directs Federal agencies to identify and address “disproportionately high and adverse human health or environmental effects” of their actions on minority populations and low-income populations to the greatest extent practicable and permitted by law. EPA defines environmental justice (EJ) as “the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies.” EPA further defines the term fair treatment to mean that “no group of people should bear a disproportionate burden of environmental harms and risks, including those resulting from the negative environmental consequences of industrial, governmental, and commercial operations or programs and policies.”

NCDAQ did not evaluate EJ considerations as part of its SIP submittal; the CAA and applicable implementing regulations neither prohibit nor require such an evaluation. EPA did not perform an EJ analysis and did not consider EJ in this action. Due to the nature of the action being taken here, this action is expected to have a neutral to positive impact on the air quality of the affected area. Consideration of EJ is not required as part of this action, and there is no information in the record inconsistent with the stated goal of E.O. 12898 of achieving EJ for people of color, low-income populations, and Indigenous peoples.

This action is subject to the Congressional Review Act, and EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by January 2, 2024. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

For the reasons stated in the preamble, EPA amends 40 CFR part 52 as follows:

I. General Information A. Does this action apply to me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of 40 CFR part 180 through the Office of the Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2023-0507 in the subject line on the first page of your submission. All requests must be in writing and must be received by the Hearing Clerk on or before January 2, 2024. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2023-0507, by one of the following methods:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001.

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/dockets.

EPA previously published final rules establishing time-limited tolerances in the Federal Register for the chemicals and commodities listed below under FFDCA section 408, 21 U.S.C. 346a. EPA established the tolerances because FFDCA section 408(l)(6) requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under FIFRA section 18. Such tolerances can be established without providing notice or period for public comment.

EPA received requests to extend emergency uses of clothianidin, kasugamycin, methyl bromide, and triclopyr on various commodities for this year's growing season. After having reviewed the submissions, EPA concurs that emergency conditions continue to exist. EPA assessed the potential risks presented by residues of each chemical in or on the pertinent commodities. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2) and decided that the necessary tolerances under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. The data and other relevant material have been evaluated and were discussed in the final rules originally establishing the time-limited tolerances. Based on those data and information considered, the Agency reaffirms that extensions of the time-limited tolerances will continue to meet the requirements of FFDCA section 408(l)(6). Therefore, the time-limited tolerances are extended until December 31, 2026. Although these tolerances will expire and are revoked on December 31, 2026, under FFDCA section 408(l)(5), residues of the pesticides not in excess of the amounts specified in the tolerances remaining in or on the commodities after that date will not be unlawful, provided the residues are present as a result of an application or use of a pesticide at a time and manner that was lawful under FIFRA, the tolerance was in place at the time of the application, and the residues do not exceed the level that was authorized by the tolerance. EPA will take action to revoke the tolerances earlier if any experience with, scientific data on, or other relevant information on any of these pesticides indicate that the residues are not safe. EPA will publish a document in the Federal Register to remove the revoked tolerances from the Code of Federal Regulations (CFR).

Time-limited tolerances for the use of the following pesticide chemicals on specific commodities as noted are being extended:

Clothianidin. Pursuant to a request by the Florida Department of Agriculture and Consumer Services, EPA authorized under FIFRA section 18 the use of clothianidin on citrus for control of the Asian citrus psyllid in Florida. This regulation extends a time-limited tolerance for residues of the insecticide clothianidin and its metabolites and degradates in or on fruit, citrus, group 10-10 at 0.07 parts per million (ppm) for an additional 3-year period. This tolerance will expire and is revoked on December 31, 2026. The time-limited tolerance was originally published in the Federal Register of February 25, 2015 (80 FR 10003) (FRL-9919-59).

Flupyradifurone. The time-limited tolerances are being removed at 40 CFR 180.679(b) for residues of the insecticide flupyradifurone and its metabolites in or on sorghum, syrup at 90.0 ppm and sweet sorghum, forage at 30.0 ppm which expired on December 31, 2022; and in or on sugarcane, cane at 3 ppm and sugarcane, molasses at 90 ppm, which expire on December 31, 2023. The applicant has not submitted a request for further use of flupyradifurone sugarcane; and use on sweet sorghum gained registration under Section 3 of FIFRA. The time-limited tolerances were originally published in the Federal Register of June 25, 2021 (86 FR 21944) (FRL-10029-49).

Kasugamycin. Pursuant to a request by the California Department of Pesticide Regulation, EPA authorized under FIFRA section 18 the use of kasugamycin on almonds for control of bacterial blast in California. This regulation extends time-limited tolerances for residues of the pesticide kasugamycin and its metabolites and degradates in or on almond at 0.04 (ppm); and almond hulls at 0.4 ppm for an additional 3-year period. The tolerances will expire and are revoked on December 31, 2026. The time-limited tolerances were originally published in the Federal Register of October 8, 2020 (85 FR 63450) (FRL-10013-94).

Methyl bromide. Pursuant to a request by the US Department of Agriculture, Animal and Plant Health Inspection Service, EPA authorized under FIFRA section 18 the use of methyl bromide on certain imported and domestic commodities, post-harvest for control of invasive non-indigenous quarantine plant pests and to prevent the introduction and/or spread of any new or recently introduced foreign pests to the United States. This regulation extends time-limited tolerances for residues of the pesticide methyl bromide, including its metabolites and degradates, in or on the commodities identified in 40 CFR 180.124(b) (and listed in the regulatory text section of this document) at the levels listed for an additional 3-year period. The tolerances will expire and are revoked on December 31, 2026. The time-limited tolerances were originally published in the Federal Register of March 1, 2018 (83 FR 8758) (FRL-9971-19) and October 16, 2020 (85 FR 65729) (FRL-10014-31).

Triclopyr. Pursuant to a request by the Louisiana Department of Agriculture and Forestry, EPA authorized under FIFRA section 18 the use of triclopyr on sugarcane for control of divine nightshade in Louisiana. This regulation extends a time-limited tolerance for residues of the herbicide triclopyr and its metabolites and degradates in or on sugarcane, cane at 40 ppm for an additional 3-year period. The tolerance will expire and is revoked on December 31, 2026. A time-limited tolerance was originally published in the Federal Register of June 8, 2017 (82 FR 26599) (FRL-9961-29).

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has not established any MRLs for flupyradifurone, kasugamycin, methyl bromide, or triclopyr in or on the commodities listed in this document. The Codex has established an MRL for clothianidin in or on citrus at 0.07 ppm, the same as the tolerance established for fruit, citrus, group 10-10 in the United States. Therefore, there are no harmonization issues.

This action establishes tolerances under FFDCA section 408(d). The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq. ), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established in accordance with FFDCA sections 408(e) and 408(l)(6), such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ), do not apply.

This action directly regulates growers, food processors, food handlers, and food retailers, not States or Tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or Tribal Governments, on the relationship between the National Government and the States or Tribal Governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian Tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq. ).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR chapter I as follows:

Background

On November 3, 2020, we published a final rule to remove the gray wolf entities that were listed at that time in the lower 48 United States and Mexico from the Federal List of Endangered and Threatened Wildlife in title 50 of the Code of Federal Regulations (CFR) at 50 CFR 17.11(h) (85 FR 69778; hereafter referred to as “our 2020 delisting rule”). Additional background information on the gray wolf in the lower 48 United States and Mexico and on that rulemaking decision, including previous Federal actions, can be found in our 2020 delisting rule. The rule became effective on January 4, 2021.

Three lawsuits challenging our 2020 delisting rule were filed in the U.S. District Court for the Northern District of California. Defenders of Wildlife v. U.S. Fish and Wildlife Service, No. 21-00344 (N.D. Cal.), WildEarth Guardians v. Bernhardt, No. 21-00349 (N.D. Cal.), NRDC v. U.S. Department of the Interior, No. 21-00561 (N.D. Cal.). On February 10, 2022, the district court vacated and remanded our 2020 delisting rule. That decision reinstated Federal protections that were in place prior to the effective date of our 2020 delisting rule. Therefore, gray wolves are once again listed as threatened in Minnesota and endangered in all or portions of 44 U.S. States and Mexico. See Effects of the Rule, below, for a description of the CFR changes resulting from this final rule.

Multiple parties, including the Service, appealed the district court's order to the U.S. Court of Appeals for the Ninth Circuit (Nos. 21-16382, 16383, 16384, 22-15529, 15532, 15534, 15535, 15536, 15537, 15262, 15627, 15628). The parties have been engaged in mediation. On January 26, 2023, the Circuit Mediator issued an order temporarily staying the appeals for administrative purposes until February 2, 2024. During the abeyance, the Service is updating the status review for the gray wolf throughout the lower 48 United States and commencing a stakeholder engagement effort.

To comply with the February 10, 2022, court order, we must reinstate the following:

• Threatened species status for gray wolf in Minnesota,

• Endangered species status for gray wolf in all or portions of 44 U.S. States and Mexico,

• Critical habitat designation for gray wolf in Minnesota and Michigan, and

• A section 4(d) rule for gray wolf in Minnesota.

Therefore, the Director has determined, pursuant to 5 U.S.C. 553(b), that prior notice and opportunity for public comment are impractical and unnecessary. The Director has further determined, pursuant to 5 U.S.C. 553(d), that the agency has good cause to make this rule effective upon publication.

We are also making the following technical revisions to the section 4(d) rule at 50 CFR 17.40(d):

(1) correcting the misspelling of “Hoodoo Point” in § 17.40(d)(1)(i);

(2) correcting the misspelling of “the Duluth, Missabe and Iron Range Railroad” in § 17.40(d)(1)(ii);

(3) substituting a higher quality image of the map of regulatory zones that appears in § 17.40(d)(1)(vi); and

(4) updating the contact information for providing notifications to the Service in § 17.40(d)(2)(D).

Rather than make these changes in a separate rulemaking, we are combining them with the section 4(d) rule reinstatement for administrative convenience. The Director has determined, pursuant to 5 U.S.C. 553(b), that prior notice and an opportunity for public comment on these revisions are unnecessary because the changes are insignificant in nature and impact and inconsequential to the public.

As a result of the February 10, 2022, district court order, any and all gray wolves in Minnesota are listed as threatened, and any and all gray wolves in all or portions of 44 U.S. States and Mexico are listed as endangered. In the United States, this includes: all of Alabama, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, West Virginia, and Wisconsin; and portions of Arizona, New Mexico, Oregon, Utah, and Washington (as depicted in figure 1 below and our November 3, 2020, delisting rule; 85 FR 69778 at 69782).

The reinstated regulations at 50 CFR 17.95(a) designate critical habitat for gray wolf in Minnesota and Michigan, and the reinstated regulations at 50 CFR 17.40(d) govern the regulation of gray wolf in Minnesota. The provisions of these regulations are the same as those in the regulations that were removed by our 2020 delisting rule (November 3, 2020; 85 FR 69778 at 69895).

This rule does not affect the status of gray wolf in Montana, Idaho, Wyoming, the eastern third of Washington and Oregon, and north-central Utah. Wolves in these areas retain their delisted status and will continue to be managed by the States and Tribes. Finally, this rule does not affect the gray wolf's Appendix II status under the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES).

By February 2, 2024, the Service intends to submit to the Office of the Federal Register a proposed rule concerning the listing status of gray wolves in the lower 48 United States under the Act. Our status determination will be based on the best available information as of the time of publication. If the appeals described earlier in this document nonetheless proceed and the district court's order is reversed, then the Service will take appropriate action to comply with and implement the Court of Appeals' judgment, including, if required, publishing another final rule reinstating the Service's 2020 delisting rule.

The primary authors of this final rule are the staff members of the U.S. Fish and Wildlife Service's Headquarters Office.

Accordingly, we amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below: