The substance of these special conditions has been published in the Federal Register for public comment in several prior instances with no substantive comments received. Therefore, the FAA finds, pursuant to Title 14, Code of Federal Regulations (14 CFR) 11.38(b), that new comments are unlikely, and notice and comment prior to this publication are unnecessary.

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 www.regulations.gov, including any personal information you provide. The FAA will also post a report summarizing each substantive verbal contact received about these special conditions.

Confidential Business Information (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 these special conditions contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to these special conditions, 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 the indicated comments will not be placed in the public docket of these proposed special conditions. Send submissions containing CBI to the individual listed in the For Further Information Contact section above. Comments the FAA receives, which are not specifically designated as CBI, will be placed in the public docket for these proposed special conditions.

The FAA invites interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.

The FAA will consider all comments received by the closing date for comments and will consider comments filed late if it is possible to do so without incurring delay. The FAA may change these special conditions based on the comments received.

On February 26, 2020, H4 applied for a supplemental type certificate to install, on the Boeing 757-200 airplane, HR Smith emergency locator transmitter (ELT) 500-32-2Y-H that contain a non-rechargeable lithium battery and battery system. The Boeing Model 757-200 airplane currently approved under Type Certificate No A2NM, are twin-engine transport category airplanes with a maximum seating of capacity of 295 passengers and has a maximum takeoff weight of 255,000 pounds.

Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.101, H4 must show that the Boeing Model 757-200 airplane, as changed, continues to meet the applicable provisions of the regulations listed in Type Certificate No. A2NM or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA.

If the Administrator finds that the applicable airworthiness regulations ( e.g., 14 CFR part 25) do not contain adequate or appropriate safety standards for the Boeing Model 757-200 airplane because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

Special conditions are initially applicable to the model for which they are issued. Should the applicant apply for a supplemental type certificate to modify any other model included on the same type certificate to incorporate the same novel or unusual design feature, these special conditions would also apply to the other model under §  21.101.

In addition to the applicable airworthiness regulations and special conditions, the Boeing Model 757-200 airplane must comply with the exhaust-emission requirements of 14 CFR part 34, and the noise-certification requirements of 14 CFR part 36.

The Boeing Model 757-200, MSN 25140 and MSN 24473 airplanes will incorporate the following novel or unusual design feature:

The installation of an HR Smith emergency locator transmitter (ELT) 500-32-2Y-H containing a non-rechargeable lithium battery and battery system.

The FAA derived the current regulations governing installation of batteries in transport category airplanes from Civil Air Regulations (CAR) 4b.625(d) as part of the recodification of CAR 4b that established 14 CFR part 25 in February 1965. This recodification basically reworded the CAR 4b battery requirements, which are currently in §  25.1353(b)(1) through (4). Non-rechargeable lithium batteries are novel and unusual with respect to the state of technology considered when these requirements were codified. Non-rechargeable lithium batteries introduce higher energy levels into airplane systems through new chemical compositions in various battery cell sizes and construction. Interconnection of these cells in battery packs introduce failure modes that require unique design considerations, such as provisions for thermal management.

In January 2013, two independent events involving rechargeable lithium batteries revealed unanticipated failure modes. A National Transportation Safety Board (NTSB) Safety Recommendation to the FAA, dated May 22, 2014, which is available at www.ntsb.gov, filename A-14-032-036.pdf, describes these events.

On July 12, 2013, an event involving a non-rechargeable lithium battery in an emergency-locator transmitter installation demonstrated unanticipated failure modes. The United Kingdom's Air Accidents Investigation Branch Bulletin S5/2013  1 describes this event. These events involving rechargeable and non-rechargeable lithium batteries prompted the FAA to initiate a broad evaluation of these energy-storage technologies.

On April 22, 2016, the FAA published special conditions no. 25-612-SC, in the Federal Register ( 81 FR 23573 ), applicable to Gulfstream Aerospace Corporation for the Model GVI airplane. Those were the first special conditions the FAA issued for non-rechargeable lithium battery installations. In that document, the FAA explained its decision to make those special conditions effective on April 22, 2017, one year after publication in the Federal Register . In those special conditions, the FAA stated its intention to apply non-rechargeable lithium battery special conditions to design changes on other airplane makes and models applied for after this same date.

Some known uses of rechargeable and non-rechargeable lithium batteries on airplanes include:

• Flight deck and avionics systems such as displays, global positioning systems, cockpit voice recorders, flight data recorders, underwater locator beacons, navigation computers, integrated avionics computers, satellite network and communication systems, communication management units, and remote-monitor electronic line-replaceable units;

• Cabin safety, entertainment, and communications equipment, including emergency locator transmitters, life rafts, escape slides, seatbelt air bags, cabin management systems, Ethernet switches, routers and media servers, wireless systems, internet and in-flight entertainment systems, satellite televisions, remotes, and handsets;

• Systems in cargo areas including door controls, sensors, video surveillance equipment, and security systems.

Some known potential hazards and failure modes associated with non-rechargeable lithium batteries are:

• Internal failures: In general, these batteries are significantly more susceptible to internal failures that can result in self-sustaining increases in temperature and pressure ( i.e., thermal runaway) than their nickel-cadmium or lead-acid counterparts. The metallic lithium can ignite, resulting in a self-sustaining fire or explosion.

• Fast or imbalanced discharging: Fast discharging or an imbalanced discharge of one cell of a multi-cell battery may create an overheating condition that results in an uncontrollable venting condition, which in turn leads to a thermal event or an explosion.

• Flammability: Unlike nickel-cadmium and lead-acid batteries, lithium batteries use higher energy and current in an electrochemical system that can be configured to maximize energy storage of lithium. They also use liquid electrolytes that can be extremely flammable. The electrolyte, as well as the electrodes, can serve as a source of fuel for an external fire if the battery casing is breached. For the purpose of these special conditions, a battery and the battery system are referred to as a battery. A battery system consists of the battery and any protective, monitoring, and alerting circuitry or hardware inside or outside of the battery. It also includes vents (where necessary) and packaging.

Special condition no. 1 of these special conditions requires that each individual cell within a non-rechargeable lithium battery be designed to maintain safe temperatures and pressures. Special condition no. 2 addresses these same issues but for the entire battery. Special condition no. 2 requires the battery be designed to prevent propagation of a thermal event, such as self-sustained, uncontrollable increases in temperature or pressure from one cell to adjacent cells.

Special condition nos. 1 and 2 are intended to ensure that the non-rechargeable lithium battery and its cells are designed to eliminate the potential for uncontrollable failures. However, a certain number of failures will occur due to various factors beyond the control of the battery designer. Therefore, other special conditions are intended to protect the airplane and its occupants if failure occurs.

Special conditions 3, 7, and 8 are self-explanatory.

Special condition no. 4 makes it clear that the flammable-fluid fire-protection requirements of §  25.863 apply to non-rechargeable lithium battery installations. Section 25.863 is applicable to areas of the airplane that could be exposed to flammable-fluid leakage from airplane systems. Non-rechargeable lithium batteries contain an electrolyte that is a flammable fluid.

Special condition no. 5 requires that each non-rechargeable lithium battery installation not damage surrounding structure or adjacent systems, equipment, or electrical wiring from corrosive fluids or gases that may escape in such a way as to cause a major or more severe failure condition.

While special condition no. 5 addresses corrosive fluids and gases, special condition no. 6 addresses heat. Special condition no. 6 requires that each non-rechargeable lithium battery installation have provisions to prevent any hazardous effect on airplane structure or systems caused by the maximum amount of heat the battery installation can generate due to any failure of it or its individual cells. The means of meeting special conditions nos. 5 and 6 may be the same, but the requirements are independent and address different hazards.

These special conditions apply to all non-rechargeable lithium battery installations in lieu of §  25.1353(b)(1) through (4) at Amendment 25-123 on Boeing Model 757-200 airplanes, as modified by H4 and described in this application. Sections 25.1353(b)(1) through (4) at Amendment 25-123 remain in effect for other battery installations.

These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

As discussed above, these special conditions are applicable to the Boeing Model 757-200 airplanes. Should H4 apply at a later date for a supplemental type certificate to modify any other model included on Type Certificate No. FAA STC ST00102IB to incorporate the same novel or unusual design feature, these special conditions would apply to that model as well.

This action affects only a certain novel or unusual design feature on one model of airplane. It is not a rule of general applicability and affects only the applicant who applied to the FAA for approval of these features on the airplane.

The authority citation for these special conditions is as follows:

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for Boeing Model 757-200 airplanes, as modified by H4 Aerospace (UK) Ltd.

In lieu of § 25.1353(b)(1) through (4) at amendment 25-123, or § 25.1353(c)(1) through (4) at earlier amendments, each non-rechargeable lithium battery installation must:

1. Be designed to maintain safe cell temperatures and pressures under all foreseeable operating conditions to prevent fire and explosion.

2. Be designed to prevent the occurrence of self-sustaining, uncontrollable increases in temperature or pressure.

3. Not emit explosive or toxic gases, either in normal operation or as a result of its failure, that may accumulate in hazardous quantities within the airplane.

4. Meet the requirements of §  25.863.

5. Not damage surrounding structure or adjacent systems, equipment, or electrical wiring from corrosive fluids or gases that may escape in such a way as to cause a major or more severe failure condition.

6. Have provisions to prevent any hazardous effect on airplane structure or systems caused by the maximum amount of heat it can generate due to any failure of it or its individual cells.

7. Have a failure sensing and warning system to alert the flightcrew if its failure affects safe operation of the airplane.

8. Have a means for the flight crew or maintenance personnel to determine the battery charge state if the battery's function is required for safe operation of the airplane.

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 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 amends the Class E airspace extending upward from 700 feet above the surface at Dixon Municipal Airport-Charles R. Walgreen Field, Dixon, IL, to support IFR operations at this airport.

The FAA published an NPRM for Docket No. FAA-2024-0271 in the Federal Register (89 FR 14426; February 27, 2024) proposing to amend the Class E airspace at Dixon, IL. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are 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 amendment to 14 CFR part 71 modifies the Class E airspace extending upward from 700 feet above the surface to within a 6.4-mile (decreased from a 6.5-mile) radius of Dixon Municipal Airport-Charles R. Walgreen Field, Dixon, IL; removes the Polo VORTAC and associated extensions from the airspace legal description; and updates the name of the airport (previously Dixon Municipal-Charles R. Walgreen Field) to coincide with the FAA's aeronautical database.

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:

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 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 updates airspace descriptions.

The FAA published a notice of proposed rulemaking for Docket No. FAA 2023-0214 in the Federal Register (88 FR 54956; August 14, 2023), proposing to amend Class D airspace, remove Class D airspace, amend Class E surface airspace, and amend Class E airspace designated as an extension to a Class D surface area at Capital City Airport, Harrisburg, PA. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

After publishing the NPRM, the FAA determined that it should have removed the Class D airspace designation for Harrisburg International Airport. The FAA is establishing Class C airspace at Harrisburg International Airport through a separate regulatory action, rendering the Class D designation obsolete. Accordingly, this rule removes that airspace.

Class D airspace and Class E airspace are published in paragraphs 5000, 6002, and 6004 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, incorporated by reference in 14 CFR 71.1 annually. 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 FAA Order JO 7400.11 update. FAA Order JO 7400.11H lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The FAA proposes an amendment to 14 CFR part 71 by:

Amending the Class D airspace for Capital City Airport, Harrisburg, PA, by removing excessive verbiage from the description header per order FAA 7400.2. Also, this action would add the Harrisburg International Airport to the Class D description header and legal description since it's used in describing the Class D airspace. In addition, this action would update the geographical coordinates of the airport to coincide with the FAA's database. Also, the legal description of the Capital City Airport would be amended to that airspace extending upward from the surface up to but not including 1,600 feet MSL beginning at the intersection of the Capital City Airport's 106° bearing and 1.5-mile radius direct to Lat. 40°14′13″ N, long. 76°53′23″ W direct to the intersection of the Capital City Airport's 287° bearing and Capital City Airport's 4-mile radius, thence clockwise along the Capital City Airport's 4-mile radius to the intersection of the Harrisburg International Airport's 5-mile radius, thence counterclockwise along the Harrisburg International Airport's 5-mile radius to the intersection of the Capital City Airport's 1.5-mile radius, thence clockwise along the Capital City Airport's 1.5-mile radius to the point of beginning; and that airspace extending upward from the surface up to but not including 2,600 feet MSL beginning at a line bearing 191° from a point at Lat. 40°12′23″ N, long. 76°48′37″ W, extending from said point to the point of intersection with the Capital City Airport's 4-mile radius, thence clockwise along the Capital City Airport's 4-mile radius to the intersection of the Capital City Airport's 287° bearing, thence direct to Lat. 40°14′13″ N, long. 76°53′23″ W, thence direct to the point of beginning. Also, this action makes editorial changes by replacing the terms Notice to Airmen with Notice to Air Missions and Airport/Facility Directory with Chart Supplement.

This would remove the Class D airspace listed under the header Harrisburg International Airport, Harrisburg, PA. The FAA intends to establish Class C airspace at Harrisburg International Airport through a separate regulatory action.

The Class E surface airspace for Capital City Airport, Harrisburg, PA, is amended by removing excessive verbiage in the description header per order FAA 7400.2. Also, this action adds the Harrisburg International Airport to the Class E surface airspace description header and legal description since it is used in describing the Class E surface airspace. In addition, this action amends the airport's geographical coordinates to coincide with the FAA's database. Also, the legal description of the Capital City Airport is amended to that airspace extending upward from the surface beginning at a line bearing 191° from a point at Lat. 40°12′23″ N, long. 76°48′37″ W, extending from said point to the point of intersection with the Capital City Airport's 4-mile radius, thence clockwise along the Capital City Airport's 4-mile radius to the intersection of the Harrisburg International Airport's 5-mile radius, thence counterclockwise along the Harrisburg International Airport's 5-mile radius to the intersection of the Capital City Airport's 1.5-mile radius, thence clockwise along the Capital City Airport's 1.5-mile radius to the intersection of the Capital City Airport's 1.5-mile radius and the Capital City Airport's 106° bearing, thence direct to Lat. 40°12′23″ N, long. 76°48′37″ W. This action would also remove the extension to the southwest as it is unnecessary, (the Class E airspace designated as an extension to a Class D surface area includes this airspace). Also, this action makes the editorial changes, replacing the terms Notice to Airmen with Notice to Air Missions and Airport/Facility Directory with Chart Supplement.

The Class E airspace designated as an extension to a Class D surface area for Capital City Airport is amended by removing excessive verbiage in the description header per order FAA 7400.2 and updating the airport's geographical coordinates to coincide with the FAA's database. In addition, the references using runways and miles off the runways are replaced with the bearings and mileage from the airport reference point; the legal description is amended to that airspace extending upward from the surface within 1.8 miles on each side of the Capital City Airport's 251° bearing extending from the airport's 4-mile radius to 7.5 miles southwest of the airport. Also, excessive verbiage in the legal description is removed since it is unnecessary.

Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations in the area. This action is necessary to support IFR operations in the area.

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 will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will 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:

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 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 amends the Class D airspace, Class E surface airspace, and Class E airspace extending upward from 700 feet above the surface at MBS International Airport, Saginaw, MI, to support IFR operations at this airport.

The FAA published an NPRM for Docket No. FAA-2024-0273 in the Federal Register (89 FR 14424; February 27, 2024) proposing to amend the Class D and Class E airspace at Saginaw, MI. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class D and E airspace designations are published in paragraphs 5000, 6002, and 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 amendment to 14 CFR part 71:

Modifies the Class D airspace to within a 4.3-mile (decreased from a 4.8-mile) radius of MBS International Airport, Saginaw, MI; and replaces the outdated terms “Notice to Airmen” and “Airport/Facility Directory” with “Notice to Air Missions” and “Chart Supplement”;

Modifies the Class E surface airspace to within a 4.3-mile (decreased from a 4.8-mile) radius of MBS International Airport; updates the name (previously Tri City International Airport) and the geographic coordinates of the airport to coincide with the FAA's aeronautical database; and replaces the outdated terms “Notice to Airmen” and “Airport/Facility Directory” with “Notice to Air Missions” and “Chart Supplement”;

And modifies the Class E airspace extending upward from 700 feet above the surface to within a 6.8-mile (decreased from a 7-mile) radius of MBS International Airport; removes the Saint Mary's Heliport and associated airspace as the instrument procedures to the heliport have been cancelled and the airspace is no longer required; updates the name of Saginaw County/H.W. Browne Airport (previously Saginaw County H.W. Browne Airport), Saginaw, MI, and the geographic coordinates of MBS International, Saginaw County/H.W. Browne Airport, and Jack Barstow Airport, Midland, MI, to coincide with the FAA's aeronautical database; and removes the cities associated with the airports in the airspace legal description to comply with changes to FAA Order JO 7400.2P, Procedures for Handling Airspace Matters.

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:

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 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 amends: the Class D airspace, Class E surface airspace, and Class E airspace extending upward from 700 feet above the surface at Lake Charles Regional Airport, Lake Charles, LA; the Class D airspace and Class E airspace extending upward from 700 feet above the surface at Chennault International Airport, Lake Charles, LA; and the Class E airspace extending upward from 700 feet above the surface at Southerland Field, Sulphur, LA, (Contained within the Lake Charles, LA, airspace legal description.) to support instrument flight rule operations at these airports.

The FAA published an NPRM for Docket No. FAA-2024-0270 in the Federal Register (89 FR 14002; February 26, 2024) proposing to amend the Class D and Class E airspace at Lake Charles, LA. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class D and E airspace designations are published in paragraphs 5000, 6002, and 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.

Subsequent to publication, the FAA discovered typos in the Class D airspace, Lake Charles, LA, and the Class E airspace extending upward from 700 feet above the surface, Lake Charles, LA, in the Chennault International Airport airspace legal descriptions. The radius in the Class D airspace legal description should be “4.4-mile” vice “4.5-mile. And the latitude for Chennault International Airport in the Class E airspace extending upward from 700 feet above the surface airspace legal description should be “long 93°08′35″ W” vice “long 93°08′36″ W.” These errors have been corrected in this action.

This amendment to 14 CFR part 71:

Modifies the Class D airspace at Lake Charles Regional Airport, Lake Charles, LA, by removing the Lake Charles VORTAC and the associated extension as they are no longer required; and replaces the outdated terms “Notice to Airmen” and “Airport/Facility Directory” with “Notice to Air Missions” and “Chart Supplement”;

Modifies the Class D airspace to within a 4.4-mile (decreased from a 4.5-mile) radius of Chennault International Airport, Lake Charles, LA; adds an extension within 1 mile each side of the 334° bearing from the airport extending from the 4.4-mile radius to 4.5 miles northwest of the airport; updates the header of the airspace legal description from “Lake Charles, Chennault International Airport, LA” to “Lake Charles, LA” to comply with changes to FAA Order JO 7400.2P, Procedures for Handling Airspace Matters; and removes the city associated with the airport to comply with changes to FAA Order JO 7400.2P; updates the geographic coordinates of the airport to coincide with the FAA's aeronautical database; and replaces the outdated terms “Notice to Airmen” and “Airport/Facility Directory” with “Notice to Air Missions” and “Chart Supplement”;

Modifies the Class E surface airspace at Lake Charles Regional Airport by removing the Lake Charles VORTAC and the associated extension as they are no longer required; and replaces the outdated terms “Notice to Airmen” and “Airport/Facility Directory” with “Notice to Air Missions” and “Chart Supplement”;

And modifies the Class E airspace extending upward from 700 feet above the surface to within a 6.9-mile (decreased from a 7-mile) radius of Chennault International Airport; removes the extension southeast of Chennault International Airport from the airspace legal description as it is no longer required; removes the Sulphur NDB and associated extension as they are no longer required; updates the geographic coordinates of Chennault International Airport to coincide with the FAA's aeronautical database; and removes the cities associated with the airports in the airspace legal description to comply with changes to FAA Order JO 7400.2P.

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:

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 identified a safety issue with similar sounding WP names, the SKNRR, MS, WP and the SKNNR, GA, WP located 209 NM to the east of SKNRR WP which contributes to communications errors resulting from the similar-sounding WP names in radio communications. To remedy this, the FAA is changing the name from the SKNRR, MS, WP to the HRISN, MS, WP in both RNAV Routes Q-30 and T-370. Additionally, the FAA identified that it had inadvertently assigned the RNAV Route number T-370 to multiple route entries in FAA Order JO 7400.11H, one in Alaska and one in the southeastern United States. The FAA corrects this error by renumbering RNAV Route number T-370 in the southeastern United States to T-486.

United States Area Navigation routes (Q-routes) are published in paragraph 2006 and United States Area Navigation (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. 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 changing the name of the “SKNRR”, MS, WP to “HRISN” in RNAV Routes Q-30 and T-370 to overcome the similar-sounding pronunciation of the SKNRR, MS, WP and the SKNNR, GA, WP which contributes to communications errors resulting from the similar-sounding WP names in radio communications. Additionally, T-370 will be renumbered to T-486 to correct a duplicative use of RNAV Route number T-370 in Alaska. The amendments are described below.

Q-30: Q-30 is an amended route that extends between the IZAAC, MS, WP and the VLKNN, AL, WP. This amended route replaces the SKNRR, MS, WP with the HRISN, MS, WP at the same location. As amended, the route continues to extend between the IZAAC WP and the VLKNN WP.

T-486: T-486 is an amended route that extends between the BURBN, TX, WP and the VLKNN, AL, WP. This amended route replaces the SKNRR, MS, WP with the HRISN, MS, WP at the same location. Additionally, T-370 is renumbered to T-486 to correct a duplicative use of RNAV Route number T-370 in Alaska. As amended, the route continues to extend between the BURBN WP and the VLKNN WP.

This action is an administrative change and does not affect the airspace boundaries or operating requirements; therefore, notice and public procedure under 5 U.S.C. 553(b) is unnecessary.

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 airspace action of amending RNAV Routes Q-30 and T-370 by changing the name of the “SKNRR”, MS, waypoint (WP) to “HRISN” and renumbering T-370 to T-486 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). 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:

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 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 amends the Class D airspace, Class E surface airspace, and Class E airspace extending upward from 700 feet above the surface at Jack Brooks Regional Airport, Beaumont/Port Arthur, TX, and the Class E airspace extending upward from 700 feet above the surface at Beaumont Municipal Airport, Beaumont, TX, and Orange County Airport, Orange, TX, (Contained within the Beaumont/Port Arthur, TX, airspace legal description.) to support instrument flight rule operations at these airports.

The FAA published an NPRM for Docket No. FAA-2024-0269 in the Federal Register (89 FR 14000; February 26, 2024) proposing to amend the Class D and Class E airspace at Beaumont/Port Arthur, TX. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class D and E airspace designations are published in paragraphs 5000, 6002, and 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 amendment to 14 CFR part 71:

Modifies the Class D airspace at Jack Brooks Regional Airport, Beaumont/Port Arthur, TX, by updating the name of the airport (previously Jefferson County Airport) to coincide with the FAA's aeronautical database; updates the header of the airspace legal description to Beaumont/Port Arthur, TX (previously Beaumont, TX) to coincide with the FAA's aeronautical database; removes the city associated with the airport in the airspace legal description to comply with changes to FAA Order JO 7400.2P, Procedures for Handling Airspace Matters; and replaces the outdated terms “Notice to Airmen” and “Airport/Facility Directory” with “Notice to Air Missions” and “Chart Supplement”;

Modifies the Class E surface airspace at Jack Brooks Regional Airport by updating the name of the airport (previously Jefferson County Airport) to coincide with the FAA's aeronautical database; updates the header of the airspace legal description to Beaumont/Port Arthur, TX (previously Beaumont, TX) to coincide with the FAA's aeronautical database; removes the city associated with the airport in the airspace legal description to comply with changes to FAA Order JO 7400.2P; and replaces the outdated terms “Notice to Airmen” and “Airport/Facility Directory” with “Notice to Air Missions” and “Chart Supplement”;

And modifies the Class E airspace extending upward from 700 feet above the surface to within a 7.5-mile (decreased from a 7.7-mile) radius of Jack Brooks Regional Airport; removes the extension northwest of Beaumont Municipal Airport, Beaumont, TX, from the airspace legal description as it is no longer needed; within a 6.5-mile (decreased from a 6.6-mile) radius of Orange County Airport, Orange, TX; updates the name of Jack Brooks Regional Airport (previously Southeast Texas Regional Airport) to coincide with the FAA's aeronautical database; updates the geographic coordinates of Beaumont Municipal Airport and Orange County Airport to coincide with the FAA's aeronautical database; updates the header of the airspace legal description to Beaumont/Port Arthur, TX (previously Beaumont, TX) to coincide with the FAA's aeronautical database; and removes the cities associated with the airports in the airspace legal description to comply with changes to FAA Order JO 7400.2P.

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:

In FR Doc. 2024-09863, on page 37972 in the Federal Register of Tuesday, May 7, 2024, in the second column, correct the DATES caption by adding “, 2024” after “May 6”.

I. Approvals

FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during January, February, and March 2024, as listed in table 1. In addition, FDA is informing the public of the availability, where applicable, of documentation of environmental review required under the National Environmental Policy Act (NEPA) and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOIA Summaries) under the Freedom of Information Act (FOIA). These documents, along with marketing exclusivity and patent information, may be obtained at Animal Drugs @FDA: https://animaldrugsatfda.fda.gov/adafda/views/#/search.

Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd., Duluth, GA 30096 (drug labeler code 000010) requested that FDA withdraw approval of the five NADAs listed in table 2 because the products are no longer manufactured or marketed. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these actions.

The sponsors of the approved applications listed in table 3 have informed FDA that they have transferred ownership of, and all rights and interest in, these applications to another sponsor. The regulations cited in table 3 are amended to reflect these actions.

The Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act of 2004) (Pub. L. 108-282) amended the FD&C Act to establish regulatory procedures that provide incentives intended to make more drugs legally available to veterinarians and animal owners for the treatment of minor animal species and uncommon diseases in major animal species.

In 2007, FDA issued final regulations (72 FR 69108, December 6, 2007) to implement section 572 of the MUMS Act entitled “Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.” These regulations establish administrative procedures and criteria for index listing a new animal drug that provide a basis for legally marketing an unapproved new animal drug for use in a minor species.

The MUMS Act and the 2007 regulations derived from it required indexed products to state their unapproved status on labeling. Subsequently, section 302 of the Animal Drug and Animal Generic Drug User Fee Amendments of 2018 (User Fee Amendments of 2018; Pub. L. 115-234) amended the required labeling statement found in section 572(h)(1) of the FD&C Act (21 U.S.C. 360ccc-1(h)(1)) to reinforce that indexed products are legally marketed.

The User Fee Amendments of 2018 also amended the required label statements found in section 572(h)(2) of the FD&C Act regarding, except for use in a non-food early life stage, the prohibition of indexed drugs for use in food-producing animals.

At this time, we are revising the animal drug regulations at § 516.155 (21 CFR 516.155) for labeling of indexed drugs to reflect the amendments made by the User Fee Amendments of 2018 to section 572(h) of the FD&C Act.

The labeling statements required under section 572(h) of the FD&C Act, as reflected in § 516.155, are public disclosure of information originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public (5 CFR 1320.3(c)(2)); therefore, they are exempt from the Office of Management and Budget review and approval under the Paperwork Reduction Act.

This final rule sets forth a technical amendment to the regulations to improve the accuracy and completeness of the regulations, and as such does not impose any burden on regulated entities. Although denominated a rule pursuant to the FD&C Act, this document does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a “rule of particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801 through 808. Likewise, this is not a rule subject to Executive Order 12866, which defines a rule as “an agency statement of general applicability and future effect, which the agency intends to have the force and effect of law, that is designed to implement, interpret, or prescribe law or policy or to describe the procedure or practice requirements of an agency.”

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 516 is amended as follows:

Background

This document contains amendments to 26 CFR part 300—User Fees. On October 4, 2023, the Department of the Treasury (Treasury Department) and the IRS published in the Federal Register (88 FR 68525) a notice of proposed rulemaking (proposed regulations) by cross-reference to an interim final rule (REG-106203-23) proposing amendments to regulations under 26 CFR part 300. On the same date, the Treasury Department and the IRS published in the Federal Register (88 FR 68456) an interim final rule (TD 9980) that reduced the PTIN user fee from $21 per application or application for renewal to $11, plus the fee payable directly to a third-party contractor. The interim final rule and the proposed regulations took into account the February 2023 memorandum opinion of the United States District Court for the District of Columbia in Steele v. United States, 657 F.Supp.3d 23 (D.D.C. 2023). The preamble to the interim final rule contains a detailed explanation of the legal background and user fee calculations regarding the amendments to these regulations. No public hearing was requested or held, and no comments were received on the proposed regulations. These final regulations therefore adopt the text of the interim final rule and proposed regulations without change.

The OMB's Office of Information and Regulatory Analysis has determined that these final regulations are not significant and are not subject to review under section 6(b) of Executive Order 12866, as amended.

Pursuant to the Regulatory Flexibility Act (5 U.S.C. chapter 6), it is hereby certified that these final regulations will not have a significant economic impact on a substantial number of small entities. Accordingly, a regulatory flexibility analysis is not required. These regulations affect all individuals who prepare or assist in preparing all or substantially all of a tax return or claim for refund for compensation. Only individuals, not businesses, can have a PTIN. Thus, the economic impact of these regulations on any small entity generally will be a result of an individual tax return preparer who is required to have a PTIN owning a small business or a small business otherwise employing an individual tax return preparer who is required to have a PTIN. The Treasury Department and the IRS estimate that approximately 847,555 individuals will apply annually for an initial or renewal PTIN. Although these regulations will likely affect a substantial number of small entities, the economic impact on those entities is not significant. These regulations establish an $11 fee per application or application for renewal (plus the fee payable directly to the third-party contractor), which is a reduction from the previously established fee, and will therefore not have a significant economic impact on small entities. Accordingly, a regulatory flexibility analysis is not required.

Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) requires that agencies assess anticipated costs and benefits and take certain other actions before issuing a final rule that includes any Federal mandate that may result in expenditures in any one year by a State, local, or Tribal government, in the aggregate, or by the private sector, of $100 million in 1995 dollars, updated annually for inflation. These final regulations do not include any Federal mandate that may result in expenditures by State, local, or Tribal governments, or by the private sector in excess of that threshold.

Executive Order 13132 (Federalism) prohibits an agency from publishing any rule that has federalism implications if the rule either imposes substantial, direct compliance costs on State and local governments, and is not required by statute, or preempts State law, unless the agency meets the consultation and funding requirements of section 6 of the Executive order. These final regulations do not have federalism implications and do not impose substantial direct compliance costs on State and local governments or preempt State law within the meaning of the Executive order.

Pursuant to section 7805(f) of the Code, the notice of proposed rulemaking and the interim final rule that preceded these final regulations was submitted to the Chief Counsel for the Office of Advocacy of the Small Business Administration for comment on its impact on small business. No comments were received on the proposed regulations or the interim final rule.

Pursuant to 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).

The principal author of these regulations is Jamie Song, Office of the Associate Chief Counsel (Procedure and Administration). Other personnel from the Treasury Department and the IRS participated in the development of the regulations.

Section 105(e) of the Federal Alcohol Administration Act (FAA Act), 27 U.S.C. 205(e), authorizes the Secretary of the Treasury to prescribe regulations for the labeling of wine, distilled spirits, and malt beverages. The FAA Act provides that these regulations should, among other things, prohibit consumer deception and the use of misleading statements on labels and ensure that labels provide the consumer with adequate information as to the identity and quality of the product. The Alcohol and Tobacco Tax and Trade Bureau (TTB) administers the FAA Act pursuant to section 1111(d) of the Homeland Security Act of 2002, codified at 6 U.S.C. 531(d). In addition, the Secretary of the Treasury has delegated certain administrative and enforcement authorities to TTB through Treasury Order 120-01.

Part 4 of the TTB regulations (27 CFR part 4) authorizes TTB to establish definitive viticultural areas and regulate the use of their names as appellations of origin on wine labels and in wine advertisements. Part 9 of the TTB regulations (27 CFR part 9) sets forth standards for the preparation and submission of petitions for the establishment or modification of American viticultural areas (AVAs) and lists the approved AVAs.

Section 4.25(e)(1)(i) of the TTB regulations (27 CFR 4.25(e)(1)(i)) defines a viticultural area for American wine as a delimited grape-growing region having distinguishing features as described in part 9 of the regulations and, once approved, a name and a delineated boundary codified in part 9 of the regulations. These designations allow vintners and consumers to attribute a given quality, reputation, or other characteristic of a wine made from grapes grown in an area to the wine's geographic origin. The establishment of AVAs allows vintners to describe more accurately the origin of their wines to consumers and helps consumers to identify wines they may purchase. Establishment of an AVA is neither an approval nor an endorsement by TTB of the wine produced in that area.

Section 4.25(e)(2) of the TTB regulations (27 CFR 4.25(e)(2)) outlines the procedure for proposing an AVA and allows any interested party to petition TTB to establish a grape-growing region as an AVA. Section 9.12 of the TTB regulations (27 CFR 9.12) prescribes standards for petitions to establish or modify AVAs. Petitions to establish an AVA must include the following:

• Evidence that the area within the proposed AVA boundary is nationally or locally known by the AVA name specified in the petition;

• An explanation of the basis for defining the boundary of the proposed AVA;

• A narrative description of the features of the proposed AVA affecting viticulture, such as climate, geology, soils, physical features, and elevation, that make the proposed AVA distinctive and distinguish it from adjacent areas outside the proposed AVA;

• The appropriate United States Geological Survey (USGS) map(s) showing the location of the proposed AVA, with the boundary of the proposed AVA clearly drawn thereon; and

• A detailed narrative description of the proposed AVA boundary based on USGS map markings.

TTB received a petition from the Appalachian Region Wine Producers Association proposing the establishment of the “Upper Cumberland” AVA in Middle Tennessee. The proposed Upper Cumberland AVA covers approximately 2,186,689 acres and is not located within any other AVA. There are 55 commercially producing vineyards covering a total of approximately 71 acres within the proposed AVA, as well as nine wineries.

According to the petition, the distinguishing features of the proposed AVA are its geology and elevation, soils, and climate. The proposed Upper Cumberland AVA covers portions of three distinct geographical regions: the western portion of the Cumberland Plateau, the Eastern Highland Ridge, and the eastern portion of the Outer Central Basin. The eastern region of the proposed AVA is located on the western portion of the Cumberland Plateau and was formed from layers of sedimentary rocks that were deposited when an ocean covered the area. The average elevations in the eastern region of the proposed AVA range from 1,500 to 1,800 feet. The middle region of the proposed AVA is located on a cuesta known as the Eastern Highland Rim. This region of the proposed AVA is comprised mainly of various limestones, chert, and shale and contains elevations ranging from 600 to 1,000 feet. The western region of the proposed Upper Cumberland AVA is mostly an escarpment located on the Outer Central Basin of Middle Tennessee with underlying rocks of limestone, chert, and shale. The petition did not include a range of elevations for the western region of the proposed AVA but noted that the elevations are higher than the average elevations of the Inner Central Basin region located farther to the west.

The petition notes that the uplifted elevations of the proposed AVA allow more direct and concentrated sunlight—particularly UV light—into the vineyards than in vineyards at lower elevations. According to the petition, for every 1,000 feet of elevation, the level of UV light increases between 10 and 20 percent. As a result of greater levels of UV rays, grapes develop thicker skins which increases the color concentration and tannins in the resulting wines.

According to the petition, regions to the north and south of the proposed AVA contain the same geological features found within the proposed AVA, but the petition did not provide information on elevations within these regions. The region east of the proposed AVA is the Valley and Ridge Province of Tennessee, where the sediment and rock was folded and faulted rather than being uplifted into a plateau. Elevations range from 1,100 to 1,500 feet in the ridges and from 700 to 1,000 feet in the valleys. To the west of the proposed AVA is the Inner Central Basin where elevations are 300 to 400 feet lower than elevations within the adjacent portion of the proposed AVA.

The petition states that there are three types of soil orders in the proposed AVA. It defines Ultisols soils as “strongly leached, acid forest soils with relatively low fertility.” Inceptisols soils “exhibit minimal horizon development” and “lack features characteristic of other soil orders.” Alfisols soils are moderately-leached soils with relatively high native fertility. The petition notes the eastern portion of the proposed AVA contains Ultisols and Inceptisols soils that are moderately deep, dominantly well-drained, and strongly acidic. These soils have an udic soil moisture regime, meaning that water moves down through the soil at some time in most years, and the amount of soil moisture plus rainfall is approximately equal to or exceeds the amount of evapotranspiration.

The middle portion of the proposed AVA contains Ultisols, Inceptisols, and Alfisols soils that are moderately-to-very deep, moderately well-drained, and loamy or clayey. These soils are in the udic soil moisture regime and are also predominantly in the thermic soil temperature regime, meaning that soil temperatures at a depth of 20 inches range from 59 to 72 degrees Fahrenheit.

The western portion of the proposed AVA contains Ultisols, Inceptisols, and Alfisols soil orders. Soils in this portion have a thermic soil temperature regime and udic soil moisture regime, similar to the soils in the middle portion of the proposed AVA. The petition notes that the acidic and well-drained soils of the proposed Upper Cumberland AVA allow grapes to retain acidity as they ripen, resulting in “brighter, more acidic finished wines.”

According to the petition, to the north and south of the proposed AVA, the soils are similar to the soils within the proposed AVA. Soils east of the proposed AVA are almost exclusively Ultisols soils that generally have a thermic soil temperature regime and an udic soil moisture regime. Soils west of the proposed AVA include Mollisols soils, which are found in grassland ecosystems and are not found in the proposed AVA. Additionally, the region west of the proposed AVA does not contain as many Ultisols soils as the proposed AVA.

The petition provided climate data, specifically annual minimum and maximum temperatures, growing season mean temperatures, growing season length, growing degree days  1 (GDDs), USDA plant hardiness zones, and annual precipitation amounts for the proposed Upper Cumberland AVA and the surrounding regions. According to the petition, the proposed AVA has a climate that is suitable for growing a wide variety of wine grapes, including vinifera, hybrid, native, and muscadine varietals currently growing within the proposed AVA. The proposed AVA has an average growing season length of 212 days, a mean growing degree temperature of 67.5 degrees Fahrenheit, and an average annual precipitation amount of 50.02 inches.

The area south of the proposed AVA has a generally warmer climate, longer growing season, and higher annual precipitation amount than the proposed AVA. In the area east of the proposed AVA, the mean growing season temperature is similar to the proposed AVA, but the growing season is slightly shorter, and the annual precipitation amount is slightly higher. The area west of the proposed AVA has a shorter mean growing season temperature and a higher mean annual precipitation amount than the proposed AVA.

TTB published Notice No. 224 in the Federal Register on August 29, 2023 (88 FR 59482), proposing to establish the Upper Cumberland AVA. In the notice, TTB summarized the evidence from the petition regarding the name, boundary, and distinguishing features for the proposed AVA. The notice also included information from the petition comparing the distinguishing features of the proposed AVA to the surrounding areas. For a detailed description of the evidence relating to the name, boundary, and distinguishing features of the proposed AVA, and for a detailed comparison of the distinguishing features of the proposed AVA to the surrounding areas, see Notice No. 224. In Notice No. 224, TTB solicited comments on the accuracy of the name, boundary, and other required information submitted in support of the petition. The comment period for Notice No. 224 closed on October 30, 2023.

In response to Notice No. 224, TTB received four comments. The commenters were Mountain Valley Vineyards, Inc, the Tennessee Wine and Grape Board, the Tennessee Farm Winegrowers Alliance, and the Upper Cumberland Tourism Association. All the comments supported the establishment of the proposed Upper Cumberland AVA, suggesting, for example, that the AVA designation would support the growth of the wine and grape industries and make the area appealing for tourism, new businesses and jobs, and new residents. The comments did not raise any new issues concerning the proposed AVA. TTB did not receive any comments opposing the establishment of the Upper Cumberland AVA.

After careful review of the petition and the comments received in response to Notice No. 224, TTB finds that the evidence provided by the petitioner supports the establishment of the Upper Cumberland AVA. Accordingly, under the authority of the FAA Act, section 1111(d) of the Homeland Security Act of 2002, and parts 4 and 9 of the TTB regulations, TTB establishes the “Upper Cumberland” AVA in Middle Tennessee, effective 30 days from the publication date of this document.

See the narrative description of the boundary of the Upper Cumberland AVA in the regulatory text published at the end of this final rule.

The petitioner provided the required maps, and they are listed below in the regulatory text. The Upper Cumberland AVA boundary may also be viewed on the AVA Map Explorer on the TTB website, at https://www.ttb.gov/wine/ava-map-explorer.

Part 4 of the TTB regulations prohibits any label reference on a wine that indicates or implies an origin other than the wine's true place of origin. For a wine to be labeled with an AVA name or with a brand name that includes an AVA name, at least 85 percent of the wine must be derived from grapes grown within the area represented by that name, and the wine must meet the other conditions listed in 27 CFR 4.25(e)(3). If the wine is not eligible for labeling with an AVA name and that name appears in the brand name, then the label is not in compliance and the bottler must change the brand name and obtain approval of a new label. Similarly, if the AVA name appears in another reference on the label in a misleading manner, the bottler would have to obtain approval of a new label. Different rules apply if a wine has a brand name containing an AVA name that was used as a brand name on a label approved before July 7, 1986. See 27 CFR 4.39(i)(2) for details.

With the establishment of the Upper Cumberland AVA, its name, “Upper Cumberland,” will be recognized as a name of viticultural significance under § 4.39(i)(3) of the TTB regulations (27 CFR 4.39(i)(3)). The text of the regulations clarifies this point. Consequently, wine bottlers using the name “Upper Cumberland” in a brand name, including a trademark, or in another label reference as to the origin of the wine, will have to ensure that the product is eligible to use the AVA name as an appellation of origin.

The establishment of the Upper Cumberland AVA will not affect any existing AVA. The establishment of the Upper Cumberland AVA will allow vintners to use “Upper Cumberland” as an appellation of origin for wines made primarily from grapes grown within the Upper Cumberland AVA if the wines meet the eligibility requirements for the appellation.

TTB certifies that this regulation will not have a significant economic impact on a substantial number of small entities. The regulation imposes no new reporting, recordkeeping, or other administrative requirement. Any benefit derived from the use of an AVA name would be the result of a proprietor's efforts and consumer acceptance of wines from that area. Therefore, no regulatory flexibility analysis is required.

It has been determined that this final rule is not a significant regulatory action as defined by Executive Order 12866, as amended. Therefore, no regulatory assessment is required.

Vonzella C. Johnson of the Regulations and Rulings Division drafted this final rule.

This final rule describes new price and product features for competitive products, by class of mail, established by the Governors of the United States Postal Service®. New prices are available under Docket Number CP2024-295 on the Postal Regulatory Commission (PRC) website at http://www.prc.gov, and on the Postal Explorer® website at http://pe.usps.com. The Postal Service will revise Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM), to reflect changes to certain pricing and mailing standards for the following competitive products:

• Parcel Select®.

• Recipient Services.

• Other.

Competitive price and product changes are identified by product as follows:

The prices for Parcel Select Destination Entry will increase an average of 25.0 percent.

The prices for USPS Connect® Local will increase 15.8 percent.

Premium Forwarding Service Local (PFS-Local) is being expanded to have mail that is addressed to a residential/individual and business/organization Post Office Box dispatched to a street address when both addresses are within the same local servicing postal facility or sorting and delivery center (S&DC).

Under Phase 1 of the Postal Service network future state, the Postal Service is revising the DMM to provide site mapping nomenclature for facilities ( e.g., NDC/RPDC). Phase 1 will not include site mapping in the Quick Service Guides (QSGs) or revisions to destination entry pricing nomenclature or labeling lists.

In some cases where there is overlapping of nomenclature in the DMM for market dominant and competitive products ( e.g., DMM 204.3.0), the site mapping nomenclature is included in the New Mailing Standards for Domestic Mailing Services Products Federal Register notice (89 FR 27330-27353).

The Postal Service provides additional resources to assist customers with this price change for competitive products. These tools include price lists, downloadable price files, and Federal Register Notices, which may be found on the Postal Explorer® website at http://pe.usps.com.

The Postal Service adopts the described changes to Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM), incorporated by reference in the Code of Federal Regulations. We will publish an appropriate amendment to 39 CFR part 111 to reflect these changes.

Accordingly, the Postal Service amends Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM), incorporated by reference in the Code of Federal Regulations as follows ( see 39 CFR 111.1):

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 EPA's tolerance regulations at 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-2023-0078 and EPA-HQ-OPP-2022-0958 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before July 15, 2024. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

EPA's Office of Administrative Law Judges (OALJ), in which the Hearing Clerk is housed, urges parties to file and serve documents by electronic means only, notwithstanding any other particular requirements set forth in other procedural rules governing those proceedings. See “Revised Order Urging Electronic Service and Filing”, dated June 22, 2023, which can be found at https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf. Although EPA's regulations require submission via U.S. Mail or hand delivery, EPA intends to treat submissions filed via electronic means as properly filed submissions; therefore, EPA believes the preference for submission via electronic means will not be prejudicial. When submitting documents to the OALJ electronically, a person should utilize the OALJ e-filing system at https://yosemite.epa.gov/OA/EAB/EAB-ALJ_Upload.nsf/HomePage?ReadForm.

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-2023-0078 and EPA-HQ-OPP-2022-0958, 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.

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

In the Federal Register of July 26, 2023 (88 FR 48179) (FRL-10579-06-OCSPP), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP2E9041) by the Interregional Research Project No. 4 (IR-4), North Carolina State University, 1730 Varsity Drive, Venture IV, Suite 210, Raleigh, NC 27606. The petition requested to amend 40 CFR 180.672 by establishing tolerances for residues of cyantraniliprole, including its metabolites and degradates, in or on the following commodities: edible podded bean subgroup 6-22A at 2 parts per million (ppm); edible podded pea subgroup 6-22B at 2 ppm; field corn subgroup 15-22C at 0.01 ppm; forage and hay of legume vegetables (except soybeans) subgroup 7-22A at 40 ppm; herb fresh leaves subgroup 25A at 40 ppm; herb dried leaves subgroup 25B at 150 ppm; hops, dried cones at 70 ppm; papaya at 1.5 ppm; pulses, dried shelled bean, except soybean, subgroup 6-22E at 1 ppm; pulses, dried shelled pea subgroup 6-22F at 1 ppm; rice subgroup 15-22F at 0.02 ppm; spices crop group 26 at 80 ppm; succulent shelled bean subgroup 6-22C at 0.3 ppm; succulent shelled pea subgroup 6-22D at 0.3 ppm; and sweet corn subgroup 15-22D at 0.01 ppm. The petitioner proposed, upon the approval of the aforementioned tolerances, to remove established tolerances for residues of cyantraniliprole, including its metabolites and degradates, in or on the following commodities: vegetable, legume, dried shelled, except soybean, subgroup 6C at 1.0 ppm; vegetable, legume, edible podded, subgroup 6A at 2.0 ppm; vegetable, legume, succulent shelled, subgroup 6B at 0.20 ppm; vegetable, foliage of legume, except soybean, group 7A at 40 ppm; corn, field, grain at 0.01 ppm; corn, pop, grain, at 0.01 ppm; corn, sweet, kernel plus cob with husks removed at 0.01 ppm; and rice, grain at 0.02 ppm. That document referenced a summary of the petition prepared by IR-4, the petitioner, which is available in the docket, https://www.regulations.gov. There were no comments received on the notice of filing.

Based upon review of the data supporting the petition and in accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA has made modifications to the proposed commodity definitions for most of the tolerances in this petition and is not establishing several of the petitioned-for tolerances because the petitioner withdrew them. The reasons for these changes are explained in Unit IV.D.

In the Federal Register of February 23, 2023 (88 FR 11401) (FRL-10579-01-OCSPP), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP2E9032) by the FMC Corporation, 2929 Walnut Street, Philadelphia, PA 19104, requesting, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing tolerances for residues of cyantraniliprole, including its metabolites and degradates in or on the following commodities: grape, table at 2.0 ppm (only for imported table grapes); avocado at 0.4 ppm (only for imported avocados); and mango at 0.7 ppm (only for imported mangos) and by revising the tolerance for imported olives from 1.5 ppm to 3.0 ppm and, upon the approval of the aforementioned tolerances, to remove established tolerances for residues of cyantraniliprole, including its metabolites and degradates, in or on olive oil at 2 ppm. That document referenced a summary of the petition prepared by FMC, the petitioner, which is available in the docket, https://www.regulations.gov. A comment was received on the notice of filing. EPA's response to the comment is discussed in Unit IV.C.

Based upon review of the data supporting the petition and in accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA has made modifications to two of the proposed tolerance values. The reason for these changes is explained in Unit IV.D.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

Consistent with FFDCA section 408(b)(2)(D), and the factors specified therein, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for cyantraniliprole including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with cyantraniliprole follows.

In an effort to streamline its publications in the Federal Register , EPA is not reprinting sections that repeat what has been previously published for tolerance rulemakings for the same pesticide chemical. Where scientific information concerning a particular chemical remains unchanged, the content of those sections would not vary between tolerance rulemakings, and EPA considers referral back to those sections as sufficient to provide an explanation of the information EPA considered in making its safety determination for the new rulemaking.

EPA has previously published tolerance rulemakings for cyantraniliprole in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to cyantraniliprole and established tolerances for residues of that chemical. EPA is incorporating previously published sections from these rulemakings as described further in this rulemaking, as they remain unchanged.

Toxicological profile. For a discussion of the Toxicological Profile of cyantraniliprole, see Unit III.A. of the cyantraniliprole tolerance rulemaking published in the Federal Register of November 13, 2018 (83 FR 56262) (FRL-9985-32).

Toxicological points of departure/Levels of concern. For a discussion of the Toxicological Points of Departure/Levels of Concern used for the safety assessment of cyantraniliprole, see Unit III.B of the February 5, 2014, rulemaking (79 FR 6826) (FRL-9388-7).

Dietary exposure assessment. Much of the exposure assessment for cyantraniliprole remains unchanged from the discussion in Unit III.C of the November 13, 2018, rulemaking, except as described below. EPA's dietary exposure assessments have been updated to include the additional exposures from the tolerances established since the November 13, 2018, rulemaking and the petitioned-for tolerances excluding the crop subgroup expansions to field corn subgroup 15-22C, sweet corn subgroup 15-22D and rice subgroup 15-22F. An acute dietary endpoint was not selected; therefore, an acute assessment was not performed. A refined chronic dietary (food and drinking water) exposure assessment was conducted using the Dietary Exposure Evaluation Model-Food Commodity Intake Database DEEM-FCID and assuming average field trial residues or mean residue values from the United States Department of Agriculture (USDA) Pesticide Data Program (PDP), empirical processing factors and/or HED's default processing factors and assumed 100 percent crop treated (PCT). In some cases, data were translated from representative commodities of their crop group.

Anticipated residue information. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.

Drinking water and non-occupational exposures. The estimated drinking water concentrations (EDWCs) have not changed since the 2018 rulemaking. For a detailed summary of the drinking water analysis for cyantraniliprole used for the human health risk assessment, see Unit III.C.2. of the November 13, 2018, tolerance rulemaking. There are no proposed residential uses or proposed uses intended for use by occupational handlers in residential settings for this action. However, there are residential exposures from currently registered uses of cyantraniliprole which have been previously assessed. The registered residential uses and exposures that are incorporated into the aggregate assessment are described in Unit III.C.3 of the November 13, 2018, final rule.

Cumulative exposures. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to cyantraniliprole and any other substances and cyantraniliprole does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that cyantraniliprole has a common mechanism of toxicity with other substances.

In 2016, EPA's Office of Pesticide Programs released a guidance document entitled, Pesticide Cumulative Risk Assessment: Framework for Screening Analysis https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework. This document provides guidance on how to screen groups of pesticides for cumulative evaluation using a two-step approach beginning with the evaluation of available toxicological information and if necessary, followed by a risk-based screening approach. This framework supplements the existing guidance documents for establishing common mechanism groups (CMG) and conducting cumulative risk assessments.

Cyantraniliprole has been grouped with the diamide pesticide class. As part of the ongoing process to review registered pesticides, the Agency intends to apply this framework to determine if the available toxicological data for cyantraniliprole suggests a candidate CMG may be established with other pesticides. If a CMG is established, a screening-level toxicology and exposure analysis may be conducted to provide an initial screen for multiple pesticide exposure.

Safety factor for infants and children. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. EPA continues to conclude that there is reliable data showing that the safety of infants and children would be adequately protected if the Food Quality Protection Act (FQPA) safety factor were reduced from 10X to 1X. The reasons for that decision are articulated in Unit III.D of the November 13, 2018, rulemaking.

Aggregate risk and Determination of safety. EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing dietary exposure estimates to the acute population-adjusted dose (aPAD) and chronic PAD (cPAD). Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated total food, water, and residential exposure to the appropriate points of departure to ensure that an adequate margin of exposure (MOE) exists. An acute dietary exposure assessment was not performed as there were no indication of an adverse effects attributable to a single dose. Cyantraniliprole is not expected to pose an acute risk.

Chronic dietary risks are below the Agency's level of concern of 100% of the cPAD; they are 85% of the cPAD for children 1 to 2 years old, the most highly exposed population subgroup. The chronic aggregate risk assessment includes only long-term exposure to residues in food and drinking water since there are no residential scenarios that result in long-term exposure; therefore, the chronic aggregate risks are equivalent to the chronic dietary risks and are not of concern.

There is potential for short-term aggregate exposure to cyantraniliprole via the dietary (food + drinking water) and residential pathways. Since there is no dermal endpoint, the short-term aggregate exposure assessment for children includes dietary (considered background) and incidental oral (primary) routes. For children 1 to 2 years old, the short-term aggregate risk estimates are not of concern. The aggregate MOE is 159, which is greater than the level of concern of 100.

Intermediate-term aggregate assessments include exposures that will occur from 30 days to 6 months. Residential intermediate-term exposures are not expected for adults, however intermediate-term incidental oral post-application exposures for children 1 to <2 years old are possible ( i.e., from contact to treated carpet), due to the persistence of cyantraniliprole. Since the incidental oral POD is the same for short-term and intermediate-term durations, the short-term aggregate risk estimates are protective of potential intermediate aggregate risks and are not of concern.

Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, cyantraniliprole is not expected to pose a cancer risk to humans.

Based on the risk assessments and information described above, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to cyantraniliprole residues. More detailed information on this action can be found in the document titled “Cyantraniliprole: New Uses of Cyantraniliprole on Herb Group 25, Hops, Papaya and Spice Group 26; Amended Application Scenario for Lettuce (Greenhouse Application) and Strawberry (Reduction in Retreatment Interval); Crop Subgroup Expansions to Field Corn Subgroup 15-22C, Sweet Corn Subgroup 15-22D and Rice Subgroup 15-22F; and Crop Subgroup Conversion to Legume Vegetable Subgroup 6-22A-F and 7-22A.” in docket ID EPA-HQ-OPP-2023-0078, and the document titled “Cyantraniliprole. Human Health Risk Assessment for the Proposed Section 3 Tolerance Request without U.S. Registration for Grape (table), Avocado, Mango, and Olive to Replace Existing Import Tolerances on Olive and Olive, Oil” in docket ID EPA-HQ-OPP-2022-0958. The rule is establishing tolerances from two separate petitions and summarizes information from both risk assessments. The dietary exposure estimates and MOE numbers referenced above are from the more recently conducted, comprehensive assessment titled “Cyantraniliprole. Human Health Risk Assessment for the Proposed Section 3 Tolerance Request without U.S. Registration for Grape (table), Avocado, Mango, and Olive to Replace Existing Import Tolerances on Olive and Olive, Oil”, which includes the additional exposures described in the other risk assessment.

For information about the available analytical enforcement method, see Unit IV.A of the November 13, 2018, rulemaking.

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 does not have MRLs for residues of cyantraniliprole in/on herbs (fresh or dried), spices, hops, papaya, or the foliage of legume vegetables. The U.S. tolerances for residues of cyantraniliprole in or on subgroups 6-22A (2 ppm), 6-22B (2 ppm), 6-22C (0.3 ppm), 6-22D (0.3 ppm), avocados (0.4 ppm), and grapes, table (2 ppm) and mango (0.7 ppm) are harmonized with the corresponding Codex MRLs. The U.S. tolerances for residues of cyantraniliprole in or on subgroups 6-22E (1 ppm) and 6-22F (1 ppm) cannot be not harmonized with the Codex MRL of 0.3 ppm because decreasing the tolerance to harmonize would put U.S. growers at risk of having violative residues despite legal use of cyantraniliprole according to the label. The U.S. tolerance for residues of cyantraniliprole on olives (3 ppm) cannot be harmonized with the Codex MRL of 1 ppm because imported olives treated legally in the exporting country could have violative residues.

There were no comments received on the notice of filing of pesticide petition PP2E9041 submitted by IR-4. One comment was received on the notice of filing of pesticide petition PP2E9032 submitted by the FMC Corporation. The comment is an inquiry from the People's Republic of China, requesting that the Agency provide the test data used for risk assessment of the relevant commodities. The data supporting the avocado, grape, mango, and olive tolerances were submitted to the Agency and were reviewed and reported in the document titled “Cyantraniliprole. Human Health Risk Assessment for the Proposed Section 3 Tolerance Request without U.S. Registration for Grape (table), Avocado, Mango, and Olive to Replace Existing Import Tolerances on Olive and Olive, Oil.” This document can be found in docket ID number EPA-HQ-OPP-2022-0958.

The Agency is revising the commodity definitions for many of the tolerances to current agency nomenclature.

EPA is also not establishing the requested tolerances of cyantraniliprole in/on the field corn subgroup 15-22C, sweet corn subgroup 15-22D and rice subgroup 15-22F because the petitioner withdrew the requested tolerances from the petition.

EPA is establishing the tolerance for residues of cyantraniliprole in or on grape, table at 2 ppm rather than 2.0 ppm and the tolerance for olive at 3 ppm rather than 3.0 ppm to be consistent with EPA rounding practices.

Therefore, tolerances are established for residues of cyantraniliprole, including its metabolites and degradates, in or on the following commodities: herb, dried leaves, subgroup 25B at 150 ppm; herb, fresh leaves, subgroup 25A at 40 ppm; hop, dried cones at 70 ppm; papaya at 1.5 ppm; spice crop group 26 at 80 ppm; vegetable, legume, bean, edible podded, subgroup 6-22A at 2 ppm; vegetable, legume, bean, succulent shelled, subgroup 6-22C at 0.3 ppm; vegetable, legume, forage and hay, except soybean, subgroup 7-22A at 40 ppm; vegetable, legume, pea, edible podded, subgroup 6-22B at 2 ppm; vegetable, legume, pea, succulent shelled, subgroup 6-22D at 0.3 ppm; vegetable, legume, pulse, bean, dried shelled, except soybean, subgroup 6-22E at 1 ppm; and vegetable, legume, pulse, pea, dried shelled, subgroup 6-22F at 1 ppm. EPA is removing the established tolerances for residues of cyantraniliprole, in or on the following commodities upon the establishment of the new tolerances: vegetable, foliage of legume, except soybean, group 7A at 40 ppm; vegetable, legume, dried shelled, except soybean, subgroup 6C at 1.0 ppm; vegetable, legume, edible podded, subgroup 6A at 2.0 ppm; and vegetable, legume, succulent shelled, subgroup 6B at 0.20 ppm.

Additionally, tolerances are established for residues of cyantraniliprole, including its metabolites and degradates, in or on the following imported commodities: avocado at 0.4 ppm; grape, table at 2 ppm; and mango at 0.7 ppm. Finally, the tolerance for residues of cyantraniliprole, including its metabolites and degradates, in or on olive is revised from 1.5 ppm to 3 ppm and the tolerance for residues in or on olive, oil at 2.0 ppm is removed.

This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. 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 on the basis of a petition under FFDCA section 408(d), 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:

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:

You may access a frequently updated electronic version of EPA's tolerance regulations at 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(g), 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-2021-0624 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before July 15, 2024. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

EPA's Office of Administrative Law Judges (OALJ), in which the Hearing Clerk is housed, urges parties to file and serve documents by electronic means only, notwithstanding any other particular requirements set forth in other procedural rules governing those proceedings. See “Revised Order Urging Electronic Service and Filing”, dated June 22, 2023, which can be found at https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf.

Although EPA's regulations require submission via U.S. Mail or hand delivery, EPA intends to treat submissions filed via electronic means as properly filed submissions; therefore, EPA believes the preference for submission via electronic means will not be prejudicial. When submitting documents to the OALJ electronically, a person should utilize the OALJ e-filing system at https://yosemite.epa.gov/oa/eab/eab-alj_upload.nsf.

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-2021-0624, 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.

In the Federal Register of July 5, 2023 (88 FR 42935) (FRL-10579-05-OCSPP) EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 3E9059) by Bayer CropScience LP, 800 N Lindbergh Blvd., St. Louis, MO 63167. The petition requested to establish a tolerance in 40 CFR part 180 for residues of the insecticide, tetraniliprole [1-(3-chloro-2-pyridinyl)- N -[4-cyano-2-methyl-6-[(methylamino)carbonyl]phenyl]-3-[[5- (trifluoromethyl)-2 H -tetrazol-2-yl]methyl]-1 H -pyrazole-5-carboxamide], in or on Tea, dried at 80 parts per million (ppm). That document referenced a summary of the petition, which is available in the docket, https://www.regulations.gov. Two comments were received in response to the Notice of Filing. EPA's response to these comments can be found in section IV.C.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

Consistent with FFDCA section 408(b)(2)(D), and the factors specified therein, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for tetraniliprole including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with tetraniliprole follows.

In an effort to streamline its publications in the Federal Register , EPA is not reprinting sections that repeat what has been previously published for tolerance rulemaking of the same pesticide chemical. Where scientific information concerning a particular chemical remains unchanged, the content of those sections would not vary between tolerance rulemaking, and EPA considers referral back to those sections as sufficient to provide an explanation of the information EPA considered in making its safety determination for the new rulemaking.

EPA has previously published a tolerance rulemaking for tetraniliprole in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to tetraniliprole and established tolerances for residues of that chemical. EPA is incorporating previously published sections from this rulemaking as described further in this rulemaking, as they remain unchanged.

For a discussion of the Toxicological Profile of tetraniliprole, see Unit III.A. of the tetraniliprole tolerance rulemaking published in the Federal Register of February 24, 2021 (86 FR 11133) (FRL-10005-77).

Based on a thorough analysis of the toxicology database of tetraniliprole, the Agency has determined that a qualitative risk assessment is more appropriate for tetraniliprole than a quantitative risk assessment. For more details, please reference Unit III.B. of the February 24, 2021, rulemaking.

There is potential for exposure to tetraniliprole via food and feed based on the proposed tolerance for residues on imported tea. However, no adverse effects were observed in the submitted toxicological studies for tetraniliprole regardless of the route of exposure. Thus, no quantitative dietary exposure assessments are needed for EPA to conclude with reasonable certainty that dietary exposures to tetraniliprole do not pose a significant human health risk.

Drinking water and non-occupational exposures. There are no residues of toxicological concern expected in drinking water from the use of tetraniliprole. Thus, no drinking water exposure assessments are needed for the Agency to conclude with reasonable certainty that drinking water exposures to tetraniliprole do not pose a significant human health risk.

Tetraniliprole is registered for use on golf course turf and sports fields that could result in residential post-application exposures. However, no adverse effects were observed in the submitted toxicological studies for tetraniliprole regardless of the route of exposure; therefore, a quantitative residential post-application exposure assessment was not conducted. Thus, no residential exposure assessments are needed for the Agency to conclude with reasonable certainty that residential exposures to tetraniliprole do not pose a significant human health risk.

Cumulative exposure. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to tetraniliprole and any other substances. Tetraniliprole does not also appear to produce a toxic metabolite produced by other substances. For the purposes of this action, therefore, EPA has not assumed that tetraniliprole has a common mechanism of toxicity with other substances.

Section 408(b)(2)(C) requires the application of an additional tenfold margin of safety to account for potential risks to infants and children, in the case of threshold effects. For tetraniliprole, EPA has not identified any toxicological endpoints of concern associated with any threshold effects and is conducting a qualitative assessment. That qualitative assessment does not use safety factors for assessing risk, and no additional safety factor is needed for assessing risk to infants and children. EPA has also evaluated the available data and concluded that there are no residual uncertainties concerning the potential risks to infants and children that would impact its conclusions about threshold effects.

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute population-adjusted dose (aPAD) and chronic population-adjusted dose (cPAD). Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate points of departure to ensure that an adequate margin of exposure (MOE) exists. For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure.

No adverse effects were observed in the submitted toxicological studies at doses relevant to human health pesticide risk assessment for tetraniliprole regardless of the route of exposure. Effects observed in the data base ( e.g., decreased body weight) were both marginal and only seen at doses not expected to occur daily or over an extended period.

Based on a lack of toxicity at exposure levels expected from approved application rates and an expectation that aggregate exposures to residues of tetraniliprole will not reach the levels required to cause any adverse effects, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to tetraniliprole residues. More detailed information on this action can be found in the document titled “Tetraniliprole: Petition for the Establishment of a Tolerance without U.S. Registration for use on Tea. Summary of Analytical Chemistry and Residue Data” in docket ID EPA-HQ-OPP-2021-0624.

For a discussion of the available analytical enforcement method, see Unit IV.A. of the February 24, 2021, rulemaking.

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).

There are no Codex MRLs for residues of tetraniliprole in or on Tea, dried.

Two comments were received in response to the Notice of Filing from different commenters. One commenter stated in part that “ I totally oppose granting any tolerance changes or added tolerances of any kind to any of the toxic chemicals that are listed in Federal Register notice ”. . . “ none of them should ever be approved or used in the world. they are harmful . . .” The other commenter opposed granting any tolerances because all active ingredients are harmful. This commenter also mentioned results related to birth defects from pesticides from a study but did not provide a citation of said study. Thus, the information cannot be substantiated or addressed. According to the commenter “ Pesticide exposure during susceptible windows and at certain doses are linked to numerous birth defects.” Holoprosencephaly (HPE), malformation of the forebrain in humans was the focus of this study, according to the commenter. Although the Agency recognizes that some individuals believe that pesticides should be banned, the existing legal framework provided by section 408 of the FFDCA authorizes EPA to establish tolerances when it determines that the tolerances are safe. Upon consideration of the validity, completeness, and reliability of the available data as well as other factors the FFDCA requires EPA to consider, EPA has determined that the tetraniliprole tolerance on tea is safe. The commenters have not provided information indicating that a safety determination cannot be supported.

Therefore, tolerances are established for residues of tetraniliprole in or on Tea, dried at 80 ppm.

This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. 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 to 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).

Because tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance 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 1 as follows:

EPA is publishing this rule without prior proposal because the EPA views this as a noncontroversial action and does not anticipate adverse comments. However, in the “Proposed Rules” section of this Federal Register , EPA is publishing a separate document that will serve as a proposal to authorize the revision should the EPA receive adverse comment. Unless EPA receives adverse written comments during the review and comment period, the decision to authorize South Dakota's UST program revision will take effect as provided below. The State's federally authorized and codified UST program, as revised pursuant to this action, will remain subject to the EPA's inspection and enforcement authorities under RCRA and other applicable statutory and regulatory provisions.

States which have received final approval from the EPA under RCRA section 9004(b) of RCRA, 42 U.S.C. 6991c(b), must maintain an underground storage tank program that is equivalent to, consistent with, and no less stringent than the Federal program. As the Federal program changes, States must change their programs to comply with the updated regulations and submit these revisions to the EPA for approval. Changes to State programs may be necessary when Federal or State statutory or regulatory authority is modified or when certain other changes occur. Most commonly, States must change their programs because of changes to EPA's regulations in 40 Code of Federal Regulations (CFR) part 280.

On October 24, 2023, the State of South Dakota submitted a final complete program revision application seeking authorization of changes to its UST program that correspond to the EPA final rule promulgated on July 15, 2015 (80 FR 41566), which revised the 1988 UST regulations and the 1988 State program approval (SPA) regulations (2015 Federal Revisions). As required by 40 CFR 281.20, the State Application contains the following: a transmittal letter from the Governor requesting approval, a description of the program and operating procedures, a demonstration of the State's procedures to ensure adequate enforcement, a Memorandum of Agreement outlining the roles and responsibilities of the EPA and the implementing agency, a statement of certification from the Attorney General, and copies of all relevant State statutes and regulations. The EPA has reviewed South Dakota's application to revise its authorized program and determined that the revisions to South Dakota's UST program are equivalent to, consistent with, and no less stringent than the corresponding Federal requirements in subpart C of 40 CFR part 281, and that the South Dakota program provides for adequate enforcement of compliance (40 CFR 281.11(b)). Therefore, we grant South Dakota final authorization to operate its UST program with the changes described in the program revision application and as outlined below in section I.G. of this document.

This action does not impose additional requirements on the regulated community because the regulations being approved by this rule are already in effect in the State of South Dakota and are not changed by this action. This action merely approves the existing State regulations as meeting the Federal requirements and renders them federally enforceable.

The EPA is publishing this direct final rule without a prior proposed rule because we view this as a noncontroversial action and we anticipate no adverse comment. South Dakota received comments during its comment period when the rules and regulations in this document were being considered and were proposed at the State level. All comments were addressed at public hearing and/or reflected in the adopted regulations.

If EPA receives comments that oppose this approval, the EPA will withdraw this direct final rule by publishing a document in the Federal Register before it becomes effective. The EPA will base any further decision on approval of the State Application after considering all comments received during the comment period. The EPA will then address all public comments in a later final rule. You may not have another opportunity to comment. If you want to comment on this approval, you must do so at this time.

On May 15, 1995, the EPA finalized a rule approving the UST program that South Dakota proposed to administer in lieu of the Federal UST program. On May 15, 1995, EPA codified the approved South Dakota program that is subject to EPA's inspection and enforcement authorities under RCRA sections 9005 and 9006, 42 U.S.C. 6991d and 6991e, and other applicable statutory and regulatory provisions.

In order to be approved, each State program application must meet the general requirements in 40 CFR 281.11, and specific requirements in 40 CFR subparts B, C, and D. This also is true for proposed revisions to approved State programs.

As more fully described below, the State has made the changes to its approved UST program to reflect the 2015 Federal Revisions. The EPA is approving the State's changes because they are equivalent to, consistent with, and no less stringent than the Federal UST program and because the EPA has confirmed that the South Dakota UST program will continue to provide for adequate enforcement of compliance as described in 40 CFR 281.11(b) and part 281, subpart D after this approval.

The South Dakota Department of Agriculture and Natural Resources (Department) is the lead implementing agency for the UST program in South Dakota, except for (1) all lands located within formal Indian Reservations within or abutting the State of South Dakota, including the Cheyenne River Indian Reservation, Crow Creek Indian Reservation, Flandreau Indian Reservation, Lower Brule Indian Reservation, Pine Ridge Indian Reservation, Rosebud Indian Reservation, Sisseton Wahpeton Indian Reservation, Standing Rock Indian Reservation, Yankton Indian Reservation; (2) any land held in trust by the United States for an Indian Tribe; and (3) any other land, whether on or off a reservation that qualifies as “Indian country” within the meaning of 18 U.S.C. 1151.

The Department continues to have broad statutory authority to regulate the installation, operation, maintenance, and closure of USTs, as well as UST releases under South Dakota Codified Laws (SDCL), Title 34A Environmental Protection, Chapter 2 Water Pollution Control, section 99 Underground Storage Tanks (2021) and selected provisions from SDCL sections 34A-12 Regulated Substance Discharges (2021), 34A-93 Implementation of and Compliance with Certain Federal Energy Acts (2009), and 34A-98 Underground Storage Tanks (2021). The South Dakota UST Program gets its enforcement authority from the powers of the Department found in SDCL sections 34A-12-3 through 34A-12-12 and 34A-13-4. Under 34A-6-1.20, an employee or agent of the Department has the authority to enter and inspect any property premises or place where regulated substances are stored at any reasonable time. In the case of a release, SDCL provisions 34A-2-99(4) and 34A-13-4 provide employees or agents of the Department the authority to take such action is necessary, including the authority to enter any property, premises or place where an UST is located for inspection, in order to conduct sampling, and to have access to records. SDCL provision 34A-2-99(4) provides the Department with rulemaking authority for corrective action. Notice of violation may be issued, and penalties for noncompliance with South Dakota's UST Act may be assessed under SDCL section 34A-2-93. The State also includes requirements for delivery prohibitions in the event of noncompliance as described in the Administrative Rules of South Dakota (ARSD) section 75:56:01:56.

Specific authorities to regulate the installation, operation, maintenance, and closure of USTs, as well as UST releases, are found under SDCL 34A-2-99, in addition to the regulatory provisions of Administrative Rules of South Dakota (ARSD) Chapter 74:56:01 Underground Storage Tanks, as amended effective April 19, 2021 and ARSD Chapter 74:56:02 Financial Responsibility, as amended effective April 19, 2021. The aforementioned statutory and regulatory sections satisfy the requirements of 40 CFR 281.40 and 281.41.

Through a Memorandum of Agreement between the State of South Dakota and the EPA, signed by the EPA Region 8 Regional Administrator October 15, 2023, the State maintains procedures for receiving and ensuring proper consideration of information about violations submitted by the public. The State agrees to comply with public participation provisions contained in 40 CFR 281.42, including the provisions that the State will investigate and provide responses to citizen complaints and not oppose citizen intervention when permissive intervention is allowed by statute, rule, or regulation. South Dakota has met the public participation requirements found in 40 CFR 281.42.

To qualify for final approval, revisions to a State's program must be “equivalent to, consistent with, and no less stringent” than the 2015 Federal Revisions. In the 2015 Federal Revisions the EPA addressed UST systems deferred in the 1988 UST regulations, and added, among other things, new operation and maintenance requirements; secondary containment requirements for new and replaced tanks and piping; operator training requirements; and a requirement to ensure UST system compatibility before storing certain biofuel blends. In addition, the EPA removed past deferrals for emergency generator tanks, field constructed tanks, and airport hydrant systems. The EPA analyzes revisions to approved State programs pursuant to the criteria found in 40 CFR 281.30 through 281.39.

The Department has revised its regulations to help ensure that the State's UST program revisions are equivalent to, consistent with, and no less stringent than the 2015 Federal Revisions. In particular, the Department has amended the Administrative Rules of South Dakota to incorporate the revised requirements of 40 CFR part 280, including the requirements added by the 2015 Federal Revisions. The State, therefore, has ensured that the criteria found in 40 CFR 281.30 through 281.38 are met.

Section 281.39 describes the State operator training requirements that must be met in order to be considered equivalent to, consistent with, and no less stringent than Federal requirements. South Dakota has promulgated and is implementing its own operator training provisions under Administrative Rules of South Dakota section 74:56:01:38:01. After a thorough review, the EPA has determined that South Dakota's operator training requirements are equivalent to, consistent with, and no less stringent than Federal requirements.

As part of the State Application, the Attorney General of South Dakota certified that the laws of the State of South Dakota provide adequate authority to carry out the “no less stringent” technical requirements submitted by the State in order to meet the criteria in 40 CFR 281.30 through 281.39. The EPA is relying on this certification in addition to the analysis submitted by the State in making our determination.

For further information on the EPA's analysis of the State's application, see the chart in the Technical Support Document (TSD) contained in the docket for this rulemaking.

Where an approved State program has a greater scope of coverage than required by Federal law, the additional coverage is not part of the federally approved program and are not federally enforceable (40 CFR 281.12(a)(3)(ii)). South Dakota's State program does not include any regulatory requirements that are considered broader in coverage than the Federal program.

Where an approved State program includes requirements that are considered more stringent than required by Federal law, the more stringent requirements become part of the federally approved program (40 CFR 281.12(a)(3)(i)).

We consider the following State requirements to be more stringent than the Federal requirements:

South Dakota does not adopt the extensive Energy Policy Act (EPAct) changes to § 280.10(a), which subjects the listed types of tanks to different regulation under the Federal program based on the tank's installation date within the unnumbered paragraph following 74:56:01:03(6). As a result, South Dakota subjects UST systems with field-constructed tanks to full regulation under the “all owners or operators of an UST system” language of 74:56:01:03 introductory paragraph and airport hydrant fuel distribution systems and tanks installed before the effective date of the rule [§ 280.10(a)(1)(ii)] to all the requirements of chapter 74:56:01, making the State more stringent than Federal.

South Dakota does not have an analog to Federal provision § 280.10(c) which allows many UST systems to be excluded from the regulations of Federal part 280. The absence of a State analog to this Federal provision results in more tanks being subject to full regulation, which is more stringent than Federal.

At ARSD 74.56.01:11(3) South Dakota requires the submittal of plans and specifications of both new and upgraded systems for approval at least 30 days prior to installation for the State to determine installed or upgraded systems meet minimum requirements. This additional State-only approval is more stringent than the Federal.

Within the second unnumbered paragraph after 74:56:01:12(5) South Dakota requires an additional State-only notification in the event of any changes of information stated in a certification of compliance form. The additional notification requirement is more stringent than Federal, which does not include a similar notification.

South Dakota does not have an analog to Federal provision § 280.43(h) which allows UST system owners and operators to use statistical inventory reconciliation as an alternative method to detect releases. The absence of a State analog to this Federal provision results in the State being more stringent as it does not allow for this alternative method to be used.

At section 74:56:01:40(2) South Dakota does not adopt the exceptions to the reporting of suspected releases included in Federal § 280.50(b)(1) through (3). As a result, South Dakota's regulations are more stringent than Federal because the State continues to require the reporting of releases in circumstances where, otherwise, under the Federal program, they would not be required to report.

Within the introductory paragraph of section 74:56:01:47(3) South Dakota requires the preparation and submittal of a free product removal report within 30 days, unlike the 45-day requirement in the Federal provision at § 280.64 introductory text. South Dakota's shorter timeline makes the State more stringent than Federal.

South Dakota is not authorized to carry out its UST program in Indian country, as defined in 18 U.S.C. 1151. This includes, but is not limited to:

1. Lands within the exterior boundaries of the following Indian Reservations located within or abutting the State of South Dakota:

a. Cheyenne River Indian Reservation,

b. Crow Creek Indian Reservation,

c. Flandreau Indian Reservation,

d. Lower Brule Indian Reservation,

e. Pine Ridge Indian Reservation,

f. Rosebud Indian Reservation,

g. Sisseton Wahpeton Indian Reservation,

h. Standing Rock Indian Reservation,

i. Yankton Indian Reservation;

2. Any land held in trust by the U.S. for an Indian Tribe, and

3. Any other land, whether on or off a reservation that qualifies as Indian country within the meaning of 18 U.S.C. 1151.

Therefore, this program revision does not extend to Indian country where EPA will continue to implement and administer the UST program in these lands. See 40 CFR 281.12(a)(2).

Codification is the process of placing a State's statutes and regulations that comprise the State's authorized UST program into the CFR. Section 9004(b) of RCRA, as amended, allows the EPA to approve State UST programs to operate in lieu of the Federal program. The EPA codifies its authorization of State programs in 40 CFR part 282 and incorporates by reference State regulations that the EPA will enforce under sections 9005 and 9006 of RCRA and any other applicable statutory provisions. The incorporation by reference of State authorized programs in the CFR should substantially enhance the public's ability to discern the current status of the approved State program and State requirements that can be federally enforced. This effort provides clear notice to the public of the scope of the approved program in each State.

EPA incorporated by reference South Dakota's then approved UST program effective May 15, 1995 (60 FR 14334; March 16, 1995). Through this action, the EPA is revising 40 CFR 282.91 to include the approval revision actions.

In this rule, we are finalizing the Federal regulatory text that incorporates by reference the federally authorized South Dakota UST Program. In accordance with the requirements of 1 CFR 51.5, we are finalizing the incorporation by reference of the South Dakota rules described in the amendments to 40 CFR part 282 set forth below. The EPA has made, and will continue to make, these documents generally available through https://www.regulations.gov and/or in hard copy at the EPA Region 8 office (see the ADDRESSES section of this preamble for more information).

One purpose of this Federal Register document is to codify South Dakota's approved UST program. The codification reflects the State program that would be in effect at the time the EPA's approved revisions to the South Dakota UST program addressed in this direct final rule become final. If, however, the EPA receives substantive comment on the proposed rule, then this codification will not take effect, and the State rules that are approved after the EPA considers public comment will be codified instead. By codifying the approved South Dakota program and by amending the CFR, the public will more easily be able to discern the status of the federally approved requirements of the South Dakota program.

The EPA is incorporating by reference the South Dakota approved UST program in 40 CFR 282.91. Section 282.91(d)(1)(i)(A) incorporates by reference for enforcement purposes the State's regulations. Section 282.91 also references the Attorney General's Statement, Demonstration of Adequate Enforcement Procedures, the Program Description, and the Memorandum of Agreement, which are approved as part of the UST program under subtitle I of RCRA.

The EPA retains the authority under sections 9003(h), 9005 and 9006 of subtitle I of RCRA, 42 U.S.C. 6991b(h), 6991d and 6991e, and other applicable statutory and regulatory provisions to undertake corrective action, inspections, and enforcement actions, and to issue orders in approved States. If the EPA determines it will take such actions in South Dakota, the EPA will rely on Federal sanctions, Federal inspection authorities, and other Federal procedures rather than the State analogs. Therefore, though the EPA has approved the State procedures listed in 40 CFR 282.91(d)(1)(ii), the EPA is not incorporating by reference South Dakota's procedural and enforcement authorities.

The public also needs to be aware that some provisions of the State's UST program are not part of the federally approved State program. Such provisions are not part of the RCRA subtitle I program because they are “broader in coverage” than subtitle I of RCRA. Section 281.12(a)(3)(ii) states that where an approved State program has provisions that are broader in coverage than the Federal program, those provisions are not a part of the federally approved program. As a result, State provisions which are “broader in coverage” than the Federal program are not incorporated by reference for purposes of enforcement in part 282. Section 282.91(d)(1)(iii) lists for reference and clarity the South Dakota statutory and regulatory provisions which are “broader in coverage” than the Federal program and which are not, therefore, part of the approved program being codified. Provisions that are “broader in coverage” cannot be enforced by EPA; the State, however, will continue to implement and enforce such provisions under State law.

This action only applies to South Dakota's UST Program requirements pursuant to RCRA section 9004 and imposes no requirements other than those imposed by State law. It complies with applicable E.O.s and statutory provisions as follows:

The Office of Management and Budget (OMB) has exempted this action from the requirements of Executive Order 12866 (58 FR 51735, Oct. 4, 1993) and 13563 (76 FR 3821, Jan. 21, 2011). This action approves and codifies State requirements for the purpose of RCRA section 9004 and imposes no additional requirements beyond those imposed by State law. Therefore, this action is not subject to review by OMB.

This action is not an Executive Order 13771 (82 FR 9339, February 3, 2017) regulatory action because actions such as this final approval of South Dakota's revised underground storage tank program under RCRA are exempted under Executive Order 12866. Accordingly, I certify that this action will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ).

Because this action approves and codifies pre-existing requirements under State law and does not impose any additional enforceable duty beyond that required by State law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538). For the same reason, this action also does not significantly or uniquely affect the communities of Tribal governments, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

This action will not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, Aug. 10, 1999), because it merely approves and codifies State requirements as part of the State RCRA Underground Storage Tank Program without altering the relationship or the distribution of power and responsibilities established by RCRA.

This action also is not subject to Executive Order 13045 (62 FR 19885, Apr. 23, 1997), because it is not economically significant and it does not make decisions based on environmental health or safety risks.

This rule is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001) because it is not a “significant regulatory action” as defined under Executive Order 12866.

Under RCRA section 9004(b), the EPA grants a State's application for approval as long as the State meets the criteria required by RCRA. It would thus be inconsistent with applicable law for the EPA, when it reviews a State approval application, to require the use of any particular voluntary consensus standard in place of another standard that otherwise satisfies the requirements of RCRA. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply.

As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, the EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct.

The EPA has complied with Executive Order 12630 (53 FR 8859, Mar. 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the Executive order.

This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). “Burden” is defined at 5 CFR 1320.3(b).

Executive Order 12898 (59 FR 7629, Feb. 16, 1994) establishes Federal executive policy on environmental justice. Its main provision directs Federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States. Because this rule approves pre-existing State rules which are at least equivalent to, consistent with, and no less stringent than existing Federal requirements, and imposes no additional requirements beyond those imposed by State law, and there are no anticipated significant adverse human health or environmental effects, the rule is not subject to Executive Order 12898.

The Congressional Review Act, 5 U.S.C. 801-808, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this document 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 in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2); however, this action will be effective July 15, 2024 because it is a direct final rule.

For the reasons set forth in the preamble, EPA is amending 40 CFR part 282 as follows: