DOE maintains a previously approved incorporation by reference and incorporates by reference the following standard into 10 CFR part 433:

For a further discussion of these standards, see section VII.N of this document.

Section 305 of ECPA, as amended, requires DOE to determine whether the energy efficiency standards for new Federal buildings  1 should be updated to reflect revisions to ASHRAE Standard 90.1 based on the cost-effectiveness of the revisions. (42 U.S.C. 6834(a)(3)(B)) Accordingly, DOE conducted a cost-effectiveness analysis that found ASHRAE Standard 90.1-2019 to be cost-effective for new Federal commercial and multi-family high-rise residential buildings. DOE's assumptions and methodology for the cost-effectiveness of this rule are based on DOE's State building energy codes program's cost-effectiveness analysis of ASHRAE Standard 90.1-2016 and ASHRAE Standard 90.1-2019. 2 These assumptions and methodology also provide the basis for the environmental assessment (EA) for this rulemaking. Therefore, in this final rule, DOE updates the energy efficiency standards for new Federal buildings to ASHRAE Standard 90.1-2019 for buildings for which design for construction begins on or after one year after this rule is published in the Federal Register . (42 U.S.C. 6834(a)(3)(A))

To ensure consistency with ASHRAE Standard 90.1-2019, this final rule also limits the types of process and receptacle loads that may be excluded from the calculation of the 30 percent improvement beyond ASHRAE Standard 90.1 by revising 10 CFR 433.101(b) to require Federal agencies to include unregulated energy use ( i.e., process loads and receptacle loads not within the scope of ASHRAE Standard 90.1) when calculating the 30 percent improvement beyond ASHRAE Standard 90.1, except for energy-intensive process loads that are: (i) Driven by mission and operational requirements, not necessarily buildings, and (ii) not influenced by conventional building energy conservation measures.

This final rule also amends the definition for “new Federal buildings” in 10 CFR 433.2 to include buildings leased by Federal agencies and privatized military housing in accordance with amendments to the underlying statutory definition of this term made by the Energy Independence and Security Act (EISA) 2007. 3 This final rule also makes technical amendments to the definitions in 10 CFR 433.2 for consistency with the materials incorporated by reference in 10 CFR 433.3.

Additionally, in the discussion of final rule, DOE clarifies and reiterates several programmatic principles related to agencies' implementation of ASHRAE Standard 90.1. These clarifications do not represent changes to the regulations in 10 CFR part 433. However, DOE frequently receives repeat questions from Federal agencies expressing confusion over particular aspects of implementing ASHRAE Standard 90.1. Accordingly, DOE wishes to reduce agencies' confusion by clarifying several important principles of implementing ASHRAE Standard 90.1 in the discussion of final rule.

ECPA, as amended, requires DOE to establish building energy efficiency standards for all new Federal buildings. (42 U.S.C. 6834(a)(1)) The standards established under section 305(a)(1) of ECPA must contain energy efficiency measures that are technologically feasible, economically justified, and meet the energy efficiency levels in the applicable voluntary consensus energy codes specified in section 305. (42 U.S.C. 6834(a)(1)-(3)) Section 306(a) of ECPA further provides that each Federal agency and the Architect of the Capitol must adopt procedures to ensure that new Federal buildings will meet or exceed the Federal building energy efficiency standards established under section 305. (42 U.S.C. 6835(a)) ECPA Section 306(b) bars the head of a Federal agency from expending Federal funds for the construction of a new Federal building unless the building meets or exceeds the applicable baseline Federal building energy standards established under section 305. (42 U.S.C. 6835(b))

Under section 305 of ECPA, the referenced voluntary consensus code for new Federal commercial buildings (including multi-family high rise residential buildings) is ASHRAE Standard 90.1. (42 U.S.C. 6834(a)(2)(A)) DOE codified this referenced code as the baseline Federal building standard in its existing energy efficiency standards found in 10 CFR part 433. Also pursuant to section 305 of ECPA, DOE must establish, by rule, Federal building energy efficiency performance standards for new Federal buildings that require such buildings be designed to achieve energy consumption levels that are at least 30 percent below the levels established in the referenced code (baseline Federal building standard), if life-cycle cost (LCC) effective. (42 U.S.C. 6834(a)(3)(A)(i)(I)) These requirements do not extend to renovations or modifications to existing buildings.

Additionally, under section 305 of ECPA, not later than one year after the date of approval of each subsequent revision of the ASHRAE Standard or the International Energy Conservation Code (IECC), DOE must determine whether to amend the baseline Federal building standards with the revised voluntary standard based on the cost-effectiveness of the revised voluntary standard. (42 U.S.C. 6834(a)(3)(B)) It is this requirement that this rulemaking addresses. ASHRAE has updated Standard 90.1 from the version currently referenced in DOE's regulations at 10 CFR part 433. In this rule, DOE revises the latest baseline Federal building standard for 10 CFR part 433 from ASHRAE Standard 90.1-2013 to ASHRAE Standard 90.1-2019. DOE notes that although ASHRAE published an update to ASHRAE Standard 90.1 in 2016, this rule updates 10 CFR part 433 to ASHRAE Standard 90.1-2019 directly, without requiring agencies to comply with ASHRAE Standard 90.1-2016. DOE notes however that because development of ASHRAE Standard 90.1 is incremental from version to version, ASHRAE Standard 90.1-2019 does include all content in ASHRAE Standard 90.1-2016 that was not specifically removed or modified during the development of ASHRAE Standard 90.1-2019.

Standard 90.1 is recognized by the U.S. Congress as the national model energy code for commercial buildings under the ECPA. Standard 90.1 is developed under ANSI-approved consensus procedures and is under continuous maintenance by a Standing Standard Project Committee (commonly referenced as SSPC 90.1). Updates to Standard 90.1 are published every three years in order for the Standard to be included in model building energy codes.

Standard 90.1 includes several paths for compliance in order to provide flexibility to users of the Standard. The prescriptive path, which is widely considered the most traditional, establishes criteria for energy-related characteristics of individual building components such as minimum insulation levels, maximum lighting power, and controls for lighting and heating, ventilation, air conditioning, and refrigeration (HVAC&R) systems. Some of those requirements are considered “mandatory,” meaning that they must be met even when one of the other optional paths are utilized ( e.g., performance path).

In addition to the prescriptive path, Standard 90.1 includes two optional whole building performance paths. The first, known as the Energy Cost Budget (ECB) method, provides flexibility in allowing a designer to “trade-off” compliance among various requirements of Standard 90.1. This effectively allows a designer to not meet a given prescriptive requirement if the impact on energy cost is offset by exceeding other prescriptive requirements, as demonstrated through established energy modeling protocols. A building is deemed in compliance when the annual energy cost of the proposed design is no greater than the annual energy cost of the reference building design (baseline). Additionally, Standard 90.1 includes a second performance approach, the Performance Rating Method in Appendix G of the Standard. Traditionally, Appendix G has been used to rate the performance of buildings that exceed the requirements of Standard 90.1 for “beyond code” programs, including the Leadership in Energy and Environmental Design (LEED) Rating System, Green Globes, ASHRAE Standard 189.1, the International Green Construction Code (IgCC), the National Green Building Standard (NGBS), and other above-code programs.

The energy efficiency standards for the design and construction of new Federal commercial and multi-family high rise buildings required by section 305 of ECPA were established by DOE under 10 CFR part 433. 4 As required by section 305 of ECPA, the standards in 10 CFR part 433 require Federal buildings be designed to achieve energy consumption levels that are at least 30 percent below the levels set by the most recently adopted version of ASHRAE Standard 90.1. When it is not LCC effective to design new Federal buildings to exceed ASHRAE Standard 90.1 performance levels by 30 percent, new Federal buildings must be designed to exceed the ASHRAE Standard 90.1 performance levels up to the percentage that is LCC effective. (10 CFR 433.100(c)). Furthermore, new Federal buildings must, at minimum, be designed to achieve the baseline standards established in ASHRAE Standard 90.1. (10 CFR 433.100(a)(1)-(4), (c)).

To determine if achieving energy consumption at least 30 percent lower than the levels of ASHRAE Standard 90.1 is LCC effective, Federal agencies must use the life-cycle-cost-effectiveness procedures set out in subpart A of 10 CFR part 436. (10 CFR 433.8) A Federal agency may choose to use one of four methods to determine LCC effectiveness: Lower LCC (10 CFR 436.19), positive net savings (10 CFR 436.20), savings-to-investment ratio estimated to be greater than one (10 CFR 436.21), and an adjusted internal rate of return estimated to be greater than the discount rate as listed in OMB Circular Number A-94 “Guidelines and Discount Rates for Benefit-Cost Analysis of Federal Programs” (10 CFR 436.22).

To determine if a proposed building's energy consumption levels are at least 30 percent better than ASHRAE Standard 90.1, Federal agencies must use the Performance Rating Method found in Appendix G of ASHRAE Standard 90.1, subject to the DOE-specific formula found in 10 CFR 433.101. See 10 CFR 433.101(a)(1)-(4). This requires the use of a whole building simulation tool and model for every new Federal building design. Similarly, if it is LCC effective for a proposed building's energy consumption levels to be at a percentage better than ASHRAE Standard 90.1, but less than 30 percent, Federal agencies must use the Performance Rating Method in Appendix G of ASHRAE Standard 90.1 to determine this percentage. However, Federal agencies may use the prescriptive or ECB methods in lieu of the Performance Rating Method when determining whether a proposed building's energy consumption levels comply with, or meet, the energy consumption levels of ASHRAE Standard 90.1.

Currently, for the purposes of calculating the 30 percent savings requirements in 10 CFR 433.100, Federal agencies must include energy consumption levels associated with the building envelope and energy consuming systems normally specified as part of the building design by ASHRAE Standard 90.1, such as space heating, space cooling, ventilation, service water heating (SWH), and lighting, but must not include receptacle and process loads not within the scope of ASHRAE Standard 90.1, such as specialized medical or research equipment and equipment used in manufacturing processes. 5 (10 CFR 433.101(b)) However, due to a change made by ASHRAE in Standard 90.1-2016, and retained in ASHRAE Standard 90.1-2019, unregulated process and receptacle loads must be accounted for in the whole building analysis to determine whether a Federal building design complies with, or meets, ASHRAE Standard 90.1-2019, and in the whole building simulation used to establish the baseline for applying the Appendix G Performance Rating Method. See section III.B for a more detailed discussion.

Under its building energy codes program, DOE evaluated ASHRAE Standard 90.1-2016 and 90.1-2019 and determined that each version would improve energy efficiency in commercial buildings subject to the code relative to the previous version of the Standard. ( See 83 FR 8463 and 86 FR 40543) The summaries of the changes between each version of the Standard in the following sections are taken directly from DOE's determinations and supporting analyses for ASHRAE Standard 90.1-2016 and ASHRAE Standard 90.1-2019. 6 Section II.D.1 describes the changes between ASHRAE Standard 90.1-2013 and ASHRAE Standard 90.1-2016, and section II.D.2 describes the changes between ASHRAE Standard 90.1-2016 and ASHRAE Standard 90.1-2019.

ASHRAE publishes changes to Standard 90.1 as individual addenda to the preceding Standard, and then bundles them together to form the next published edition. In creating the 2016 edition, ASHRAE published 121 addenda in total (listed in Appendix H of Standard 90.1-2016). DOE characterized the individual addenda into four categories:

DOE analyzed these addenda in preliminary and final energy savings analyses in making its determination that changes in ASHRAE Standard 90.1-2016 would lead to improved overall energy efficiency in buildings subject to the code compared to the 2013 edition of the Standard. ( See 83 FR 8463) A more detailed discussion of the individual addenda may be found in DOE's energy savings analysis technical support document (TSD) for the final determination, which may be accessed at www.energycodes.gov/determinations.

For the purposes of this final rule, the most significant changes in ASHRAE Standard 90.1-2016 and beyond are to the Appendix G Performance Rating Method. The changes include: moving to a fixed baseline for calculating baseline building costs in the Performance Rating Method, adjustments to the associated equation for demonstrating compliance with the Performance Rating Method, and the application of a second equation that includes selecting building type and climate zone from a new table included in the revision. These changes are discussed in more detail in this section. However, as before, the calculations in the Appendix G Performance Rating Method are expressed in terms of energy costs.

Another significant change is that the new Appendix G Performance Rating Method may now be used to demonstrate compliance with ASHRAE Standard 90.1. In previous versions of the Standard, the Appendix G Performance Rating Method could only be used to make “beyond code” determinations of a proposed building's energy efficiency improvement beyond ASHRAE Standard 90.1. To demonstrate compliance, users were required to use either the prescriptive path or the ECB model to determine compliance. With the changes to the Appendix G Performance Rating Method formula, users may now use the Performance Rating Method to determine compliance with ASHRAE Standard 90.1.

In Standard 90.1-2016, Appendix G was redesigned to have a consistent baseline across future versions for purposes of calculating baseline building energy costs, as opposed to having a baseline based on the prescriptive requirements of each new Standard. The new baseline for the Appendix G Performance Rating Method is now fixed at a level of performance approximately equal to the requirements in ASHRAE Standard 90.1-2004. That baseline is then used in a new formula found in Section 4.2.1.1 of ASHRAE Standard 90.1-2016 to set a compliance baseline for buildings designed under ASHRAE Standard 90.1-2016. The formula uses factors for different building types and climate zones, the building performance factors (BPFs) which are established in ASHRAE Standard 90.1-2016, and will be updated in each subsequent version. The BPFs are based upon the percent improvement in energy cost savings that is required by each successive ASHRAE Standard 90.1 compared to the fixed baseline. The resulting target represents the increase in energy cost savings beyond the fixed baseline that is required in each successive ASHRAE Standard 90.1 for each building type and climate zone.

The intent of these changes is to encourage the development of software tools that implement the Appendix G Performance Rating Method by providing a consistent baseline for Standard 90.1-2016 and future versions. This would allow software developers to more easily update programs to account for subsequent versions of the Standard by simply updating the BPFs used in the subsequent Standard. These efforts could have significant value to Federal agencies because the software tools envisioned would perform both the baseline and proposed building performance calculations and keep track of the relationships between the baseline building performance and proposed building performance, as noted in Table G3.1 of the Appendix G Performance Rating Method in ASHRAE Standard 90.1-2016. While these tools do not currently exist, it is expected that adhering to a consistent baseline will encourage software development.

To accommodate the new baseline, and because ASHRAE Standard 90.1 prescriptive requirements are now significantly more stringent than that baseline, ASHRAE revised the formula for demonstrating compliance with, and improvement beyond, the Appendix G Performance Rating Method in Standard 90.1-2016. The new formula requires the user to determine a metric first established in ASHRAE Standard 90.1-2016, the Performance Cost Index (PCI), which is calculated as follows:

To determine compliance with, or improvement beyond, ASHRAE Standard 90.1, the user must then compare the PCI with a PCI Target (PCI t ). The PCI t is the energy cost value that a proposed building must meet in order to comply with ASHRAE Standard 90.1 and, as noted above, it represents the increase in energy cost savings beyond the fixed baseline that is required in new versions of ASHRAE Standard 90.1 for that specific building type and climate zone. Accordingly, where PCI ≤ PCI t the proposed building design complies with ASHRAE Standard 90.1.

To calculate PCI t , users must use the formula in Section 4.2.1.1, first established in ASHRAE Standard 90.1-2016 and repeated in Standard 90.1-2019, which is quoted below:

“When using Appendix G, the Performance Cost Index (PCI) shall be less than or equal to the Performance Cost Index Target (PCI t ) when calculated in accordance with the following:

PCI t = [BBUEC + (BPF × BBREC)]/BBP

This formula is used in conjunction with Table 4.2.1.1, which provides BPFs for 9 building area types: Multifamily, Healthcare/Hospital, Hotel/Motel, Office, Restaurant, Retail, School, Warehouse, and All Others. BPFs are also provided for 17 climate zones: 0A and 1A, 0B and 1B, 2A, 2B, 3A, 3B, 3C, 4A, 4B, 4C, 5A, 5B, 5C, 6A, 6B, 7, and 8. Table 4.2.1.1 may be viewed in the online read-only version of ASHRAE Standard 90.1-2019. 7

As noted previously, there are two key terms used in the formula in Section 4.2.1.1 of ASHRAE Standard 90.1: “regulated energy use” and “unregulated energy use.” ASHRAE defines “regulated energy use” as “energy used by building systems and components with requirements prescribed in sections 5 through 10. This includes energy used by HVAC, lighting, SWH, motors, transformers, vertical transportation, refrigeration equipment, computer-room cooling equipment, and other building systems, components, and processes with requirements in sections 5 through 10.” ASHRAE defines “unregulated energy use” as “energy used by building systems and components that is not regulated energy use (see regulated energy use).” For purposes of clarity, DOE notes that the definition of “regulated energy use” should include SWH used for pools, both interior lighting and exterior lighting, and service water pressure booster systems.

DOE also notes that in ASHRAE Standard 90.1-2016, ASHRAE considered plug loads such as computers, printers, copiers, and other electronic devices to be “unregulated energy use” for purposes of ASHRAE Standard 90.1. While automatic receptacle control  8 for plug loads is required by Section 8.4.2 of ASHRAE Standard 90.1, the actual plug loads themselves are not regulated. DOE also notes that cooking equipment other than refrigeration equipment should be considered “unregulated energy use” as well. DOE notes that both plug loads and cooking equipment are covered by Federal energy efficient product procurement requirements in 10 CFR part 436.

In creating Standard 90.1-2019, ASHRAE published 88 addenda in total, of which:

• 29 are expected to decrease energy use ( i.e., increased energy savings);

• none are expected to increase energy use ( i.e., decreased energy savings), and;

• 59 are expected to have no direct impact on energy savings (such as administrative or clarifications or changes to alternative compliance paths).

DOE analyzed these addenda in preliminary and final energy savings analyses in making its determination that changes in ASHRAE Standard 90.1-2019 will lead to improved overall energy efficiency in buildings subject to the code compared to the 2016 edition of the Standard. ( See 86 FR 20674 (April 21, 2021) and 86 FR 40543 (July 28, 2021)) A more detailed discussion of the individual addenda may be found in DOE's energy savings analysis TSD for the final determination, which may be accessed at www.energycodes.gov/determinations.

The 29 changes considered that are expected to decrease energy use are:

The remaining 59 changes were considered administrative in nature or were determined to not be energy related. These changes are discussed in more detail in Appendix A of Preliminary Energy Savings Analysis: ANSI/ASHRAE/IES Standard 90.1-2019. 9 One change that is considered administrative in DOE's determination but is significant to this rulemaking is that ASHRAE updated the BPFs in Table 4.2.1.1 that are used in the Performance Rating Method in Standard 90.1-2019. This change reflects the increased performance of buildings designed to Standard 90.1-2019. The changes made to the Performance Rating Method that are discussed previously in section II.D.1 were carried over from ASHRAE Standard 90.1-2016 and included in ASHRAE Standard 90.1-2019.

DOE is issuing this action as a final rule. As indicated previously, DOE must determine whether the energy efficiency standards for new Federal buildings should be updated to reflect revisions to ASHRAE Standard 90.1 based on the cost-effectiveness of the revisions. (42 U.S.C. 6834(a)(3)(B)). In this final rule, DOE determines that the energy efficiency standards for new Federal buildings should be updated to reflect the 2019 revisions to ASHRAE Standard 90.1 based on the cost-effectiveness of the revisions. This final rule amends 10 CFR part 433 to update the referenced baseline Federal energy efficiency performance standards and provides a formula for Federal agencies to use when implementing the Appendix G Performance Rating Method based on the changes in ASHRAE Standard 90.1-2016, detailed in section II.D.1, that were carried over into ASHRAE Standard 90.1-2019. These amendments are described in sections II.D.1. and II.D.2. of this document. Additionally, DOE clarifies and reiterates several programmatic principles for Federal agencies implementing ASHRAE Standard 90.1 based on frequently asked questions received by DOE.

DOE also notes that there are a number of energy management requirements for Federal buildings found in statutory provisions, regulations, Executive Orders, and associated guidance, including, but not limited to the National Energy Conservation Policy Act, as amended (42 U.S.C. 8253-8258); the Energy Policy Act (EPAct) of 2005 (42 U.S.C. 15852); 10 CFR parts 433 and 435; and Executive Order 13834 (83 FR 23771 (May 22, 2018)). This final rule supports and does not supplant other legal requirements governing energy consumption in new Federal buildings. For example, by designing buildings to meet the ASHRAE Standard 90.1-2019 baseline, Federal agencies also help achieve the energy intensity reductions mandated under 42 U.S.C. 8253(a).

DOE has determined that the energy efficiency standards for new Federal buildings should be updated to reflect the 2019 revisions to ASHRAE Standard 90.1 because these revisions are cost-effective for the Federal government. DOE's determination that the revisions to ASHRAE Standard 90.1 are cost effective for new Federal buildings is based on several forms of analysis.

DOE is required by ECPA section 304(b) to determine whether revisions to ASHRAE Standard 90.1 would improve energy efficiency in commercial buildings and must publish notice of its determination in the Federal Register . (42 U.S.C. 6833(b)(2)(A)). Although DOE's review of ASHRAE Standard 90.1 is required for the activities of DOE's State building energy codes program, DOE also uses the analysis as part of its review for purposes of the baseline standard update for new Federal buildings. Accordingly, DOE first compared ASHRAE Standard 90.1-2016 to the 2013 version of the standard and found that the revisions in the 2016 version achieved greater energy efficiency. ( See 82 FR 34513 (July 25, 2017)). This determination was subject to notice and comment. ( See 83 FR 8463 (Feb. 27, 2018)). In that determination, DOE found that the 2016 version of Standard 90.1 would have energy cost, source energy, and site energy savings of 8.3, 7.9, and 6.8 percent, respectively, compared to the 2013 version of Standard 90.1. Similarly, DOE compared ASHRAE Standard 90.1-2019 to the 2016 version of the standard and found that the revisions in the 2019 version would achieve greater energy efficiency. ( See 86 FR 20674 (April 21, 2021)) This determination was subject to notice and comment. ( See 86 FR 40543; July 28, 2021). In that determination, DOE found that the 2019 version of Standard 90.1 would have energy cost, source energy, and site energy savings of 4.3, 4.3, and 4.7 percent, respectively, compared to the 2016 version of Standard 90.1. DOE also conducted an independent, supplemental analysis of the updated ASHRAE Standard 90.1 as applied to the Federal sector, and found that the 2019 version of Standard 90.1 would have energy cost, source energy, and site energy savings of 11.3, 11.3, and 11.2 percent, respectively, compared to the 2013 version of Standard 90.1.

Second, DOE conducted an analysis of the cost-effectiveness of the updated ASHRAE Standard 90.1 as part of DOE's required activities for its building energy codes program and found the updated version to be cost-effective. DOE determines the cost effectiveness of revisions to ASHRAE Standard 90.1 as part of DOE's participation in the code development process. Section 307(b) of ECPA requires DOE to participate in the ASHRAE code development process and to assist in determining the cost-effectiveness of the voluntary standards. (42 U.S.C. 6836). DOE is required to periodically review the economic basis of the voluntary building energy codes and participate in the industry process for review and modification, including seeking adoption of all technologically feasible and economically justified energy efficiency measures. (42 U.S.C. 6836(b)).

Finally, DOE conducted an independent, supplemental analysis of ASHRAE Standard 90.1-2019 as applied to the Federal sector (baseline ASHRAE Standard 90.1-2013), and found that the energy efficiency gains resulted in $161.9 million annual life-cycle-cost net savings overall for an assumed 19.54 million square feet of annual new Federal construction, with a cumulative net present value (NPV) of total benefits of $1.66 billion (at a 7-percent discount rate) and $3.48 billion (at a 3-percent discount rate). This NPV expresses the estimated total value of future operating cost savings minus the estimated increased building costs for new Federal construction for 2022-2051 with a 30-year lifetime, along with monetized estimates of climate and health benefits. As part of the development of this rule, for the purpose of complying with the requirements of Executive Order 12866, DOE considered the estimated monetary benefits from the reduced emissions of CO 2, CH 4 , N 2 O, NO X , and SO 2 that are expected to result from this rule. On March 16, 2022, the Fifth Circuit Court of Appeals (No. 22-30087) granted the federal government's emergency motion for stay pending appeal of the February 11, 2022, preliminary injunction issued in Louisiana v. Biden, No. 21-cv-1074-JDC-KK (W.D. La.). As a result of the Fifth Circuit's order, the preliminary injunction is no longer in effect, pending resolution of the federal government's appeal of that injunction or a further court order. Among other things, the preliminary injunction enjoined the defendants in that case from “adopting, employing, treating as binding, or relying upon” the interim estimates of the social cost of greenhouse gases—which were issued by the Interagency Working Group on the Social Cost of Greenhouse Gases on February 26, 2021—to monetize the benefits of reducing greenhouse gas emissions. In the absence of further intervening court orders, DOE will revert to its approach prior to the injunction and present monetized benefits where appropriate and permissible under law. These results are discussed in greater detail in section IV of this document.

DOE's assumptions and methodology for the supplemental review cost-effectiveness of this rule are based on the cost-effectiveness analysis of ASHRAE Standard 90.1-2016 and ASHRAE Standard 90.1-2019 conducted by DOE's State building energy codes program. These assumptions and methodology also provide the basis for the EA for this rulemaking. In this supplemental review, DOE recognized differences in Federal sector building types and attempted to address these differences by drawing functional equivalencies among building types that were analyzed in the cost-effectiveness analysis described above. DOE also calculated the weighted average incremental costs for the 14 Federal building types that most closely matched the prototypes analyzed in DOE's cost-effectiveness analysis of Standard 90.1-2019. These Federal building types comprise 79.3 percent of estimated Federal construction. DOE assumes that all other Federal building types are represented by the average of the Federal buildings that were mapped to DOE's cost-effectiveness analysis building types. The results of this supplemental review are discussed in detail in section IV of this document.

Accordingly, based on these analyses, DOE has determined that the energy efficiency standards for new Federal buildings should be updated to reflect the 2019 revisions to ASHRAE Standard 90.1 based on the cost-effectiveness of the revisions.

As previously discussed, ASHRAE Standard 90.1-2016 was the first version of Standard 90.1 in which the Appendix G Performance Rating Method may be used to demonstrate compliance with Standard 90.1. In previous versions, Appendix G was limited to demonstrating the percentage improvement above Standard 90.1. Federal agencies can now use Appendix G for both compliance and demonstrating the percentage improvement better than ASHRAE Standard 90.1-2019. Federal agencies may also choose to use one of the other compliance methods (the prescriptive path or the ECB method) to demonstrate compliance with Standard 90.1-2019. However, Federal agencies can only use the Appendix G Performance Rating Method for calculating the 30 percent improvement beyond ASHRAE Standard 90.1 as required in 10 CFR 433.100 and 433.101.

DOE notes that not all Federal building types are explicitly covered by the BPFs listed in Table 4.2.1.1 of ASHRAE Standard 90.1-2019. DOE plans to work with Federal agencies to define the most appropriate building area type for various types of buildings constructed in the Federal sector, such as courthouses, barracks, and industrial type facilities.

To calculate the percent improvement beyond ASHRAE Standard 90.1-2019, Federal agencies must use the formula in new 10 CFR 433.101(a)(5). The formula is as follows:

Percent improvement beyond code = 100 × ((PCIt—PCI)/PCIt)

This formula differs from previous formulas that DOE has required in 10 CFR 433.101 due to the new ASHRAE requirement to calculate PCI t to determine whether a proposed building design exceeds the energy costs savings of ASHRAE Standard 90.1-2019.

Importantly, section 4.2.1.1 requires that the Baseline Building Unregulated Energy Consumption (BBUEC) be included in the calculation of a building's PCI t . DOE notes that Federal agencies have always been required to include energy consumption that has generally been “unregulated” by ASHRAE Standard 90.1 ( i.e., certain process loads and receptacle loads) for purposes of determining compliance with ASHRAE Standard 90.1. Additionally, Federal agencies are required to include such unregulated energy use to conduct the required whole building simulation to establish the baseline for applying the Appendix G Performance Rating Method.

However, Federal agencies are currently required to exclude unregulated energy use not within the scope of ASHRAE Standard 90.1 when determining whether a design has met the required 30 percent improvement below ASHRAE Standard 90.1. (10 CFR 433.101(b)) In the initial promulgation of the energy efficiency standards for Federal commercial and multi-family high rises, DOE stated that such an exclusion for process loads was warranted because process loads in government facilities typically involve specialized equipment for which improvements in energy efficiency may affect the functionality of the equipment or where improvements are not available at all. Additionally, some Federal buildings use most of their energy serving process loads, and application of the energy savings requirement to these buildings would likely place an undue burden on the rest of the building if the 30 percent savings is to be achieved. ( See 72 FR 72565, 72567-72568 (Dec. 21, 2007)). With respect to receptacle loads, DOE stated that it is often not possible to identify all receptacle loads when a building is designed or constructed as the occupants will to some degree establish what is plugged in, and that as equipment is replaced over time the initial savings from receptacle loads may diminish. ( See 72 FR 72567-72568) Moreover, DOE stated that the energy efficiency of many receptacle loads was addressed in section 104 of EPAct 2005 (Pub. L. 109-58), which requires Federal agencies to purchase energy efficient appliances and equipment. (42 U.S.C 8259b).

However, due to ASHRAE's explicit inclusion of unregulated energy use in the PCI t equation, in this final rule, DOE limits the types of unregulated loads that may be excluded from the calculation of the 30 percent improvement beyond ASHRAE Standard 90.1. This final rule revises 10 CFR 433.101(b) to require Federal agencies to include unregulated energy use ( i.e., process loads and receptacle loads not within the scope of ASHRAE Standard 90.1) in agencies' determination of PCI t when calculating the 30 percent improvement beyond ASHRAE Standard 90.1, except for energy-intensive process loads that are (i) driven by mission and operational requirements, not necessarily buildings, and (ii) not influenced by conventional building energy conservation measures. Examples would include training simulators, health-care equipment, facilities which generate and/or transmit electricity or steam, waterway shipping locks, and transmitters and other types of electronic installations. This exception aligns with DOE's exception for certain assumed exclusions of structures and processes under the Federal energy performance and reporting requirements of section 543 of the National Energy Conservation Policy Act (NECPA), as amended by EPAct. 10 ( See 42 U.S.C. 8253(a)) This final rule also removes paragraph (b) from 10 CFR 433.100, as this paragraph is duplicative of the current paragraph (b) in 10 CFR 433.101, and is not reflective of the changes in this final rule. Moreover, the content in this paragraph, how to incorporate process and receptacle loads in the calculation of the 30 percent improvement, is best placed in 10 CFR 433.101, which prescribes the equations for the 30 percent improvement calculation.

DOE acknowledges that the inclusion of unregulated loads into the 30 percent or more determination is a change from prior practice. However, the changes in this final rule ensure consistency between ASHRAE Standard 90.1-2019 and the application of the Standard to Federal buildings, as required by section 305 of ECPA, while still providing agencies the flexibility to exclude unique mission-focused, energy-intensive process loads from the 30 percent improvement calculation so that the functionality of such loads is not jeopardized and an undue burden is not placed on the rest of the building if the 30 percent savings is to be achieved. The inclusion of unregulated energy, particularly receptacle loads, into the 30 percent improvement calculation may mean that fewer building designs will meet the 30 percent threshold, where such designs would otherwise meet that threshold if unregulated energy loads were excluded from the calculation. However, DOE believes that the inclusion of unregulated energy use into this calculation is more consistent with the text of section 305 of EPAct 2005, which requires that Federal buildings be designed to achieve energy savings of 30 percent or more below ASHRAE Standard 90.1, without reference to or exception for process or receptacle loads. Moreover, DOE notes that such buildings consume the same amount of energy, regardless of whether unregulated energy is included in the 30 percent or more calculation. Additionally, DOE reiterates that a building design is compliant with 10 CFR 433.100 even if the design does not meet the 30 percent or more threshold, provided the design obtains the most energy savings below ASHRAE Standard 90.1 that is cost-effective, in accordance with 10 CFR 433.100(c) (now section 433.100(b)).

The definition of “New Federal building” in 10 CFR part 433 has not previously been updated to match what is found in 42 U.S.C. 6832(6). EISA 2007 (Pub. L. 110-140, 121 Stat. 1614 (Dec. 19, 2007)) updated the definition of “Federal building” to include privatized military family housing and leased buildings. Accordingly, in order to bring 10 CFR part 433 into agreement with 42 U.S.C. 6832(6), DOE is updating the definition of “New Federal building” to mean ” any new building (including a complete replacement of an existing building from the foundation up) to be constructed by, or for the use of, any Federal agency. Such term shall include new buildings (including a complete replacement of an existing building from the foundation up) built for the purpose of being leased by a Federal agency, and privatized military housing.”

As noted previously, DOE is clarifying and reiterating several programmatic principles regarding implementation of ASHRAE Standard 90.1-2019 in the preamble of final rule. The clarifications and reiterations are not changes to the regulatory text. Instead, DOE is taking this opportunity to provide answers and clarifications for frequent questions that DOE receives from Federal agencies in order to reduce confusion over agencies' implementation of ASHRAE Standard 90.1.

Based on frequent questions regarding the issue, DOE reiterates that the use of the ASHRAE Standard 90.1 Appendix G Performance Rating Method requires the consideration of the building envelope and the use of a whole-building simulation tool and simulation model for the chosen tool of the proposed building design. As noted previously, Federal agencies must use the Performance Rating Method when determining if their proposed buildings are 30 percent or better beyond ASHRAE Standard 90.1. Since all Federal agencies must determine if they can meet the 30 percent or more threshold, this means that all Federal agencies must use a whole building simulation tool and a building model for every new Federal building design. Additionally, where a Federal agency uses the Performance Rating Method to determine compliance with ASHRAE Standard 90.1-2019, the agency must use a whole building simulation tool and whole building model.

DOE has often received questions regarding enforcement of the energy efficiency standards for Federal commercial and multi-family high rise buildings, including for situations when agencies may seek exceptions to particular aspects of ASHRAE Standard 90.1. Specifically, agencies have asked whether DOE is the “authority having jurisdiction” referenced in ASHRAE Standard 90.1, and whether DOE is the “authority having jurisdiction” for purposes of granting exceptions to aspects of the Standard for Federal agencies. As with prior versions of ASHRAE Standard 90.1, Standard 90.1-2019 provides some flexibility to building designers based upon the type of code requirement at issue. Standard 90.1 contains “prescriptive requirements,” which may have exceptions to them or may be “traded off” in the Performance Rating Method if designers are unable or choose not to meet a specific prescriptive requirement. Such an approach means that another building component would need to be improved beyond what was required prescriptively by the Standard for that component, or else the overall score of the building design under the Performance Rating Method will be lowered. Standard 90.1 also contains “mandatory requirements,” which may not be traded off with other requirements. However, Standard 90.1 allows building designs to be excepted from meeting certain mandatory requirements in certain situations if allowed by the “authority having jurisdiction,” “building code official,” and/or “code official.” For example, the “authority having jurisdiction” or “code official” is the person who authorizes the use of alternative materials, methods of construction, or design (see, e.g., section 4.1.3 of Standard 90.1-2019), and is also the person charged with determining if there is a conflict between the Standard and other laws or requirements and how to address such conflict (see section 4.1.5 of Standard 90.1-2019).

For the purposes of the energy efficiency standards for Federal buildings, DOE does not have authority to grant exceptions to the Standard for any Federal agency. The statute does not provide a specific enforcement authority beyond the statutory requirements, but section 548(a) of NEPCA (42 U.S.C. 8258(a)) requires Federal agencies to submit to DOE an annual report that describes activities to meet the energy management requirements of section 543 of NECPA (42 U.S.C. 8253). This submittal includes a list of all new Federal buildings owned, operated, or controlled by the Federal agency, for which designs were started since the beginning of FY 2007 (begun since October 1, 2006), and a statement specifying whether the Federal buildings are expected to meet or exceed the Federal building efficiency standards in 10 CFR part 433, as applicable. (See www.energy.gov/eere/femp/downloads/annual-energy-management-data-report ). The DOE Annual Energy Management Data Report Reporting workbook and associated guidance can be found on the DOE Federal Energy Management Program (FEMP) website. 11 Federal agencies themselves are responsible for implementing the energy efficiency standards for Federal buildings and meeting any applicable statutory and regulatory requirements. Accordingly, where the terms are used in ASHRAE Standard 90.1, Federal agencies are their own “authority having jurisdiction,” “building official,” and/or “code official,” and may use their own best judgment in determining whether to exempt a proposed Federal building from aspects of the Standard or seek an alternative energy conservation measure to meet a particular aspect of the Standard where such exceptions or alternatives are permitted by the Standard. However, agencies must still comply with all relevant Federal energy efficiency statutes and regulations, including 10 CFR part 433. DOE notes that, as a general rule, any prescriptive requirement in ASHRAE Standard 90.1-2019 can be “traded off” in the Performance Rating Method if agencies are unable or choose not to meet a specific prescriptive requirement. Such an approach means that another building component would need to be improved beyond what was required prescriptively by the Standard for that component, or else the overall score of the building design under the Performance Rating Method will be lowered. With respect to mandatory requirements in the Standard, DOE notes that, as the “authority having jurisdiction,” “building official,” or “code official,” agencies should only be making exceptions to mandatory requirements where the Standard allows for the “authority having jurisdiction,” “building official,” and/or “code official” to make exceptions to such requirements. DOE welcomes Federal agencies' questions and requests for assistance in implementing the energy efficiency standards for Federal buildings, and DOE will provide guidance and assistance upon request.

DOE's assumptions and methodology for the cost-effectiveness of this rule are based on cost-effectiveness analysis of ASHRAE Standard 90.1-2016 and ASHRAE Standard 90.1-2019 conducted by DOE's State building energy codes program, 12 as well as DOE's EA for this rulemaking. 13 As described in the EA, DOE identified a rate of new Federal commercial construction of 19.54 million square feet per year with a distribution of building types as shown in Table IV.1. The distribution of building types is based on an extraction of the latest 10 years of new construction data entered into the Federal Real Property Portfolio Management System (FRPP MS). 14 Table IV.1 also shows the prototype buildings incorporated into computer simulations that are used to estimate energy use in each building type. DOE derived these prototype buildings from 16 building types in 17 climate zones  15 using its Commercial Prototype Building models. 16 Of the 16 prototype buildings, DOE developed costs for 6 prototype buildings to determine the cost effectiveness of ASHRAE Standard 90.1-2016 and ASHRAE Standard 90.1-2019. DOE then extracted the cost-effectiveness information for those prototype buildings and weighted those values as appropriate to obtain an average cost effectiveness value for building types found in the Federal commercial sector.

DOE has determined incremental construction first cost information for the building types and climate zones analyzed for ASHRAE Standard 90.1-2016 versus ASHRAE Standard 90.1-2013 (see Table IV.2), 17 ASHRAE Standard 90.1-2019 versus ASHRAE Standard 90.1-2016 (see Table IV.3), and for ASHRAE Standard 90.1-2019 versus ASHRAE Standard 90.1-2013 (see Table IV.4).

The FAA published a final rule in the Federal Register for Docket No. FAA-2021-0596 (87 FR 15879; March 21, 2022) amending VOR Federal airways V-6, V-10, V-30, V-100, and V-233 due to the planned decommissioning of the VOR portion of the Litchfield, MI, VOR/DME. The effective date of that rule is May 19, 2022. Subsequent to the final rule, unanticipated requirements and issues affecting the completion of related instrument procedure amendments and the associated flight inspection activities required to adopt those amendments by the published effective date have been identified. As a result, the planned Litchfield, MI, VOR decommissioning has been slipped to April 20, 2023.

The FAA has reviewed the Litchfield, MI, VOR decommissioning project and determined additional time is required to complete the related instrument procedure amendments and associated flight inspection activities to ensure an efficient implementation and integration with other ongoing VOR MON program actions. Therefore, the final rule is being withdrawn.

The existing VOR Federal airways (V-6, V-10, V-30, V-100, and V-233) addressed in the final rule remain unchanged.

The FAA will publish a new notice of proposed rulemaking action at a later date, using a new airspace docket number, to coincide with the slipped Litchfield, MI, VOR decommissioning now planned for April 20, 2023.

Background

The Entity List (supplement no. 4 to part 744 of the Export Administration Regulations (EAR)) identifies entities for which there is reasonable cause to believe, based on specific and articulable facts, that the entities have been involved, are involved, or pose a significant risk of being or becoming involved in activities contrary to the national security or foreign policy interests of the United States. The EAR (15 CFR parts 730-774) imposes additional license requirements on, and limit the availability of most license exceptions for exports, reexports, and transfers (in-country) to listed entities. The license review policy for each listed entity is identified in the “License Review Policy” column on the Entity List, and the impact on the availability of license exceptions is described in the relevant Federal Register document that added the entity to the Entity List. The Bureau of Industry and Security (BIS) places entities on the Entity List pursuant to part 744 (Control Policy: End-User and End-Use Based) and part 746 (Embargoes and Other Special Controls) of the EAR. Paragraphs (b)(1) through (5) of § 744.11 include an illustrative list of activities that could be contrary to the national security or foreign policy interests of the United States. As discussed further later in this preamble, 95 entities are being added in this rule on the basis of §§ 744.11(b) and 744.21 and will receive a footnote 3 designation because the End-User Review Committee (ERC) has determined they are `military end users' in accordance with § 744.21. A footnote 3 designation subjects these entities to the Russia/Belarus foreign “direct product” (FDP) rule, detailed in § 734.9(g). The other 25 entities are being added solely on the basis of § 744.11(b).

The ERC, composed of representatives of the Departments of Commerce (Chair), State, Defense, Energy and, where appropriate, the Treasury, makes all decisions regarding additions to, removals from, or other modifications to the Entity List. The ERC makes all decisions to add an entry to the Entity List by majority vote and makes all decisions to remove or modify an entry by unanimous vote.

The ERC determined to add the following entities to the Entity List on the basis of §§ 744.11(b) and 744.21 under the destination of Belarus: 140 Repair Plant JSC; 558 Aircraft Repair Plant JSC; 2566 Radioelectronic Armament Repair Plant JSC; AGAT—Control Systems—Managing Company of Geoinformation Control Systems Holding JSC; Agat-Electromechanical Plant OJSC; AGAT-SYSTEM; ATE-Engineering LLC; BelOMO Holding; Belspetsvneshtechnika SFTUE; BSVT-New Technologies; CJSC Beltechexport; Department of Internal Affairs of the Gomel Region Executive Committee; Internal Troops of The Ministry of Internal Affairs of the Republic of Belarus; JSC Transaviaexport Airlines; KGB Alpha; Kidma Tech OJSC; Minotor-Service; Minsk Wheeled Tractor Plant; Oboronnye Initsiativy LLC; OJS KB Radar Managing Company; Peleng JSC; State Authority for Military Industry of the Republic of Belarus; State Security Committee of the Republic of Belarus; and Volatavto OJSC to the Entity List. All of these entities will be designated with a footnote 3. These entities are being added to the Entity List consistent with BIS's response to Belarus's substantial enabling and support of Russia's invasion of Ukraine and of Russia's military forces. Specifically, these entities are being added to the Entity List for acquiring and attempting to acquire items subject to the EAR in support of Belarus' military. Their addition to the Entity List and a footnote 3 designation means these entities are subject to a license requirement for the export, reexport, export from abroad (as described under Russia/Belarus foreign “direct product” (FDP) rule, § 746.8(a)(3)), or transfers (in-country) of all items subject to the EAR that are destined to these entities. BIS will review license applications under a policy of denial. No license exceptions are available for exports, reexports, exports from abroad (as described under Russia/Belarus foreign “direct product” (FDP) rule, § 746.8(a)(3)), or transfers (in-country) to the entities being added.

In addition, the ERC determined to add the following entities to the Entity List on the basis of §§ 744.11(b) and 744.21 under the destination of Russia: 5th Shipyard; Alagir Resistor Factory; All-Russian Scientific-Research Institute Etalon JSC; Almaz JSC; Dolgoprudniy Design Bureau of Automatics; Electronic Computing Technology Scientific-Research Center; Electrosignal JSC; Inteltech PJSC; Joint Stock Company NPO Elektromechaniki; Kulon Scientific-Research Institute JSC; Lutch Design Office JSC; Meteor Plant JSC; Moscow Communications Research Institute JSC; Moscow Order of the Red Banner of Labor Research Radio Engineering Institute JSC; Omsk Production Union Irtysh JSC; Omsk Scientific-Research Institute of Instrument Engineering JSC; Optron JSC; Polyot Chelyabinsk Radio Plant JSC; Pskov Distance Communications Equipment Plant; Radiozavod JSC; Razryad JSC; Research Production Association Mars; Ryazan Radio-Plant; Scientific-Production Association and Scientific-Research Institute of Radio-Components; Scientific-Production Enterprise Almaz JSC; Scientific-Production Enterprise “Kant”; Scientific Production Enterprise “Radiosviaz”; Scientific-Production Enterprise “Svyaz”; Scientific-Production Enterprise Volna; Scientific-Production Enterprise Vostok JSC; Scientific-Research Institute “Argon”; Scientific-Research Institute of Automated Systems and Communications Complexes Neptune JSC; Scientific Research Institute of Communication Management Systems; Scientific Research Institute Ferrite-Domen; Special Design and Technical Bureau for Relay Technology; Tactical Missile Corporation, 711 Aircraft Repair Plant (711 ARZ); Tactical Missile Corporation, AO GNPP “Region”; Tactical Missile Corporation, AO TMKB “Soyuz”; Tactical Missile Corporation, Azov Optical and Mechanical Plant; Tactical Missile Corporation, “Central Design Bureau of Automation”; Tactical Missile Corporation, Concern “MPO—Gidropribor”; Tactical Missile Corporation, Joint Stock Company Avangard; Tactical Missile Corporation, Joint Stock Company Concern Granit-Electron; Tactical Missile Corporation, Joint Stock Company Elektrotyaga; Tactical Missile Corporation, Joint Stock Company GosNIIMash; Tactical Missile Corporation JSC “KRASNY GIDROPRESS”; Tactical Missile Corporation, Joint Stock Company PA Strela; Tactical Missile Corporation, Joint Stock Company “Plant Dagdiesel”; Tactical Missile Corporation, Joint Stock Company Plant Kulakov; Tactical Missile Corporation, Joint Stock Company Ravenstvo; Tactical Missile Corporation, Joint Stock Company Ravenstvo-service; Tactical Missile Corporation, Joint-Stock Company “Research Center for Automated Design”; Tactical Missile Corporation, Joint Stock Company “Salute”; Tactical Missile Corporation, Joint Stock Company Saratov Radio Instrument Plant; Tactical Missile Corporation Joint Stock Company “Scientific Research Institute of Marine Heat Engineering”; Tactical Missile Corporation, Joint Stock Company Severny Press; Tactical Missile Corporation, Joint Stock Company “State Machine Building Design Bureau “Vympel” By Name I.I. Toropov”; Tactical Missile Corporation, Joint Stock Company “URALELEMENT”; Tactical Missile Corporation, KB Mashinostroeniya; Tactical Missile Corporation, NPO Electromechanics; Tactical Missile Corporation, NPO Lightning; Tactical Missile Corporation, Petrovsky Electromechanical Plant “Molot”; Tactical Missile Corporation, PJSC ANPP Temp Avia; Tactical Missile Corporation, PJSC “MBDB ISKRA”; Tactical Missile Corporation, Raduga Design Bureau; Tactical Missile Corporation, RKB Globus; Tactical Missile Corporation, Smolensk Aviation Plant; Tactical Missile Corporation, TRV Engineering; Tactical Missile Corporation, Ural Design Bureau “Detal”; Tactical Missile Corporation, Zvezda-Strela Limited Liability Company; and United Shipbuilding Corporation “Production Association Northern Machine Building Enterprise”. All the entities will be designated with footnote 3. These entities are being added to the Entity List consistent with BIS's response to Russia's invasion of Ukraine, which include restricting Russia's access to items subject to the EAR that allow it to project power and fulfill its strategic ambitions. Specifically, these entities are being added to the Entity List for acquiring and attempting to acquire items subject to the EAR in support of Russia's military. Their addition to the Entity List and footnote 3 designation means these entities are subject to a license requirement for exports, reexports, exports from abroad (as described under Russia/Belarus foreign “direct product” (FDP) rule, § 746.8(a)(3)), or transfers (in-country) of all items subject to the EAR that are destined to these entities. BIS will review license applications under a policy of denial. No license exceptions are available for exports, reexports, exports from abroad (as described under Russia/Belarus foreign “direct product” (FDP) rule § 746.8(a)(3)), or transfers (in-country) to the entities being added.

Moreover, the ERC determined to add the following entities to the Entity List on the basis of § 744.11(b) under the destination of Russia: 46th TSNII Central Scientific Research Institute; All Russia Scientific Research Institute of Optical Physical Measurements; Arzam Scientific Production Enterprise Temp Avia; Automated Procurement System for State Defense Orders, LLC; Engineering Center Moselectronproekt; Etalon Scientific and Production Association; Evgeny Krayushin; Far-East Factory Zvezda; Federal Center for Dual-Use Technology (FTsDT) Soyuz; Foreign Trade Association Mashpriborintorg; Ineko LLC; Informakustika JSC; Institute of High Energy Physics; Institute of Theoretical and Experimental Physics; ISE SO RAN Institute of High-Current Electronics; JSC Energiya, Kaluga Scientific-Research Institute of Telemechanical Devices JSC; OJSC Pella Shipyard; Scientific Production Center Vigstar JSC; Scientific-Production Enterprise Salyut JSC; Scientific-Research Institute and Factory Platan; Special Design Bureau Salute JSC; Tambov Plant (TZ) “October”; Turayev Machine Building Design Bureau Soyuz; and Zhukovskiy Central Aerohydrodynamics Institute (TsAGI). These entities are being added to the Entity List consistent with BIS's response to Russia's invasion of Ukraine, which include restricting Russia's access to items subject to the EAR that allow it to project power and fulfill its strategic ambitions. Specifically, BIS is adding these entities to the Entity List for acquiring and attempting to acquire items subject to the EAR in support of Russia's military modernization efforts. These entities will be added to the Entity List with a license requirement for all items subject to the EAR. BIS will review license applications under a policy of denial. No license exceptions are available for exports, reexports, or transfers (in-country) to the entities being added.

For the reasons described above, this final rule adds the following 120 entities under 120 entries to the Entity List and includes, where appropriate, aliases:

In summary, for the 120 entities added to the Entity List by this final rule, BIS imposes a license requirement that applies to all items subject to the EAR. For the 95 entities added under both §§ 744.11 and 744.21, BIS is also listing those entities with a footnote 3 designation. No license exceptions are available for exports, reexports, exports from abroad (as described under Russia/Belarus foreign “direct product” (FDP) rule, § 746.8(a)(3)), or transfers (in-country) to these entities; BIS will review all license applications for these entities under a policy of denial.

For the 25 entities added solely on the basis of § 744.11, BIS is not listing those entities with a footnote 3 designation. No license exceptions are available for exports, reexports, or transfers (in-country) to these entities. BIS will review all license applications for these entities under a policy of denial.

For the changes being made in this final rule, shipments of items removed from eligibility for a License Exception or export, reexport, or transfer (in-country) without a license (NLR) as a result of this regulatory action that were en route aboard a carrier to a port of export, reexport, or transfer (in-country), on April 1, 2022, pursuant to actual orders for export, reexport, or transfer (in-country) to or within a foreign destination, may proceed to that destination under the previous eligibility for a License Exception or export, reexport, or transfer (in-country) without a license (NLR).

On August 13, 2018, the President signed into law the John S. McCain National Defense Authorization Act for Fiscal Year 2019, which included the Export Control Reform Act of 2018 (ECRA) (50 U.S.C. 4801-4852). ECRA provides the legal basis for BIS's principal authorities and serves as the authority under which BIS issues this rule.

1. This rule has been determined to be not significant for purposes of Executive Order 12866.

2. Notwithstanding any other provision of law, no person is required to respond to or be subject to a penalty for failure to comply with a collection of information, subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) (PRA), unless that collection of information displays a currently valid Office of Management and Budget (OMB) Control Number. This regulation involves collections previously approved by OMB under control number 0694-0088, Simplified Network Application Processing System, which includes, among other things, license applications and commodity classifications, and carries a burden estimate of 29.6 minutes for a manual or electronic submission for a total burden estimate of 33,133 hours. Total burden hours associated with the PRA and OMB control number 0694-0088 are not expected to increase as a result of this rule.

3. This rule does not contain policies with federalism implications as that term is defined in Executive Order 13132.

4. Pursuant to section 1762 of the Export Control Reform Act of 2018, this action is exempt from the Administrative Procedure Act (5 U.S.C. 553) requirements for notice of proposed rulemaking, opportunity for public participation, and delay in effective date.

5. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule by 5 U.S.C. 553, or by any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq., are not applicable. Accordingly, no regulatory flexibility analysis is required and none has been prepared.

Accordingly, part 744 of the Export Administration Regulations (15 CFR parts 730-774) is amended as follows:

All comments received in response to this docket are considered part of the public record. The Drug Enforcement Administration (DEA) will make comments available, unless reasonable cause is given, for public inspection online at http://www.regulations.gov. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter. The Freedom of Information Act applies to all comments received. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want DEA to make it publicly available, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all of the personal identifying information you do not want made publicly available in the first paragraph of your comment and identify what information you want redacted.

If you want to submit confidential business information as part of your comment, but do not want DEA to make it publicly available, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify the confidential business information to be redacted within the comment.

DEA will generally make available in publicly redacted form comments containing personal identifying information and confidential business information identified, as directed above. If a comment has so much confidential business information or personal identifying information that DEA cannot effectively redact it, DEA may not make available publicly all or part of that comment. Comments posted to http://www.regulations.gov may include any personal identifying information (such as name, address, and phone number) included in the text of your electronic submission that is not identified as confidential as directed above.

An electronic copy of this document and supplemental information to this interim final rule (IFR) are available at http://www.regulations.gov for easy reference.

Pursuant to 21 U.S.C. 811(a), this action is a formal rulemaking “on the record after opportunity for a hearing”. Such proceedings are conducted pursuant to the provisions of the Administrative Procedure Act (APA), 5 U.S.C. 551-559. 21 CFR 1308.41-1308.45; 21 CFR part 1316, subpart D. Interested persons may file requests for a hearing or notices of intent to participate in a hearing in conformity with the requirements of 21 CFR 1308.44(a) or (b), and such requests must include a statement of the person's interests in the proceeding and the objections or issues, if any, concerning which the person desires to be heard. 21 CFR 1316.47(a). Any interested person may file a waiver of an opportunity for a hearing or to participate in a hearing together with a written statement regarding the interested person's position on the matters of fact and law involved in any hearing as set forth in 21 CFR 1308.44(c).

All requests for hearings and waivers of participation, together with a written statement of position on the matters of fact and law involved in such hearing, must be sent to DEA using the address information provided above.

Under the Controlled Substances Act (CSA), as amended in 2015 by the Improving Regulatory Transparency for New Medical Therapies Act (section 2(b) of Pub. L. 114-89), DEA is required to commence an expedited scheduling action with respect to certain new drugs approved by the Food and Drug Administration (FDA). As provided in 21 U.S.C. 811(j), this expedited scheduling is required where both of the following conditions apply: (1) The Secretary of the Department of Health and Human Services (HHS) has advised DEA that an NDA has been submitted for a drug that has a stimulant, depressant, or hallucinogenic effect on the central nervous system (CNS), and that it appears that such drug has an abuse potential; and (2) the Secretary recommends that DEA control the drug in schedule II, III, IV, or V pursuant to 21 U.S.C. 811(a) and (b). In these circumstances, DEA is required to issue an IFR controlling the drug within 90 days.

Subsection (j)(2) states that the 90-day timeframe starts the later of (1) the date DEA receives HHS' scientific and medical evaluation/scheduling recommendation, or (2) the date DEA receives notice of the NDA approval by HHS. Subsection (j)(3) specifies that the rulemaking shall become immediately effective as an IFR without requiring DEA to demonstrate good cause therefore. Thus, the purpose of subsection (j) is to speed the process by which DEA schedules newly approved drugs that are currently either in schedule I or not controlled (but which have sufficient abuse potential to warrant control) so that such drugs may be marketed without undue delay following FDA approval. 1

Subsection (j)(3) further provides that the IFR shall give interested persons the opportunity to comment and to request a hearing. After the conclusion of such proceedings, DEA must issue a final rule in accordance with the scheduling criteria of 21 U.S.C. 811(b) through (d) and 812(b).

Daridorexant, chemically known as [(S)-2-(5-chloro-4-methyl-1 H -benzo[ d ]imidazol-2-yl)-2-methylpyrrolidin-1-yl](5-methoxy-2-(2 H -1,2,3-triazol-2-yl)phenyl)methanone, is a new molecular entity (NME) with CNS activity. Daridorexant is a dual orexin receptor antagonist that inhibits the orexin neuropeptide-induced activation of the orexin receptor type 1 (OX1R) and orexin receptor type 2 (OX2R) subtypes. Daridorexant shares chemical structure and pharmacological mechanism of action with certain schedule IV CNS depressants such as suvorexant and lemborexant.

On January 8, 2021, Idorsia Pharmaceuticals, Ltd (Sponsor) submitted an NDA to FDA for QUIVIVIQ (daridorexant) tablets for use as a treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. On January 7, 2022, DEA received notification that FDA, on the same date, approved this NDA. The recommended dosage is 25-50 mg once per night, taken orally within 30 minutes before going to bed, with at least seven hours remaining prior to planned awakening.

On December 22, 2021, DEA received from HHS a scientific and medical evaluation entitled “Basis for the Recommendation to Control Daridorexant and its Salts in schedule IV of the Controlled Substances Act” and a scheduling recommendation. Pursuant to 21 U.S.C. 811(b) and (c), this document contained an eight-factor analysis of the abuse potential, legitimate medical use, and dependence liability of daridorexant, along with HHS's recommendation to control daridorexant and its salts under schedule IV of the CSA.

In response, DEA reviewed the scientific and medical evaluation and scheduling recommendation provided by HHS, along with all other relevant data, and completed its own eight-factor review pursuant to 21 U.S.C. 811(c). DEA concluded that daridorexant meets the 21 U.S.C. 812(b)(4) criteria for placement in schedule IV of the CSA.

Pursuant to subsection 811(j), and based on HHS' scheduling recommendation, the approval of the NDA by HHS/FDA, and DEA's determination, DEA is issuing this IFR to schedule daridorexant as a schedule IV controlled substance under the CSA.

Included below is a brief summary of each factor as analyzed by HHS and DEA, and as considered by DEA in its scheduling action. Please note that both DEA and HHS analyses are available in their entirety under “Supporting Documents” in the public docket for this interim final rule at http://www.regulations.gov, under Docket Number “DEA-949.” Full analysis of, and citations to, the information referenced in the summary may also be found in the supporting and related material.

Daridorexant is an NME that has not been marketed in the United States or any country; evidence regarding its diversion, illicit manufacturing, or deliberate ingestion is lacking. There are no reports of law enforcement encounters of daridorexant in the National Forensic Laboratory Information System (NFLIS) database. 2 However, daridorexant is related in action to schedule IV depressants such as suvorexant and lemborexant. It is thus reasonable to assume that daridorexant may be diverted from legitimate channels, used contrary to or without medical advice, and otherwise abused so as to create hazards to the users and to the safety of the community to an extent similar to that of schedule IV CNS depressants. In clinical studies, daridorexant produced abuse-related effects in humans similar to suvorexant and zolpidem (schedule IV sedatives) and shares pharmacological mechanism of action similar to suvorexant and lemborexant; thus, it is likely to be abused for its sedative effects contrary to medical advice.

Daridorexant shares pharmacological profiles with other dual orexin receptor antagonists such as suvorexant and lemborexant, schedule IV CNS depressants. Data from the orexin binding studies demonstrated that daridorexant behaved as an insurmountable antagonist at the dual orexin receptors (OXIR and OX2R). Daridorexant is similar to suvorexant in its potency and duration of action at OX1R; however, it is more potent and has double the occupancy time as suvorexant at OX2R.

In animal studies, oral doses of daridorexant (100, 300, and 1000 mg/kg) produced transient decrease in rectally measured body temperature and increased incidence of whole-body tremors. Dose-dependent decline in activity was observed in unstimulated rats. In a study conducted to measure locomotor activity following daridorexant administration, rats given single oral dose of 300 mg/kg showed decline in locomotor activity when compared to the vehicle control group. Daridorexant's reinforcing properties were assessed by determining whether self-administration behavior was maintained when the drug was substituted for cocaine. Data from this study showed that rats self-administered cocaine (0.8 mg/kg/infusion), but doses of 0.1, 0.3, and 1 mg/kg/infusion of daridorexant produced a significantly lower mean number of active lever presses.

A randomized, double-blind, double-dummy, active-and placebo-controlled, 6-way cross-over study was conducted to determine the abuse potential of single oral doses of daridorexant. Suvorexant (150 mg) and Zolpidem (30 mg) served as the positive controls. Subjects received daridorexant at therapeutic (50 mg) and supratherapeutic (100 and 150 mg) doses. Bipolar visual analog scale (VAS) for Drug-Liking (0-100) served as the primary end. A score of 0 described a drug-disliking response; a score of 50 represented a neutral response, while a score of 100 described a strong drug liking. Drug liking scores following supratherapeutic doses (100 and 150 mg) of daridorexant showed statistically significant increases as compared to placebo on positive subjective measures (VAS measures for Drug Liking, Take Drug Again, Overall Drug Liking, High, and Good Drug Effects) and were statistically similar to those following suvorexant and zolpidem. Further, using a Drowsiness/Alertness VAS and an observer assessment of alertness/sedation, daridorexant's sedative properties were assessed. Both measures demonstrate that similar to suvorexant and zolpidem, daridorexant elicits drowsiness and sedation.

Data from Phase 1 clinical safety studies showed that daridorexant (5-200 mg) administered to 478 subjects produced somnolence in 52.7 percent (252), fatigue in 10.9 percent (52), and disturbances in attention in 3.8 percent (18) of subjects, respectively. Daridorexant at every dose produced somnolence at a rate that is 2- to 3-fold higher than that reported in the placebo-treated group. In two Phase 2 studies conducted to evaluate the efficacy and safety of daridorexant in subjects with insomnia disorder (one with adults (aged 18-64 years) at doses of 5-50 mg and the other with the elderly (≥65 years) at doses of 10-50 mg), daridorexant treatment led to reports of somnolence that exceeded reports of other effects that may be associated with abuse potential, including fatigue (5 (2.1 percent)) and dizziness (3 (1.3 percent). In three Phase 3 studies, which were conducted as confirmatory studies in adults and elderly subjects with insomnia disorder and were similarly designed to the two Phase 2 studies, the treatment-emergent adverse effects with the highest number of reports were somnolence (38 (2.14 percent)), fatigue (34 (1.91 percent)), and dizziness (26 (1.46 percent)). These types of reports were similar to those reported in the Phase 1 and 2 studies. The reported adverse events from the Phase 1, 2, and 3 studies demonstrate there were no significant abuse-related signals in these studies.

Daridorexant, similar to schedule IV drugs such as suvorexant and zolpidem, has sedative effects. In a human abuse potential (HAP) study, daridorexant produced abuse-related effects in humans similar to those of suvorexant and zolpidem. The abuse-related neuropharmacology profile of daridorexant is similar to that of schedule IV CNS depressants, such as suvorexant and lemborexant, and is consistent with its mechanism of action as a dual orexin receptors antagonist.

Daridorexant, chemically known as [(S)-2-(5-chloro-4-methyl-1 H -benzo[ d ]imidazol-2-yl)-2-methylpyrrolidin-1-yl](5-methoxy-2-(2 H -1,2,3-triazol-2-yl)phenyl)methanone, is an NME. It is soluble in acidic water and slightly soluble in ethanol. It has one stereoisomer with one chiral center. The drug product is manufactured in tablet dose strengths that contain 25 mg and 50 mg of the active ingredient ( i.e., daridorexant) and a series of excipients to aid in taste and tablet disintegration. The excipients in the tablet have no known abuse liability. Daridorexant plasma exposure is dose proportional from 25 mg to 50 mg with an absolute bioavailability of 62 percent, and has consistent pharmacokinetic profile following multiple-dose and single-dose administration with no accumulation.

As discussed in the background section, daridorexant has an accepted medical use in the United States.

There is no information on the history and current pattern of abuse for daridorexant, since it has not been marketed, legally or illegally, in the United States or any country. There is no evidence of diversion of daridorexant that has been distributed for research, such as for clinical trials. Data from preclinical and clinical studies indicate that the abuse potential of daridorexant is similar to that of schedule IV CNS depressants such as suvorexant and lemborexant. Consistent with the fact that daridorexant is an NME; NFLIS database had no records of encounters by the law enforcement.

The pharmacological mechanism of action of daridorexant as a dual orexin receptor antagonist suggests that its pattern of abuse would be similar to schedule IV depressants with a similar mechanism of action, such as suvorexant and lemborexant.

Data from preclinical and clinical studies showed that daridorexant has an abuse potential similar to that of the schedule IV depressants such as suvorexant and zolpidem. Thus, daridorexant, similar to these schedule IV substances, will have low potential for abuse relative to drugs and substances in schedule III. A search by DEA of the NFLIS database found no evidence of law enforcement encounters of daridorexant in the United States. Because daridorexant has a mechanism of action similar to schedule IV drugs suvorexant and lemborexant, it is likely that upon availability of daridorexant in the market, it will be abused similar to these schedule IV depressants.

The public health risk associated with daridorexant is largely due to its abuse potential. Data from preclinical and clinical studies showed that daridorexant has abuse potential similar to that of schedule IV depressants zolpidem and suvorexant. Therefore, upon availability for marketing, it is likely to pose a public health risk to a degree similar to these schedule IV depressants. Data from clinical trials showed that daridorexant has rewarding and depressant effects. The abuse of daridorexant may present risks to the public health at a level similar to those associated with the abuse of schedule IV CNS depressants.

Data obtained from a HAP study demonstrate that similar to suvorexant and zolpidem, daridorexant produced subjective responses to measures such as Drug Liking, Overall Drug Liking, Good Drug Effects, High, and Take Drug Again; indicative of psychological effects. HHS states that the data suggest daridorexant can produce psychic dependence similar to zolpidem and suvorexant, schedule IV depressants.

Results from a physiologic dependence study conducted in rats demonstrate that oral doses (0, 20, or 200 mg/kg/day) of daridorexant administered for 28-days followed by a 14-days discontinuation period did not produce alterations in physiological, neurobehavioral, or locomotor parameters during the discontinuation Phase of the study. Physical dependence signs were not observed in clinical studies after discontinuation of treatment in Phase 3 studies.

Data from animal studies and clinical trials demonstrate that chronic administration of daridorexant did not produce withdrawal signs or symptoms upon discontinuation. Daridorexant does not produce physical dependence.

Daridorexant is not an immediate precursor of any controlled substance, as defined by 21 U.S.C. 802(23).

Conclusion: After considering the scientific and medical evaluation and scheduling recommendation provided by HHS, and its own eight-factor analysis, DEA has determined that these facts and all relevant data constitute substantial evidence of potential for abuse of daridorexant. As such, DEA hereby schedules daridorexant as a controlled substance under the CSA.

The CSA lists the findings required to place a drug or other substance in any particular schedule (I, II, III, IV, or V). 21 U.S.C. 812(b). After consideration of the analysis and recommendation of the Assistant Secretary for Health of HHS and review of all available data, the Administrator of DEA (Administrator), pursuant to 21 U.S.C. 812(b)(4), finds that:

(1) Daridorexant has a low potential for abuse relative to the drugs or other substances in Schedule III.

Daridorexant, similar to schedule IV depressants such as suvorexant and lemborexant, is an orexin receptor antagonist. It produced sedation in general behavioral and locomotor studies. In a HAP study, oral administration of therapeutic (50 mg) and supratherapeutic doses (100 and 150 mg) of daridorexant produced increases in positive subjective measures such as Drug Liking, Overall Drug Liking, Good Drug Effects, High, and Take Drug Again that were statistically greater than those produced by placebo. These subjective responses following daridorexant were statistically similar to those produced by the positive control drugs that are schedule IV depressant such as zolpidem and suvorexant. These data show that daridorexant has an abuse potential that is similar to the schedule IV drugs zolpidem and suvorexant. Because daridorexant is similar to suvorexant and zolpidem in its abuse potential, daridorexant has a low potential for abuse relative to the drugs or other substances in schedule III.

(2) Daridorexant has a currently accepted medical use in treatment in the United States.

FDA recently approved the NDA for daridorexant as an oral treatment for adult patients with insomnia characterized by difficulties with sleep onset and/or sleep maintenance. Thus, daridorexant has a currently accepted medical use in treatment in the United States.

(3) Abuse of daridorexant may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule III.

Data from both preclinical and clinical studies demonstrate that discontinuation of daridorexant was not associated with withdrawal symptoms indicative of physical dependence. Because daridorexant produced positive subjective responses in a HAP study similar to those of zolpidem and suvorexant (both schedule IV drugs), it is likely that daridorexant can produce psychic dependence to an extent that is similar to these schedule IV substances. Thus, abuse of daridorexant may lead to limited physical or psychological dependence relative to the drugs or other substances in schedule III.

Based on these findings, the Administrator concludes that daridorexant warrants control in schedule IV of the CSA. 21 U.S.C. 812(b)(4).

Daridorexant is subject to the CSA's schedule IV regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, dispensing, importing, exporting, research, and conduct of instructional activities and chemical analysis with, and possession involving schedule IV substances, including the following:

1. Registration. Any person who handles (manufactures, distributes, reverse distributes, dispenses, imports, exports, engages in research, or conducts instructional activities or chemical analysis with, or possesses), or who desires to handle, daridorexant must be registered with DEA to conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and 958 and in accordance with 21 CFR parts 1301 and 1312. Any person who currently handles or intends to handle daridorexant and is not registered with DEA must submit an application for registration and may not continue to handle daridorexant unless DEA has approved that application, pursuant to 21 U.S.C. 822, 823, 957, and 958, and in accordance with 21 CFR parts 1301 and 1312. These registration requirements, however, are not applicable to patients (end users) who possess daridorexant pursuant to a lawful prescription.

2. Disposal of stocks. Any person unwilling or unable to obtain a schedule IV registration must surrender all quantities of currently held daridorexant, or may transfer all quantities of currently held daridorexant to a person registered with DEA. Daridorexant is required to be disposed of in accordance with 21 CFR part 1317, in addition to all other applicable Federal, state, local, and tribal laws.

3. Security. Daridorexant is subject to schedule III-V security requirements for DEA registrants and it must be handled and stored in accordance with 21 CFR 1301.71-1301.77. Non-practitioners handling daridorexant must also comply with the employee screening requirements of 21 CFR 1301.90-1301.93. These requirements, however, are not applicable to patients (end users) who possess daridorexant pursuant to a lawful prescription.

4. Labeling and Packaging. All labels, labeling, and packaging for commercial containers of daridorexant must comply with 21 U.S.C. 825 and 958(e), and be in accordance with 21 CFR part 1302.

5. Inventory. Every DEA registrant who possesses any quantity of daridorexant must take an inventory of daridorexant on hand, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11(a) and (d).

Any person who registers with DEA to handle daridorexant must take an initial inventory of all stocks of controlled substances (including daridorexant) on hand on the date the registrant first engages in the handling of controlled substances, pursuant to 21 U.S.C. 827 and 958(e), and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11(a) and (b).

After the initial inventory, every DEA registrant must take an inventory of all stocks of controlled substances (including daridorexant) on hand every two years, pursuant to 21 U.S.C. 827 and 958(e), and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. These requirements, however, are not applicable to patients (end users) who possess daridorexant pursuant to a lawful prescription.

6. Records and Reports. DEA registrants must maintain records and submit reports for daridorexant, pursuant to 21 U.S.C. 827, 832(a), and 958(e), and in accordance with 21 CFR 1301.74(b) and (c) and parts 1304, 1312, and 1317.

7. Prescriptions. All prescriptions for daridorexant, or products containing daridorexant, must comply with 21 U.S.C. 829, and be issued in accordance with 21 CFR parts 1306 and 1311, subpart C.

8. Manufacturing and Distributing. In addition to the general requirements of the CSA and DEA regulations that are applicable to manufacturers and distributors of schedule IV controlled substances, such registrants should be advised that (consistent with the foregoing considerations) any manufacturing or distribution of daridorexant may only be for the legitimate purposes consistent with the drug's labeling, or for research activities authorized by the Federal Food, Drug, and Cosmetic Act (FDCA), as applicable, and the CSA.

9. Importation and Exportation. All importation and exportation of daridorexant must comply with 21 U.S.C. 952, 953, 957, and 958, and in accordance with 21 CFR part 1312.

10. Liability. Any activity involving daridorexant not authorized by, or in violation of, the CSA or its implementing regulations, is unlawful, and may subject the person to administrative, civil, and/or criminal sanctions.

Section 553 of the APA (5 U.S.C. 553) generally requires notice and comment for rulemakings. However, 21 U.S.C. 811(j) provides that in cases where a certain new drug is (1) approved by HHS, under section 505(c) of the FDCA and (2) HHS recommends control in CSA schedule II-V, DEA shall issue an IFR scheduling the drug within 90 days. As stated in the legal authority section, the 90-day time frame is the later of: (1) The date DEA receives HHS's scientific and medical evaluation/scheduling recommendation, or (2) the date DEA receives notice of the NDA approval by HHS. Additionally, subsection (j) specifies that the rulemaking shall become immediately effective as an IFR without requiring DEA to demonstrate good cause.

In accordance with 21 U.S.C. 811(a) and (j), this scheduling action is subject to formal rulemaking procedures performed “on the record after opportunity for a hearing,” which are conducted pursuant to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the procedures and criteria for scheduling a drug or other substance. Such actions are exempt from review by the Office of Management and Budget (OMB) pursuant to section 3(d)(1) of Executive Order (E.O.) 12866 and the principles reaffirmed in E.O. 13563.

This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.

This rulemaking does not have federalism implications warranting the application of E.O. 13132. The rule does 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.

This rule does not have tribal implications warranting the application of E.O. 13175. It does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.

The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to rules that are subject to notice and comment under section 553(b) of the APA. As noted in the above discussion regarding the applicability of the APA, DEA is not required to publish a general notice of proposed rulemaking. Consequently, the RFA does not apply to this IFR.

In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1501 et seq., DEA has determined that this action would not result in any Federal mandate that may result “in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any 1 year.” Therefore, neither a Small Government Agency Plan nor any other action is required under UMRA of 1995.

This action does not impose a new collection of information requirement under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521. This action would not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

This rule is not a major rule as defined by the Congressional Review Act (CRA), 5 U.S.C. 804. However, pursuant to the CRA, DEA is submitting a copy of this IFR to both Houses of Congress and to the Comptroller General.

For the reasons set out above, DEA amends 21 CFR part 1308 as follows:

In this final rule, the Drug Enforcement Administration (DEA) is permanently scheduling the following five controlled substances in schedule I of the Controlled Substances Act (CSA), including their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:

• Ethyl 2-(1-(5-fluoropentyl)-1 H -indazole-3-carboxamido)-3,3-dimethylbutanoate (other name: 5F-EDMB-PINACA),

• Methyl 2-(1-(5-fluoropentyl)-1 H -indole-3-carboxamido)-3,3-dimethylbutanoate (other names: 5F-MDMB-PICA; 5F-MDMB-2201),

• N -(Adamantan-1-yl)-1-(4-fluorobenzyl)-1 H -indazole-3-carboxamide (other names: FUB-AKB48; FUB-APINACA; AKB48 N -(4-fluorobenzyl)),

• 1-(5-Fluoropentyl)- N -(2-phenylpropan-2-yl)-1 H -indazole-3-carboxamide (other names: 5F-CUMYL-PINACA; SGT-25), and

• (1-(4-Fluorobenzyl)-1 H -indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (other name: FUB-144).

The CSA provides that issuing, amending, or repealing of the scheduling of any drug or other substance may be initiated by the Attorney General (1) on his own motion; (2) at the request of the Secretary of the Department of Health and Human Services (HHS);  1 or (3) on the petition of any interested party. 21 U.S.C. 811(a). The then-Acting Administrator of DEA (as delegated by the Attorney General to the Administrator of DEA) initiated this action on his own motion, and is supported by, inter alia, a recommendation from the then-Acting Assistant Secretary for Health of HHS and an evaluation of all relevant data by DEA. The regulatory controls and administrative, civil, and criminal sanctions of schedule I controlled substances on any person who handles (manufactures, distributes, imports, exports, engages in research, or conducts instructional activities or chemical analysis with, or possesses) or proposes to handle 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144 will continue to apply as a result of this action.

On April 16, 2019, DEA published an order in the Federal Register amending 21 CFR 1308.11(h) to temporarily place ethyl 2-(1-(5-fluoropentyl)-1 H -indazole-3-carboxamido)-3,3-dimethylbutanoate (trivial name: 5F-EDMB-PINACA); methyl 2-(1-(5-fluoropentyl)-1 H -indole-3-carboxamido)-3,3-dimethylbutanoate (trivial name: 5F-MDMB-PICA); N -(adamantan-1-yl)-1-(4-fluorobenzyl)-1 H -indazole-3-carboxamide (trivial names: FUB-AKB48; FUB-APINACA; AKB48 N-(4-FLUOROBENZYL)); 1-(5-fluoropentyl)- N -(2-phenylpropan-2-yl)-1 H -indazole-3-carboxamide (trivial names: 5F-CUMYL-PINACA; SGT-25); and (1-(4-fluorobenzyl)-1 H -indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (trivial name: FUB-144) in schedule I of the CSA pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). 84 FR 15505. That temporary scheduling order took effect on the date of publication, and was based on findings by the then-Acting Administrator of DEA that the temporary scheduling of these five synthetic cannabinoids (SCs) was necessary to avoid an imminent hazard to the public safety pursuant to 21 U.S.C. 811(h)(1).

On March 30, 2021, DEA published a notice of proposed rulemaking (NPRM) in the Federal Register to permanently control the five SCs in schedule I of the CSA. 86 FR 16553. On March 31, 2021, DEA published an order to extend the temporary scheduling of the five SCs by one year, until April 16, 2022. 86 FR 16669.

On February 26, 2021, HHS provided DEA with a scientific and medical evaluation and scheduling recommendation, prepared by the Food and Drug Administration (FDA), entitled “Basis for the Recommendation to Place Ethyl 2-(1-(5-fluoropentyl)-1 H -indazole-3-carboxamido)-3,3-dimethylbutanoate [5F-EDMB-PINACA]; methyl 2-(1-(5-fluoropentyl)-1 H -indole-3-carboxamido)-3,3-dimethylbutanoate [5F-MDMB-PICA]; N -(adamantan-1-yl)-1-(4-fluorobenzyl)-1 H -indazole-3-carboxamide [FUB-AKB48;FUB-APINACA; AKB48 N -(4-fluorobenzyl)]; 1-(5-fluoropentyl)- N -(2-phenylpropan-2-yl)-1 H -indazole-3-carboxamide [5F-CUMYL-PINACA; SGT-25]; and (1-(4-fluorobenzyl)-1 H -indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone [FUB-144; FUB-UR-144] and Their Salts, Isomers, and Salts of Isomers in Schedule I of the Controlled Substances Act.”

After considering the eight factors in 21 U.S.C. 811(c), each substance's abuse potential, lack of legitimate medical use in the United States, and lack of accepted safety for use under medical supervision pursuant to 21 U.S.C. 812(b), the then-Acting Assistant Secretary for Health of HHS recommended that 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144 be placed in schedule I of the CSA. In response, DEA conducted its own eightfactor analysis of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144.

Both DEA and HHS eight-factor analyses are available in their entirety in the public docket for this rule (Docket Number DEA-491) at http://www.regulations.gov under “Supporting Documents.”

On March 30, 2021, DEA published an NPRM entitled “Schedules of Controlled Substances: Placement of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 in Schedule I.” 86 FR 16553. Specifically, the NPRM proposed to add the five SCs to the hallucinogenic substances list under 21 CFR 1308.11(d), and assign them paragraph numbers 87 through 91 under paragraph (d). In addition, the NPRM listed these five SCs by their chemical and trivial names as follows:

• (87) Ethyl 2-(1-(5-fluoropentyl)-1 H -indazole-3-carboxamido)-3,3-dimethylbutanoate (trivial name: 5F-EDMB-PINACA);

• (88) methyl 2-(1-(5-fluoropentyl)-1 H -indole-3-carboxamido)-3,3-dimethylbutanoate (trivial name: 5F-MDMB-PICA);

• (89) N -(adamantan-1-yl)-1-(4-fluorobenzyl)-1 H -indazole-3-carboxamide (trivial names: FUB-AKB48; FUB-APINACA; AKB48 N -(4-fluorobenzyl));

• (90) 1-(5-fluoropentyl)- N -(2-phenylpropan-2-yl)-1 H -indazole-3-carboxamide (trivial names: 5F-CUMYL-PINACA; SGT-25); and

• (91) (1-(4-fluorobenzyl)-1 H -indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (trivial name: FUB-144).

The NPRM provided an opportunity for interested persons to file a request for hearing in accordance with DEA regulations, as well as to submit comments on the proposed rule, on or before April 29, 2021. DEA did not receive any requests for such a hearing or any public comments on the proposed rule.

After considering the scientific and medical evaluations and accompanying recommendation of HHS, and conducting an independent eight-factor analysis, DEA finds substantial evidence of abuse potential for 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144. DEA is therefore permanently scheduling 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144 as controlled substances under the CSA.

The CSA establishes five schedules of controlled substances known as schedules I, II, III, IV, and V. The CSA also outlines the findings required to place a drug or other substance in any particular schedule. 21 U.S.C. 812(b). After consideration of the analysis and recommendation of the then-Acting Assistant Secretary for Health of HHS and review of all other available data, the Administrator of DEA, pursuant to 21 U.S.C. 811(a) and 812(b)(1), finds that:

(1) 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144 have a high potential for abuse that is comparable to other schedule I substances such as delta-9-tetrahydrocannabinol (Δ 9 -THC) and JWH-018;

(2) 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144 currently have no accepted medical use in treatment in the United States;  2 and

(3) There is a lack of accepted safety for use of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144 under medical supervision.

Based on these findings, the Administrator concludes that ethyl 2-(1-(5-fluoropentyl)-1 H -indazole-3-carboxamido)-3,3-dimethylbutanoate (other name: 5F-EDMB-PINACA); methyl 2-(1-(5-fluoropentyl)-1 H -indole-3-carboxamido)-3,3-dimethylbutanoate (other names: 5F-MDMB-PICA; 5F-MDMB-2201); N -(adamantan-1-yl)-1-(4-fluorobenzyl)-1 H -indazole-3-carboxamide (other names: FUB-AKB48; FUB-APINACA; AKB48 N -(4-fluorobenzyl)); 1-(5-fluoropentyl)- N -(2-phenylpropan-2-yl)-1 H -indazole-3-carboxamide (other names: 5F-CUMYL-PINACA; SGT-25); and (1-(4-fluorobenzyl)-1 H -indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (other name: FUB-144), including their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation, warrant control in schedule I of the CSA. 21 U.S.C. 812(b)(1).

As discussed in the above NPRM section, DEA proposed to place 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144 in 21 CFR 1308.11(d) as paragraphs 87 through 91, respectively. The NPRM listed chemical, as well as trivial, names for the five substances. Regarding the substance methyl 2-(1-(5-fluoropentyl)-1 H -indole-3-carboxamido)-3,3-dimethylbutanoate, the NPRM listed only one trivial name (5F-MDMB-PICA). Since the publication of the NPRM, DEA has found another trivial name (5F-MDMB-2201) for this substance. In addition, DEA has issued several final rules which updated the numbering of listed hallucinogenic substances in paragraph (d). As a result, this final rule assigns paragraphs 89 through 93 to 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144, respectively. This final rule now refers to “trivial” names as “other” names, and lists both 5F-MDMB-PICA and 5F-MDMB-2201 as other names for methyl 2-(1-(5-fluoropentyl)-1 H -indole-3-carboxamido)-3,3-dimethylbutanoate.

5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144 will continue  3 to be subject to the CSA's schedule I regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, dispensing, importing, exporting, research, and conduct of instructional activities, including the following:

1. Registration. Any person who handles, or desires to handle, 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, or FUB-144 must be registered with DEA to conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and 958 and in accordance with 21 CFR parts 1301 and 1312.

2. Security. 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144 are subject to schedule I security requirements and must be handled in accordance with 21 CFR 1301.71-1301.76. Non-practitioners handling these five substances must also comply with the employee screening requirements of 21 CFR 1301.90-1301.93.

3. Labeling and Packaging. All labels, labeling, and packaging for commercial containers of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144 must be in compliance with 21 U.S.C. 825 and 958(e), and be in accordance with 21 CFR part 1302.

4. Quota. Only registered manufacturers are permitted to manufacture 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, or FUB-144 in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303.

5. Inventory. Every DEA registrant who possesses any quantity of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144 was required to keep an inventory of all stocks of these substances on hand as of April 16, 2019, pursuant to 21 U.S.C. 827 and 958 and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11(a) and (d).

6. Records and Reports. Every DEA registrant must maintain records and submit reports with respect to 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and/or FUB-144, pursuant to 21 U.S.C. 827 and 958(e), and in accordance with 21 CFR 1301.74(b) and (c) and parts 1304, 1312, and 1317. Manufacturers and distributors must submit reports regarding 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and/or FUB-144 to the Automation of Reports and Consolidated Order System pursuant to 21 U.S.C. 827 and in accordance with 21 CFR parts 1304 and 1312.

7. Order Forms. Every DEA registrant who distributes 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, or FUB-144 must continue to comply with the order form requirements, pursuant to 21 U.S.C. 828 and in accordance with 21 CFR part 1305.

8. Importation and Exportation. All importation and exportation of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144 must continue to be in compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance with 21 CFR part 1312.

9. Liability. Any activity involving 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, or FUB-144 not authorized by, or in violation of, the CSA or its implementing regulations is unlawful, and may subject the person to administrative, civil, and/or criminal sanctions.

In accordance with 21 U.S.C. 811(a), this final scheduling action is subject to formal rulemaking procedures performed “on the record after opportunity for a hearing,” which are conducted pursuant to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the criteria for scheduling a drug or other substance. Such actions are exempt from review by the Office of Management and Budget (OMB) pursuant to section 3(d)(1) of Executive Order (E.O.) 12866 and the principles reaffirmed in E.O. 13563.

This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.

This rulemaking does not have federalism implications warranting the application of E.O. 13132. The rule does not have substantial direct effects on the States, on the relationship between the national government and the states, or the distribution of power and responsibilities among the various levels of government.

This rule does not have tribal implications warranting the application of E.O. 13175. It does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.

The Administrator, in accordance with the Regulatory Flexibility Act, 5 U.S.C. 601-612, has reviewed this final rule and by approving it certifies that it will not have a significant economic impact on a substantial number of small entities. On April 16, 2019, DEA published an order to temporarily place these five substances in schedule I of the CSA pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h).

DEA estimates that all entities handling or planning to handle these substances have already established and implemented the systems and processes required to handle 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144 as schedule I controlled substances. There are currently 28 registrations authorized to handle 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and/or FUB-144 specifically, as well as a number of registered analytical labs that are authorized to handle schedule I controlled substances generally. DEA estimates these 28 registrations encompass 22 entities. Some of these entities are likely to be large entities. However, DEA does not have information of registrant size and the majority of DEA registrants are small entities or are employed by small entities. Therefore, DEA conservatively estimates as many as 22 small entities are affected by this rule.

A review of the 28 registrations indicates that all entities that currently handle 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, or FUB-144 also handle other schedule I controlled substances, and have established and implemented (or maintain) the systems and processes required to handle 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, or FUB-144. Therefore, DEA anticipates that this rule will impose minimal or no economic impact on a substantial number of small entities.

In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1501 et seq., DEA has determined and certifies that this action would not result in any Federal mandate that may result “in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any 1 year * * *.” Therefore, neither a Small Government Agency Plan nor any other action is required under UMRA of 1995.

This rule is not a major rule as defined by the Congressional Review Act (CRA), 5 U.S.C. 804. However, pursuant to the CRA, DEA is submitting a copy of this final rule to the Government Accountability Office, the House, and the Senate under the CRA.

This action does not impose a new collection of information under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521. This action would not impose recordkeeping or reporting requirements on state or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

As indicated above, this rule finalizes the schedule I control status of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144 that has already been in effect for over two years by virtue of the April 16, 2019, temporary scheduling order (84 FR 15505) and the subsequent one-year extension of that order (March 31, 2021, 86 FR 16669). The April 2019 order was effective on the date of publication, and was based on findings by the then-Acting Administrator that the temporary scheduling of these substances was necessary to avoid an imminent hazard to the public safety pursuant to 21 U.S.C. 811(h)(1).

Because this rule finalizes the control status of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA, and FUB-144 that has already been in effect for over two years, it does not alter the legal obligations of any person who handles these substances. Rather, it merely makes permanent the current scheduling status and corresponding legal obligations. Therefore, DEA is making the rule effective on the date of publication in the Federal Register , as any delay in the effective date is unnecessary and would be contrary to the public interest. See 5 U.S.C. 553(d).

For the reasons set out above, 21 CFR part 1308 is amended as follows:

DOL is informing the public that, consistent with the Supreme Court's decision in Bostock v. Clayton County, 140 S. Ct. 1731 (2020), and Title IX of the Education Amendments of 1972, 20 U.S.C. 1681 et seq., DOL, beginning April 7, 2022, will interpret the prohibition on discrimination on the basis of sex in Section 188 of the Workforce Innovation and Opportunity Act (WIOA), 29 U.S.C. 3248, to include discrimination on the basis of sexual orientation. 1 DOL will continue to interpret and enforce Section 188's prohibition on discrimination on the basis of sex to include discrimination on the basis of gender identity and transgender status, as set forth in the regulations issued under Section 188.29 CFR 38.7.

The Civil Rights Center (CRC) at DOL is responsible for enforcing Section 188 of WIOA and regulations issued under Section 188, which prohibit exclusion of an individual from participation in, denial of the benefits of, discrimination in, or denial of employment in the administration of or in connection with, any programs and activities funded or otherwise financially assisted in whole or in part under Title I of WIOA on various bases, including sex. 29 U.S.C. 3248(a).

On June 15, 2020, the U.S. Supreme Court held that the prohibition on employment discrimination based on sex in Title VII of the Civil Rights Act of 1964, 42 U.S.C. 2000e et seq., encompasses discrimination based on sexual orientation, gender identity, and transgender status. The Court concluded that the plain meaning of “because of sex” in Title VII necessarily includes discrimination because of sexual orientation, gender identity, and transgender status. Bostock v. Clayton County, 140 S. Ct. 1731, 1753-54 (2020).

Since Bostock, at least one Federal circuit court of appeal has concluded that the plain language of Title IX's prohibition on sex discrimination must be read similarly, and the Supreme Court has denied review of that decision. Grimm v. Gloucester Cnty. Sch. Bd., 972 F.3d 586, 616 (4th Cir. 2020), as amended (Aug. 28, 2020), petition for cert. denied, No. 20-1163 (June 28, 2021).

On March 26, 2021, the Civil Rights Division of the U.S. Department of Justice, the agency charged with coordination of the implementation and enforcement of Title IX by executive agencies, issued a memorandum concluding that “the best reading of Title IX's prohibition on discrimination `on the basis of sex' is that it includes discrimination on the basis of gender identity and sexual orientation.”  2 The Civil Rights Division reached this conclusion after considering the text of Title IX, Bostock and other Supreme Court case law, including dissenting opinions, and developing jurisprudence in this area, including the circuit court opinion cited above. The Civil Rights Division subsequently updated its Title IX Legal Manual to state that the Department of Justice interprets Title IX to prohibit discrimination based on gender identity and sexual orientation. 3

In addition, on June 22, 2021, the Office for Civil Rights of the U.S. Department of Education, the agency responsible for that Department's enforcement of Title IX, published a notice in the Federal Register clarifying that it will enforce Title IX's prohibition on discrimination based on sex to include discrimination based on both sexual orientation and gender identity. 4 The Office for Civil Rights concluded that the Supreme Court's interpretation of sex discrimination in Bostock properly applies to Title IX based on the textual similarity between Title VII and Title IX; subsequent case law including the Grimm decision cited above, as well as cases recognizing the harm that students may endure as a result of differential treatment based on gender identity or sexual orientation;  5 and the Civil Rights Division's memorandum discussed above.

Section 188 of WIOA expressly incorporates Title IX's prohibition on sex discrimination. 29 U.S.C. 3248(a)(2) (specifying that “[n]o individual shall be excluded from participation in, denied the benefits of, subjected to discrimination under, or denied employment in the administration of or in connection with, any such program or activity [funded or otherwise financially assisted in whole or in part under Title I of WIOA] because of . . . sex (except as otherwise permitted under title IX of the Education Amendments of 1972 . . .)”); see also id. 3248(a)(1) (providing that “programs and activities funded or otherwise financially assisted in whole or in part under [WIOA] are considered to be programs and activities receiving Federal financial assistance” for the purpose of applying the prohibition against discrimination on the basis of sex under Title IX).

Consistent with the Supreme Court's interpretation of Title VII in Bostock and with the case law and interpretations discussed above applying the same conclusion to Title IX, beginning April 7, 2022, CRC interprets Section 188's prohibition on discrimination on the basis of sex to include discrimination on the basis of sexual orientation, as well as gender identity and transgender status. This interpretation will guide CRC in processing complaints and conducting investigations and compliance reviews, but it does not determine the outcome in any particular case, which will depend on the specific facts and circumstances. Any action taken by CRC in a specific case will take account of all relevant facts and legal requirements, including, where applicable, Title IX's religious exemption and other exemptions, which are incorporated into Section 188, see 29 U.S.C. 3248(a)(2), and the Religious Freedom Restoration Act, 42 U.S.C. 2000bb et seq.

If you think that you have, or any specific class of individuals has, been subjected to discrimination under a WIOA Title I-financially assisted program or activity, you may file a complaint within 180 days from the date of the alleged violation with either: (1) The recipient's Equal Opportunity Officer (or the person whom the recipient has designated for this purpose) or (2) CRC, via postal mail addressed to The Director, Civil Rights Center (CRC), U.S. Department of Labor, 200 Constitution Avenue NW, Room N-4123, Washington, DC 20210, or electronically as directed on the CRC website at https://www.dol.gov/agencies/oasam/centers-offices/civil-rights-center/external/how-to-file-complaint. The complaint will be processed in accordance with the procedures at 29 CFR 38.69-.85. After investigating the complaint, if the Director of CRC finds reasonable cause to believe that the recipient has violated WIOA Section 188 or its implementing regulations, the Director is required to issue an Initial Determination that includes the opportunity for the recipient to engage in voluntary compliance negotiations. 29 CFR 38.87(e).

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

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable and contrary to the public interest to do so. We must establish this safety zone by April 16, 2022, to protect the public from hazards associated with the fireworks event. Hazards include explosive materials, dangerous projectiles, and falling debris. The fireworks fall out zone extends across the navigable channel.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule would be impracticable and contrary to the public interest because immediate action is needed to respond to the potential safety hazards associated with the fireworks display.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The Captain of the Port, Maryland-National Capital Region (COTP) has determined that potential hazards associated with the fireworks to be used in the April 16, 2022 display will be a safety concern for anyone near the fireworks barge. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone before, during, and after the scheduled event.

This rule establishes a temporary safety zone from 7:30 p.m. on April 16, 2022, through 9:30 p.m. on April 17, 2022. The rule will be enforced from 7:30 p.m. through 9:30 p.m. on April 16, 2022, or in the event of inclement weather on April 16, those same hours on April 17, 2022. The safety zone covers all navigable waters of the Anacostia River within 500 feet of the fireworks barge in approximate position latitude 38°52′15.39″ N, longitude 77°00′09.39″ W, located near Nationals Park in Washington, DC. The size of the zone and duration of the rule are intended to protect personnel, vessels, and the marine environment in these navigable waters before, during, and after the scheduled fireworks display. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.

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

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

This regulatory action determination is based on the size, duration, and time-of-day of the safety zone, which will impact a small designated area of the Anacostia River for no more than 4 enforcement-hours during evening hours when vessel traffic is normally low. Moreover, the Coast Guard will issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

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

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

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

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

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

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

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone that will be enforced for 3 hours that will prohibit entry within a portion of the Anacostia River. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the ADDRESSES section of this preamble.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to call or email the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

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

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.

Bulk Silos is a portland cement distribution terminal in the Ramsey County PM 10 maintenance area, also known as the Red Rock Road maintenance area, in St. Paul (Ramsey County), Minnesota. The area was designated nonattainment for the 1987 PM 10 standard on March 15, 1991 (56 FR 11101), and was redesignated to attainment on July 26, 2002 (67 FR 48787). On June 16, 2021, MPCA submitted a request to EPA to approve into the Minnesota SIP the conditions cited as “Title I Condition: 40 CFR 50.6 (PM 10 SIP).” The submission contains measures for Bulk Silos to implement changes that increase efficiency through new and existing equipment, as well as clarifying amendments to the document's language. MPCA posted a background document and permit issuance notice for public comment in the Minnesota State Register on April 30, 2021, and the comment period ended on June 1, 2021. MPCA received no comments on the document or permit.

Bulk Silos currently operates six silos with pollution control equipment; the silos are used for storage and distribution of cementitious products. The material is currently received by rail, stored in silos, and distributed by truck. The facility is subject to a State Individual Permit containing title I PM 10 SIP conditions (Permit No. 12300391-002, published September 11, 2007, 72 FR 51713), which will continue to apply until this SIP revision is approved by the EPA. These conditions are intended to ensure that the Red Rock Road area continues to maintain the PM 10 NAAQS.

The previous SIP revision, approved September 11, 2007 (72 FR 51713), consisted of a FESOP issued to Lafarge-Childs Road Terminal which serves as a joint title I/FESOP document. In the September 11, 2007, action, EPA approved into the Minnesota PM 10 SIP the portions of Minnesota Air Emission Permit No. 12300391-002 issued to Lafarge-Childs Road Terminal on November 17, 2006, cited as “Title I condition: SIP for PM 10 NAAQS.” As part of that action, EPA approved Minnesota's request to revoke from the SIP several Administrative Orders for Lafarge-Childs Road Terminal that had been approved on February 15, 1994 (60 FR 7218), June 13, 1995 (60 FR 31088), and February 8, 1999 (64 FR 5936).

The 2007 title I SIP revisions approved the installation of a new rail siding for rail delivery of material to the silos, the installation of a related railcar-to-silo pneumatic conveyance, the redesign of the pneumatic conveyance system to allow dedicated use of Silos Nos. 1 and 2, and the installation of new pollution control devices (a low temperature fabric filter) on each of the two dedicated silos. The modeling results demonstrated that to comply with the FESOP, Lafarge-Childs Road Terminal was limited to a maximum daily throughput of 1,100 tons per day (tpd) using a 24-hour rolling average and an annual throughput of 100,000 tons per year (tpy), using a 12-month rolling average.

This SIP revision is being approved in conjunction with a major amendment to a State Individual Permit containing federally enforceable title I SIP conditions (Air Emission Permit No. 12300391-102), submitted to EPA on June 16, 2021. The submittal included the replacement of three existing fabric filters, the construction of three new silos, a new bucket elevator, twelve new fabric filters, paving of roads, and new barge unloading operations. The suggested facility changes in operation require increased throughput limits for overall facility operations, truck loading operations, and bucket elevator operations. To offset increases in throughput limits, Bulk Silos' new permit allows unloading of product from one silo at a time, and the emission limits of unloading will be decreased after approval of the updated title I SIP conditions. Further, MPCA included updated modeling with improved emission factors demonstrating decreased allowable PM 10 emissions with the proposed facility changes and reduced emission limits. New equipment would not be operable by Bulk Silos until EPA approves the requirements into Minnesota's SIP.

MPCA's June 16, 2021, submission contains amended SIP conditions that, when combined, decrease total allowable emission rates of PM 10 from Bulk Silos while increasing throughput limits, adding/improving fabric filters, and constructing three new silos. See Table 1 at the end of this review for a list of detailed changes to PM 10 allowable emissions limits associated with this action. Additionally, see “Process flow diagram” included at the end of MPCA's Background document submission for a detailed diagram of the facility's operations. The amended SIP conditions in the provided background document include:

New construction in the SIP revision would include the installation of twelve new fabric filters: Replacement of three fabric filters (Treatment “TREA” 5, 6 and 9 replacing TREA 1-3) and installation of nine new fabric filters (TREA 7, 8, 10-16). Additionally, the revised SIP would authorize construction and operation of a new bucket elevator (Equipment “EQUI” 5) and three new silos (EQUI 8-10). Further, because Bulk Silos' roadways have been paved since the issuance of Permit No. 123000391-102, the SIP revision will remove the emission limit requirements for unpaved roads at the permit condition addressing fugitive emissions at “FUGI” 2. The facility will be subject to emission limit requirements for paved roads that were previously SIP-approved on July 27, 2020 (85 FR 45094), and contain permit content requirements in Minnesota Rule (Minn. R.) 7007.0800, subpart 2(A) and subpart 5, prevention of airborne particulate matter in Minn. R. 7011.0150, and standards for dry bulk agricultural commodity requirements in Minn. R. 7011.1005, subpart 1(A).

Throughput limits for facility operations, specifically silo unloading (COMG 2), truck loading operations (EQUI 4), and bucket elevator operations (EQUI 5), will be increased or established for new processes with this SIP revision. Previously, unloading operations were limited to rail and required throughput limits of 1,100 tpd/100,000 tpy, truck loading operations had no emission limits, and the facility did not include bucket elevator operations or barge unloading. The proposed revisions add barge unloading to the facility's operations, incorporate throughput limits of 2,500 tpd/740,000 tpy each for unloading and truck loading, and 1,100 tpd/100,000 tpy for the proposed bucket elevator operations. Facility-specific emission factors and other proposed facility changes demonstrate no increased emissions of PM 10 from increased throughput limits based on improved modeling. Permit No. 12300391-102 includes language specifying “This requirement expires upon startup of the Project” for current operational throughput, or silo unloading (COMG 2, 5.3.1 and 5.3.2). Additionally, the permit states the increased limits would go into effect “Upon startup of the Project” (COMG 2, 5.3.3 and 5.3.4) for operational throughput, and similarly for the newly established truck loading throughput limits (EQUI 4, 5.7.3 and 5.7.4) and bucket elevator throughput limits (EQUI 5, 5.8.1 and 5.8.2). See Table 1 for equipment-specific emission limit changes from the effective permit (No. 12300391-002, 72 FR 51713) to the new permit (No. 12300391-102).

To approve the new conditions listed in Permit No. 12300391-102, the MPCA conducted Significant Impact Level (SIL) modeling to determine compliance with the PM 10 NAAQS using both existing and new PM 10 emissions sources. The permit update replaces equivalent-or-better modeling demonstration requirements at the permit condition titled Total Facility “TFAC” 1, 5.1.1 and 6.1.1 to include specific modeling triggers when future changes are made in the parameters contained in Appendix A or emission sources. Specifically, TFAC 5.1.1 indicates no change can be made to the facility that would result in an increase in PM 10 or PM 2.5 emissions until it can be demonstrated that it would not cause an exceedance of the NAAQS and 6.1.1 contains corrective actions for failed emission rate performance tests.

The required modeling exercise to review and reissue Permit No. 12300391-102 to Bulk Silos included new, significantly lower process-specific factors not identified in prior modeling demonstrations for the facility, provided by Bulk Silos through performance testing  1 and reference from EPA's Compilation of Air Pollutant Emissions Factors (AP-42). 2 The SIL modeling demonstration allowed MPCA to increase throughput limits while decreasing the allowable PM 10 emission rate (Table 1). Performance testing requirements at a minimum of once every 60 months will be used to demonstrate continued compliance and verify the updated emission factors (see 6.2.1 (permit condition titled Component Group “COMG” 2 unloading silos), 6.3.1 (COMG 3 existing unloading silos), 6.4.1 (COMG 4, bucket elevator and silo 3 operations), 6.5.1 (EQUI 4, truck loading operations)).

The approval of MPCA's submittal would strengthen the Minnesota SIP by requiring more stringent emission limits, counteracting the revision of increased throughput limits. Table 1, below, shows the previous emission limit and new emission limit applicable to each unit at the facility. Considered together, allowable emissions will be decreased by 1.18 lb/hr and 0.45 lb/hr for the 24-hour limit and the annual limit, respectively. These changes become effective upon the effective date of EPA's approval of MPCA's June 16, 2021, request.

The approval of the SIP revisions allows the unloading of product into EQUIs 1, 2, 6, 7, 8, 9, 10, or 12, contained in COMG 2. Product would no longer be loaded into Silo 3 (EQUI 11). Instead, Silo 3 would serve as a storage silo to transfer cementitious product between silos 7-9 (EQUI 8, 9 and 10). Units contained in COMG 2 are collectively subject to the Unloading Process Throughput limits and the “New SIP PM 10 Limit” of 0.009 lb/hr. Previously, EQUI 3 contained EQUI 6, EQUI 7, EQUI 11, and EQUI 12. These four units are subject to the combined PM 10 limit of 0.84 lb/hr at COMG 1 until startup of the Project. Then, the PM 10 limit for EQUIs 6, 7, and 12 will be encompassed by the PM 10 limit at COMG 2 and the PM 10 limit for EQUI 11 will be at EQUI 11.

In this action, EPA is approving MPCA's request to update title I SIP Conditions related to the Bulk Silos' portland cement distribution terminal. MPCA's submission includes a noninterference demonstration clarification letter included within the docket of this rulemaking intended to show that its SIP revision is approvable under Section 110(l) of the CAA; such a demonstration is sometimes called an anti-backsliding demonstration. Section 110(l) provides that EPA cannot approve a SIP revision if the revision would interfere with any applicable requirement concerning attainment or reasonable further progress (RFP), or any other applicable requirement of the CAA.

Additionally, Section 110(l) makes clear that each SIP revision is subject to the requirements of Section 110(l). A state may demonstrate the revision will not interfere with attainment of the NAAQS through an air quality modeling analysis. As previously mentioned, MPCA performed a SIL modeling demonstration to determine compliance with the PM 10 NAAQS, concluding that the facility changes at Bulk Silos will not interfere with the facility's ability to maintain the PM 10 NAAQS and total allowable PM 10 emissions will be decreased. The modeling demonstration included updated facility-specific emission factors developed through performance testing. Further, MPCA has made updates to the modeling requirements in the Bulk Silos' permit, specifically, TFAC 5.1.1 states no change can be made to the facility that would result in an increase in PM 10 or PM 2.5 emissions until it can be demonstrated that it would not cause an exceedance of the NAAQS. For these reasons, we conclude that the revisions will not interfere with attainment and maintenance of the NAAQS, RFP, or any other applicable requirement of the CAA. EPA has determined that MPCA's SIP submission meets the requirements of section 110(l) of the CAA.

SIP control measures were contained in permits issued to culpable sources in Minnesota until 1990 when EPA determined that limits in state-issued permits are not federally enforceable because the permits expire. The state then issued permanent Administrative Orders to culpable sources in nonattainment areas from 1991 to February of 1996.

Minnesota's consolidated permitting regulations, approved into the State SIP on May 2, 1995 (60 FR 21447), include the term “Title I condition” which was written, in part, to satisfy EPA requirements that SIP control measures remain permanent. A “Title I condition” is defined as “any condition based on source-specific determination of ambient impacts imposed for the purposes of achieving or maintaining attainment with the national ambient air quality standard and which was part of the state implementation plan approved by EPA or submitted to the EPA pending approval under section 110 of the act . . .” The rule also states that “Title I conditions and the permittee's obligation to comply with them, shall not expire, regardless of the expiration of the other conditions of the permit.” Further, “any title I condition shall remain in effect without regard to permit expiration or reissuance, and shall be restated in the reissued permit.”

Minnesota has also initiated using joint title I/title V-FESOP documents as the enforceable document for imposing emission limitations and compliance requirements in SIPs. The SIP requirements in joint title I/title V-FESOP documents submitted by MPCA are cited as “Title I conditions,” therefore ensuring that SIP requirements remain permanent and enforceable. EPA reviewed the State's procedure for using joint title I/title V-FESOP documents to implement site-specific SIP requirements and found it to be acceptable under both titles I and V of the Act (July 3, 1997 letter from David Kee, EPA, to Michael J. Sandusky, MPCA).

EPA is approving a revision to Minnesota's PM 10 SIP for Bulk Silos, as submitted by MPCA on June 16, 2021, and reflected in conditions labeled “40 CFR pt. 51, Title I Condition: 40 CFR 50.6 (PM 10 SIP), Title I Condition: 40 CFR pt. 52, subp. Y” in the background document and permit (No. 12300391-102).

We are publishing this action without prior proposal because we view this as a noncontroversial amendment and anticipate no adverse comments. However, in the proposed rules section of this Federal Register publication, we are publishing a separate document that will serve as the proposal to approve the State plan if relevant adverse written comments are filed. This rule will be effective June 6, 2022 without further notice unless we receive relevant adverse written comments by May 9, 2022. If we receive such comments, we will withdraw this action before the effective date by publishing a subsequent document that will withdraw the final action. All public comments received will then be addressed in a subsequent final rule based on the proposed action. EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment. If we do not receive any comments, this action will be effective June 6, 2022.

In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of the Minnesota Regulations described in this preamble and set forth in the amendments to 40 CFR part 52 below. EPA has made, and will continue to make, these documents generally available through www.regulations.gov and at the EPA Region 5 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information). Therefore, these materials have been approved by EPA for inclusion in the SIP, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference in the next update to the SIP compilation. 3

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

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

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

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

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

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

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

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

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

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

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

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by June 6, 2022. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of this Federal Register , rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

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

Throughout this document “we,” “us,” and “our” refer to EPA.

The EPA is taking final action to determine that the Muscatine SO 2 nonattainment area attained the 2010 1-hour SO 2 primary NAAQS by the applicable attainment date of October 4, 2018, based upon a weight-of-evidence analysis using available air quality information. This action also fulfills the EPA's obligation under a consent decree in Center for Biological Diversity, et al. v. Regan, No. 3:20-cv-05436-EMC (N.D. Cal June 25, 2021), which established a deadline of March 31, 2022, for the EPA to determine under CAA section 179(c) whether the Muscatine SO 2 nonattainment area attained the NAAQS by the October 4, 2018, attainment date. The consent decree deadline was extended by stipulation to June 30, 2022.

CAA section 179(c)(1) requires the Agency to “determine, based on the area's air quality as of the attainment date, whether the area attained the standard by that date.”

On January 26, 2022, the EPA published a notice of proposed rulemaking (NPRM) to determine that the Muscatine SO 2 nonattainment area attained the NAAQS by the October 4, 2018, attainment date. (87 FR 3958) During the comment period on EPA's NPRM, open from January 26, 2022, to February 25, 2022, EPA received no comments.

As discussed in the NPRM, the EPA first assessed what air quality information was available related to making a determination of attainment by the attainment date for the Muscatine area. The EPA chose to employ a weight-of-evidence approach for making this determination because the EPA does not have any analysis (including modeling) associated with the monitor siting to demonstrate that the monitors record maximum ambient SO 2 concentrations in the NAA, nor does EPA have modeling of actual emissions to support a determination based on modeled ambient concentrations whether the area attained the NAAQS by the attainment date. The available modeling of permitted allowable emissions in the area, as discussed in the NPRM, does not on its own provide a basis for determining whether the area attained by the attainment date. Thus, EPA relied upon SO 2 emissions data and trends, relevant air monitoring data and trends, SO 2 monitoring data incorporated with local meteorological data, as well as available modeling information in order to make its determination under CAA section 179(c)(1).

The EPA finds that the analysis of multiple types of air-quality related information supports our determination and is consistent with section 179(c)(1)'s direction to determine the area's air quality as of the attainment date. Further detail on EPA's weight-of-evidence analysis is contained in the NPRM and TSD included in the docket for this action.

As discussed in the NPRM and in the TSD, we find that the weight of the available evidence indicates that the Muscatine area attained the 2010 1-hour SO 2 NAAQS in the 2015-2017 timeframe by the October 4, 2018, attainment date. Specifically, the significant reductions in emissions during the relevant time period from sources within the nonattainment area and a nearby source outside the nonattainment area, coupled with corresponding decreased monitored SO 2 concentrations within the nonattainment area during that same time period lead us to our determination that the area attained by its attainment date.

The EPA conducted a weight-of-evidence analysis, described in detail in the NPRM and the TSD, to determine if the Muscatine SO 2 nonattainment area attained the 2010 1-hour SO 2 NAAQS by the October 4, 2018, attainment date by evaluating all available technical information and data relevant to the SO 2 air quality ( e.g., emissions, monitoring, meteorological data, and modeling) in the Muscatine, Iowa, area. Based on the analysis and information presented in the NPRM and the TSD contained in the docket for this action, the EPA determines that the Muscatine SO 2 NAA attained the 2010 1-hour SO 2 standard by the applicable attainment date of October 4, 2018, consistent with CAA section 179(c)(1).

On January 26, 2022, the EPA published a NPRM to determine that the Muscatine SO 2 nonattainment area attained the NAAQS by the October 4, 2018, attainment date. (87 FR 3958) The EPA sought public comment on the proposed determination and received no comments. Therefore, the EPA is finalizing the determination as proposed.

In addition, this action addresses EPA's obligation under a consent decree in Center for Biological Diversity, et al. v. Regan, which established a deadline of March 31, 2022, for the EPA to determine under CAA section 179(c) whether the Muscatine County SO 2 nonattainment area attained the NAAQS by the October 4, 2018, attainment date. The consent decree deadline was extended by stipulation to June 30, 2022.

This action does not constitute a redesignation of the Muscatine SO 2 NAA to attainment for the 2010 1-hour SO 2 NAAQS under CAA section 107(d)(3) because we have not yet approved a maintenance plan for the area as meeting the requirements of section 175A of the CAA and have not determined that the area has met the other CAA section 107(d)(3)(E) requirements for redesignation. The classification and designation status in 40 CFR part 81 will remain nonattainment until the EPA has determined that Iowa has met the CAA requirements for redesignation to attainment for the Muscatine SO 2 nonattainment area.

When the EPA establishes a new or revised NAAQS, the CAA requires the EPA to designate all areas of the U.S. as either nonattainment, attainment, or unclassifiable. Area designations address environmental justice concerns by ensuring that the public is properly informed about the air quality in an area.

The EPA utilized the EJSCREEN tool to evaluate environmental and demographic indicators within the area. The tool outputs report is contained in the docket for this action. While the EPA's EJSCREEN tool demonstrates that demographic indicators are consistent or lower than national averages, there are vulnerable populations in the area including low-income populations and persons over 64 years of age.

This action addresses EPA's determination, as required by the CAA, of whether the Muscatine County, Iowa, area attained the 2010 1-hour SO 2 NAAQS by the relevant attainment date. This action determines an area has attained the NAAQS by the relevant attainment date, but it does not change the geographic status of the area nor does it impose additional or modify existing requirements on sources. Based on the information presented in the NPRM and the TSD, the EPA determines that the air quality in the Muscatine County area is attaining the NAAQS. For these reasons, this action does not result in disproportionately high and adverse human health or environmental effects on minority populations, low-income populations and/or indigenous peoples.

This action determines an area has attained the NAAQS by the relevant attainment date and does not impose additional or modify existing requirements. For that reason, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

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

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

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

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

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

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

• Is not subject to requirements of the National Technology Transfer and Advancement Act (NTTA) because this rulemaking does not involve technical standards; and

• This action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). The basis for this determination is contained in section IV of this action, “Environmental Justice Concerns.”

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

• Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by June 6, 2022. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements (see section 307(b)(2)).

For the reasons stated in the preamble, the EPA amends 40 CFR part 52 as set forth below:

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.

On January 19, 2022 (87 FR 2731), EPA proposed to approve revisions excluding ethanol production facilities that produce ethanol by natural fermentation from the chemical process plant source category in Indiana's PSD rules at 326 Indiana Administrative Code (IAC) 2-2-1 and Ohio's title V operating permit rules at Ohio Administrative Code (OAC) 3745-77-01. An explanation of the CAA requirements, a detailed analysis of the revisions, and EPA's reasons for proposing approval were provided in the notice of proposed rulemaking (NPRM), and will not be restated here. The public comment period for this proposed rule ended on February 18, 2022. EPA received no comments on the proposal.

EPA is approving revisions to the Indiana SIP in 40 CFR 52.770. EPA is also approving revisions to the Ohio title V operating permit program in 40 CFR part 70, appendix A. The revisions that EPA is approving change the definition of “major stationary source” under Indiana's PSD regulations at 326 IAC 2-2-1(ff)(1) and Ohio's operating permit program at 3745-77-01(W). EPA is not taking action on changes related to Indiana's nonattainment new source review regulations in this action. EPA is taking no further action with respect to the 2014 revisions to the Ohio PSD SIP in 40 CFR 52.1870 related to the 2007 Ethanol Rule because we received no comments on this issue in the NPRM. As explained in the NPRM, EPA has determined that these revisions are consistent with EPA's PSD and title V regulations and that approval of these revisions is consistent with the requirements of CAA section 110(l) and will not adversely impact air quality.

In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of the Indiana Regulations described in Section II of this preamble and set forth in the amendments to 40 CFR part 52 below. EPA has made, and will continue to make, these documents generally available through www.regulations.gov, and at the EPA Region 5 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information). Therefore, these materials have been approved by EPA for inclusion in the SIP, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference in the next update to the SIP compilation. 1

Under the CAA, the Administrator is required to approve a SIP submission and a state title V program submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a); 42 U.S.C. 7661a(d); 40 CFR 70.1(c), 70.4(i). Thus, in reviewing SIP submissions and title V program revision submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

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

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

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

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

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

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

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

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

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

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by June 6, 2022. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

For the reasons stated in the preamble, EPA amends 40 CFR parts 52 and 70 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:

• 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.

To access the OCSPP test guidelines referenced in this document electronically, please go to https://www.epa.gov/ocspp and select “Test Methods and Guidelines.”

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-2021-0154 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 June 6, 2022. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2021-0154, 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 April 22, 2021 (86 FR 21317) (FRL-10022-59), 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 0F8868) by Syngenta Crop Protection, LLC, P.O. Box 18300 Greensboro, NC 27419. The petition requested that 40 CFR 180.672 be amended by establishing a tolerance for inadvertent residues of the insecticide, cyantraniliprole, 3-bromo-1-(3-chloro-2-pyridinyl)-N-[4-cyano-2-methyl-6-[(methylamino)carbonyl] phenyl]-1H-pyrazole-5-carboxamide in or on sugarcane at 0.01 parts per million (ppm). That document referenced a summary of the petition prepared by Syngenta Crop Protection, LLC, the registrant, which is available in the docket (EPA-HQ-OPP-2021-0154), http://www.regulations.gov. One comment was received on the notice of filing. EPA's response to this comment is discussed in Unit IV.C.

Based upon review of the data supporting the petition, EPA has revised the commodity definition for sugarcane. The reason for this change 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 in FFDCA section 408(b)(2)(D), 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 tolerance 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 of 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 those 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 5826) (FRL-9388-7).

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 current exposure assessment has been updated to include the additional exposure from this petitioned-for tolerance for residues of cyantraniliprole on sugarcane. The rotational crop use does not result in an increase in the estimated residue levels in drinking water or in exposure from residential sources relative to those used in the last assessment. EPA's aggregate exposure assessment incorporated this additional dietary exposure, as well as exposure from drinking water and from residential sources. There are no changes to EPA's conclusions in the November 13, 2018, rulemaking concerning cumulative effects.

Safety Factor 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.

Assessment of aggregate risks. EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs 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. Acute dietary risks are below the Agency's level of concern. Since no effects of concern have been identified for cyantraniliprole resulting from 1-day or single exposures, a qualitative acute dietary exposure assessment is unnecessary. Chronic dietary risks are likewise below the Agency's level of concern: 64% of the cPAD for all infants (<1 year old), the group with the highest exposure. EPA has concluded the combined short-term food, water, and residential exposures result in aggregate margins of exposure above the level of concern of 100 for all scenarios assessed and are not of concern. All risk estimates for intermediate-term aggregate risk are not of concern. An aggregate cancer risk assessment was not conducted because cyantraniliprole is not considered to be a carcinogen. The chronic aggregate assessment did not result in risk estimates of concern.

Determination of safety. Based on these risk assessments, 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.

Further information about EPA's risk assessment and determination of safety supporting the new cyantraniliprole tolerance can be found at https://www.regulations.gov in the document titled “Cyantraniliprole. Human Health Risk Assessment for an Inadvertent Tolerance on Sugarcane” in docket ID EPA-HQ-OPP-2021-0154.

Adequate enforcement methodology (liquid chromatography with tandem mass spectroscopy (LC/MS/MS)) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: residuemethods@epa.gov.

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 established for residues of cyantraniliprole on sugarcane.

EPA received one comment in response to the April 22, 2021, notice of filing. The comment seems to express general concern about pesticides, and specifically requests that EPA not permit the use of “cyanide”—a completely unrelated chemical—on “sugar”. No specific concerns about EPA's current evaluation were raised. While the agency recognizes that some people oppose the use of pesticides in or on food commodities, the FFDCA allows EPA to establish tolerances for residues of pesticides in or on food as long as the Agency can determine those tolerances are safe. The Agency has evaluated the aggregate exposures of cyantraniliprole and has determined 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. The commenter has provided no information to support a conclusion that the tolerance is not safe.

The Agency is establishing a tolerance for the commodity “sugarcane, cane” rather than “sugarcane”, as requested, to be consistent with the food commodity nomenclature.

Therefore, a tolerance is established for inadvertent residues of cyantraniliprole in or on sugarcane, cane at 0.01 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 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 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 I as follows:

We received a petition from the Center for Biological Diversity (CBD) on September 18, 2017, requesting that the Dixie Valley toad be listed as a threatened or endangered species and that the petition be considered on an emergency basis (CBD 2017, entire). The Endangered Species Act of 1973, as amended (Act; 16 U.S.C. 1531 et seq. ), does not provide a process to petition for emergency listing; therefore, we evaluated the petition to determine if it presented substantial scientific or commercial information indicating that the petitioned action may be warranted. We published a 90-day finding in the Federal Register on June 27, 2018 (83 FR 30091), stating that the petition presented substantial scientific or commercial information indicating that listing the Dixie Valley toad may be warranted.

A species status assessment (SSA) team prepared an SSA report for the Dixie Valley toad. The SSA team was composed of Service biologists, in consultation with other scientific experts. The SSA report represents a compilation of the best scientific and commercial data available concerning the status of the species, including the impacts of past, present, and future factors (both negative and beneficial) affecting the species and its habitat. In accordance with our joint policy on peer review published in the Federal Register on July 1, 1994 (59 FR 34270), and our August 22, 2016, memorandum updating and clarifying the role of peer review of listing actions under the Act, we will seek expert opinions of at least three appropriate specialists regarding the SSA concurrent with the open comment period identified in the proposed rule that is published concurrently with this emergency action (emergency rule) and found in the Proposed Rules section of this issue of the Federal Register . The SSA report and other materials related to this emergency rule, including the proposed rule, can be found at https://www.regulations.gov under Docket No. FWS-R8-ES-2022-0024. We note that, because we were already conducting a status review of the species, we had completed an SSA prior to publishing this emergency listing rule. Therefore, we have incorporated the information from the SSA here. However, given the purpose of emergency listing rules, they do not require this level of detail and analysis.

A thorough review of the taxonomy, life history, and ecology of the Dixie Valley toad ( Anaxyrus williamsi ) is presented in the SSA report (Service 2022, entire).

The Dixie Valley toad was described as a distinct species in the western toads ( Anaxyrus boreas ) species complex in 2017 due to morphological differences, genetic information, and its isolated distribution (Gordon et al. 2017, entire). Forrest et al. (2017, entire) also published a paper describing Dixie Valley toad and came up with similar results but stopped short of concluding it is a unique species. We evaluated both papers and concluded that the Gordon et al. (2017, entire) paper provided a better sampling design to answer species-level genetic questions and included a more thorough morphological analysis. Additionally, the Dixie Valley toad has been accepted as a valid species by the two leading authoritative amphibian internet sites: (1) Amphibiaweb.org (AmphibiaWeb 2022, website) and (2) Amphibian Species of the World (Frost 2021, website). Because both the larger scientific community and our own analysis of the best available scientific information indicate that the findings of Gordon et al. (2017 entire) are well supported, we are accepting their conclusions that the Dixie Valley toad is a unique species ( Anaxyrus williamsi ). Therefore, we have determined that the Dixie Valley toad is a listable entity under the Act.

Fourteen different morphological characteristics of Dixie Valley toads were measured and compared to several other species within the western toads species complex (Gordon et al. 2017, pp. 125-131). While all 14 morphological characteristics measured for Dixie Valley toad were significantly different from the other species within the western toads species complex, the most striking differences were the average size of adults (the mean snout-to-vent length (SVL) is 54.6 millimeters (mm) (2.2 inches (in)), which makes the Dixie Valley toad the smallest species within the A. boreas species complex), the close-set eyes and perceptively large tympanum (eardrum), and its unique coloration (Gordon et al. 2017, pp. 125-131).

Limited information is available specific to the life history of the Dixie Valley toad; therefore, closely associated species are used as surrogates where appropriate. Breeding (denoted by observing a male and female in amplexus, egg masses, or tadpoles) occurs annually between March and May (Forrest 2013, p. 76). Breeding appears protracted due to the thermal nature of the habitat and can last up to 3 months (March-May) with toads breeding early in the year in habitats closer to the thermal spring sources and then moving downstream into habitats as they warm throughout spring and early summer. Other toad species typically have a much more contracted breeding season of 3-4 weeks ( e.g., Sherman 1980, pp. 18-19, 72-73). Dixie Valley toad tadpoles hatch shortly after being deposited; time to hatching is not known but is likely dependent on water temperature ( e.g., black toad ( Anaxyrus exsul ) tadpoles hatch in 7 to 9 days; Sherman 1980, p. 97). Fully metamorphosed Dixie Valley toadlets were observed 70 days after egg laying (Forrest 2013, pp. 76-77).

The Dixie Valley toad is a narrow-ranging endemic (highly local and known to exist only in their place of origin) known from one population in the Dixie Meadows area of Churchill County, Nevada. The species occurs primarily on Department of Defense (DoD; Fallon Naval Air Station) lands (90 percent) and Bureau of Land Management (BLM) lands (10 percent). The wetlands located in Dixie Meadows cover 307.6 hectares (ha) (760 acres (ac)) and are fed by geothermal springs. The potential area of occupancy is estimated to be 146 ha (360 ac) based on the extent of wetland-associated vegetation. The species is heavily reliant on these wetlands, as it is rarely encountered more than 14 meters (m) (46 feet (ft)) from aquatic habitat (Halstead et al. 2021, p. 7).

Section 4 of the Act (16 U.S.C. 1533) and its implementing regulations (50 CFR part 424) set forth the procedures for determining whether a species is an endangered species or a threatened species. The Act defines an “endangered species” as a species that is in danger of extinction throughout all or a significant portion of its range, and a “threatened species” as a species that is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range. The Act requires that we determine whether any species is an endangered species or a threatened species because of any of the following factors:

These factors represent broad categories of natural or human-caused actions or conditions that could have an effect on a species' continued existence. In evaluating these actions and conditions, we look for those that may have a negative effect on individuals of the species, as well as other actions or conditions that may ameliorate any negative effects or may have positive effects.

We use the term “threat” to refer in general to actions or conditions that are known to or are reasonably likely to negatively affect individuals of a species. The term “threat” includes actions or conditions that have a direct impact on individuals (direct impacts), as well as those that affect individuals through alteration of their habitat or required resources (stressors). The term “threat” may encompass—either together or separately—the source of the action or condition or the action or condition itself.

However, the mere identification of any threat(s) does not necessarily mean that the species meets the statutory definition of an “endangered species” or a “threatened species.” In determining whether a species meets either definition, we must evaluate all identified threats by considering the species' expected response and the effects of the threats—in light of those actions and conditions that will ameliorate the threats—on an individual, population, and species level. We evaluate each threat and its expected effects on the species, then analyze the cumulative effect of all of the threats on the species as a whole. We also consider the cumulative effect of the threats in light of those actions and conditions that will have positive effects on the species, such as any existing regulatory mechanisms or conservation efforts. The Secretary determines whether the species meets the definition of an “endangered species” or a “threatened species” only after conducting this cumulative analysis and describing the expected effect on the species now and in the foreseeable future.

The Act does not define the term “foreseeable future,” which appears in the statutory definition of “threatened species.” Our implementing regulations at 50 CFR 424.11(d) set forth a framework for evaluating the foreseeable future on a case-by-case basis. The term “foreseeable future” extends only so far into the future as we can reasonably determine that both the future threats and the species' responses to those threats are likely. In other words, the foreseeable future is the period of time in which we can make reliable predictions. “Reliable” does not mean “certain”; it means sufficient to provide a reasonable degree of confidence in the prediction. Thus, a prediction is reliable if it is reasonable to depend on it when making decisions.

It is not always possible or necessary to define foreseeable future as a particular number of years. Analysis of the foreseeable future uses the best scientific and commercial data available and should consider the timeframes applicable to the relevant threats and to the species' likely responses to those threats in view of its life-history characteristics. Data that are typically relevant to assessing the species' biological response include species-specific factors such as lifespan, reproductive rates or productivity, certain behaviors, and other demographic factors.

The SSA report documents the results of our comprehensive biological review of the best scientific and commercial data regarding the status of the species, including an assessment of the potential threats to the species (Service 2022, entire). The SSA report does not represent our decision on whether the species should be listed as an endangered or threatened species under the Act. However, it does provide the scientific basis that informs our regulatory decisions, which involve the further application of standards within the Act and its implementing regulations and policies. The following is a summary of the key results and conclusions from the SSA report; the full SSA report can be found at Docket No. FWS-R8-ES-2022-0024 on https://www.regulations.gov.

To assess Dixie Valley toad viability, we used the three conservation biology principles of resiliency, redundancy, and representation (Shaffer and Stein 2000, pp. 306-310). Briefly, resiliency supports the ability of the species to withstand environmental and demographic stochasticity (for example, wet or dry, warm or cold years), redundancy supports the ability of the species to withstand catastrophic events (for example, droughts, large pollution events), and representation supports the ability of the species to adapt over time to long-term changes in the environment (for example, climate changes). In general, the more resilient and redundant a species is and the more representation it has, the more likely it is to sustain populations over time, even under changing environmental conditions. Using these principles, we identified the species' ecological requirements for survival and reproduction at the individual, population, and species levels, and described the beneficial and risk factors influencing the species' viability.

The SSA process can be categorized into three sequential stages. During the first stage, we evaluated the individual species' life-history needs. The next stage involved an assessment of the historical and current condition of the species' demographics and habitat characteristics, including an explanation of how the species arrived at its current condition. The final stage of the SSA involved making predictions about the species' responses to positive and negative environmental and anthropogenic influences. Throughout all of these stages, we used the best available information to characterize viability as the ability of a species to sustain populations in the wild over time. We used this information to inform our regulatory decision.

We note that, by using the SSA framework to guide our analysis of the scientific information documented in the SSA report, we have not only analyzed individual effects on the species, but we have also analyzed their potential cumulative effects. We incorporate the cumulative effects into our SSA analysis when we characterize the current and future condition of the species. To assess the current and future condition of the species, we undertake an iterative analysis that encompasses and incorporates the threats individually and then accumulates and evaluates the effects of all the factors that may be influencing the species, including threats and conservation efforts. Because the SSA framework considers not just the presence of the factors, but to what degree they collectively influence risk to the entire species, our assessment integrates the cumulative effects of the factors and replaces a standalone cumulative effects analysis.

In this discussion, we review the biological condition of the species and its resources, and the threats that influence the species' current and future condition, in order to assess the species' overall viability and the risks to that viability.

Dixie Meadows contains 122 known spring and seep sources and discharges approximately 1,109,396 cubic meters per year (m 3 /yr) (900 acre-feet per year (afy)) (McGinley and Associates 2021, pp. 1-2), which distributes across the wetland complex water that then flows out to the playa or is collected in a large ephemeral pond in the northeast portion of the wetland complex. Some of the larger springs have springbrooks that form channels while in other areas the water spreads out over the ground or through wetland vegetation creating a thin layer of water or wet soil that helps maintain the wetland. Spring discharge is inherently linked to the amount of wetted area within the wetland complex. Spring discharge is important for the viability of the Dixie Valley toad because changes to discharge rates likely impact the ability of the toad to survive in a particular spring complex.

Dixie Valley toad is a highly aquatic species rarely found more than 14 m (46 ft) away from water (Halstead et al. 2021, pp. 28, 30). The species needs wetted area for shelter, feeding, reproduction, and dispersal. Any change in the amount of wetted area will directly influence the amount of habitat available to the Dixie Valley toad. Due to the already restricted range of the habitat, the species needs to maintain the entirety of the 1.46-square-kilometer (km 2 ) (360-ac) potential area of occupancy, based on the extent of the wetland-associated vegetation.

In addition to the Dixie Valley toad being highly aquatic, the temperature of the water is also important to its life history. The species needs warm temperatures for shelter and reproduction. The Dixie Valley toad selects water or substrate that is warmer compared to nearby random paired locations, particularly in spring, fall, and winter months (Halstead et al. 2021, pp. 30, 33-34). During spring, they select areas with warmer water for breeding (oviposition sites), which allows for faster egg hatching and time to metamorphosis (Halstead et al. 2021, pp. 30, 33-34). During fall, they select warmer areas (closer to thermal springs with dense vegetation), which satisfies their thermal preferences as nighttime temperatures decrease (Halstead et al. 2021, pp. 30, 33-34). As winter approaches, toads find areas with consistent warm temperatures during brumation (hibernation for cold-blooded animals), so they do not freeze (Halstead et al. 2021, pp. 30, 33-34). This affinity for warm water temperature during brumation is unique to the Dixie Valley toad as compared to other species within the western toad species complex, which select burrows, rocks, logs, or other structures to survive through winter (Browne and Paszkowski 2010, pp. 53-56; Halstead et al. 2021, p. 34). Therefore, although the exact temperatures are unknown (range between 10-41 degrees Celsius (°C) (50-106 degrees Fahrenheit (°F)), Dixie Valley toad requires water temperatures warm enough to successfully breed and survive colder months during the year.

The most common wetland vegetation found within Dixie Meadows includes Juncus balticus (Baltic rush), Schoenoplectus spp. (bulrushes), Phragmites australis (common reed), Eleocharis spp. (spikerushes), Typha spp. (cattails), Carex spp. (sedges), and Distichilis spicata (saltgrass) (AMEC Environment and Infrastructure 2014, p. I-1; Tierra Data 2015, pp. 2-25—2-29; McGinley and Associates 2021, pp. 50-52, 93-99). Several species of invasive and nonnative plants also occur in Dixie Meadows including Cicuta maculate (water hemlock), Cardaria draba (hoary cress), Lepidium latifolium (perennial pepperweed), Eleagnus angustifolius (Russian olive), and Tamarix ramosissima (saltcedar) (AMEC Environment and Infrastructure 2014, p. 3-59). The Dixie Valley toad needs sufficient wetland vegetation to use as shelter. At a minimum, maintaining the current heterogeneity of the wetland vegetation found in Dixie Meadows is a necessary component for maintaining the resiliency of the Dixie Valley toad (Halstead et al. 2021, p. 34).

Amphibian species spend all or part of their life cycle in water; therefore, water quality characteristics directly affect amphibians. Dissolved oxygen, potential hydrogen (pH), salinity, water conductivity, and excessive nutrient concentrations (among other water quality metrics) all have direct and indirect impacts to the survival, growth, maturation, and physical development of amphibian species when found to be outside of naturally occurring levels for any particular location (Sparling 2010, pp. 105-117).

Various water quality data have been collected from a few springs within Dixie Meadows and from wells drilled during geothermal exploration activities (McGinley and Associates 2021, pp. 57-64). The exact water quality parameters preferred by the Dixie Valley toad are unknown; however, this species has evolved only in Dixie Meadows and is presumed to thrive in the current existing, complex mix of water emanating from both the basin-fill aquifer and the deep geothermal reservoir. Within the unique habitat in Dixie Meadows, and given the life history and physiological strategies employed by the species, a good baseline of existing environmental water quality factors that are most important for all life stages should be studied (Rowe et al. 2003, p. 957). The Dixie Valley toad needs the natural variation of the current water quality parameters found in Dixie Meadows to maintain resiliency.

We reviewed the potential risk factors ( i.e., threats, stressors) that may be currently affecting the Dixie Valley toad. In this rule, we discuss only those factors in detail that could meaningfully affect the status of the species.

The primary threats affecting the status of the Dixie Valley toad are geothermal development and associated groundwater pumping (Factor A); establishment of Batrachochytrium dendrobatidis ( Bd; hereafter referred to as amphibian chytrid fungus), which causes the disease chytridiomycosis (Factor C); predation by the invasive American bullfrog ( Lithobates catesbeianus ) (Factor C); groundwater pumping associated with human consumption, agriculture, and county planning (Factor A); and climate change (Factor A). Climate change may further influence the degree to which these threats, individually or collectively, may affect the Dixie Valley toad. The risk factors that are unlikely to have significant effects on the Dixie Valley toad, such as livestock grazing and historical spring modifications, are not discussed here but are evaluated in the current condition assessment of the SSA report.

Geothermal resources are reservoirs of hot water or steam found at different temperatures and depths below the ground. These geothermal reservoirs can be used to produce energy by drilling a well and bringing the heated water or steam to the surface. Geothermal energy plants use the steam or heat created by the hot water to drive turbines that produce electricity. Three main technologies are being used today to convert geothermal water into electricity: Dry steam, flash steam, and binary cycle. Binary technology is the focus for this analysis, because that type of geothermal power technology has been approved for development at Dixie Meadows.

Binary cycle power plants use the heat from the geothermal reservoir to heat a secondary fluid ( e.g., butane) that generally has a much lower boiling point than water. This process is accomplished through a heat exchanger, and the secondary fluid is flashed into vapor by the heat from the geothermal fluid; the vapor drives the turbines to generate electricity. The geothermal fluid is then reinjected back into the ground to maintain pressure and be reheated.

General impacts from geothermal production facilities are presented below. Because every geothermal field is unique, it is difficult to predict what effects from geothermal production may occur.

Prior to geothermal development, the flow path of water underneath the land surface is usually not known with sufficient detail to understand and prevent impacts to the surface wetlands dependent upon those flows (Sorey 2000, p. 705). Changes associated with surface expression of thermal waters from geothermal production are common and are expected. Typical changes seen in geothermal fields include, but are not limited to, changes in water temperature, flow, and water quality, which are all resource needs of the Dixie Valley toad that could be negatively affected by geothermal production (Sorey 2000, entire; Bonte et al. 2011, pp. 4-8; Kaya et al. 2011, pp. 55-64; Chen et al. 2020, pp. 2-6).

Steam discharge, land subsidence ( i.e., gradual settling or sudden sinking of the ground surface due to the withdrawal of large amounts of groundwater), and changes in water temperature and flow have all been documented from geothermal production areas throughout the western United States (Sorey 2000, entire). For example:

(1) Long Valley Caldera near Mammoth, California. Geothermal pumping in the period 1985-1998 resulted in several springs ceasing to flow and declines in pressure of the geothermal reservoir, which has caused reductions of 10-15 °C (50-59 °F) in the reservoir temperature and a localized decrease of approximately 80 °C (176 °F) near the reinjection zone (Sorey 2000, p. 706).

(2) Steamboat Springs near Reno, Nevada. Geothermal development resulted in the loss of surface discharge (geysers and springs) on the main terrace and a reduction of thermal water discharge to Steamboat Creek by 40 percent (Sorey 2000, p. 707).

(3) Northern Dixie Valley near Reno, Nevada. Other common changes that accompany the loss of surficial water sources, such as geysers and thermal springs, from geothermal production include an increase in steam discharge and land subsidence (Sorey 2000, p. 705). Both steam discharge and land subsidence were detected at an existing 56-megawatt (MW) geothermal plant in northern Dixie Valley, Nevada, which has been in production since 1985 (Sorey 2000, p. 708; Huntington et al. 2014, p. 5). The northern Dixie Valley geothermal plant began pumping water from the cold basin fill aquifer (local aquifer) and reinjecting it above the hot geothermal reservoir (regional aquifer) to try and alleviate land subsidence issues (Huntington et al. 2014, p. 5). This approach may have led to an increase in depth to groundwater from 1.8 m (6 ft) in 1985 to 4.3-4.6 m (14-15 ft) in 2009-2011 (Albano et al. 2021, p. 78).

(4) Jersey Valley near Reno, Nevada. In 2011, a 23.5-MW geothermal power plant started production in Jersey Valley, just north of Dixie Valley. Measured springflow of 0.08-0.17 cubic feet per second (cfs) (35-75 gallons per minute (gpm)) at a perennial thermal spring began to decline almost immediately after the power plant began operation (BLM 2022, p. 1; Nevada Department of Water Resources (NDWR) 2022, unpublished data). By 2014, the Jersey Valley Hot Spring ceased flowing (BLM 2022, p. 1; NDWR 2022, unpublished data). The loss of aquatic insects from the springbrook has diminished the foraging ability of eight different bat species that occur in the area (BLM 2022, p. 28). To mitigate for the spring going dry, the BLM proposed to pipe geothermal fluid 1.1 km (3,600 ft) to the spring source (BLM 2022, p. 8); however, mitigation has not yet occurred. If a similar outcome were to occur in Dixie Meadows, resulting in the complete drying of the springs, the Dixie Valley toad would likely be extirpated if mitigation to prevent the drying of the springs is not satisfactorily or timely achieved.

In an effort to minimize changes in water temperature, quantity, and quality, and to maintain pressure of the geothermal reservoir, geothermal fluids are reinjected into the ground, though reinjected water is at a lower temperature than when it was pumped out of the ground. This practice entails much trial and error in an attempt to equilibrate subsurface reservoir pressure. It can take several years to understand how a new geothermal field will react to production and reinjection wells; however, reinjection does not always have the desired effect (Kaya et al. 2011, pp. 55-64).

Geothermal energy production has been cited as the greatest threat to the persistence of Dixie Valley toad (Forrest et al. 2017, pp. 172-173; Gordon et al. 2017, p. 136; Halstead et al. 2021, p. 35). Geothermal environments often harbor unique flora and fauna that have evolved in these rare habitats (Boothroyd 2009, entire; Service 2019, entire). Changes to these rare habitats often cause declines in these endemic organisms or even result in the destruction of their habitat (Yurchenko 2005, p. 496; Bayer et al. 2013, pp. 455-456; Service 2019, pp. 2-3). Because the Dixie Valley toad relies heavily on wetted area and warm water temperature to remain viable, reduction of these two resource needs could cause significant declines in the population and changes to its habitat that are detrimental to the species and result in it being in danger of extinction.

Over roughly the last four decades, pathogens have been associated with amphibian population declines, mass die-offs, and extinctions worldwide (Bradford 1991, pp. 174-176; Muths et al. 2003, pp. 359-364; Weldon et al. 2004, pp. 2,101-2,104; Rachowicz et al. 2005, pp. 1,442-1,446; Fisher et al. 2009, pp. 292-302; Knapp et al. 2011, pp. 8-19). One pathogen strongly associated with dramatic declines on all continents that harbor amphibians is chytridiomycosis caused by amphibian chytrid fungus (Rachowicz et al. 2005, pp. 1,442-1,446). Chytrid fungus has now been reported in amphibian species worldwide (Fellers et al. 2001, pp. 947-952; Rachowicz et al. 2005, pp. 1,442-1,446). Early doubt that this particular pathogen was responsible for worldwide die-offs has largely been overcome by the weight of evidence documenting the appearance, spread, and detrimental effects to affected populations (Vredenburg et al. 2010, pp. 9,690-9,692).

Clinical signs of chytridiomycosis and diagnosis include abnormal posture, lethargy, and loss of righting reflex (the ability to correct the orientation of the body when it is not in its normal upright position) (Daszak et al. 1999, p. 737). Chytridiomycosis also causes gross lesions, which are usually not apparent and consist of abnormal epidermal sloughing and ulceration, as well as hemorrhages in the skin, muscle, or eye (Daszak et al. 1999, p. 737). Chytridiomycosis can be identified in some species of amphibians by examining the oral discs (tooth rows) of tadpoles that may be abnormally formed or lacking pigment (Fellers et al. 2001, pp. 946-947).

Despite the acknowledged impacts of chytridiomycosis to amphibians, little is known about this disease outside of mass die-off events. There is high variability between species of amphibians in response to being infected including within the western toads species complex. Two long-term study sites have documented differences in apparent survival of western toads between two different sites in Montana and Wyoming (Russell et al. 2019, pp. 300-301). The chytrid-positive western toad population in Montana was reduced by 19 percent compared to chytrid-negative toads in that area—in comparison to the western toad population in Wyoming, which was reduced by 55 percent (Russell et al. 2019, p. 301). Various diseases are confirmed to be lethal to Yosemite toads (Green and Sherman 2001, p. 94), and research has elucidated the potential role of chytrid fungus infection as a threat to Yosemite toad populations (Dodge 2013, pp. 6-10, 15-20; Lindauer and Voyles 2019, pp. 189-193). These various diseases and infections, in concert with other factors, have likely contributed to the decline of the Yosemite toad (Sherman and Morton 1993, pp. 189-197) and may continue to pose a risk to the species (Dodge 2013, pp. 10-11; Lindauer and Voyles 2019, pp. 189-193). Amargosa toads are known to have high infection rates and high chytrid fungus loads; however, they do not appear to show adverse impacts from the disease (Forrest et al. 2015, pp. 920-922). Not all individual amphibians that test positive for chytrid fungus develop chytridiomycosis.

Dixie Valley toad was sampled for chytrid fungus in 2011-2012 (before it was recognized as a species) and 2019-2021 (Forrest 2013, p. 77; Kleeman et al. 2021, entire); chytrid fungus was not found during either survey. However, chytrid fungus has been documented in bullfrogs in Dixie Valley (Forrest 2013, p. 77), which is a known vector species for spreading chytrid fungus and diseases to other species of amphibians (Daszak et al. 2004, pp. 203-206; Urbina et al. 2018, pp. 271-274; Yap et al. 2018, pp. 4-8).

The best available information indicates that the thermal nature of the Dixie Valley toad habitat may keep chytrid fungus from becoming established; therefore, it is imperative that the water maintains its natural thermal characteristics (Forrest 2013, pp. 75-85; Halstead et al. 2021, pp. 33-35). Boreal toads exposed to chytrid fungus survive longer when exposed to warmer environments (mean 18 °C (64 °F)) as compared to boreal toads in cooler environments (mean 15 °C (59 °F)) (Murphy et al. 2011, pp. 35-38). Additionally, chytrid fungus zoosporangia grown at 27.5 °C (81.5 °F) remain metabolically active; however, no zoospores are produced, indicating no reproduction at this high temperature (Lindauer et al. 2020, pp. 2-5). Generally, chytrid fungus does not seem to become established in water warmer than 30 °C (86 °F) (Forrest and Schlaepfer 2011, pp. 3-7). Dixie Meadows springhead water temperatures range from 13 °C (55 °F) to 74 °C (165 °F), though the four largest spring complexes (springs that create the largest wetland areas and are inhabited by a majority of the Dixie Valley toad population) range from 16 °C (61 °F) to 74 °C (165 °F) with median temperatures of at least 25 °C (77 °F). Additionally, water temperatures measured in 2019 at toad survey sites throughout Dixie Meadows ( i.e., not at springheads) ranged from 10 to 41 °C (50 to 106 °F). Any reduction in water temperature, including reductions caused by geothermal development, would not only affect the ability of Dixie Valley toads to survive during cold months, but could also make the species vulnerable to chytrid fungus.

Predation has been reported in species similar to the Dixie Valley toad and likely occurs in Dixie Meadows; however, predation of Dixie Valley toads has not been documented. Likely predators on the egg and aquatic larval forms of Dixie Valley toad include predacious diving beetles ( Dytiscus sp.) and dragonfly larvae (Odonata). Common ravens ( Corvus corax ) and other corvids are known to feed on juvenile and adult black toads and Yosemite toads (Sherman 1980, pp. 90-92; Sherman and Morton 1993, pp. 194-195). Raven populations are increasing across the western United States and are clearly associated with anthropogenic developments, such as roads and power lines (Coates and Delehanty 2010, pp. 244-245; Howe et al. 2014, pp. 44-46). Ravens are known to nest within Dixie Valley (Environmental Management and Planning Solutions 2016, pp. 3-4).

The American bullfrog, a ranid species native to much of central and eastern North America, now occurs within Dixie Meadows (Casper and Hendricks 2005, pp. 540-541; Gordon et al. 2017, p. 136). Bullfrogs are recognized as one of the 100 worst invasive species in the world (Global Invasive Species Database 2021, pp. 1-17). Bullfrogs are known to compete with and prey on other amphibian species (Moyle 1973, pp. 19-21; Kiesecker et al. 2001, pp. 1,966-1,969; Pearl et al. 2004, pp. 16-18; Casper and Hendricks 2005, pp. 543-544; Monello et al. 2006, p. 406; Falaschi et al. 2020, pp. 216-218).

Bullfrogs are a gape-limited predator, which means they eat anything they can swallow (Casper and Hendricks 2005, pp. 543-544). Dixie Valley toad is the smallest toad species in the western toads species complex and can easily be preyed upon by bullfrogs. Smaller bullfrogs eat mostly invertebrates (Casper and Hendricks 2005, p. 544), and thus may compete with Dixie Valley toad for food resources. Within Dixie Valley, bullfrogs are known to occur at Turley Pond and in one area of Dixie Meadows adjacent to occupied Dixie Valley toad habitat (Forrest 2013, pp. 74, 87; Rose et al. 2015, p. 529; Halstead et al. 2021, p. 24).

Both human settlements and natural ecosystems in the Southwestern United States are largely dependent on groundwater resources, and decreased groundwater recharge may occur as a result of climate change (U.S. Global Change Research Program 2009, p. 133). Furthermore, the human population in the Southwest is expected to increase 70 percent by mid-century (Garfin 2014, p. 470). Resulting increases in urban development, agriculture, and energy-production facilities will likely place additional demands on already limited water resources. Climate change will likely increase water demand while at the same time shrink water supply, since water loss may increase evapotranspiration rates and runoff during storm events (Archer and Predick 2008, p. 25).

In order to identify changing climatic conditions more specific to Dixie Meadows, we conducted a climate analysis using the Climate Mapper web tool (Hegewisch et al. 2020, online). The Climate Mapper is a web tool for visualizing past and projected climate and hydrology of the contiguous United States. This tool maps real-time conditions, current forecasts, and future projections of climate information across the United States to assist with decisions related to agriculture, climate, fire conditions, and water.

For our analysis, we analyzed mean annual temperature and percent precipitation using the historical period of 1971-2000 and the projected future time period 2040-2069. We examined emission scenarios that used representative concentration pathways (RCPs) 4.5 and 8.5 using ArcGIS Pro.

Our analysis predicts increased air temperatures in Dixie Meadows, along with a slight increase in precipitation. Annual mean air temperature is projected to increase between 2.5 and 3.4 °C (4.5 and 6.1 °F) and result in average temperatures 3.0 °C (5.3 °F) warmer throughout Dixie Meadows between 2040 and 2069 (Hegewisch et al. 2020, Geographic Information System (GIS) data). Under two emission scenarios, annual precipitation is projected to increase by 4.5 to 7.7 percent (Hegewisch et al. 2020, GIS data).

Climate change may impact the Dixie Valley toad and its habitat in two main ways: (1) Reductions in springflow as a result of changes in the amount, type, and timing of precipitation, increased evapotranspiration rates, and reduced aquifer recharge; and (2) reductions in springflow as a result of changes in human behavior in response to climate change ( e.g., increased groundwater pumping as surface water resources disappear). A reduction in springflow could be exacerbated by the greater severity of droughts being experienced in the Southwestern United States, including Nevada (Snyder et al. 2019, pp. 2-4; Williams et al. 2020, pp. 1-5). Higher temperatures and drier conditions could result in greater evapotranspiration, leading to increased drying of wetland habitat. Impacts vary geographically, and identifying the vulnerability of individual springs is challenging. For example, a study examining different springs over a 14-year period at Arches National Park in Utah found that each spring responded to local precipitation and recharge differently, despite similarities to Dixie Valley in topographic setting, aquifer type, and climate exposure (Weissinger 2016, p. 9).

Predicting individual spring response to climate change is further complicated by the minimal information available about the large hydrological connections for most sites and the high degree of uncertainty inherent in future precipitation models. Regardless, the best available data indicate that Dixie Valley toad may be vulnerable to climate change to an unknown degree, but we cannot say with any certainty where impacts may be manifested or the greatest.

The basin is fully appropriated for consumptive groundwater uses (18,758,663 cubic meters per year (m 3 /yr) (15,218 acre-feet per year (afy)) of an estimated 18,489,943 m 3 /yr (15,000 afy) perennial yield), and the proposed Dixie Valley groundwater export project by Churchill County is seeking an additional 12,326,628-18,489,943 m 3 /yr (10,000-15,000 afy) (Huntington et al. 2014, p. 2). Total geothermal water rights appropriated in Dixie Valley as of 2020 are 15,659,749 m 3 /yr (12,704 afy) (BLM 2021b, pp. 2-28).

Increased groundwater pumping in Nevada is primarily driven by human water demand for municipal purposes, irrigation, and development for oil, gas, geothermal resources, and minerals. Many factors associated with groundwater pumping can affect whether or not an activity will impact a spring. These factors include the amount of groundwater to be pumped, period of pumping, the proximity of pumping to a spring, depth of pumping, and characteristics of the aquifer being impacted. Depending on these factors, groundwater withdrawal may result in no measurable impact to springs or may reduce spring discharge, change the temperature of the water, reduce free-flowing water, dry springs, alter Dixie Valley toad habitat size and heterogeneity, or create habitat that is more suited to nonnative species than to native species (Sada and Deacon 1994, p. 6). Pumping rates that exceed perennial yield can lower the water table, which in turn will likely affect riparian vegetation (Patten 2008, p. 399).

Determining when groundwater withdrawal exceeds perennial yield is difficult to ascertain and reverse due to inherent delays in detection of pumping impacts and the subsequent lag time required for recovery of discharge at a spring (Bredehoeft 2011, p. 808). Groundwater pumping initially captures stored groundwater near the pumping area until water levels decline and a cone of depression expands, potentially impacting water sources to springs or streams (Dudley and Larson 1976, p. 38). Spring aquifer source and other aquifer characteristics influence the ability and rate at which a spring fills and may recover from groundwater pumping (Heath 1983, pp. 6, 14). Depending on aquifer characteristics and rates of pumping, recovery of the aquifer is variable and may take several years or even centuries (Heath 1983, p. 32; Halford and Jackson 2020, p. 70). Yet where reliable records exist, most springs fed by even the most extensive aquifers are affected by exploitation, and springflow reductions relate directly to quantities of groundwater removed (Dudley and Larson 1976, p. 51).

The most extreme potential effects of groundwater withdrawal on Dixie Valley toad are likely desiccation and extirpation or extinction. If groundwater withdrawal occurs but does not cause a spring to dry, there can still be adverse effects to Dixie Valley toads or their habitat because reduction in springflow reduces both the amount of water and amount of occupied habitat. If the withdrawals also coincide with altered precipitation and temperature from climate change, even less water will be available. Cumulatively, these conditions could result in a delay in groundwater recharge at springs, which may then result in a greater effect to the Dixie Valley toad than the effects of the individual threats acting alone. Across the Dixie Meadows springs, discharge varies greatly, with some springs with low discharge at the current time likely due to a combination of influences, both natural and anthropogenic. Though there is much uncertainty around the magnitude and timing of groundwater withdrawal, and thus the possible effects on the Dixie Meadows spring system, we anticipate that the future effects of groundwater withdrawal could have significant effects on the Dixie Meadows spring system.

Population estimates are not available for the Dixie Valley toad. Time-series data of toad abundance are available from various surveys conducted by the Service and the Nevada Department of Wildlife (NDOW) during the period 2009-2012 (before the Dixie Valley toad was recognized as a species); however, differences in sample methodology between years and low recapture rates indicate that consistent reproduction is occurring.

In 2018, Dixie Valley toads were detected in 38 of 60 randomized plots in the Dixie Meadows wetlands, with a 95 percent credible interval (Bayesian equivalent of a confidence interval) for probability of toad occurrence of 0.55-0.98 in plots of average water temperature (18.8 °C (65.8 °F)) (Halstead et al. 2019, p. 9). In other words, adult toads currently have high occupancy rates and are generally more likely than not to occur across the Dixie Meadows wetlands. The 95 percent credible interval for the probability of reproduction in an average plot (18.8 °C (65.8 °F) and 45 percent wetted area) was 0.01-0.26 and increased as a function of wetted surface area in plots with adults present (Halstead et al. 2019, p. 10). Although larvae have a lower probability of occurring within an average plot than adults, warmer water temperatures strongly influence the probability of reproduction (Halstead et al. 2019, pp. 10-11). This finding suggests that adult toads are seeking out a specific subset of habitat for reproduction based in part on water temperature. The percentage of the range currently occupied by adults remained similarly high throughout 2018-2021 and across seasons (Rose et al. 2022, entire).

The high occupancy rate observed from 2018 through 2021 and evidence of reproduction observed in the period 2009-2021 suggest that the Dixie Valley toad is currently maintaining resilience to the historical and current environmental stochasticity present at Dixie Meadows. However, the narrowly distributed, isolated nature of the single population of the species indicates that the Dixie Valley toad has little ability to withstand stochastic or catastrophic events through dispersal. Because the species evolved in a unique spring system with little historical variation, we conclude that it has low potential to adapt to a fast-changing environment. As a single-site endemic with no dispersal opportunities outside the current range, the species has inherently low redundancy and representation and depends entirely on the continued availability of habitat in Dixie Meadows.

The following section discusses the potential impacts the Dixie Meadows Geothermal Utilization Project could have on both the current and future status of the Dixie Valley toad. Based on an expert knowledge elicitation (discussed further below) conducted on the potential outcomes of this geothermal project, peak change to the spring system could occur as early as the current year of 2022 (year 1 of geothermal pumping), with a 90 percent chance that peak change will occur within 10 years of the start of geothermal pumping (Service 2022, pp. 42-43).

In addition to 50 active geothermal leases within Dixie Valley in Churchill County, two geothermal exploration projects were approved in Dixie Meadows in 2010 and 2011 (BLM 2010, entire; BLM 2011, entire). Most recently, on November 23, 2021, BLM approved and permitted the Dixie Meadows Geothermal Utilization Project (BLM 2021b, entire) after issuing two draft environmental assessments, receiving extensive comments from the Service and NDOW, and developing an Aquatic Resources Monitoring and Mitigation Plan (hereafter referred to as the Monitoring and Mitigation Plan). This project will consist of up to two 30-MW geothermal power plants on 6.5 ha (16 ac) each; up to 18 well pads (107×114 m (350×375 ft)), upon which up to three wells per pad may be drilled for exploration, production, or injection; pipelines to carry geothermal fluid between well fields and the power plant(s); and either a 120-kilovolt (kV) or a 230-kV transmission gen-tie and associated access roads and structures (BLM 2021b, p. 1-1). The project proponent (Ormat Nevada Inc. (Ormat)) began construction on the first geothermal plant the week of February 14, 2022, and plans to begin geothermal production by December 2022; therefore, we assume it is possible that both construction and production will occur in 2022. To see a more detailed overview of the approved and permitted project, refer to the BLM environmental assessment (BLM 2021b, entire).

As mentioned above, two geothermal exploration projects were approved by the BLM in 2010 and 2011 (BLM 2010, entire; BLM 2011, entire); however, required monitoring and baseline environmental surveys for those exploration projects did not occur (BLM 2021a, pp. 3-17-3-18). As a result, key environmental information ( e.g., water quality metrics data such as flow, water temperature, and water pressure) is lacking to determine the effects of the project on the surrounding environment. Most of the information collected during this timeframe were singular measurements taken quarterly or annually, which do not characterize the variability in environmental conditions observed in Dixie Meadows. The lack of robust baseline environmental information is part of why we, along with experts from the expert knowledge elicitation workshop panel (described below), conclude that the Monitoring and Mitigation Plan associated with the Dixie Meadows Geothermal Utilization Project, discussed further in the Conservation Efforts and Regulatory Mechanisms section, below, needs further refinement to adequately detect and respond to changes in the wetlands and toad populations. The ability of the Monitoring and Mitigation Plan to detect changes in baseline conditions, and mitigate those changes, is discussed further in the Expert Knowledge Elicitation and Conservation Efforts and Regulatory Mechanisms sections, below.

An expert knowledge elicitation workshop was carried out during the period August 17-20, 2021, using the [then] proposed Dixie Meadows Geothermal Utilization Project, January 2021 draft environmental assessment (BLM 2021a, entire) and draft Monitoring and Mitigation Plan (BLM 2021a, Appendix H), and a summary of all existing data to determine the range of outcomes of the approved project. This analysis used a modified version of the Sheffield elicitation framework, which follows established best practices for eliciting expert knowledge (Gosling 2018, entire; O'Hagan 2019, pp. 73-81; Oakley and O'Hagan 2019, entire). The expert panel consisted of a multidisciplinary group with backgrounds in the geologic structure of basin and range systems, various components of deep and shallow groundwater flow, as well as geothermal exploration and development. All panelists have direct experience in the Great Basin, and most in Dixie Valley and Dixie Meadows, specifically. The panelists were asked questions regarding the time until peak changes to the spring system would occur, the ability of the Monitoring and Mitigation Plan to detect and mitigate change, the amount of time it would take to mitigate change if mitigation is possible, and what the peak changes to springflow and spring temperature could be. For a detailed overview of the expert knowledge elicitation process, refer to the SSA report (Service 2022, Appendix A).

The expert panelists concluded that the Dixie Meadows spring system will change quickly, and detrimentally, once geothermal energy production begins, with a median response time of roughly 4 years and a 90 percent chance that the largest magnitude changes will occur within 10 years (Service 2022, Appendix A). Uncertainty within individual judgments on response time was related to the efficacy of mitigation measures and interactions between short-term impacts from geothermal development and longer term impacts from climate change and consumptive water use.

Experts had low confidence in the ability of the Monitoring and Mitigation Plan to both detect and mitigate changes to the temperature and flow of surface springs in Dixie Meadows. Although the aggregated distribution for the ability to detect changes ranged from 0 to 100 percent, the median expectation was a roughly 38 percent chance of detecting changes (Service 2022, Appendix A). These judgments reflect an expectation that there is less than 50 percent confidence from the experts that the Monitoring and Mitigation Plan could detect changes in the spring system due to the complexity and natural variability of the system, limited baseline data, and perceived inadequacies of the Monitoring and Mitigation Plan. The Monitoring and Mitigation Plan was perceived as inadequate due in part to limited monitoring locations, low frequency of monitoring and reporting, and lack of a statistical approach for addressing variability and uncertainty. The degree of confidence in the ability to mitigate environmental impacts of the project was even lower (median of roughly 29 percent; Service 2022, Appendix A) based on previously stated concerns about the plan, lack of information on how water quality would be addressed, interacting effects of climate change and extractive water use, and questions about the motivation to mitigate if measures ran counter to other operating goals of the plant.

The expert panel was asked what timeframe would be required to fully mitigate changes in spring temperature and springflow once detected—assuming that changes have been detected, it is technically feasible to mitigate the problem, and there is a willingness to participate from all parties. Based on those assumptions, the experts judged that it could take multiple years to mitigate perturbations once detected, with a median expectation of 4 years (Service 2022, Appendix A).

At the time the expert knowledge elicitation occurred, the Dixie Meadows Geothermal Utilization Project was not approved. However, in the discussion about expected peak change in spring temperature and springflow, the experts considered how the spring system would change if the geothermal project was not approved or the Monitoring and Mitigation Plan was improved. Expert judgments on expected peak change in spring temperature and springflow that considered the geothermal project not getting approved and an improvement in the Monitoring and Mitigation Plan were not considered in our analysis because the geothermal project was approved (BLM 2021b, entire) in November 2021. Additionally, although the Monitoring and Mitigation Plan was changed, changes were minimal and did not affect the ability of the plan to detect or mitigate changes. Therefore, the results of the expert knowledge elicitation completed on the January 2021 draft environmental assessment and the then-existing Monitoring and Mitigation Plan (BLM 2021a, entire) would not have changed meaningfully in response to the final approved environmental assessment and Monitoring and Mitigation Plan (BLM 2021b, entire).

Although there is large uncertainty in the magnitude of expected changes from the approved project, there is a high degree of certainty that geothermal energy development will have severe and negative effects on the geothermal springs relied upon by the Dixie Valley toad, including reductions in spring temperature and springflow, which directly affect the resource needs of the species. The plausible range of changes to spring temperatures ranged from a lower limit of a 55- °C (99- °F) decrease to an upper limit of a 10- °C (18- °F) decrease (Service 2022, Appendix A). This uncertainty is due to the wide spatial variation in spring temperatures across the spring system and reflects the expectation that the spring temperatures could plausibly drop to ambient levels ( i.e., a complete loss of geothermal contributions). Similarly, the lower limit of the aggregated expert judgments considered it plausible that springs in Dixie Meadows could dry up (no surface discharge) as the geothermal contribution was reduced, with an upper limit of a 31-percent decrease in surface discharge. These judgments reflect the high anticipated pumping rates of the proposed plants, perceived inadequacies with the Monitoring and Mitigation Plan, and the fact that drying of surface springs has been documented at other nearby geothermal development projects (BLM 2019, p. 1).

In the SSA report, we analyzed four scenarios based on the expert knowledge elicitation. As mentioned earlier, these scenarios could plausibly affect both the current and future condition of the species. Three of the scenarios (scenarios 1-3) assume the Dixie Meadows Geothermal Utilization Project will begin construction as approved, while scenario 4 assumes there will be no geothermal development or the Monitoring and Mitigation Plan will be significantly improved before project implementation. Scenario 4 was not considered in this decision given the approval of the geothermal project, the beginning of construction on the project, and the lack of substantive improvements to the Monitoring and Mitigation Plan. As discussed above in the Expert Knowledge Elicitation section, we have low confidence in the ability of the Monitoring and Mitigation Plan to detect or mitigate changes to the spring system. Therefore, only scenarios 1-3 were considered for this decision.

The scenarios incorporated the following considerations from the expert knowledge elicitation: The efficacy of the Monitoring and Mitigation Plan; how the surficial spring system will respond to geothermal production; and changes in temperature, evapotranspiration, and extreme precipitation events related to climate change. For all scenarios, we project that the basin will remain over-allocated. The lower bound of scenarios (scenario 1) projects that the Monitoring and Mitigation Plan is ineffective, the springs dry completely, and there are increases in air temperature, evapotranspiration, and extreme precipitation events seen under RCP 8.5. This scenario represents the low confidence the experts have in the Monitoring and Mitigation Plan and reflects the results in a similar situation that occurred in Jersey Valley where geothermal production caused the spring system to go dry within 3 years of the start of operation (BLM 2022, p. 1; NDWR 2022, unpublished data). The upper bound of scenarios (scenario 3) projects that the Monitoring and Mitigation Plan is moderately effective, geothermal production has moderate effects on the surficial spring system, and increases in temperature, evapotranspiration, and moderate changes in precipitation seen under RCP 4.5 occur. Because the experts expressed less than 50 percent confidence in the ability of the Monitoring and Mitigation Plan to both detect and mitigate change, it was logical for this scenario to represent the upper bound of plausibility.

These scenarios include the range of peak changes to spring temperature and springflow as discussed earlier (a 55- °C (99- °F)) decrease to a 10- °C (18- °F) decrease in spring temperature and a 100-percent decrease to a 31-percent decrease in springflow). These projected changes in spring temperature and flow were used as inputs into a multistate, dynamic occupancy model, which is described further in the SSA report (Service 2022, pp. 61-64). Scenario 1 results in complete reproductive failure because of the drying of springs, and scenarios 2 and 3 project a risk of reproductive failure after 1 year of geothermal production (lower credible interval of 0 percent of the range occupied by larvae). Under scenario 2, the mean percentage of the range occupied by larvae drops to 0 percent by 2024 with an upper credible interval of 2 percent of the range occupied by larvae. Scenario 3 projects a mean of 1 percent of the range occupied by larvae with an upper credible interval of 5 percent of the range occupied by 2026. All scenarios result in a high level of risk of reproductive failure for the Dixie Valley toad in the near future.

Although the occupancy model described above represents the best available projection framework for the Dixie Valley toad, not all demographic and risk factors relevant to understanding species viability are included. One major threat not accounted for is the synergistic effect of changes in temperature with the risk posed by exposure to the fungal pathogen chytrid fungus that causes the disease chytridiomycosis (see Disease, above). Chytrid fungus growth and survival are sensitive to both cold and hot temperatures, with optimal growth conditions in culture occurring between 15 and 25 °C (59 and 77 °F). There is equivocal evidence on whether colder temperatures limit the effects of chytrid fungus (Voyles et al. 2017, pp. 367-369); however, hot geothermal waters above 25 °C (77 °F) appear to provide protection against chytrid fungus by allowing individuals to raise body temperatures through behavioral fever (Forrest and Schlaepfer 2011, entire; Murphy et al. 2011, p. 39). This information indicates that future decreases in water temperature associated with scenarios 2 and 3 are likely to increase the risk that chytrid fungus could become established within the Dixie Valley toad population. If chytrid fungus becomes established within the Dixie Valley toad population, there would be negative, and plausibly catastrophic, effects to the species.

The seasonal timing of changes in water temperature is also particularly important. Dixie Valley toads strongly rely on aquatic environments throughout their life cycle (Halstead et al. 2021, entire). Unlike Western toads that may be found hundreds to thousands of meters from aquatic breeding sites, in surveys Dixie Valley toads are almost always found in water (Halstead et al. 2021, pp. 30-31). When not detected in water, Dixie Valley toads are found 4.2 m (13.8 ft) from water on average and are found both in and above water during brumation (Halstead et al. 2021, p. 30). Autumn brumation sites are found to be warmer than random locations available, and toads are 1.3 times more likely to select sites for each 1- °C increase in water temperature (Halstead et al. 2021, p. 30). Because toads are found closer to spring heads in autumn compared to sites selected during other times of year, it is likely that they are selecting areas where water temperatures will remain stable throughout the winter (Halstead et al. 2021, p. 34). The selection of areas with stable, warm water temperatures indicates that reductions in geothermal contributions during winter could lead to thermal stress, reductions in available habitat as waters cool, or even mortality if geothermal contributions are removed completely or reduced to a level that toads are unable to adapt their brumation strategies.

The Dixie Valley toad occurs only on Federal lands (the DoD's Fallon Naval Air Station and BLM). Various laws, regulations, policies, and management plans may provide conservation or protections for Dixie Valley toads. As such, the following management plans are the existing conservation tools driving the management of Dixie Valley toads and their habitat:

• As required by the Sikes Act (16 U.S.C. 670 et seq., as amended), the DoD has an integrated natural resources management plan in place for supporting both the installation mission as well as protecting and enhancing installation resources for multiple use, sustainable yield, and biological integrity. This plan also includes a strategic plan for amphibian (and reptile) conservation and management, to include management for Dixie Meadows and the Dixie Valley toad.

• As required by the Federal Land Policy and Management Act of 1976 (43 U.S.C. 1701 et seq. ), BLM has a resource management plan for all actions and authorizations involving BLM-administered lands and resources, including actions specific to Dixie Valley toads and their habitat.

In compliance with the National Environmental Policy Act of 1970 (as amended; 42 U.S.C. 4321 et seq. ), which is a procedural statute, for projects that Federal agencies fund, authorize, or carry out, BLM, with input from Ormat, developed a Monitoring and Mitigation Plan (McGinley and Associates 2021, entire) for the Dixie Meadows Geothermal Utilization Project; it is an appendix in BLM's environmental assessment (BLM 2021b, Appendix H). The goal of the Monitoring and Mitigation Plan is to identify hydrologic and biologic resources, spring-dependent ecosystems, aquatic habitat, and species that could be affected by geothermal exploration, production, and injection in the Dixie Meadows area (McGinley and Associates 2021, p. 1). The Monitoring and Mitigation Plan will describe the plan Ormat would implement to monitor and mitigate potential effects to those resources, ecosystems, habitat, and species (McGinley and Associates 2021, p. 1).

The Monitoring and Mitigation Plan includes adaptive management and mitigation measures that Ormat would implement if changes are detected in baseline conditions and threshold values are exceeded. Management actions may include geothermal reservoir pumping and injection adjustments ( e.g., redistribution of injection between shallow and deep aquifers). Other more aggressive actions include augmenting affected springs with geothermal fluids or fresh water to restore preproduction temperature, flow, stage, and water chemistry. The Monitoring and Mitigation Plan states that if mitigation actions are not sufficient for the protection of species and aquatic habitat, pumping and injection would be suspended until appropriate mitigation measures are identified, implemented, and shown to be effective (McGinley and Associates 2021, p. 34).

We, along with other interested parties ( e.g., Department of the Navy, NDOW) provided comments to the BLM regarding the Monitoring and Mitigation Plan, which was first made available to the public in January 2021. We have low confidence in the ability of the Monitoring and Mitigation Plan to adequately detect and respond to changes because of the complexity and natural variability of the spring system, limited baseline data, and perceived inadequacies of the plan. We determined the Monitoring and Mitigation Plan is inadequate because of the inadequate time to collect relevant baseline information prior to beginning operation of the plant, limited monitoring locations, low frequency of monitoring and reporting, lack of a statistical approach for addressing variability and uncertainty, lack of information on how water quality would be addressed, interacting effects of climate change and extractive water use, and uncertainty about mitigation if measures ran counter to other operating goals of the plant.

The Dixie Valley toad is classified as protected by the State of Nevada under Nevada Administrative Code (NAC) 503.075(2)(b). Per NAC 503.090(1), there is no open season on those species of amphibian classified as protected. Per NAC 503.094, the State issues permits for the take and possession of any species of wildlife for strictly scientific or educational purposes. The State's Department of Conservation and Natural Resources includes the Nevada Division of Natural Heritage (NDNH), which tracks the species status of plants and animals in Nevada. The NDNH recognizes Dixie Valley toads as critically imperiled, rank S1 . Ranks of S1 are defined as species with very high risks of extirpation in the jurisdiction due to very restricted range, very few populations or occurrences, very steep declines, severe threats, or other factors.

Section 4 of the Act (16 U.S.C. 1533) and its implementing regulations (50 CFR part 424) set forth the procedures for determining whether a species meets the definition of “endangered species” or “threatened species.” The Act defines an “endangered species” as a species in danger of extinction throughout all or a significant portion of its range and a “threatened species” as a species likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range. The Act requires that we determine whether a species meets the definition of an “endangered species” or a “threatened species” because of any of the following factors: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; or (E) other natural or manmade factors affecting its continued existence.

In conducting our status assessment of the Dixie Valley toad, we evaluated all identified threats under the Act's section 4(a)(1) factors and assessed how the cumulative impact of all threats acts on the viability of the species as a whole. That is, all the anticipated effects from both habitat-based and direct mortality-based threats are examined in total and then evaluated in the context of what those combined negative effects will mean to the future condition of the Dixie Valley toad.

After evaluating threats to the species and assessing the cumulative effect of the threats under the section 4(a)(1) factors, we determined that the Dixie Valley toad is at risk of extinction throughout its range primarily due to the approval and commencement of geothermal development. Other threats identified in this status determination include increased severity of drought due to climate change (Factor A), the threat of chytrid fungus establishing itself in the population (Factor C), groundwater pumping associated with human consumption, agriculture, and county planning (Factor A), and predation by invasive bullfrogs (Factor C). These three threats will likely exacerbate the main threat of geothermal development. Existing regulatory mechanisms do not address the primary threat to the species (Factor D).

Construction of the Dixie Meadows Geothermal Utilization Project has begun, and geothermal production is assumed to begin before the end of 2022. Based upon the best available scientific and commercial information as described in this determination, the Service has a high degree of certainty that geothermal production will have severe, negative effects on the geothermal springs the species relies upon for habitat (Factor A). These negative effects include reductions in spring temperature and springflow, which directly affect the needs of the species ( i.e., adequate water temperature, sufficient wetted areas, sufficient wetland vegetation, including vegetation cover, and adequate water quality (see Species Needs, above)). The best available information indicates that a complete reduction in springflow and significant reduction of water temperature are plausible outcomes of the geothermal project, and these conditions could result in the species no longer persisting ( i.e., becoming extinct or functionally extinct as a result of significant habitat degradation, or no reproduction due to highly isolated, non-recruiting individuals).

The narrowly distributed, isolated nature of the single, small population of the species indicates that the Dixie Valley toad will have no ability to withstand stochastic or catastrophic events through dispersal. Because the species occurs in only one spring system and has experienced little historical variation, it has low potential to adapt to a fast-changing environment. As a single-site endemic with no dispersal opportunities outside the current range and low adaptive capacity, the species has inherently low redundancy and representation, and depends entirely on the continued availability of wetland habitat in Dixie Meadows. Low redundancy and representation make the Dixie Valley toad particularly vulnerable to fast-paced change to its habitat and catastrophic events, any of which could plausibly result from the permitted Dixie Meadows Geothermal Utilization Project.

The Dixie Valley toad exists in one population that will likely be directly affected to a significant degree by geothermal production in a short timeframe, resulting in a high risk that the species could become extinct.

In addition to the current development of the geothermal project, a combination of threats will act synergistically to exacerbate effects from geothermal production on the Dixie Meadows spring system. A reduction in springflow could be exacerbated by the greater severity of droughts being experienced in the Southwestern United States, including Nevada (Snyder et al. 2019, pp. 2-4; Williams et al. 2020, pp. 1-5). Higher temperatures and drier conditions could result in greater evapotranspiration, leading to increased drying of wetland habitat. A reduction in water temperature could allow chytrid fungus to become established and negatively impact the Dixie Valley toad population. Chytrid fungus would likely be catastrophic to Dixie Valley toads, as it has caused severe declines in other amphibian species, and the fungus has been found in another known vector species (bullfrog) in Dixie Valley (Forrest 2013, p. 77). Bullfrogs themselves are a threat to the species, as Dixie Valley toads could be easily preyed upon because of their small size. If bullfrogs were to become established throughout Dixie Valley toad habitat, there would likely be a reduction in Dixie Valley toad abundance.

Thus, after assessing the best available information, we conclude that the Dixie Valley toad is currently in danger of extinction throughout all of its range due to the immediacy of the threat of geothermal production, including negative effects such as reductions in spring temperature and springflow, which would directly affect the needs of the species ( i.e., adequate water temperature, sufficient wetted areas, sufficient wetland vegetation, including vegetation cover, and adequate water quality), and low confidence in the ability of the Mitigation and Monitoring Plan to effectively minimize and mitigate for potential effects that are likely to manifest in the near term. We find that threatened species status is not appropriate because the threat of extinction is imminent as opposed to being likely to develop within the foreseeable future.

Under the Act and our implementing regulations, a species may warrant listing if it is in danger of extinction or likely to become so in the foreseeable future throughout all or a significant portion of its range. We have determined that the Dixie Valley toad is in danger of extinction throughout all of its range and, accordingly, did not undertake an analysis of any significant portion of its range. Because the Dixie Valley toad warrants listing as endangered throughout all of its range, our determination does not conflict with the decision in Center for Biological Diversity v. Everson, 435 F. Supp. 3d 69 (D.D.C. 2020), because that decision related to SPR analyses for species that warrant listing as threatened, not endangered, throughout all of their range.

Our review of the best available scientific and commercial information indicates that the Dixie Valley toad meets the definition of an endangered species. For the reasons discussed below, we further find that the threats facing the Dixie Valley toad at this time constitute an emergency posing a significant risk to the well-being of the Dixie Valley toad. Therefore, we are emergency listing the Dixie Valley toad as an endangered species in accordance with sections 3(6), 4(a)(1), and 4(b)(7) of the Act.

Under section 4(b)(7) of the Act and regulations at 50 CFR 424.20, we may emergency list a species if the threats to the species constitute an emergency posing a significant risk to its well-being. An emergency listing expires 240 days following publication in the Federal Register unless, during this 240-day period, we list the species following the normal listing procedures. In accordance with the Act, if at any time after we publish this emergency rule, we determine that substantial evidence does not exist to warrant such a rule, we will withdraw it.

We conclude that emergency listing the Dixie Valley toad as endangered is warranted. In making this determination, we have carefully assessed the best scientific and commercial data available regarding the past, present, and future threats faced by the Dixie Valley toad. As discussed above in detail, the Dixie Meadows Geothermal Utilization Project poses a high degree of threat to the Dixie Valley toad, such that it poses a significant risk to the well-being of the species. Moreover, the project has been permitted, construction has already begun, and power plant production is projected to begin this calendar year. Significant and possibly irreversible negative impacts to the species may occur before listing could become effective following completion of the usually required rulemaking procedures for listing a species. We therefore conclude that the current circumstances constitute an emergency.

By emergency listing the Dixie Valley toad as an endangered species, the protections of the Act (through sections 7, 9, and 10) and recognition that will immediately become available to the species will increase the likelihood that it can be saved from extinction.

Conservation measures provided to species listed as endangered or threatened species under the Act include recognition, recovery actions, requirements for Federal protection, and prohibitions against certain practices. Recognition through listing results in public awareness, and conservation by Federal, State, Tribal, and local agencies, private organizations, and individuals. The Act encourages cooperation with the States and requires that recovery actions be carried out for listed species. The protection required by Federal agencies and the prohibitions against certain activities are discussed, in part, below.

The primary purpose of the Act is the conservation of endangered and threatened species and the ecosystems upon which they depend. The ultimate goal of such conservation efforts is the recovery of these listed species, so that they no longer need the protective measures of the Act. Section 4(f) of the Act calls for the Service to develop and implement recovery plans for the conservation of endangered and threatened species. The recovery planning process involves the identification of actions that are necessary to halt or reverse the species' decline by addressing the threats to its survival and recovery. The goal of this process is to restore listed species to a point where they are secure, self-sustaining, and functioning components of their ecosystems.

Recovery planning includes the development of a recovery outline shortly after a species is listed and preparation of a draft and final recovery plan. The recovery outline guides the immediate implementation of urgent recovery actions and describes the process to be used to develop a recovery plan. Revisions of the plan may be done to address continuing or new threats to the species, as new substantive information becomes available. The recovery plan identifies site-specific management actions that set a trigger for review of the five factors that control whether a species remains endangered or may be downlisted or delisted and methods for monitoring recovery progress. Recovery plans also establish a framework for agencies to coordinate their recovery efforts and provide estimates of the cost of implementing recovery tasks. Recovery teams (composed of species experts, Federal and State agencies, nongovernmental organizations, and stakeholders) are often established to develop recovery plans. When completed, the recovery outline, draft recovery plan, and the final recovery plan will be available on our website ( http://www.fws.gov/endangered ) (see FOR FURTHER INFORMATION CONTACT ).

Implementation of recovery actions generally requires the participation of a broad range of partners, including other Federal agencies, States, Tribes, nongovernmental organizations, businesses, and private landowners. Examples of recovery actions include habitat restoration ( e.g., restoration of native vegetation), research, captive propagation and reintroduction, and outreach and education.

Following publication of a final listing rule, funding for recovery actions is available from a variety of sources, including Federal budgets, State programs, the academic community, and nongovernmental organizations. In addition, pursuant to section 6 of the Act, the State of Nevada will be eligible for Federal funds to implement management actions that promote the protection or recovery of the Dixie Valley toad. Information on our grant programs that are available to aid species recovery can be found at: http://www.fws.gov/grants.

Although the Dixie Valley toad is only emergency listed under the Act at this time, please let us know if you are interested in participating in recovery efforts for this species. Additionally, we invite you to submit any new information on this species whenever it becomes available and any information you may have for recovery planning purposes (see FOR FURTHER INFORMATION CONTACT ).

Section 7(a) of the Act requires Federal agencies to evaluate their actions with respect to any species that is listed as an endangered or threatened species and with respect to its critical habitat, if any is designated. Regulations implementing this interagency cooperation provision of the Act are codified at 50 CFR part 402. Section 7(a)(4) of the Act requires Federal agencies to ensure that activities they authorize, fund, or carry out are not likely to jeopardize the continued existence of any endangered or threatened species or destroy or adversely modify its critical habitat. If a Federal action may affect a listed species or its critical habitat, the responsible Federal agency must enter into consultation with the Service.

Federal agency actions within the species' habitat that may require conference or consultation or both as described in the preceding paragraph may include, but are not limited to, management and any other landscape-altering activities on Federal lands: Aquatic habitat restoration, fire management plans, fire suppression, fuel reduction treatments, mining permits, integrated natural resources management plans, land resource management plans, oil and natural gas permits, renewable energy development, renewable and alternative energy projects, and geothermal project approvals and implementation.

The Act and its implementing regulations set forth a series of general prohibitions and exceptions that apply to endangered wildlife. The prohibitions of section 9(a)(1) of the Act, codified at 50 CFR 17.21, make it illegal for any person subject to the jurisdiction of the United States to take (which includes harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect; or to attempt any of these) endangered wildlife within the United States or on the high seas. In addition, it is unlawful to import; export; deliver, receive, carry, transport, or ship in interstate or foreign commerce in the course of commercial activity; or sell or offer for sale in interstate or foreign commerce any species listed as an endangered species. It is also illegal to possess, sell, deliver, carry, transport, or ship any such wildlife that has been taken illegally. Certain exceptions apply to employees of the Service, the National Marine Fisheries Service, other Federal land management agencies, and State conservation agencies.

We may issue permits to carry out otherwise prohibited activities involving endangered wildlife under certain circumstances. Regulations governing permits are codified at 50 CFR 17.22. With regard to endangered wildlife, a permit may be issued for the following purposes: For scientific purposes, to enhance the propagation or survival of the species, and for incidental take in connection with otherwise lawful activities. The statute also contains certain exemptions from the prohibitions, which are found in sections 9 and 10 of the Act.

It is our policy, as published in the Federal Register on July 1, 1994 (59 FR 34272), to identify to the maximum extent practicable at the time a species is listed those activities that would or would not constitute a violation of section 9 of the Act. Based on the best available information, the following actions are unlikely to result in a violation of section 9, if these activities are carried out in accordance with existing regulations and permit requirements; this list is not comprehensive:

(1) Vehicle use on existing roads and trails in compliance with the BLM Carson City District's resource management plan.

(2) Recreational use with minimal ground disturbance ( e.g., hiking, walking).

Based on the best available information, the following activities may potentially result in a violation of section 9 of the Act if they are not authorized in accordance with applicable law, including the Endangered Species Act; this list is not comprehensive:

(1) Unauthorized handling or collecting of the species;

(2) Unauthorized livestock grazing that results in direct mortality and direct or indirect destruction of vegetation and aquatic habitat;

(3) Destruction/alteration of the species' habitat by draining, ditching, stream channelization or diversion, or diversion or alteration of surface or ground water flow into or out of the wetland;

(4) Introduction of nonnative species that compete with or prey upon the Dixie Valley toad or wetland vegetation;

(5) The unauthorized release of biological control agents that attack any life stage of the Dixie Valley toad;

(6) Modification of the vegetation components on sites known to be occupied by the Dixie Valley toad; and

(7) Modification of spring and wetland water temperatures.

Questions regarding whether specific activities would constitute a violation of section 9 of the Act should be directed to the Reno Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT ).

It is our position that, outside the jurisdiction of the U.S. Court of Appeals for the Tenth Circuit, we do not need to prepare environmental analyses pursuant to the National Environmental Policy Act (42 U.S.C. 4321 et seq. ) in connection with regulations adopted pursuant to section 4(a) of the Act. We published a notice outlining our reasons for this determination in the Federal Register on October 25, 1983 (48 FR 49244). This position was upheld by the U.S. Court of Appeals for the Ninth Circuit ( Douglas County v. Babbitt, 48 F.3d 1495 (9th Cir. 1995), cert. denied 516 U.S. 1042 (1996)).

In accordance with the President's memorandum of April 29, 1994 (Government-to-Government Relations with Native American Tribal Governments; 59 FR 22951, May 4, 1994), E.O. 13175 (Consultation and Coordination with Indian Tribal Governments), and the Department of the Interior's manual at 512 DM 2, we readily acknowledge our responsibility to communicate meaningfully with recognized Federal Tribes on a government-to-government basis. In accordance with Secretarial Order 3206 of June 5, 1997 (American Indian Tribal Rights, Federal-Tribal Trust Responsibilities, and the Endangered Species Act), we readily acknowledge our responsibilities to work directly with Tribes in developing programs for healthy ecosystems, to acknowledge that Tribal lands are not subject to the same controls as Federal public lands, to remain sensitive to Indian culture, and to make information available to Tribes. We requested information from the Paiute-Shoshone Tribe of the Fallon Reservation and Colony and have continued to coordinate during the SSA process. We are requesting the Tribe's partner review of the SSA report concurrent with the open comment period identified in the proposed rule that is published concurrently with this emergency rule and found in the Proposed Rules section of this issue of the Federal Register (see Docket No. FWS-R8-ES-2022-0024 in https://www.regulations.gov ). We will continue to work with Tribal entities during the development of a final listing determination for the Dixie Valley toad.

A complete list of references cited in this rulemaking is available on the internet at https://www.regulations.gov and upon request from the Reno Fish and Wildlife Office (see FOR FURTHER INFORMATION CONTACT ).

The primary authors of this rule are the staff members of the Fish and Wildlife Service's Species Assessment Team and the Reno Fish and Wildlife Office.

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

The Mid-Atlantic and New England Fishery Management Councils jointly manage the Atlantic Spiny Dogfish Fishery Management Plan (FMP), with the Mid-Atlantic Council acting as the administrative lead. Additionally, the Atlantic States Marine Fisheries Commission manages the spiny dogfish fishery in state waters from Maine to North Carolina through an interstate fishery management plan. The Councils' FMP requires the specification of regulatory harvest limits, including: An acceptable biological catch (ABC); annual catch limit (ACL); annual catch target (ACT); total allowable landings value (TAL); and coastwide commercial quota. These limits and other management measures may be set for up to five fishing years at a time, with each fishing year running from May 1 through April 30. This action implements status quo specifications for fishing year 2022 and an increased commercial trip limit for the Atlantic spiny dogfish fishery, as recommended by the Councils.

The spiny dogfish fishery is currently operating under multi-year specifications for fishing years 2021 and 2022 based on a 2020 assessment update and the Mid-Atlantic Council's updated risk policy. The Councils found no reason to change the previously projected status quo specifications for fishing year 2022. However, both Councils did recommend an increase to the commercial trip limit based on requests from fishery stakeholders to provide more economic stability and opportunity to fully achieve the provided commercial quota.

The proposed rule for this action published in the Federal Register on February 25, 2022 (87 FR 10762), and comments were accepted through March 14, 2022. NMFS received five comments from the public, and no changes to the final rule are necessary as a result of those comments (see Comments and Responses for additional detail). Additional background information regarding the development of these specifications was provided in the proposed rule and is not repeated here.

This action implements the Councils' recommendations for status quo 2022 spiny dogfish catch limit specifications (Table 1), and a 25-percent increase to the commercial trip limit from 6,000 lb (2,722 kg) per trip to 7,500 lb (3,402 kg) per trip, as outlined in the proposed rule.

There is a research track stock assessment in progress for Atlantic spiny dogfish. This assessment is expected to inform development of the next set of specifications, beginning in fishing year 2023.

The public comment period for the proposed rule ended on March 14, 2022, and NMFS received five comments from the public. No changes were made to final rule as a result of these comments.

Two commenters voiced similar concerns with the action, saying that increasing the trip limit only benefits the processors but not the harvesters. Both were also concerned that a higher limit will cause the price per pound to crash and ruin the market for dogfish. Another commenter agreed with the first two comments about the potential price drop, and also said that the trip limit should remain status quo until after the current stock assessment is complete. The fourth comment also disagrees with the trip limit increase, because there is no data showing that catch rates in the fishery have increased to warrant this change. This commenter is concerned that without these data, increasing the trip limit will cause a loss of industry jobs.

These concerns were discussed throughout the development of this action and in discussion of trip limit adjustments in recent years. There has been support for raising the trip limit from harvesters as well as processors during this action's development in 2021 by members of the public at meetings of the Advisory Panel, Committee, Atlantic Marine Fisheries Commission, and both Councils. Further, an increase of 25 percent (1,500 lb/680 kg) was recommended as a compromise when compared to other suggested alternatives that could have raised the limit even more. The change in this action is expected to provide some additional flexibility and opportunity to industry, with minimal negative impacts on the fishery, market, and other aspects of the human environment. Both Councils also plan to reconsider the trip limit after the results from the stock assessment become available.

The final comment was submitted by a college student and is primarily a brief history of Atlantic spiny dogfish management. This comment supports the action overall, but cautions that economic gain should not be valued more highly than the health of the stock. NMFS agrees with the sentiments of this comment, and will not implement catch limits or management measures that are likely to cause overfishing, in accordance with National Standard 1 of the Magnuson-Stevens Act.

NMFS has not made any changes to the proposed regulatory text, and there are no substantive changes from the proposed rule.

Pursuant to section 304(b)(3) of the Magnuson Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), the NMFS Assistant Administrator, Greater Atlantic Region, has determined that these final specifications are necessary for the conservation and management of the Atlantic spiny dogfish fishery, and that they are consistent with the Atlantic Spiny Dogfish FMP, other provisions of the Magnuson-Stevens Act, and other applicable law.

The Councils reviewed the regulations for this action and deemed them necessary and appropriate to implement consistent with section 303(c) of the Magnuson-Stevens Act.

The need to implement these measures in a timely manner to ensure that these final specifications and increased trip limit are in place for the start of the 2022 spiny dogfish fishing year constitutes good cause under the authority contained in 5 U.S.C. 553(d)(3) to waive the 30-day delay in effective date of this action. The 2022 fishing year begins on May 1, 2022. A delay in effectiveness beyond May 1 would be contrary to the public interest as it could create confusion in the spiny dogfish industry, and cause potential economic harm to the fishery through lost opportunity to fish under the higher trip limit. NMFS has also received several direct requests from industry stakeholders that the higher trip limit be implemented as soon as possible, which supports the conclusion that any further delay is contrary to public interest.

Finally, regulated parties do not require any additional time to come into compliance with this rule, and thus, a 30-day delay before the final rule becomes effective does not provide any benefit. Unlike actions that require an adjustment period, vessels fishing for spiny dogfish will not have to purchase new equipment or otherwise expend time or money to comply with these management measures. Rather, complying with this action simply means adhering to the new, increased trip limit. Fishery stakeholders have also been involved in the development of this action and are anticipating this rule, even requesting it be effective as soon as practicable. Therefore, NMFS finds good cause not to delay this final rule's effectiveness, consistent with 5 U.S.C. 553(d)(3). As a result, there is good cause to implement this action on May 1, 2022.

This final rule has been determined to be not significant for purposes of Executive Order 12866.

The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this action would not have a significant economic impact on a substantial number of small entities. The factual basis for the certification was published in the proposed rule and is not repeated here. No comments were received regarding this certification, and the initial certification remains unchanged. As a result, a final regulatory flexibility analysis is not required and none was prepared.

This final rule does not duplicate, conflict, or overlap with any existing Federal rules.

This action contains no information collection requirements under the Paperwork Reduction Act of 1995.

For the reasons set out in the preamble, 50 CFR part 648 is amended as follows: