In FR Doc. 2025-14949, appearing on pages 37822 to 37823 in the Federal Register of Wednesday, August 6, 2025, the following corrections are made:

1. In the Supplementary Information section, in subsection VII: Preliminary Economic Analysis of Impact, on page 37822, remove the extraneous paragraph starting with the sentence, “The proposed rule, if finalized, would not require firms in the POJ industry to change their manufacturing practices or behavior in any way” and ending with the sentence, “We request comment on our described benefits and costs of the proposed rule.”

2. In the Supplementary Information section, in subsection VII: Preliminary Economic Analysis of Impact, on page 37823, remove “Table 1—Summary of Benefits, Costs and Distributional Effects of the Proposed Rule”.

3. In the Supplementary Information section, in subsection VII: Preliminary Economic Analysis of Impact, on page 37823, remove the extraneous sentence “In line with Executive Order 14192, in 2 we estimate present and annualized values of cost, cost savings, and net costs over an infinite time horizon.”

4. In the Supplementary Information section, in subsection VII: Preliminary Economic Analysis of Impact, on page 37823, remove “Table 2—E.O. 14192 Summary Table”.

The full preliminary analysis of economic impacts remains available in the docket for this proposed rule (Ref. 2) and at https://www.fda.gov/about-fda/economics-staff/regulatory-impact-analyses-ria.

EPA is proposing to approve a SIP revision submitted by the NCDEQ, on November 28, 2023, that revises Rule 15A North Carolina Administrative Code (NCAC) 02D .0516, Sulfur Dioxide Emissions from Combustible Sources. Rule 02D .0516 requires sources emitting SO 2 through combustion and discharging through a vent, stack, or chimney to comply with an emission standard of 2.3 pounds per million British thermal unit (lbs/MMBtu). The Rule also provides criteria for how affected sources should determine compliance with the emission standard. North Carolina's November 28, 2023, SIP revision seeks to modify the Rule 02D .0516 applicability criteria respecting control devices and the provisions for determining compliance with the SO 2 emission standard. More specifically, the SIP revision seeks to provide clarity and consistency with North Carolina's position that the use of supplemental fuels in combustion units beyond what is needed for proper operation is not a means for compliance with the SO 2 emission standard at Rule 02D .0516.

SO 2 is one of the group of gases called sulfur oxides (SO X ). EPA's SO 2 national ambient air quality standards (NAAQS)  1 are designed to protect against exposure to the entire group of SO X . Thus, control measures that reduce SO 2 emissions can generally be expected to reduce exposure to all gaseous SO X . Emissions of SO 2 are mostly generated through the combustion of fuel or waste that contain sulfur.

North Carolina's November 28, 2023, SIP revision was developed in response to a declaratory ruling  2 issued by the State's Environmental Management Commission (EMC) that the plain language of Rule 02D .0516 does not prohibit the use of supplemental fuels, including natural gas, to determine compliance with the 2.3 lbs/MMBtu SO 2 emission standard. As a result, NCDEQ revised Rule 02D .0516 to align with its position that sources cannot demonstrate compliance with the SO 2 emission standard by burning excess supplemental fuel beyond what is necessary for proper operation of a combustion unit.

North Carolina's SIP revision modifies and reformats Rule 02D .0516 such that paragraph (a) is split into two separate paragraphs, (a) and (b); renumbers existing paragraph 02D .0516(b) to new paragraph 02D .0516(c); and includes minor grammatical and rewording edits for clarity. Changes to paragraph 02D .0516(a) include the addition of the phrase “air pollution control devices” and the term “flare” as well as minor grammatical edits due to these additions. These amendments clarify that any source of combustion includes air pollution control devices and that the rule applies to subject emissions discharged through a flare as well as a chimney, vent, or stack.

The compliance language at paragraph 02D. 0516(a) in the SIP states, “Sulfur dioxide formed by the combustion of sulfur in fuels, wastes, ores and other substances shall be included when determining compliance with this standard. Sulfur dioxide formed or reduced as a result of treating flue gases with sulfur trioxide or other materials shall also be accounted for when determining compliance with this standard.” This language is moved to paragraph 02D. 0516(b) as subparagraphs (b)(1)1 and (b)(1)2. The criteria at subparagraph (b)(1) is further amended by removing the phrase “included when determining compliance with this standard.” This language is repurposed as the introduction of paragraph (b), “When determining compliance with this standard” ( i.e., the SO 2 emission standard at paragraph 02D. 0516(a)). The criteria at paragraph (b)(2) is revised by replacing the phrase “also be accounted for when determining compliance with this standard” with the phrase “be included in the computation of emissions.” This amendment clarifies the discharge or reduction of SO 2 through the stated process shall be included in the computation of emissions to determine compliance with the SO 2 emission standard.

The SIP revision also adds the following new compliance requirement at paragraph 02D. 0516(b)(3): “the determination of Btu input shall not include the contribution from any portion of fuels used exclusively to inflate the heat input value used to demonstrate compliance with the emission standard in Paragraph (a) of this Rule.” The addition of paragraph (b)(3) provides that the computation of emissions to determine compliance with the emission standard shall not include SO 2 emissions from the use of excess supplemental fuel beyond what is necessary to operate a combustion unit. The revisions to paragraph (b)(3) provide clarity and consistency with the State's position that the use of supplemental fuel beyond what is needed for proper operation of a combustion unit is not a means for determining compliance with the 2.3 lbs/MMBtu SO 2 emission limit.

Former paragraph 02D. 0516(b) is renumbered to paragraph 02D. 0516(c) with no modifications to the original language. Lastly, DAQ's SIP revision also makes non-substantive grammatical or typographical changes because of modifications to Rule 02D .0516. DAQ's revisions to Rule 15A NCAC 02D .0516 became state-effective on June 1, 2023.

For the reasons discussed above, these proposed changes will not interfere with any applicable requirement concerning attainment and reasonable further progress, or any other applicable requirement of the Act. Therefore, EPA is proposing to approve North Carolina's November 28, 2023, SIP revision.

In this document, EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, and as discussed in Sections I and II of this preamble, EPA is proposing to incorporate by reference North Carolina Rule 15A NCAC 02D .0516, Sulfur Dioxide Emissions from Combustible Sources, effective June 1, 2023, which clarifies that sources cannot demonstrate compliance with the SO 2 emission standard in the rule by burning excess supplemental fuel beyond what is necessary for proper operation of the combustion unit. EPA has made, and will continue to make, these materials generally available through www.regulations.gov and at the EPA Region 4 office (please contact the person identified in the “For Further Information Contact” section of this preamble for more information).

EPA is proposing to approve North Carolina's November 28, 2023, SIP revision at Rule 15A NCAC 02D .0516 to provide clarity and consistency with the State's position that the use of supplemental fuels in combustion units beyond what is needed for proper operation is not a means for compliance with the 2.3 lbs/MMBtu SO 2 emission standard at Rule 02D .0516.

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

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

• Is not subject to Executive Order 14192 (90 FR 9065, February 6, 2025) because SIP actions are exempt from review under Executive Order 12866;

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

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

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

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

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

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

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

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

EPA is proposing to approve GA EPD's July 18, 2024, SIP submission which updates the State's regulations for trading programs at Rule 391-3-1-.02(12), “Cross State Air Pollution Rule NO X Annual Trading Program;” Rule 391-3-1-.02(13), “Cross State Air Pollution Rule SO 2 Annual Trading Program;” and Rule 391-3-1-.02(14), “Cross State Air Pollution Rule NO X Ozone Season Trading Program.” Large EGUs in Georgia are subject to these three State CSAPR trading programs for annual NO X and SO 2 emissions—which are precursors to PM 2.5 —and ozone season NO X emissions—which are precursors to ground-level ozone—to address the State's good neighbor obligations with respect to the 1997 annual fine particulate matter (PM 2.5 ) NAAQS, the 2006 24-hour PM 2.5 NAAQS, and the 1997 8-hour ozone NAAQS. Pursuant to CAA section 110(a)(2)(D)(i)(I), known as the “good neighbor” provision, states are required to address air pollution from sources within their jurisdiction that affects downwind states' ability to attain and maintain the NAAQS. See 42 U.S.C. 7410(a)(2)(D)(i)(I). The State CSAPR trading programs are integrated with the Federal CSAPR NO X Annual Trading Program, the Federal CSAPR NO X Ozone Season Group 1 Trading Program, and the Federal CSAPR SO 2 Group 2 Trading Program established by EPA's regulations at 40 CFR part 97, subparts AAAAA, BBBBB, and DDDDD, respectively. As adopted by the State before this SIP revision, and as previously approved by EPA into Georgia's SIP, Georgia's CSAPR trading program regulations generally IBR the Federal CSAPR trading program regulations as the Federal regulations had been amended through October 26, 2016. 1

Georgia's July 18, 2024, SIP submission updates the IBR language to reflect amendments EPA made to the Federal CSAPR trading program regulations in the 2021 Revised CSAPR Update, 2 the 2022 Recordation Rule, 3 the 2023 Good Neighbor Plan  4 (GNP), and a subsequent interim final rule administratively staying the GNP for sources in several states in response to judicial orders partially staying another EPA action. 5 Section II, below, briefly summarizes the framework of the CSAPR trading programs and how those programs are implemented in Georgia. Additionally, this SIP revision also updates Georgia's volatile organic compounds (VOC) definition at Rule 391-3-1-.01, “Definitions.”

EPA is proposing to approve Georgia's July 18, 2024, SIP revision because it is consistent with EPA's good neighbor CSAPR trading programs and the CAA. 6 Please refer to the Federal Register citations referenced herein for additional detailed background on the CSAPR and subsequent rulemakings.

EPA published the original CSAPR in August 2011 to address the good neighbor requirements of CAA section 110(a)(2)(D)(i)(I), concerning interstate transport of air pollution. 7 See 42 U.S.C. 7410(a)(2)(D)(i)(I). Acting to address the same statutory provision, EPA published the CSAPR Update on October 26, 2016 (81 FR 74504) and the Revised CSAPR Update on April 30, 2021 (86 FR 23054). These three rules collectively require 27 states to limit their statewide emissions of SO 2 and/or NO X to mitigate transported air pollution unlawfully impacting other states' ability to attain or maintain one or more of the following four NAAQS: the 1997 annual PM 2.5 NAAQS, the 2006 24-hour PM 2.5 NAAQS, the 1997 8-hour ozone NAAQS, and the 2008 8-hour ozone NAAQS. To implement the required emissions reductions, the rules include Federal implementation plans (FIPs) that require EGUs in each covered state to participate in one or more of six Federal emissions trading programs established under regulations set forth at 40 CFR part 97, subparts AAAAA through EEEEE and GGGGG. 8

Georgia has been subject to CSAPR since its inception, with EGUs required to participate in Federal trading programs for NO X and SO 2 emissions. As part of the original CSAPR in 2011, EPA determined that emissions from Georgia significantly contributed to nonattainment or interference with maintenance of the 1997 ozone NAAQS, 1997 annual PM 2.5 NAAQS, and 2006 24-hour PM 2.5 in other states. 9 To address Georgia's good neighbor obligations, the State's large EGUs became subject to the Federal CSAPR NO X Annual Trading Program established in subpart AAAAA of 40 CFR part 97, the Federal CSAPR NO X Ozone Season Group 1 Trading Program established in subpart BBBBB of 40 CFR part 97, and the Federal CSAPR SO 2 Group 2 Trading Program established in subpart DDDDD of 40 CFR part 97. 10

In the 2016 CSAPR Update, EPA did not reopen the previous determination that Georgia has a good neighbor obligation with respect to the 1997 ozone NAAQS, but found that the State does not need to implement further emissions reductions to meet its good neighbor obligations with respect to the 2008 ozone NAAQS. 11 Georgia's original CSAPR NO X ozone season requirements (including its emission budget) continued unchanged. 12 The CSAPR Update included technical corrections to all the trading programs established in CSAPR but did not otherwise address the 1997 or 2006 PM 2.5 NAAQS. Georgia's EGUs that meet the CSAPR applicability criteria therefore continued to be subject to the CSAPR requirements to participate in the Federal CSAPR NO X Annual Trading Program, the Federal CSAPR NO X Ozone Season Group 1 Trading Program, 13 and the Federal CSAPR SO 2 Group 2 Trading Program to address the State's good neighbor obligations with respect to the 1997 ozone NAAQS and the 1997 and 2006 PM 2.5 NAAQS.

CSAPR includes provisions under which states may submit and EPA will approve SIP revisions to modify or replace the CSAPR FIP requirements while allowing states to continue to meet their good neighbor obligations using either CSAPR's Federal emissions trading programs or State emissions trading programs integrated with the Federal programs. 14 Georgia took advantage of these provisions in 2017. That year, Georgia submitted and EPA approved revisions to Georgia's SIP establishing three State CSAPR trading programs that replaced the three Federal CSAPR trading programs regarding Georgia EGUs for annual emissions of NO X and SO 2 and NO X ozone season emissions. EPA approved Georgia's July 26, 2017 SIP submission in an action published on October 13, 2017, 15 which added to the SIP Georgia Rules 391-3-1-.02(12), “Cross State Air Pollution Rule NO X Annual Trading Program;” Rule 391-3-1-.02(13), “Cross State Air Pollution Rule SO 2 Annual Trading Program;” and Rule 391-3-1-.02(14), “Cross State Air Pollution Rule NO X Ozone Season Trading Program,” comprising Georgia's versions of the Federal trading program regulations. In general, each State CSAPR trading program rule is designed to replace the corresponding Federal trading program regulation. These Georgia CSAPR State trading programs are now integrated with the Federal CSAPR NO X Annual Trading program, the Federal CSAPR SO 2 Group 2 Trading Program, and the Federal CSAPR NO X Ozone Season Group 1 Trading Program, respectively. The State trading programs are substantively identical to the Federal trading programs. 16 Georgia units subject to the State CSAPR trading programs are generally required to meet the same requirements they would otherwise have been subject to under the corresponding CSAPR Federal trading programs. 17

Since EPA's approval of the three State CSAPR trading programs into Georgia's SIP in 2017, EPA has promulgated changes to the Federal CSAPR trading programs at 40 CFR part 97, subparts AAAAA, BBBBB, and DDDDD, starting with the 2021 Revised CSAPR Update, whose primary purpose was to complete the evaluation and implementation of good neighbor obligations of certain states (not including Georgia) with respect to the 2008 ozone NAAQS. 18 However, that rule also modified subparts AAAAA, BBBBB, and DDDDD of part 97, including (1) adjustments to the procedures for allocating allowances from the portions of the states' emissions budgets set aside for potential allocation to new units ( i.e., new unit set-asides or NUSAs)—with conforming adjustments to the assurance provisions  19 —and (2) extensions to the deadlines for EPA to record allocations of allowances in sources' compliance accounts and for sources to hold allowances after each control period, whether the sources participate in the integrated trading programs under FIPs or under approved SIP revisions. EPA's 2022 Recordation Rule further extended the deadlines for EPA to record allocations of allowances in sources' compliance accounts. 20

In March 2023, EPA promulgated the Good Neighbor Plan (GNP), which determined the good neighbor obligations of 23 states (not including Georgia) with respect to the 2015 ozone NAAQS, establishing FIP requirements for emissions sources in those states to address their obligations by reducing ozone season NO X emissions. 21 The GNP modified the CSAPR NO X Ozone Season Group 3 trading program at subpart GGGGG of 40 CFR 97, expanding the program to apply to EGUs in additional states to address their good neighbor obligations for the 2015 ozone NAAQS.

EPA previously had found that sources in Georgia did not need to implement further emissions reductions to satisfy good neighbor obligations with respect to the 2015 ozone NAAQS, 22 and in the GNP EPA did not establish a new NO X ozone season FIP for the State. However, the GNP also finalized updates to the Federal trading programs integrated with Georgia's State CSAPR trading programs, in 40 CFR part 97 at subparts AAAAA (NO X Annual), BBBBB (NO X Ozone Season Group 1), and DDDDD (SO 2 Group 2) (88 FR 36654). These updates included technical corrections regarding allowance allocations for units in Indian Country and cross-reference updates for conformity with the amended provisions of the CSAPR NO X Ozone Season Group 3 trading program at subpart GGGGG.

Following the finalization of the GNP and a related action published in February 2023 that disapproved states' good neighbor SIPs, 23 multiple parties challenged one or both actions in eight Federal circuit courts. During 2023, several courts granted requests to stay the SIP disapprovals for certain states pending judicial review, thereby effectively suspending EPA's authority to implement the GNP in those affected states. 24 Then, on June 27, 2024, the U.S. Supreme Court issued a decision staying enforcement of the GNP's requirements against the stay applicants, which included three states, several owners of affected sources, and several trade associations. 25 In response to the judicial stay orders, EPA issued three interim final rules in 2023 and 2024. The interim final rules administratively stayed the effectiveness of all GNP requirements established to address obligations of the states to mitigate interstate air pollution with respect to the 2015 ozone NAAQS. 26 The three interim final rules also include provisions (including some additional conforming cross-reference updates to subpart BBBBB of 40 CFR part 75) to ensure that power plants in GNP-affected states with previously established requirements to mitigate interstate air pollution with respect to the 2008 ozone NAAQS will remain subject to equivalent requirements while the GNP's effectiveness is stayed.

Just as the GNP and the related action disapproving states' SIPs did not apply to Georgia or sources in Georgia, the judicial orders partially staying those rules do not apply to Georgia or sources in Georgia. Further, the interim final rules administratively staying the effectiveness of the GNP provisions addressing the 2015 ozone NAAQS did not stay the technical corrections or cross-reference updates to subparts AAAAA, BBBBB, or DDDDD of 40 CFR part 97 that were included in the GNP final rule. As a result, Georgia's July 18, 2024, SIP submission, which IBRs Federal good neighbor regulation updates included in the GNP and the first interim final rule, is not affected by the stay orders.

As described in Section II of this preamble, EPA approved Georgia's CSAPR SIP revision adopting the State rules at 391-3-1-.02(12), 391-3-1-.02(13), and 391-3-1-.02(14) in an action published on October 13, 2017, 27 replacing the Federal CSAPR NO X Annual, CSAPR SO 2 Group 2, and CSAPR NO X Ozone Season Group 1 trading programs at 40 CFR part 97, subparts AAAAA, DDDDD, and BBBBB, respectively, for Georgia EGUs with State CSAPR trading programs that are integrated with and substantively identical to the Federal trading programs.

Georgia's July 18, 2024, SIP submission seeks approval into the SIP of the State's revisions to its CSAPR trading program rules that IBR more recent amendments to the Federal CSAPR trading program regulations. Specifically, the submission revises the IBR language in 391-3-1-.02(12), 391-3-1-.02(13), and 391-3-1-.02(14) to IBR revisions to the Federal CSAPR trading programs made after the previous October 26, 2016, IBR date and through July 31, 2023. The revisions also correct the amounts that are reserved from the State's emissions budgets in NUSAs to match the current amounts set forth in the Federal regulations. Lastly, Georgia's July 18, 2024, SIP revision also proposes to update Georgia's volatile organic compounds definition at Rule 391-3-1-.01, Definitions.

EPA is proposing to approve Georgia's July 18, 2024, SIP revision that update the State's CSAPR trading program rules. First, the SIP revision revises the IBR language for 391-3-1-.02(12), “Cross State Air Pollution Rule NO X Annual Trading Program;” 391-3-1-.02(13), “Cross State Air Pollution Rule SO 2 Annual Trading Program;” and 391-3-1-.02(14), “Cross State Air Pollution Rule NO X Ozone Season Trading Program.” Georgia Rule 391-3-1-.02(12)(a) and Georgia Rule 391-3-1-.02(13)(a) are revised to update the IBR date from October 26, 2016, to June 5, 2023, and Georgia Rule 391-3-1-.02(14)(a) is revised to update the IBR date from October 26, 2016, to July 31, 2023, to incorporate the relevant amendments to the Federal rules at 40 CFR part 97 subpart AAAAA, DDDDD, and BBBBB, respectively. Specifically, Georgia's SIP revision replaces these citations with the updated citations to June 5, 2023 (88 FR 36654) for subparts AAAAA and DDDDD at Rules 391-3-1-.02(12) and 391-3-1-.02(13), and to July 31, 2023 (88 FR 49295) for subpart BBBBB at Rule 391-3-1-.02(14). This revised IBR language ensures that the text of the Federal regulations incorporated into Georgia's SIP is consistent with the most recent Federal amendments through the date of Georgia's SIP submission.

Second, Georgia's SIP revision updates the portions of the emissions budgets reserved in NUSAs for all three trading programs. In 2021, EPA promulgated the corrected NUSA amounts in part 97 in the Revised CSAPR Update. 28 Georgia's July 18, 2024, SIP revision corrects the NUSA amounts from 1,075 tons to 1,074 tons for the CSAPR NO X Annual allowances at Georgia Rule 391-3-1-.02(12)(f)2.; from 2,711 tons to 2,721 tons for the CSAPR SO 2 Group 2 allowances at Georgia Rule 391-3-1-.02(13)(f)2.; and from 481 tons to 485 tons for the CSAPR NO X Ozone Season Group 1 allowances at Georgia Rule 391-3-1-.02(14)(f)2.

The changes included in Georgia's July 18, 2024, SIP revision make Georgia's State CSAPR trading program regulations more consistent with the current Federal CSAPR trading program regulations by incorporating more recent amendments. EPA has reviewed Georgia's SIP revision and finds that the updates and corrections align the State's regulations with the amendments codified in part 97, subparts AAAAA, BBBBB, and DDDDD, as part of the Revised CSAPR Update, the Recordation Rule, the GNP (only the revisions to subparts AAAAA, BBBBB, and DDDDD of part 97, which do not address the 2015 ozone NAAQS), and the July 31, 2021, interim final rule.

EPA has determined that the IBR update at Rules 391-3-1-.02(12), 391-3-1-.02(13), and 391-3-1-.02(14) included in Georgia's SIP revision is consistent with the Federal CSAPR NO X Annual, CSAPR SO 2 Group 2, and CSAPR NO X Ozone Season Group 1 Trading Program regulations. EPA proposes to find that, with these updates, Georgia's State CSAPR rules would continue to satisfy Georgia's obligations under CAA section 110(a)(2)(D)(i)(I) to prohibit emissions that significantly contribute to nonattainment or interfere with maintenance of the 1997 ozone NAAQS and the 1997 and 2006 PM 2.5 NAAQS in downwind states.

Additionally, the submission includes changes to Rule 391-3-1-.01, Definitions, where Georgia updates the definitions of “volatile organic compound” (VOC) at subparagraph (llll) to align with the federal definition at 40 CFR 51.100(s). Tropospheric or ground-level ozone occurs when VOC and NO X react in the atmosphere in the presence of sunlight. Because of the harmful effects of ozone, EPA and State governments implement rules to limit the amount of certain VOC and NO X that can be released into the atmosphere. CAA section 302(s) specifies that EPA has the authority to define the meaning of “VOC” and hence, what compounds shall be treated as VOC for regulatory purposes. 29 EPA's longstanding policy is that compounds of carbon with negligible reactivity need not be regulated to reduce ground-level ozone and should be excluded from the regulatory definition of VOC. See 42 FR 35314 (July 18, 1977), 70 FR 54046 (September 13, 2005). EPA lists these compounds in its regulations at 40 CFR 51.100(s) and excludes them from the definition of VOC. Georgia's VOC definition update at subparagraph (llll) adds trans-1,1,1,4,4,4-hexafluorobut-2-ene (HFO-1336mzz(E)) on the list of organic compounds having negligible photochemical reactivity to align with EPA's addition at 40 CFR 51.100(s), where EPA excludes compounds from the definition of regulated VOCs due to negligible reactivity and therefore contribution to ground-level ozone formation. 30 See 88 FR 8226 (February 8, 2023) (adding trans-1,1,1,4,4,4-hexafluorobut-2-ene (HFO-1336mzz(E)) to the exclusion list at 40 CFR 51.100(s)).

EPA proposes to find that Georgia's revised VOC definition will not interfere with attainment or maintenance of any national ambient air quality standards, reasonable further progress, or any other applicable requirement of the CAA, consistent with CAA section 110(l), because EPA has found the excluded chemical to be negligibly reactive.

In addition, Georgia's SIP revision makes administrative updates to the definition of VOC, including: converting the term “Organic Compound” to lower case “organic compound” at Rule 391-3-1-.01(llll); updating the VOC definition term for “chlorodifluoromethane (CFC)” to “chlorodifluoromethane (HCFC-22)” and the term for “trifluoromethane (FC-23)” to “trifluoromethane (HFC-23)” to be consistent with the designations established at 40 CFR 51.100(s); changing the spelling of “Sulphur” to “Sulfur” at Rule 391-3-1-.01(llll)4.; and revising the terms “tertiaryamines” and “nonreactive” at Rule 391-3-1-.01(llll)3. and 5. to “tertiary-amines” and “non-reactive,” respectively. The EPA proposes to approve Georgia's revisions to the “VOC” definition at Rule 391-3-1-.01, subparagraph (llll) because these changes are administrative in nature and increase consistency with the Federal VOC definition at 40 CFR 51.100(s).

In this document, EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, and as discussed in Section III of this preamble, EPA is proposing to incorporate by reference Georgia Rules 391-3-1-.02(12), Cross State Air Pollution Rule NO X Annual Trading Program; 391-3-1-.02(13), Cross State Air Pollution Rule SO 2 Annual Trading Program; and 391-3-1-.02(14), Cross State Air Pollution Rule NO X Ozone Season Trading Program, state effective July 15, 2024, which adopt and incorporate by reference Federal amendments to 40 CFR part 97, subpart AAAAA—CSAPR NO X Annual Trading Program, and subpart DDDDD—CSAPR SO 2 Group 2 Trading Program, as promulgated after October 26, 2016, through June 5, 2023 and subpart BBBBB—CSAPR NO X Ozone Season Group 1 Trading Program through July 31, 2023. EPA is also proposing to incorporate by reference Georgia Rule 391-3-1-.01, Definitions, state effective July 15, 2024, 31 which updates the definitions of “volatile organic compound.” EPA has made, and will continue to make, these materials generally available through www.regulations.gov and at the EPA Region 4 office (please contact the person identified in the For Further Information Contact section of this preamble for more information).

For the aforementioned reasons, EPA is proposing to approve the July 18, 2024, SIP revision consisting of changes to Georgia Air Quality Rules related to the CSAPR trading programs found at 391-3-1-.02(12), 391-3-1-.02(13), and 391-3-1-.02(14), and the definition for “Volatile Organic Compound” found at 391-3-1-.01.

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

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

• Is not subject to Executive Order 14192 (90 FR 9065, February 6, 2025) because SIP actions are exempt from review under Executive Order 12866;

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

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

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

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

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

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

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

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

On June 22, 2010 (75 FR 35520), EPA published a new SO 2 NAAQS of 75 parts per billion (ppb), which is met at an ambient air quality monitoring site when the 3-year average of the annual 99th percentile of daily maximum 1-hour average concentrations does not exceed 75 ppb, as determined in accordance with appendix T of 40 CFR part 50.

Upon promulgation of a new or revised NAAQS, section 107(d)(1)(B) of the CAA requires EPA to designate as nonattainment any areas that are violating the NAAQS. On August 5, 2013 (78 FR 47191), EPA designated the Detroit area, a portion of Wayne County, Michigan, as nonattainment for the 2010 SO 2 NAAQS based on ambient air quality data collected at the Detroit SW monitoring site (AQS ID 26-163-0015) from 2009 to 2011. The nonattainment area designation became effective on October 4, 2013. Section 191 of the CAA directs states to submit a State Implementation Plan (SIP) for an area designated as nonattainment for the 2010 SO 2 NAAQS to EPA within 18 months of the effective date of the designation, i.e., by no later than April 4, 2015, in this case. The SIP must demonstrate attainment of the NAAQS as expeditiously as practicable, but no later than five years from the effective date of designation, which was October 4, 2018, for the Detroit nonattainment area.

On March 18, 2016 (81 FR 14736), EPA published an action finding that Michigan had failed to submit the required SO 2 nonattainment plan by the submittal deadline. This finding initiated deadlines under CAA section 179(a) for the potential imposition of 2-to-1 New Source Review (NSR) offset and Federal highway funding sanctions. Additionally, under CAA section 110(c), the finding triggered a requirement that EPA promulgate a Federal Implementation Plan (FIP) within two years of the finding unless, by that time, (a) the State had made the necessary complete submittal, and (b) EPA had approved the submittal as meeting applicable requirements.

On May 31, 2016, Michigan submitted a Detroit SO 2 attainment plan and on June 30, 2016, submitted associated final enforceable measures. Michigan's submission of a complete attainment plan terminated the deadlines for imposing sanctions, pursuant to 40 CFR 52.31(d)(5), but it did not terminate EPA's FIP obligation. On March 19, 2021 (86 FR 14827), EPA partially approved and partially disapproved Michigan's SO 2 plan as submitted in 2016. EPA's March 19, 2021, action approved the enforceable control measures for two facilities, approved the base-year emissions inventory, and affirmed that the NSR requirements for the area had previously been met. In the same March 19, 2021, action, EPA disapproved the attainment demonstration, as well as the requirements for meeting reasonable further progress (RFP) toward attainment of the NAAQS, reasonably available control measures/reasonably available control technology (RACM/RACT), and contingency measures. Additionally, EPA disapproved the plan's control measures for two facilities as insufficient to demonstrate attainment. These disapprovals started a new sanctions clock under CAA section 179(a).

On January 28, 2022 (87 FR 4501), EPA issued a finding of failure to attain for the Detroit SO 2 nonattainment area, determining that the area failed to attain the 2010 SO 2 NAAQS by the applicable attainment date of October 4, 2018, and established a requirement that Michigan submit a revised SIP by January 30, 2023, that would provide for expeditious attainment of the NAAQS within the time period specified in CAA sections 179(d)(3) and 172(a)(2).

On October 12, 2022 (87 FR 61514), EPA promulgated a FIP for the Detroit SO 2 nonattainment area, which satisfied EPA's duty to promulgate a FIP for the area under CAA section 110(c) that resulted from the March 18, 2016, finding of failure to submit. While EPA's FIP for the Detroit area met the requirements for SO 2 nonattainment area plans, the FIP did not relieve Michigan of the previously discussed CAA requirement to submit a plan that provides for attainment of the 2010 SO 2 NAAQS for the Detroit nonattainment area. On December 20, 2022, Michigan submitted a revised attainment plan for the Detroit SO 2 nonattainment area mirroring EPA's FIP to remedy Michigan's 2016 plan deficiencies specified in EPA's March 19, 2021, rulemaking partially approving and partially disapproving Michigan's SIP.

Michigan's revised plan, as submitted on December 20, 2022, depended, in part, upon permits that had not yet been issued but would include limits and associated requirements for the United States Steel Corporation (U.S. Steel), EES Coke Battery (EES Coke), and Dearborn Industrial Generation (DIG) facilities containing emission limits and associated requirements no less stringent than those set forth in EPA's FIP, codified at 40 CFR 52.1189. On February 21, 2023, Michigan submitted a clarification letter committing to submit the necessary permits by April 30, 2024. On March 23, 2023 (88 FR 17488), EPA proposed to conditionally approve Michigan's plan, conditioned upon the issuance of and submission for incorporation into the SIP the applicable permits for the U.S. Steel, EES Coke, and DIG facilities. Also, on March 23, 2023 (88 FR 17376), EPA issued an interim final determination to stay and defer sanctions in the Detroit SO 2 nonattainment area based on EPA's proposed conditional approval.

On December 14, 2023, Michigan submitted three applicable permits for the U.S. Steel, EES Coke, and DIG facilities. On April 2, 2024, the State submitted the final applicable permit for the DIG facility, along with a request that EPA approve its revised plan. On April 29, 2024, EPA issued a completeness letter, included in the docket for this action, determining that Michigan's submittal had satisfied the completeness criteria set forth at 40 CFR part 51, appendix V and met the requirement for a SIP submittal that provides for expeditious attainment set forth in EPA's January 28, 2022, finding of failure to attain.

On May 19, 2025 (90 FR 21228), EPA approved Michigan's revised SIP submission, which the State submitted to EPA on December 20, 2022, and supplemented on February 21, 2023, December 14, 2023, and April 2, 2024, for attaining the 2010 SO 2 NAAQS for the Detroit area and for meeting other nonattainment area planning requirements of CAA sections 110, 172, 179 and 192. EPA approved Michigan's demonstration that these requirements provide for attainment of the 2010 SO 2 NAAQS in Detroit and concluded that Michigan had satisfied the other applicable requirements for nonattainment areas. In the same action, EPA determined that the conditions articulated in 40 CFR 52.31(d) had been met, thereby terminating the sanctions clock resulting from EPA's March 19, 2021, partial disapproval of the prior SIP.

On May 5, 2025, Michigan submitted a redesignation request and maintenance plan for the Detroit nonattainment area for the 2010 SO 2 NAAQS. Under section 107(d)(3)(E) of the CAA, EPA may promulgate a redesignation of a nonattainment area provided that:

1. EPA has determined that the area has attained the NAAQS;

2. EPA has fully approved the applicable implementation plan for the area under section 110(k) of the CAA;

3. EPA has determined that improvement in air quality is due to permanent and enforceable reductions in emissions resulting from implementation of the applicable implementation plan and applicable Federal air pollution control regulations and other permanent and enforceable reductions;

4. EPA has fully approved a maintenance plan for the area under section 175A of the CAA; and

5. The State containing such area has met all requirements applicable to the area under section 110 of the CAA and part D.

On May 5, 2025, Michigan submitted a request that EPA redesignate the Detroit 2010 SO 2 nonattainment area to attainment and a SIP revision containing a maintenance plan for the area.

EPA's evaluation of Michigan's redesignation request and maintenance plan was based on consideration of the five redesignation criteria provided under CAA section 107(d)(3)(E) and is described in the remainder of this section.

In accordance with CAA section 107(d)(3)(E)(i), for redesignation of a nonattainment area to attainment, the CAA requires EPA to determine that the area has attained the applicable NAAQS. As stated in EPA's April 23, 2014, “Guidance for 1-Hour SO 2 Nonattainment Area SIP Submissions” (“April 2014 SO 2 Guidance”), there are two components needed to support an attainment determination: (1) a review of representative air quality monitoring data located in the area of maximum concentration; and (2) a further analysis, using air quality dispersion modeling, which will generally be needed to estimate SO 2 concentrations throughout the nonattainment area to demonstrate that the entire area is attaining the applicable NAAQS, based on current actual emissions or the fully implemented control strategy. Michigan's May 5, 2025, redesignation request addresses both components, as described below.

Under 40 CFR 50.17(b), the 2010 SO 2 NAAQS is met at an ambient air quality monitoring site when the three-year average of the annual (99th percentile) daily maximum 1-hour average concentrations is less than or equal to 75 ppb, as determined in accordance with appendix T of 40 CFR part 50, at all relevant monitoring sites in the subject area. In a year with 365 days of valid monitoring data, the 99th percentile would be the fourth highest daily maximum 1-hour value.

Michigan operates five SO 2 monitors in the Detroit nonattainment area: Detroit SW (AQS ID 26-163-0015; 150 Waterman Street), NMH 48217 (AQS ID 26-163-0097; 3225 South Deacon Street), DP4th (AQS ID 26-163-0098; 4700 West Fort Street), Trinity (AQS ID 26-163-0099; 9191 West Fort Street), and Military Park (AQS ID 26-163-0100; 1238 Military Street). Tables 1 and 2 below show the 99th percentile results and three-year average design values, respectively, for the five monitors in the Detroit SO 2 nonattainment area for 2019-2023. The design values for 2019-2021 range from 14-37 ppb, the design values for 2020-2022 range from 16-41 ppb, and the design values for 2021-2023 range from 15-38, which are all below the SO 2 NAAQS. Furthermore, Michigan's redesignation request states that the originally violating monitor, Detroit SW, has shown attainment since 2014, and all other monitors in the nonattainment area have shown attainment since they began monitoring in 2016 and 2018. Documentation of the monitoring data is included as appendix A of Michigan's redesignation request. Therefore, EPA finds that Michigan has demonstrated that the SO 2 monitors in the Detroit area show attainment.

In FR Doc. 2025-13271 of July 16, 2025, the CY 2026 PFS proposed rule (90 FR 32352), there were typographical and technical errors that are identified and corrected in this correcting document.

On page 32352, we inadvertently made a typographical error.

On page 32353, we inadvertently included an incorrect Summary of the Key Provisions.

On page 32386, we inadvertently omitted a potentially misvalued code nomination.

On page 32503, we inadvertently omitted the section titled Outpatient Therapy Services and KX Modifier Thresholds from the proposed rule.

On page 32637, we inadvertently included language related to the transfer of labeler codes.

On page 32671, we inadvertently included an incorrect reference in footnote 323.

On page 32717, we inadvertently made a technical error in the number of proposed substantive changes.

On page 32770, we inadvertently included an incomplete sentence.

On page 32771, we inadvertently included a typographical error.

On page 32776, we inadvertently made a technical error in a table reference.

On page 32777, we inadvertently included language that reflected the standard non-rule PRA process.

On page 32778, we made an inadvertent typographical error in a section reference.

On page 32779, we inadvertently made a typographical error.

On page 32781, we inadvertently omitted text preceding table `Table 82: TABLE 82: Annual Responses Beginning with the CY 2027 Performance Period/2029 MIPS Payment Year Under OMB Control Number 0938-1222 (CMS-10450).

On page 32793, we inadvertently referenced a regulatory citation and made technical errors in Table 87: Proposed Annual Requirements and Burden Estimates.

On page 32799, we inadvertently made two typographical errors.

On page 32801, in Tables 89, 90, and 91, the CY 2026 RVU Budget Neutrality Adjustment we inadvertently made typographical errors in the conversion factors.

On page 32818, we made an inadvertent typographical error in a section reference.

On page 32834, we inadvertently omitted a section heading.

On page 32850, we inadvertently omitted regulation text changes to a definition in § 414.1305 and made formatting and paragraph designation errors in § 414.1380.

On page 32851, we made technical errors in § 414.1400(d)(3)(vi)(A).

On page 33162, under Table DD.2 Colorectal Cancer Screening, we inadvertently made a typographical error in the Substantive Change row.

On page 33183, we inadvertently made a typographical error in omitting the asterisk (*) key after “Symbol Key:”

On page 33208 in Table B.2, we inadvertently omitted quality measure Q144: Oncology: Medical and Radiation, Plan of Care for Pain under the Advancing Cancer Care MVP, the Radiation Oncology Clinical Grouping.

On page 33219, we made inadvertent errors in the list of Improvement Activities included in the Coordinating Stroke Care to Promote Prevention and Cultivate Positive Outcomes MVP.

On page 33255, we inadvertently repeated several paragraphs.

Under section 553(b) of the Administrative Procedure Act (the APA) (5 U.S.C. 553(b)), the agency is required to publish a notice of proposed rulemaking in the Federal Register before the provisions of a rule take effect. Similarly, section 1871(b)(1) of the Social Security Act (the Act) requires the Secretary to provide for notice of the proposed rule in the Federal Register and provide a period of not less than 60 days for public comment. Section 553(b)(B) of the APA provides for exceptions from the APA notice and comment requirements; in cases in which these exceptions apply, section 1871(b)(2)(C) of the Act provides exceptions from the notice and 60-day comment period requirements of the Act as well. Section 553(b)(B) of the APA and section 1871(b)(2)(C) of the Act authorize an agency to dispense with normal notice and comment rulemaking procedures for good cause if the agency makes a finding that the notice and comment process is impracticable, unnecessary, or contrary to the public interest, and includes a statement of the finding and the reasons for it in the rule. In our view, this correcting document does not constitute a rulemaking that would be subject to these requirements. The corrections made through this correcting document are intended to resolve inadvertent errors so that the CY 2026 PFS proposed rule accurately reflects the policies proposed therein.

In addition, even if this were a rulemaking to which the notice and comment requirements applied, we find that there is good cause to waive such requirements. The 60-day comment period referenced in section 1871(b)(1) of the Act may be shortened, as provided under section 1871(b)(2)(C) of the Act, when the Secretary finds good cause that a 60-day comment period would be impracticable, unnecessary, or contrary to the public interest and incorporates a statement of the finding and its reasons in the rule issued. For this proposed rule correcting document, we are waiving the 60-day comment period for good cause and allowing a comment period that coincides with the comment period provided for the CY 2026 PFS proposed rule. Undertaking further notice and comment procedures to incorporate the corrections in this document into the CY 2026 PFS proposed rule would be contrary to the public interest because a full 60-day comment period would end on a date that would not allow the agency sufficient time to process the comments and respond to them in a meaningful manner by the November 1, 2025 date for issuing the final rule. If we allowed for a full 60-day comment period, timely filed comments would receive a shorter period of time for consideration by the agency, and the agency would be left with insufficient time to properly respond to comments and appropriately resolve whether any of the proposed policies should be modified in light of comments received. For all of these reasons, we find good cause to waive the 60-day comment period for this proposed rule correcting document, and we are instead providing for a comment period that coincides with the comment period provided for the CY 2026 PFS proposed rule that appeared in the July 16, 2025 Federal Register .

In FR Doc. 2025-13271 of July 16, 2025 (90 FR 32352), make the following corrections:

On page 32352, first column, first full paragraph, line 21, the phrase “Qualified Health Centers update to the” is corrected to read “Qualified Health Centers; update to the”.

2. On page 32353, third column, nineth bulleted paragraph, the phrase “Access to Behavioral Health Services (section II.I.) ” is corrected to read “Policies to Improve Care for Chronic Illness and Behavioral Health Needs (section II.I.)”.

3. On page 32386, third column, following the first full paragraph, the text is corrected by adding the following:

For CY 2026, an interested party re-nominated CPT code 95800 ( Sleep study, unattended, simultaneous recording; heart rate, oxygen saturation, respiratory analysis (e.g., by airflow or peripheral arterial tone, and sleep time ). This code was recently nominated two times as potentially misvalued in the CY 2024 PFS proposed rule (88 FR 52283 through 52284) and the CY 2025 PFS proposed rule (89 FR 61618 through 61619).

For the CY 2024 and CY 2025 PFS final rules, we stated that we were unable to properly assess whether CPT code 95800 is potentially misvalued and further stated that we could not identify whether disposable or reusable home sleep apnea testing (HSAT) devices are more commonly used based on the evidence submitted with the original nominations and subsequent comments that CMS received. To confirm whether disposable devices were more commonly used, the nominator commissioned a consulting group to conduct an independent survey of sleep medicine providers, developed with input from the American Academy of Sleep Medicine (AASM), which found that 60 percent of procedures reported with CPT code 95800 used fully disposable HSAT equipment among respondents who reported this service in 2023.

The nominator stated that CPT code 95800 is misvalued because there has been a fundamental shift in clinical practice from reusable equipment to disposable HSAT devices, but the current direct practice expense (PE) inputs still reflect the older reusable technology assumptions. The nominator stated that CMS currently models' payment for CPT code 95800 based on the use of a reusable sleep testing device (the WatchPAT 200) with a consumable component (WatchPAT probe), but the survey data demonstrates that the majority of procedures now use fully disposable devices like the WatchPAT ONE. According to the nominator, this misalignment between current medical practice and the direct PE inputs has resulted in inaccurate direct practice expenses for CPT code 95800 and created access challenges for Medicare beneficiaries, particularly in rural and remote areas, since the payment structure does not accurately reflect the actual costs and technologies used in contemporary sleep study practices. The nominator recommended deleting the current equipment codes for reusable devices and adding a new supply code for the disposable WatchPAT ONE device to ensure that Medicare reimbursement rates align with the “typical procedure” methodology that now involves disposable rather than reusable equipment. For more details, we refer to the CY 2025 PFS final rule (89 FR 97741 through 97743). Also, we refer readers to the submitted nomination, which is posted in the public use files for this proposed rule available on our public website under PFS Federal Regulation Notices at https://www.cms.gov/medicare/payment/fee-schedules/physician/federal-regulation-notices.

While we appreciate the survey, we note that there are several limitations that can influence the survey's generalizability, validity, and reliability. Some key limitations include a small sample of 25 complete responses with a low 12 percent survey engagement rate, and methodological constraints such as the short 17-day survey period.

Given that we only have access to the nominator's summary of their internal data and survey results with a few notable limitations, we propose to maintain the current direct PE supply and equipment inputs for CPT code 95800. We are not proposing to nominate the code as potentially misvalued. We welcome public comments, published studies, other surveys, and data on whether the typical procedure described by CPT code 95800 now involves the use of a disposable HSAT device rather than reusable equipment.”.

4. On page 32503, first column before the first paragraph, the language is corrected by adding the following:

In the CY 2009 PFS final rule (73 FR 69874 through 69875) we finalized the addition of a new paragraph at § 410.62(c) for the services of speech-language pathologists (SLPs) in private practice (SLPPPs) allowed through the amendments in section 143 of the Medicare Improvement for Patients and Providers Act of 2008 (MIPPA); and, we also finalized a new condition of payment at § 410.62(a)(3)(ii) requiring these SLPPPs to meet the qualifications of SLPs at 42 CFR part 484 that is specified in the basic rule for outpatient speech-language pathology services at § 410.62(a).

During a recent review of our regulations at §§ 410.62, we noticed an error in § 410.62(a). That is, the basic rule at § 410.62(a) does not correctly reflect the policy that for Medicare Part B to pay for outpatient speech-language pathology services, those services are required to be delivered only by SLPs—including the SLPPPs specified at paragraph (a)(3)(ii)—meeting the requirements for an SLP at § 484.115. Instead, § 410.62(a) states that “Except as specified in paragraph (a)(3)(ii) of this section” rather than paragraph (a)(3)(iii) which was paragraph (a)(3)(ii) before being repositioned to paragraph (a)(3)(iii) when the condition of payment was added for the services of SLPPPs. We inadvertently did not update the exception paragraph during CY 2009 PFS rulemaking to reflect the correct policy under which the individual furnishing services incident to the services of physicians, physician assistants (PAs), clinical nurse specialists (CNSs), or nurse practitioner (NPs) does not have to meet the state licensure requirement at § 484.115 (although they are required to meet the other standards and conditions that apply to SLPs). Therefore, we propose to revise § 410.62(a) to reflect the policy related to qualifications for individuals furnishing services incident to the services of physicians, PAs, CNSs, and NPs by correctly referencing paragraph (a)(3)(iii) in place of paragraph (a)(3)(ii). We are also proposing to make a conforming regulatory change at § 410.26(c)(2) to refer readers to § 410.62(a)(3)(iii) instead of § 410.62(a)(3)(ii) for the correct policy related to the qualifications for individuals providing speech-language pathology services furnished incident to the services of physicians, PAs, CNSs, and NPs.

The KX modifier thresholds were established through section 50202 of the Bipartisan Budget Act of 2018 (Pub. L. 115-123, February 9, 2018) (BBA) and were formerly referred to as the therapy cap amounts. These per-beneficiary amounts under section 1833(g) of the Act (as amended by section 4541 of the Balanced Budget Act of 1997) (Pub. L. 105-33, August 5, 1997) are updated each year based on the percentage increase in the Medicare Economic Index (MEI). Specifically, these amounts are calculated by updating the previous year's amount by the percentage increase in the MEI for the upcoming calendar year and rounding to the nearest $10.00. Thus, for CY 2026, we propose to increase the CY 2025 KX modifier threshold amount by the most recent forecast of the 2017-based MEI. For CY 2026, the proposed MEI increase is estimated to be 2.7 percent and is based on the expected historical percentage increase of the 2017-based MEI. Multiplying the CY 2025 KX modifier threshold amount of $2,410 by the proposed CY 2026 percentage increase in the MEI of 2.7 percent ($2,410 x 1.027) and rounding to the nearest $10.00 results in a proposed CY 2026 KX modifier threshold amount of $2,480 for physical therapy and speech-language pathology services combined and $2,480 for occupational therapy services. We also propose to update the MEI increase for CY 2026 based on historical data through the second quarter of 2025, and we propose to use such data, if appropriate, to determine the final MEI percentage increase and the CY 2026 KX modifier threshold amounts in the CY 2026 PFS final rule.

Section 1833(g)(7)(B) of the Act describes the targeted medical review (MR) process for services of physical therapy, speech-language pathology, and occupational therapy services. The threshold for targeted MR is $3,000 through CY 2027. Effective beginning with CY 2028, the MR threshold levels will be annually updated by the percentage increase in the MEI, per section 1833(g)(7)(B) of the Act. Consequently, for CY 2026, the MR threshold is $3,000 for physical therapy and speech-language pathology services combined and $3,000 for occupational therapy services. Section 1833(g)(5)(E) of the Act states that CMS shall identify and conduct targeted medical review using factors that may include the following:

• The therapy provider has had a high claims denial percentage for therapy services under this part or is less compliant with applicable requirements under this title.

• The therapy provider has a billing pattern for therapy services under this part that is aberrant compared to peers or otherwise has questionable billing practices for such services, such as billing medically unlikely units of services in a day.

• The therapy provider is newly enrolled under this title or has not previously furnished therapy services under this part.

• The services are furnished to treat a type of medical condition.

• The therapy provider is part of a group that includes another therapy provider identified using the factors described previously in this section.

We track each beneficiary's incurred expenses for therapy services annually and count them towards the KX modifier and MR thresholds by applying the PFS rate for each service less any applicable multiple procedure payment reduction (MPPR) amount for services of CMS-designated “always therapy” services (see the CY 2011 PFS final rule at 75 FR 73236). We also track therapy services furnished by critical access hospitals (CAHs), applying the same PFS-rate accrual process, even though they are not paid for their therapy services under the PFS and may be paid on a cost basis (effective January 1, 2014) (see the CY 2014 PFS final rule at 78 FR 74406 through 74410).

When the beneficiary's incurred expenses for the year for outpatient therapy services exceed one or both of the KX modifier thresholds, therapy suppliers and providers use the KX modifier on claims for subsequent medically necessary services. Using the KX modifier, the therapist and therapy provider attest that the services above the KX modifier thresholds are reasonable and necessary and that documentation of the medical necessity for the services is in the beneficiary's medical record. Claims for outpatient therapy services exceeding the KX modifier thresholds without the KX modifier included are denied.”.

5. On page 32637, second column, first partial paragraph, lines 10 through 12, the phrase “information (see also section III.E.2.a. of this proposed rule regarding transfer of labeler codes); and” is corrected to read “information; and”.

6. On page 32671, first column, first footnote paragraph (footnote 323), line 1 through 5, the sentence “Refer to Executive Order 14192 “Unleashing Prosperity Through Deregulation” https://www.federalregister.gov/documents/2025/02/06/2025-02345/unleashing-prosperity-through-deregulation” is corrected to read “See discussion on use of our authority under section 1899(i)(3) of the Act, at 87 FR 69950.”.

7. On page 32717,

a. Second column, last paragraph, line 3, the phrase “42 MIPS quality measures.” is corrected to read “32 MIPS quality measures.”.

b. Third column, third bulleted paragraph, line 1, the phrase “42 MIPS” is corrected to read “32 MIPS”.

8. On page 32770, lower two-thirds of the page, second column, first partial paragraph, last line, the sentence “In the 414.1425(d).” is corrected by removing the sentence.

9. On page 32771, first column, last partial paragraph, lines 1 and 2, the phrase “a conforming revision at §  414.1425(c)(3)(i)” is corrected to read “conforming revisions at § 414.1425(c)(3)(i) and (4)”.

10. On page 32776, third column, third full paragraph, line 1, the reference “Table 73” is corrected to read “Table 74”.

11. On page 32777, upper half of the page, first column, first paragraph, lines 1 through 14, the sentences “Pending our finalization of the following proposed provisions, the changes will submitted to OMB for review and approval under control number 0938-0921 (CMS-10110) using the standard PRA process. The process includes the publication of 60- and 30-day Federal Register notices that will provide the public with additional opportunities to review and comment on the changes. The following proposed changes will be submitted to OMB for review under control number 0938-0921 (CMS-10110).” are corrected to read “The following proposed changes will be submitted to OMB for review under control number 0938-0921 (CMS-10110).”.

12. On page 32778, lower third of the page, first column, last paragraph, line 8, the reference “section VII.E.” is corrected to read “section VII.”.

13. On page 32779, third column, partial paragraph, line 44, the phrase “component” is corrected to read “component”.

14. On page 32781, middle of the page, after the table notes for TABLE 81 and before the table titled “TABLE 82: ANNUAL RESPONSES BEGINNING WITH THE CY 2027 PERFORMANCE PERIOD/2029 MIPS PAYMENT YEAR UNDER OMB CONTROL NUMBER 0938-1222 (CMS-10450)” the language is corrected by adding the following:

“For the Consumer Assessment of Healthcare Providers and Systems (CAHPS) for MIPS Survey ICRs under OMB control number 0938-1222 (CMS-10450) (see section V.B.5.b.(1) of this proposed rule), we estimate that the policy proposals in this proposed rule would result in an annual change of 0 responses, +10 hours, and +$1,077 (see total of Total Change in Tables 82, 83, and 84, respectively), beginning with the CY 2027 performance period/2029 MIPS payment year.”.

15. On page 32793, lower half of the page, in the table titled “TABLE 87: PROPOSED ANNUAL REQUIREMENTS AND BURDEN ESTIMATES”, the sixth and seventh rows are corrected to read as follows:

16. On page 32799,

a. Second column, last full paragraph, line 1, the reference “section III.H.” is corrected to read “section III.G.”.

b. Third column, third full paragraph, line 4, the phrase “ased on our” is corrected to read “Based on our”.

17. On page 32801,

a. Top half of the page in the table titled “TABLE 89: CALCULATION OF THE CY 2026 PFS NON-QUALIFYING APM CONVERSION FACTOR, THE CY 2026 RVU BUDGET NEUTRALITY ADJUSTMENT”, third row, second column the entry “0.55 percent (1.0045)” is corrected to read “0.55 percent (1.0055)”.

b. Middle of the page, in the table titled “TABLE 90: CALCULATION OF THE CY 2026 ANESTHESIA QUALIFYING APM CONVERSION FACTOR, THE CY 2026 RVU BUDGET NEUTRALITY ADJUSTMENT third row, second column the entry “0.55 percent (1.0045)” is corrected to read “0.55 percent (1.0055)”.

c. Lower one-half of the page, in the table titled “TABLE 91: CALCULATION OF THE CY 2026 ANESTHESIA NON-QUALIFYING APM CONVERSION FACTOR, THE CY 2026 RVU BUDGET NEUTRALITY ADJUSTMENT” third row, second column the entry “0.55 percent (1.0045)” is corrected to read “0.55 percent (1.0055)”.

18. On page 32818, first column, last partial paragraph, line 1, the reference “section III.H.” is corrected to read “section III.G.”.

19. On page 32834, second column, first full paragraph, line 1, the phrase “In our MIPs eligible clinician” is corrected to read as follows:

“f. Assumptions & Limitations

In our MIPS eligible clinician”.

Executive Summary

Why we need to publish a rule. Under the Act, a species warrants listing if it meets the definition of an endangered species (in danger of extinction throughout all or a significant portion of its range) or a threatened species (likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range). If we determine that a species warrants listing, we must list the species promptly and designate the species' critical habitat to the maximum extent prudent and determinable. We have determined that the Borneo earless monitor meets the Act's definition of a threatened species; therefore, we are proposing to list it as such. Listing a species as an endangered or threatened species can be completed only by issuing a rule through the Administrative Procedure Act rulemaking process (5 U.S.C. 551 et seq. ).

What this document does. We propose to list the Borneo earless monitor as a threatened species with a species-specific protective regulation under section 4(d) of the Act.

The basis for our action. Under the Act, we may determine that a species is an endangered or threatened species because of any of five 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. We have determined that the Borneo earless monitor meets the Act's definition of a threatened species due primarily to the threats of overcollection and illegal trade for the pet trade, deforestation, and the inadequacy of existing regulatory mechanisms.

We intend that any final action resulting from this proposed rule will be based on the best scientific and commercial data available and be as accurate and as effective as possible. Therefore, we request comments or information from other governmental agencies, Native American Tribes, the scientific community, industry, or any other interested parties concerning this proposed rule. We particularly seek comments concerning:

(1) The species' biology, range, and population trends, including:

(a) Biological or ecological requirements of the species, including habitat requirements for feeding, breeding, and sheltering;

(b) Genetics and taxonomy;

(c) Historical and current range, including distribution patterns and the locations of any additional populations of this species;

(d) Historical and current population levels, and current and projected trends; and

(e) Past and ongoing conservation measures for the species, its habitat, or both.

(2) Threats and conservation actions affecting the species, including:

(a) Factors that may be affecting the continued existence of the species, which may include habitat destruction, modification, or curtailment; overutilization; disease; predation; the inadequacy of existing regulatory mechanisms; or other natural or manmade factors;

(b) Biological, commercial trade, or other relevant data concerning any threats (or lack thereof) to this species; and

(c) Existing regulations or conservation actions that may be addressing threats to this species.

(3) Additional information concerning the historical and current status of this species.

(4) Information to assist us with applying or issuing protective regulations under section 4(d) of the Act that may be necessary and advisable to provide for the conservation of the Borneo earless monitor. In particular, we seek information concerning:

(a) The extent to which we should include any of the Act's section 9 prohibitions in the 4(d) rule;

(b) Whether we should consider any additional or different exceptions from the prohibitions in the 4(d) rule; and

(c) Information on impacts (conservation and economic) associated with implementing the 4(d) rule.

Please include any supplemental information with your submission (such as scientific journal articles or other publications) to allow us to verify any scientific or commercial information you include.

Please note that submissions merely stating support for, or opposition to, the action under consideration without providing supporting information, although noted, do not provide substantial information necessary to support a determination, as section 4(b)(1)(A) of the Act directs that determinations as to whether any species is an endangered or a threatened species must be made solely on the basis of the best scientific and commercial data available.

You may submit your comments and materials concerning this proposed rule by one of the methods listed in ADDRESSES . We request that you send comments only by the methods described in ADDRESSES .

If you submit information via https://www.regulations.gov, your entire submission—including any personal identifying information—will be posted on the website. If your submission is made via a hardcopy that includes personal identifying information, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so. We will post all hardcopy submissions on https://www.regulations.gov.

Comments and materials we receive, as well as supporting documentation we used in preparing this proposed rule, will be available for public inspection on https://www.regulations.gov.

Our final determination may differ from this proposal because we will consider all comments we receive during the comment period as well as any information that may become available after this proposal. Based on the new information we receive (and, if relevant, any comments on that new information), we may conclude that the species is endangered instead of threatened, or we may conclude that the species does not warrant listing as either an endangered species or a threatened species. In addition, we may change the parameters of the prohibitions or the exceptions to those prohibitions in the protective regulations issued under section 4(d) of the Act if we conclude it is appropriate in light of comments and new information received. For example, we may expand the prohibitions if we conclude that the protective regulation as a whole, including those additional prohibitions, is necessary and advisable to provide for the conservation of the species. Conversely, we may establish additional or different exceptions to the prohibitions in the final rule if we conclude that the activities would facilitate or are compatible with the conservation and recovery of the species. In our final rule, we will clearly explain our rationale and the basis for our final decision, including why we made changes, if any, that differ from this proposal.

Section 4(b)(5) of the Act provides for a public hearing on this proposal, if requested. Requests must be received by the date specified in DATES . Such requests must be sent to the address shown in FOR FURTHER INFORMATION CONTACT . We will schedule a public hearing on this proposal, if requested, and announce the date, time, and place of the hearing, as well as how to obtain reasonable accommodations, in the Federal Register at least 15 days before the hearing. We may hold the public hearing in person or virtually via webinar. We will announce any public hearing on our website, in addition to the Federal Register . The use of virtual public hearings is consistent with our regulations at 50 CFR 424.16(c)(3).

On November 2, 2022, we received a petition from the Center for Biological Diversity to list the Borneo earless monitor as an endangered species under the Act (16 U.S.C. 1531 et seq. ). On August 17, 2023, we published in the Federal Register (88 FR 55991) a 90-day finding that the petition presented substantial scientific and commercial information indicating that the petitioned action may be warranted. This 90-day finding notice initiated a status review for the Borneo earless monitor.

A species status assessment (SSA) team prepared an SSA report for the Borneo earless monitor. The SSA team was composed of Service biologists, in consultation with other species 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.

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 in listing and recovery actions under the Act ( https://www.fws.gov/sites/default/files/documents/peer-review-policy-directors-memo-2016-08-22.pdf ), we solicited independent scientific review of the information contained in the Borneo earless monitor SSA report. We sent the SSA report to three independent peer reviewers and received two responses. The peer reviews can be found at https://www.regulations.gov at Docket No. FWS-HQ-ES-2025-0110. In preparing this proposed rule, we incorporated the results of these reviews, as appropriate, into the SSA report, which is the foundation for this proposed rule.

As discussed in Peer Review above, we received comments from two peer reviewers on the draft SSA report. We reviewed all comments we received from the peer reviewers for substantive issues and new information regarding the contents of the SSA report. The peer reviewers generally concurred with our methods and conclusions, and provided additional references, clarifications, suggestions, and information on the species' reproductive biology, occurrence records, and presence in both international and domestic wildlife trade. No substantive changes to our analysis and conclusions within the SSA report were deemed necessary, and peer reviewer comments are addressed in version 1.0 of the SSA report (Service 2025, entire).

The Borneo earless monitor ( Lanthanotus borneensis; hereafter “earless monitor”) is a lizard species that is endemic to the island of Borneo in Southeast Asia (Das and Auliya 2021, p. 2) and occurs in all three of Borneo's range states: Malaysia, Indonesia, and Brunei Darussalam (Service 2025, p. 3). The species is the only extant member of the monotypic family, Lanthanotidae (Steindachner 1877, p. 160). It is distinguished by a long, brown body covered in six longitudinal rows of keeled scales and several morphological features that make it well adapted for subterranean and semi-aquatic lifestyles, including short limbs, sharp claws, a prehensile tail, small eyes with a translucent lower eyelid, small dorsal nostrils, and no external ear opening (Steindachner 1877, p. 160; McDowell and Bogert 1954, pp. 9-10; Nijman and Stoner 2014, p. 6).

There is limited information available that describes the species' life-history and habitat requirements. Earless monitors are rarely encountered in the wild because they are nocturnal, fossorial ( i.e., adapted to digging and lives primarily underground), semi-aquatic, and capable of entering a semi-torpid state where they may remain hidden for up to 8 days (Das and Auliya 2021, p. 4; Leah et al. 2023, pp. 510-512). Earless monitors are carnivorous (Rehak et al. 2019, p. 32), and their natural diet is known to include earthworms, shrimp, and fish (Shirawa and Bacchini 2015, p. 15; Langner 2017, p. 7), and may also include tadpoles, small frogs, and insects (Arida et al. 2018, p. 88). The species occupies flat, low-lying tropical forests below 300 meters (m) (984 feet (ft)) in elevation (Stoner and Nijman 2015, p. 55). It is known to occur in areas with shallow freshwater streams that are either rocky or sandy and in areas with a closed canopy (Yaap et al. 2012, p. 3069; Langner 2017, pp. 3-4; Das and Auliya 2021, p. 4; Leah et al. 2023, pp. 510-511).

We are not aware of any published studies that describe the reproductive biology of the earless monitor in the wild; however, the species has successfully reproduced in captivity (Shirawa and Bacchini 2015, pp. 15-18). The species can survive in captivity for up to 7.5 years (Mendyk et al. 2015, p. 46) and reaches sexual maturity at approximately 2 to 3 years of age (Sprackland pers. comm. 2025). Earless monitors are oviparous, meaning they reproduce by laying eggs outside of their body, and produce between 2 and 8 oval, leathery-shelled eggs that measure approximately 30 millimeters in length (Das 2013, p. 533; Voronin and Kudryavtsev 2019, p. 61). Eggs take approximately 62 to 90 days to hatch when incubated at 27 to 31 degrees Celsius (°C) (80.6 to 87.8 degrees Fahrenheit (°F)) (Shirawa and Bacchini 2015, p. 18; Voronin and Kudryavtsev 2019, p. 61; Das and Auliya 2021, p. 4; Sprackland pers. comm. 2025). The total time from fertilization to hatching can exceed six months (Das and Auliya 2021, p. 5).

A thorough review of the taxonomy, life history, and ecology of the earless monitor is presented in the SSA report (version 1.0; Service 2025, pp. 2-8).

Section 4 of the Act (16 U.S.C. 1533) and the implementing regulations in title 50 of the Code of Federal Regulations set forth the procedures for determining whether a species is an endangered species or a threatened species, issuing protective regulations for threatened species, and designating critical habitat for endangered and 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 five 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.

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.

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, which is further described in the 2009 Memorandum Opinion on the foreseeable future from the Department of the Interior, Office of the Solicitor (M-37021, January 16, 2009; “M-Opinion,” available online at https://www.doi.gov/sites/doi.opengov.ibmcloud.com/files/uploads/M-37021.pdf ). The foreseeable future extends as far into the future as the Service can make reasonably reliable predictions about the threats to the species and the species' responses to those threats. We need not identify the foreseeable future in terms of a specific period of time. We will describe the foreseeable future on a case-by-case basis, using the best scientific and commercial data available and taking into account considerations such as the species' life-history characteristics, threat projection timeframes, and environmental variability. In other words, the foreseeable future is the period of time over which we can make reasonably reliable predictions. “Reliable” does not mean “certain”; it means sufficient to provide a reasonable degree of confidence in the prediction, in light of the conservation purposes of the Act.

The SSA report documents the results of our comprehensive biological review of the best scientific and commercial data available regarding the status of the species, including an assessment of the potential threats to the species. The SSA report does not represent our decision on whether the species should be proposed for listing 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.

To assess the earless monitor's viability, we used the three conservation biology principles of resiliency, redundancy, and representation (Shaffer and Stein 2000, pp. 306-310). Briefly, resiliency is the ability of the species to withstand environmental and demographic stochasticity ( e.g., wet or dry, warm or cold years); redundancy is the ability of the species to withstand catastrophic events ( e.g., droughts, large pollution events); and representation is the ability of the species to adapt to both near-term and long-term changes in its physical and biological environment ( e.g., climate conditions, pathogens). In general, species viability will increase with increases in (and decrease with decreases in) resiliency, redundancy, and representation (Smith et al. 2018, p. 306). 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' future condition, including responses to positive and negative environmental and anthropogenic influences. Throughout each of these stages, we used the best scientific and commercial data available to characterize viability as the ability of a species to sustain populations in the wild over time, which we then used to inform our regulatory decision.

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-HQ-ES-2025-0110 on https://www.regulations.gov.

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.

Based on the species' biology described above and in the SSA report (version 1.0; Service 2025, pp. 2-8), the earless monitor requires clear flowing freshwater streams with adequate invertebrate food resources; intact, connected lowland forest habitats with a closed canopy; and sufficient conspecific individuals to reproduce with and sustain a population. Due to the limited data available, our assessment of species-level needs is developed further based on general principles as they apply to lizard biology.

Earless monitors are protected in all three of their range states (Malaysia, Indonesia, and Brunei Darussalam). It is illegal to remove the species from the wild without a permit. “Wild” includes specimens taken from the wild and held in captivity, specimens born in captivity where the parents mated in the wild (such as from fertilized eggs or gravid females collected from the wild), and any specimens for which there is insufficient evidence that the specimen meets the requirements for bred in captivity under the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) Resolution 10.16 (Rev. CoP19). However, with a permit, it is legal to export individuals bred in captivity, identified using CITES source code C (50 CFR part 23; Service 2025, pp. 9-10). Only one registered captive-breeding facility in Indonesia is permitted to legally harvest earless monitors from the wild to be used as breeding stock. These wild-caught individuals cannot be offered for sale, and only individuals sourced from an F2 generation ( i.e., the second generation of offspring resulting from breeding of wild-caught individuals) or subsequent generation may be legally exported (Service 2025, p. 9). The Indonesian government regulates captive breeding of their native reptiles through a captive-breeding production plan, which calculates a quota of animals allowed to be produced by registered captive-breeding facilities and exported with a permit (Janssen and Chng 2018, p. 19). The captive-breeding quota for earless monitors allows for the legal exportation of 20 individuals from Indonesia on an annual basis (Janssen and Chng 2018, p. 22).

Malaysia, Indonesia, and Brunei Darussalam are all parties to CITES, and the trade of CITES-listed wildlife from all three range states is internationally monitored and regulated (Nijman and Stoner 2014, p. 8). Earless monitors were included in Appendix II of CITES in 2016—a measure that regulates, but does not ban, international trade (Nijman 2021, p. 71). International trade to, from, or through the U.S. in Appendix-II specimens must meet all applicable requirements under U.S. CITES implementing regulations (50 CFR part 23), wildlife import/export requirements (50 CFR part 14), and general permitting requirements (50 CFR part 13).

While there are several protected areas within northwestern Borneo, the majority protect high-elevation areas (above 300 m (984 ft)) where earless monitors have not been observed (Service 2025, pp. 10-11). Illegal logging also occurs within many of the protected areas that overlap the earless monitor's known range (Service 2025, p. 12), so it is unlikely that these areas offer the species reliable protection.

Rare species with unique taxonomic status are more valuable on the international pet market (Altherr and Lameter 2020, p. 6), and consequently, there is a significant demand for earless monitors in international trade (Arida et al. 2018, p. 83). Shortly after earless monitors were first discovered in Indonesia, individuals were offered for sale online for as much as $20,000 (Sprackland pers. comm. 2025). However, current prices have dropped to approximately $2,500 ( coldbloodedshop.com , accessed March 12, 2025). The financial reward of successfully smuggling earless monitors out of Borneo likely outweighs the risk of getting caught (Nijman and Stoner 2014, p. 12), incentivizing the illegal smuggling of wild-caught earless monitors into the international market.

While earless monitors have legal protection in all three of their range states (see Conservation Efforts and Regulatory Mechanisms, above), wildlife conservation laws in Indonesia are rarely enforced (Shepherd et al. 2004, as cited in Eaton et al. 2015, p. 8), and illegal trade of protected species often goes unpunished (Natusch and Lyons 2012, p. 2902). Wildlife traffickers use a variety of methods to illegally smuggle earless monitors out of Borneo, such as deliberately concealing them on their bodies, or falsifying the contents of luggage or international shipments (Baderan et al. 2023, p. 156). At least 12 thwarted smuggling attempts between October 2015 and March 2024 resulted in the seizure of 101 earless monitors (Baderan et al. 2023, p. 156; Shepherd 2023, p. 1; Shepherd and Shepherd 2024, p. 1). Smuggling earless monitors out of Borneo carries considerable risk because there is more direct culpability when caught, and earless monitors may die along the way due to the stressful and inhumane conditions they experience (Shepherd 2023, p. 1).

At least 695 earless monitors have been taken from the wild in Indonesia since the species was first discovered there in 2008 (Yaap et al. 2012, p. 3069). This estimate includes earless monitors seized from smugglers (Baderan et al. 2023, p. 156; Shepherd 2023, p. 1; Shepherd and Shepherd 2024, p. 1), offered for sale online (Stoner and Nijman 2015, pp. 55-56; Janssen and Krishnasamy 2018, pp. 3-4), offered for sale in pet shops (Janssen 2018, p. 86), reported in trade databases (Service 2025, pp. 34-35), circulated within Indonesia's domestic wildlife trade (Nijman pers. comm. 2024), or on exhibit at zoos (Rehak et al. 2019, pp. 30-40, Nijman 2021, pp. 73-74). This number is likely a low estimate because it does not account for individuals that were involved in private transactions or that died along the trade route.

Primary forests in Borneo are quickly declining due to intensive logging, fire, and conversion to agricultural plantations (Gaveau et al. 2014, p. 1). Between 1973 and 2015, approximately 50 percent of the forests in Borneo were cut down and converted to oil palm and other industries (Gaveau et al. 2016, pp. 3-4). All three of the earless monitor's range states experienced major deforestation during this 42-year period: Kalimantan, Indonesia; Sarawak, Malaysia; and Brunei Darussalam lost 35, 26, and 10 percent of their forest area, respectively (Gaveau et al. 2016, pp. 3-4). While rates of forest loss have slowed in the past decade, Borneo has continued to lose an annual average of 248,000 hectares of primary forest since 2015 (Service 2025, p. 16). If similar historical deforestation trends continue, only approximately 33 percent of Borneo's tropical forests are projected to remain by 2050 (Trancoso et al. 2022, pp. 6-7), the majority of which will occur in high-elevation areas (above 300 m (984 ft)) that the earless monitor likely does not occupy (Trancoso et al. 2022, p. 7). While the earless monitor's range may be wider than what is currently known (Das pers. comm. 2019, as cited in Das and Auliya 2021, p. 2; Sprackland pers. comm. 2025), any potentially undiscovered subpopulations are likely vulnerable to deforestation because it is a pervasive threat throughout Borneo's low-elevation areas (below 300 m (984 ft)) (Gaveau et al. 2014, p. 5; Service 2025, pp. 16-19), and it directly diminishes many specific habitat features upon which earless monitors are dependent.

Earless monitors rely on low-elevation tropical rainforests with a closed canopy and access to freshwater streams (see Background, above). Extensive canopy cover contributes to high rates of evapotranspiration that help maintain a lower air temperature (Bonan 2008, pp. 1444-1445). Deforestation reduces canopy cover (Gorte and Sheikh 2010, p. 3), which results in an average temperature increase of 1.7 degrees Celsius (°C) (3.1 degrees Fahrenheit (°F)), and an increased frequency of extreme temperatures (>31 °C (87.8 °F)) in deforested areas (McAlpine et al. 2018, p. 7). Many reptile species likely cannot withstand an average temperature increase of 2 °C (3.6 °F) (Johnson 2012, p. 71), and because fossorial lizards are especially vulnerable to deforestation (Theisinger and Ratinarivo 2015, p. 278), temperature increases alone may render deforested areas unsuitable for earless monitors. Deforestation also reduces daily precipitation (McAlpine et al. 2018, pp. 5-7) and contributes to stream channel narrowing, which diminishes the pollution processing capabilities of stream habitats (Sweeney et al. 2004, p. 14134). In addition, forests that are converted to oil palm plantations are often cleared with slash-and-burn agriculture (Dhandapani and Evers 2020, p. 4), a method that causes riparian areas to quickly lose tree root systems that stabilize stream banks and prevent erosion (Iwata et al. 2003, pp. 468-471). Erosion directly increases the amount of fine substrate in the stream bed, which diminishes abundance and biodiversity of their benthic assemblages ( i.e., groups of organisms that live on the bottom sediments of a water body; Iwata et al. 2003, pp. 468-470). These conditions likely reduce food availability for earless monitors because they feed on invertebrates that are present in benthic assemblages, such as worms and crustaceans (see Background, above). These invertebrates are likely further diminished by the use of insecticides on oil palm plantations, which are commonly applied to crops (Dearlove et al. 2024, p. 2). Insecticide use in Indonesia increased by approximately 700 percent from 1990 to 2021 (Ritchie et al. 2022, unpaginated), a rise that is likely correlated with the expansion of oil palm plantations in the country. Insecticides are most commonly detected in soil and water (Dearlove et al. 2024, p. 9) and therefore likely cause the mortality of many invertebrates that earless monitors eat.

Nevertheless, the earless monitor may tolerate some limited anthropogenic disturbance. In the 1960s, several specimens were collected from flat coastal areas, some of which were long-cultivated and included rice farms (Harrisson 1963, p. 407). The majority of published 21st century encounters with the species occurred in forests adjacent to human-modified areas, such as oil palm plantations, agricultural fields, and logging camps (Yaap et al. 2012, pp. 3069-3070; Langner 2017, pp. 3-4; Leah et al. 2023, p. 510). Collectively, these published encounters provide evidence that earless monitors are capable of persisting both within and adjacent to human-modified habitats. However, the edge effects ( e.g., increased temperature, increased wind exposure, reduced moisture, etc.) resulting from oil palm establishment extend over 300 m (984 ft) into adjacent forests (Nunes et al. 2021, pp. 5-6), and because over 60 percent of the known earless monitor subpopulations that were historically found near agricultural areas within coastal Sarawak are now considered extirpated (Das and Auliya 2021, pp. 2-4), it is probable that earless monitors were simply persisting near these human-modified areas, and the species is not capable of sustaining populations adjacent to these areas over the long-term.

Earless monitors persisting in diminished habitats adjacent to anthropogenic disturbance are vulnerable to the increased risk of fire associated with these habitats. Deforestation and the subsequent conversion of cleared forest to oil palm plantations increase fire risk (Trancoso et al. 2022, p. 13; Dhandapani and Evers 2020, pp. 3-4), and Borneo has recently experienced an increase in forest fires as a consequence of deforestation (Gaveau et al. 2018, p. 3). Deforestation increases temperature extremes (Trancoso et al. 2022, p. 2; McAlpine et al. 2018, p. 7), and the subsequent conversion of deforested areas to oil palm plantations exacerbates local fire risk because oil palms use more water, lowering the water table and leaving behind highly flammable fuel (Dhandapani and Evers 2020, pp. 3-4). Even selective logging—a practice that is pervasive throughout much of the earless monitor's known range (Service 2025, p. 19)—increases fire risk (Langner et al. 2007, p. 2338).

The Intergovernmental Panel on Climate Change predicts that continued greenhouse gas emissions will likely increase global temperatures to 1.5 °C (2.7 °F) above pre-industrial levels by 2040, even under low-emissions scenarios (Lee et al. 2023, p. 12). In addition, the cumulative effects of deforestation and climate change are projected to increase the average temperature of low-elevation (below 500 m (1640 ft)) areas in Borneo by 3.5 °C (6.3 °F) by the end of the 21st century (Davies-Barnard et al. 2023, p. 4). Reptiles are more susceptible to temperature increases than other taxa due to their limited dispersal ability and reliance on ambient temperature to regulate their body temperature (Root and Schneider 2002, pp. 20-21). Consequently, many species of reptiles may not be able to withstand temperature increases of 2 °C (3.6 °F) (Johnson 2012, p. 73). Fossorial lizards are particularly sensitive to thermoregulatory constraints caused by temperature increases (Theisinger and Ratinarivo 2015, p. 278), so the earless monitor is likely more susceptible to temperature increases than other reptile species, to the extent that increased ambient temperature increases soil temperatures.

Higher temperatures caused by both climate change and deforestation are also expected to exacerbate fire risk in Borneo (Davies-Barnard et al. 2023, p. 8), further contributing to the loss of earless monitor habitat. Climate change is also expected to increase the frequency of extreme rainfall and winds from tropical cyclones in Southeast Asia (Christensen et al. 2007, pp. 885-887). Extreme rainfall has previously caused mass mortality events in earless monitors (Harrisson 1963, pp. 408), so an increase in frequency of extreme weather events is likely to increase the risk of extirpation of earless monitor subpopulations.

We note that by using the SSA framework to guide our analysis of the scientific information documented in the SSA report, we have analyzed the cumulative effects of identified threats and conservation actions on the species. To assess the current and future condition of the species, we evaluate the effects of all the relevant 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.

We describe the current condition of the earless monitor based on the needs of the species and their relation to resiliency, redundancy, and representation. Species with high resiliency are able to withstand environmental, demographic, and genetic stochasticity by having self-sustaining ( i.e., large, high fecundity), connected populations occupying suitable habitat across spatial heterogenous conditions. Resiliency of the earless monitor is primarily influenced by the health of the subpopulations and the extent and connectivity of suitable habitat. While no numerical population data is available to quantitatively assess the status and trends of earless monitors (Das and Auliya 2021, p. 4), we are able to assess the resiliency of the species based on a multitude of factors.

Earless monitors are known from approximately 15 confirmed historical localities, only 5 of which are considered extant (Das and Auliya 2021, pp. 1-2). Unconfirmed reports suggest additional extralimital subpopulations may exist (Das pers. comm. 2019, as cited in Das and Auliya 2021, p. 2; Sprackland pers. comm. 2025). Extant earless monitor subpopulations are likely vulnerable to habitat loss resulting from deforestation, overcollection and illegal trade, and climate change.

Over the past 50 years, the majority of forests in coastal Sarawak have been cleared and subsequently converted to oil palm plantations (Service 2025, p. 17), resulting in the extirpation of earless monitors from these areas (Das and Auliya 2021, p. 2). The cumulative effects of deforestation ( e.g., loss of canopy cover, temperature increases, stream narrowing, sediment alterations, increase in fire risk; see Threats, above) render the remaining habitat largely unsuitable for earless monitors, and deforestation is likely to blame for the extirpation of the species from coastal Sarawak. It is unknown the specific degree of human disturbance earless monitors are capable of tolerating, and it is probable that subpopulations are simply persisting within and adjacent to agricultural areas, rather than successfully thriving there. At a minimum, stream habitats adjacent to deforested areas are hotter, contaminated by insecticides, have diminished pollution processing capabilities, and contain fewer potential food resources (see Threats, above). Yet, some earless monitor encounters in the 21st century have occurred in forests adjacent to agricultural areas ( e.g., Yaap et al. 2012, pp. 3069-3070; Langner 2017, p. 3), and more research is needed to determine if these individuals are successfully reproducing or are simply persisting as a sink population. Earless monitors are also threatened by overcollection and illegal trade for the pet trade, and subpopulations that are targeted by wildlife traffickers cannot adequately replace themselves. Disproportionate exploitation is probable to lead to earless monitors becoming a rarer and more appealing target for wildlife traffickers and may ultimately lead to the extirpation of targeted subpopulations (Janssen and Krishnasamy 2018, p. 2). Overharvesting for the pet trade has caused the extirpation of other reptile subpopulations in the past (Stuart et al. 2006, p. 1137), and earless monitor subpopulations that are targeted by wildlife traffickers are similarly vulnerable. Considering these factors, the earless monitor has low resiliency to adapt to and withstand environmental and demographic stochasticity.

Species with high redundancy are less prone to the negative effects of random, catastrophic, local events because they have many populations that are geographically dispersed over a wide area. The complete range of earless monitors is not known, yet the remaining known extant subpopulations occupy a narrow range (52 square kilometers (20.1 square miles); Das and Auliya 2021, p. 1). Deforestation is removing viable forest habitat throughout the earless monitor's known range, degrading the quality of the remaining habitat and likely isolating remaining earless monitor subpopulations from each other (see Threats, above). In addition, climate change is predicted to increase the frequency of extreme fire and flooding events (Davies-Barnard et al. 2023, p. 8; Christensen et al. 2007, pp. 885-887), which will consequently increase the vulnerability of all earless monitor subpopulations to these threats. We have no information on the size or health of the remaining earless monitor subpopulations; however, we consider them to be vulnerable to deforestation, extreme weather events, and overcollection and illegal trade for the pet trade (see Threats, above). While unconfirmed reports of extralimital encounters with earless monitors suggest the potential existence of additional subpopulations (Das pers. comm. 2019, as cited in Das and Auliya 2021, p. 2; Sprackland pers. comm. 2025), we lack information detailed enough to assess the extent to which these subpopulations support redundancy. Considering the five known subpopulations that occupy a limited range, earless monitors likely have limited redundancy; however, we acknowledge that other subpopulations may exist that would contribute to redundancy to some degree.

Representation is improved in species with high genetic variability, or which inhabit a wide range of ecological settings. Both of these characteristics facilitate adaptation to future environmental changes, whether natural or anthropogenic. On the other hand, representation is reduced in the absence of these characteristics. Earless monitors do not occupy a wide range of ecological settings and are restricted to flat tropical forests at low elevations with access to freshwater streams (see Background, above). There is no available information about the genetic diversity within or between any earless monitor subpopulations, and there is no information on the degree to which the species exhibits behavioral plasticity. Reptiles tend to have a low dispersal ability (Root and Schneider 2002, pp. 20-21), and if the earless monitor's dispersal ability is also low, then there is likely limited gene flow between the remaining extant earless monitor subpopulations. Earless monitors likely have low representation because they are dependent on a specific habitat type, have a limited dispersal ability, and have a small number of known subpopulations that are not dispersed over a wide area (Das and Auliya 2021, p. 1).

Based on our assessment, we concluded that the primary potential threats to the earless monitor are (1) overcollection and illegal trade for the pet trade and (2) habitat loss resulting from deforestation and increasing temperatures, both of which are exacerbated by the inadequacy of existing regulatory mechanisms. Because of the high uncertainty associated with the earless monitor's abundance, geographic range, adaptive capacity, and ability to tolerate anthropogenic disturbance, the foreseeable future by which we can assess the threats to this species—and its response to those threats—is relatively short (10 to 20 years).

We expect the collection and illegal trade of earless monitors for the pet trade to continue into the future. As long as earless monitors retain a high market value in the pet trade, they will continue to be targeted by wildlife traffickers. A species' value in the pet trade is often driven by many traits earless monitors possess, such as unique taxonomic status and rarity in the market (Altherr and Lameter 2020, p. 6). These traits increase the potential for overcollection and illegal trade of wild earless monitors from wild populations, making the species even more rare and more valuable in the pet trade. While legitimate captive-breeding efforts may open another avenue for earless monitors to enter the pet trade without harming wild populations, there is limited evidence for these efforts in range states. Therefore, it is reasonable to assume that future harvesting pressure on earless monitors will, at a minimum, continue at the same level as the current condition, and may increase until legitimately bred in captivity earless monitors help alleviate the demand for wild-caught individuals.

The best available scientific and commercial data suggests that if the current rates of deforestation continue, the majority of Borneo's low-elevation areas will be deforested by 2050 (Trancoso et al. 2022, pp. 6-7), and most of the remaining forests will occur in high-elevation areas that earless monitors do not occupy. Because the remaining known extant earless monitor subpopulations occupy a narrow range, this amount of forest loss would equate to a significant loss of habitat for the species. Furthermore, climate change is projected to increase global temperatures by at least 1.5 °C (2.7 °F) above pre-industrial levels by 2040 (Lee et al. 2023, p. 12), and on Borneo, by 3.5 °C (6.3 °F) in elevations below 500 m by the end of this century (Davies-Barnard et al. 2023, p. 4). Among reptiles, fossorial lizards such as the earless monitor are particularly susceptible to temperature increases (Theisinger and Ratinarivo 2015, p. 278). Given that an increase of 2 °C (3.6 °F) will render much of Borneo's lowlands climatically unsuitable for many native reptile species (Johnson 2012, p. 71). it is likely that earless monitors will be unable to withstand the temperature increases projected within the foreseeable future.

In summary, earless monitors, will continue to face the threats of habitat loss and overcollection and illegal trade for the pet trade, and these threats may increase in the future. Deforestation was a contributing factor in the extirpation of over 60 percent of the historical earless monitor subpopulations (Das and Auliya 2021, p. 1), and it is expected to continue to remove suitable forest habitat, diminish the quality of the remaining forest habitat, increase fire risk, and reduce the connectivity between the remaining known extant earless monitor subpopulations and other unconfirmed subpopulations, affecting viability within the foreseeable future (see Threats, above). In addition, should collection pressure from wildlife traffickers continue or potentially increase as anticipated in the future, overexploitation may lead to the extirpation of targeted subpopulations (Janssen and Krishnasamy 2018, p. 2). Although the earless monitor currently maintains subpopulations, including in disturbed areas, and reportedly occupies additional areas within Borneo, the species' resiliency, redundancy, and representation are likely to decrease within the foreseeable future as they continue to be affected by threats of deforestation and overcollection and illegal trade.

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 an endangered species or a 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 five 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.

After evaluating threats to the species and assessing the cumulative effect of the threats under the factors in section 4(a)(1) of the Act, we determined that ongoing deforestation and overcollection and illegal trade for the international pet trade will likely reduce the viability of the earless monitor within the foreseeable future.

The complete range of the earless monitor is unknown, due in part to the species' cryptic nature and limited number of occurrence records (see Background, above). In the past decade, demand from the international pet trade has driven a renewed effort to locate the species, and because at least 695 individuals have entered the pet trade since 2012 (see Threats, above), the existence of additional subpopulations beyond those that are known is plausible. However, the threat of habitat loss from deforestation and land use change is so pervasive throughout the lowlands of Borneo that any potentially undiscovered subpopulations are likely vulnerable to these threats. The earless monitor's ability to sustain populations long-term in forested habitats adjacent to anthropogenically disturbed areas is likely limited because the majority of historical subpopulations that have occupied similar areas are presumed to be extirpated. Furthermore, we expect many of the negative impacts associated with deforestation ( e.g., increased temperature, increased fire risk, reduced precipitation, etc.) to be exacerbated by climate change (see Threats, above). The projected increase of these threats in the foreseeable future is likely to reduce the species' viability to a point that it lacks sufficient resiliency, representation, and redundancy for its continued existence to be secure.

The threats of ongoing deforestation and overcollection and illegal trade for the international pet trade are further exacerbated by the inadequacy of existing regulatory mechanisms (see Threats, above). Wildlife traffickers are known to illegally smuggle earless monitors out of the wild for international trade (Baderan et al. 2023, p. 156; Baderan et al. 2023, p. 156; Shepherd 2023, p. 1; Shepherd and Shepherd 2024, p. 1).

Thus, after assessing the best scientific and commercial data available, we conclude that the earless monitor is not currently in danger of extinction but is likely to become in danger of extinction within the foreseeable future throughout all of its range due to habitat loss and degradation (Factor A), overcollection and illegal trade for the pet trade (Factor B), and the inadequacy of existing regulatory mechanisms (Factor D).

Under the Act and our implementing regulations, a species may warrant listing if it is in danger of extinction or likely to become so within the foreseeable future throughout all or a significant portion of its range. The court in Center for Biological Diversity v. Everson, 435 F. Supp. 3d 69 (D.D.C. 2020) ( Everson ), vacated the provision of the Final Policy on Interpretation of the Phrase “Significant Portion of Its Range” in the Endangered Species Act's Definitions of “Endangered Species” and “Threatened Species” (hereafter “Final Policy”; 79 FR 37578, July 1, 2014) that provided if the Service and the National Marine Fisheries Service (NMFS) (collectively, “the Services”) determine that a species is threatened throughout all of its range, the Services will not analyze whether the species is endangered in a significant portion of its range.

Therefore, we proceed to evaluating whether the species is endangered in a significant portion of its range—that is, whether there is any portion of the species' range for which both (1) the portion is “significant” and (2) the species is in danger of extinction in that portion. We can choose to address either question first. Regardless of which question we address first, if we reach a negative answer with respect to the first question that we address, we do not need to evaluate the other question for that portion of the species' range.

Following the court's holding in Everson, we now consider whether the species is in danger of extinction throughout a significant portion of its range. In undertaking this analysis for the earless monitor, we choose to address the status question first.

We evaluated the range of the earless monitor to determine if the species is in danger of extinction throughout any portion of its range. The range of a species can theoretically be divided in an infinite number of ways. We focused our analysis on portions of the species' range that may meet the Act's definition of an endangered species. For the earless monitor, we considered whether the threats or their effects on the species are greater in any biologically meaningful portion of the species' range than in other portions such that the species is in danger of extinction in that portion.

We examined the following threats: habitat loss from deforestation and overcollection and illegal trade for the pet trade, including cumulative effects.

Because habitat loss from deforestation and land use change is such a pervasive threat throughout the lowlands of Borneo, its impact is ubiquitous across all portions of the earless monitor's range. Overcollection and illegal trade for the pet trade can occur wherever earless monitor subpopulations are found. Thus, we found no biologically meaningful portion of the earless monitor's range where threats are impacting individuals differently from how they are affecting the species elsewhere in its range such that the status of the species in that portion differs from any other portion of the species' range.

Therefore, no portion of the species' range provides a basis for determining that the species is in danger of extinction in a significant portion of its range, and we determine that the species is likely to become in danger of extinction within the foreseeable future throughout all of its range. This finding does not conflict with the courts' holdings in Desert Survivors v. U.S. Department of the Interior, 321 F. Supp. 3d 1011, 1070-74 (N.D. Cal. 2018) and Center for Biological Diversity v. Jewell, 248 F. Supp. 3d 946, 959 (D. Ariz. 2017) because, in reaching this conclusion, we did not apply the aspects of the Final Policy, including the definition of “significant” that those court decisions held to be invalid.

Based on the best scientific and commercial data available, we determine that the earless monitor meets the Act's definition of a threatened species. Therefore, we propose to list the earless monitor as a threatened species in accordance with sections 3(20) and 4(a)(1) of the Act.

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.

Conservation measures provided to species listed as endangered or threatened species under the Act include recognition as a listed species, planning and implementation of 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, foreign governments, private organizations, and individuals. The Act encourages cooperation with the States and other countries and calls for recovery actions to be carried out for listed species. The protection required by Federal agencies, including the Service, and the prohibitions against certain activities are discussed, in part, below.

Section 7 of the Act, titled “Interagency Cooperation,” mandates all Federal action agencies to use their existing authorities to further the conservation purposes of the Act and to ensure that their actions are not likely to jeopardize the continued existence of listed species or adversely modify critical habitat. Regulations implementing section 7 are codified at 50 CFR part 402.

Section 7(a)(2) states that each Federal action agency shall, in consultation with the Secretary, ensure that any action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a listed species or result in the destruction or adverse modification of designated critical habitat. Each Federal agency shall review its action at the earliest possible time to determine whether it may affect listed species or critical habitat. If a determination is made that the action may affect listed species or critical habitat, formal consultation is required (50 CFR 402.14(a)), unless the Service concurs in writing that the action is not likely to adversely affect listed species or critical habitat. At the end of a formal consultation, the Service issues a biological opinion, containing its determination of whether the Federal action is likely to result in jeopardy or adverse modification.

With respect to the earless monitor, no known actions require consultation under section 7(a)(2) of the Act. Given the regulatory definition of “action” at 50 CFR 402.02, which clarifies that it applies to activities or programs carried out “in the United States or upon the high seas,” the earless monitor is unlikely to be the subject of section 7 consultations because the entire life cycle of the species occurs in terrestrial areas outside of the United States and the species is unlikely to be affected by Federal actions. Additionally, no critical habitat will be designated for the earless monitor because, under 50 CFR 424.12(g), we will not designate critical habitat within foreign countries or in other areas outside of the jurisdiction of the United States.

Section 8(a) of the Act (16 U.S.C. 1537(a)) authorizes the provision of limited financial assistance for the development and management of programs that the Secretary determines to be necessary or useful for the conservation of endangered or threatened species in foreign countries. Sections 8(b) and 8(c) of the Act (16 U.S.C. 1537(b) and (c)) authorize the Secretary to encourage conservation programs for foreign listed species, and to provide assistance for such programs, in the form of personnel and the training of personnel.

Additional requirements apply to activities with the earless monitor, separate from their proposed listing as a threatened species. As a CITES-listed species, all international trade of earless monitors by persons subject to the jurisdiction of the United States must also comply with CITES requirements pursuant to section 9, paragraphs (c) and (g), of the Act (16 U.S.C. 1538(c) and (g)) and to 50 CFR part 23. As “fish or wildlife” (16 U.S.C. 1532(8)), earless monitor imports and exports must also meet applicable wildlife import/export requirements established under section 9, paragraphs (d), (e), and (f), of the Act (16 U.S.C. 1538(d), (e), and (f)); the Lacey Act Amendments of 1981 (16 U.S.C. 3371 et seq. ); and 50 CFR part 14. Questions regarding whether specific activities with the earless monitor would constitute a violation of section 9 of the Act should be directed to the Service's Division of Management Authority ( managementauthority@fws.gov; 703-358-2104). Section 9(a) of the Act provides a specific list of prohibitions for endangered species but does not provide these same prohibitions for threatened species. Instead, pursuant to section 4(d) of the Act, for any species listed as a threatened species, the Secretary must issue protective regulations that are “necessary and advisable to provide for the conservation of such species” (these are referred to as “4(d) rules”). Additional measures for the earless monitor are described below (see Protective Regulations Under Section 4(d) of the Act, below).

We may issue permits to carry out otherwise prohibited activities involving threatened wildlife under certain circumstances. Regulations governing permits for threatened wildlife are codified at 50 CFR 17.32, and general Service permitting regulations are codified at 50 CFR part 13. With regard to threatened wildlife, a permit may be issued for scientific purposes, to enhance propagation or survival, for economic hardship, for zoological exhibition, for educational purposes, for incidental taking, or for special purposes consistent with the purposes of the Act. The statute also contains certain exemptions from the prohibitions, which are found in sections 9 and 10 of the Act.

The Service may also register persons subject to the jurisdiction of the United States through its captive-bred wildlife (CBW) program if certain established requirements are met under the CBW regulations (see 50 CFR 17.21(g)). Through a CBW registration, the Service may allow a registrant to conduct certain otherwise prohibited activities under certain circumstances to enhance the propagation or survival of the affected species, including take; export or re-import; delivery, receipt, carriage, transport, or shipment in interstate or foreign commerce in the course of a commercial activity; or sale or offer for sale in interstate or foreign commerce. A CBW registration may authorize interstate purchase and sale only between entities that both hold a registration for the taxon concerned. The CBW program is available for species having a natural geographic distribution not including any part of the United States and other species that the Service Director has determined to be eligible by regulation. The individual specimens must have been born in captivity in the United States.

The provisions in section 9(b)(1) of the Act (16 U.S.C. 1538(b)(1)) provide a limited exemption from certain otherwise prohibited activities regarding wildlife specimens held in captivity or in a controlled environment on the pre-Act date (for species first listed after the enactment of the Endangered Species Act, the pre-Act date is the date of publication in the Federal Register of the final regulation adding such species to the List of Endangered and Threatened Wildlife for the first time), provided that such holding and any subsequent holding or use of the wildlife was not in the course of a commercial activity (commonly referred to as “pre-Act” specimens) (96 Stat. 1426-27 (1982); H.R. Rep. No. 97-835, 97th Cong., 2nd Sess., at 35 (1982) (Conf. Rep.); S. Rep. No. 97-418, 97th Cong., 2nd Sess., at 24-25 (1982)). Specifically, section 9(b)(1) of the Act states that the prohibitions of sections 9(a)(1)(A) and 9(a)(1)(G) shall not apply to any fish or wildlife which was held in captivity or in a controlled environment on (A) December 28, 1973, or (B) the date of the publication in the Federal Register of a final regulation adding such fish or wildlife to any list of species published pursuant to section 4(c) of the Act (as relevant to listed wildlife, the List of Endangered and Threatened Wildlife at 50 CFR 17.11(h)) that such holding and any subsequent holding or use of the fish or wildlife was not in the course of a commercial activity.

Therefore, for pre-Act wildlife, there is a limited exemption from the prohibitions associated with: (1) import into, or export from, the United States of any endangered wildlife, or (2) violation of regulations pertaining to endangered or threatened wildlife. Other prohibitions of section 9—including those at section 9(a)(1)(B)-(F) regarding take of endangered wildlife, possession and other acts with unlawfully taken wildlife, interstate or foreign commerce in endangered wildlife, and sale or offer for sale of endangered wildlife—continue to apply to activities with qualifying endangered pre-Act wildlife specimens. Specimens born after the pre-Act date and specimens taken from the wild after the pre-Act date do not qualify as “pre-Act” wildlife under the text of section 9(b)(1) of the Act. If a person engages in any commercial activity with a pre-Act specimen on or after the pre-Act date, the wildlife would immediately cease to qualify as pre-Act wildlife and become subject to the relevant prohibitions because it has been held or used in the course of a commercial activity.

As discussed above under Available Conservation Measures, section 9(a) of the Act provides a specific list of prohibitions for endangered species but does not provide these same prohibitions for threatened species. Instead, pursuant to section 4(d) of the Act, for any species listed as a threatened species, the Secretary must issue protective regulations that are “necessary and advisable to provide for the conservation of such species” (referred to as “4(d) rules”). Section 4(d) of the Act contains two sentences. The first sentence states that the Secretary shall issue such regulations as they deem necessary and advisable to provide for the conservation of species listed as threatened species. “Conservation” is defined in the Act to mean the use of all methods and procedures which are necessary to bring any endangered species or threatened species to the point at which the measures provided pursuant to the Act are no longer necessary. Additionally, the second sentence of section 4(d) of the Act states that the Secretary may prohibit by regulation, with respect to any threatened species, any act prohibited under section 9(a)(1), in the case of fish or wildlife, or section 9(a)(2), in the case of plants. With these two sentences in section 4(d), Congress delegated broad authority to the Secretary to determine what protections would be necessary and advisable to provide for the conservation of threatened species, and even broader authority to put in place any of the section 9 prohibitions, for a given species.

Courts have recognized the extent of the Secretary's discretion under section 4(d) to develop regulations that are appropriate for the conservation of threatened species. For example, courts have upheld, as a valid exercise of agency authority, rules developed under section 4(d) that included limited prohibitions against takings (see Alsea Valley Alliance v. Lautenbacher, 2007 WL 2344927 (D. Or. 2007); Washington Environmental Council v. National Marine Fisheries Service, 2002 WL 511479 (W.D. Wash. 2002)). Courts have also upheld 4(d) rules that do not address all of the threats a species faces (see State of Louisiana v. Verity, 853 F.2d 322 (5th Cir. 1988)). As noted in the legislative history when the Act was initially enacted, “once an animal is on the threatened list, the Secretary has an almost infinite number of options available to him [or her] with regard to the permitted activities for those species. He [or she] may, for example, permit taking, but not importation of such species, or he [or she] may choose to forbid both taking and importation but allow the transportation of such species” (H.R. Rep. No. 412, 93rd Cong., 1st Sess. 1973).

Under our 4(d) authorities, we put in place protections intended to both prevent a threatened species from becoming an endangered species and to promote its recovery. 4(d) rules explain what is prohibited for a threatened species, thus making the activity unlawful without a permit or authorization under the Act unless otherwise excepted in the 4(d) rule and may also include affirmative requirements. Section 4(d) rules are therefore directly related to what actions may require permits in the future. As discussed in Available Conservation Measures, permits may be issued for purposes described in our threatened species permitting regulations at 50 CFR 17.32 and 17.72, including for recovery actions. We may also except otherwise prohibited activities through a 4(d) rule itself, in which case threatened species permits would not be required for those activities.

The provisions of this species' proposed protective regulations under section 4(d) of the Act are one of many tools that we would use to promote the conservation of the earless monitor. The proposed protective regulations would apply only if and when we make final the listing of the earless monitor as a threatened species. The proposed protective regulations would promote conservation of the earless monitor by ensuring that activities undertaken with this species by any person under the jurisdiction of the United States are also supportive of the conservation efforts undertaken for the species in Indonesia, Malaysia, and Brunei Darussalam, as well as under the CITES Appendix-II listing.

Exercising the Secretary's authority under section 4(d) of the Act, we have developed a proposed rule that is designed to address the earless monitor's conservation needs. As discussed above under Summary of Biological Status and Threats, we have concluded that the earless monitor is likely to become in danger of extinction within the foreseeable future primarily due to habitat loss and overcollection and illegal trade for the pet trade. Section 4(d) requires the Secretary to issue such regulations as he deems necessary and advisable to provide for the conservation of each threatened species and authorizes the Secretary to include among those protective regulations any of the prohibitions that section 9(a)(1) of the Act prescribes for endangered species ( In re: Polar Bear Endangered Species Act Listing and 4(d) Rule Litigation, 818 F. Supp. 2d 214, 228 (D.D.C. 2011) (citing Sweet Home Chapter of Cmtys. for a Great Or. v. Babbitt, 1 F.3d 1, 8 (D.C. Cir. 1993), rev'd on other grounds, 515 U.S. 687 (1995))). Our necessary and advisable determination includes consideration of conservation and economic impacts ( Kansas Natural Resources Coalition, et al. v. USFWS, et al. No. 23CV-00159-DC-RCG (W.D. Tex. 2025). We explain below why we find that, if finalized, the prohibitions and exceptions in this proposed rule as a whole satisfy the requirement in section 4(d) of the Act to issue regulations deemed necessary and advisable to provide for the conservation of the earless monitor.

The protective regulations we are proposing for the earless monitor incorporate prohibitions from section 9(a)(1) to address the threats to the species. The prohibitions of section 9(a)(1) of the Act, and implementing regulations codified at 50 CFR 17.21, make it illegal for any person subject to the jurisdiction of the United States to commit, to attempt to commit, to solicit another to commit, or to cause to be committed any of the following acts with regard to any endangered wildlife: (1) import into, or export from, the United States; (2) take (which includes harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to attempt to engage in any such conduct) within the United States, within the territorial sea of the United States, or on the high seas; (3) possess, sell, deliver, carry, transport, or ship, by any means whatsoever, any such wildlife that has been taken illegally; (4) deliver, receive, carry, transport, or ship in interstate or foreign commerce, by any means whatsoever and in the course of commercial activity; or (5) sell or offer for sale in interstate or foreign commerce. This protective regulation includes all of these prohibitions because the earless monitor is at risk of extinction within the foreseeable future and putting these prohibitions in place will help to preserve the species' remaining populations.

As discussed above under Summary of Biological Status and Threats, overcollection and illegal trade for pet trade is affecting the status of the earless monitor; therefore, regulating activities associated with potential removal of earless monitors from the wild and preventing illegal trade is essential for their conservation. The section 9(a)(1) prohibitions related to trade and commerce through our application of 50 CFR 17.21(b), (e), and (f) will help regulate these activities. As discussed in Background, it is illegal to remove the species from the wild without a permit; however, it is legal to export individuals bred in captivity. We are aware of one company that imports earless monitors into the United States and at least two companies with earless monitors in captivity in the United States that engage in interstate commerce with the species. Therefore, we propose to regulate take of individuals within the United States, territorial seas, and high seas (50 CFR 17.21(c)(1)), as well as possession and other acts with unlawfully taken specimens (50 CFR 17.21(d)).

Regulating import and export into, from, and through the United States, take, and interstate and foreign commerce by persons subject to the jurisdiction of the United States would contribute to conservation of the species in its range states and help conserve the species by eliminating the United States as a potential market for illegally taken and traded earless monitors. It would ensure any legal activities with earless monitors under jurisdiction of the United States contribute to enhancing the conservation of the species, and that any domestic demand for earless monitors does not contribute to the decline of earless monitors in the wild.

The proposed 4(d) rule would also provide for the conservation of the species by allowing exceptions that are intended to incentivize conservation actions or that are not expected to rise to the level that would have a negative impact ( i.e., would have only de minimis impacts) on the species' conservation. Exceptions to the prohibitions include those set forth in 50 CFR 17.21(c)(2)-(c)(4), (d)(2), and 50 CFR 17.31(c). These exceptions include allowing any person to take earless monitors in defense of their own life or the lives of others and for law enforcement to possess and conduct other acts with illegally taken earless monitors.

We also propose certain exceptions related to import, export, trade, and commerce of earless monitors. While we have determined overcollection and illegal trade are threats to the species, we propose that legal trade and commerce of bred in captivity specimens that meet the requirements of CITES (source code C, 50 CFR part 23), including those that are legally bred in captivity in the United States, can provide a sustainable use alternative to unsustainable or illegal sourcing of wild specimens and breeding stock. We have no information that suggests current legal interstate commerce activities with legally sourced earless monitors are associated with threats to the species or would negatively affect any efforts aimed at the recovery of wild populations of the species. Furthermore, allowing interstate commerce with legally sourced earless monitors is expected to provide a conservation benefit to the species because the demands of the pet trade can be supplied with bred in captivity specimens sourced from within the United States, which will reduce collection pressure on wild populations in its range states. Therefore, we are proposing exceptions to prohibitions and threatened species permitting requirements for import, export, and interstate and foreign commerce to facilitate legal trade in bred in captivity specimens (source code C) that are in accordance with other applicable regulations, including 50 CFR part 23 regulations implementing CITES. Additionally, under 50 CFR 17.8, import permits are exempted for threatened wildlife species included in Appendix II of CITES so long as certain requirements are met. The requirements at 50 CFR 17.8 for exemption from a threatened species import permit include that the specimen was not acquired in foreign commerce or imported in the course of a commercial activity; the species is included in Appendix II of CITES; the specimen is imported under a valid CITES document and subsequently used in accordance with CITES regulations (50 CFR part 23); at the time of import, the importer must provide to the Service documentation that shows the specimen was not acquired in foreign commerce in the course of commercial activity; and that all applicable requirements of 50 CFR part 14 have been satisfied.

In addition, to further the conservation of the species, any employee or agent of the Service, any other Federal land management agency, the NFMS, a State conservation agency, or a federally recognized Tribe, who is designated by their agency or Tribe for such purposes, may, when acting in the course of their official duties, take threatened wildlife without a permit if such action is necessary to: (i) aid a sick, injured, or orphaned specimen; (ii) dispose of a dead specimen; (iii) salvage a dead specimen that may be useful for scientific study; or (iv) remove specimens that constitute a demonstrable but nonimmediate threat to human safety, provided that the taking is done in a humane manner. Such taking may involve killing or injuring only if it has not been reasonably possible to eliminate such threat by live capturing and releasing the specimen unharmed, in an appropriate area.

We recognize the special and unique relationship that we have with our State natural resource agency partners in contributing to conservation of listed species. State agencies often possess scientific data and valuable expertise on the status and distribution of endangered, threatened, and candidate species of wildlife and plants. State agencies, because of their authorities and their close working relationships with local governments and landowners, are in a unique position to assist us in implementing all aspects of the Act. In this regard, section 6 of the Act provides that we must cooperate to the maximum extent practicable with the States in carrying out programs authorized by the Act. Therefore, any qualified employee or agent of a State conservation agency that is a party to a cooperative agreement with us in accordance with section 6(c) of the Act, who is designated by their agency for such purposes, would be able to conduct activities designed to conserve the earless monitor that may result in otherwise prohibited take without additional authorization.

In addition, any employee or agent of the Service or of the NMFS, who is designated by their agency for such purposes, may, when acting in the course of their official duties, take those species.

Furthermore, we may under certain circumstances issue permits to carry out one or more otherwise-prohibited activities, including those described above. The regulations that govern permits for threatened wildlife state that the Director may issue a permit authorizing any activity otherwise prohibited with regard to threatened species. These permits may be issued for the following purposes: scientific purposes, to enhance propagation or survival, economic hardship, zoological exhibition, educational purposes, incidental taking, or special purposes consistent with the purposes of the Act (50 CFR 17.32). The criteria for issuance of threatened species permits to authorize otherwise-prohibited activities other than incidental taking are found in 50 CFR 17.32(a)(2). The import exemption for threatened wildlife included in Appendix II of CITES (50 CFR 17.8; section 9(c)(2) of the Act) would apply to this species for qualifying specimens and activities. Further, as noted above, we may also authorize certain activities associated with conservation breeding under CBW registrations. We recognize that captive breeding of wildlife can support conservation, for example, by producing animals that could be used for reintroductions. We are not aware of any captive-breeding programs of earless monitors for this purpose. The proposed 4(d) rule would apply to all live earless monitors and dead parts and products of the species and supports conservation management efforts for earless monitors in the wild in their native range.

The statute also contains certain exemptions from the prohibitions, which are found in sections 9 and 10 of the Act.

In summary, we find this proposed 4(d) rule contains all the prohibitions and exceptions necessary and advisable for the conservation of the earless monitor. The 4(d) rule is necessary and advisable to provide for the conservation of the earless monitor because it will regulate activities that pose a threat to the species and provide certain exceptions for activities with legally sourced and traded bred in captivity specimens (source code C) that are otherwise in accordance with relevant regulations, including CITES. In terms of potential economic impacts, there is minimal current legal import, export, trade, or commerce of the earless monitor that would be affected by the 4(d) rule.

We are required by Executive Orders 12866 and 12988 and by the Presidential memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:

(1) Be logically organized;

(2) Use the active voice to address readers directly;

(3) Use clear language rather than jargon;

(4) Be divided into short sections and sentences; and

(5) Use lists and tables wherever possible.

If you feel that we have not met these requirements, send us comments by one of the methods listed in ADDRESSES. To better help us revise the rule, your comments should be as specific as possible. For example, you should tell us the numbers of the sections or paragraphs that are unclearly written, which sections or sentences are too long, the sections where you feel lists or tables would be useful, etc.

Under the Regulatory Flexibility Act (RFA; 5 U.S.C. 601 et seq. ), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA; title II of Pub. L. 104-121, March 29, 1996), whenever a Federal agency is required to publish a notice of rulemaking for any proposed or final rule, it must prepare and make available for public comment a regulatory flexibility analysis that describes the effects of the rule on small entities ( i.e., small businesses, small organizations, and small government jurisdictions). However, no regulatory flexibility analysis is required if the head of the agency certifies the rule will not have a significant economic impact on a substantial number of small entities. The SBREFA amended the RFA to require Federal agencies to provide a certification statement of the factual basis for certifying that the rule will not have a significant economic impact on a substantial number of small entities.

While we do not conduct RFA analyses on our classification determinations under the Act, in accordance with recent caselaw ( Kansas Natural Resources Coalition, et al. v. USFWS, et al. No. 23-CV-00159-DC-RCG (W.D. Tex. 2025)), we comply with RFA through consideration of conservation and economic impacts when promulgating 4(d) rules.

According to the Small Business Administration, small entities include small organizations such as independent nonprofit organizations; small governmental jurisdictions, including school boards and city and town governments that serve fewer than 50,000 residents; and small businesses (13 CFR 121.201). Small businesses include manufacturing and mining concerns with fewer than 500 employees, wholesale trade entities with fewer than 100 employees, retail and service businesses with less than $5 million in annual sales, general and heavy construction businesses with less than $27.5 million in annual business, special trade contractors doing less than $11.5 million in annual business, and agricultural businesses with annual sales less than $750,000. To determine if potential economic impacts to these small entities are significant, we considered the types of activities that might trigger regulatory impacts under this designation as well as types of project modifications that may result. In general, the term “significant economic impact” is meant to apply to a typical small business firm's business operations.

Under the RFA, as amended, and as understood in light of recent court decisions, Federal agencies are required to evaluate the potential incremental impacts of rulemaking on those entities directly regulated by the rulemaking itself; in other words, the RFA does not require agencies to evaluate the potential impacts to indirectly regulated entities.

As discussed above, in terms of potential economic impacts, there is minimal current legal import, export, trade, or commerce of earless monitor that would be affected by the 4(d) rule. We propose exceptions that would continue to allow import, export, trade, or commerce with legally obtained earless monitors without additional threatened species permits, as described above. Possession of a specimen is not itself a violation and does not require a permit as long as there is not an unauthorized otherwise-prohibited activity, such as take. Additionally, the definition of “harass” in 50 CFR 17.3, when applied to captive wildlife, does not include the following practices, procedures, and provisions if they are “generally accepted” and “not likely to result in injury to the wildlife” at issue: animal husbandry practices that meet or exceed the minimum standards for facilities and care under the Animal Welfare Act; breeding procedures; or provisions of veterinary care for confining, tranquilizing, or anesthetizing. The take prohibition against harm and kill would apply to earless monitors in the United States, requiring a permit for any such activity, except for qualifying non-commercial acts with pre-ESA wildlife. For the above reasons and based on currently available information, we certify that, if made final, the proposed 4(d) rule would not have a significant economic impact on a substantial number of small business entities. Therefore, an initial regulatory flexibility analysis is not required.

Regulations adopted pursuant to section 4(a) of the Act are exempt from the National Environmental Policy Act (NEPA; 42 U.S.C. 4321 et seq. ) and do not require an environmental analysis under NEPA. We published a notice outlining our reasons for this determination in the Federal Register on October 25, 1983 (48 FR 49244). This includes listing, delisting, and reclassification rules, as well as critical habitat designations and species-specific protective regulations promulgated concurrently with a decision to list or reclassify a species as threatened. The courts have upheld this position ( e.g., Douglas County v. Babbitt, 48 F.3d 1495 (9th Cir. 1995) (critical habitat); Center for Biological Diversity v. U.S. Fish and Wildlife Service, 2005 WL 2000928 (N.D. Cal. Aug. 19, 2005) (concurrent 4(d) rule)).

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

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