The Massachusetts Bay Transportation Authority (MBTA) will be replacing the North Station Draw One Bridge over the Charles River in Boston, MA. As described on an MBTA North Station Drawbridge Replacement website, 1 the project includes the replacement of a control tower, the extension of the bridge platform to include four to six additional river-crossing bridge tracks, the connection of tracks 11 and 12 to the existing network, and upgrades to track, signal, communications, and infrastructure. The Federal Transit Administration (FTA) and the MBTA have prepared an Environmental Assessment (EA) under the National Environmental Policy Act and, on January 16, 2025, the FTA issued a FONSI (Finding of No Significant Impact) for the project. The EA and FONSI are available at the MBTA website provided in footnote 1 of this Notice of Proposed Rulemaking (NPRM).

On April 22, 2025, the MBTA held a meeting with the Coast Guard to present its construction plan for the demolition and replacement of the superstructure and substructures of the MBTA North Station Draw One Railroad Bridge spans and approach spans over the Charles River, Boston, Massachusetts (MA). North Station is a major commuter and intercity rail terminal in Boston, MA, which is served by four MBTA commuter lines and the Amtrak Downeaster. Due to the complex construction staging required to maintain service levels at North Station, the MBTA anticipates that construction and demolition activities for the project, which may begin as early as January 1, 2026, may take up to eight years to complete. Construction activities may occur up to seven days a week, with primary work shifts scheduled during the daytime from 7 a.m. to 3 p.m. Nighttime work may also take place during certain phases, between 3 p.m. and 11 p.m., and 11 p.m. to 7 a.m.

In-river construction and demolition will involve removing eleven caissons that previously supported the former Draw One Bridge piers. Two cofferdams may be installed to facilitate this work. One cofferdam, approximately 98 feet by 58 feet—would encapsulate eight caissons on the north side of the channel, while the second, approximately 104 feet by 27 feet, would surround the “main deck beam pier” and three associated caissons on the south side. Cofferdam installation would be conducted from a barge, prior to the construction of temporary work trestles. Silt curtains or similar sediment control measures would be used around the cofferdams during their removal, as needed.

Temporary work trestles, potentially in place for up to six years, would be constructed following cofferdam installation. Construction work would begin concurrently at multiple locations, starting with pile driving for the trestles using barge-mounted equipment. Drilled shaft construction for the lift span piers may also proceed simultaneously, using similar barge-based methods. Multiple barges are anticipated for various construction functions, including supporting cranes, storing materials, and facilitating material delivery. Dredging is also expected within the project area.

Demolition of the MBTA North Station Draw One Railroad Bridge will likely involve cutting the steel trusses into sections, which would then be lifted by crane and floated out by barge. Approximately 1,380 timber piles, along with the majority of construction and demolition debris, will also be removed by barge.

The Coast Guard has coordinated with the MBTA to assess whether the project can proceed without requiring channel closures and to understand the potential impact on the project timeline. Fortunately, most construction activities will not necessitate enforcement of the safety zone or waterway closures. Certain critical tasks that must be performed within the channel will, however, require enforcement of the safety zone, effectively closing the waterway during those periods.

The extremely complex marine construction and demolition activities described above present many hazardous conditions, including pile driving operations, heavy lift operations, overhead cutting operations, potential falling debris, increased construction vessel traffic, and stationary vessels and barges operating in close proximity to the bridge and to each other. These construction and demolition activities are expected to impact navigation on the Charles River within a 100-yard radius of the center point of the MBTA North Station Draw One Railroad Bridge.

Based on these circumstances, the COTP, Sector Boston has determined that establishment of a safety zone through rulemaking is warranted to ensure the safety of life, property, and the environment on the Charles River within a 100-yard radius of the center point of the MBTA North Station Draw One Railroad Bridge during construction and demolition operations.

The Coast Guard is proposing this rule under the authority provided in 46 U.S.C. 70034.

The COTP, Sector Boston proposes to establish a safety zone on the Charles River, in Boston, MA, within 100-yards of the center point of the MBTA North Station Draw One Railroad Bridge, (approximate position 42°22′08.5″ N 71°03′55.0″ W expressed in Degrees (°) Minutes (′) Seconds (″) (DMS) based on North American Datum 1983 (NAD 83)), effective from January 1, 2026, through the completion of the project. The project is expected to take up to eight years to complete. We will remove the regulation when the project is completed, and the safety zone is no longer needed.

The New Source Review (NSR) program is a preconstruction permitting program that requires certain stationary sources of air pollution to obtain permits prior to beginning construction. The NSR permitting program applies to new construction and to modifications of existing sources. New construction and modifications that emit “regulated NSR pollutants” over certain thresholds are subject to major NSR requirements, while smaller emitting sources and modifications may be subject to minor NSR requirements.

Major NSR permits for sources that are located in attainment or unclassifiable areas are referred to as Prevention of Significant Deterioration (PSD) permits. Major NSR permits for sources located in nonattainment areas and that emit pollutants above the specified thresholds for which the area is in nonattainment are referred to as NNSR permits.

A new stationary source is subject to major NSR requirements if its potential to emit (PTE) a regulated NSR pollutant exceeds certain emission thresholds. If it exceeds the applicable threshold, the NSR regulations define it as a “major stationary source.” An existing major stationary source triggers major NSR permitting requirements when it undergoes a “major modification,” which occurs when a source undertakes a physical change or change in method of operation ( i.e., a “project”) that would result in (1) a significant emissions increase from the project, and (2) a significant net emissions increase from the source. See, e.g., 40 CFR 51.166(b)(2)(i), (b)(3), and (b)(51).

Effective January 6, 1992, EPA designated 13 counties surrounding Atlanta, Georgia, as nonattainment for the 1-hour ozone NAAQS and classified them as a “serious” nonattainment area (hereinafter referred to as the Atlanta 1-hour Ozone Area). 1 See 56 FR 56694 (November 6, 1991). Effective January 1, 2004, the Atlanta 1-hour Ozone Area was reclassified as a “severe” nonattainment area. See 68 FR 55469 (September 26, 2003). This classification requires, among other things, that a “major source” and a “major stationary source” be defined to include certain sources that emit or have the potential to emit 25 tons or more of nitrogen oxides (NO X ) or volatile organic compounds (VOC) and that emissions offsets apply at a ratio of at least 1.3 or 1.2:1 (depending on the criteria in CAA section 182(d)(2)). 2 EPA redesignated the Atlanta 1-hour Ozone Area to attainment for the 1-hour ozone NAAQS, effective June 14, 2005. See 70 FR 34660 (June 15, 2005). Effective June 15, 2005, EPA revoked the 1-hour ozone NAAQS. See 69 FR 23951 (April 30, 2004) and 70 FR 44470 (August 3, 2005).

Effective June 15, 2004, 20 counties surrounding Atlanta were designated as nonattainment and classified as a “marginal” nonattainment area for the 1997 8-hour ozone NAAQS (hereinafter referred to as the Atlanta 1997 8-hour Ozone Area). 3 See 69 FR 23858 (April 30, 2004). Effective April 7, 2008, the Atlanta 1997 8-hour Ozone Area was reclassified as a “moderate” nonattainment area. See 73 FR 12013 (March 6, 2008). This classification requires, among other things, that a “major source” and a “major stationary source” be defined to include certain sources that emit or have the potential to emit 100 tons or more of NO X or VOC and that emissions offsets apply at a ratio of at least 1.15:1. The Atlanta 1997 8-hour Ozone Area was redesignated to attainment, effective January 1, 2014. See 78 FR 72040 (December 2, 2013). Effective April 6, 2015, EPA revoked the 1997 8-Hour Ozone NAAQS. See 80 FR 12264 (March 6, 2015).

Effective July 20, 2012, 15 counties surrounding Atlanta were designated as nonattainment and classified as a “marginal” nonattainment area for the 2008 8-hour ozone NAAQS (hereinafter referred to as the Atlanta 2008 8-hour Ozone Area). 4 See 77 FR 30088 (May 21, 2012). This classification requires, among other things, that a “major source” and a “major stationary source” be defined to include certain sources that emit or have the potential to emit 100 tons or more of NO X or VOC and that emissions offsets apply at a ratio of at least 1.1:1. The Atlanta 2008 8-hour Ozone Area was redesignated to attainment, effective June 2, 2017. See 82 FR 25523 (June 2, 2017).

Approximately one year later, EPA designated seven counties in and around metropolitan Atlanta as nonattainment and classified them as a “marginal” nonattainment area for the 2015 8-hour ozone NAAQS (hereinafter referred to as the Atlanta 2015 8-hour Ozone Area). 5 See 83 FR 25776 (June 4, 2018). As discussed above, the “marginal” classification requires that a “major source” and a “major stationary source” be defined to include certain sources that emit or have the potential to emit 100 tons or more of NO X or VOC and that emissions offsets apply at a ratio of at least 1.1:1. In 2022, EPA redesignated the Atlanta 2015 8-hour Ozone Area to attainment for the 2015 8-hour ozone standard. See 87 FR 62733 (October 17, 2022).

As a result of EPA's redesignation of the Atlanta 2015 8-hour Ozone Area to attainment, there are no longer any areas within Georgia that are currently designated as nonattainment for any of the NAAQS. Therefore, Georgia is no longer required to include regulations pertaining to NNSR in its SIP. Georgia's June 27, 2024, revision, as discussed in more detail below, thus requests removal of NNSR requirements from Georgia's SIP as obsolete. Georgia's submittal also requests the removal of other provisions related to nonattainment from the SIP. Georgia's submittal includes a demonstration, pursuant to CAA section 110(l), that the proposed revisions would not interfere with any applicable requirement concerning attainment of the NAAQS and reasonable further progress or any other applicable requirement of the CAA. EPA's analysis of Georgia's June 27, 2024, SIP revision and the Agency's rationale for proposing to approve these changes are provided below.

EPA is proposing to approve changes to the Georgia SIP submitted by the State on June 27, 2024, that would remove NNSR requirements from Georgia's SIP, remove certain provisions related to the use of ERCs, and makes other changes based upon the lack of any areas designated as in nonattainment of the NAAQS in Georgia. Specifically, the changes address Rules 391-3-1-.02(1), General Requirement; 391-3-1-.02(2)(nnn), NO X Emissions from Large Stationary Gas Turbines; 391-3-1-.03(1), Construction (SIP) Permit;   6 391-3-1-.03(6)(j), Construction Permit Exemption for Pollution Control Projects; 391-3-1-.03(8), Permit Requirements; and 391-3-1-.03(13), Emission Reduction Credits. 7

The State requests that EPA revise Rule 391-3-1-.02(1), General Requirement, to change the word “nonattainment” to “non-attainment” in Rule 391-3-1-.02(1)(d) for internal consistency. This is a minor typographical change that does not alter the meaning of any terms or provisions. EPA is therefore proposing to revise Rule 391-3-1-.02(1) in the Georgia SIP because the proposed revision will not interfere with any applicable requirement concerning attainment and reasonable further progress, or any other applicable requirement of the Act.

The State requests that EPA revise Rule 391-3-1-.02(2)(nnn), NO X Emissions from Large Stationary Gas Turbines. The purpose of this Rule is to establish NO X emission limits for stationary gas turbines with nameplate capacities greater than 25 megawatts (MWe). There are two main revisions proposed within this rule, as discussed below.

First, SIP-approved Rule 391-3-1-.02(2)(nnn)(1)(ii) contains a NO X emission limit for large stationary gas turbines permitted prior to April 1, 2000, located at a stationary source with no natural gas. The updated version of this subparagraph would read “[reserved].” Georgia removed this subparagraph from its rule and replaced it with the word “[reserved]” in 2006 because Georgia determined that it was no longer applicable to any source in Georgia, as there were no longer any existing stationary sources to which this limitation applied. Additionally, because the provision only applied to large stationary gas turbines permitted before April 1, 2000, no future, new, or modified gas turbines would be subject to this regulation.

Second, Rule 391-3-1-.02(2)(nnn)(4) as currently approved into the SIP exempts large stationary gas turbines constructed on or after April 1, 2000, from the 6 ppm @15% O 2 , dry basis NO X emission limit contained in Rule 391-3-1-.02(2)(nnn)(1)(iii) if the turbine is otherwise subject to Rule 391-3-1-.03(8)(c)(14)  8 or Rule 391-3-1-.03(8)(c)(15). 9 As discussed later in this notice, Georgia has requested that EPA remove Rule 391-3-1-.03(8)(c)(14) and Rule 391-3-1-.03(8)(c)(15) from Georgia's SIP. Because Rule 391-3-1-.02(2)(nnn)(4) contains cross-references to these two rules identified for removal, Georgia's submittal also includes revised language for Rule 391-3-1-.02(2)(nnn)(4). The revised language states that the emission limit in Rule 391-3-1-.02(2)(nnn)(1)(iii) “shall not apply to stationary gas turbines subject to NO X emission limits established between April 1, 2000, and February 21, 2023.” According to EPD's submittal, the February 21, 2023, date is simply a date chosen prior to when the rule revisions were submitted to the Georgia Department of Natural Resources Board for briefing and subsequent adoption. 10

Minor changes were also made within Rule 391-3-1-.02(2)(nnn) for internal consistency to update labels ( i.e., subparagraphs, paragraphs, sections, and subsections) used to cite or refer to various referenced portions of the rules, per Georgia's State-only procedural Rule 590-2-1-.02, Numbering System.

In support of its submittal, Georgia provided an analysis pursuant to CAA section 110(l). Georgia explains that “[t]he large stationary gas turbines that were subject to requirements under Rules 391-3-1-.03(8)(c)14. and 391-3-1-.03(8)(c)15. are the same as the large stationary gas turbines that had NOx emission limits established between April 1, 2000, and February 21, 2023.” Thus, Georgia states that its proposed revision “does not change or broaden the NO X emission limit exemption for Rule 391-3-1-.02(2)(nnn)1.” Georgia notes its intent with this change is to “leave the already established [Lowest Achievable Emission Rate and Best Available Control Technology] limits in place for the affected turbines.”

EPA agrees that the proposed revisions to Rule 391-3-1-.02(2)(nnn) would preserve the status quo. EPA additionally notes that 40 CFR 51.160 requires each state's SIP to contain enforceable procedures that prevent the permitting of new sources or modifications that would interfere with the attainment or maintenance of a NAAQS, and Georgia's SIP contains such a provision at Rule 391-3-1-.03(8)(a). This permitting provision provides an additional backstop to ensure that future permitting of new sources will not interfere with attainment or maintenance of the NAAQS. EPA is therefore proposing to revise Rule 391-3-1-.02(2)(nnn) in the Georgia SIP because the proposed revision will not interfere with any applicable requirement concerning attainment and reasonable further progress, or any other applicable requirement of the Act.

The State requests that EPA revise Rule 391-3-1-.03(1), Construction (SIP) Permit, to remove a requirement for any person applying for a permit for construction or modification of a facility to include information on any ERCs on which the permit applicant intends to rely. The ERC program allows eligible sources that voluntarily reduce emissions to certify and “bank” these reductions as ERCs for future use. By its terms, the ERC program only applies in counties in a nonattainment area or in counties determined by EPD to contribute to ambient air quality in the nonattainment area. 11 The banked ERCs hold their value for ten years, at which point they begin devaluing ten percent per year until they have reached 50 percent of their original value. The ERC program was intended to help the Atlanta metropolitan region achieve compliance with federal standards for ground-level ozone. The program does not allow for any increase in emissions of NO X or VOC in the area to which it is applicable. 12

Although EPD has requested that EPA remove the phrase “information regarding any Emission Reduction Credits on which the applicant intends to rely” from Rule 391-3-1-.03(1)(b), this phrase is not in the SIP. Therefore, EPA is taking no action on EPD's request to revise Rule 391-3-1-.03(1).

The State requests that EPA revise Rule 391-3-1-.03(6)(j), Construction Permit Exemption for Pollution Control Projects to remove the phrase “or the non-attainment new source review permitting requirements of subparagraph 391-3-1-03(8)(c).” Because EPD's submittal requests the removal of all of the existing language within subparagraph 391-3-1-.03(8)(c), the cross-reference in Rule 391-3-1-.03(6)(j) to this subparagraph would be obsolete. Removal of the existing language within subparagraph 391-3-1-.03(8)(c) is discussed below. EPA is therefore proposing to revise subparagraph 391-3-1-.03(6)(j) in the Georgia SIP. The proposed revision will not interfere with any applicable requirement concerning attainment and reasonable further progress, or any other applicable requirement of the Act.

The State requests that EPA revise Rule 391-3-1-.03(8), Permit Requirements. The purpose of Rule 391-3-1-.03(8) is to provide permit requirements for stationary sources. The proposed revision would primarily remove permitting requirements related to nonattainment from this rule within Georgia's SIP. The State's submittal requests the removal of subparagraphs (c), (d), (e), and (g) and minor revisions to subparagraphs (a), (b), and (f) of Rule 391-3-1-.03(8).

The State is seeking to remove subparagraph (c), which provides permit requirements for new or modified major stationary sources in areas of the State designated by EPA or the State as not attaining a NAAQS, or in areas contributing to the ambient air levels of such pollutants in such areas of nonattainment. 13 Provisions proposed for removal include NNSR requirements, such as requiring proposed sources to comply with the Lowest Achievable Emission Rate (LAER). EPA is also proposing to remove the additional provisions for ozone areas in Rule 391-3-1-.03(8)(c)14  14 and provisions contained within Rule 391-3-1-.03(8)(c)15. 15 If these nonattainment-related permitting provisions are removed, the PSD permitting program will continue to apply to major stationary sources within areas classified as in attainment with the NAAQS or unclassifiable and ensure that a new or modified major source will not cause or contribute to a violation of a NAAQS. See 40 CFR 51.166(k). Additionally, 40 CFR 51.160 requires each state's SIP to contain enforceable procedures that prevent the permitting of new sources or modifications that would interfere with the attainment or maintenance of a NAAQS, and Georgia's SIP contains such a provision at Rule 391-3-1-.03(8)(a). These permitting provisions provide an adequate backstop to ensure that future permitting of new sources will not interfere with attainment or maintenance of the NAAQS.

The State is also seeking to remove subparagraph (d), a placeholder subparagraph that had been reserved for numbering purposes in the rule. Removal of this provision from the SIP is non-substantive.

The State is further seeking to remove subparagraph (e), which provides that the Director shall determine and designate areas of the State which are not attaining any NAAQS and any areas contributing to the ambient air level of pollutants in these nonattainment areas to “meet the requirements of Title 1, Part D of the Federal Act” ( i.e., the Act's nonattainment provisions). This provision also designated Banks, Barrow, Butts, Carroll, Chattooga, Clarke, Dawson, Floyd, Gordon, Hall, Haralson, Heard, Jackson, Jasper, Jones, Lamar, Lumpkin, Madison, Meriwether, Monroe, Morgan, Oconee, Pickens, Pike, Polk, Putnam, Spalding, Troup, Upson, and Walton counties as areas contributing to the ambient air level of ozone in the Atlanta 2008 8-hour Ozone Area. Finally, this provision applies the nonattainment permitting provisions of Rule 391-3-1-.03(8)(c) to the construction of electric generating units at new or modified stationary sources “in this area.” Subparagraph (e) of subparagraph 391-3-1-.03(8) is not needed because there are currently no nonattainment areas in the State.

The State is also seeking to remove subparagraph (g), which provides a list of provisions from Rule 391-3-1-.02(7), Prevention of Significant Deterioration of Air Quality, which would apply to projects subject to the nonattainment permitting provisions of Rule 391-3-1-.03(8)(c). If the nonattainment permitting provisions of Rule 391-3-1-.03(8)(c) are removed from the SIP, there is no need to retain 391-3-1-.03(8)(g).

Minor changes were also made within subparagraphs (a), (b), and (f) of Rule 391-3-1-.03(8) for internal consistency to update labels ( i.e., subparagraphs, paragraphs, sections, subsections) used to cite or refer to various referenced portions of rules, per Georgia Rule 590-2-1-.02, Numbering System. Subparagraph (f) would also be re-numbered to subparagraph (c) due to the removal of the other subparagraphs mentioned above.

As there are no nonattainment areas in Georgia, permitting provisions related to nonattainment are no longer required in Georgia's SIP. EPA is therefore proposing to revise Rule 391-3-1-.03(8) in the Georgia SIP because the proposed revision will not interfere with any applicable requirement concerning attainment and reasonable further progress, or any other applicable requirement of the Act.

The State requests that EPA revise Rule 391-3-1-.03(13), Emission Reduction Credits, to remove wording that allows or refers to the use of ERCs. As noted above, the ERC program only applies in counties in a nonattainment area, or in counties determined by EPD to contribute to ambient air quality in the nonattainment area. Because Georgia no longer has any nonattainment areas or areas contributing to ambient air quality in nonattainment areas, the rationale that use of these credits will help the Atlanta metropolitan region “achieve compliance with federal standards for ground-level ozone” no longer applies. 16 The State's requested changes only apply to the use of ERCs and do not remove the mechanism to create, bank, or transfer ERCs. Other ERC provisions not related to use of the ERCs are being retained in the SIP. Wording within Rule 391-3-1-.03(13) has also been revised for internal consistency to update labels ( i.e., subparagraphs, paragraphs, sections, subsections) and to correct grammatical errors. EPA agrees with the State's rationale and is therefore proposing to revise Rule 391-3-1-.03(13) because the proposed revision will not interfere with any applicable requirement concerning attainment and reasonable further progress, or any other applicable requirement of the Act.

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 the following rules into Georgia's SIP with a state effective date of June 19, 2023: Rule 391-3-1-.02(1), General Requirement; Rule 391-3-1-.02(2)(nnn), NO X Emissions from Large Stationary Gas Turbines; Rule 391-3-1-.03(6)(j), Construction Permit Exemption for Pollution Control Projects; Rule 391-3-1-.03(8), Permit Requirements; and Rule 391-3-1-.03(13), Emission Reduction Credits. EPA has made, and will continue to make, the State Implementation Plan 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 reasons discussed above, EPA is proposing to approve the June 27, 2024, Georgia SIP revision consisting of changes to Georgia's SIP for Rule 391-3-1-.02(1), General Requirement; Rule 391-3-1-.02(2)(nnn), NO X Emissions from Large Stationary Gas Turbines; Rule 391-3-1-.03(6)(j), Construction Permit Exemption for Pollution Control Projects; Rule 391-3-1-.03(8), Permit Requirements; and Rule 391-3-1-.03(13), Emission Reduction Credits.

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).

Submit your comments, identified by Docket ID No. EPA-HQ-OLEM-2025-0221, at https://www.regulations.gov (our preferred method), or the other methods identified in the ADDRESSES section. Once submitted, comments cannot be edited or removed from the docket. EPA may publish any comment received to its public docket. Do not submit to EPA's docket at https://www.regulations.gov any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission ( i.e., on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

EPA will begin pre-registering speakers for the hybrid public hearing upon publication of this document in the Federal Register . To register to speak at the hearing, please use the online registration form available on EPA's CCR website ( https://www.epa.gov/coalash/us-state-wyoming-coal-combustion-residuals-permit-program ) or contact the person listed in the FOR FURTHER INFORMATION CONTACT section to register to speak at the hearing. Both in-person and virtual hearing attendees are requested to pre-register at the link provided above. The last day to pre-register to speak at the hearing will be October 30, 2025.

EPA will make every effort to follow the schedule as closely as possible on the day of the hearing; however, please plan for the hearings to run either ahead of schedule or behind schedule. Additionally, requests to speak will be taken the day of the hearing at the hearing registration desk or via the Q&A functionality of the online platform. EPA will make every effort to accommodate all speakers who arrive and register, although preferences on speaking times may not be able to be fulfilled.

Each commenter will have five (5) minutes to provide oral testimony. EPA encourages commenters to provide EPA with a copy of their oral testimony electronically by emailing it to the person listed in the FOR FURTHER INFORMATION CONTACT section. EPA also recommends submitting the text of your oral comments as written comments to the rulemaking docket. If EPA is anticipating a high attendance, the time allotment per testimony may be shortened to no shorter than three (3) minutes per person to accommodate all those wishing to provide testimony and who have pre-registered. While EPA will make every effort to accommodate all speakers who do not preregister, opportunities to speak may be limited based upon the number of pre-registered speakers. Therefore, EPA strongly encourages anyone wishing to speak to preregister. Participation in the public hearing does not preclude any entity or individual from submitting a written comment.

EPA may ask clarifying questions during the oral presentations but will not respond to the presentations at that time. Written statements and supporting information submitted during the comment period will be considered with the same weight as oral comments and supporting information presented at the public hearing.

Please note that any updates made to any aspect of the hearing are posted online at EPA's CCR website at https://www.epa.gov/coalash/us-state-wyoming-coal-combustion-residuals-permit-program. While EPA expects the hearing to go forward as set forth above, please monitor our website or contact the person listed in the FOR FURTHER INFORMATION CONTACT section to determine if there are any updates. EPA does not intend to publish a document in the Federal Register announcing updates.

If you require the services of an interpreter or special accommodations such as audio transcription or closed captioning, please pre-register for the hearing and describe your needs on the registration form by October 16, 2025. Alternatively, registrants may notify the person listed in the FOR FURTHER INFORMATION CONTACT section of any special needs. EPA may not be able to arrange accommodations without advance notice.

On April 17, 2015, EPA published a final rule creating 40 CFR part 257, subpart D, which establishes a comprehensive set of minimum Federal requirements for the disposal of CCR in landfills and surface impoundments (80 FR 21302) (“Federal CCR regulations”). 1 Section 2301 of the 2016 Water Infrastructure Improvements for the Nation (WIIN) Act amended RCRA section 4005 to create a new subsection (d) that requires EPA to establish a Federal CCR permitting program. See 42 U.S.C. 6945(d).

As amended, RCRA section 4005(d) also allows States to seek approval for a State CCR permit program that will operate in lieu of a Federal CCR permit program in the State. The statute provides that within 180 days after a State submits a complete application to the Administrator for approval, EPA shall approve the State permit program if the Administrator determines that the State program requires each CCR unit located in the State to achieve compliance with either the Federal requirements or other State requirements that EPA determines, after consultation with the State, are at least as protective as those included in the Federal CCR regulations. See 42 U.S.C. 6945(d)(1)(B).

On February 6, 2023, WDEQ submitted its State CCR permit program application to EPA Region 8 requesting approval of the State's partial CCR permit program. 2 EPA is proposing to approve the Wyoming partial CCR permit program pursuant to RCRA 4005(d)(1)(B). 42 U.S.C. 6945(d)(1)(B). The fact that Wyoming is seeking approval of a partial program does not mean it must subsequently apply for full program approval. However, Wyoming could apply for revised partial program approval or full program approval at some point in the future if it chooses to do so. If approved, the Wyoming CCR permit program will operate in lieu of the Federal CCR program (codified at 40 CFR part 257, subpart D), with the exception of the provisions specifically identified below for which the State is not seeking approval and for which the corresponding provisions of the Federal CCR program would remain in effect. For the approved provisions, EPA would retain its inspection and enforcement authorities under RCRA sections 3007 and 3008, 42 U.S.C. 6927 and 6928, consistent with EPA's ongoing oversight authority under RCRA. See 42 U.S.C. 6945(d)(4)(B).

EPA has also engaged Federally recognized Tribes within the State of Wyoming in consultation and coordination regarding the program determination. EPA established opportunities for an informational session and consultation, beginning with EPA Region 8 sending a letter to the Eastern Shoshone Tribe at Wind River Reservation and the Northern Arapaho Tribe at Wind River Reservation. Tribal consultation has been and will continue to be conducted in accordance with the EPA policy on Consultation and Coordination with Indian Tribes ( https://www.epa.gov/sites/production/files/2013-08/documents/cons-and-coord-with-indian-tribes-policy.pdf ). Neither Tribe sought Tribal consultation.

CCR are generated from the combustion of coal, including solid fuels classified as anthracite, bituminous coal, subbituminous coal, and lignite, for the purpose of generating steam to power a generator to produce electricity or electricity and other thermal energy by electric utilities and independent power producers. CCR, commonly known as coal ash, include fly ash, bottom ash, boiler slag, and flue gas desulfurization materials. CCR can be sent offsite for disposal or beneficial use or disposed of in on-site landfills or surface impoundments. This section summarizes EPA's regulatory actions on CCR to date to provide relevant background on this proposed approval of Wyoming's partial CCR permit program.

On April 17, 2015, EPA published a final rule creating 40 CFR part 257, subpart D, which established a comprehensive set of minimum Federal requirements for the disposal of CCR in landfills and surface impoundments (80 FR 21302). The rule created a self-implementing program that regulates the location, design, operating criteria, and groundwater monitoring and corrective action for CCR units, as well as the closure and post-closure care of CCR units. It also requires recordkeeping and notifications for CCR units. EPA has since amended 40 CFR part 257, subpart D on August 5, 2016 (81 FR 51802), July 30, 2018 (83 FR 36435), August 28, 2020 (85 FR 53516), November 12, 2020 (85 FR 72506), May 8, 2024 (89 FR 38950), and November 8, 2024 (89 FR 88650). More information on these rules is provided in the Technical Support Document in the docket for this document.

EPA is issuing this proposed action pursuant to RCRA sections 4005(d) and 7004(b)(1). See 42 U.S.C. 6945(d) and 6974(b)(1). As amended by section 2301 of the 2016 WIIN Act, RCRA section 4005(d) instructs EPA to establish a Federal permit program similar to those under RCRA subtitle C and other environmental statutes and authorizes States to develop their own CCR permitting programs that go into effect in lieu of the Federal permit program upon approval by EPA. See 42 U.S.C. 6945(d).

Under RCRA section 4005(d)(1)(A), 42 U.S.C. 6945(d)(1)(A), States seeking approval of a State CCR program must submit to the Administrator “in such form as the Administrator may establish, evidence of a permit program or other system of prior approval and conditions under state law for regulation by the State of coal combustion residuals units that are located in the state.” The statute provides that EPA shall approve a State CCR permit program if the Administrator determines that the State program will require each CCR unit located in the State to achieve compliance with either: (1) The Federal CCR requirements at 40 CFR part 257, subpart D; or (2) Other State criteria that the Administrator, after consultation with the State, determines to be “at least as protective as” the Federal requirements. 42 U.S.C. 6945(d)(1)(B). The Administrator must make a final determination, after providing for public notice and an opportunity for public comment, within 180 days of receiving a State's complete submittal of the information specified in RCRA section 4005(d)(1)(A). 42 U.S.C. 6945(d)(1)(B). EPA may approve a State CCR permit program in whole or in part. Id. Once approved, the State permit program operates in lieu of the Federal requirements. 42 U.S.C. 6945(d)(1)(A). In a State with a partial program, only the State requirements that have been approved by EPA operate in lieu of the Federal requirements, and facilities remain responsible for compliance with all remaining Federal requirements in 40 CFR part 257.

As noted above, the Federal CCR regulations are self-implementing, meaning that CCR landfills and surface impoundments must comply with the terms of the regulations prior to obtaining a Federal permit or a permit issued by an approved State. Noncompliance with the Federal CCR regulations can be the subject of an enforcement action brought directly against the facility. Once a final CCR permit is issued by an approved State or pursuant to a Federal CCR permit program, however, the terms of the permit apply in lieu of the terms of the Federal CCR regulations and/or requirements in an approved State program, and RCRA section 4005(d)(3) provides a permit shield against direct enforcement of the applicable Federal or State CCR regulations (meaning the permit's terms become the enforceable requirements for the permittee). 3

RCRA section 7004(b), which applies to all RCRA programs, directs that “public participation in the development, revision, implementation, and enforcement of any . . . program under this chapter shall be provided for, encouraged, and assisted by the Administrator and the States.” 42 U.S.C. 6974(b)(1). Accordingly, EPA considers permitting requirements, requirements for compliance monitoring authority, requirements for enforcement authority, and requirements for intervention in civil enforcement proceedings in evaluating State CCR permit program applications.

Once a State CCR permit program is approved, the Administrator must review the approved program no less frequently than every 12 years, no later than three years after a revision to an applicable section of 40 CFR part 257, subpart D, and no later than one year after any unauthorized significant release from a CCR unit located in the State. EPA also must review an approved State CCR permit program at the request of another State alleging that the soil, groundwater, or surface water of the requesting State is or is likely to be adversely affected by a release from a CCR unit in the approved State. See 42 U.S.C. 6945(d)(1)(D)(i)(I) through (IV).

In a State with an approved State CCR permit program, EPA may commence administrative or judicial enforcement actions under RCRA section 3008, 42 U.S.C. 6928, if the State requests assistance or if EPA determines that an EPA enforcement action is likely to be necessary to ensure that a CCR unit is operating in accordance with the criteria of the State's permit program. 42 U.S.C. 6945(d)(4). EPA can enforce any Federal requirements that remain in effect ( i.e., those for which there is no corresponding approved State provision). EPA may also exercise its inspection and information gathering authorities under RCRA section 3007 in a State with an approved program. 42 U.S.C. 6927.

EPA began working with WDEQ in September 2019 as the State developed its application for the State's partial CCR permit program. 4 As it has with other States, EPA discussed with WDEQ the process for EPA to review and approve the State's CCR permit program, WDEQ's anticipated timeline for submitting a CCR permit program application to EPA, and WDEQ's regulations for issuing permits. On February 6, 2023, WDEQ submitted its CCR permit program application to EPA Region 8 requesting approval of the State's partial CCR permit program.

EPA reviewed WDEQ's submission and, on March 27, 2023, sent a letter acknowledging receipt of the application and clarifying the statutory 180-day review period for a final determination of adequacy. 5 After reviewing the application in more detail, on December 5, 2023, EPA sent a letter stating that the formal review period had not yet begun; discussing further information that would strengthen the application; and discussing the State interpretation of the regulatory performance standards. 6 On January 29, 2024, WDEQ sent a letter to EPA asserting that EPA's review period had expired, discussing the State's interpretation of the scope of EPA's review of the State CCR permit program application, and responding to EPA's questions from the December 2023 letter. 7 After further discussions between EPA and WDEQ, on May 16, 2025, EPA sent to WDEQ additional clarification questions to supplement its application. On June 20, 2025, WDEQ responded to EPA's questions. 8

RCRA section 4005(d) requires EPA to evaluate two components of a State CCR permitting program to determine whether it meets the standard for approval: the program itself, and the technical criteria that will be included in each permit issued under the State program. This section discusses EPA's review of both requirements under RCRA section 4005(d) and the criteria EPA uses to conduct this review.

First, EPA must evaluate the permit program itself (or other system of prior approval and conditions). See 42 U.S.C. 6945(d)(1)(A) through (B). RCRA section 4005(d)(1)(A) directs the State to provide evidence of a State permit program's compliance with RCRA requirements in such form as determined by the Administrator. In turn, RCRA section 4005(d)(1)(B) directs EPA to approve the State program based upon a determination that the program “requires each coal combustion residuals unit located in the state to achieve compliance with the applicable [Federal or State] criteria.” In other words, the statute directs EPA to determine that the State has sufficient authority to require compliance at all CCR units located within the State. See also 42 U.S.C. 6945(d)(1)(D)(ii)(I). To make this determination, EPA evaluates the State's authority to issue permits and impose conditions in those permits, as well as the State's authority to conduct compliance monitoring and enforcement.

During this review of the State permit program, EPA also determines whether the program contains procedures consistent with the public participation directive in RCRA section 7004(b). RCRA section 7004(b), which applies to all RCRA programs, directs that “public participation in the development, revision, implementation, and enforcement of any . . . program under this chapter shall be provided for, encouraged, and assisted by the Administrator and the States.” 42 U.S.C. 6974(b)(1). To make this determination, EPA evaluates the State's public participation procedures for issuing permits and for intervention in civil enforcement proceedings.

Although 40 CFR part 239 applies to the approval of State Municipal Solid Waste Landfill (MSWLF) programs under RCRA section 4005(c)(1) rather than EPA's evaluation of CCR permit programs under RCRA section 4005(d), the specific criteria outlined in that regulation provide a helpful framework to examine the relevant aspects of a State's CCR permit program. States are familiar with these criteria because all States have MSWLF programs that have been approved pursuant to these regulations, and the regulations are generally regarded as protective and appropriate.

Consequently, EPA relied on the four categories of criteria outlined in 40 CFR part 239 as guidelines to evaluate the Wyoming CCR permit program: permitting requirements, requirements for compliance monitoring authority, requirements for enforcement authority, and requirements for intervention in civil enforcement proceedings.

Second, EPA must evaluate the technical criteria that will be included in each permit issued under the State CCR permit program to determine whether they are the same as the Federal criteria, or to the extent they differ, whether the modified criteria are “at least as protective as” the Federal requirements. See 42 U.S.C. 6945(d)(1)(B). Only if both components meet the statutory requirements may EPA approve the program. See 42 U.S.C. 6945(d)(1). EPA makes this determination by comparing the State's technical criteria to the corresponding Federal criteria and, where necessary, evaluating whether different State criteria are at least as protective as the Federal criteria.

Upon careful review, and as discussed in more detail below, EPA has preliminarily determined that Wyoming's partial CCR permit program includes all the elements of an adequate State CCR permit program. It also contains all the technical criteria in 40 CFR part 257, subpart D, except for the provisions specifically discussed below that Wyoming has not included in its partial CCR permit program. Consequently, EPA is proposing to approve the entirety of Wyoming's partial CCR permit program application. The State's CCR permit program does not encompass the full scope of Federal CCR requirements as presently constituted, and the provisions of the Federal CCR regulations that are not part of Wyoming's approved CCR permit program will remain directly applicable to affected CCR units. 42 U.S.C. 6945(d)(1)(B).

EPA's full analysis of the Wyoming CCR permit program, and how the Wyoming regulations differ from the Federal requirements, can be found in the Technical Support Document. EPA determined that the Wyoming CCR permit program application was complete and notified Wyoming of its determination by letter. 9

Section 4005(d)(1)(A) of RCRA, 42 U.S.C. 6945(d)(1)(A), requires a State seeking State CCR permit program approval to submit to EPA, “in such form as the Administrator may establish, evidence of a permit program or other system of prior approval and conditions under State law for regulation by the State of coal combustion residuals units that are located in the State.” Although the statute directs EPA to establish the form of such evidence, the statute does not require EPA to promulgate regulations governing the process or standard for determining the adequacy of such State programs. EPA, therefore, developed the Coal Combustion Residuals State Permit Program Guidance Document; Interim Final (82 FR 38685, August 15, 2017) (the “Guidance Document”). The Guidance Document provides recommendations on a process and standards that States may choose to use to apply for EPA approval of its CCR permit programs, based on the standards in RCRA section 4005(d), existing regulations at 40 CFR part 239, and the Agency's experience in reviewing and approving State programs.

EPA evaluated the Wyoming CCR permit program using the process and statutory and regulatory standards discussed in sections II.C. and IV.A. of this preamble. EPA's findings are summarized below and provided in more detail in the Technical Support Document located in the docket supporting this proposed determination.

In EPA's judgment, an adequate State CCR permit program must ensure that: (1) Existing and new facilities are permitted or otherwise approved and in compliance with either 40 CFR part 257 or other State criteria; (2) The State has the authority to collect all information necessary to issue permits that are adequate to ensure compliance with relevant 40 CFR part 257, subpart D requirements; and (3) The State has the authority to impose requirements for CCR units adequate to ensure compliance with either 40 CFR part 257, subpart D, or such other State criteria that have been determined and approved by the Administrator to be at least as protective as 40 CFR part 257, subpart D.

The permitting process in Wyoming involves three entities: (1) WDEQ; (2) The Solid and Hazardous Waste Division (SHWD) within WDEQ; and (3) The Environmental Quality Council (Council), an independent body whose members are appointed by the Governor. For a more detailed description, see section 5.0 of the Narrative Statement.

All owners and operators of existing and new CCR facilities in Wyoming are required to comply with State CCR rules found at Wyoming Administrative Rules, Environmental Quality, Solid Waste Rules (SWR) chapter 18, and to obtain a permit in accordance with Wyoming Statutes (WS) section 35-11-502 and SWR chapters 1 and 18. Wyoming law requires every person who treats or transports solid waste or operates a solid waste management unit or facility, including CCR units, to have a valid permit issued by WDEQ. WS section 35-11-502(a); SWR chapter 1, section 1(c), chapter 18, section 4(a). Permit application requirements can be found in SWR chapter 1, section 2, and chapter 18, section 4(d).

WDEQ has the authority to collect all information necessary to issue permits that are adequate to ensure compliance with SWR chapter 18. WS section 35-11-109. In addition, SWR chapter 18, section 4(d) specifies the information that applicants for a solid waste permit, including a CCR unit permit, are required to submit to show compliance with the SWR.

Existing CCR landfills must submit a permit renewal application no later than 12 months prior to the expiration date of the facility's existing solid waste permit. SWR chapter 18, section 4(d). Existing CCR surface impoundments must submit a new permit application within 12 months of the effective date of the State rule. Owners and operators of existing CCR landfills and surface impoundments that intend to cease disposal of all waste before obtaining a permit through the post-closure care period shall submit a closure permit application within 12 months prior to the expiration date of the facility's existing permit or the date the facility anticipates to cease disposal of CCR, whichever comes first. An alternate schedule to submit a new application, renewal application or closure permit application may be approved by the SHWD for good cause. SWR chapter 18, section 4(b).

Applications for renewal permits and closure permits are subject to the application procedures set forth in WS section 35-11-502 and SWR chapter 1, section 2(a), (b), and (c) and must follow the procedures and provisions of SWR chapter 1, section 2(d) and (e) respectively. CCR permits may be transferred from one operator to a new operator with written approval from WDEQ SHWD's Solid Waste Permitting and Corrective Action (SWPCA) Program Director (Director) in accordance with SWR chapter 1, section 3(d).

The permit duration for new or existing CCR surface impoundments and CCR landfills renewal permits will be for the operating life of the facility through post-closure, and closure permits will be issued for a period that includes the time required to complete closure activities and a minimum 30-year post-closure term. SWR chapter 18, section 4(c).

Within sixty days after a permit application has been submitted, WDEQ must notify the applicant whether or not the application is complete. WS section 35-11-502(e). Once WDEQ determines that an application is complete, WDEQ issues a letter of completeness and initiates a technical review of the permit application. At that time, the applicant must conduct a public notice and initiate a 30-day public comment period for the complete application, as described below. WS section 35-11-502(g), (h); SWR chapter 18, section 4. WDEQ must complete the technical review of the application within 90 days. During technical review of the application, WDEQ considers public comments submitted during the public comment period for the complete application. SWR chapter 18, section 2(c)(i)(C). Within WDEQ, the SHWD manages and implements the Wyoming CCR permit program. The SHWD may opt to conduct a public hearing on the application. SWR chapter 18 section 2(c)(i)(D).

Once the SHWD completes technical review of the application, it may make one of three determinations: (1) The permit application is technically inadequate; (2) The permit application is technically adequate, and a proposed permit is suitable for publication; or (3) The permit application is denied. WDEQ may modify, suspend, revoke, or deny a permit if: (1) Permit issuance would not meet the provisions of the Wyoming Environmental Quality Act, WS section 35-11-101 et seq. (the Act) or regulations; (2) The applicant fails to submit the required information; (3) The facility has a history of noncompliance; (4) The applicant indicates the facility would not comply with provisions of the regulations or misrepresents actual site conditions; (5) The applicant fails to employ a qualified solid waste manager; or (6) The applicant, or any partners, executive officers, or corporate directors has been found liable of violating environmental quality laws or criminal racketeering laws or regulations which constitute evidence that the applicant cannot be relied upon to conduct the operations described in the permit application in compliance with the Act or regulations. SWR chapter 1, section 4.

Provisions for amending permits for solid waste handling facilities are in SWR chapter 18, section 4(f). SWR chapter 18, section 3(c) specifies those changes to a permit that qualify as major amendments and which are minor amendments. Major amendments to permits may be requested by the Permittee and are reviewed and processed by the SHWD in accordance with the procedures for new or renewal permits described above. Minor amendments to permits may be completed through written notice and approval by the SHWD within 60 days. SWR chapter 18, section 3(c). A written notice of a minor amendment to a permit can be determined to be deficient, approved, or denied. Permittees can provide additional information to the SHWD in response to any deficiency notice.

EPA has preliminarily determined that the Wyoming approach to CCR permit applications and approvals is adequate, and that this aspect of the Wyoming CCR permit program meets the standard for program approval.

Based on RCRA section 7004, 42 U.S.C. 6974, it is EPA's judgment that an adequate State CCR permit program will ensure that: (1) Documents for permit determinations are made available for public review and comment; (2) Final determinations on permit applications are made known to the public; and (3) Public comments on permit determinations are considered and significant comments are responded to in the permit record. EPA's review of Wyoming's CCR permit program indicates that the State has adopted public participation procedures that allow interested parties to talk openly and frankly about permit issues and search for mutually agreeable solutions to differences in views. An overview of Wyoming's public participation provisions is provided below.

The State program provides public notice in several ways and at several different stages of the permitting process, which taken together ensure that documents for permit determinations are subject to public review and comment. WDEQ requires State CCR permit applicants to provide notice to the public. Once WDEQ determines that an application is complete, WDEQ issues a letter of completeness and initiates a technical review of the permit application. At this time, the applicant must conduct a public notice and initiate a 30-day public comment period for the complete application. WS section 35-11-502(g), (h); SWR chapter 18, section 4. The public notice must provide specific information about the facility, including its proposed size and location; the types of waste to be managed; methods that will be used to manage the waste; and the operating life of the unit. WDEQ must complete technical review of the application within 90 days. During technical review of the application, WDEQ considers public comments submitted during the public comment period for the complete application. SWR chapter 18, section 2(c)(i)(C). The SHWD may opt to conduct a public hearing on the application. SWR chapter 18 section 2(c)(i)(D). Permit renewals are subject to the same public notice and comment requirements as new permit applications and are therefore subject to two, 30-day public comment periods with options to hold a public hearing for each.

All applicants for solid waste permits that submit a new, renewal, closure or major amendment permit application are required to complete two public comment periods during the permitting process. The first public comment period occurs after the SHWD deems the permit application complete, and the second occurs when the SHWD deems the permit application technically adequate and issues a proposed permit in accordance with WS section 35-11-502, SWR chapter 1, section 2(c), and SWR chapter 18 section 4(f). Public notice for the complete application and for the proposed permit must contain information about the permit application including the applicant; the proposed facility location and size; the waste types intended for management; the method of waste management; and the operating life of the unit. Public notices must also contain information on how to obtain special assistance or alternate formats of a notice for individuals with disabilities and inform the reader to visit WDEQ's website for a Spanish translation.

The applicant is required to publish each written notice once a week for two consecutive weeks in a newspaper of general circulation within the county where the applicant plans to locate the facility or where an existing facility is currently located, for each public comment period. WS section 35-11-502 (g through k) and SWR chapter 18 section 2. Each public comment period begins on the first day of the notice publication and continues until 30 days after the second publication. The applicant is required to give written notice of the permit application to landowners with property located within one-half mile of the site, the mayor of each city or town within 50 miles of the site, the Local County Commission, any solid waste district located in the county, and the Solid Waste Permitting and Corrective Action Program Interested Parties Mailing List (hard copy). The written notice is also posted to WDEQ's Public Notice website.

Permit applications and review documents are available for public review at any WDEQ office and can be sent digitally upon request. Specific information on how to request access to permit documents is found in Wyoming's CCR permit program narrative Section 7.0 Public Participation (Page 14), Appendix G Public Notice Templates, SWR chapter 1 section 2(c), and WS section 35-11-502. Additionally, the public can contact the WDEQ and request to be added to a listserv or mailing list (Interested Parties Mailing List). Written comments on permit applications are accepted by mail, fax, and through WDEQ's digital comment portal. If a commenter has technical difficulties with the digital comment portal, the portal website has instructions for obtaining assistance.

Public comments received by WDEQ during the first public comment period for the complete application are considered by WDEQ in drafting a proposed permit. If substantial written comments, including objections to a proposed permit, are filed during the public comment period for the proposed permit, a public hearing shall be held by the Council within twenty days after the end of the public comment period. WS section 35-11-502(k). The Director shall render a decision on the proposed permit within 30 days after completion of the public comment period if no hearing is requested. If a hearing is held, the Director will issue or deny the permit no later than 15 days from receipt of any findings of fact and decision of the Council. WS section 35-11-502(k) and (m).

All comments received are considered and WDEQ provides a response to each commenter prior to making a final permit determination. In addition to providing responses to individual commenters, all files in WDEQ are available for the public to review unless they are found to be confidential under WS section 35-11-1101 or otherwise protected under the Wyoming Public Records Act. The public can submit a record request using the WDEQ website. The public can also request to view documents at any of WDEQ's offices.

Final permit determinations are required to be added to the owner or operator's CCR website within five days of the owner or operator's receipt of the determination. SWR chapter 18, section 11(c)(i). Documents produced and distributed as part of the permitting process are maintained by WDEQ as a public record in accordance with Wyoming Public Records Act and must be made available to the public accordingly. Public comments are subject to the Wyoming Public Records Act and maintained by WDEQ.

In accordance with WS section 35-11-502(k), any interested person has the right to file written objections to the proposed permit with the Director within 30 days after the last publication of the written notice given for the proposed permit. If substantial written objections are filed, the Wyoming Environmental Council (Council) holds a public hearing. WS section 35-11-502(k). To notify the public of a pending hearing, the Council must publish written notice of the time, date, and location of the public hearing in a newspaper of general circulation in the county where the facility would be located once a week for two consecutive weeks immediately prior to the hearing. The public hearing is to be conducted as a contested case under the Wyoming Administrative Procedure Act (WY APA). WS 16-3-107 through 16-3-112. Judicial review can be obtained pursuant to the WY APA. WS 16-3-114.

If a public hearing is held, the Council shall issue findings of fact and a decision on the proposed permit within 30 days afterward. WDEQ shall issue or deny the permit within 15 days after receiving findings of fact and decision of the Council. WS section 35-11-502(m)

WS section 35-11-1001 provides that any aggrieved party under the Act may obtain judicial review by filing a petition for review within 30 days after entry of the order or other final action complained of pursuant to the provisions of the WY APA. Any interested person has the right to file written objections to a proposed permit with the Director within 30 days after the last publication of the public notice for the public comment period for the permit. If substantial written objections are filed, a public hearing shall be held by the Council. WS section 35-11-112 charges the Council to act as the hearing examiner for WDEQ in any case contesting the grant, denial, suspension, revocation or renewal of any permit required by the Act. The hearing shall be conducted as a contested case in accordance with WY APA, WS sections 16-3-101 et seq.

The WY APA provides that any person aggrieved or adversely affected in fact by a final decision of an agency in a contested case, or by any other agency action or inaction, is entitled to judicial review. WS section 16-3-114.

EPA has preliminarily determined that the Wyoming approach to public participation requirements provides adequate opportunities for public participation in the permitting process sufficient to meet the standard for program approval. The provisions described above meet the three criteria listed at the beginning of this section by providing several means by which documents for draft and final permit determinations are made available for public review and comment, as well as ensuring that public comments on permit determinations are considered and significant comments are responded to in the permit record.

An adequate permit program must provide the State with the authority to gather information about compliance, perform inspections, and ensure that the information it gathers is suitable for enforcement. WDEQ has authority under WS section 35-11-109 to obtain any necessary documents and to conduct monitoring and testing to determine if an owner or operator of a CCR unit is in compliance with the permit and applicable regulations.

The Director or designated officers, employees, or representatives of WDEQ are also granted the authority under WS section 35-11-109 to conduct inspections of facilities, to inspect and copy any records, and to inspect any monitoring equipment or method of operation required to be maintained pursuant to the Act. Further, the application for a CCR unit includes an access agreement authorizing WDEQ to enter an operator's premises where a regulated facility or activity is located or conducted, or where records are kept, to perform inspections and to collect data for the purposes of ensuring compliance or as otherwise authorized by the appropriate rules and regulations of WDEQ. No permit shall be issued unless the owner of the facility provides the written authorization. SWR chapter 1, section 1(g).

In addition, the information that WDEQ collects or obtains during inspections, compliance monitoring, and enforcement, allows the State to verify the accuracy of information submitted by owners or operators of CCR units; verify the adequacy of methods (including sampling) used by owners or operators in developing that information; and produce evidence admissible in an enforcement proceeding. WS section 35-11-109.

Accordingly, EPA has preliminarily determined that these compliance monitoring authorities are adequate, and that this aspect of the Wyoming CCR permit program meets the standard for program approval.

An adequate State CCR permit program must provide the State with adequate enforcement authority to administer its State CCR permit program, including the authority to: (1) Restrain any person from engaging in activity which may damage human health or the environment, (2) Sue to enjoin prohibited activity, and (3) Sue to recover civil penalties for prohibited activity.

WS section 35-11-701 authorizes the Director to issue an order requiring the cessation and desistance of violations of the Act, rules, regulations, standards, permits, licenses or variances under the Act. In addition, if the Director has evidence that any pollution source presents an immediate and substantial danger to human or environmental health or safety, the Director may institute, through the Wyoming Attorney General, a civil action for immediate injunctive relief to halt any activity causing the danger. WS section 35-11-115(a). Further, WS section 35-11-109(a)(i) grants WDEQ wide-ranging authority to perform acts necessary to enforce the provisions of the Act and any rules, regulations, orders, or permits established or issued thereunder, and WS section 35-11-109(a)(vii) grants the Director wide latitude to prepare and present enforcement cases before the Council for violations of the Act or regulations promulgated under the Act. When compliance with the Act or the regulations applicable to CCR units, SWR chapter 18, is not achieved, WDEQ is authorized under the Act to engage in voluntary stipulated settlement or to initiate a civil enforcement action in Wyoming District Court.

Finally, under WS section 35-11-901(a), the Director can bring an administrative action for the assessment of civil penalties in Wyoming District Court against any person who violates, or any director, officer or agent of a corporate permittee who willfully and knowingly authorizes, orders or carries out the violation of any provision of the Act, or any rule, regulation, standard, or permit adopted thereunder or who violates any determination or order of the Council pursuant to the Act or any rule, regulation, standard, permit, license, or variance. Such violations are subject to a penalty not to exceed $10,000.00 for each violation for each day during which a violation continues; a temporary or permanent injunction; or both a penalty and an injunction. WS section 35-11-901(a).

Based on the foregoing, EPA has preliminarily determined that this aspect of the Wyoming CCR permit program meets the standard for program approval.

Based on RCRA section 7004, an adequate CCR State permit program must provide an opportunity for citizen intervention in civil enforcement proceedings. Specifically, the State must either: (1) Provide for citizen intervention as a matter of right; or (2) Have in place a process to: (a) Provide notice and opportunity for public involvement in civil enforcement actions, (b) Investigate and provide responses to citizen complaints about violations, and (c) Not oppose citizen intervention when permissive intervention is allowed by statute, rule, or regulation.

WS section 35-11-904(c)(ii) provides that any person may intervene as a matter of right when WDEQ, through the attorney general, has commenced a civil action to require compliance with the provisions of the Act, or any rule, regulation, order or permit issued pursuant to the Act. Additionally, WDEQ has the authority under WS 35-11-701(a) to investigate citizen complaints concerning violations.

Inasmuch as the State explicitly provides for citizen intervention in civil enforcement proceedings as a matter of right, EPA has preliminarily determined that these authorities provide for an adequate level of citizen involvement in the enforcement process, and that this aspect of the Wyoming CCR permit program meets the standard for program approval.

EPA conducted an analysis of the Wyoming CCR permit program application, including a thorough analysis of Wyoming statutory authorities for the CCR program, as well as its regulations at Solid Waste Rules chapter 18: Disposal of Coal Combustion Residuals in Landfills and Surface Impoundments. As noted above, Wyoming has requested approval of a partial CCR permit program.

WDEQ has identified 19 disposal units that are currently or have been used for disposal of CCR wastes (3 landfills and 16 surface impoundments) at 4 facilities in Wyoming. 10 WDEQ has demonstrated that it has the personnel to administer a permit program that is at least as protective as the Federal requirements. 11 The WDEQ SHWD is the lead program for permitting, compliance, and enforcement of CCR units. The WDEQ CCR Program is funded through the State budget process. The WDEQ budget is approved by the Wyoming State Legislature as identified in the Wyoming State Budget. In addition, WDEQ applied for EPA State and Tribal Assistance Grants (STAG) funding for Fiscal Years 2021 through 2023. In total, WDEQ has received $571,396 in funding to develop its CCR permit program. If EPA receives future appropriations, WDEQ can continue to apply for funds for implementation of its CCR permit program. EPA has preliminarily determined that the WDEQ staffing and funding are adequate for WDEQ to administer the CCR permit program.

EPA has preliminarily determined that the portions of the Wyoming CCR permit program that were submitted for approval meet the standard for approval under RCRA section 4005(d)(1)(B)(i), 42 U.S.C. 6945(d)(1)(B)(i). To make this preliminary determination, EPA compared the technical requirements in the Wyoming CCR regulations at SWR chapter 18 to the Federal CCR regulations at 40 CFR part 257 to determine whether they differed from the Federal requirements, and if so, whether those differences met the standard in RCRA sections 4005(d)(1)(B)(ii) and (C), 42 U.S.C. 6945(d)(1)(B)(ii) and (C).

WDEQ previously regulated CCR in landfills under the SWR starting in 1990. Under the Wyoming Water Quality Rules promulgated in 1975, Wyoming began regulating CCR surface impoundments. WDEQ incorporated by reference the Federal CCR regulations, promulgated through December 14, 2020, with the addition of those portions of the Act (appendix A of the application) and SWR (appendix B of the application) that were more stringent. This includes additional definitions, general facility information, design and operating criteria, groundwater monitoring, and requirements for co-disposing of other waste streams, which are described further in section V. of the TSD. WDEQ amended the regulations to adopt EPA amendments through December 14, 2020, and chapter 18 became effective on August 19, 2022.

WDEQ is seeking approval of its partial State CCR permit program pursuant to RCRA section 4005(d). The WDEQ's rules adopt the Federal CCR regulations promulgated through December 14, 2020. Wyoming is not seeking approval for the following four requirements of the Federal CCR regulations and, therefore, those requirements in the Federal CCR regulations will continue to apply directly to each regulated CCR unit in Wyoming:

With the exception of these four items, EPA has preliminarily determined that the Wyoming CCR regulations contain all of the technical elements of the Federal CCR regulations, including requirements for location restrictions, design and operating criteria, groundwater monitoring and corrective action, closure requirements and post-closure care, recordkeeping, notification, and CCR website posting requirements. The Wyoming CCR permit program also contains State-specific language, references, definitions, and State-specific requirements that differ from the Federal CCR regulations, but which EPA has determined to be “at least as protective as” the Federal criteria. These State-specific requirements are also discussed further in sections III.1. and V. of the Technical Support Document.

The effect of approving a State CCR permit program is that, except for the provisions for which EPA has not granted approval, the Wyoming CCR permit program will apply in lieu of the Federal CCR regulations. For the State provisions that will not be approved upon finalization, the corresponding Federal requirements will continue to apply directly to facilities, and therefore facilities must comply with both the Federal requirements and the State requirements.

In accordance with the Wyoming SWR, chapter 18, section 4(a), all CCR units must be permitted in accordance with chapter 18. WDEQ has not issued any SWR chapter 18 CCR permits in the State. In accordance with the SWR, chapter 18, section 4(b), existing CCR landfills and surface impoundments must submit an operating or closure permit application under chapter 18 under certain timeframes unless an alternate schedule is approved by the SHWD for good cause. New CCR units must obtain a permit under chapter 18 prior to construction.

Since WDEQ has not issued permits under the chapter 18 regulations, no Wyoming permits are part of the permit program record under review. In accordance with RCRA sections 4005(d)(3)(A) and 4005(d)(6), in the absence of a permit issued under an approved State program, the owner or operator of a CCR unit must continue to comply with the Federal CCR regulations until a permit from an approved State is issued. 42 U.S.C. 6945(d)(3)(A), (d)(6). Any permits issued after approval will be subject to program review provisions required by RCRA sections 4005(d)(1)(D)(i) and 4005(d)(1)(D)(ii). 42 U.S.C. 6945(d)(1)(D)(i), (ii).

EPA has preliminarily determined that the Wyoming partial CCR permit program meets the statutory standard for approval. Therefore, in accordance with 42 U.S.C. 6945(d), EPA is proposing to approve the Wyoming partial CCR permit program.

This is a summary of the Commission's Third Further Notice of Proposed Rulemaking ( Third FNPRM ), PS Docket Nos. 21-346 and 15-80; ET Docket No. 04-35, FCC 25-45, adopted August 4, 2025, and released August 6, 2025. The full text of this document is available by downloading the text from the Commission's website at: https://docs.fcc.gov/public/attachments/FCC-25-45A1.pdf. The full text of this document is available for public inspection and copying during regular business hours in the FCC Reference Center, 45 L Street NE, Washington, DC 20554. To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to FCC504@fcc.gov or call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice). A RULE relating to 47 CFR part 4 is published elsewhere in this issue of the Federal Register .

The proceeding this Third FNPRM initiates shall be treated as a “permit-but-disclose” proceeding in accordance with the Commission's ex parte rules. Persons making ex parte presentations must file a copy of any written presentation or a memorandum summarizing any oral presentation within two business days after the presentation (unless a different deadline applicable to the Sunshine period applies). Persons making oral ex parte presentations are reminded that memoranda summarizing the presentation must (1) list all persons attending or otherwise participating in the meeting at which the ex parte presentation was made, and (2) summarize all data presented and arguments made during the presentation. If the presentation consisted in whole or in part of the presentation of data or arguments already reflected in the presenter's written comments, memoranda or other filings in the proceeding, the presenter may provide citations to such data or arguments in his or her prior comments, memoranda, or other filings (specifying the relevant page and/or paragraph numbers where such data or arguments can be found) in lieu of summarizing them in the memorandum. Documents shown or given to Commission staff during ex parte meetings are deemed to be written ex parte presentations and must be filed consistent with § 1.1206(b). In proceedings governed by § 1.49(f) or for which the Commission has made available a method of electronic filing, written ex parte presentations and memoranda summarizing oral ex parte presentations, and all attachments thereto, must be filed through the electronic comment filing system available for that proceeding, and must be filed in their native format ( e.g., .doc, .xml, .ppt, searchable .pdf). Participants in this proceeding should familiarize themselves with the Commission's ex parte rules.

The Regulatory Flexibility Act of 1980, as amended (RFA), requires that an agency prepare a regulatory flexibility analysis for notice-and-comment rulemaking proceedings, unless the agency certifies that “the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities.” Accordingly, the Commission has prepared an Initial Regulatory Flexibility Analysis (IRFA) concerning potential rule and policy changes contained in this Third FNPRM. The IRFA is set forth in Appendix D of the FCC document, https://www.fcc.gov/document/fcc-proposes-modernization-nations-alerting-systems. The Commission invites the general public, in particular small businesses, to comment on the IRFA. Comments must be filed by the deadlines for comments on the NPRM indicated on the first page of this Third FNPRM and must have a separate and distinct heading designating them as responses to the IRFA.

This Third Further Notice of Proposed Rulemaking may contain revised information collection requirements. The Commission, as part of its continuing effort to reduce paperwork burdens, invites the general public and the Office of Management and Budget (OMB) to comment on the information collection requirements contained in this document, as required by the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4), we seek specific comment on how we might further reduce the information collection burden for small business concerns with fewer than 25 employees.

Consistent with the Providing Accountability Through Transparency Act, Public Law 118-9, a summary of this Third FNPRM will be available on https://www.fcc.gov/proposed-rulemakings.

The Third FNPRM proposes to redesign the DIRS user interface to offer manual DIRS filers the ability to file a single, dynamic form instead of the current array of ten separate worksheets concerning different types of service and infrastructure, and seek comment on this proposal. Under the current framework, when the Bureau activates DIRS, providers must log into DIRS the day after activation (and on each subsequent day during which DIRS remains active) to complete worksheets applicable to its infrastructure. As described below, each of the ten DIRS worksheets is about one page in length and includes multiple information fields for providers to complete, and providers that file manually must input line-item data for each report applicable to the services they provide—and sometimes must complete multiple versions of the same worksheet if, for instance, they have more than one type of major equipment affected by the disaster. Many of the worksheets request overlapping data, rendering the current DIRS manual reporting framework cumbersome and inefficient for manual filers. Moreover, the frequency and intensity of disasters has increased since the Commission first established DIRS in 2007, leading to more frequent and lengthier DIRS activations. This increase, combined with newly effective mandatory DIRS reporting obligations for cable communications, wireless, wireline and interconnected VoIP providers, makes it appropriate for us to examine whether to simplify the DIRS reporting framework.

Under our proposal, rather than filling out a series of separate, overlapping worksheets, providers that log into DIRS would respond to initial questions concerning the types of services they provide in the DIRS activation area and the types of equipment and facilities affected by the disaster. Based on these initial responses, each provider would be presented with questions seeking information relevant only to the services it provides, and would only be required to provide information common to multiple services and equipment types (such as the location and number of subscribers affected) once. For DIRS filers who complete the current worksheets manually, who we acknowledge represent a minority of the providers who are required to report in DIRS, this will also eliminate the need to complete multiple copies of certain worksheets if, for instance, they must report damage to multiple types of equipment or cell sites out in multiple counties. We further propose to include a “one-click” option on the consolidated worksheet for providers to indicate there is “no change” from the preceding day's DIRS report, which would eliminate the current need for providers to complete multiple steps to report each day when their infrastructure status has not changed. We believe these modifications may significantly simplify and reduce the time burden associated with manual DIRS data entry, while preserving the value of DIRS for the Commission and emergency management officials. We seek comment on this assessment.

We seek comment on how we could best implement these changes to DIRS. In an appendix, we propose sets of fields that we tentatively believe will be most relevant to each type of provider in DIRS and that therefore would need to be completed by those providers as part of the dynamic manual form. Should changes be made to this approach to ensure that providers are completing both all the fields that are relevant to them, and only the fields that are relevant to them? Are there additional ways in which we can streamline the method by which providers report in DIRS without adversely impacting either the quality or utility of information that DIRS provides to public safety stakeholders and emergency managers?

We have identified several of the current DIRS worksheets and information fields that we propose to eliminate or modify because they are duplicative or may not provide information that provides significant value for emergency response. Specifically, we seek comment on whether we should take the following actions:

• Eliminate the fields from the Inter-exchange Carrier (IXC) Blocking worksheet, which does not appear to have proven useful for disaster response.

• Eliminate the Satellite worksheet, which we believe is unnecessary because no satellite service providers have ever made a DIRS filling.

• Eliminate the “Percent of Historical Capacity Available” field from the Wireless Cell Site by County worksheet, because the Commission can determine the extent to which capacity is available based on the number of cell sites reported as up or down.

• Eliminate fields from the Cable System worksheet that request both the number of cable telephone subscribers served and the number whose service is down, as these fields duplicate data that also must be reported for VoIP service.

• Eliminate fields from the Cable System and Major Equipment worksheets that request the numbers of video subscribers served and the number whose service is down, because we do not believe the availability of cable video service constitutes critical disaster-response information.

• Eliminate the “Number of Access Lines” field from the Major Equipment worksheet, which is covered in more granular questions elsewhere on the same worksheet.

• Harmonize fields on the Interoffice Facilities—TSP worksheet with NORS by requesting information about the number of Optical Carrier circuits (or their functional equivalent) affected, and eliminating the requirement to report the “number of DS3s down.”

• Make it voluntary for providers to report the number of remote aggregation devices that are down on the Remote Aggregation Devices worksheet, which seeks information that is less crucial for emergency response than data requested elsewhere on the same worksheet.

• Make it voluntary, instead of mandatory, for providers to report the number of broadband data users served and the number of those users whose service is down, as found on the Major Equipment and Cable System worksheets (except as the Commission requires as a condition for the receipt of Universal Service Funds).

• Instead of the current approach, under which some worksheets request both the address and latitude and longitude of affected equipment or facilities, we would request location information in one of these formats (but not both) for each type of facility or equipment. We seek comment on whether this change would both reduce the number of fields in DIRS and improve the data by making it more uniform, and on whether, for each type of equipment or facility for which information is requested in DIRS, it would be more useful to request latitude and longitude or address.

We seek comment on whether eliminating or modifying these worksheets and fields would reduce the time burden associated with both manual and batch DIRS filing, and on whether the elimination or modification of these worksheets and fields would have a positive or negative effect on public safety or disaster recovery. For example, would eliminating fields concerning cable communications service video subscribers reduce emergency managers' visibility into disaster impacts to people with disabilities, given the role of video-enabled alerting and notifications for people with access and functional needs? We also seek comment on additional ways we can streamline the substance of DIRS reporting for manual and batch filers to reduce filing burdens and without sacrificing the value of DIRS for emergency response and recovery. Are there other ways the Commission can modify or improve the reporting process to reduce compliance burdens for smaller providers?

Because information reported in DIRS is vital to determining where the “reparation, replacement, and restoration of communications infrastructure” is needed, we seek to increase DIRS's utility as a key input to disaster recovery efforts. Given the emergence of public safety communications networks and offerings such as FirstNet, Verizon Frontline, and T-Priority, we seek comment on whether to add fields to DIRS, as shown in an appendix, to enable voluntary reporting on the status of public safety broadband networks during DIRS. Currently, AT&T's, Verizon's, and T-Mobile's DIRS infrastructure status reports do not distinguish impacts to their respective public safety broadband networks from effects on other customers. This prevents the Commission from disseminating information to emergency management agencies about outages that may affect first responders' ability to communicate with one another and with PSAPs in disaster-affected areas. The Commission proposed requiring FirstNet to report information about its infrastructure status in DIRS in the Second Report and Order & FNPRM, which most commenters supported in view of FirstNet's role in enabling communications for first responders during disaster response and recovery. FirstNet opposed this proposal, arguing that the information that it already provides to customers via its FirstNet Central platform is a sufficient source of near real-time operational status information. FirstNet Central, however, does not report outages within any specific required timeframe and is not accessible to non-FirstNet users. First responders rely on public safety broadband networks to access key technologies that affect situational awareness, such as cameras that convey real-time or historical data; internet-connected devices and sensors that monitor weather, traffic, environmental issues, or access to secured locations; and maps and Geographic Information Systems (GIS) that may provide the location of responders or assets, potential hazards, or relational information between personnel and assets. Thus, FirstNet and other public safety broadband networks are a critical component of timely and effective emergency response. Any disruption to these services could literally be a matter of life or death for first responders themselves or members of the public who rely on police, fire, and emergency medical services that subscribe to these services. In view of the particularly sensitive role FirstNet and other public safety communications networks can play by enabling first responders to communicate during emergencies, we believe it appropriate to collect information during disasters on the operational status of FirstNet and similar public safety communications networks on a voluntary basis and seek comment on this approach. How would public safety stakeholders use this information if it were to be collected? We also seek comment on the burdens that collecting and reporting this information in DIRS would pose to the providers of these public safety networks, and whether these providers should report this information on a mandatory or voluntary basis. In seeking comment, we seek to both refresh the record on this issue from the Second Report and Order & FNPRM and broaden its potential scope to include other public safety communications networks.

We also seek comment on whether the Commission should collect more granular information in DIRS from wireless providers on the location of cell sites that are out of service. Wireless service is an important lifeline during disasters and emergencies, including by enabling the public to receive Wireless Emergency Alerts (WEA). Currently, DIRS collects information about the county in which out-of-service cell sites are located. However, the average geographic size of a county in the United States is over 1,100 square miles, so the county-based data DIRS collects is often insufficient to pinpoint which communities have lost wireless connectivity. Emergency managers have often requested more specific cell site location and coverage information from the Commission to help prioritize recovery efforts. To provide first responders more actionable information, we propose to revise our Wireless Cell Site by County worksheet to enable wireless providers to voluntarily provide more granular location information for cell sites in a DIRS activation area, or, alternatively, to attach geospatial data describing cell site location and coverage to their DIRS submissions. In what format(s) and level of granularity should the Commission collect this data? We seek comment on whether and how public safety officials would use this information to support disaster response. We understand that many wireless providers already have this information and seek comment on the burden associated with providing it as part of their DIRS reports.

The Commission has delegated authority to the Bureau “to administer the communications disruption reporting requirements contained in part 4 of this chapter and to revise the filing system and template used for the submission of such communications disruption reports.” We believe that this existing delegation is sufficiently broad to allow the Bureau to implement these changes to DIRS, as well as future modifications to DIRS and its fields that may be needed to ensure that the system continues to serve its crucial role in disaster response and recovery. We seek comment on this view, including whether this delegation should be amended to more clearly describe the Bureau's administrative responsibilities.

We propose to eliminate the requirement for mandatory DIRS filers to submit a final report within 24 hours of DIRS deactivation and seek comment on this proposal. Based on our experience administering the DIRS final report requirement, we tentatively conclude that final DIRS reports are not sufficiently beneficial to justify the burden they impose. We do not believe that these reports contain additional information beyond what is included in regular DIRS filings that meaningfully improves the Commission's (or public safety officials') situational awareness. We have found that, during the 24-hour period between DIRS deactivation and the deadline to submit final DIRS reports, providers do not develop significantly deeper insight into the expected repair time for their degraded facilities. Indeed, 24 hours after DIRS deactivation, the timeframe for the recovery of damaged assets may still depend on factors outside of the service provider's control, such as the accessibility of the damaged area to service technicians or the availability of replacement parts. In such circumstances, providing a service restoration estimate to local emergency managers could do more harm than good by inviting reliance on an uncertain service restoration timeline. We also believe that eliminating final reports would reduce the overall DIRS reporting burden for mandatory DIRS filers and enable these providers to better focus their resources on restoration and recovery activities, rather than regulatory reporting, without adversely affecting public safety stakeholders. We seek comment on these beliefs.

We also seek comment on whether requiring mandatory DIRS reporting for cable communications, wireline, wireless, and interconnected VoIP providers has resulted in useful information for emergency managers and other public safety officials. For those public safety officials who have experienced DIRS activations under both voluntary and mandatory reporting regimes, are public safety officials receiving more useful and/or complete information than they did when DIRS reporting was voluntary? How are public safety officials using this information? Is it premature to make this assessment given that DIRS filing only became mandatory in February 2025 and there has only been one DIRS activation since then? If so, how much additional time do parties anticipate is needed to make an assessment? Are there additional changes to DIRS that would make it easier for providers to use and reduce the burdens associated with reporting? Are there other ways the Commission can modify or improve the reporting process to facilitate compliance with DIRS reporting obligations, e.g., how DIRS is activated, or how the Commission notifies communications service providers of DIRS activations?

DIRS enables the Commission to collect infrastructure status and restoration information from communications service providers during disasters and subsequent recovery efforts. However, as currently constituted, the Commission's mandatory DIRS reporting rules also apply to communications service providers that do not own their own infrastructure or other facilities, i.e., Mobile Virtual Network Operators (MVNOs) and wireline and interconnected VoIP resellers. As a result, these non-facilities-based providers are required to submit reports concerning infrastructure they do not own that will already be the subject of DIRS reporting by their facilities-based counterparts, creating additional burdens for them and for the underlying facilities-based providers who must relay infrastructure status to their non-facilities based partners to enable their reporting. To eliminate unnecessary burdens on MVNOs and resellers, as well as on the underlying facilities-based providers who support them, we propose to limit DIRS reporting to facilities-based providers and thereby exempt MVNOs and resellers from the obligation to file DIRS reports. We seek comment on this proposal.

Given the importance of wireless service in emergencies, in order to maintain situational awareness about the impact of disasters on service to customers of MVNOs, we propose to require facilities-based wireless providers to list in their initial report in DIRS which MVNOs utilize their respective networks within the DIRS activation area. In this way, providers would only need to list their MVNO information once. Further, we expect that facilities-based providers to have this information readily available, as such network use arrangements are governed by detailed agreements with the MVNOs, and seek comment on this belief. Alternatively, would requiring MVNOs to identify their underlying network provider as part of a limited DIRS filing be a more efficient and less burdensome way to collect this information? Would information about the operational status of MVNOs be valuable to federal, state, Tribal, territorial, and local stakeholders for maintaining visibility into the operational status of all wireless service providers and their subscribers? To what extent would this proposal reduce compliance burdens for non-facilities-based providers and/or their facilities- based partners? Would it be useful for the Commission to also require facilities-based wireline and VoIP providers to list in DIRS which resellers utilize their respective networks within the DIRS activation area?

In its petition, ATIS asked the Commission to clarify whether the Commission's waiver of NORS filing obligations during DIRS activations extends to activations of DIRS Lite. DIRS Lite collects information about the status of major wireline and wireless assets, such as switches, and PSAPs, for disaster events that are less serious than those triggering DIRS activations. Instead of filers reporting in an online system as they do when DIRS is activated, DIRS Lite consists of information compiled by Commission staff in response to email and telephone requests to communications service providers. As a result, the scope of the DIRS-Lite information collection is narrower than that of DIRS and is not available to agencies with NORS or DIRS access. We seek comment on whether the NORS reporting waiver afforded to mandatory DIRS filers should be extended to providers that share information with the Commission during DIRS-Lite activations. Is the information the Commission receives in DIRS-Lite activations an appropriate substitute for NORS reporting in situations where DIRS-Lite is activated? Would public safety stakeholders have sufficient visibility into communications infrastructure status from DIRS-Lite submissions, given both the voluntary nature of DIRS-Lite activations and the fact that the Commission's NORS and DIRS information sharing regime does not extend to DIRS Lite? Would extending the NORS waiver to DIRS-Lite activations create a gap in the Commission's outage records and data analysis, allowing providers to avoid NORS filings, which require information about the cause and scope of an outage, while submitting only information the provider chooses to include as part of a voluntary oral or emailed submission to Commission staff?

Since direct access to NORS and DIRS filings became available on September 30, 2022, only 22 federal, state, Tribal, or territorial emergency management or public safety agencies have sought and been granted direct access. Our understanding is that several emergency management agencies have declined to participate in the Commission's NORS and DIRS information sharing program because they regard the requirements as too burdensome. As a result of this relatively low rate of adoption, we are concerned that NORS and DIRS information is being underutilized during emergencies. We seek comment on this view.

We seek comment on ways to simplify our information sharing requirements to make it easier for emergency management agencies to obtain direct access to NORS and DIRS filings for use in restoration and recovery efforts. For example, we seek comment on whether eliminating the following provisions of the Participating Agency Certification Form would encourage greater participation by federal and state agencies while continuing to safeguard confidential information: (1) remove provisions that simply restate the rules and associated training materials; (2) eliminate requirements that agencies annually recertify to the terms of access; (3) dispose of requirements that agencies regularly change user account passwords; and (4) remove requirements that requesting agency employees complete initial and annual security trainings to access NORS and DIRS reports. We also seek comment on whether to loosen the restrictions on how non-confidential NORS and DIRS data can be shared and used, so that the information can be shared more broadly with local public safety agencies and government agencies with relevant equities outside the emergency-management space. If these restrictions are loosened, which sharing restrictions should be modified or eliminated and what kinds of additional uses should be allowed? We seek comment on whether these actions would further our goal of promoting more robust participation in the Commission's information sharing program, which would in turn enhance emergency response and public safety efforts.

The Commission could also ease access to DIRS data by making some information included in DIRS filings more widely available to the public. We seek comment on whether there are types of information currently included in DIRS filings that could be subject to public disclosure without adversely impacting national security or commercially sensitive interests. Narrowing the presumption of confidentiality for DIRS filings may allow the Commission to include more data in public DIRS reports, eliminating the need for emergency management agencies to enter into complex information sharing agreements with the Commission while still protecting providers' most sensitive data. This approach would also increase overall transparency into the reliability of providers' networks, which will increase competition between providers. Allowing greater public access to DIRS reports could result in a variety of potential benefits, including more information for the public about the scope of outages and disaster-related service disruptions when they occur, so that they can fund alternative means of communications. Moreover, researchers or other groups could collate and analyze the data in DIRS reports to help identify systemic or provider-specific problems and recommend solutions. As the Commission has recognized, even limited information disclosure from outage reports can spur industry-wide collaboration to improve network reliability issues and other improvements. Is it necessary for all of the information filed in DIRS to continue to be treated confidentially? What specific categories of information do providers view as particularly sensitive that may warrant continued confidential treatment, and what harms may arise if that information was publicly released?

We believe that our proposals to reduce the burdens of DIRS reporting on service providers will result in annual cost savings of approximately $4 million, which outweighs the $1,400 one-time cost and the $215,000 annual recurring costs to implement these changes. The approximate $4 million benefit estimate includes cost savings of $143,000 for streamlining the filing process and eliminating the final report requirement for facilities-based voice providers, $3.9 million from eliminating DIRS reporting obligations for MVNOs and VoIP resellers, and $700 for waiving the NORS filing requirement when DIRS LITE is activated. The cost estimates include a $1,400 one-time cost for DIRS batch filing reconfiguration, an annual cost of $143,000 for facilities-based wireless providers to include MVNO information in DIRS filing, and an annual cost of $72,000 for public safety broadband networks to report outages when DIRS is activated. These net cost savings, along with freeing up resources to restore and maintain service, will outweigh any potential effects on public safety from the Commission no longer receiving and sharing certain types of infrastructure status information.

Pursuant to staff estimation, at the county-level, there are on average 53 fixed voice providers, including cable communications, wireline, and VoIP providers per county. Among these, an average of 12 fixed voice providers are facilities-based, and 41 are non-facilities-based resellers. We further estimate that there are an average of six facilities-based mobile wireless voice providers and 82 MVNOs per county. We estimate the overall benefits from cost savings for providers that arise from modifying DIRS as proposed above to be approximately $143,000. By removing the need for providers to select from the current array of ten separate forms concerning different types of service and infrastructure, we estimate that manual filers should be able to complete their filings more quickly than prior to these changes. In addition, we estimate that eliminating unnecessary and duplicative fields will allow DIRS filings to be submitted more quickly. While it is difficult to precisely estimate the change in burden for providers overall due to differences in burdens that arise from differing service types, size, extent of service area, and preferred filing method, we estimate that these changes are likely to result in at least a 20% reduction in the amount of time that providers must spend on average when filing in DIRS on average. Our proposal to eliminate the requirement to file a final DIRS report further reduces this burden. 2025 statistics suggest a base hourly wage of $24.12/hour. According to the Bureau of Labor Statistics, as of March 2025, civilian wages and salaries averaged $32.92/hour and benefits averaged $15/hour. Using these figures, benefits constitute a markup of $15/$32.92 ~46%. Taking 46% for cost of benefits ($11.10/hour), we arrive at an hourly compensation of $35.22/hour ($24.12/hour + $11.10/hour). We estimate the cost saving from streamlining DIRS reporting with a (20% cost reduction) × 1 office and administrative support worker × ($35.22 hourly compensation) × [(10/60) hours for the initial entry + (10/60) hours for daily updates × 14 days] × 339 counties × 18 facilities-based service providers = $107,456. We further estimate a $35,819 cost saving from eliminating the final reporting requirement as 1 office and administrative support worker × ($35.22 hourly compensation) × (10/60) hours for the final report entry × 339 counties × 18 facilities-based service providers = $35,819. The aggregate cost saving is $143,275 (= $107,456 + $35,819), which we round to $143,000. Using the updated 2025 hourly compensation figure of $35.22, we estimate a total annual cost savings of $143,000 for facilities-based providers. We seek comment on our analysis. We seek comment on whether this methodology remains an appropriate starting point for identifying the cost savings that arise from the changes to DIRS that we propose today. If not, what methodology should we use to determine the costs associated with DIRS filings?

We recognize that our proposal to eliminate certain data fields may cause service providers that use the DIRS batch filing option to incur one-time costs. In batch filing, a service provider utilizes the Commission's spreadsheet template so that multiple DIRS worksheets can be filed simultaneously. In response to our proposed reporting field changes, a provider may need to reconfigure its systems to reorganize how it exports data, and to ensure that the data is formatted in a manner accepted by DIRS. This may involve a one-time cost of an Information Technology (IT) professional, such as a database administrator, setting up the new index. According to the BLS, a database administrator has an average hourly wage of $51.65 per hour, which would amount to a total hourly compensation of $75.41/hour. We find this by taking 46% for cost of benefits ($23.76/hour), arriving at an hourly compensation of $75.41/hour (= $51.65/hour + $23.76/hour). Updating a provider's systems can take anywhere from a few seconds to several hours, depending on the amount of data fields. The amount of data required for a DIRS report is relatively minimal. Accordingly, we estimate that the one-time costs would require an average of one hour in view of the amount of data being modified. We estimate the total cost to be no more than $1,357 = 1 database administrator × $75.41/hour × 1 hour × 18 facilities-based cable, wireline, wireless, and interconnected VoIP providers, which we round to $1,400. This would result in an upfront cost of no more than $1,400 if all the DIRS filers use the batch filing option, which we believe would be significantly outweighed by the recurring cost savings described above. We seek comments on these cost estimates.

We estimate that clarifying that we are excluding resellers and MVNOs from the requirements to file in DIRS will result in additional savings of $3.9 million for those categories of providers. In the Second Report and Order, we did not include resellers and MVNOs in the cost calculation. Instead, we estimated that an average county would be supported by 54 voice providers, including facilities-based providers and VoIP resellers but omitting any MVNOs. As currently constituted, the Commission's mandatory DIRS reporting rules also apply to service providers that do not own their own infrastructure, i.e., MVNOs and wireline and interconnected VoIP resellers. To eliminate unnecessary burdens on MVNOs and resellers, we propose to limit DIRS reporting to facilities-based providers and thereby exempt MVNOs and resellers from the obligation to file DIRS reports. We estimate that the proposed exclusion of non-facilities-based providers from the DIRS filing requirement will result in an annual cost savings of $3.9 million for these affected MVNOs and resellers. We arrived at this estimate by calculating an average of 82 MVNOs and 41 resellers providing service in each county, and then applying the same cost methodology for DIRS filings that we use in the Second Report and Order. Specifically, we estimate the cost savings as follows: 1 office and administrative support worker × ($35.22 hourly compensation) × [(10/60) hours for the initial entry + (10/60) hours for daily updates × 14 days + (10/60) hours for the final report entry] × 339 counties × (82 MVNOs + 41 resellers) = $3,916,182, which we round to $3.9 million. To maintain situational awareness about the impact of disasters on service to customers of MVNOs, we propose to require facilities-based wireless providers to list in DIRS which MVNOs utilize their respective networks within the DIRS activation area. We believe the cost of requiring facilities-based wireless providers to list in DIRS which MVNOs utilize their respective networks within the DIRS activation area would be minimal because facilities-based providers should have this information readily available. Nevertheless, we conservatively estimate that the additional reporting cost should not be greater than the overall DIRS reporting burden for these wireless facilities-based providers. We estimate $143,000 as an upper bound of such incremental costs, as follows: (1-20% cost saving) × 1 office and administrative support worker × ($35.22/hour) × [(10/60) hours for the initial entry + (10/60) hours for daily updates × 14 days] × 339 counties × 6 facilities-based wireless providers = $143,275, which we round to $143,000. We recognize that requiring information on public safety broadband networks to be included in DIRS reports may trigger additional costs. We estimate this additional filing cost will not exceed $72,000, using (1-20% cost saving) × {1 office and administrative support worker × ($35.22/hour) × [(10/60) hours for the initial entry + (10/60) hours for daily updates × 14 days] × 339 counties × 3 public safety broadband network providers} = $71,637, which we round to $72,000. We do not account for any benefits and costs arising from collecting additional voluntary information ( e.g., granular location information) because providers will only voluntarily provide such information when they deem the benefits from providing such information outweigh the costs. We seek comment on these estimates.

For extending the NORS suspension to DIRS Lite, we estimate the cost savings to be approximately $70 per DIRS-Lite responder. The Commission has historically estimated that a provider requires two hours to complete all of the NORS filing requirements. The Commission previously activated DIRS Lite for New Mexico wildfires in 2024 and for Hawaii wildfires in 2023. Our records indicate that 10 service providers responded during each DIRS-Lite activation. In view of this information, we estimate that providers would have saved approximately $700 per year by having their NORS filings requirements waived, by estimating that that the task of reporting outages in NORS can be accomplished by a miscellaneous office and administrative support worker × 2 hours per provider × $35.22 per hour × 10 providers = $704, which we round to $700 per year. We seek comment on our analysis.

We seek comment on the benefit from cost savings associated with our proposed changes to the Commission's NORS and DIRS information sharing requirements. In the past, we have estimated that each agency participating in that framework would spend five hours preparing, reviewing, and submitting its initial request for NORS and DIRS access to the FCC and a similar amount of time annually to re-certify their qualifications to access NORS in every year thereafter. These initial and annual requirements include the review of the security training materials and the submission of the certification and recertification forms, which we propose to simplify in the Third FNPRM. Would the proposed changes reduce the number of hours that agencies would require to apply for NORS and DIRS access, and if so, by how much? Are there other ways in which the changes to NORS and DIRS that we propose above would reduce burdens on agencies that seek NORS and DIRS information?

We further seek comment on the benefits and costs associated with loosening the restrictions on how non-confidential NORS and DIRS data can be shared and used, and making more data publicly available. Commenters are encouraged to provide specific examples, suggesting guiding criteria for making confidentiality determinations when the harms of disclosure outweigh the benefits of public access to these data. We particularly welcome input supported by data, legal precedent, and practical experience.

As required by the Regulatory Flexibility Act of 1980, as amended (RFA), the Federal Communications Commission (Commission) has prepared an Initial Regulatory Flexibility Analysis (IRFA) of the policies and rules proposed in the Third FNPRM assessing the possible significant economic impact on a substantial number of small entities. The Commission requests written public comments on this IRFA. Comments must be identified as responses to the IRFA and must be filed by the deadlines for comments specified on the first page of the Third FNPRM. The Commission will send a copy of the Third FNPRM, including this IRFA, to the Chief Counsel for the Small Business Administration (SBA) Office of Advocacy. In addition, the Third FNPRM and IRFA (or summaries thereof) will be published in the Federal Register .

The Third FNPRM explores the benefits of reducing burdens faced by small and other service providers and government agencies so that they can dedicate more resources to restoring and maintaining service during a disaster. The Third FNPRM also seeks comment on collecting new information that we believe would offer significant public safety value, namely collecting infrastructure status information for public safety communications service offerings like FirstNet, and collecting cell site location data for downed cell sites on a voluntary basis. Our proposals not only reduce burdens from the mandated reporting requirements of the Second Report and Order, but also burdens that arise from the Commission's sharing information contained within the outage reports. The Commission believes the proposals in the Third FNPRM strike the appropriate balance of reducing regulatory burdens for providers while insuring we collect necessary and relevant information when disasters occur.

This action is authorized pursuant to sections 1, 4, 201, 214, 218, 251, 301, 303(b), 303(g), 303(j), 303(r), 307, 309, 316, 332, and 403, of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154, 201, 214, 218, 251, 301, 303(b), 303(g), 303(j), 303(r), 307, 309, 316, 332, 403; and sections 2, 3(b), and 6-7 of the Wireless Communications and Public Safety Act of 1999, 47 U.S.C. 615 note, 615, 615a-1, and 615b.

Small Businesses, Small Organizations, Small Governmental Jurisdictions. Our actions, over time, may affect small entities that are not easily categorized at present. We therefore describe three broad groups of small entities that could be directly affected by our actions. First, while there are industry specific size standards for small businesses that are used in the regulatory flexibility analysis, in general, a small business is an independent business having fewer than 500 employees. These types of small businesses represent 99.9% of all businesses in the United States, which translates to 34.75 million businesses. Next, “small organizations” are not-for-profit enterprises that are independently owned and operated and not dominant their field. While we do not have data regarding the number of non-profits that meet that criteria, over 99 percent of nonprofits have fewer than 500 employees. Finally, “small governmental jurisdictions” are defined as cities, counties, towns, townships, villages, school districts, or special districts with populations of less than fifty thousand. Based on the 2022 U.S. Census of Governments data, we estimate that at least 48,724 out of 90,835 local government jurisdictions have a population of less than 50,000.

The rules proposed in the Third FNPRM if adopted will apply to small entities in the following industries: All Other Telecommunications; Media Streaming Distribution Services, Social Networks, and Other Media Networks and Content Providers; Radio Stations; Satellite Telecommunications; Telecommunications Resellers; Television Broadcasting; Wired Telecommunications Carriers; and Wireless Telecommunications Carriers (except Satellite). Affected entities within these identified industries include: Competitive Local Exchange Carriers; Incumbent Local Exchange Carriers; Local Exchange Carriers; Wired Telecommunications Carriers; Interexchange Carriers; Local Resellers; Toll Resellers; Telecommunications Resellers; Wireless Telecommunications Carriers (except Satellite); and Wireless Telephony.

The proposed requirements in the Third FNPRM, if adopted, will impose new or modified reporting, recordkeeping and/or other compliance obligations on small entities which should simplify and reduce regulatory reporting and filing requirements. These proposed requirements include exempting non-facilities-based providers from mandatory DIRS reporting and eliminating the DIRS final report; redesigning the DIRS user interface to allow manual DIRS filers to use a single dynamic form instead of completing a series of forms and overlapping worksheets; presenting small and other providers only with questions relevant to the services they provide and only require information common to multiple services and equipment types to be provided once; voluntarily collecting infrastructure status information for public safety communication service offerings like FirstNet and cell site location data for downed cell sites; and eliminating or making voluntary completion of specific data fields not core to disaster recovery and response. While the majority of the Commission's proposals in the Third FNPRM, if adopted, will result in cost saving for small and other providers, the Commission is aware that our proposal to eliminate certain data fields may result in small and other providers that use the DIRS batch filing option to incur a one-time cost for an Information Technology (IT) professional, such as a database administrator. Small entities therefore may have to hire an IT professional to the extent they do not already have one. We believe this expense would be significantly outweighed by the recurring cost savings of our other proposal in Third FNPRM. We also recognize that requiring information on public safety broadband networks to be included in DIRS reports may trigger additional costs.

None.

The Third FNPRM seeks comment on proposals to reduce burdens for service providers during a disaster. We expect the comments we receive in response to the Third FNPRM to include information which should help the Commission further identify, and evaluate relevant issues and burdens for small entities, including compliance costs, before adopting final rules. The Commission's proposals in the Third FNPRM reflect the significant alternatives we considered to reduce the burdens of DIRS reporting and minimize the economic impact for small and other providers. While we continue believe the benefits of DIRS reporting for purposes of disaster response and recovery outweighs its burdens, the Commission is mindful that DIRS reporting requires providers to allocate resources to reporting while they are simultaneously responding to an ongoing disaster. We consider several alternatives in the Third FNPRM that seek to give small and other providers maximum flexibility and reduce potential costs of compliance with our various proposals, and seek comment on other means to reduce DIRS reporting burdens. We expect to consider the economic impact more fully on small entities following our review of comments filed in response to the Third FNPRM and the IFRA. The Commission's evaluation of this information will shape the final alternatives it considers to minimize any significant economic impact that may occur on small entities, the final conclusions it reaches and any final rules it promulgates in this proceeding. The Third FNPRM seeks comment on any alternatives to the Commission's proposals that could reduce burdens, particularly for small entities, while preserving the intended benefits of DIRS reporting.

Accordingly, it is ordered , pursuant to the authority contained in sections 1, 4, 201, 214, 218, 251, 301, 303(b), 303(g), 303(j), 303(r), 307, 309, 316, 332, and 403, of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154, 201, 214, 218, 251, 301, 303(b), 303(g), 303(j), 303(r), 307, 309, 316, 332, 403, sections 2, 3(b), and 6-7 of the Wireless Communications and Public Safety Act of 1999, 47 U.S.C. 615 note, 615, 615a-1, and 615b, that this Third Further Notice of Proposed Rulemaking in PS Docket Nos. 21-346 and 15-80 and ET Docket No. 04-35 is adopted .

It is further ordered that the Commission's Office of the Secretary shall send a copy of this Notice of Proposed Rulemaking, including the Initial Regulatory Flexibility Analysis, to the Chief Counsel for Advocacy of the Small Business Administration.

For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR part 4 as follows:

DOT requires urine drug testing and authorizes oral fluid drug testing as an alternative methodology to urine drug testing of safety-sensitive transportation industry employees subject to drug testing under part 40 of Title 49 of the Code of Federal Regulations (part 40). DOT's part 40 regulations are in turn incorporated by reference in the drug and alcohol testing requirements of each of its operating administrations such that updates to part 40 automatically update the pertinent requirements of DOT's operating administrations. 1

DOT is issuing this NPRM to harmonize part 40, as appropriate, with the revised HHS UrMG published on October 12, 2023 (88 FR 70768), the HHS OFMG published on October 12, 2023 (88 FR 70814), and the HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs-Authorized Testing Panels published on January 16, 2025 (90 FR 4662). The Department proposes to harmonize with these HHS Mandatory Guidelines because the Omnibus Transportation Employee Testing Act (OTETA) of 1991 requires DOT to incorporate the HHS scientific and technical guidelines that establish comprehensive standards for all aspects of laboratory testing of controlled substances to ensure full reliability and accuracy in testing. DOT also proposes to clarify certain existing part 40 drug testing program provisions and to make technical amendments.

This NPRM is issued pursuant to OTETA of 1991 (Pub. L. 102-143, Tit. V, 105 Stat. 952). While DOT has discretion concerning many aspects of the regulations governing testing in the transportation industries' regulated programs, the Department must follow the HHS Mandatory Guidelines for the minimum list of drugs for which DOT requires testing and the standards for laboratory drug testing. Section 503 of the Supplemental Appropriations Act, 1987 (Pub. L. 100-71, 101 Stat 391, 468), 5 U.S.C. 7301, and Executive Order 12564 establish HHS as the agency that establishes scientific and technical guidelines for Federal workplace drug-testing programs and standards for certification of laboratories engaged in such drug testing.

DOT first published its drug-testing program regulation, part 40, on November 21, 1988, as an interim final rule (53 FR 47002). The Department based the rule on HHS's April 11, 1988, Mandatory Guidelines for Federal Workplace Drug Testing Programs (See 53 FR 11970), which, in part, required Federal agencies to test employees for cocaine and marijuana. HHS based this requirement on the incidence and prevalence of the abuse of these two substances in the general population and on the experiences, at the time, of the Departments of Defense and Transportation in screening their workforces (See 53 FR 11970). Agencies also were authorized under the 1988 HHS Mandatory Guidelines to test for phencyclidine, amphetamines, and opiates. Among other provisions from those guidelines, DOT published a final rule on December 1, 1989 (54 FR 49854) that incorporated a 5-panel test with all of the drugs HHS authorized for testing.

The Department made comprehensive revisions to part 40 on several occasions and harmonized with the HHS Mandatory Guidelines where necessary. For example, on August 16, 2010 (See 75 FR 49850), DOT harmonized with the HHS Mandatory Guidelines effective October 1, 2010 (See 73 FR 71858; 75 FR 22809). Specifically, the Department required initial and confirmatory testing for methylenedioxymethamphetamine (MDMA), confirmatory testing for methylenedioxyamphetamine (MDA) and methylenedioxymethamphetamine (MDEA); and initial testing for 6-acetylmorphine (6-AM). The Department also lowered the initial and confirmatory test cutoff concentrations for amphetamines and cocaine to conform with HHS changes. On November 13, 2017 (See 82 FR 52229), DOT harmonized with HHS Mandatory Guidelines effective October 1, 2017 (See 82 FR 7920). Specifically, the Department required the initial and confirmatory testing for four additional Controlled Substances Act (CSA) Schedule II prescription opioid medications: hydrocodone, hydromorphone, oxycodone, and oxymorphone. DOT also removed MDEA as a confirmatory test analyte and added MDA as an initial test analyte from the existing drug-testing panel. On May 2, 2023 (See 88 FR 27596), the Department harmonized with the HHS OFMG effective January 1, 2020 (See 88 FR 57554). Specifically, DOT amended part 40 to authorize oral fluid drug testing in the DOT drug testing program. This additional methodology for drug testing gives employers a choice that will help combat employee cheating on urine drug tests as oral fluid tests are inherently directly observed. Oral fluids testing provides a less intrusive means of achieving the safety goals of the program.

After declaring the opioid crisis a public health emergency in 2017, the President signed the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) into law on October 24, 2018. Section 8105 of the Fighting Opioid Abuse in Transportation Act, included in the SUPPORT Act, required the Secretary of HHS to determine whether it is justified, based on the reliability and cost-effectiveness of testing, to revise the Mandatory Guidelines to include fentanyl. 2 In addition, Section 8105 required the Secretary of HHS to consider whether to include any other drugs or other substances listed in Schedule I and II of section 202 of the Controlled Substances Act (CSA) (21 U.S.C. 812). 3

Historically, when adding or removing drugs/analytes from the authorized drug testing panel, which was included in the HHS Mandatory Guidelines, HHS would publish “proposed revised Mandatory Guidelines” and after reviewing public comment and consulting with its Drug Testing Advisory Board (DTAB), publish “revised Mandatory Guidelines.” On April 7, 2022 HHS proposed (87 FR 20560; 87 FR 20522), and then revised on October 12, 2023, its UrMG (88 FR 70768) and OFMG (88 FR 70814), establish a new process for adding and removing drugs/analytes from its drug testing panel that would be more responsive to drug use trends, as well as provide flexibility based on the state of the science ( e.g., new technologies and research including dosing studies). Using this new process, HHS would conduct a thorough review of the scientific and medical literature, solicit input from subject matter experts including DTAB, and provide an opportunity for public comment. Rather than publish the updated drug testing panels ( i.e., drugs, analytes, and cutoffs) in the HHS Mandatory Guidelines, HHS would publish them annually or as necessary, in the Federal Register and post them on the HHS website. The drug testing panels are still part of the HHS Mandatory Guidelines by reference in Section 3.4 in both the UrMG and OFMG.

Utilizing the new process described above, HHS issued a notice in the Federal Register on October 17, 2023 announcing a December 5, 2023 DTAB meeting and agenda, which included a proposal to update the HHS drug testing panels to include fentanyl and norfentanyl (88 FR 71582). On November 17, 2023, HHS published a notice of correction to the October 17, 2023 notice stating that the DTAB Board would discuss the Mandatory Guidelines and the proposed revisions to the drug testing panels to (1) add fentanyl for urine and oral fluid and norfentanyl for urine, (2) remove MDMA and MDA, and (3) ask for public comment on its recommended changes to the authorized drug testing panels (88 FR 80323). In both notices, HHS listed the proposed initial and confirmation cutoffs for fentanyl and norfentanyl in urine, listed the proposed initial and confirmation cutoffs for fentanyl in oral fluid, and asked for public comment on the proposed cutoffs.

HHS said:

Fentanyl accounts for a large proportion of overdose deaths in the United States and is therefore an important public safety concern. Furthermore, fentanyl is increasingly used as a stand-alone substance of abuse, not in conjunction with heroin and other substances as was common in the past. According to the National Forensic Laboratory Information System (NFLIS) 2021 report, fentanyl was the 4th most frequently identified drug and accounted for 11.61% of all drugs reported by forensic laboratories. Norfentanyl is an important component of identifying fentanyl users when urine is the specimen matrix. Fentanyl has been detected in oral fluid in pain management patients, overdose cases, and driving under the influence of drugs (DUID) cases. Information provided by HHS-certified laboratories in 2023 indicated that a majority (84%) of the laboratories have previously analyzed non-regulated workplace specimens for fentanyl and/or norfentanyl and that all had the ability to analyze urine specimens for fentanyl with sufficiently sensitive detection limits using commercially available immunoassay kits and confirmatory test instrumentation commonly used in HHS-certified laboratories. 4

On November 1, 2023, DOT sent out a listserv notice  5 informing employers, employees, and testing service providers involved in the DOT drug testing program of the upcoming DTAB meeting, and that the meeting agenda included a discussion regarding a possible update to the HHS analyte table to include fentanyl. DOT reminded the readers that it must follow the HHS scientific guidelines for DOT-regulated drug testing laboratory procedures, and that any change to the HHS analyte table may affect the DOT testing program under part 40, but only after DOT conducts its own conforming rulemaking. The listserv notice also stated that HHS was requesting public comment on the recommendation to add fentanyl and norfentanyl (along with their proposed testing cutoffs) to the analyte table and that comments could be submitted (1) prior to the DTAB meeting, (2) during the DTAB meeting, (3) up to 30 days after the DTAB meeting, but no later than January 4, 2024, or (4) via email to HHS.

On February 9, 2024, HHS published a notice announcing a March 5, 2024 open-session DTAB meeting (89 FR 9166) with presentations regarding the proposed changes to the analyte table, fentanyl prevalence, fentanyl immunoassay updates, cost and benefits analysis, and a summary of public comments received regarding the proposed changes to the HHS drug testing panels. As with the other DTAB-related notices discussed earlier, this notice discussed the reasons for adding fentanyl/norfentanyl and removing MDA and MDMA from the panel and requested public comment on the proposed changes. At the March 5, 2024 open-session DTAB meeting, there were presentations on (1) the prevalence of fentanyl and norfentanyl in non-regulated specimens, (2) the availability of fentanyl and norfentanyl assays, (3) the costs of testing for fentanyl and norfentanyl, and (4) a summary of the public comments received regarding the proposed panel changes ( i.e., addition of fentanyl and norfentanyl and removal of MDMA and MDA from the panel). 6 There were 118 commenters and 176 comments received. 7 The commenters included substance abuse professionals (SAPs), designated employer representatives (DERs), medical review officers (MROs), laboratory responsible persons, employer safety directors/managers, truck drivers, consortium/third-party administrators (C/TPAs), nurses, school district transportation services managers, and national drug testing associations and transportation industry associations. 8

In a January 16, 2025 Federal Register notice (90 FR 4662), HHS added fentanyl (for urine and oral fluid) and norfentanyl (for urine only) to the authorized drug testing panels after (1) conducting studies to determine the prevalence of fentanyl in drug testing specimens, (2) examining the current state of the technology available to HHS-certified laboratories for initial and confirmatory testing for fentanyl and norfentanyl, (3) identifying and analyzing peer-reviewed publications that reported concentrations of fentanyl and/or norfentanyl in urine and oral fluid to help identify the appropriate testing cutoff concentrations, (4) requesting, receiving, and reviewing public comment, (5) conducting a cost analysis, and (6) considering input from DTAB.

HHS also said that though they had proposed to remove MDMA and MDA from the drug testing panels due to the significantly low laboratory positivity rates, retain MDMA and MDA on the testing panels. This decision was based on HHS's review of all the comments to the docket. HHS said that removing MDMA and MDA from the testing panels was not warranted at this time, but that it will continue to monitor MDMA and MDA prevalence, assess the costs and benefits of removing one or both analytes in the future, and engage with DTAB on the issue.

In the same Federal Register notice, HHS included separate tables with abbreviations for the drug analytes and required HHS laboratories and MROs to report results using this nomenclature. This was done for consistency and to avoid misinterpretations of test results. Specific to marijuana, the drug testing panels include revised abbreviations for the marijuana test analytes to be consistent with current scientific nomenclature. In the urine drug test panel, both the initial and confirmatory test analytes for marijuana were changed from THCA to Δ9THCC. In the oral fluid drug testing panel, both the initial and confirmatory test analytes for marijuana were changed from THC to Δ9THC. HHS also edited Footnote 1 in both drug testing panels to include more specific and updated criteria for alternate technology initial drug tests.

In the latest revisions to the UrMG (effective February 1, 2024) and the OFMG (effective October 10, 2023), HHS also authorized laboratories to conduct biomarker testing in urine and oral fluid specimens after HHS approval and made edits to reflect this change ( e.g., adding and defining the terms “biomarker,” “biomarker testing panel,” and “drug testing panel,” and revising the existing definition of “substituted” to address the change to report specimens as substituted based on biomarker testing). Once a biomarker test has been added to the HHS-authorized biomarker testing panel, HHS-certified laboratories may routinely conduct the test without requiring an MRO request, and only require a signed MRO request for case-by-case biomarker testing (in accordance with OFMG section 3.5). HHS continued to require the National Laboratory Certification Program (NLCP) to review biomarker assay validation records before allowing a laboratory to use the test for federally regulated workplace specimens. 9 HHS will review and approve biomarkers based on submitted laboratory data and support from the scientific and medical literature, then will add approved biomarkers to the biomarker testing panel in a subsequent Federal Register notice. At the time of this NPRM, no biomarkers have been approved for Federal workplace drug testing.

HHS also made other revisions to the UrMG  10 and OFMG, 11 including (1) revising the urine confirmatory test cutoff for morphine, (2) removing the additional decision point of 15,000 ng/mL for codeine and morphine in urine, (3) removing the MRO requirement to determine clinical evidence of illegal opioid use to support a positive codeine or morphine result in urine and oral fluid drug testing, and (4) revising the definitions of “adulterated specimen,” “cutoff,” “initial specimen validity test,” “negative result,” “substituted specimen,” and “positive result.”

In keeping with the Department's statutory obligation under OTETA of 1991 to incorporate the HHS Mandatory Guidelines specifically for the minimum list of drugs for which DOT requires testing, and for the scientific and technical guidelines related to laboratory testing procedures, the Department proposes to amend part 40 to (1) add the drugs fentanyl and norfentanyl and their respective cutoffs for initial and confirmatory testing (as listed in the HHS urine and oral fluid drug testing panels published in the Federal Register on January 16, 2025, (90 FR 4662)) to the DOT drug testing panels (fentanyl would be added to both the urine and oral fluid testing panels, and norfentanyl to the urine testing panel); (2) adjust the laboratory confirmatory test cutoff for morphine in urine drug testing; (3) remove the MRO requirement to determine clinical evidence of illegal opioid use to support a positive codeine or morphine result in urine and oral fluid drug testing; (4) add and define the term “biomarker” and revise the definitions of “adulterated specimen,” “cutoff,” “initial specimen validity test,” “negative result,” “positive result,” and “substituted specimen” for clarity and consistency with HHS; (5) authorize laboratories to conduct biomarker testing once HHS approves laboratory biomarker testing; (6) amend the analyte nomenclature for marijuana in both drug testing panels; and (7) revise the footnotes in both drug testing panels to include more specific and updated criteria for alternate technology initial drug tests. The Department will also provide clarification for certain existing drug testing program provisions and make certain technical amendments.

There are two types of fentanyl: pharmaceutical fentanyl and illicitly manufactured fentanyl. Both are considered synthetic opioids. Pharmaceutical fentanyl is prescribed by doctors to treat severe pain, especially after surgery and for advanced-stage cancer. Most cases of fentanyl-related overdose are linked to illicitly manufactured fentanyl, 12 which is distributed through illegal drug markets for its heroin-like effect. It is often added to other illicit drugs because of its extreme potency, which makes those drugs cheaper, more powerful, more addictive, and more dangerous. Fentanyl is up to 50 times stronger than heroin and 100 times stronger than morphine. It is a major contributor to fatal and nonfatal overdoses in the U.S. 13 Even in small doses, it can be deadly. Over 150 people die in the U.S. every day from overdoses related to synthetic opioids, primarily fentanyl. 14

The following is a representative sampling of information provided by various organizations that have reported on fentanyl use trends over the past few years:

• Drug overdose death rates involving fentanyl increased by 279 percent from 5.7 per 100,000 in 2016 to 21.6 in 2021, according to new data from the CDC's National Center for Health Statistics (NCHS). 15

• In 2022, the CDC's NCHS reported and predicted that the number of drug overdose deaths involving synthetic opioids (including fentanyl but excluding methadone) and psychostimulants with abuse potential (such as methamphetamine) continue to increase compared to the previous year. 16

• According to the State Health Access Data Assistance Center (SHADAC), “Not only has fentanyl become the dominant substance driving today's crisis of drug overdose deaths, but it also has become the center of gravity around which other drugs orbit.”  17

• According to the DEA, “While recent data shows progress in reducing overdose deaths from record highs, nearly half of teens still don't know that counterfeit prescription pills often contain lethal amounts of fentanyl. This lack of knowledge is leading to tragic consequences—young people are dying simply because they didn't know the pill they took was fake. That's why we need to turn awareness into action.”  18

• “While provisional data from the CDC indicates a 25.5% decrease in overdose deaths in the 12 months ending October 2024 compared with the same period in 2023, approximately 150 Americans die every day from overdose involving illegal, synthetic opioids such as illegally made fentanyl. Overdose remains the leading cause of death among Americans aged 18-44. The Administration and HHS remain committed to preventing substance use initiation, reducing the number of lives lost to overdose, and helping Americans to overcome substance use disorders, achieve recovery, and live healthy lives.”  19

• “Approximately 70% of U.S. overdose deaths in 2023 were estimated to involve illegally manufactured fentanyls (IMFs). Local reports indicate reemergence of carfentanil, a fentanyl analog.”  20

In light of this compelling information regarding fentanyl use (and the national attention on this issue), and consistent with the action taken by HHS, the Department proposes to amend the DOT drug testing panels to meet our statutory obligation under OTETA of 1991, and to raise the level of safety for the transportation industry and the transported public. Specifically, the Department proposes to amend the drug-testing panels in sections 40.85(a) and 40.91(a) to include fentanyl in the urine and oral fluid testing panel and norfentanyl to the urine testing panel (along with their corresponding test cutoff concentrations), amend the MRO verification process to include these drugs, and amend Appendices D and E of part 40 to add fentanyl and norfentanyl to the drugs listed on the laboratory reports to employers and DOT.

Recognizing that the term “opioid” is used in a broad context to include various natural, synthetic, and semi-synthetic opioids, the Department proposes to modify its definition of “opioid” in section 40.137 to remove the specific semi-synthetic compounds ( i.e., hydrocodone, hydromorphone, oxycodone, and oxymorphone) and use the term “opioids” when referring to the opiates, synthetic opioids, and semi-synthetic opioid test results that an MRO may review and verify.

Currently, for a laboratory to report a positive codeine/morphine  21 result for a urine specimen, the laboratory-confirmed result must be greater than or equal to 2,000 ng/mL. 22 In our December 19, 2000 final rule (65 FR 79462), the Department established a process to address a laboratory-reported positive result, which depends on the laboratory-reported codeine/morphine level. If the morphine level is between 2,000 and 15,000 the burden of proof is on the MRO, if the level is above 15,000 the burden of proof is on the employee. This process was established, in part, to address positive laboratory-reported codeine/morphine results that may be due to poppy seed ingestion. Specifically, if the laboratory-reported codeine or morphine concentration for a urine specimen is greater than 2,000 ng/mL and less than 15,000 ng/mL, the MRO is required to examine the employee for clinical signs of unauthorized use or refer the employee to another physician for this purpose. In conducting the examination of the employee, the MRO or physician may consider such factors as needle tracks, behavioral or psychological signs of acute addiction, clinical history of unauthorized use including admissions by employees, or use of foreign opiate medication without substantiation that the medication was obtained and used legally. 23 The MRO is to use his/her best professional and ethical judgment on a case-by-case basis. If the MRO finds clinical evidence, then the result is verified as “positive.” If the MRO does not establish that there is clinical evidence of unauthorized use of an opiate, then the result is verified as “negative.” If the laboratory-reported codeine/morphine concentration is 15,000 ng/mL or greater, then the burden of proof falls on the employee to provide a legitimate medical explanation, which the employee may meet by showing that she or he had used a legally prescribed medication. When an employee cannot establish a legitimate medical explanation for codeine/morphine at or above 15,000 ng/mL, then the MRO verifies the test as positive.

On April 7, 2022, HHS proposed revisions to its UrMG to (1) raise the confirmatory test cutoff for morphine in urine from 2,000 ng/mL to 4,000 ng/mL and (2) remove the additional requirement for clinical evidence of illegal opioid use to verify laboratory-reported positive codeine/morphine results less than 15,000 ng/mL as positive (87 FR 20560). Regarding morphine cutoff levels, HHS stated that it had reviewed several studies and concluded that those studies “. . . confirm that urine morphine concentrations exceeding 4,000 ng/mL would be very rare, transient, and a consequence of unrealistic and extreme poppy seed exposure ( i.e., ingesting barely tolerable amounts of raw and/or unwashed poppy seeds).” HHS also cited the DEA's 2019 warning about unwashed poppy seeds from online retailers, which stated “. . . their use and misuse may result in unpredictable outcomes including death when used alone or in combination with other drugs. DEA reiterated that morphine and codeine, if present as contaminants on poppy seed material, are not exempted from Controlled Substances Act (CSA) control.” HHS concluded that “. . . the Department is not aware of any evidence that reasonable or realistic consumption of poppy seed-containing food products would cause a positive drug test using the codeine and morphine cutoffs specified by these Guidelines. Only purposeful consumption of large amounts ( e.g., 15 g or more) of raw and/or unwashed poppy seeds has been shown to result in codeine at or above 600 ng/mL or in morphine exceeding 4,000 ng/mL, and the extreme amounts of poppy seeds in these studies, described by subjects as intolerable or barely tolerable, do not represent a real-world situation for donors in a Federal agency testing program.” Based on its review of existing research, which did not show that reasonable or realistic consumption of poppy seed-containing products would cause a positive urine drug test result for codeine at the established cutoff of 2,000 ng/mL, HHS did not propose to adjust the cutoff level for codeine in urine.

As mentioned above, the requirement to look for clinical evidence of illegal opioid use to verify laboratory-reported positive codeine/morphine results of less than 15,000 ng/mL (for urine) was established to address positive laboratory-reported codeine/morphine results that may be due to poppy seed ingestion. Because HHS has now identified a morphine cutoff level at which reasonable or realistic consumption of poppy seed-containing products would not trigger a positive urine drug test result, and because the existing codeine cutoff level would also not trigger a positive urine drug test result, HHS has removed the requirement for MROs to look for clinical evidence of illicit opiate use as a decision point on whether to report a urine codeine/morphine result as negative or positive due to poppy seed ingestion.

In its October 2023 revised UrMG effective February 1, 2024, HHS adjusted only the confirmatory test cutoff for morphine from 2,000 ng/mL to 4,000 ng/mL and removed the requirement for clinical evidence of illegal opioid use to verify laboratory-reported positive urine codeine/morphine results less than 15,000 ng/mL as positive as proposed. HHS said that it had received one comment agreeing with the proposed change. HHS made these changes following a notice and opportunity for public comment.

Because DOT's laboratory drug testing procedures must remain consistent with the HHS UrMG as required by OTETA of 1991, the Department proposes to amend the urine drug testing panel in section 40.85 by adjusting the morphine confirmation cutoff from 2,000 ng/mL to 4,000 ng/mL and propose to remove the word “concentrations” from the header in the table to be consistent with the terminology in the HHS urine drug testing panel. Because the proposed morphine cutoff is at a level at which reasonable or realistic consumption of poppy seed-containing products would not trigger a positive urine drug test result, and because the existing codeine cutoff level would also not trigger a positive urine drug test result, there is no need for an additional decision point ( i.e., clinical evidence of illegal opioid use). Therefore, the Department proposes to remove the additional requirement in section 40.139 for a clinical exam to identify evidence of illicit opiate use as a decision point on whether to report a codeine/morphine result as negative or positive due to poppy seed ingestion. Instead, DOT proposes that MROs follow the existing verification process outlined in section 40.137. Accordingly, the Department proposes to modify section 40.137 to include the verification of opiates (6-AM, codeine, and morphine) previously found in section 40.139.

In further support of this proposal, the Department has heard from MROs anecdotally that they have difficulty finding a physician to complete the required clinical examination and that a majority of those examinations result in the MRO verifying the result as “negative.” Based on calendar year 2023 data from four HHS-certified laboratories (which conduct approximately 44 percent of the annual DOT tests), approximately 1,782 of the 6.8 million drug tests administered in the DOT program were reported with morphine results between 2,000 ng/mL and 15,000 ng/mL (899 tests were between 2,000-4,000 ng/mL, and 883 tests were between 4,000-15,000 ng/mL). By adjusting the urine morphine confirmation cutoff in part 40, and by removing the requirement for clinical evidence of illegal opioid use for laboratory-reported positive codeine/morphine results less than 15,000 ng/mL, the Department expects that MROs will be better able to verify laboratory-reported urine codeine/morphine results.

In the OFMG effective January 1, 2020, HHS established a confirmatory cutoff of 15 ng/mL for both codeine and morphine for laboratories to report a laboratory-confirmed positive result and a codeine/morphine level of 150 ng/mL (10 times that of the confirmatory test cutoff) as a conservative decision point for MROs to rule out the possibility of a positive result due to poppy seed consumption. HHS noted that “the 150 ng/mL concentration is higher than the highest concentration seen in study subjects at one hour and later after consumption of raw poppy seeds and products containing poppy seeds.”  24 In its OFMG effective October 10, 2023, HHS maintained the confirmatory cutoff of 15 ng/mL for both codeine and morphine for laboratories to report a laboratory-confirmed positive result. HHS also maintained a codeine/morphine level of 150 ng/mL). The MRO must report a codeine/morphine result at or above 150 ng/mL as “positive” unless the employee provides a legitimate medical explanation for the result.

HHS removed the requirement for the MRO to conduct a clinical examination ( i.e., physical examination) for laboratory-reported oral fluid results between 15 ng/mL and 150 ng/mL when the donor claimed the result was due to poppy seed consumption. In these cases, the MRO reports the result as “negative” unless the employee admits illicit use. As explained in the HHS April 7, 2022 proposed OFMG (87 FR 20522), MROs routinely conduct donor interviews by telephone, rather than in-person, and some MROs had expressed concern about the feasibility of making a clinical assessment ( i.e., physical examination) of the donor. HHS concluded that the additional requirement for clinical evidence of illegal opioid use in these situations was no longer practical or effective. HHS adopted the proposed revisions with no changes in the October 2023 revised OFMG.

DOT proposes to harmonize with HHS on this point as well. Given that HHS has established a “bright line” for codeine/morphine results of 150 ng/mL (having determined that results above this level cannot be caused by the ingestion of poppy seed products and that results below this level are those that MROs are most likely to report a “negative” result based on a clinical exam), the Department does not see the need for an additional decision point (clinical evidence of illegal opioid use) to rule out codeine/morphine results that may have been due to ingestion of poppy seed products. Therefore, the Department proposes to remove the requirement for the MRO to conduct a clinical exam if the result is at or above 15 mg/mL and less than 150 ng/mL, and to report codeine/morphine levels between 15 ng/mL and 150 ng/mL as “negative” when the employee claims poppy seed ingestion. If the employee does not claim poppy seed ingestion (and for all other codeine/morphine results), the Department proposes that MROs follow the existing verification process outlined in section 40.137.

Because the Department is proposing for an MRO to report a “negative” when the oral fluid codeine/morphine oral fluid results are at or above 15 mg/mL and less than 150 ng/mL when the employee claims poppy seed ingestion, the Department is therefore also proposing to amend section 40.151(d) to include an exception for laboratory positive codeine or morphine, or both, results. Currently paragraph (d) instructs the MRO not to consider an employee's claim of passive or unknown ingestion stories as a legitimate medical explanation.

Since the Department is proposing to remove the requirement for MROs to look for clinical evidence of illegal opioid use in codeine/morphine results in urine and oral fluid specimens, and instead follow the process outlined in section 40.137, there is no need for section 40.139. The Department therefore proposes to move the verification of 6-AM results from section 40.139 to section 40.137 and to remove the remaining section 40.139 in its entirety. DOT specifically seeks comments from MROs on these issues.

A biomarker is an endogenous substance used to validate a biological specimen. The purpose of a biomarker test is to determine if the submitted specimen is a human urine or oral fluid specimen as there are many ways a DOT-regulated transportation employee could effectively mask illicit drug use. In essence, a biomarker test is a specimen validity test (SVT). In the October 2023 revisions to the UrMG, HHS adopted its proposed changes to modify the definition of “substituted specimen” to include biomarker test results as an additional reason indicating that a specimen has been submitted in place of an actual donor specimen, and the process for adding biomarkers as well as including them in a biomarker testing panel. HHS adopted procedures to allow for review and comment before any biomarker panel change is published in the Federal Register . If a laboratory identifies and validates a biomarker test and submits it to HHS for approval, HHS will follow its established process for ensuring the test result is scientifically valid and forensically defensible. A laboratory can only conduct biomarker testing once approved by HHS and the biomarker is added to the authorized biomarker panel. HHS has not made biomarker testing mandatory.

Consistent with HHS's April 2004 (69 FR 19644)  25 amendments to make SVT mandatory for Federal employee testing under the HHS Federal Workplace Drug Testing Program, the Department made SVT on DOT urine specimens mandatory in 2008 as an appropriate response to the use of adulterants and attempts to subvert the specimen collection and laboratory testing process. (73 FR35961). 26 The widespread availability of various adulteration and substitution products has not changed since then, and DOT believes that more products are available, including information and online personal testimonials from individuals who have used those products. A simple internet search for “how to beat a drug test” yields hundreds, if not thousands, of results. Any individual who intentionally tries to “beat a drug test” is of significant concern to transportation safety and the traveling public. That said, the drug testing process is in place to ensure that individuals can perform their job functions safely and effectively, and do not subvert drug testing procedures that help ensure public safety.

Given that the purpose of a biomarker test—a laboratory standard for drug testing—is to determine if the submitted specimen is a human specimen, the Department proposes to harmonize with HHS to include biomarker testing as an additional component of SVT for urine. The Department realizes that as biomarker tests are developed by individual laboratories, approved by HHS, and added to HHS's biomarker panel(s), not all laboratories may have the technical capability to conduct biomarker testing and, therefore, will not offer that testing. Therefore, the Department thinks it is prudent to wait until more laboratories have the technical ability to conduct biomarker testing before making it mandatory for DOT testing. Like HHS, DOT will not propose to make biomarker testing mandatory in either urine or oral fluid at this time. DOT proposes to amend sections 40.86, 40.87, and 40.88 to authorize biomarker testing in urine. Though DOT has already authorized SVT for oral fluid specimens (See section 40.92), the Department will clarify that SVT testing may include testing for biomarkers. DOT also proposes to amend section 40.93 by removing albumin or immunoglobulin G (IgG) as examples of biomarkers. Though they serve as examples, the Department, like HHS, is removing them because there is a process HHS established to have biomarkers approved and DOT does not want to mislead anyone into thinking that they are approved biomarkers for testing. Furthermore, DOT proposes to harmonize with HHS to amend the definition of “substituted specimen” in section 40.3, add a definition for “biomarker” in the same section, and require a laboratory to report a “substituted” result when a biomarker is absent or when its concentration is not consistent with that established for human urine. However, DOT does not propose to include a biomarker testing panel in part 40, but simply to refer to HHS's published biomarker panel as reference in the Mandatory Guidelines. The Department welcomes comments on this issue.

Because the Department proposes to amend the definition of “substituted specimen” to include the results of a urine or oral fluid biomarker test, DOT also proposes to amend an existing procedural safeguard for employees in the MRO review process for laboratory-reported substituted results. Specifically, in section 40.145, DOT proposes to include a biomarker test result as a test result for which the employee can provide medical evidence to the MRO that the employee can produce a specimen without the presence of a specific biomarker when one is expected in a human specimen, or a specimen with a biomarker concentration that is not consistent with that established for human specimens.

The Department proposes to modify some existing definitions and add a new term to section 40.3 to align more closely with definitions in the revised HHS Mandatory Guidelines. DOT welcomes your comments on these proposed changes. Specifically, the Department proposes to revise the following definitions, consistent with the HHS definitions:

• Adulterated specimen revised to include “nitrite” as an example of a substance present in urine that will cause a laboratory to report an adulterated result;

• Cutoff revised to include “biomarkers” as criteria used in the decision for the laboratory in reporting a specimen result or the need for further testing;

• Initial specimen validity test revised to state that a “dilute” result is applicable only to a urine specimen;

• Negative result revised to include the text “drug metabolite.” This is to clarify that a drug or drug metabolite, or both, is either not present or less than the cutoff concentration for the drug or drug metabolite;

• Positive result revised to clarify that the quantity of drug reported by the laboratory is equal to or greater than the confirmatory test cutoff. This should help to alleviate any misunderstanding that the final result is not based on the initial test cutoff, but on the confirmatory test cutoff; and

• Substituted specimen revised to clarify that a urine or oral fluid specimen can also be reported as substituted based on evidence of either the absence of a biomarker or a biomarker concentration inconsistent with that of a human specimen.

The Department proposes to add the following definition:

• Biomarker is an endogenous substance used to validate a biological specimen.

In the urine and oral fluid drug testing panels, HHS revised the drug analyte name and abbreviation nomenclature specifically for the marijuana metabolite. The change was made to be consistent with current scientific nomenclature. In the urine drug test panel, both the initial and confirmatory test analytes for marijuana were changed from THCA to Δ9THCC. In the oral fluid drug testing panel, both the initial and confirmatory test analytes for marijuana were changed from THC to Δ9THC. The oral fluid drug testing panel does not identify the THCA metabolite as in the urine drug testing panel, but identifies the active Δ9THC analyte. This nomenclature change does not affect the testing process for marijuana, but instead, just affects how laboratories and MROs are to refer to the marijuana analyte. Also, based on current technology and program experience, HHS revised Footnote No. 1 to both drug testing panels to include more specific and updated criteria for alternate technology initial drug tests. In keeping with the OTETA of 1991 requirement to incorporate HHS laboratory standards, the Department proposes revising the drug testing panels in sections 40.85 and 40.91 to harmonize with HHS by incorporating this nomenclature change for marijuana and the revisions in Footnote No. 1.

As discussed in the May 2023 final rule, section 40.40(c)(2) no longer mandates that fax numbers be included on the chain of custody form (CCF). Sections 40.14(d) and (f), however, require the employer to provide employer and MRO fax numbers to the collector. This was an oversight, and the Department proposes to correct section 40.14 to be consistent with section 40.40. Specifically, in sections 40.14(d) and (f), DOT proposes to amend the text to make providing the employer and MRO fax numbers to the collectors optional.

The Department proposes to fix an incorrect reference in section 40.25(a)(2), which states that as “ . . . an employer regulated by FMCSA, you must comply with the requirements of this section by using the FMCSA's Drug and Alcohol Clearinghouse in accordance with 49 CFR 382.71(a).” That reference should read section 382.701(a), and not section 382.71(a). Also, in section 40.25(b)(5), DOT directs employers to request certain drug and alcohol information about a prospective employee seeking to begin performing safety-sensitive duties. Though the Department did not specify in (b)(5) all the documents relating to the return-to-duty requirements, these documents include two SAP reports (the initial assessment report and the follow up evaluation, which also includes the follow up testing plan), the return-to-duty test result(s), and the completed follow up test results. DOT is proposing to amend (b)(5) by listing these documents so employers know what documents they need to obtain so they can verify that the prospective employee has completed the DOT return-to-duty requirements.

As discussed in the preamble to the May 23, 2023 final rule, and consistent with numerous other deletions of the term “urine” in instances where the rule was intended to cover both urine and oral fluid specimens, the Department amended section 40.31 to separately specify the requirements for collectors of urine and oral fluid specimens. In doing so, DOT did not remove the word “urine” from paragraph (a). Also, DOT believes that paragraphs (b) and (c) should be subparagraphs to paragraph (a). As such, the Department is proposing to remove the word “urine” from paragraph (a) and redesignate (b) and (c) to be subparagraphs (a)(1) and (a)(2) respectively and redesignate paragraphs (d) to (b), (e) to (c) and (f) to (d).

Over time, the Department has heard from associations and individual trainers suggesting that the program and collectors (for urine and oral fluid) would greatly benefit if both the qualification training and the initial proficiency demonstration were completed within 30 days of the completing the qualification training. They also suggested that if an individual cannot complete the entire training within 30 days, the individual re-take the qualification training. The associations and trainers said that the longer the timeframe between the qualification training and the mock collections ( i.e., the initial proficiency demonstration), the more the trainee will forget the part 40 required procedures, making it harder for the trainee to demonstrate proficiency during the mock collections. They also pointed out that the “Breath Alcohol Technician Training: DOT Model Course” already has this standard as a recommendation. Specifically, the model course recommends that: (1) individuals arrange to take the procedural and device proficiency training simultaneously, (2) the entire training process should be completed within 30 days, and (3) the individual be required to retake the procedural training program if the student has not completed the device proficiency training within 30-days of the start of the qualification training.

The Department agrees that the closer in time the qualification training and initial training proficiency are completed, the greater the retention of information and the greater the chances of successfully completing the initial proficiency demonstration. As a program, the Department wants only those qualified to be collectors and Screening Test Technicians (STT)/Breath Alcohol Technicians (BAT) to collect specimens and administer alcohol tests. The Department also agrees that this should be the standard for all collectors and alcohol test technicians ( i.e., urine collectors, oral fluid collectors, screening test technicians, and breath alcohol technicians). With the above in mind, DOT proposes to amend sections 40.33, 40.35, and 40.213 to include a 30-day timeframe within which the qualification training and initial proficiency demonstration must be completed when an individual becomes qualified as a collector or alcohol technician, or both, for the first time. There will be no additional costs associated with this proposal as the qualification training and initial proficiency demonstration are already required. The Department is not proposing, however, that the 30-day timeframe also apply to when the oral fluid collector or alcohol technician, or both, seek to qualify on a second device. Because they have already demonstrated proficiency in part 40 when they first became qualified, they will only need to complete mock collections that demonstrate proficiency on the “new-second” device they will be using.

As stated above, the Department paralleled the oral fluid collector qualifications in section 40.35 as closely as possible to our existing urine collector qualifications in section 40.33. Regarding the mock collection scenarios specified in section 40.33(c)(1), one scenario is the employee refuses to sign the CCF and initial the specimen bottle tamper-evident seal. In the Department's May 2023 final rule (88 FR 27596), DOT included the first part of the scenario (refusing to sign the CCF) but inadvertently left out the second part (refusing to initial the specimen bottle tamper-evident seal). The Department proposes to correct this omission.

Also in the May 2023 final rule, DOT amended section 40.33(f) to not require error correction training for a urine collector when a test was cancelled for circumstances that are beyond the control of the collector. For example, when a specimen is damaged by a delivery truck or is lost in transit. DOT intended to mirror this amendment in section 40.35(f) for oral fluid collectors as it made sense that similar situations could happen with oral fluid specimens and the oral fluid collector should not be held accountable for those errors. To ensure as much consistency as possible, between the urine and oral fluid collector training requirements and to not burden the oral fluid collector with unnecessary error correction training, the Department is proposing to amend section 40.35(f) to not require error correction training for an oral fluid urine collector when a test is cancelled for circumstances that are beyond the control of the collector.

Part 40 is clear when the employer is responsible for determining if a refusal to test occurred. For example, with respect to collections, the collector documents what happened at the collection site and provides the employer with the information for the employer to make a final decision about whether the employee's conduct constitutes a refusal to test (See sections 40.191(d)(1)) and 40.355(i)). Section 40.61(f), however, provides incorrect instructions for the specimen collector when an employee fails to comply with the collector's directions. Specifically, it directs the collector to advise the employee that failure to comply with the collector's directions constitutes a refusal to test. This is inconsistent with other sections of part 40 that, in similar circumstances, direct the collector to stop the collection, note the circumstances on the CCF, and report the information to the employer/DER to make the refusal determination. To the maximum extent practicable, to provide for uniformity and consistency in the requirements for urine and oral fluid testing throughout part 40, the Department proposes to remove the last sentence in section 40.61(f) and mirror section 40.72(b)(2), stating the collector must terminate the collection, note the circumstances in the Remarks section of the CCF, and report the information to the DER as described in section 40.191(a)(8) (failure to cooperate) so that the employer can decide whether to deem the situation a refusal. Except for section 355(j), a service agent should not be determining a refusal that may have part 40 and DOT agency consequences; this is the purview of the employer.

Part 40 authorizes an employer to use oral fluid specimen collections. For problematic urine collections ( e.g., insufficient specimen), section 40.193(a) authorizes the employer to either continue with the original specimen type (urine) for the second collection, or to continue with an alternate specimen type (oral fluid). Section 40.65, however, instructs the urine collector that, in the event of an insufficient urine specimen, the collector is to follow the “shy bladder” procedures in section 40.193(b), which instruct the collector to collect another urine specimen. This is contrary to the instructions in section 40.193(a) that offer the employer the choice of continuing with a urine specimen or to move to an oral fluid specimen. Therefore, the Department proposes to revise the incorrect reference to have section 40.65(a)(1) read “If it does not, you must follow the procedures in 40.193(a).”

In section 40.72(b)(2), the Department proposes to correct a typographical error. Specifically, at the end of the paragraph, the last word “refusal” should read “refusal to test.”

In § 40.73(c)(4), DOT requires an oral fluid collector to collect a second oral fluid specimen if it is apparent to the collector that the employee tampered with the first specimen. The logical progression would be for the oral fluid collector to complete the first specimen collection, prepare it for shipment to the laboratory, immediately begin a second oral fluid specimen collection, and send both specimens to the laboratory. The instructions in section 40.73(c)(4), however, only tell the collector to collect a second specimen and are currently silent as to what to do with the tampered first specimen. The Department proposes to correct this “gap” by including supplemental instructions for the collector to complete the first collection and to send both specimens to the laboratory. In this same section, there are no instructions regarding what a collector is to do if the donor refuses to provide a subsequent oral fluid specimen due to tampering with their first specimen. Therefore, the Department proposes to add a new subparagraph to (c)(4)(iii) instructing the collector to discard any specimen the employee provided during the specimen collection procedure, and to notify the DER as soon as practicable so the employer can determine whether the situation constitutes a refusal to test by the employee. Both proposals are consistent with existing part 40 procedures for urine specimen collections (See section 40.65(c)).

HHS added a new “fatal flaw” to its OFMG specifying that the laboratory must reject an oral fluid specimen when a collector fails to document that she or he observed the volume indicator at the time of the collection. (88 FR 70814)  27 HHS's basis for this amendment was that the oral fluid specimen volume is critical to determining specimen concentration, therefore the collector must document that she or he observed the volume indicator at the time of the collection. The Department agrees with this important procedural check, and therefore proposes to amend sections 40.83(c) and 40.199(b) to add this new “fatal flaw” in each section.

MROs are authorized to ask HHS certified labs to run additional drug tests on a case-by-case basis and use the results of those tests to provide information that the MRO would use to verify a drug test result. These additional tests included D, L stereoisomers of amphetamine and methamphetamine (for amphetamine results) and tetrahydrocannabivarin (THC-V) (for marijuana results). In its October 2023 OFMG, HHS did not include testing for THC-V as it relates to oral fluid drug testing because in oral fluid drug testing the test is for active THC, the parent drug, and not for the THCA metabolite. Because the oral fluid test is for the parent drug, THC, there is no question that the employee ingested marijuana and no need for additional testing. The Department agrees and proposes to clarify in section 40.141(b)(2) that the MRO's request for additional testing for tetrahydrocannabivarin (THC-V) would only apply to urine specimens.

In both the UrMG and OFMG, HHS added procedures for how a laboratory tests a split specimen when the primary specimen was reported substituted based on testing for a biomarker. As such, the Department is proposing to amend section 40.181 to provide instructions to the “B” laboratory on how to test a urine or oral fluid specimen when testing the split specimen for biomarkers.

When it comes to what action a laboratory and MRO must take when a split is identified as substituted, the Department looks to section 40.187(b)(2). Should biomarker testing be authorized, laboratories and MROs would need instructions on how to proceed if the split specimen was reported substituted based on biomarker testing. The Department believes section 40.187(b)(2) contains the necessary instructions for laboratories and MROs and does not propose to amend it. DOT specifically requests comments from MROs and laboratories on this issue.

In § 40.193(a) the Department proposes to add the words “or standing orders” after the word “instructions.” This is to ensure consistency with section 40.210, which instructs the collector to follow the employer's instructions, which could be via a discussion or “standing orders” when a decision needs to be made on whether a different specimen type is to be collected during the testing event.

The Department is also proposing to amend section 40.193(b)(2) by adding two sets of instructions for the oral fluid collector. The first proposal is to discard any insufficient specimen the employee provided that had unusual characteristics or signs of tampering (See section 40.73(c)(4)), which results in a subsequent oral fluid specimen collection where the employee fails to provide a sufficient oral fluid specimen after the one hour wait period. Regarding this proposal, it makes sense to rely solely on the outcome of the insufficient specimen process (See section 40.193(c)) as the intent of the “dry mouth” evaluation is to provide the employee with an opportunity to provide an explanation for the inability to provide a sufficient oral fluid specimen. In the insufficient specimen process, an MRO with advice from a referral physician determines whether a medical condition has, or with a high degree of probability could have, precluded the employee from providing a sufficient amount of specimen. This rationale becomes blurred with a verified drug test result from the same collection event. The reasoning for discarding the insufficient “suspect” specimen is simple. It should reduce opportunities for confusion by the collector on whether to send an insufficient “specimen” to the laboratory when the employee did not provide a sufficient specimen after the one hour wait period and will leave the MRO to report only the outcome of the “dry mouth” evaluation. This proposal is consistent with the existing part 40 instructions for urine collectors during the “shy bladder” period (See section 40.193 (b)(1)(iv)).

The second proposal is to include instructions in section 40.193(b)(2) for the oral fluid collector to discontinue the collection if the employee refuses to provide a subsequent specimen and to notify the employer of the refusal event. The Department is proposing this because this section does not address this possibility. This proposal is consistent with the existing part 40 instructions for urine collectors during the “shy bladder” period (See section 40.193 (b)(1)(iii)).

In the Department's May 2023 final rule, DOT established a 15-minute period during which the employee is permitted to attempt to provide a sufficient oral fluid specimen, codified in 49 CFR 40.193(b)(2)(i). If the employee does not provide a sufficient specimen, the oral fluid collector will again attempt to collect a sufficient specimen. DOT established the 15-minute wait period based on the HHS OFMG (84 FR 57554). According to HHS, the collector sets the reasonable time limit for the specimen collection (based on the device used, but not to exceed 15 minutes (per device)). It was our understanding that the 15-minute period was more of a general rule, and not device-specific. The Department has since learned that for at least one specific oral fluid collection device that has been approved by the Food and Drug Administration (FDA), the 15-minute period exceeds that device's instructions on the specified period (10 minutes) in which to collect a sufficient specimen. The Department understands that exceeding that device's timeframe for collecting a sufficient specimen would not in and of itself cause the device to fail, but doing so could potentially expose the device to unintentional tongue or other oral movement that may end up breaking or tearing the pad. The Department has also learned that for this specific device, if the volume indicator does not register a sufficient volume during the 10-minute period, waiting an additional 5 minutes will not result in the device registering a sufficient volume. The Department expects that other oral fluid devices will eventually be approved, and that those other devices may have different specimen collection timeframes. To ensure the timeframe in which oral fluid specimens are being collected in accordance with the device manufacturer's instructions, the Department proposes to amend section 40.193(b)(2)(i) to remove the 15-minute period, and instead refer to the manufacturer's instructions.

Section 40.329(c) directs the SAP to redact the follow-up testing plan from the SAP report when providing the report to an employee. Section 40.311(f) directs the SAP to provide the SAP reports to the employee if the employee has no current employer but makes no mention of redacting the follow up testing information as stated in section 40.329(c). Without a cross-reference to section 40.329(c), it may lead the SAP or the employee to believe that the reports in their entirety are to be provided.

As such, the Department is proposing to amend section 40.311(f) to clarify that in cases where the report required by section 40.311 is provided to an employee with no current employer, the follow-up testing plan information (required by section 40.311(d)(9) of that report) must be redacted before it is sent to the employee, consistent with section 40.329(c).

Section 40.355(j)(2) states that an MRO may make a determination that an employee has refused a drug or alcohol test on the basis of adulteration or substitution. However, the Department omitted the scenario in which the MRO also makes the refusal to test determination when there is not an adequate basis for determining that a medical condition has, or with a high degree of probability could have, precluded the employee from providing a sufficient amount of specimen (See section 40.191(d)(2) and section 40.193(d)(2)(i)). As such the Department is proposing to include this “refusal to test” scenario to section 40.355(j)(2) as another situation in which an MRO makes the determination on a refusal to test.

While the Department is proposing to harmonize part 40 with the laboratory drug testing standards in the revised HHS Mandatory Guidelines as required by OTETA of 1991, which are the core scientific laboratory functions necessary for the DOT's program, there are some items in the revised HHS Mandatory Guidelines that are not specifically related to laboratory drug testing standards that DOT is not proposing to adopt. It is important to note the DOT has the discretion concerning many other aspects of the regulations governing testing in the transportation industries' regulated programs.

For example, HHS established a requirement in both the UrMG and OFMG that MROs must submit semiannual reports to HHS on laboratory-reported positive specimens that were verified negative by the MRO, including the reason for the negative verification. Specifically, these reports provide HHS with oversight of the MRO reporting practices for such specimens, enhance HHS's ability to verify the accuracy of MRO reports, and address areas of confusion about the Mandatory Guideline requirements. These semiannual reports also provide HHS with a clearer picture of illicit drug use by Federal job applicants and employees.

The DOT's drug testing program already has other mechanisms in place to assess MRO compliance, and to gauge illicit drug use by applicants and DOT-regulated safety-sensitive employees. For example, during inspections, audits, 28 or both, DOT agency auditors, inspectors, or investigators review the MRO drug test verifications and reporting practices for compliance with part 40. Also, when required by DOT agency regulations, DOT-regulated employers submit their Management Information System (MIS) reports ( i.e., annual aggregate drug/alcohol testing data) to the DOT agency. The DOT agencies use this data to assess illicit drug use by employees and applicants and to calculate the yearly industry annual drug/alcohol random testing rates. Therefore, requiring approximately 2,400 MROs involved in the DOT drug testing program to submit semi-annual reports on laboratory-positive/MRO-verified negative results to DOT would be an undue burden to the industry, and an added, unnecessary administrative task for DOT to review, analyze, and follow up on each report. For these reasons, the Department is not proposing this non-laboratory drug testing requirement.

HHS also revised both the UrMG and OFMG to remove two exceptions for collectors reporting a refusal to test for a pre-employment test: (1) when an applicant fails to appear for the collection in a reasonable time; and (2) when an applicant leaves the collection site before the collection process begins. HHS explained that there is no justification for altering a refusal to test determination based on whether a test is being conducted in the employment, or pre-employment, context, and removed the exceptions. 29 HHS requires all donors to arrive at the collection site in a reasonable time (as established by the Federal agency employer) and requires all donors to remain at the collection site until the collection is complete. When the collector reports a refusal to test, the Federal agency takes action consistent with applicable agency regulations.

In the August 9, 2001 final rule (66 FR 41944), 30 DOT clarified the application of refusal determinations during pre-employment testing. The Department said that an applicant can fail to appear for a test for a number of legitimate reasons ( e.g., took another job, decided they did not want to change their present job, or decided they did not want to work for a particular employer). In this type of situation, the Department believed—and still does—that it would be unfair to impose the consequences of a refusal ( e.g., having to complete the return-to-duty process or take actions to revoke a certification under some DOT agency regulations) on the applicant. Similarly, there can be situations in which an applicant could legitimately leave a collection site before the test actually commences ( e.g., there is a long wait for the test and the applicant has another obligation). DOT additionally clarified that, for the purposes of this provision, the commencement of the pre-employment test means the collector or applicant has selected a collection container (See section 40.191(a)(2) & (3)). Once the collection has commenced, the applicant has committed to the process and must complete it. If the applicant then leaves before the process is complete, or takes another action listed in this section as a refusal, the consequences of a refusal attach. However, if the applicant leaves the site before the test commences, then the applicant is in the same situation as someone who does not appear at all for the pre-employment test. The consequences of a refusal do not apply in this situation. For these reasons, which the Department believes are still valid today, DOT is not proposing this non-laboratory drug testing standard issue.

Though HHS did not propose any changes to the MRO training requirements, they did receive and respond to comments. Specifically, a commenter said there needs to be substantial clarification regarding additional MRO training on the annual drug testing panel changes and suggested that MROs register with SAMHSA to get updates/announcements and acknowledge review of the information received. For oral fluid testing, a commenter stated that new and existing MROs should receive additional training for oral fluid testing.

HHS responded, and revised its MRO training requirements to clarify that MROs must be trained on any revisions to the drug and biomarker testing panels. HHS stated that it relies on the approved MRO certification entities to ensure that the MROs certified by their organizations meet the HHS Mandatory Guidelines requirements. HHS also clarified that, in addition to posting the HHS Medical Review Officer Guidance Manual and MRO case studies (urine and oral fluid) on its website, it issues notices through the NLCP to the approved MRO certification entities for dissemination to their certified MROs.

DOT believes that its MRO training requirements in section 40.121 already address both issues. First, DOT requires MROs to be knowledgeable of alternative medical explanations for laboratory-confirmed drug test results (urine and oral fluid), and issues relating to substituted specimens. Part 40 also requires the MRO training to include instruction on interpreting drug and validity test results. The Department addressed the issue of whether MROs need additional training for oral fluid testing in our May 2023 rule that permits the use of oral fluid testing in the DOT program. Based on public comments received, DOT stated that it would not require MROs to undergo recertification training, but strongly suggested that MROs seek supplemental information about oral fluid testing by the time HHS certifies at least two oral fluid drug testing laboratories. The Department also stated that it supported the approach of MRO training organizations offering oral fluid modules to augment the training of MROs who are already current on their training certification requirements. Like HHS, DOT relies on the MRO certification organizations to ensure MROs meet the DOT training requirements. Second, regarding receiving updates/announcements from DOT, the Department already has a regulatory requirement in place for MROs to subscribe to ODAPC's listserv as a mechanism for MROs to keep current on any changes to part 40 and other DOT agency-related information. 31

HHS revised both the UrMG and OFMG to clarify that only prescription medications can be offered as a legitimate medical explanation for a positive drug test. HHS made this clarification given its concern, rightfully so, that several State laws currently allow a physician to write an “authorization” or “medical recommendation” for a Schedule I substance, specifically marijuana. However, no Schedule I drug, including marijuana, has a currently accepted medical use in the United States. Part 40 already requires the MRO to accept only a legally valid prescription consistent with the Controlled Substance Act (See section 40.137(a) & 40.141(b)).

Changes to Federal regulations must undergo several analyses. First, Executive Order (E.O.) 12866 and E.O. 13563 direct that each Federal agency shall propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify its costs. Second, the Regulatory Flexibility Act of 1980 (Pub. L. 96-354), as codified in 5 U.S.C. 601 et seq., requires agencies to analyze the economic impact of regulatory changes on small entities. The Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 et seq. ) requires that DOT consider the impact of paperwork and other information collection burdens imposed on the public and, under the provisions of PRA section 3507(d), obtain approval from OMB for each collection of information it conducts, sponsors, or requires through regulations. Section (a)(5) of division H of the Fiscal Year 2005 Omnibus Appropriations Act, Public Law 108-447, 118 Stat. 3268 (Dec. 8, 2004), and section 208 of the E-Government Act of 2002, Public Law 107-347, 116 Stat. 2889 (Dec. 17, 2002) require DOT to conduct a Privacy Impact Assessment (PIA) of a regulation that will affect the privacy of individuals. Finally, the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321 et seq. ) requires DOT to analyze this action to determine whether it will have an effect on the quality of the environment. This portion of the preamble summarizes DOT's analyses of these impacts with respect to this notice.

This proposed rule is not a significant regulatory action under E.O. 12866 and E.O. 13563, as well as under the Department's Regulatory Policies and Procedures (49 CFR part 5 and DOT Order 2100.6B). It harmonizes specific part 40 procedures with recently revised HHS Mandatory Guidelines for urine and oral fluid. The economic impact of this rulemaking is discussed in the sections that follow.

OST has reviewed this NPRM for compliance with E.O. 14192 (“Unleashing Prosperity Through Deregulation”), which requires Federal agencies to offset the number and cost of new regulations through the repeal, revocation, or revision of existing regulations. As discussed above, this action is not a significant rule under E.O. 12866. Accordingly, this proposed rule is not an E.O. 14192 regulatory action because this rule is not significant under E.O. 12866.

HHS addressed the cost burdens associated with the addition of a new drug to the drug testing panel during the March 5, 2024 DTAB open session and its January 16, 2025 Federal Register notice (90 FR 4662). 32 According to HHS, HHS-certified test facilities and MROs will incur initial costs for administrative and programming changes for the addition of fentanyl and norfentanyl. 33 The cost impact of drug testing for fentanyl and norfentanyl would be minimal for those laboratories that already offer fentanyl and norfentanyl testing for non-DOT testing. Those laboratories that use the same cutoff(s) for their non-regulated clients may experience some savings compared to laboratories that do not test for these analytes. Because these costs would be realized due to participating in the Federal Workplace Drug Testing program, the proposed rule will not duplicate this cost.

Once the testing has been implemented, according to HHS, the laboratory cost for screening a specimen for the added analytes would range from $0.23 to $5.00 due to reagent and administrative costs (sample preparation, analysis, and reporting). The cost for each confirmatory test would range from $8.00 to $25.00 for each specimen due to reagent and administrative costs. 34 For our analysis, the Department will use the average of the low and high values for screening ($2.61) and confirmation ($16.5) costs for testing, given that the cost will be less based on the volume of tests a laboratory conducts and that a majority of the specimens are analyzed by less than half of the laboratories conducting the testing. DOT will not consider the cost of reviewing negative fentanyl results in this analysis as it would be duplicative of costs already incurred for the administrative task of reviewing/reporting other negative results for the same specimen. Similarly, DOT will not consider specimen collection costs as there will not be any additional costs related to the collection of a urine specimen, as the urine specimen is already being collected for the analysis of the other drugs for which the Department requires testing.

HHS indicated that based on information from non-regulated workplace drug testing for these analytes in 2017, 2019, and 2022 and testing performed on de-identified federally regulated specimens in 2023, approximately 0.19 percent of the submitted specimens are expected to be screened as positive for the added analytes and that 84 percent of those specimens that screen positive will confirm positive. Based on this information and the approximate 6.9M annual DOT drug tests, DOT estimates 13,110 specimens to screen positive (6.9M × .19%) and 11,012 specimens to confirm positive (13,110 × 84%). The estimated lab costs for screening tests are $18,009,000 (6.9M × $2.61) and the estimated lab costs for confirmation tests are $216,315 (13,110 × $16.5).

Testing for fentanyl will also result in an increased number of positive results requiring MRO reviews. Regarding MRO review fees, the Department understands that most MROs offer bundled pricing ( e.g., one fee for reviewing/reporting negative and non-negative results). The Department also understands that the fee for a bundled review ranges from $8-$18. Using an average of the high and low fee of $13 for our analysis, DOT estimates $143,156 in MRO costs (11,102 × $13/MRO review) for reviewing laboratory confirmed fentanyl results.

Therefore, with the estimated 6.9M drug tests conducted annually, laboratory and MRO costs, an estimated annual cost of $18,368,471 would be realized in the DOT-regulated urine drug testing program.

Regarding the adjustment to the morphine cutoff from 2,000 ng/mL to 4,000 ng/ml, DOT estimates that approximately 1,782 of the 6.9 million drug tests administered in the DOT program in 2023 were reported with morphine results between 2,000 ng/mL and 15,000 ng/mL (899 tests were between 2,000-4,000 ng/mL, and 883 tests were between 4,000-15,000 ng/mL). Based on the current morphine cutoff, with an average clinical exam cost of $200 and $13 for the MRO review, DOT estimates the cost for the 1,782 clinical exams would be approximately $379,566. Given the proposed morphine cutoff, those same 1,782 test results would now just be MRO reviewed with no clinical exam resulting in a cost of $23,166 (1,782 × $13). Therefore, the Department estimates a cost savings of approximately $356,400 ($379,566−$23,166).

At this time, HHS does not require HHS-certified test facilities to implement authorized biomarker tests. Each laboratory and IITF should conduct its own cost analysis when deciding whether to offer biomarker testing to federally regulated clients. HHS will consider costs when deciding whether to require all certified test facilities to test for a specific biomarker.

The estimated cost of adding fentanyl to the drug testing panel and adjusting the morphine cutoff level and not requiring a clinical exam would be $18,102,071. If identifying illicit drug use by safety-sensitive transportation employees subjected to drug testing prevents a single serious accident, then the benefits of this rule outweigh its minimal cost. Testing for fentanyl will add another layer of deterrence to illicit drug use. Identifying fentanyl as the drug used by the employee will assist SAPs in their assessments and determinations on the appropriate recommendations for education or treatment, or both, of the employee. This rule would not have a major impact under Executive Order 12866 because it would not have an annual effect on the economy of $100 million or more, nor would it adversely affect any sector of the economy. Because fentanyl is extremely potent, powerful, addictive, and dangerous, it is a significant factor in both fatal and nonfatal overdoses in the United States, making it a crucial public safety issue. Therefore, the Department believes that the benefits of this rulemaking outweigh the associated costs.

The Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et seq. ) requires Federal agencies to consider the effects of their regulatory actions on small businesses and other small entities and minimize any significant economic impact. The term “small entities” comprises small businesses and not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with a population of less than 50,000.

The Department does not expect that the proposed rule would have a significant economic impact on a substantial number of small entities. Many thousands of covered employers are small businesses ( e.g., small trucking companies, small transit authorities), as are many service agents ( e.g., drug testing laboratories, medical review officers), but given the small net change in regulatory costs spread over these thousands of small entities, the cost impact per entity is expected to be negligible. Our ability to create special provisions for small entities is limited by the need to have uniform requirements to ensure safety and fairness to employees. There must be a single standard for the accuracy and integrity of the program and the protection of legitimate employee interests that cannot vary with the size of the employer or service agent.

The proposed rule, if adopted, would modify certain part 40 procedures and is intended only to further align our laboratory procedures and processes and MRO procedures, with those requirements that are being directed by the HHS Guidelines, which were considered nonsignificant. The Department would note that all HHS-certified laboratories must have the capability to accurately test for fentanyl and norfentanyl to pass certification requirements of the National Laboratory Certification Program. In addition, Federal agency employee testing programs are already testing for fentanyl and norfentanyl and MROs are no longer required to conduct clinical evaluations to determine illicit opioid use. Our harmonizing on these matters will only bring clarity and consistency to the efforts of the Federal testing programs, programs that are internal to the Federal Government, and those that are regulated by the Federal Government.

E.O. 13132 requires Federal agencies to carefully examine actions to determine if they contain policies that have federalism implications or that preempt State law. As defined in the order, “policies that have federalism implications” refer to regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government.

Most of the regulated parties under the Department's drug testing program are private entities. Some regulated entities are public entities ( e.g., transit authorities and public works departments); however, the Secretary has determined that the proposed rule, which, if adopted, would require the testing of safety-sensitive employees in the transportation industry for fentanyl and norfentanyl, remove the requirement for MROs to look for clinical evidence of illicit opiate use, and authorize the use of biomarker testing to determine if a specimen was substituted does not contain policies that have federalism implications.

The Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) (PRA) requires that DOT consider the impact of paperwork and other information collection burdens imposed on the public. This proposed rule would not require any new collection of information under the PRA. Notwithstanding any other provision of law, no person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a currently valid Office of Management and Budget (OMB) control number. Information collections for part 40 currently are approved under OMB Control No. 2105-0529. This proposed rule will not create any new paperwork or other information collection burdens that require approval.

The Privacy Act provides safeguards against invasion of personal privacy through the misuse of records by Federal agencies. It establishes controls over what personal information is collected, maintained, used, and disseminated by agencies in the executive branch of the Federal Government. Anyone is able to search the electronic form of all comments received in any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). For information on DOT's compliance with the Privacy Act, please visit https://www.transportation.gov/privacy.

The Department has analyzed the environmental impacts of this notice of proposed rulemaking pursuant to NEPA (42 U.S.C. 4321 et seq. ). The Department has determined that this rule is categorically excluded pursuant to 23 CFR 771.118(c)(4). Categorical exclusions are categories of actions that the agency has determined normally do not significantly affect the quality of the human environment and therefore do not require either an environmental assessment (EA) or environmental impact statement (EIS). See DOT Order 5610.1D § 9. In analyzing the applicability of a categorical exclusion, the agency must also consider whether extraordinary circumstances are present that would warrant the preparation of an EA or EIS. Id. § 9(b). The Department's Operating Administrations (OAs) may apply CEs established in another OA's procedures. Id. § 9(f). To do so, the Operating Administration “must evaluate the action for extraordinary circumstances identified in the OA procedures in which the CE is established to determine if a normally excluded action may have a significant impact and coordinate with the originating OA to ensure that the CE is being applied correctly.” Id. This rulemaking, which proposes to amend its drug-testing program regulation, 49 CFR part 40 (part 40), to add fentanyl and norfentanyl to its drug testing program, to amend certain provisions of part 40 to harmonize, as appropriate, with the recently revised HHS Mandatory Guidelines using urine and oral fluid, and to make technical amendments, is categorically excluded pursuant to 23 CFR 771.118(c)(4): “Planning and administrative activities not involving or leading directly to construction, such as: Training, technical assistance and research; promulgation of rules, regulations, directives, or program guidance; approval of project concepts; engineering; and operating assistance to transit authorities to continue existing service or increase service to meet routine demand.” The Department has coordinated with the Federal Transit Administration to ensure that this CE is being applied correctly. The Department does not anticipate any environmental impacts, and there are no extraordinary circumstances present in connection with this rulemaking.

The Secretary has examined the impact of this proposed rule under the Unfunded Mandates Reform Act (UMRA) of 1995 (Pub. L. 104-4). This proposed rule does not trigger the requirement for a written statement under sec. 202(a) of the UMRA because this rulemaking does not impose a mandate that results in an expenditure of $100 million or more by either State, local, and Tribal governments in the aggregate or by the private sector in any one year.

For reasons discussed in the preamble, the Department of Transportation proposes to amend part 40 of Title 49 Code of Federal Regulations, as follows: