{"operation":"document","citation":"90 FR 42363","title":"Procedures for Transportation Workplace Drug and Alcohol Testing Programs: Addition of Fentanyl to the Department of Transportation's Drug-Testing Panel; Harmonization With Certain Items in the HHS Mandatory Guidelines for Urine and Oral Fluid; and Technical Amendments","source_type":"rulemaking","agency":"Office of the Secretary","status":"proposed","official":true,"published_on":"2025-09-02","effective_on":null,"summary":"The U.S. Department of Transportation (Department or DOT) proposes to amend its drug-testing program regulation, 49 CFR part 40 (part 40), to add fentanyl (a synthetic opioid) and norfentanyl (a metabolite of fentanyl) to its drug testing panels. The proposed rulemaking would harmonize part 40 with the U.S. Department of Health and Human Services (HHS) Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines), which DOT must follow for the minimum list of drugs for which DOT requires testing, and the comprehensive standards for laboratory drug testing per the Omnibus Employee Testing Act of 1991. Adding fentanyl and norfentanyl is also in the interest of transportation safety, given compelling information regarding the number of overdose deaths in the United States involving fentanyl. The Department also proposes to amend certain provisions of part 40 to harmonize, as appropriate, with the current HHS Mandatory Guidelines using urine (UrMG) and oral fluid (OFMG). This NPRM also proposes to clarify certain existing part 40 drug testing program provisions and to make technical amendments.","machine_formats":{"json":"https://regulus.evalyn.ai/document/federal-register-2025-16720.json","markdown":"https://regulus.evalyn.ai/document/federal-register-2025-16720.md"},"app_url":"https://regulus.evalyn.ai/document/federal-register-2025-16720","source_url":"https://www.federalregister.gov/documents/2025/09/02/2025-16720/procedures-for-transportation-workplace-drug-and-alcohol-testing-programs-addition-of-fentanyl-to","body":"Federal Register, Volume 90 Issue 167 (Tuesday, September 2, 2025) [Federal Register Volume 90, Number 167 (Tuesday, September 2, 2025)] [Proposed Rules] [Pages 42363-42381] From the Federal Register Online via the Government Publishing Office [ www.gpo.gov ] [FR Doc No: 2025-16720] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF TRANSPORTATION Office of the Secretary 49 CFR Part 40 [Docket DOT-OST-2025-0049] RIN 2105-AF26 Procedures for Transportation Workplace Drug and Alcohol Testing Programs: Addition of Fentanyl to the Department of Transportation's Drug-Testing Panel; Harmonization With Certain Items in the HHS Mandatory Guidelines for Urine and Oral Fluid; and Technical Amendments AGENCY: Office of the Secretary of Transportation (OST), U.S. Department of Transportation. ACTION: Notice of proposed rulemaking (NPRM). ----------------------------------------------------------------------- SUMMARY: The U.S. Department of Transportation (Department or DOT) proposes to amend its drug-testing program regulation, 49 CFR part 40 (part 40), to add fentanyl (a synthetic opioid) and norfentanyl (a metabolite of fentanyl) to its drug testing panels. The proposed rulemaking would harmonize part 40 with the U.S. Department of Health and Human Services (HHS) Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines), which DOT must follow for the minimum list of drugs for which DOT requires testing, and the comprehensive standards for laboratory drug testing per the Omnibus Employee Testing Act of 1991. Adding fentanyl and norfentanyl is also in the interest of transportation safety, given compelling information regarding the number of overdose deaths in the United States involving fentanyl. The Department also proposes to amend certain provisions of part 40 to harmonize, as appropriate, with the current HHS Mandatory Guidelines using urine (UrMG) and oral fluid (OFMG). This NPRM also proposes to clarify certain existing part 40 drug testing program provisions and to make technical amendments. DATES: Comments to this notice of proposed rulemaking should be submitted by October 17, 2025. Late-filed comments will be considered to the extent possible. FOR FURTHER INFORMATION CONTACT: Bohdan Baczara, Deputy Director, Office of Drug and Alcohol Policy and Compliance, 1200 New Jersey Avenue SE, Washington, DC 20590; telephone number 202-366-3784; [email protected] . ADDRESSES: To ensure that you do not duplicate your docket submissions, please submit them by only one of the following means: Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for submitting comments. Mail: Dockets Operations, U.S. Department of Transportation, 1200 New Jersey Ave. SE, West Building, Ground Floor, Washington, DC 20590-0001; Hand Delivery: West Building, Ground Floor, 1200 New Jersey Ave. SE, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The telephone number is 202-366-9329; Instructions: You must include the agency name and docket number DOT-OST-2025-0049 or the Regulatory Identification Number (2105- AF26) for the rulemaking at the beginning of your comments. All comments received will be posted without change to http://www.regulations.gov , including any personal information provided. SUPPLEMENTARY INFORMATION: I. Purpose 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\\ --------------------------------------------------------------------------- \\1\\ See Sec. 40.3 (defining ``DOT, The Department, DOT Agency'' to include each of the DOT operating administrations). --------------------------------------------------------------------------- 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. II. Authority for This Rulemaking 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. [[Page 42364]] III. Background Relevant History of the DOT Drug Testing Program Regulation 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. Relevant Changes to the HHS Mandatory Guidelines 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\\ --------------------------------------------------------------------------- \\2\\ Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act or the SUPPORT for Patients and Communities Act, Public Law 115-271, 132 Stat. 3895 (Oct. 24, 2018). \\3\\ Schedules of Controlled Substances, 21 CFR part 1308. https://www.ecfr.gov/current/title-21/chapter-II/part-1308?toc=1 . --------------------------------------------------------------------------- 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 [[Page 42365]] instrumentation commonly used in HHS-certified laboratories.\\4\\ --------------------------------------------------------------------------- \\4\\ 88 FR 71582, HHS Substance Abuse and Mental Health Services Administration (SAMSHA) Notice of Meeting (Oct. 17, 2023), https://www.govinfo.gov/content/pkg/FR-2023-10-17/pdf/2023-22797.pdf (footnote omitted). --------------------------------------------------------------------------- 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. --------------------------------------------------------------------------- \\5\\ U.S. DOT, The Substance Abuse and Mental Health Services Administration Requests Public Comment on the Possible Addition of Fentanyl to the Urine and Oral Fluid Analyte Table (Nov. 1, 2023), https://content.govdelivery.com/accounts/USDOT/bulletins/378c63a . --------------------------------------------------------------------------- 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\\ --------------------------------------------------------------------------- \\6\\ Substance Abuse and Mental Health Services Administration, DTAB Meeting March 2024, https://www.samhsa.gov/meetings/dtab-meeting-march-2024 . \\7\\ Substance Abuse and Mental Health Services Administration, DTAB Meeting Open Session Transcript, at 47 (Mar. 5, 2024), https://www.samhsa.gov/sites/default/files/meeting/transcripts/dtab-meeting-transcript-03052024.pdf . \\8\\ Substance Abuse and Mental Health Services Administration, DTAB Meeting March 2024, Public Comments to Analyte Table Change, https://www.samhsa.gov/sites/default/files/meeting/documents/adding-fentanyl-drug-testing-panel.pdf . --------------------------------------------------------------------------- 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 [Delta]9THCC. In the oral fluid drug testing panel, both the initial and confirmatory test analytes for marijuana were changed from THC to [Delta]9THC. 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. --------------------------------------------------------------------------- \\9\\ 87 FR 20560, Mandatory Guidelines for Federal Workplace Drug Testing Programs (Apr. 7, 2022), https://www.govinfo.gov/content/pkg/FR-2022-04-07/pdf/2022-06886.pdf . --------------------------------------------------------------------------- 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 [[Page 42366]] definitions of ``adulterated specimen,'' ``cutoff,'' ``initial specimen validity test,'' ``negative result,'' ``substituted specimen,'' and ``positive result.'' --------------------------------------------------------------------------- \\10\\ https://www.govinfo.gov/content/pkg/FR-2023-10-12/pdf/2023-21734.pdf . \\11\\ https://www.govinfo.gov/content/pkg/FR-2023-10-12/pdf/2023-21735.pdf . --------------------------------------------------------------------------- IV. Discussion of the Proposals Summary of Proposed Changes to the DOT Drug-Testing Program Regulation 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. Proposal To Add Fentanyl and Norfentanyl to DOT Drug Testing Panels 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\\ --------------------------------------------------------------------------- \\12\\ United States Drug Enforcement Administration, Facts about Fentanyl, https://www.dea.gov/resources/facts-about-fentanyl ; National Institute of Drug Abuse, Drug Overdose Deaths: Facts and Figures (Aug. 2024), https://nida.nih.gov/research-topics/trends-statistics/overdose-death-rates#Fig2 . \\13\\ Wilson N, Kariisa M, Seth P, Smith H IV, Davis NL. Drug and Opioid-Involved Overdose Deaths--United States, 2017-2018. MMWR Morb Mortal Wkly Rep 2020; 69:290-297. DOI: http://dx.doi.org/10.15585/mmwr.mm6911a4 . \\14\\ NCHS, National Vital Statistics System. Estimates for 2020 are based on provisional data. Estimates for 2015-2019 are based on final data (available from: https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm ). --------------------------------------------------------------------------- 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\\ --------------------------------------------------------------------------- \\15\\ Spencer, M.R., Warner, M., Cisewski, J.A., Mini[ntilde]o, A., Dodds, D., Perera, J., & Ahmad, F.B. (May 2023). Estimates of Drug Overdose Deaths Involving Fentanyl, Methamphetamine, Cocaine, Heroin, and Oxycodone: United States, 2021 (NVSS Rapid Release Report No.27), National Center for Health Statistics (NCHS), https://www.cdc.gov/nchs/data/vsrr/vsrr027.pdf . --------------------------------------------------------------------------- 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\\ --------------------------------------------------------------------------- \\16\\ NCHS, National Vital Statistics System. Estimates for 2022 are based on provisional data (May 18, 2023) (available from: https://blogs.cdc.gov/nchs/2023/05/18/7365/ ). --------------------------------------------------------------------------- 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\\ --------------------------------------------------------------------------- \\17\\ Planalp, C, & Stewart, A (Nov. 2023). The Opioid Crisis in the Pandemic Era. State Health Access Data Assistance Center (SHADAC) (available from: https://www.shadac.org/sites/default/files/publications/Opioid_Crisis/Opioid%20Crisis%20Pandemic-2023%20Brief.pdf ). --------------------------------------------------------------------------- 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\\ --------------------------------------------------------------------------- \\18\\ DEA, April 29, 2025 National Fentanyl Awareness Day, https://fentanylawarenessday.org/ . --------------------------------------------------------------------------- ``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\\ --------------------------------------------------------------------------- \\19\\ Secretary Kennedy Renews Public Health Emergency Declaration to Address National Opioid Crisis, https://www.hhs.gov/press-room/secretary-kennedy-opiod-crisis-emergency-declaration.html . --------------------------------------------------------------------------- ``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\\ --------------------------------------------------------------------------- \\20\\ Detection of Illegally Manufactured Fentanyls and Carfentanil in Drug Overdose Deaths--United States, 2021-2024, https://www.cdc.gov/mmwr/volumes/73/wr/mm7348a2.htm . --------------------------------------------------------------------------- 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. [[Page 42367]] 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. For Urine Drug Testing--Proposal To Adjust the Laboratory Morphine Confirmatory Cutoff and Remove the Additional Requirement for MROs To Look for Clinical Evidence of Illegal Opioid Use 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. --------------------------------------------------------------------------- \\21\\ Codeine and morphine are both metabolites of heroin. Heroin occurs naturally in the poppy seed plant. \\22\\ 49 CFR 40.85(a). \\23\\ 49 CFR 40.139. --------------------------------------------------------------------------- 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 [[Page 42368]] 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. For Oral Fluid Drug Testing--Proposal To Remove Additional Requirement for MROs To Look for Clinical Evidence of Illegal Opioid Use 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 positiv","truncated":true,"body_characters":136440}