Mandatory Guidelines for Federal Workplace Drug Testing Programs-Authorized Testing Panels

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <CFR>42 CFR Chapter 1</CFR> <SUBJECT>Mandatory Guidelines for Federal Workplace Drug Testing Programs—Authorized Testing Panels</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Substance Abuse and Mental Health Services Administration (SAMHSA), Department of Health and Human Services (HHS) <HD SOURCE="HED">ACTION:</HD> Issuance of authorized drug testing panels. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Department of Health and Human Services (“HHS” or “Department”) herein publishes the panels of Schedule I and II drugs and biomarkers authorized for testing in Federal workplace drug testing programs. The Department has revised the drug testing panels for both urine and oral fluid, and revised required nomenclature for laboratory and Medical Review Officer Reports. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> The authorized drug testing panels and required report nomenclature are effective July 7, 2025. </EFFDATE> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Eugene D. Hayes, Ph.D., MBA, SAMHSA, CSAP, DWP; 5600 Fishers Lane, Room 16N02, Rockville, MD 20857, by telephone (240) 276-1459 or by email at <E T="03">Eugene.Hayes@samhsa.hhs.gov</E> . </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> The drug testing panels in this Notification specify the analytes and cutoffs for Federal agency workplace drug testing specimens and the nomenclature ( <E T="03">i.e.,</E> analyte names and abbreviations) that must be used to report Federal workplace drug test results, in accordance with Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (UrMG, 88 FR 70768) and the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG, 88 FR 70814). Section 3.4 of Subpart C calls upon the Secretary of HHS (Secretary) to “publish the drug and biomarker test analytes and cutoffs ( <E T="03">i.e.,</E> the `drug testing panel' and `biomarker testing panel') for initial and confirmatory drug and biomarker tests in the <E T="04">Federal Register</E> each year,” and make them available on the internet at <E T="03">http://www.samhsa.gov/workplace.</E> Section 3.4 of the UrMG and the OFMG also requires HHS-certified laboratories, instrumented initial test facilities (IITFs, urine only), and Medical Review Officers (MROs) to use the nomenclature ( <E T="03">i.e.,</E> analyte names and abbreviations) published with the drug and biomarker testing panels to report Federal workplace drug test results. This <E T="04">Federal Register</E> Notification (FRN) contains only the drug testing panel because, to date, HHS has not approved any biomarker tests for use with Federal workplace drug testing specimens. The drug testing panels in Section 3.4 of the UrMG and OFMG will remain in effect until July 7, 2025. <HD SOURCE="HD1">Background</HD> HHS, by the authority of section 503 of Public Law 100-71, 5 U.S.C., and Executive Order 12564, establishes the scientific and technical guidelines for Federal workplace drug testing programs and establishes standards for certification of laboratories engaged in drug testing for Federal agencies. In addition, the Department specifies the drugs and biomarkers for which Federal employees may be tested. To facilitate timely analyte and cutoff changes based on the state of the science, the Department publishes the HHS authorized drug and biomarker testing panels separately from the Mandatory Guidelines. Analyte changes are based on a thorough review of relevant information, including drug prevalence estimates, the current state of the science, laboratory capabilities, costs associated with the change, and benefits of the change to Federal agencies. To identify panel changes needed, the Department solicits review and input from subject matter experts such as Responsible Persons (RPs) of HHS-certified laboratories, Medical Review Officers (MROs), research scientists, and manufacturers of collection devices and/or immunoassay kits, as well as Federal partners such as the Department of Transportation (DOT), the Food and Drug Administration (FDA), the Department of Defense (DOD), and the Drug Enforcement Administration (DEA). The Department also seeks public comment to inform decisions related to analyte changes. Using this process for recommending changes to the analyte table, the Department proposed the removal of methylenedioxyamphetamine (MDA) and methylenedioxymethamphetamine (MDMA) and the addition of fentanyl in the notice for the December 5, 2023, Drug Testing Advisory Board (DTAB) meeting published in the November 17, 2023, <E T="04">Federal Register</E> . The meeting notice included supporting information for the proposed changes and a request for public comment, along with the January 4, 2024, due date for public comments and the methods for comment submission. During the December 5th, 2023, DTAB meeting, the Department presented the basis for the proposed changes including technical and scientific support. The Department received and reviewed 176 comments from 118 commenters. All comments were reviewed and taken into consideration in the preparation of draft final drug testing panels. During the DTAB meeting on March 5, 2024, the Department presented a summary of the public comments, along with additional supporting information for the proposed changes including workplace testing prevalence information, cost estimates and areas of agreement and concerns The comments are available for public view on the SAMHSA website at <E T="03">https://www.samhsa.gov/meetings/dtab-meeting-december-2023</E> and <E T="03">https://www.samhsa.gov/meetings/dtab-meeting-march-2024.</E> During the June 4-5, 2024, DTAB meeting, the Department provided updated information on fentanyl positivity in workplace testing (urine and oral fluid). DTAB members agreed with the proposed changes. The Department continued to assess the proposed testing panel changes and as described below, has decided not to remove MDMA and MDA from the urine and oral fluid drug testing panels at this time. <HD SOURCE="HD1">Summary of Public Comments and HHS's Response</HD> The following provides the basis for the changes to nomenclature and the drug testing panel. The issues and concerns raised in public comments and HHS responses are set forth under each topic. <HD SOURCE="HD1">Nomenclature</HD> For consistency and to avoid misinterpretation of test results, the UrMG and OFMG require HHS-certified test facilities and MROs to report results using the nomenclature ( <E T="03">i.e.,</E> analyte names and abbreviations) in the drug and biomarker testing panels published in the <E T="04">Federal Register</E> . The drug testing panel includes revised abbreviations for marijuana test analytes, consistent with current scientific nomenclature. The Department previously used the abbreviation THC for Δ-9-tetrahydrocannabinol and THCA for Δ-9-tetrahydrocannabinol-9-carboxylic acid. The new abbreviations are Δ9THC in place of THC and Δ9THCC in place of THCA. Including “Δ9” in these abbreviations distinguishes them from other compounds ( <E T="03">e.g.,</E> Δ-8-tetrahydrocannabinol-9-carboxylic acid and Δ-8-tetrahydrocannabinol). The revised abbreviation Δ9THCC also distinguishes this marijuana metabolite from Δ9-tetrahydrocannabinolic acid, a non-psychoactive cannabinoid in the cannabis plant that is also commonly abbreviated as THCA. This plant compound is an important precursor integral to the growth, definition, and production of legal hemp as defined by the US Department of Agriculture (USDA). <E T="51">1 2</E> <HD SOURCE="HD1">Drug Testing Panel</HD> <NOTE> <HD SOURCE="HED">Note: </HD> <E T="03">Oral fluid cutoffs in the authorized drug testing panel are based on undiluted (neat) oral fluid.</E> </NOTE> <HD SOURCE="HD2">Removed Drugs: Methylenedioxyamphetamine (MDA) and Methylenedioxymethamphetamine (MDMA)</HD> The Department proposed to remove MDA and MDMA from the drug testing panel because the number of positive specimens reported by HHS-certified laboratories did not seem to support testing all specimens for MDA and MDMA in Federal workplace drug testing programs. Information provided to the Department through the National Laboratory Certification Program (NLCP) in 2024 shows the MDMA positivity rate for the past three years (2021-2023) has been at or below 0.002% and a review of the results indicates that >25% of the positive specimens are likely agency blind samples. A further review of the NLCP data shows that almost 40% of MDMA positive urine specimens are also positive for another drug to include amphetamines (7%), benzoylecgonine (9%) and THC (21%), indicating that these specimens would be identified as drug positive by other means. MDMA accounts for only 0.28% of the drugs identified in exhibits submitted to crime laboratories. Tablets sold as MDMA on the street often do not contain MDMA and instead contain another phenethylamine compound such as dipentylone. <E T="51">3 4</E> In addition, the NLCP information shows that MDA has a significantly lower positivity rate (0.00008% of tested specimens) than MDMA, with only six specimens identified as containing MDA without MDMA in 2023, and both analytes have lower positivity rates than phencyclidine (PCP). While PCP has an overall positivity rate nearly as low as MDMA, there are regional differences in the positivity of PCP in federally regulated and general workplace drug testing populations with some areas of the country having much higher rates, so the Department has determined that PCP remains a regulated test analyte. <SU>5</SU> A total of 10 commenters addressed the removal of MDMA and MDA from the testing panel. Of these, four agreed with removal of these drugs, while six disagreed. Four commenters who disagreed noted tha ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 50k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━