4662 Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Rules and Regulations 

17 ChloroSense. ‘‘Measurement of Free and Total Chlorine in Drinking Water by Palintest ChloroSense,’’ August 2009. Available at https://

www.nemi.gov or from Palintest Ltd, 1455 Jamike Avenue (Suite 100), Erlanger, KY 41018. 

* * * * * * * 28Standard Methods for the Examination of Water and Wastewater, 22nd edition (2012). Available from American Public Health Association, 

800 I Street NW, Washington, DC 20001–3710. 

******* 31 Hach Company. ‘‘Hach Method 10260-Determination of Chlorinated Oxidants (Free and Total) in Water Using Disposable Planar Reagentfilled Cuvettes and Mesofluidic Channel Colorimetry,’’ April 2013. 5600 Lindbergh Drive, P.O. Box 389, Loveland, CO 80539. 

* * * * * * * 34 Hach Company. ‘‘Hach Method 10241-Spectrophotometric Measurement of Free Chlorine (Cl2) in Drinking Water,’’ November 2015. Revision 1.2. 5600 Lindbergh Drive, P.O. Box 389, Loveland, CO 80539. 

* * * * * * * 49Standard Methods for the Examination of Water and Wastewater, 23rd edition (2017). Available from American Public Health Association, 

800 I Street NW, Washington, DC 20001–3710. 

******* 55EPA Method 127. ‘‘Determination of Monochloramine Concentration in Drinking Water.’’ January 2021. EPA 815–B–21–004. Available at the 

National Service Center for Environmental Publications at https://www.epa.gov/nscep. 

******* 59 ChloroSense, Rev. 1.1. ‘‘Free and Total Chlorine in Drinking Water by Amperometry using Disposable Sensors.’’ February 2020. Palintest 

Ltd, 400 Corporate Circle, Suite J, Golden, CO 80401. 

* * * * * * * 66Standard Methods for the Examination of Water and Wastewater, 24th edition (2023). Available from American Public Health Association, 

800 I Street NW, Washington, DC 20001–3710. 

******* 69 e-sens, Inc. ‘‘e-sens, Inc. Automated Micro Chlorine Detection (AMCD) Method for the Determination of Residual Free and Total Chlorine in 

Water.’’ December 2023. Available from e-sens, Inc., 630 Komas Dr., Ste 235, Salt Lake City, Utah 84108. 70EPA Method 537.1, Version 1.0. ‘‘Determination of Selected Per- and Polyfluorinated Alkyl Substances (PFAS) in Drinking Water by Solid 

Phase Extraction and Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS).’’ November 2018. EPA/600/R–18/352. Approved as alternative testing method to support initial PFAS monitoring (for monitoring-frequency determinations) until April 26, 2027 as described at 40 CFR 

141.902(b)(1) [Monitoring requirements for PFAS—Initial monitoring]. Available at the National Service Center for Environmental Publications at 

https://www.epa.gov/nscep. 

[FR Doc. 2025–00464 Filed 1–15–25; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Chapter 1 

Mandatory Guidelines for Federal 

Workplace Drug Testing Programs— 

Authorized Testing Panels 

AGENCY: Substance Abuse and Mental 

Health Services Administration 

(SAMHSA), Department of Health and 

Human Services (HHS) 

ACTION: Issuance of authorized drug 

testing panels. 

SUMMARY: 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. 

DATES: The authorized drug testing 

panels and required report 

nomenclature are effective July 7, 2025. 

FOR FURTHER INFORMATION CONTACT: 

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 Eugene.Hayes@

samhsa.hhs.gov. 

SUPPLEMENTARY INFORMATION: The drug 

testing panels in this Notification 

specify the analytes and cutoffs for 

Federal agency workplace drug testing 

specimens and the nomenclature (i.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 (i.e., the ‘drug testing panel’ 

and ‘biomarker testing panel’) for initial 

and confirmatory drug and biomarker 

tests in the Federal Register each year,’’ 

and make them available on the internet 

at http://www.samhsa.gov/workplace. 

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 (i.e., analyte names and 

abbreviations) published with the drug 

and biomarker testing panels to report 

Federal workplace drug test results. 

This Federal Register 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. 

Background 

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 HHScertified 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. 


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Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Rules and Regulations 4663 

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, Federal Register. 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 

https://www.samhsa.gov/meetings/dtabmeeting-december-2023 and https://

www.samhsa.gov/meetings/dtabmeeting-march-2024. 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. 

Summary of Public Comments and 

HHS’s Response 

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. 

Nomenclature 

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 (i.e., analyte 

names and abbreviations) in the drug 

and biomarker testing panels published 

in the Federal Register. 

The drug testing panel includes 

revised abbreviations for marijuana test 

analytes, consistent with current 

scientific nomenclature. The 

Department previously used the 

abbreviation THC for D-9- 

tetrahydrocannabinol and THCA for D9-tetrahydrocannabinol-9-carboxylic 

acid. The new abbreviations are D9THC 

in place of THC and D9THCC in place 

of THCA. Including ‘‘D9’’ in these 

abbreviations distinguishes them from 

other compounds (e.g., D-8- 

tetrahydrocannabinol-9-carboxylic acid 

and D-8-tetrahydrocannabinol). The 

revised abbreviation D9THCC also 

distinguishes this marijuana metabolite 

from D9-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).1 2

Drug Testing Panel 

Note: Oral fluid cutoffs in the authorized 

drug testing panel are based on undiluted 

(neat) oral fluid. 

Removed Drugs: 

Methylenedioxyamphetamine (MDA) 

and Methylenedioxymethamphetamine 

(MDMA) 

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.3 4 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.5

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 that, because drug testing deters 

use, MDMA and MDA use may increase 

after removal from the panel. Another 

commenter who disagreed with removal 

stated that growing interest in MDMA 

use for post-traumatic stress disorder 

and anxiety may lead to increased 

MDMA use. This commenter also noted 

that the National Survey on Drug Use 

and Health (NSDUH) showed adults’ 

self-reported use of MDMA (i.e., 

Ecstasy) was higher than for 

phencyclidine (PCP).6 A commenter 

who agreed with removal noted that 

SAMHSA might consider removing 

MDA and keeping MDMA on the testing 

panel with amphetamine and 

methamphetamine, based on current 

amphetamines immunoassay crossreactivity to MDMA. 

Three commenters stated that MDMA/ 

MDA positivity rates in DOT-regulated 

programs have remained steady over 

time. One of these agreed with removal 

and had no safety concerns, while the 

other two commenters cited this as a 

reason for continuing to test these drugs. 

The Department considered all 

comments and has decided that the 

removal of MDMA and MDA from the 

urine and oral fluid drug testing panels 

requires further study, and therefore, 

MDMA/MDA will not be removed from 

the drug testing panels at this time. The 

Department will continue to monitor 

MDMA/MDA prevalence and will 

engage with the DTAB and continue to 

assess the costs and benefits of 

removing one or both analytes in the 

future. 

Added Drugs: Fentanyl and Norfentanyl 

After declaring the opioid crisis, a 

public health emergency in 2017, former 

President Trump signed the SUPPORT 

for Patients and Communities Act 

(SUPPORT Act) into law on October 24, 

2018. Section 8105 of the Fighting 

Opioid Abuse in Transportation Act, 


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4664 Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Rules and Regulations 

included in the SUPPORT Act, required 

the Secretary to determine whether it is 

justified, based on the reliability and 

cost-effectiveness of testing, to revise 

the Mandatory Guidelines for Federal 

Workplace Drug Testing Programs to 

include fentanyl.7 Section 8105 

additionally required the Secretary to 

consider whether to include any other 

drugs or other substances listed in 

Schedule I and II of Controlled 

Substances Act (CSA).8 Norfentanyl is a 

metabolite of fentanyl. Because it is also 

an immediate precursor used in the 

illicit manufacture of fentanyl, it is a 

Schedule II substance under the CSA. 

Fentanyl was considered for inclusion 

in the proposed Mandatory Guidelines 

of May 2015. At that time, fentanyl was 

primarily found as a mixture with 

heroin. Because the heroin metabolite 6- 

acetylmorphine was already included in 

the Mandatory Guidelines, it was 

decided that the addition of fentanyl 

was not needed to identify fentanyl use. 

However, the illicit drug market and 

epidemiological data on drug use and 

overdose have changed since that time: 

fentanyl, primarily illicitly made 

fentanyl, is involved in a large 

percentage of overdose deaths in the 

United States and is therefore an 

important public safety concern.9 10

Furthermore, illicitly made fentanyl is 

increasingly used as a stand-alone 

substance among people who use drugs, 

not in conjunction with heroin and 

other substances.3 According to the 

National Forensic Laboratory 

Information System (NFLIS) 2022 

Annual Report, fentanyl was the 3rd 

most frequently identified drug and 

accounted for 13.81% of all drugs 

reported by forensic laboratories. 

The Department conducted studies to 

determine the prevalence of fentanyl in 

regulated drug testing specimens and 

examined the current state of the 

technology available to HHS-certified 

laboratories for initial and confirmatory 

testing of fentanyl and norfentanyl. A 

review of the literature was conducted 

to identify peer-reviewed publications 

that reported concentrations of fentanyl 

and/or norfentanyl in urine and oral 

fluid, to determine whether the current 

initial and confirmatory test 

technologies available in HHS-certified 

laboratories are appropriate for testing 

for fentanyl and/or norfentanyl and to 

assist in decisions regarding appropriate 

cutoff concentrations. 

Fentanyl Prevalence 

When the Department assessed 

fentanyl prevalence, two HHS-certified 

laboratories offered urine testing for 

fentanyl upon request of a Federal 

agency or an MRO. Data from the NLCP 

included six laboratory-reported 

positive test results from 52 requests for 

fentanyl testing from January 1, 2017, 

through December 31, 2022. Three of 

the specimens were also positive for at 

least one other drug: two specimens 

were positive for D9THCC, and one was 

positive for other opioids (i.e., 

hydrocodone, hydromorphone) in 

addition to fentanyl. 

The Department also gathered 

information through a query of HHScertified laboratories that perform 

fentanyl and norfentanyl testing (urine 

and/or oral fluid) for non-regulated 

clients (e.g., workplace testing, 

compliance testing of healthcare 

providers) and through pulse testing 

studies (i.e., retesting several 

deidentified federally regulated urine 

specimens using the laboratory’s 

fentanyl and norfentanyl testing 

procedures). Based on information from 

non-regulated workplace drug testing 

and the pulse testing studies, it is 

estimated that approximately 0.27– 

0.37% of submitted Federal workplace 

urine specimens will screen positive 

during initial testing and 0.1 to 0.3% 

will confirm positive for fentanyl and/ 

or its primary metabolite norfentanyl. 

Additionally, a recent pulse testing 

study showed that norfentanyl was 36% 

more prevalent than 6-acetylmorphine 

in specimens with a positive opiate 

initial test. 

Of the total 118 commenters, 115 

supported the addition of fentanyl to the 

authorized drug testing panels. Most 

commenters noted the prevalence of 

fentanyl use and overdoses, based on 

their professional or personal 

experience, and the threat to workplace 

and public safety, particularly in 

transportation industries. Of the three 

individuals who disagreed: one 

incorrectly stated that fentanyl would be 

detected and reported using current 

opioid tests for Federal agency urine 

specimens; one incorrectly indicated 

that fentanyl would only be detected 

within a few hours of use; and the third 

disagreed with any additional Federal 

regulations for truck drivers. 

The Department considered all 

comments and has added fentanyl to the 

urine and oral fluid drug testing panels 

and added its metabolite norfentanyl to 

the urine drug testing panel. Until the 

effective date of the new drug testing 

panel, fentanyl and/or norfentanyl can 

be analyzed under the Mandatory 

Guidelines only upon request of a 

Federal agency for a reasonable 

suspicion or post-accident specimen or 

routinely with a waiver from the 

Secretary (in accordance with Section 

3.2 of the UrMG and OFMG). A detailed 

discussion is provided below. 

Fentanyl Analyte Selection and Cutoff 

Determination—Urine 

Information provided by HHScertified laboratories in 2023 indicated 

that a majority (84%) of the laboratories 

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. The 

laboratories’ initial test cutoffs ranged 

from 0.5 to 2 ng/mL for fentanyl and 

confirmatory test cutoffs for fentanyl 

and norfentanyl ranged from 0.5 to 2 ng/ 

mL for fentanyl and 0.5 to 5 ng/mL for 

norfentanyl. 

Fentanyl and norfentanyl prevalence 

and concentrations appear to vary 

considerably depending on the 

population studied and the applied 

cutoff. Laboratory data from nonregulated workplace drug testing are 

around 1% fentanyl positivity in urine. 

The median, mean and max fentanyl 

concentrations were 12.6 ng/mL, 257.5 

ng/mL and 36,199 ng/mL, respectively. 

Norfentanyl concentrations were 

reported to be around 4 times higher 

than those of fentanyl.11 A recent pulse 

testing study on regulated urine 

workplace specimens showed that 

norfentanyl concentrations were 5.5 

times higher than fentanyl 

concentrations (median, Q1–Q3, 2.5– 

13.3 times higher).12 The median 

fentanyl and norfentanyl concentrations 

were 159 and 1,521 ng/mL, respectively. 

In a large study of 1 million urine 

specimens conducted by healthcare 

professionals for routine care, the 

positivity rate for fentanyl was 1.4% 

(13,770 specimens) using cutoffs of 2 

ng/mL for fentanyl and 8 ng/mL for 

norfentanyl.13 Using immunoassay 

screening and a GC–MS confirmatory 

test cutoff of 1 ng/mL, fentanyl was 

positive in 4.2% (458 specimens) of 

specimens among patients being treated 

for pain conditions.14 The median, 

mean, and range of fentanyl 

concentrations were 23 ng/mL, 87 ng/ 

mL, and 1 to 2382 ng/mL, respectively. 

Another study of patients with chronic 

pain demonstrated that norfentanyl can 

be an important component of 

identifying people who use fentanyl 

when urine is the specimen matrix.15

The authors showed that including 

norfentanyl increased the number of 

positive specimens by 42% over 

analyzing for fentanyl alone. The 

fentanyl median, mean and range 

concentrations were 22 ng/ml, 59.2 ng/ 

mL, and 0.5 to 596 ng/mL, respectively. 


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Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Rules and Regulations 4665 

Norfentanyl median, mean and range 

concentrations were 25.5 ng/mL, 134 

ng/mL, and 0.5 to 1,772 ng/ml, 

respectively. A study of 77,018 urine 

specimens from patients treated with 

fentanyl using a transdermal patch 

reported median and mean fentanyl 

concentration of 37 and 88 ng/mL.16

When comparing doses of 12 and 100 

mg/h, the mean fentanyl concentration 

increased from 32 to 137 ng/mL, and the 

norfentanyl mean concentration 

increased from 176 to 695 ng/mL, 

illustrating the dose-response 

relationships. 

Based on this information, the 

Department originally proposed a 1 ng/ 

mL initial test cutoff for both fentanyl 

and norfentanyl in urine, with a 0.5 ng/ 

mL confirmatory test cutoff for both 

analytes. 

Ten commenters disagreed with 

adding norfentanyl as an initial test 

analyte for urine. Nine of these 

specifically disagreed with norfentanyl 

as an initial test analyte, noting that no 

current FDA-cleared immunoassay has 

sufficient cross-reactivity for fentanyl 

and norfentanyl to meet the program 

requirement for grouped analytes (i.e., at 

least 80% cross-reactivity to the nontarget analyte). One commenter 

suggested that the Department lower the 

cross-reactivity requirement to 5%, 

noting that norfentanyl is often at higher 

concentrations than fentanyl. One 

suggested including fentanyl as the 

initial test analyte and norfentanyl only 

as a confirmatory test analyte, noting it 

is a Schedule II drug because it is used 

in the synthesis of fentanyl, and is not 

a pharmacologically active metabolite or 

a separate drug of misuse. 

Nine commenters addressed the 

proposed 1 ng/mL fentanyl initial test 

cutoff for urine. Of these, one agreed 

with the fentanyl cutoff, noting that 

current FDA-cleared immunoassays 

used for initial testing can meet this 

cutoff. Eight commenters disagreed, 

stating that a 1 ng/mL cutoff is beyond 

the limits of traditional immunoassay 

technologies, and that laboratories 

would not be able to meet the UrMG 

requirement for initial test controls 

targeted at 25% above and below the 

cutoff. One commenter suggested a 

lower cutoff (0.75 ng/mL) but did not 

provide supporting information. The 

Department notes that there is a 

commercial immunoassay at this cutoff. 

Regarding the proposed confirmatory 

test analytes and cutoffs, one 

commenter agreed with testing both 

fentanyl and norfentanyl using the 

proposed 0.5 ng/mL cutoff. Two other 

commenters agreed with norfentanyl as 

a confirmatory test analyte but disagreed 

with the proposed cutoff. One of these 

commenters provided 2022–2023 data 

from non-regulated drug testing 

showing that only 1.6% of specimens 

had results below 1.0 ng/mL, while 

more than 50% had results above 100 

ng/mL for fentanyl and above 1000 ng/ 

mL for norfentanyl. The commenter did 

not indicate the initial test cutoff(s) used 

for these specimens. An initial test 

cutoff of 1 or 2 ng/mL could explain the 

low percentage of confirmatory test 

results below 1 ng/mL. 

One commenter disagreed with the 

proposed fentanyl cutoffs for both initial 

and confirmatory testing, stating the 

cutoffs were too low and would present 

legal challenges due to long elimination 

times in urine following fentanyl use. 

The commenter noted that there are no 

controlled studies in the literature on 

this topic. Concerns were based on a 

laboratory’s reports of six cases 

involving norfentanyl >0.5 ng/mL for at 

least one month after self-reported 

cessation of fentanyl use, and two other 

studies indicating possible long 

elimination time based on positive 

results after self-reported cessation of 

fentanyl use by individuals with opioid 

use disorder.17

The Department considered all 

comments. Regarding initial test analyte 

selection, the Department agrees with 

commenters that, at the time of this 

writing, most commercial 

immunoassays for fentanyl in urine are 

calibrated to fentanyl and exhibit little 

cross-reactivity to norfentanyl. The 

Department is aware of one 

immunoassay for fentanyl that has 5– 

7% cross-reactivity to norfentanyl and 

another immunoassay for norfentanyl in 

urine with a 5 ng/mL cutoff (i.e., above 

the cutoff specified in the drug testing 

panel). As detailed above, HHS-certified 

laboratory test information, the pulse 

testing study, and review of fentanyl 

and norfentanyl concentrations from 

other tested populations demonstrate 

the importance of testing for 

norfentanyl. 

To facilitate implementation of 

fentanyl testing into Federal workplace 

drug testing programs, the Department 

has decided to include only fentanyl 

(not norfentanyl) as the sole initial test 

analyte for urine at a cutoff of 1 ng/mL 

and require a fentanyl immunoassay 

initial test to exhibit at least 5% crossreactivity for norfentanyl. The 

Department also increased the proposed 

0.5 ng/mL confirmatory test cutoffs to 1 

ng/mL for both fentanyl and 

norfentanyl. These changes are 

consistent with the current initial and 

confirmatory test technologies already 

available in HHS-certified laboratories 

and detailed in the current scientific 

literature. 

Fentanyl Analyte Selection and Cutoff 

Determination—Oral Fluid 

Information provided by HHScertified urine laboratories in 2023 

indicated that 43% offered oral fluid 

testing to non-regulated workplace 

clients and that 71% of these 

laboratories offered testing for fentanyl. 

These laboratories indicated they had 

the ability to analyze oral fluid 

specimens for fentanyl with sufficiently 

sensitive detection limits using 

commercially available immunoassay 

kits and confirmatory test 

instrumentation commonly used in 

HHS-certified laboratories. The 

laboratories’ initial test cutoffs ranged 

from 1 to 4 ng/mL for fentanyl and 

confirmatory test cutoffs for fentanyl 

ranged from 0.5 to 1 ng/mL for fentanyl. 

Fentanyl has been detected in oral 

fluid in non-regulated workplace drug 

testing, patients receiving pain 

management, overdose cases, and 

driving under the influence of drugs 

(DUID) cases. Laboratory data from nonregulated workplace drug testing show 

around 4% fentanyl positivity in oral 

fluid. The median, mean and max 

fentanyl concentrations were 8.6 ng/mL, 

55.7 ng/mL and 17,409 ng/mL, 

respectively.11 The median norfentanyl 

concentration was 4.5 ng/mL. For DUID 

testing, cutoffs of 1 ng/mL for the initial 

test and 0.5 ng/mL for the confirmatory 

test have been recommended for 

fentanyl in oral fluid.18 In a study of 

people arrested for DUID, 59% of oral 

fluid specimens had concentrations 

above 20 ng/mL.19 In a large study, oral 

fluid specimens were collected from 

6,441 patients receiving pain care and 

screened by immunoassay (1 ng/mL 

fentanyl cutoff) and confirmed by LC– 

MS/MS.20 Of the collected specimens, 

6.9% screened positive (443 specimens) 

and 98.4% of those (436 specimens) 

were confirmed positive. The fentanyl, 

median, mean, and range concentrations 

were, 6.6, 49.8, and 0.2 to 5,341.3 ng/ 

mL, respectively. For the 148 confirmed 

positive norfentanyl specimens, the 

norfentanyl median, mean, and range 

concentrations were 1.6, 4.7, and 0.5 to 

125 ng/mL, respectively. In a study of 

patients treated with buprenorphine, the 

prevalence of fentanyl in oral fluid was 

2.9% (n=146) with a median 

concentration of 1.3 ng/mL (Q1–Q3, 

0.4–10.4).21 In a study of patients 

wearing fentanyl patches (n=162), the 

median fentanyl concentration was 

around 5 ng/mL, range 0.012–38.4 ng/ 

mL.22

Based on this information and review 

of the scientific literature, the 

Department originally proposed 

fentanyl as the only analyte for oral 


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4666 Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Rules and Regulations 

fluid, with a 1 ng/mL initial test cutoff 

and a 0.5 ng/mL confirmatory test 

cutoff. 

Three commenters disagreed with 

testing fentanyl in oral fluid noting that, 

because there are no FDA-cleared 

immunoassays meeting program 

requirements, inclusion of fentanyl 

would delay implementation of oral 

fluid into Federal workplace drug 

testing programs. One of these 

commenters raised concern that the 

added burden and cost to develop and 

implement an alternate technology 

initial test (e.g., LC–MS/MS) would 

deter some laboratories from applying 

for oral fluid certification. Another 

commenter noted that, unless the 

regulatory process is streamlined, HHS 

will not be able to respond quickly to 

changes in drug use. 

One commenter agreed with the 

proposed 1 ng/mL fentanyl initial test 

cutoff for oral fluid, while 10 

commenters disagreed. Most 

commenters were concerned that the 

cutoff was too low, stating that oral fluid 

collection devices containing a buffer 

(i.e., diluting the oral fluid) would not 

be able to meet program analytical 

requirements (e.g., controls at 25% 

above and below the initial test cutoff). 

Many of the commenters indicated that 

a higher cutoff is supported by drug test 

results. One commenter suggested 

raising the cutoff: suggesting that the 

Department select a cutoff between 2 

and 4 ng/mL. Two commenters 

requested research supporting the 

proposed 1 ng/mL initial test cutoff and 

0.5 confirmatory test cutoff. This 

information is provided above. One 

commenter recommended a lower 

initial test cutoff (0.75 ng/mL) and a 

higher confirmatory cutoff (5 ng/mL), 

with no scientific support. 

The Department has considered all 

comments and has decided to increase 

the initial test cutoff to 4 ng/mL and the 

confirmatory test cutoff for fentanyl to 1 

ng/mL. Based on information provided 

by the public, review of the scientific 

literature, and current methods and 

technologies used for oral fluid drug 

testing, the Department has determined 

that these fentanyl cutoffs are 

appropriate for initial and confirmatory 

tests. 

Revised Criteria for Grouped Analytes 

Using an Alternate Technology Initial 

Drug Test 

The Department defines grouped 

initial test analytes as two or more 

analytes that are in the same drug class 

and have the same initial drug test 

cutoff. Footnote 1 of the drug testing 

panel specifies requirements for initial 

tests using immunoassay and those 

using an alternate technology (e.g., 

liquid chromatography-tandem mass 

spectrometry, LC–MS/MS). The 

Department has revised Footnote 1 of 

the Section 3.4 tables in the UrMG and 

OFMG to include more specific and 

updated criteria for alternate technology 

initial drug tests, based on current 

technology and program experience. 

For a technology other than 

immunoassay that measures a response 

from the entire group without 

differentiating between analytes (e.g., an 

activity-based assay, a mass 

spectrometric assay that does not 

differentiate isobaric compounds), the 

laboratory must compare the result to 

the initial test cutoff. In the case of an 

alternate technology that differentiates 

and quantifies each analyte in the 

group, the laboratory must compare 

each analyte’s result to the confirmatory 

test cutoff and reflex specimens with a 

positive initial test result to 

confirmatory testing. 

Biomarker Testing Panel 

Section 3.4 of the UrMG and OFMG 

call upon the Secretary to add 

biomarkers to the biomarker testing 

panel; however, at the time of this 

writing, no biomarkers have been 

approved for Federal workplace drug 

testing. The Department will review and 

approve biomarkers based on laboratory 

data and support from the scientific and 

medical literature and add them to the 

biomarker testing panel in a subsequent 

FRN. 

A biomarker is defined in Section 1.5 

of the UrMG and OFMG as ‘‘an 

endogenous substance used to validate 

a biological specimen’’. While 

creatinine in urine meets this definition, 

it is not sufficient as a sole analyte. The 

UrMG include requirements for testing 

both creatinine and specific gravity to 

report a specimen as dilute, invalid, or 

substituted. 

Costs and Benefits 

HHS-certified test facilities and MROs 

will incur initial costs for administrative 

and programming changes for the 

addition of fentanyl and/or norfentanyl. 

Laboratories that already offer 

fentanyl and norfentanyl testing and use 

the same cutoff(s) for their nonregulated clients may experience some 

savings compared to laboratories that do 

not test for these analytes. Estimated 

costs for testing for fentanyl range from 

$0.23 to $5.00 (for initial testing) and 

$8.00 to $25.00 (for confirmatory 

testing) per specimen tested. Total 

laboratory costs for fentanyl 

confirmatory testing of Federal 

employee specimens are estimated to 

range from $577–$4,750. Based on the 

number of tests performed on Federal 

employees, the added cost for fentanyl 

confirmatory testing will be $0.0152 to 

$0.125 per submitted specimen, and the 

total cost for adding fentanyl will range 

from $9,317 to $194,750, based on these 

estimates. 

MROs may experience increased costs 

when an agency chooses to test their 

federal job applicants and employees for 

the added analytes, as fentanyl analytes 

are expected to have high positivity 

rates and, in addition, fentanyl is a 

Schedule II drug with approved 

therapeutic uses requiring the MRO to 

review potential medical explanations. 

Additional costs for testing and MRO 

review will be incorporated into the 

overall costs for the Federal agency 

submitting the specimen to the 

laboratory. Added costs to MROs would 

be expected to shift to Federal agencies 

over time, as existing contracts expire, 

and new contract terms are negotiated. 

Currently, the Department does not 

require HHS-certified test facilities to 

implement authorized biomarker tests. 

Each laboratory and IITF should 

conduct their own cost analysis when 

deciding whether to offer biomarker 

testing to federally regulated clients. 

The Department will consider costs 

when deciding whether to require all 

certified test facilities to test for a 

specific biomarker. 

References 

1. Agriculture Improvement Act of 2018, 

Public Law 115–334 (2018). 115th 

Congress. https://www.congress.gov/115/ 

plaws/publ334/PLAW-115publ334.pdf. 

2. Agricultural Marketing Service. (2021). 

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2022 Annual Report. U.S. Department of 

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fluids. DTAB Meeting. https://

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meeting/documents/crl-testingexperience-fentanyl-urine-oralfluids.pdf. 

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meeting/documents/dtab-summary-ofpulse-testing-2023.pdf 

13. LaRue, L., Twillman, R.K., Dawson, E., 

Whitley, P., Frasco, M.A., Huskey, A., & 

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Caplan, Y.H., & Cone, E.J. (2010). Urine 

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2023ProgramBook-Digital.pdf. 

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j.clinthera.2015.09.002. 

REPORT NOMENCLATURE—URINE

Urine 

Abbreviation Analyte 

D9THCC ......... D-9-tetrahydrocannabinol-9-carboxylic acid. 

BZE ................ Benzoylecgonine. 

COD ............... Codeine. 

MOR ............... Morphine. 

HYC ............... Hydrocodone. 

HYM ............... Hydromorphone. 

OXYC ............. Oxycodone. 

OXYM ............ Oxymorphone. 

6-AM .............. 6-Acetylmorphine. 

PCP ................ Phencyclidine. 

FENT .............. Fentanyl. 

NFENT ........... Norfentanyl. 

AMP ............... Amphetamine. 

MAMP ............ Methamphetamine. 

MDMA ............ Methylenedioxymethamphetamine. 

MDA ............... Methylenedioxyamphetamine. 

HHS DRUG TESTING PANEL—URINE

Initial test analyte Initial 

test cutoff 1 Confirmatory test analyte Confirmatory test cutoff 

Marijuana metabolite (D9THCC) ............................... 50 ng/mL. D9THCC .................................................................... 15 ng/mL. 

Cocaine metabolite (Benzoylecgonine) ..................... 150 ng/mL.2 Benzoylecgonine ....................................................... 100 ng/mL. 

Codeine/Morphine ..................................................... 2,000 ng/mL. Codeine .....................................................................

Morphine ...................................................................

2,000 ng/mL. 

4,000 ng/mL. 

Hydrocodone/Hydromorphone ................................... 300 ng/mL. Hydrocodone .............................................................

Hydromorphone ........................................................

100 ng/mL. 

100 ng/mL. 

Oxycodone/Oxymorphone ......................................... 100 ng/mL. Oxycodone ................................................................

Oxymorphone ............................................................

100 ng/mL. 

100 ng/mL. 

6-Acetylmorphine ....................................................... 10 ng/mL. 6-Acetylmorphine ...................................................... 10 ng/mL. 

Phencyclidine ............................................................. 25 ng/mL. Phencyclidine ............................................................ 25 ng/mL. 

Fentanyl 3 ................................................................... 1 ng/mL. Fentanyl ....................................................................

Norfentanyl ................................................................

1 ng/mL. 

1 ng/mL. 

Amphetamine/Methamphetamine .............................. 500 ng/mL. Amphetamine ............................................................

Methamphetamine ....................................................

250 ng/mL. 

250 ng/mL. 

MDMA/MDA ............................................................... 500 ng/mL. Methylenedioxymethamphetamine ...........................

Methylenedioxyamphetamine ...................................

250 ng/mL. 

250 ng/mL. 

1For grouped analytes (i.e., two or more analytes that are in the same drug class and have the same initial test cutoff): 

Immunoassay: The test must be calibrated with one analyte from the group identified as the target analyte. The cross-reactivity of the 

immunoassay to the other analyte(s) within the group must be 80 percent or greater; if not, separate immunoassays must be used for the 

analytes within the group. 


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Alternate technology: Either one analyte or all analytes from the group must be used for calibration, depending on the technology. For a technology that measures a response from the entire group without differentiating between analytes (e.g., an activity-based assay, a mass spectrometric assay that does not differentiate isobaric compounds), the laboratory must compare the result to the initial test cutoff. In the case of an 

alternate technology that differentiates and quantifies each analyte in the group, the laboratory must compare each analyte’s result to the confirmatory test cutoff and reflex specimens with a positive initial test result to confirmatory testing. 2Alternate technology (BZE): The confirmatory test cutoff must be used for an alternate technology initial test that is specific for the target 

analyte (i.e., 100 ng/mL for benzoylecgonine). 3A fentanyl immunoassay must have at least 5% cross-reactivity to norfentanyl. 

HHS Biomarker Testing Panel—Urine 

SAMHSA has not yet authorized 

routine testing for any biomarker in 

urine. HHS-certified laboratories and 

instrumented initial test facilities (IITFs) 

may request authorization to test 

Federal agency specimens for a 

biomarker upon Medical Review Officer 

(MRO) request by submitting supporting 

documentation and assay validation 

records to the National Laboratory 

Certification Program (NLCP) for 

SAMHSA review and approval. 

REPORT NOMENCLATURE—ORAL FLUID

Oral fluid 

Abbreviation Analyte 

D9THC ........... D-9-tetrahydrocannabinol. 

COC ............... Cocaine. 

BZE ................ Benzoylecgonine. 

COD ............... Codeine. 

MOR ............... Morphine. 

HYC ............... Hydrocodone. 

HYM ............... Hydromorphone. 

OXYC ............. Oxycodone. 

OXYM ............ Oxymorphone. 

6-AM .............. 6-Acetylmorphine. 

REPORT NOMENCLATURE—ORAL

FLUID—Continued 

Oral fluid 

Abbreviation Analyte 

PCP ................ Phencyclidine. 

FENT .............. Fentanyl. 

AMP ............... Amphetamine. 

MAMP ............ Methamphetamine. 

MDMA ............ Methylenedioxymethamphetamine. 

MDA ............... Methylenedioxyamphetamine. 

HHS DRUG TESTING PANEL—ORAL FLUID

HHS drug testing panel—undiluted (neat) oral fluid 

Initial test analyte Initial 

test cutoff 1 Confirmatory test analyte Confirmatory 

test cutoff 

Marijuana (D9THC) .................................................... 4 ng/mL. D9THC ....................................................................... 2 ng/mL. 

Cocaine/Benzoylecgonine ......................................... 15 ng/mL. Cocaine .....................................................................

Benzoylecgonine .......................................................

8 ng/mL. 

8 ng/mL. 

Codeine/Morphine ..................................................... 30 ng/mL. Codeine .....................................................................

Morphine ...................................................................

15 ng/mL. 

15 ng/mL. 

Hydrocodone/Hydromorphone ................................... 30 ng/mL. Hydrocodone .............................................................

Hydromorphone ........................................................

15 ng/mL. 

15 ng/mL. 

Oxycodone/Oxymorphone ......................................... 30 ng/mL. Oxycodone ................................................................

Oxymorphone ............................................................

15 ng/mL. 

15 ng/mL. 

6-Acetylmorphine ....................................................... 4 ng/mL.2 6-Acetylmorphine ...................................................... 2 ng/mL. 

Phencyclidine ............................................................. 10 ng/mL. Phencyclidine ............................................................ 10 ng/mL. 

Fentanyl ..................................................................... 4 ng/mL. Fentanyl .................................................................... 1 ng/mL. 

Amphetamine/Methamphetamine .............................. 50 ng/mL. Amphetamine ............................................................

Methamphetamine ....................................................

25 ng/mL. 

25 ng/mL. 

MDMA/MDA ............................................................... 50 ng/mL. Methylenedioxymethamphetamine ...........................

Methylenedioxyamphetamine ...................................

25 ng/mL. 

25 ng/mL. 

1For grouped analytes (i.e., two or more analytes that are in the same drug class and have the same initial test cutoff): 

Immunoassay: The test must be calibrated with one analyte from the group identified as the target analyte. The cross reactivity of the 

immunoassay to the other analyte(s) within the group must be 80 percent or greater; if not, separate immunoassays must be used for the 

analytes within the group. 

Alternate technology: Either one analyte or all analytes from the group must be used for calibration, depending on the technology. For a technology that measures a response from the entire group without differentiating between analytes (e.g., an activity-based assay, a mass spectrometric assay that does not differentiate isobaric compounds), the laboratory must compare the result to the initial test cutoff. In the case of an 

alternate technology that differentiates and quantifies each analyte in the group, the laboratory must compare each analyte’s result to the confirmatory test cutoff and reflex specimens with a positive initial test result to confirmatory testing. 2Alternate technology (6-AM): The confirmatory test cutoff must be used for an alternate technology initial test that is specific for the target 

analyte (i.e., 2 ng/mL for 6-AM). 

HHS Biomarker Testing Panel—Oral 

Fluid 

SAMHSA has not yet authorized 

routine testing for any biomarker in oral 

fluid. HHS-certified laboratories may 

request authorization to test Federal 

agency specimens for a biomarker by 

submitting supporting documentation 

and assay validation records to the 

National Laboratory Certification 

Program (NLCP) for SAMHSA review 

and approval. Authorized biomarker test 

cutoffs for oral fluid will be based on 

undiluted (neat) oral fluid. 

Xavier Becerra, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2025–00425 Filed 1–15–25; 8:45 am] 

BILLING CODE 4162–20–P 


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