49 CFR Part 40

Office of the Secretary of Transportation
part 39 from then DOT Departmental
Office of Civil Rights and/or DOT Office
of General Counsel, 1200 New Jersey
Avenue, SE., Washington, DC 20590.
§ 39.109 What
enforcement
actions
may be taken under this Part?
(a) The Department of Transportation investigates complaints and
conducts reviews or other inquiries
into the compliance with this Part of
PVOs that are Title II entities.
(b) As a PVO subject to Title II of the
ADA, you must be prepared to provide
to the Department of Transportation a
written explanation of your action in
any situation in which you exclude or
restrict an individual with a disability
or any mobility or other assistive device used by such an individual with respect to the use of your vessel.
(c) The Department of Transportation investigates complaints conducts compliance reviews or other inquiries into the compliance of this Part
of PVOs, whether private or public entities, that receive Federal financial
assistance from the Department, under
section 504 of the Rehabilitation Act of
1973, as amended.
(d) The Department may refer any
matter concerning the compliance of
PVOs with this Part to the Department
of Justice for enforcement action.
(e) The Department of Justice investigates complaints and conducts reviews or other inquiries into the compliance with this Part of PVOs that are
Title III entities.
(f) The Department of Justice may
file suit in Federal court against both
Title II and Title III PVOs for violations of this part.

PART
40—PROCEDURES
FOR
TRANSPORTATION WORKPLACE
DRUG AND ALCOHOL TESTING
PROGRAMS

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Subpart A—Administrative Provisions
Sec.
40.1 Who does this regulation cover?
40.3 What do the terms used in this part
mean?
40.5 Who issues authoritative interpretations of this regulation?
40.7 How can you get an exemption from a
requirement in this regulation?

Pt. 40
Subpart B—Employer Responsibilities
40.11 What are the general responsibilities
of employers under this regulation?
40.13 How do DOT drug and alcohol tests relate to non-DOT tests?
40.14 What collection information must employers provide to collectors?
40.15 May an employer use a service agent
to meet DOT drug and alcohol testing requirements?
40.17 Is an employer responsible for obtaining information from its service agents?
40.19 [Reserved]
40.21 May an employer stand down an employee before the MRO has completed the
verification process?
40.23 What actions do employers take after
receiving verified test results?
40.25 Must an employer check on the drug
and alcohol testing record of employees
it is intending to use to perform safetysensitive duties?
40.26 What form must an employer use to
report Management Information System
(MIS) data to a DOT agency?
40.27 May an employer require an employee
to sign a consent or release in connection
with the DOT drug and alcohol testing
program?
40.29 Where is other information on employer responsibilities found in this regulation?

Subpart C—Urine Collection Personnel
40.31 Who may collect urine specimens for
DOT drug testing?
40.33 What training requirements must a
collector meet?
40.35 What information about the DER must
employers provide to collectors?
40.37 Where is other information on the role
of collectors found in this regulation?

Subpart D—Collection Sites, Forms, Equipment and Supplies Used in DOT Urine
Collections
40.41 Where does a urine collection for a
DOT drug test take place?
40.43 What steps must operators of collection sites take to protect the security
and integrity of urine collections?
40.45 What form is used to document a DOT
urine collection?
40.47 May employers use the CCF for nonFederal collections or non-Federal forms
for DOT collections?
40.49 What materials are used to collect
urine specimens?
40.51 What materials are used to send urine
specimens to the laboratory?

Subpart E—Urine Specimen Collections
40.61 What are the preliminary steps in the
collection process?

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Pt. 40

49 CFR Subtitle A (10–1–21 Edition)

40.63 What steps does the collector take in
the collection process before the employee provides a urine specimen?
40.65 What does the collector check for
when the employee presents a specimen?
40.67 When and how is a directly observed
collection conducted?
40.69 How is a monitored collection conducted?
40.71 How does the collector prepare the
specimens?
40.73 How is the collection process completed?

Subpart F—Drug Testing Laboratories
40.81 What laboratories may be used for
DOT drug testing?
40.83 How do laboratories process incoming
specimens?
40.85 What drugs do laboratories test for?
40.87 What are the cutoff concentrations for
drug tests?
40.89 What is validity testing, and are laboratories required to conduct it?
40.91 What validity tests must laboratories
conduct on primary specimens?
40.93 What criteria do laboratories use to
establish that a specimen is dilute or
substituted?
40.95 What are the adulterant cutoff concentrations for initial and confirmation
tests?
40.96 What criteria do laboratories use to
establish that a specimen is invalid?
40.97 What do laboratories report and how
do they report it?
40.99 How long does the laboratory retain
specimens after testing?
40.101 What relationship may a laboratory
have with an MRO?
40.107 Who may inspect laboratories?
40.109 What documentation must the laboratory keep, and for how long?
40.111 When and how must a laboratory disclose statistical summaries and other information it maintains?
40.113 Where is other information concerning laboratories found in this regulation?

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Subpart G—Medical Review Officers and
the Verification Process
40.121 Who is qualified to act as an MRO?
40.123 What are the MRO’s responsibilities
in the DOT drug testing program?
40.125 What relationship may an MRO have
with a laboratory?
40.127 What are the MRO’s functions in reviewing negative test results?
40.129 What are the MRO’s functions in reviewing laboratory confirmed non-negative drug test results?
40.131 How does the MRO or DER notify an
employee of the verification process

after receiving laboratory confirmed
non-negative drug test results?
40.133 Without interviewing the employee,
under what circumstances may the MRO
verify a test result as positive, or as a refusal to test because of adulteration or
substitution, or as cancelled because the
test was invalid?
40.135 What does the MRO tell the employee
at the beginning of the verification interview?
40.137 On what basis does the MRO verify
test results involving marijuana, cocaine, amphetamines, semi-synthetic
opioids, or PCP?
40.139 On what basis does the MRO verify
test results involving 6-acetylmorphine,
codeine, and morphine?
40.141 How does the MRO obtain information for the verification decision?
40.143 [Reserved]
40.145 On what basis does the MRO verify
test results involving adulteration or
substitution?
40.147 [Reserved]
40.149 May the MRO change a verified drug
test result?
40.151 What are MROs prohibited from doing
as part of the verification process?
40.153 How does the MRO notify employees
of their right to a test of the split specimen?
40.155 What does the MRO do when a negative or positive test result is also dilute?
40.157 [Reserved]
40.159 What does the MRO do when a drug
test result is invalid?
40.160 What does the MRO do when a valid
test result cannot be produced and a negative result is required?
40.161 What does the MRO do when a drug
test specimen is rejected for testing?
40.162 What must MROs do with multiple
verified results for the same testing
event?
40.163 How does the MRO report drug test
results?
40.165 To whom does the MRO transmit reports of drug test results?
40.167 How are MRO reports of drug results
transmitted to the employer?
40.169 Where is other information concerning the role of MROs and the
verification process found in this regulation?

Subpart H—Split Specimen Tests
40.171 How does an employee request a test
of a split specimen?
40.173 Who is responsible for paying for the
test of a split specimen?
40.175 What steps does the first laboratory
take with a split specimen?
40.177 What does the second laboratory do
with the split specimen when it is tested

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Office of the Secretary of Transportation
to reconfirm the presence of a drug or
drug metabolite?
40.179 What does the second laboratory do
with the split specimen when it is tested
to reconfirm an adulterated test result?
40.181 What does the second laboratory do
with the split specimen when it is tested
to reconfirm a substituted test result?
40.183 What information do laboratories report to MROs regarding split specimen
results?
40.185 Through what methods and to whom
must a laboratory report split specimen
results?
40.187 What does the MRO do with split
specimen laboratory results?
40.189 Where is other information concerning split specimens found in this regulation?

Pt. 40
Subpart K—Testing Sites, Forms, Equipment
and Supplies Used in Alcohol Testing
40.221 Where does an alcohol test take
place?
40.223 What steps must be taken to protect
the security of alcohol testing sites?
40.225 What form is used for an alcohol test?
40.227 May employers use the ATF for nonDOT tests, or non-DOT forms for DOT
tests?
40.229 What devices are used to conduct alcohol screening tests?
40.231 What devices are used to conduct alcohol confirmation tests?
40.233 What are the requirements for proper
use and care of EBTs?
40.235 What are the requirements for proper
use and care of ASDs?

Subpart L—Alcohol Screening Tests

Subpart I—Problems in Drug Tests
40.191 What is a refusal to take a DOT drug
test, and what are the consequences?
40.193 What happens when an employee does
not provide a sufficient amount of urine
for a drug test?
40.195 What happens when an individual is
unable to provide a sufficient amount of
urine for a pre-employment follow-up or
return-to-duty test because of a permanent or long-term medical condition?
40.197 What happens when an employer receives a report of a dilute specimen?
40.199 What problems always cause a drug
test to be cancelled?
40.201 What problems always cause a drug
test to be cancelled and may result in a
requirement for another collection?
40.203 What problems cause a drug test to
be cancelled unless they are corrected?
40.205 How are drug test problems corrected?
40.207 What is the effect of a cancelled drug
test?
40.208 What problem requires corrective action but does not result in the cancellation of a test?
40.209 What procedural problems do not result in the cancellation of a test and do
not require correction?
40.210 Are drug tests other than urine permitted under the regulations?

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Subpart J—Alcohol Testing Personnel
40.211 Who conducts DOT alcohol tests?
40.213 What training requirements must
STTs and BATs meet?
40.215 What information about the DER do
employers have to provide to BATs and
STTs?
40.217 Where is other information on the
role of STTs and BATs found in this regulation?

40.241 What are the first steps in any alcohol screening test?
40.243 What is the procedure for an alcohol
screening test using an EBT or non-evidential breath ASD?
40.245 What is the procedure for an alcohol
screening test using a saliva ASD or a
breath tube ASD?
40.247 What procedures does the BAT or
STT follow after a screening test result?

Subpart M—Alcohol Confirmation Tests
40.251 What are the first steps in an alcohol
confirmation test?
40.253 What are the procedures for conducting an alcohol confirmation test?
40.255 What happens next after the alcohol
confirmation test result?

Subpart N—Problems in Alcohol Testing
40.261 What is a refusal to take an alcohol
test, and what are the consequences?
40.263 What happens when an employee is
unable to provide a sufficient amount of
saliva for an alcohol screening test?
40.265 What happens when an employee is
unable to provide a sufficient amount of
breath for an alcohol test?
40.267 What problems always cause an alcohol test to be cancelled?
40.269 What problems cause an alcohol test
to be cancelled unless they are corrected?
40.271 How are alcohol testing problems corrected?
40.273 What is the effect of a cancelled alcohol test?
40.275 What is the effect of procedural problems that are not sufficient to cancel an
alcohol test?
40.277 Are alcohol tests other than saliva or
breath permitted under these regulations?

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Pt. 40

49 CFR Subtitle A (10–1–21 Edition)

Subpart O—Substance Abuse Professionals
and the Return-to-Duty Process
40.281 Who is qualified to act as a SAP?
40.283 How does a certification organization
obtain recognition for its members as
SAPs?
40.285 When is a SAP evaluation required?
40.287 What information is an employer required to provide concerning SAP services to an employee who has a DOT drug
and alcohol regulation violation?
40.289 Are employers required to provide
SAP and treatment services to employees?
40.291 What is the role of the SAP in the
evaluation, referral, and treatment process of an employee who has violated DOT
agency drug and alcohol testing regulations?
40.293 What is the SAP’s function in conducting the initial evaluation of an employee?
40.295 May employees or employers seek a
second SAP evaluation if they disagree
with the first SAP’s recommendations?
40.297 Does anyone have the authority to
change a SAP’s initial evaluation?
40.299 What is the SAP’s role and what are
the limits on a SAP’s discretion in referring employees for education and treatment?
40.301 What is the SAP’s function in the follow-up evaluation of an employee?
40.303 What happens if the SAP believes the
employee needs additional treatment,
aftercare, or support group services even
after the employee returns to safety-sensitive duties?
40.305 How does the return-to-duty process
conclude?
40.307 What is the SAP’s function in prescribing the employee’s follow-up tests?
40.309 What are the employer’s responsibilities with respect to the SAP’s directions
for follow-up tests?
40.311 What are requirements concerning
SAP reports?
40.313 Where is other information on SAP
functions and the return-to-duty process
found in this regulation?

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Subpart P—Confidentiality and Release of
Information
40.321 What is the general confidentiality
rule for drug and alcohol test information?
40.323 May program participants release
drug or alcohol test information in connection with legal proceedings?
40.325 [Reserved]
40.327 When must the MRO report medical
information gathered in the verification
process?

40.329 What information must laboratories,
MROs, and other service agents release
to employees?
40.331 To what additional parties must employers and service agents release information?
40.333 What records must employers keep?

Subpart Q—Roles And Responsibilities of
Service Agents
40.341 Must service agents comply with DOT
drug and alcohol testing requirements?
40.343 What tasks may a service agent perform for an employer?
40.345 In what circumstances may a C/TPA
act as an intermediary in the transmission of drug and alcohol testing information to employers?
40.347 What functions may C/TPAs perform
with respect administering testing?
40.349 What records may a service agent receive and maintain?
40.351 What confidentiality requirements
apply to service agents?
40.353 What principles govern the interaction between MROs and other service
agents?
40.355 What limitations apply to the activities of service agents?

Subpart R—Public Interest Exclusions
40.361 What is the purpose of a public interest exclusion (PIE)?
40.363 On what basis may the Department
issue a PIE?
40.365 What is the Department’s policy concerning starting a PIE proceeding?
40.367 Who initiates a PIE proceeding?
40.369 What is the discretion of an initiating
official in starting a PIE proceeding?
40.371 On what information does an initiating official rely in deciding whether to
start a PIE proceeding?
40.373 Before starting a PIE proceeding,
does the initiating official give the service agent an opportunity to correct problems?
40.375 How does the initiating official start
a PIE proceeding?
40.377 Who decides whether to issue a PIE?
40.379 How do you contest the issuance of a
PIE?
40.381 What information do you present to
contest the proposed issuance of a PIE?
40.383 What procedures apply if you contest
the issuance of a PIE?
40.385 Who bears the burden of proof in a
PIE proceeding?
40.387 What matters does the Director decide concerning a proposed PIE?
40.389 What factors may the Director consider?
40.391 What is the scope of a PIE?
40.393 How long does a PIE stay in effect?
40.395 Can you settle a PIE proceeding?

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Office of the Secretary of Transportation
40.397 When does the Director make a PIE
decision?
40.399 How does the Department notify service agents of its decision?
40.401 How does the Department notify employers and the public about a PIE?
40.403 Must a service agent notify its clients
when the Department issues a PIE?
40.405 May the Federal courts review PIE
decisions?
40.407 May a service agent ask to have a
PIE reduced or terminated?
40.409 What does the issuance of a PIE mean
to transportation employers?
40.411 What is the role of the DOT Inspector
General’s office?
40.413 How are notices sent to service
agents?
APPENDIX A TO PART 40—DOT STANDARDS
FOR URINE COLLECTION KITS
APPENDIX B TO PART 40—DOT DRUG-TESTING
SEMI-ANNUAL LABORATORY REPORT TO
EMPLOYERS
APPENDIX C TO PART 40—DOT DRUG-TESTING
SEMI-ANNUAL LABORATORY REPORT TO
DOT
APPENDIX D TO PART 40—REPORT FORMAT:
SPLIT SPECIMEN FAILURE TO RECONFIRM
APPENDIX E TO PART 40—SAP EQUIVALENCY
REQUIREMENTS FOR CERTIFICATION ORGANIZATIONS

APPENDIX F TO PART 40—DRUG AND ALCOHOL
TESTING INFORMATION THAT C/TPAS MAY
TRANSMIT TO EMPLOYERS
APPENDIX G TO PART 40—ALCOHOL TESTING
FORM (ATF)
APPENDIX H TO PART 40—DOT DRUG AND ALCOHOL TESTING MANAGEMENT INFORMATION SYSTEM (MIS) DATA COLLECTION
FORM
AUTHORITY: 49 U.S.C. 102, 301, 322, 5331,
20140, 31306, and 54101 et seq.
SOURCE: 65 FR 79526, Dec. 19, 2000, unless
otherwise noted.
EDITORIAL NOTE: Nomenclature changes to
part 40 appear at 73 FR 33329, June 12, 2008.

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Subpart A—Administrative
Provisions
§ 40.1 Who does this regulation cover?
(a) This part tells all parties who
conduct drug and alcohol tests required
by Department of Transportation
(DOT) agency regulations how to conduct these tests and what procedures
to use.
(b) This part concerns the activities
of transportation employers, safetysensitive transportation employees (including self-employed individuals, contractors and volunteers as covered by

§ 40.3
DOT agency regulations), and service
agents.
(c) Nothing in this part is intended to
supersede or conflict with the implementation of the Federal Railroad Administration’s post-accident testing
program (see 49 CFR 219.200).
§ 40.3 What do the terms used in this
part mean?
In this part, the terms listed in this
section have the following meanings:
Adulterated specimen. A specimen that
has been altered, as evidenced by test
results showing either a substance that
is not a normal constituent for that
type of specimen or showing an abnormal concentration of an endogenous
substance.
Affiliate. Persons are affiliates of one
another if, directly or indirectly, one
controls or has the power to control
the other, or a third party controls or
has the power to control both. Indicators of control include, but are not limited to: interlocking management or
ownership; shared interest among family members; shared facilities or equipment; or common use of employees.
Following the issuance of a public interest exclusion, an organization having the same or similar management,
ownership, or principal employees as
the service agent concerning whom a
public interest exclusion is in effect is
regarded as an affiliate. This definition
is used in connection with the public
interest exclusion procedures of Subpart R of this part.
Air blank. In evidential breath testing
devices (EBTs) using gas chromatography technology, a reading of the
device’s internal standard. In all other
EBTs, a reading of ambient air containing no alcohol.
Alcohol. The intoxicating agent in
beverage alcohol, ethyl alcohol or
other low molecular weight alcohols,
including methyl or isopropyl alcohol.
Alcohol concentration. The alcohol in
a volume of breath expressed in terms
of grams of alcohol per 210 liters of
breath as indicated by a breath test
under this part.
Alcohol confirmation test. A subsequent test using an EBT, following a
screening test with a result of 0.02 or
greater, that provides quantitative
data about the alcohol concentration.

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§ 40.3

49 CFR Subtitle A (10–1–21 Edition)

Alcohol screening device (ASD). A
breath or saliva device, other than an
EBT, that is approved by the National
Highway Traffic Safety Administration
(NHTSA) and appears on ODAPC’s Web
page for ‘‘Approved Screening Devices
to Measure Alcohol in Bodily Fluids’’
because it conforms to the model specifications from NHTSA.
Alcohol screening test. An analytic
procedure to determine whether an employee may have a prohibited concentration of alcohol in a breath or saliva specimen.
Alcohol testing site. A place selected
by the employer where employees
present themselves for the purpose of
providing breath or saliva for an alcohol test.
Alcohol use. The drinking or swallowing of any beverage, liquid mixture
or preparation (including any medication), containing alcohol.
Aliquot. A fractional part of a specimen used for testing. It is taken as a
sample representing the whole specimen.
Breath Alcohol Technician (BAT). A
person who instructs and assists employees in the alcohol testing process
and operates an evidential breath testing device.
Cancelled test. A drug or alcohol test
that has a problem identified that cannot be or has not been corrected, or
which this part otherwise requires to
be cancelled. A cancelled test is neither a positive nor a negative test.
Chain of custody. The procedure used
to document the handling of the urine
specimen from the time the employee
gives the specimen to the collector
until the specimen is destroyed. This
procedure uses the Federal Drug Testing Custody and Control Form (CCF) as
approved by the Office of Management
and Budget.
Collection container. A container into
which the employee urinates to provide
the specimen for a drug test.
Collection site. A place selected by the
employer where employees present
themselves for the purpose of providing
a urine specimen for a drug test.
Collector. A person who instructs and
assists employees at a collection site,
who receives and makes an initial inspection of the specimen provided by

those employees, and who initiates and
completes the CCF.
Confirmatory drug test. A second analytical procedure performed on a different aliquot of the original specimen
to identify and quantify the presence of
a specific drug or drug metabolite.
Confirmatory validity test. A second
test performed on a different aliquot of
the original urine specimen to further
support a validity test result.
Confirmed drug test. A confirmation
test result received by an MRO from a
laboratory.
Consortium/Third-party administrator
(C/TPA). A service agent that provides
or coordinates the provision of a variety of drug and alcohol testing services
to employers. C/TPAs typically perform administrative tasks concerning
the operation of the employers’ drug
and alcohol testing programs. This
term includes, but is not limited to,
groups of employers who join together
to administer, as a single entity, the
DOT drug and alcohol testing programs
of its members. C/TPAs are not ‘‘employers’’ for purposes of this part.
Continuing education. Training for
substance abuse professionals (SAPs)
who have completed qualification
training and are performing SAP functions, designed to keep SAPs current
on changes and developments in the
DOT drug and alcohol testing program.
Designated
employer
representative
(DER). An employee authorized by the
employer to take immediate action(s)
to remove employees from safety-sensitive duties, or cause employees to be
removed from these covered duties, and
to make required decisions in the testing and evaluation processes. The DER
also receives test results and other
communications for the employer, consistent with the requirements of this
part. Service agents cannot act as
DERs.
Dilute specimen. A urine specimen
with creatinine and specific gravity
values that are lower than expected for
human urine.
DOT, The Department, DOT Agency.
These terms encompass all DOT agencies, including, but not limited to, the
Federal
Aviation
Administration
(FAA), the Federal Railroad Administration (FRA), the Federal Motor Carrier Safety Administration (FMCSA),

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Office of the Secretary of Transportation
the Federal Transit Administration
(FTA), the National Highway Traffic
Safety Administration (NHTSA), the
Pipeline and Hazardous Materials Safety Administration (PHMSA), and the
Office of the Secretary (OST). For purposes of this part, the United States
Coast Guard (USCG), in the Department of Homeland Security, is considered to be a DOT agency for drug testing purposes only since the USCG regulation does not incorporate Part 40 for
its alcohol testing program. These
terms include any designee of a DOT
agency.
Drugs. The drugs for which tests are
required under this part and DOT agency regulations are marijuana, cocaine,
amphetamines, phencyclidine (PCP),
and opioids.
Employee. Any person who is designated in a DOT agency regulation as
subject to drug testing and/or alcohol
testing. The term includes individuals
currently performing safety-sensitive
functions designated in DOT agency
regulations and applicants for employment subject to pre-employment testing. For purposes of drug testing under
this part, the term employee has the
same meaning as the term ‘‘donor’’ as
found on CCF and related guidance materials produced by the Department of
Health and Human Services.
Employer. A person or entity employing one or more employees (including
an individual who is self-employed)
subject to DOT agency regulations requiring compliance with this part. The
term includes an employer’s officers,
representatives, and management personnel. Service agents are not employers for the purposes of this part.
Error Correction Training. Training
provided to BATs, collectors, and
screening test technicians (STTs) following an error that resulted in the
cancellation of a drug or alcohol test.
Error correction training must be provided in person or by a means that provides real-time observation and interaction between the instructor and
trainee.
Evidential
Breath
Testing
Device
(EBT). A device that is approved by the
National Highway Traffic Safety Administration (NHTSA) for the evidential testing of breath at the .02 and .04
alcohol concentrations, and appears on

§ 40.3
ODAPC’s Web page for ‘‘Approved Evidential Breath Measurement Devices’’
because it conforms with the model
specifications available from NHTSA.
HHS. The Department of Health and
Human Services or any designee of the
Secretary, Department of Health and
Human Services.
Initial drug test (also known as a
‘‘Screening drug test’’). The test used to
differentiate a negative specimen from
one that requires further testing for
drugs or drug metabolites.
Initial specimen validity test. The first
test used to determine if a urine specimen is adulterated, diluted, substituted, or invalid.
Invalid drug test. The result reported
by an HHS-certified laboratory in accordance with the criteria established
by HHS Mandatory Guidelines when a
positive, negative, adulterated, or substituted result cannot be established
for a specific drug or specimen validity
test.
Invalid result. The result reported by
a laboratory for a urine specimen that
contains an unidentified adulterant,
contains an unidentified interfering
substance, has an abnormal physical
characteristic, or has an endogenous
substance at an abnormal concentration that prevents the laboratory from
completing testing or obtaining a valid
drug test result.
Laboratory. Any U.S. laboratory certified by HHS under the National Laboratory Certification Program as meeting the minimum standards of Subpart
C of the HHS Mandatory Guidelines for
Federal Workplace Drug Testing Programs; or, in the case of foreign laboratories, a laboratory approved for participation by DOT under this part.
Limit of Detection (LOD). The lowest
concentration at which a measurand
can be identified, but (for quantitative
assays) the concentration cannot be accurately calculated.
Limit of Quantitation. For quantitative assays, the lowest concentration at which the identity and concentration of the measurand can be accurately established.
Medical Review Officer (MRO). A person who is a licensed physician and
who is responsible for receiving and reviewing laboratory results generated
by an employer’s drug testing program

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§ 40.3

49 CFR Subtitle A (10–1–21 Edition)

and evaluating medical explanations
for certain drug test results.
Negative result. The result reported by
an HHS-certified laboratory to an MRO
when a specimen contains no drug or
the concentration of the drug is less
than the cutoff concentration for the
drug or drug class and the specimen is
a valid specimen.
Non-negative specimen. A urine specimen that is reported as adulterated,
substituted, positive (for drug(s) or
drug metabolite(s)), and/or invalid.
Office of Drug and Alcohol Policy and
Compliance (ODAPC). The office in the
Office of the Secretary, DOT, that is
responsible for coordinating drug and
alcohol testing program matters within the Department and providing information concerning the implementation
of this part.
Oxidizing adulterant. A substance that
acts alone or in combination with
other substances to oxidize drugs or
drug metabolites to prevent the detection of the drug or drug metabolites, or
affects the reagents in either the initial or confirmatory drug test.
Primary specimen. In drug testing, the
urine specimen bottle that is opened
and tested by a first laboratory to determine whether the employee has a
drug or drug metabolite in his or her
system; and for the purpose of validity
testing. The primary specimen is distinguished from the split specimen, defined in this section.
Positive result. The result reported by
an HHS-certified laboratory when a
specimen contains a drug or drug metabolite equal to or greater than the
cutoff concentrations.
Qualification Training. The training
required in order for a collector, BAT,
MRO, SAP, or STT to be qualified to
perform their functions in the DOT
drug and alcohol testing program.
Qualification training may be provided
by any appropriate means (e.g., classroom instruction, internet application,
CD-ROM, video).
Reconfirmed. The result reported for a
split specimen when the second laboratory is able to corroborate the original
result reported for the primary specimen.
Refresher Training. The training required periodically for qualified collectors, BATs, and STTs to review basic

requirements and provide instruction
concerning changes in technology (e.g.,
new testing methods that may be authorized) and amendments, interpretations, guidance, and issues concerning
this part and DOT agency drug and alcohol testing regulations. Refresher
training can be provided by any appropriate means (e.g., classroom instruction, internet application, CD-ROM,
video).
Rejected for testing. The result reported by an HHS-certified laboratory
when no tests are performed for a specimen because of a fatal flaw or a correctable flaw that is not corrected.
Screening drug test. See Initial drug
test definition above.
Screening Test Technician (STT). A
person who instructs and assists employees in the alcohol testing process
and operates an ASD.
Secretary. The Secretary of Transportation or the Secretary’s designee.
Service agent. Any person or entity,
other than an employee of the employer, who provides services to employers and/or employees in connection
with DOT drug and alcohol testing requirements. This includes, but is not
limited to, collectors, BATs and STTs,
laboratories, MROs, substance abuse
professionals, and C/TPAs. To act as
service agents, persons and organizations must meet DOT qualifications, if
applicable. Service agents are not employers for purposes of this part.
Shipping container. A container that
is used for transporting and protecting
urine specimen bottles and associated
documents from the collection site to
the laboratory.
Specimen bottle. The bottle that, after
being sealed and labeled according to
the procedures in this part, is used to
hold the urine specimen during transportation to the laboratory.
Split specimen. In drug testing, a part
of the urine specimen that is sent to a
first laboratory and retained unopened,
and which is transported to a second
laboratory in the event that the employee requests that it be tested following a verified positive test of the
primary specimen or a verified adulterated or substituted test result.
Split specimen collection. A collection
in which the urine collected is divided
into two separate specimen bottles, the

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Office of the Secretary of Transportation
primary specimen (Bottle A) and the
split specimen (Bottle B).
Stand-down. The practice of temporarily removing an employee from the
performance of safety-sensitive functions based only on a report from a laboratory to the MRO of a confirmed
positive test for a drug or drug metabolite, an adulterated test, or a substituted test, before the MRO has completed verification of the test result.
Substance Abuse Professional (SAP). A
person who evaluates employees who
have violated a DOT drug and alcohol
regulation and makes recommendations concerning education, treatment,
follow-up testing, and aftercare.
Substituted specimen. A urine specimen with creatinine and specific gravity values that are so diminished or so
divergent that they are not consistent
with normal human urine.
Verified test. A drug test result or validity testing result from an HHS-certified laboratory that has undergone
review and final determination by the
MRO.
[65 FR 79526, Dec. 19, 2000, as amended at 66
FR 41950, Aug. 9, 2001; 71 FR 49384, Aug. 23,
2006; 71 FR 55347, Sept. 22, 2006; 73 FR 35969,
June 25, 2008; 75 FR 49861, Aug. 16, 2010; 76 FR
59577, Sept. 27, 2011; 80 FR 19553, Apr. 13, 2015;
81 FR 52365, Aug. 8, 2016; 82 FR 52243, Nov. 13,
2017]

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§ 40.5 Who issues authoritative interpretations of this regulation?
ODAPC and the DOT Office of General Counsel (OGC) provide written interpretations of the provisions of this
part. These written DOT interpretations are the only official and authoritative interpretations concerning the
provisions of this part. DOT agencies
may incorporate ODAPC/OGC interpretations in written guidance they issue
concerning drug and alcohol testing
matters. Only Part 40 interpretations
issued after August 1, 2001, are considered valid.
§ 40.7 How can you get an exemption
from a requirement in this regulation?
(a) If you want an exemption from
any provision of this part, you must request it in writing from the Office of
the Secretary of Transportation, under
the provisions and standards of 49 CFR
part 5. You must send requests for an

§ 40.13
exemption to the following address: Department of Transportation, Deputy
Assistant General Counsel for Regulation and Enforcement, 1200 New Jersey
Avenue, SE., Washington, DC 20590.
(b) Under the standards of 49 CFR
part 5, we will grant the request only if
the request documents special or exceptional circumstances, not likely to
be generally applicable and not contemplated in connection with the rulemaking that established this part, that
make your compliance with a specific
provision of this part impracticable.
(c) If we grant you an exemption, you
must agree to take steps we specify to
comply with the intent of the provision
from which an exemption is granted.
(d) We will issue written responses to
all exemption requests.

Subpart B—Employer
Responsibilities
§ 40.11 What are the general responsibilities of employers under this
regulation?
(a) As an employer, you are responsible for meeting all applicable requirements and procedures of this part.
(b) You are responsible for all actions
of your officials, representatives, and
agents (including service agents) in
carrying out the requirements of the
DOT agency regulations.
(c) All agreements and arrangements,
written or unwritten, between and
among employers and service agents
concerning the implementation of DOT
drug and alcohol testing requirements
are deemed, as a matter of law, to require compliance with all applicable
provisions of this part and DOT agency
drug and alcohol testing regulations.
Compliance with these provisions is a
material term of all such agreements
and arrangements.
§ 40.13 How do DOT drug and alcohol
tests relate to non-DOT tests?
(a) DOT tests must be completely
separate from non-DOT tests in all respects.
(b) DOT tests must take priority and
must be conducted and completed before a non-DOT test is begun. For example, you must discard any excess
urine left over from a DOT test and

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§ 40.14

49 CFR Subtitle A (10–1–21 Edition)

collect a separate void for the subsequent non-DOT test.
(c) Except as provided in paragraph
(d) of this section, you must not perform any tests on DOT urine or breath
specimens other than those specifically
authorized by this part or DOT agency
regulations. For example, you may not
test a DOT urine specimen for additional drugs, and a laboratory is prohibited from making a DOT urine specimen available for a DNA test or other
types of specimen identity testing.
(d) The single exception to paragraph
(c) of this section is when a DOT drug
test collection is conducted as part of a
physical examination required by DOT
agency regulations. It is permissible to
conduct required medical tests related
to this physical examination (e.g., for
glucose) on any urine remaining in the
collection container after the drug test
urine specimens have been sealed into
the specimen bottles.
(e) No one is permitted to change or
disregard the results of DOT tests
based on the results of non-DOT tests.
For example, as an employer you must
not disregard a verified positive DOT
drug test result because the employee
presents a negative test result from a
blood or urine specimen collected by
the employee’s physician or a DNA test
result purporting to question the identity of the DOT specimen.
(f) As an employer, you must not use
the CCF or the ATF in your non-DOT
drug and alcohol testing programs.
This prohibition includes the use of the
DOT forms with references to DOT programs and agencies crossed out. You
also must always use the CCF and ATF
for all your DOT-mandated drug and
alcohol tests.

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§ 40.14 What collection information
must employers provide to collectors?
As an employer, or an employer’s
service agent—for example a C/TPA,
you must ensure the collector has the
following information when conducting
a urine specimen collection for you:
(a) Full name of the employee being
tested.
(b) Employee SSN or ID number.
(c) Laboratory name and address (can
be pre-printed on the CCF).

(d) Employer name, address, phone
number, and fax number (can be preprinted on the CCF at Step 1–A).
(e) DER information required at
§ 40.35 of this part.
(f) MRO name, address, phone number, and fax number (can be pre-printed
on the CCF at Step 1–B).
(g) The DOT Agency which regulates
the employee’s safety-sensitive duties
(the checkmark can pre-printed in the
appropriate box on the CCF at Step 1–
D).
(h) Test reason, as appropriate: Preemployment; Random; Reasonable Suspicion/Reasonable Cause; Post-Accident; Return-to-Duty; and Follow-up.
(i) Whether the test is to be observed
or not (see § 40.67 of this part).
(j) (Optional) C/TPA name, address,
phone, and fax number (can be preprinted on the CCF).
[75 FR 59107, Sept. 27, 2010]

§ 40.15 May an employer use a service
agent to meet DOT drug and alcohol testing requirements?
(a) As an employer, you may use a
service agent to perform the tasks
needed to comply with this part and
DOT agency drug and alcohol testing
regulations, consistent with the requirements of Subpart Q and other applicable provisions of this part.
(b) As an employer, you are responsible for ensuring that the service
agents you use meet the qualifications
set forth in this part (e.g., § 40.121 for
MROs). You may require service agents
to show you documentation that they
meet the requirements of this part
(e.g., documentation of MRO qualifications required by § 40.121(e)).
(c) You remain responsible for compliance with all applicable requirements of this part and other DOT drug
and alcohol testing regulations, even
when you use a service agent. If you
violate this part or other DOT drug and
alcohol testing regulations because a
service agent has not provided services
as our rules require, a DOT agency can
subject you to sanctions. Your good
faith use of a service agent is not a defense in an enforcement action initiated by a DOT agency in which your alleged noncompliance with this part or

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Office of the Secretary of Transportation
a DOT agency drug and alcohol regulation may have resulted from the service agent’s conduct.
(d) As an employer, you must not
permit a service agent to act as your
DER.
§ 40.17 Is an employer responsible for
obtaining information from its service agents?
Yes, as an employer, you are responsible for obtaining information required by this part from your service
agents. This is true whether or not you
choose to use a C/TPA as an intermediary in transmitting information
to you. For example, suppose an applicant for a safety-sensitive job takes a
pre-employment drug test, but there is
a significant delay in your receipt of
the test result from an MRO or C/TPA.
You must not assume that ‘‘no news is
good news’’ and permit the applicant to
perform safety-sensitive duties before
receiving the result. This is a violation
of the Department’s regulations.

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§ 40.19

[Reserved]

§ 40.21 May an employer stand down
an employee before the MRO has
completed the verification process?
(a) As an employer, you are prohibited from standing employees down, except consistent with a waiver a DOT
agency grants under this section.
(b) You may make a request to the
concerned DOT agency for a waiver
from the prohibition of paragraph (a) of
this section. Such a waiver, if granted,
permits you to stand an employee
down following the MRO’s receipt of a
laboratory report of a confirmed positive test for a drug or drug metabolite,
an adulterated test, or a substituted
test pertaining to the employee.
(1) For this purpose, the concerned
DOT agency is the one whose drug and
alcohol testing rules apply to the majority of the covered employees in your
organization. The concerned DOT agency uses its applicable procedures for
considering requests for waivers.
(2) Before taking action on a waiver
request, the concerned DOT agency coordinates with other DOT agencies
that regulate the employer’s other covered employees.
(3) The concerned DOT agency provides a written response to each em-

§ 40.21
ployer that petitions for a waiver, setting forth the reasons for the agency’s
decision on the waiver request.
(c) Your request for a waiver must include, as a minimum, the following elements:
(1) Information about your organization:
(i) Your determination that standing
employees down is necessary for safety
in your organization and a statement
of your basis for it, including any data
on safety problems or incidents that
could have been prevented if a standdown procedure had been in place;
(ii) Data showing the number of confirmed laboratory positive, adulterated, and substituted test results for
your employees over the two calendar
years preceding your waiver request,
and the number and percentage of
those test results that were verified
positive, adulterated, or substituted by
the MRO;
(iii) Information about the work situation of the employees subject to
stand-down, including a description of
the size and organization of the unit(s)
in which the employees work, the process through which employees will be
informed of the stand-down, whether
there is an in-house MRO, and whether
your organization has a medical disqualification or stand-down policy for
employees in situations other than
drug and alcohol testing; and
(iv) A statement of which DOT agencies regulate your employees.
(2) Your proposed written company
policy concerning stand-down, which
must include the following elements:
(i) Your assurance that you will distribute copies of your written policy to
all employees that it covers;
(ii) Your means of ensuring that no
information about the confirmed positive, adulterated, or substituted test
result or the reason for the employee’s
temporary removal from performance
of safety-sensitive functions becomes
available, directly or indirectly, to
anyone in your organization (or subsequently to another employer) other
than the employee, the MRO and the
DER;
(iii) Your means of ensuring that all
covered employees in a particular job
category in your organization are

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§ 40.23

49 CFR Subtitle A (10–1–21 Edition)

treated the same way with respect to
stand-down;
(iv) Your means of ensuring that a
covered employee will be subject to
stand-down only with respect to the actual performance of safety-sensitive
duties;
(v) Your means of ensuring that you
will not take any action adversely affecting the employee’s pay and benefits
pending the completion of the MRO’s
verification process. This includes continuing to pay the employee during the
period of the stand-down in the same
way you would have paid him or her
had he or she not been stood down;
(vi) Your means of ensuring that the
verification process will commence no
later than the time an employee is
temporarily removed from the performance of safety-sensitive functions
and that the period of stand-down for
any employee will not exceed five days,
unless you are informed in writing by
the MRO that a longer period is needed
to complete the verification process;
and
(vii) Your means of ensuring that, in
the event that the MRO verifies the
test negative or cancels it—
(A) You return the employee immediately to the performance of safetysensitive duties;
(B) The employee suffers no adverse
personnel or financial consequences as
a result; and
(C) You maintain no individually
identifiable record that the employee
had a confirmed laboratory positive,
adulterated, or substituted test result
(i.e., you maintain a record of the test
only as a negative or cancelled test).
(d) The Administrator of the concerned DOT agency, or his or her designee, may grant a waiver request only
if he or she determines that, in the
context of your organization, there is a
high probability that the procedures
you propose will effectively enhance
safety and protect the interests of employees in fairness and confidentiality.
(1) The Administrator, or his or her
designee, may impose any conditions
he or she deems appropriate on the
grant of a waiver.
(2) The Administrator, or his or her
designee, may immediately suspend or
revoke the waiver if he or she determines that you have failed to protect

effectively the interests of employees
in fairness and confidentiality, that
you have failed to comply with the requirements of this section, or that you
have failed to comply with any other
conditions the DOT agency has attached to the waiver.
(e) You must not stand employees
down in the absence of a waiver, or inconsistent with the terms of your waiver. If you do, you are in violation of
this part and DOT agency drug testing
regulations, and you are subject to enforcement action by the DOT agency
just as you are for other violations of
this part and DOT agency rules.
§ 40.23 What actions do employers take
after receiving verified test results?
(a) As an employer who receives a
verified positive drug test result, you
must immediately remove the employee involved from performing safety-sensitive functions. You must take
this action upon receiving the initial
report of the verified positive test result. Do not wait to receive the written
report or the result of a split specimen
test.
(b) As an employer who receives a
verified adulterated or substituted
drug test result, you must consider this
a refusal to test and immediately remove the employee involved from performing safety-sensitive functions. You
must take this action on receiving the
initial report of the verified adulterated or substituted test result. Do not
wait to receive the written report or
the result of a split specimen test.
(c) As an employer who receives an
alcohol test result of 0.04 or higher,
you must immediately remove the employee involved from performing safety-sensitive functions. If you receive
an alcohol test result of 0.02–0.039, you
must temporarily remove the employee
involved from performing safety-sensitive functions, as provided in applicable DOT agency regulations. Do not
wait to receive the written report of
the result of the test.
(d) As an employer, when an employee has a verified positive, adulterated, or substituted test result, or has
otherwise violated a DOT agency drug
and alcohol regulation, you must not
return the employee to the performance of safety-sensitive functions until

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Office of the Secretary of Transportation
or unless the employee successfully
completes the return-to-duty process of
Subpart O of this part.
(e) As an employer who receives a
drug test result indicating that the employee’s specimen was dilute, take action as provided in § 40.197.
(f) As an employer who receives a
drug test result indicating that the employee’s urine specimen test was cancelled because it was invalid and that a
second collection must take place
under direct observation—
(1) You must immediately direct the
employee to provide a new specimen
under direct observation.
(2) You must not attach consequences to the finding that the test
was invalid other than collecting a new
specimen under direct observation.
(3) You must not give any advance
notice of this test requirement to the
employee.
(4) You must instruct the collector to
note on the CCF the same reason (e.g.,
random test, post-accident test) and
DOT Agency (e.g., check DOT and
FMCSA) as for the original collection.
(5) You must ensure that the collector conducts the collection under direct observation.
(g) As an employer who receives a
cancelled test result when a negative
result is required (e.g., pre-employment, return-to-duty, or follow-up
test), you must direct the employee to
provide another specimen immediately.
(h) As an employer, you may also be
required to take additional actions required by DOT agency regulations (e.g.,
FAA rules require some positive drug
tests to be reported to the Federal Air
Surgeon).
(i) As an employer, you must not
alter a drug or alcohol test result
transmitted to you by an MRO, BAT,
or C/TPA.

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[65 FR 79526, Dec. 19, 2000, as amended at 71
FR 49384, Aug. 23, 2006; 73 FR 35970, June 25,
2008; 75 FR 59107, Sept. 27, 2010]

§ 40.25 Must an employer check on the
drug and alcohol testing record of
employees it is intending to use to
perform safety-sensitive duties?
(a) Yes, as an employer, you must,
after obtaining an employee’s written
consent, request the information about
the employee listed in paragraph (b) of

§ 40.25
this section. This requirement applies
only to employees seeking to begin
performing safety-sensitive duties for
you for the first time (i.e., a new hire,
an employee transfers into a safetysensitive position). If the employee refuses to provide this written consent,
you must not permit the employee to
perform safety-sensitive functions.
(b) You must request the information
listed in this paragraph (b) from DOTregulated employers who have employed the employee during any period
during the two years before the date of
the employee’s application or transfer:
(1) Alcohol tests with a result of 0.04
or higher alcohol concentration;
(2) Verified positive drug tests;
(3) Refusals to be tested (including
verified adulterated or substituted
drug test results);
(4) Other violations of DOT agency
drug and alcohol testing regulations;
and
(5) With respect to any employee who
violated a DOT drug and alcohol regulation, documentation of the employee’s successful completion of DOT return-to-duty requirements (including
follow-up tests). If the previous employer does not have information about
the return-do-duty process (e.g., an employer who did not hire an employee
who tested positive on a pre-employment test), you must seek to obtain
this information from the employee.
(c) The information obtained from a
previous employer includes any drug or
alcohol test information obtained from
previous employers under this section
or other applicable DOT agency regulations.
(d) If feasible, you must obtain and
review this information before the employee first performs safety-sensitive
functions. If this is not feasible, you
must obtain and review the information as soon as possible. However, you
must not permit the employee to perform safety-sensitive functions after 30
days from the date on which the employee first performed safety-sensitive
functions, unless you have obtained or
made and documented a good faith effort to obtain this information.
(e) If you obtain information that the
employee has violated a DOT agency
drug and alcohol regulation, you must

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§ 40.26

49 CFR Subtitle A (10–1–21 Edition)

not use the employee to perform safety-sensitive functions unless you also
obtain information that the employee
has subsequently complied with the return-to-duty requirements of Subpart
O of this part and DOT agency drug and
alcohol regulations.
(f) You must provide to each of the
employers from whom you request information under paragraph (b) of this
section written consent for the release
of the information cited in paragraph
(a) of this section.
(g) The release of information under
this section must be in any written
form (e.g., fax, e-mail, letter) that ensures confidentiality. As the previous
employer, you must maintain a written
record of the information released, including the date, the party to whom it
was released, and a summary of the information provided.
(h) If you are an employer from
whom information is requested under
paragraph (b) of this section, you must,
after reviewing the employee’s specific,
written consent, immediately release
the requested information to the employer making the inquiry.
(i) As the employer requesting the information required under this section,
you must maintain a written, confidential record of the information you obtain or of the good faith efforts you
made to obtain the information. You
must retain this information for three
years from the date of the employee’s
first performance of safety-sensitive
duties for you.
(j) As the employer, you must also
ask the employee whether he or she
has tested positive, or refused to test,
on any pre-employment drug or alcohol
test administered by an employer to
which the employee applied for, but did
not obtain, safety-sensitive transportation work covered by DOT agency
drug and alcohol testing rules during
the past two years. If the employee admits that he or she had a positive test
or a refusal to test, you must not use
the employee to perform safety-sensitive functions for you, until and unless the employee documents successful completion of the return-to-duty
process (see paragraphs (b)(5) and (e) of
this section).

§ 40.26 What form must an employer
use to report Management Information System (MIS) data to a DOT
agency?
As an employer, when you are required to report MIS data to a DOT
agency, you must use the U.S. Department of Transportation Drug and Alcohol Testing MIS Data Collection Form
to report that data. You must use the
form and instructions referenced at Appendix H to part 40. You must submit
the MIS report in accordance with rule
requirements (e.g., dates for submission; selection of companies required
to submit, and method of reporting) established by the DOT agency regulating your operation.
[84 FR 16773, Apr. 23, 2019]

§ 40.27 May an employer require an
employee to sign a consent or release in connection with the DOT
drug and alcohol testing program?
No, as an employer, you must not require an employee to sign a consent,
release, waiver of liability, or indemnification agreement with respect to
any part of the drug or alcohol testing
process covered by this part (including,
but not limited to, collections, laboratory testing, MRO and SAP services).
[66 FR 41950, Aug. 9, 2001]

§ 40.29 Where is other information on
employer responsibilities found in
this regulation?
You can find other information on
the responsibilities of employers in the
following sections of this part:
§ 40.3—Definition.
§ 40.35—Information about DERs that employers must provide collectors.
§ 40.45—Modifying CCFs, Use of foreign-language CCFs.
§ 40.47—Use of non-Federal forms for DOT
tests or Federal CCFs for non-DOT tests.
§ 40.67—Requirements for direct observation.
§ 40.173—Responsibility to ensure test of split
specimen.
§ 40.193—Action in ‘‘shy bladder’’ situations.
§ 40.197—Actions following report of a dilute
specimen.
§ 40.207—Actions following a report of a cancelled drug test.
§ 40.209—Actions following and consequences
of non-fatal flaws in drug tests.
§ 40.215—Information about DERs that employers must provide BATs and STTs.

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Office of the Secretary of Transportation
§ 40.225—Modifying ATFs; use of foreign-language ATFs.
§ 40.227—Use of non-DOT forms for DOT tests
or DOT ATFs for non-DOT tests.
§ 40.235 (c) and (d)—responsibility to follow
instructions for ASDs.
§ 40.255 (b)—receipt and storage of alcohol
test information.
§ 40.265 (c)–(e)—actions in ‘‘shy lung’’ situations.
§ 40.267—Cancellation of alcohol tests.
§ 40.271—Actions in ‘‘correctable flaw’’ situations in alcohol tests.
§ 40.273—Actions following cancelled tests in
alcohol tests.
§ 40.275—Actions in ‘‘non-fatal flaw’’ situations in alcohol tests.
§§ 40.287–40.289—Responsibilities
concerning
SAP services.
§§ 40.295–40.297—Prohibition on seeking second SAP evaluation or changing SAP
recommendation.
§ 40.303—Responsibilities
concerning
aftercare recommendations.
§ 40.305—Responsibilities concerning returnto-duty decision.
§ 40.309—Responsibilities concerning followup tests.
§ 40.321—General
confidentiality
requirement.
§ 40.323—Release of confidential information
in litigation.
§ 40.331—Other circumstances for the release
of confidential information.
§ 40.333—Record retention requirements.
§ 40.345—Choice of who reports drug testing
information to employers.
[65 FR 79526, Dec. 19, 2000. Redesignated at 66
FR 41950, Aug. 9, 2001, as amended at 82 FR
52244, Nov. 13, 2017]

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Subpart C—Urine Collection
Personnel
§ 40.31 Who may collect urine specimens for DOT drug testing?
(a) Collectors meeting the requirements of this subpart are the only persons authorized to collect urine specimens for DOT drug testing.
(b) A collector must meet training
requirements of § 40.33.
(c) As the immediate supervisor of an
employee being tested, you may not
act as the collector when that employee is tested, unless no other collector is available and you are permitted to do so under DOT agency drug
and alcohol regulations.
(d) You must not act as the collector
for the employee being tested if you
work for a HHS-certified laboratory
(e.g., as a technician or accessioner)

§ 40.33
and could link the employee with a
urine specimen, drug testing result, or
laboratory report.
§ 40.33 What training requirements
must a collector meet?
To be permitted to act as a collector
in the DOT drug testing program, you
must meet each of the requirements of
this section:
(a) Basic information. You must be
knowledgeable about this part, the current ‘‘DOT Urine Specimen Collection
Procedures Guidelines,’’ and DOT agency regulations applicable to the employers for whom you perform collections. DOT agency regulations, the
DOT Urine Specimen Collection Procedures Guidelines, and other materials
are available from ODAPC (Department of Transportation, 1200 New Jersey Avenue SE., Washington DC, 20590,
202–366–3784, or on the ODAPC Web site
(https://www.transportation.gov/odapc).
You must keep current on any changes
to these materials. You must subscribe
to the ODAPC list-serve at: https://
www.transportation.gov/odapc/get-odapcemail-updates.
(b) Qualification training. You must
receive qualification training meeting
the requirements of this paragraph.
Qualification training must provide instruction on the following subjects:
(1) All steps necessary to complete a
collection correctly and the proper
completion and transmission of the
CCF;
(2) ‘‘Problem’’ collections (e.g., situations like ‘‘shy bladder’’ and attempts
to tamper with a specimen);
(3) Fatal flaws, correctable flaws, and
how to correct problems in collections;
and
(4) The collector’s responsibility for
maintaining the integrity of the collection process, ensuring the privacy of
employees being tested, ensuring the
security of the specimen, and avoiding
conduct or statements that could be
viewed as offensive or inappropriate;
(c) Initial Proficiency Demonstration.
Following your completion of qualification training under paragraph (b) of
this section, you must demonstrate
proficiency in collections under this
part by completing five consecutive
error-free mock collections.

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§ 40.35

49 CFR Subtitle A (10–1–21 Edition)

(1) The five mock collections must
include two uneventful collection scenarios, one insufficient quantity of
urine scenario, one temperature out of
range scenario, and one scenario in
which the employee refuses to sign the
CCF and initial the specimen bottle
tamper-evident seal.
(2) Another person must monitor and
evaluate your performance, in person
or by a means that provides real-time
observation and interaction between
the instructor and trainee, and attest
in writing that the mock collections
are ‘‘error-free.’’ This person must be a
qualified collector who has demonstrated necessary knowledge, skills,
and abilities by—
(i) Regularly conducting DOT drug
test collections for a period of at least
a year;
(ii) Conducting collector training
under this part for a year; or
(iii) Successfully completing a ‘‘train
the trainer’’ course.
(d) You must meet the requirements
of paragraphs (b) and (c) of this section
before you begin to perform collector
functions.
(e) Refresher training. No less frequently than every five years from the
date on which you satisfactorily complete the requirements of paragraphs
(b) and (c) of this section, you must
complete refresher training that meets
all the requirements of paragraphs (b)
and (c) of this section.
(f) Error Correction Training. If you
make a mistake in the collection process that causes a test to be cancelled
(i.e., a fatal or uncorrected flaw), you
must undergo error correction training. This training must occur within 30
days of the date you are notified of the
error that led to the need for retraining.
(1) Error correction training must be
provided and your proficiency documented in writing by a person who
meets the requirements of paragraph
(c)(2) of this section.
(2) Error correction training is required to cover only the subject matter
area(s) in which the error that caused
the test to be cancelled occurred.
(3) As part of the error correction
training, you must demonstrate your
proficiency in the collection procedures of this part by completing three

consecutive error-free mock collections. The mock collections must include one uneventful scenario and two
scenarios related to the area(s) in
which your error(s) occurred. The person providing the training must monitor and evaluate your performance
and attest in writing that the mock
collections were ‘‘error-free.’’
(g) Documentation. You must maintain documentation showing that you
currently meet all requirements of this
section. You must provide this documentation on request to DOT agency
representatives and to employers and
C/TPAs who are using or negotiating to
use your services.
[65 FR 79526, Dec. 19, 2000; 66 FR 3885, Jan. 17,
2001, as amended at 66 FR 41950, Aug. 9, 2001;
82 FR 52244, Nov. 13, 2017]

§ 40.35 What information about the
DER must employers provide to collectors?
As an employer, you must provide to
collectors the name and telephone
number of the appropriate DER (and C/
TPA, where applicable) to contact
about any problems or issues that may
arise during the testing process.
§ 40.37 Where is other information on
the role of collectors found in this
regulation?
You can find other information on
the role and functions of collectors in
the following sections of this part:
§ 40.3—Definition.
§ 40.43—Steps to prepare and secure collection sites.
§§ 40.45–40.47—Use of CCF.
§§ 40.49–40.51—Use of collection kit and shipping materials.
§§ 40.61–40.63—Preliminary steps in collections.
§ 40.65—Role in checking specimens.
§ 40.67—Role in directly observed collections.
§ 40.69—Role in monitored collections.
§ 40.71—Role in split specimen collections.
§ 40.73—Chain of custody completion and finishing the collection process.
§ 40.191—Action in case of refusals to take
test.
§ 40.193—Action in ‘‘shy bladder’’ situations.
§ 40.199–40.205—Collector errors in tests, effects, and means of correction.
[65 FR 79526, Dec. 19, 2000, as amended at 82
FR 52244, Nov. 13, 2017]

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Subpart
D—Collection
Sites,
Forms, Equipment and Supplies Used in DOT Urine Collections
§ 40.41 Where does a urine collection
for a DOT drug test take place?
(a) A urine collection for a DOT drug
test must take place in a collection
site meeting the requirements of this
section.
(b) If you are operating a collection
site, you must ensure that it meets the
security requirements of § 40.43.
(c) If you are operating a collection
site, you must have all necessary personnel, materials, equipment, facilities
and supervision to provide for the collection, temporary storage, and shipping of urine specimens to a laboratory, and a suitable clean surface for
writing.
(d) Your collection site must include
a facility for urination described in either paragraph (e) or paragraph (f) of
this section.
(e) The first, and preferred, type of
facility for urination that a collection
site may include is a single-toilet
room, having a full-length privacy
door, within which urination can
occur.
(1) No one but the employee may be
present in the room during the collection, except for the observer in the
event of a directly observed collection.
(2) You must have a source of water
for washing hands, that, if practicable,
should be external to the closed room
where urination occurs. If an external
source is not available, you may meet
this requirement by securing all
sources of water and other substances
that could be used for adulteration and
substitution (e.g., water faucets, soap
dispensers)
and
providing
moist
towelettes outside the closed room.
(f) The second type of facility for urination that a collection site may include is a multistall restroom.
(1) Such a site must provide substantial visual privacy (e.g., a toilet stall
with a partial-length door) and meet
all other applicable requirements of
this section.
(2) If you use a multi-stall restroom,
you must either—
(i) Secure all sources of water and
other substances that could be used for

§ 40.43
adulteration and substitution (e.g.,
water faucets, soap dispensers) and
place bluing agent in all toilets or secure the toilets to prevent access; or
(ii) Conduct all collections in the facility as monitored collections (see
§ 40.69 for procedures). This is the only
circumstance in which you may conduct a monitored collection.
(3) No one but the employee may be
present in the multistall restroom during the collection, except for the monitor in the event of a monitored collection or the observer in the event of a
directly observed collection.
(g) A collection site may be in a medical facility, a mobile facility (e.g., a
van), a dedicated collection facility, or
any other location meeting the requirements of this section.
§ 40.43 What steps must operators of
collection sites take to protect the
security and integrity of urine collections?
(a) Collectors and operators of collection sites must take the steps listed in
this section to prevent unauthorized
access that could compromise the integrity of collections.
(b) As a collector, you must do the
following before each collection to
deter tampering with specimens:
(1) Secure any water sources or otherwise make them unavailable to employees (e.g., turn off water inlet, tape
handles to prevent opening faucets);
(2) Ensure that the water in the toilet is blue;
(3) Ensure that no soap, disinfectants, cleaning agents, or other possible
adulterants are present;
(4) Inspect the site to ensure that no
foreign or unauthorized substances are
present;
(5) Tape or otherwise secure shut any
movable toilet tank top, or put bluing
in the tank;
(6) Ensure that undetected access
(e.g., through a door not in your view)
is not possible;
(7) Secure areas and items (e.g.,
ledges, trash receptacles, paper towel
holders, under-sink areas) that appear
suitable for concealing contaminants;
and
(8) Recheck items in paragraphs
(b)(1) through (7) of this section following each collection to ensure the
site’s continued integrity.

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§ 40.45

49 CFR Subtitle A (10–1–21 Edition)

(c) If the collection site uses a facility normally used for other purposes,
like a public rest room or hospital examining room, you must, as a collector, also ensure before the collection
that:
(1) Access to collection materials and
specimens is effectively restricted; and
(2) The facility is secured against access during the procedure to ensure privacy to the employee and prevent distraction of the collector. Limited-access signs must be posted.
(d) As a collector, you must take the
following additional steps to ensure security during the collection process:
(1) To avoid distraction that could
compromise security, you are limited
to conducting a collection for only one
employee at a time. However, during
the time one employee is in the period
for drinking fluids in a ‘‘shy bladder’’
situation (see § 40.193(b)), you may conduct a collection for another employee.
(2) To the greatest extent you can,
keep an employee’s collection container within view of both you and the
employee between the time the employee has urinated and the specimen
is sealed.
(3) Ensure you are the only person in
addition to the employee who handles
the specimen before it is poured into
the bottles and sealed with tamper-evident seals.
(4) In the time between when the employee gives you the specimen and
when you seal the specimen, remain
within the collection site.
(5) Maintain personal control over
each specimen and CCF throughout the
collection process.
(e) If you are operating a collection
site, you must implement a policy and
procedures to prevent unauthorized
personnel from entering any part of the
site in which urine specimens are collected or stored.
(1) Only employees being tested, collectors and other collection site workers, DERs, employee and employer representatives authorized by the employer (e.g., employer policy, collective
bargaining agreement), and DOT agency representatives are authorized persons for purposes of this paragraph (e).
(2) Except for the observer in a directly observed collection or the monitor in the case of a monitored collec-

tion, you must not permit anyone to
enter the urination facility in which
employees provide specimens.
(3) You must ensure that all authorized persons are under the supervision
of a collector at all times when permitted into the site.
(4) You or the collector may remove
any person who obstructs, interferes
with, or causes a delay in the collection process.
(f) If you are operating a collection
site, you must minimize the number of
persons handling specimens.
§ 40.45 What form is used to document
a DOT urine collection?
(a) The Federal Drug Testing Custody and Control Form (CCF) must be
used to document every urine collection required by the DOT drug testing
program. You may view this form on
the Department’s Web site (http://
www.transportation.gov/odapc) or the
HHS
Web
site
(http://
www.workplace.samhsa.gov).
(b) You must not use a non-Federal
form or an expired CCF to conduct a
DOT urine collection. As a laboratory,
C/TPA or other party that provides
CCFs to employers, collection sites, or
other customers, you must not provide
copies of an expired CCF to these participants. You must also affirmatively
notify these participants that they
must not use an expired CCF.
(c) As a participant in the DOT drug
testing program, you are not permitted
to modify or revise the CCF except as
follows:
(1) You may include, in the area outside the border of the form, other information needed for billing or other purposes necessary to the collection process.
(2) The CCF must include the names,
addresses, telephone numbers and fax
numbers of the employer and the MRO,
which may be preprinted, typed, or
handwritten. The MRO information
must include the specific physician’s
name and address, as opposed to only a
generic clinic, health care organization, or company name. This information is required, and it is prohibited for
an employer, collector, service agent
or any other party to omit it. In addition, a C/TPA’s name, address, fax
number, and telephone number may be

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Office of the Secretary of Transportation
included, but is not required. The employer may use a C/TPA’s address in
place of its own, but must continue to
include its name, telephone number,
and fax number.
(3) As an employer, in Step 1–D of the
CCF you may preprint the box for the
DOT Agency under whose authority the
test will occur.
(4) As a collector, you may use a CCF
with your name, address, telephone
number, and fax number preprinted,
but under no circumstances may you
sign the form before the collection
event.
(5) When using an electronic CCF,
you must establish adequate confidentiality and security measures to ensure
that confidential employee records are
not available to unauthorized persons.
This includes protecting the physical
security of records, access controls,
and computer security measures to
safeguard confidential data in electronic form.
(d) Under no circumstances may the
CCF transmit personal identifying information about an employee (other
than a social security number (SSN) or
other employee identification (ID)
number) to a laboratory.
(e) As an employer, you may use an
equivalent foreign-language version of
the CCF approved by ODAPC. You may
use such a non-English language form
only in a situation where both the employee and collector understand and
can use the form in that language.
(f) An employer who uses an electronic CCF must ensure that the collection site, the primary and split laboratories, and MRO have compatible
systems, and that the employee and
any other program participants in the
testing process will receive a legible
copy of the CCF.

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[65 FR 79526, Dec. 19, 2000, as amended at 66
FR 41950, Aug. 9, 2001; 75 FR 59107, Sept. 27,
2010; 76 FR 59577, Sept. 27, 2011; 80 FR 19553,
Apr. 13, 2015; 82 FR 52244, Nov. 13, 2017]

§ 40.47 May employers use the CCF for
non-Federal collections or non-Federal forms for DOT collections?
(a) No, as an employer, you are prohibited from using the CCF for nonFederal urine collections. You are also
prohibited from using non-Federal
forms for DOT urine collections. Doing

§ 40.61
either subjects you to enforcement action under DOT agency regulations.
(b) (1) In the rare case where the collector, either by mistake or as the only
means to conduct a test under difficult
circumstances (e.g., post-accident or
reasonable suspicion test with insufficient time to obtain the CCF), uses a
non-Federal form for a DOT collection,
the use of a non-Federal form does not
present a reason for the laboratory to
reject the specimen for testing or for
an MRO to cancel the result.
(2) The use of the non-Federal form is
a ‘‘correctable flaw.’’ As an MRO, to
correct the problem you must follow
the procedures of § 40.205(b)(2).
[65 FR 79526, Dec. 19, 2000, as amended at 66
FR 41950, Aug. 9, 2001]

§ 40.49 What materials are used to collect urine specimens?
For each DOT drug test, you must
use a collection kit meeting the requirements of Appendix A of this part.
§ 40.51 What materials are used to
send urine specimens to the laboratory?
(a) Except as provided in paragraph
(b) of this section, you must use a shipping container that adequately protects the specimen bottles from shipment damage in the transport of specimens from the collection site to the
laboratory.
(b) You are not required to use a
shipping container if a laboratory courier hand-delivers the specimens from
the collection site to the laboratory.

Subpart E—Urine Specimen
Collections
§ 40.61 What are the preliminary steps
in the collection process?
As the collector, you must take the
following steps before actually beginning a collection:
(a) When a specific time for an employee’s test has been scheduled, or the
collection site is at the employee’s
work site, and the employee does not
appear at the collection site at the
scheduled time, contact the DER to determine the appropriate interval within which the DER has determined the
employee is authorized to arrive. If the
employee’s arrival is delayed beyond

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§ 40.61

49 CFR Subtitle A (10–1–21 Edition)

that time, you must notify the DER
that the employee has not reported for
testing. In a situation where a C/TPA
has notified an owner/operator or other
individual employee to report for testing and the employee does not appear,
the C/TPA must notify the employee
that he or she has refused to test (see
§ 40.191(a)(1)).
(b) Ensure that, when the employee
enters the collection site, you begin
the testing process without undue
delay. For example, you must not wait
because the employee says he or she is
not ready or is unable to urinate or because an authorized employer or employee representative is delayed in arriving.
(1) If the employee is also going to
take a DOT alcohol test, you must, to
the greatest extent practicable, ensure
that the alcohol test is completed before the urine collection process begins.

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Example to paragraph (b)(1): An employee
enters the test site for both a drug and an alcohol test. Normally, the collector would
wait until the BAT had completed the alcohol test process before beginning the drug
test process. However, there are some situations in which an exception to this normal
practice would be reasonable. One such situation might be if several people were waiting
for the BAT to conduct alcohol tests, but a
drug testing collector in the same facility
were free. Someone waiting might be able to
complete a drug test without unduly delaying his or her alcohol test. Collectors and
BATs should work together, however, to ensure that post-accident and reasonable suspicion alcohol tests happen as soon as possible (e.g., by moving the employee to the
head of the line for alcohol tests).

(2) If the employee needs medical attention (e.g., an injured employee in an
emergency medical facility who is required to have a post-accident test), do
not delay this treatment to collect a
specimen.
(3) You must not collect, by catheterization or other means, urine from an
unconscious employee to conduct a
drug test under this part. Nor may you
catheterize a conscious employee. However, you must inform an employee
who normally voids through self-catheterization that the employee is required to provide a specimen in that
manner.

(4) If, as an employee, you normally
void through self-catheterization, and
decline to do so, this constitutes a refusal to test.
(c) Require the employee to provide
positive identification. You must see a
photo ID issued by the employer (other
than in the case of an owner-operator
or other self-employed individual) or a
Federal, state, or local government
(e.g., a driver’s license). You may not
accept faxes or photocopies of identification. Positive identification by an
employer representative (not a coworker or another employee being tested) is also acceptable. If the employee
cannot produce positive identification,
you must contact a DER to verify the
identity of the employee.
(d) If the employee asks, provide your
identification to the employee. Your
identification must include your name
and your employer’s name, but does
not have to include your picture, address, or telephone number.
(e) Explain the basic collection procedure to the employee, including
showing the employee the instructions
on the back of the CCF.
(f) Direct the employee to remove
outer clothing (e.g., coveralls, jacket,
coat, hat) that could be used to conceal
items or substances that could be used
to tamper with a specimen. You must
also direct the employee to leave these
garments and any briefcase, purse, or
other personal belongings with you or
in a mutually agreeable location. You
must advise the employee that failure
to comply with your directions constitutes a refusal to test.
(1) If the employee asks for a receipt
for any belongings left with you, you
must provide one.
(2) You must allow the employee to
keep his or her wallet.
(3) You must not ask the employee to
remove other clothing (e.g., shirts,
pants, dresses, underwear), to remove
all clothing, or to change into a hospital or examination gown (unless the
urine collection is being accomplished
simultaneously with a DOT agency-authorized medical examination).
(4) You must direct the employee to
empty his or her pockets and display
the items in them to ensure that no
items are present which could be used
to adulterate the specimen. If nothing

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Office of the Secretary of Transportation
is there that can be used to adulterate
a specimen, the employee can place the
items back into his or her pockets. As
the employee, you must allow the collector to make this observation.
(5) If, in your duties under paragraph
(f)(4) of this section, you find any material that could be used to tamper
with a specimen, you must:
(i) Determine if the material appears
to be brought to the collection site
with the intent to alter the specimen,
and, if it is, conduct a directly observed collection using direct observation procedures (see § 40.67); or
(ii) Determine if the material appears
to be inadvertently brought to the collection site (e.g., eye drops), secure and
maintain it until the collection process
is completed and conduct a normal
(i.e., unobserved) collection.
(g) You must instruct the employee
not to list medications that he or she
is currently taking on the CCF. (The
employee may make notes of medications on the back of the employee copy
of the form for his or her own convenience, but these notes must not be
transmitted to anyone else.)

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§ 40.63 What steps does the collector
take in the collection process before
the employee provides a urine specimen?
As the collector, you must take the
following steps before the employee
provides the urine specimen:
(a) Complete Step 1 of the CCF.
(b) Instruct the employee to wash
and dry his or her hands at this time.
You must tell the employee not to
wash his or her hands again until after
delivering the specimen to you. You
must not give the employee any further access to water or other materials
that could be used to adulterate or dilute a specimen.
(c) Select, or allow the employee to
select, an individually wrapped or
sealed collection container from collection kit materials. Either you or the
employee, with both of you present,
must unwrap or break the seal of the
collection container. You must not unwrap or break the seal on any specimen
bottle at this time. You must not allow
the employee to take anything from
the collection kit into the room used

§ 40.65
for urination except the collection container.
(d) Direct the employee to go into
the room used for urination, provide a
specimen of at least 45 mL, not flush
the toilet, and return to you with the
specimen as soon as the employee has
completed the void.
(1) Except in the case of an observed
or a monitored collection (see §§ 40.67
and 40.69), neither you nor anyone else
may go into the room with the employee.
(2) As the collector, you may set a
reasonable time limit for voiding.
(e) You must pay careful attention to
the employee during the entire collection process to note any conduct that
clearly indicates an attempt to tamper
with a specimen (e.g., substitute urine
in plain view or an attempt to bring
into the collection site an adulterant
or urine substitute). If you detect such
conduct, you must require that a collection take place immediately under
direct observation (see § 40.67) and complete Step 2 by noting the conduct in
the ‘‘Remarks’’ line of the CCF and the
fact that the collection was observed
by checking the ‘‘Observed’’ box. You
must also, as soon as possible, inform
the DER and collection site supervisor
that a collection took place under direct observation and the reason for
doing so.
[65 FR 79526, Dec. 19, 2000, as amended at 75
FR 59107, Sept. 27, 2010]

§ 40.65 What does the collector check
for when the employee presents a
specimen?
As a collector, you must check the
following when the employee gives the
collection container to you:
(a) Sufficiency of specimen. You must
check to ensure that the specimen contains at least 45 mL of urine.
(1) If it does not, you must follow
‘‘shy
bladder’’
procedures
(see
§ 40.193(b)).
(2) When you follow ‘‘shy bladder’’
procedures, you must discard the original specimen, unless another problem
(i.e., temperature out of range, signs of
tampering) also exists.
(3) You are never permitted to combine urine collected from separate
voids to create a specimen.

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§ 40.67

49 CFR Subtitle A (10–1–21 Edition)

(4) You must discard any excess
urine.
(b) Temperature. You must check the
temperature of the specimen no later
than four minutes after the employee
has given you the specimen.
(1) The acceptable temperature range
is 32–38 °C/90–100 °F.
(2) You must determine the temperature of the specimen by reading the
temperature strip attached to the collection container.
(3) If the specimen temperature is
within the acceptable range, you must
mark the ‘‘Yes’’ box on the CCF (Step
2).
(4) If the specimen temperature is
outside the acceptable range, you must
mark the ‘‘No’’ box and enter in the
‘‘Remarks’’ line (Step 2) your findings
about the temperature.
(5) If the specimen temperature is
outside the acceptable range, you must
immediately conduct a new collection
using direct observation procedures
(see § 40.67).
(6) In a case where a specimen is collected under direct observation because
of the temperature being out of range,
you must process both the original
specimen and the specimen collected
using direct observation and send the
two sets of specimens to the laboratory. This is true even in a case in
which the original specimen has insufficient volume but the temperature is
out of range. You must also, as soon as
possible, inform the DER and collection site supervisor that a collection
took place under direct observation
and the reason for doing so.
(7) In a case where the employee refuses to provide another specimen (see
§ 40.191(a)(3)) or refuses to provide another specimen under direct observation (see § 40.191(a)(4)), you must notify
the DER. As soon as you have notified
the DER, you must discard any specimen the employee has provided previously during the collection procedure.
(c) Signs of tampering. You must inspect the specimen for unusual color,
presence of foreign objects or material,
or other signs of tampering (e.g., if you
notice any unusual odor).
(1) If it is apparent from this inspection that the employee has tampered
with the specimen (e.g., blue dye in the

specimen, excessive foaming when
shaken, smell of bleach), you must immediately conduct a new collection
using direct observation procedures
(see § 40.67).
(2) In a case where a specimen is collected under direct observation because
of showing signs of tampering, you
must process both the original specimen and the specimen collected using
direct observation and send the two
sets of specimens to the laboratory.
This is true even in a case in which the
original specimen has insufficient volume but it shows signs of tampering.
You must also, as soon as possible, inform the DER and collection site supervisor that a collection took place
under direct observation and the reason for doing so.
(3) In a case where the employee refuses to provide a specimen under direct observation (see § 40.191(a)(4)), you
must discard any specimen the employee provided previously during the
collection procedure. Then you must
notify the DER as soon as practicable.
[65 FR 79526, Dec. 19, 2000, as amended at 66
FR 41950, Aug. 9, 2001]

§ 40.67 When and how is a directly observed collection conducted?
(a) As an employer, you must direct
an immediate collection under direct
observation with no advance notice to
the employee, if:
(1) The laboratory reported to the
MRO that a specimen is invalid, and
the MRO reported to you that there
was not an adequate medical explanation for the result;
(2) The MRO reported to you that the
original positive, adulterated, or substituted result had to be cancelled because the test of the split specimen
could not be performed; or
(3) The laboratory reported to the
MRO that the specimen was negativedilute with a creatinine concentration
greater than or equal to 2 mg/dL but
less than or equal to 5 mg/dL, and the
MRO reported the specimen to you as
negative-dilute and that a second collection must take place under direct
observation (see § 40.197(b)(1)).
(b) As an employer, you must direct
a collection under direct observation of
an employee if the drug test is a return-to-duty test or a follow-up test.

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Office of the Secretary of Transportation
(c) As a collector, you must immediately conduct a collection under direct observation if:
(1) You are directed by the DER to do
so (see paragraphs (a) and (b) of this
section); or
(2) You observed materials brought
to the collection site or the employee’s
conduct clearly indicates an attempt
to tamper with a specimen (see
§§ 40.61(f)(5)(i) and 40.63(e)); or
(3) The temperature on the original
specimen was out of range (see
§ 40.65(b)(5)); or (4) The original specimen appeared to have been tampered
with (see § 40.65(c)(1)).
(d)(1) As the employer, you must explain to the employee the reason for a
directly observed collection under
paragraph (a) or (b) of this section.
(2) As the collector, you must explain
to the employee the reason, if known,
under this part for a directly observed
collection under paragraphs (c)(1)
through (3) of this section.
(e) As the collector, you must complete a new CCF for the directly observed collection.
(1) You must mark the ‘‘reason for
test’’ block (Step 1) the same as for the
first collection.
(2) You must check the ‘‘Observed,
(Enter Remark)’’ box and enter the
reason (see § 40.67(b)) in the ‘‘Remarks’’
line (Step 2).
(f) In a case where two sets of specimens are being sent to the laboratory
because of suspected tampering with
the specimen at the collection site,
enter on the ‘‘Remarks’’ line of the
CCF (Step 2) for each specimen a notation to this effect (e.g., collection 1 of
2, or 2 of 2) and the specimen ID number of the other specimen.
(g) As the collector, you must ensure
that the observer is the same gender as
the employee. You must never permit
an opposite gender person to act as the
observer. The observer can be a different person from the collector and
need not be a qualified collector.
(h) As the collector, if someone else
is to observe the collection (e.g., in
order to ensure a same gender observer), you must verbally instruct
that person to follow procedures at
paragraphs (i) and (j) of this section. If
you, the collector, are the observer,
you too must follow these procedures.

§ 40.69
(i) As the observer, you must request
the employee to raise his or her shirt,
blouse, or dress/skirt, as appropriate,
above the waist; and lower clothing
and underpants to show you, by turning around, that they do not have a
prosthetic device. After you have determined that the employee does not
have such a device, you may permit the
employee to return clothing to its
proper position for observed urination.
(j) As the observer, you must watch
the employee urinate into the collection container. Specifically, you are to
watch the urine go from the employee’s
body into the collection container.
(k) As the observer but not the collector, you must not take the collection container from the employee, but
you must observe the specimen as the
employee takes it to the collector.
(l) As the collector, when someone
else has acted as the observer, you
must include the observer’s name in
the ‘‘Remarks’’ line of the CCF (Step
2).
(m) As the employee, if you decline
to allow a directly observed collection
required or permitted under this section to occur, this is a refusal to test.
(n) As a service agent, when you
learn that a directly observed collection should have been collected but was
not, you must inform the employer
that it must direct the employee to
have an immediate recollection under
direct observation.
[65 FR 79526, Dec. 19, 2000, as amended at 66
FR 41950, Aug. 9, 2001; 68 FR 31626, May 28,
2003; 69 FR 64867, Nov. 9, 2004; 73 FR 35970,
June 25, 2008; 73 FR 50223, Aug. 26, 2008; 73 FR
62910, Oct. 22, 2008; 73 FR 70284, Nov. 20, 2008;
74 FR 37952, July 30, 2009; 82 FR 52244, Nov. 13,
2017]

§ 40.69 How is a monitored collection
conducted?
(a) As the collector, you must secure
the room being used for the monitored
collection so that no one except the
employee and the monitor can enter it
until after the collection has been completed.
(b) As the collector, you must ensure
that the monitor is the same gender as
the employee, unless the monitor is a
medical professional (e.g., nurse, doctor, physician’s assistant, technologist,
or technician licensed or certified to

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§ 40.71

49 CFR Subtitle A (10–1–21 Edition)

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practice in the jurisdiction in which
the collection takes place). The monitor can be a different person from the
collector and need not be a qualified
collector.
(c) As the collector, if someone else
is to monitor the collection (e.g., in
order to ensure a same-gender monitor), you must verbally instruct that
person to follow the procedures of paragraphs (d) and (e) of this section. If
you, the collector, are the monitor,
you must follow these procedures.
(d) As the monitor, you must not
watch the employee urinate into the
collection container. If you hear
sounds or make other observations indicating an attempt to tamper with a
specimen, there must be an additional
collection under direct observation (see
§§ 40.63(e), 40.65(c), and 40.67(b)).
(e) As the monitor, you must ensure
that the employee takes the collection
container directly to the collector as
soon as the employee has exited the enclosure.
(f) As the collector, when someone
else has acted as the monitor, you
must note that person’s name in the
‘‘Remarks’’ line of the CCF (Step 2).
(g) As the employee being tested, if
you decline to permit a collection authorized under this section to be monitored, it is a refusal to test.
[65 FR 79526, Dec. 19, 2000, as amended at 66
FR 41951, Aug. 9, 2001]

specimen bottle to be used for the split
specimen.
(4) You, not the employee, must place
and secure (i.e., tighten or snap) the
lids/caps on the bottles.
(5) You, not the employee, must seal
the bottles by placing the tamper-evident bottle seals over the bottle caps/
lids and down the sides of the bottles.
(6) You, not the employee, must then
write the date on the tamper-evident
bottle seals.
(7) You must then ensure that the
employee initials the tamper-evident
bottle seals for the purpose of certifying that the bottles contain the
specimens he or she provided. If the
employee fails or refuses to do so, you
must note this in the ‘‘Remarks’’ line
of the CCF (Step 2) and complete the
collection process.
(8) You must discard any urine left
over in the collection container after
both specimen bottles have been appropriately filled and sealed. There is one
exception to this requirement: you
may use excess urine to conduct clinical tests (e.g., protein, glucose) if the
collection was conducted in conjunction with a physical examination required by a DOT agency regulation.
Neither you nor anyone else may conduct further testing (such as adulteration testing) on this excess urine and
the employee has no legal right to demand that the excess urine be turned
over to the employee.

§ 40.71 How does the collector prepare
the specimens?

[65 FR 79526, Dec. 19, 2000, as amended at 66
FR 41951, Aug. 9, 2001]

(a) All collections under DOT agency
drug testing regulations must be split
specimen collections.
(b) As the collector, you must take
the following steps, in order, after the
employee brings the urine specimen to
you. You must take these steps in the
presence of the employee.
(1) Check the box on the CCF (Step 2)
indicating that this was a split specimen collection.
(2) You, not the employee, must first
pour at least 30 mL of urine from the
collection container into one specimen
bottle, to be used for the primary specimen.
(3) You, not the employee, must then
pour at least 15 mL of urine from the
collection container into the second

§ 40.73 How is the collection process
completed?
(a) As the collector, when using the
paper CCF, you must do the following
things to complete the collection process. You must complete the steps
called for in paragraphs (a)(1) through
(7) of this section in the employee’s
presence.
(1) Direct the employee to read and
sign the certification statement on
Copy 2 (Step 5) of the CCF and provide
date of birth, printed name, and day
and evening contact telephone numbers. If the employee refuses to sign
the CCF or to provide date of birth,
printed name, or telephone numbers,
you must note this in the ‘‘Remarks’’
line (Step 2) of the CCF, and complete

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Office of the Secretary of Transportation
the collection. If the employee refuses
to fill out any information, you must,
as a minimum, print the employee’s
name in the appropriate place.
(2) Complete the chain of custody on
the CCF (Step 4) by printing your name
(note: you may pre-print your name),
recording the time and date of the collection, signing the statement, and entering the name of the delivery service
transferring the specimen to the laboratory,
(3) Ensure that all copies of the CCF
are legible and complete.
(4) Remove Copy 5 of the CCF and
give it to the employee.
(5) Place the specimen bottles and
Copy 1 of the CCF in the appropriate
pouches of the plastic bag.
(6) Secure both pouches of the plastic
bag.
(7) Advise the employee that he or
she may leave the collection site.
(8) To prepare the sealed plastic bag
containing the specimens and CCF for
shipment you must:
(i) Place the sealed plastic bag in a
shipping container (e.g., standard courier box) designed to minimize the possibility of damage during shipment.
(More than one sealed plastic bag can
be placed into a single shipping container if you are doing multiple collections.)
(ii) Seal the container as appropriate.
(iii) If a laboratory courier hand-delivers the specimens from the collection site to the laboratory, prepare the
sealed plastic bag for shipment as directed by the courier service.
(9) Send Copy 2 of the CCF to the
MRO and Copy 4 to the DER. You must
fax or otherwise transmit these copies
to the MRO and DER within 24 hours or
during the next business day. Keep
Copy 3 for at least 30 days, unless otherwise specified by applicable DOT
agency regulations.
(b) As a collector, when using other
forms of the CCF as approved by the
Office of Management and Budget, you
must follow the procedures approved
for that form.
(c) As a collector or collection site,
you must ensure that each specimen
you collect is shipped to a laboratory
as quickly as possible, but in any case,

§ 40.81
within 24 hours or during the next business day.
[65 FR 79526, Dec. 19, 2000, as amended at 71
FR 49384, Aug. 23, 2006; 80 FR 19553, Apr. 13,
2015]

Subpart F—Drug Testing
Laboratories
§ 40.81 What laboratories may be used
for DOT drug testing?
(a) As a drug testing laboratory located in the U.S., you are permitted to
participate in DOT drug testing only if
you are certified by HHS under the National Laboratory Certification Program (NLCP) for all testing required
under this part.
(b) As a drug testing laboratory located in Canada or Mexico which is not
certified by HHS under the NLCP, you
are permitted to participate in DOT
drug testing only if:
(1) The DOT, based on a written recommendation from HHS, has approved
your laboratory as meeting HHS laboratory certification standards or
deemed your laboratory fully equivalent to a laboratory meeting HHS laboratory certification standards for all
testing required under this part; or
(2) The DOT, based on a written recommendation from HHS, has recognized a Canadian or Mexican certifying
organization as having equivalent laboratory certification standards and
procedures to those of HHS, and the
Canadian or Mexican certifying organization has certified your laboratory
under those equivalent standards and
procedures.
(c) As a laboratory participating in
the DOT drug testing program, you
must comply with the requirements of
this part. You must also comply with
all applicable requirements of HHS in
testing DOT specimens, whether or not
the HHS requirements are explicitly
stated in this part.
(d) If DOT determines that you are in
noncompliance with this part, you
could be subject to PIE proceedings
under Subpart R of this part. If the Department issues a PIE with respect to
you, you are ineligible to participate in
the DOT drug testing program even if
you continue to meet the requirements
of paragraph (a) or (b) of this section.

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§ 40.83

49 CFR Subtitle A (10–1–21 Edition)

§ 40.83 How do laboratories process incoming specimens?
As the laboratory, you must do the
following when you receive a DOT specimen:
(a) You are authorized to receive
only Copy 1 of the CCF. You are not authorized to receive other copies of the
CCF or any copies of the alcohol testing form.
(b) You must comply with applicable
provisions of the HHS Guidelines concerning accessioning and processing
urine drug specimens.
(c) You must inspect each specimen
and CCF for the following ‘‘fatal
flaws’’:
(1) There is no CCF;
(2) In cases where a specimen has
been collected, there is no specimen
submitted with the CCF;
(3) There is no printed collector’s
name and no collector’s signature;
(4) Two separate collections are performed using one CCF;
(5) The specimen ID numbers on the
specimen bottle and the CCF do not
match;
(6) The specimen bottle seal is broken
or shows evidence of tampering, unless
a split specimen can be redesignated
(see paragraph (h) of this section);
(7) There is an insufficient amount of
urine in the primary bottle for analysis, unless the specimens can be redesignated (see paragraph (h) of this section).
(d) When you find a specimen meeting the criteria of paragraph (c) of this
section, you must document your findings and stop the testing process. Report the result in accordance with
§ 40.97(a)(3) .
(e) You must inspect each CCF for
the presence of the collector’s signature on the certification statement in
Step 4 of the CCF. Upon finding that
the signature is omitted, document the
flaw and continue the testing process.
(1) In such a case, you must retain
the specimen for a minimum of 5 business days from the date on which you
initiated action to correct the flaw.
(2) You must then attempt to correct
the flaw by following the procedures of
§ 40.205(b)(1).
(3) If the flaw is not corrected, report
the result as rejected for testing in accordance with § 40.97(a)(3).

(f) If you determine that the specimen temperature was not checked and
the ‘‘Remarks’’ line did not contain an
entry regarding the temperature being
outside of range, you must then attempt to correct the problem by following the procedures of § 40.208.
(1) In such a case, you must continue
your efforts to correct the problem for
five business days, before you report
the result.
(2) When you have obtained the correction, or five business days have
elapsed, report the result in accordance
with § 40.97(a).
(g) If you determine that a CCF that
fails to meet the requirements of
§ 40.45(a) (e.g., a non-Federal form or an
expired Federal form was used for the
collection), you must attempt to correct the use of the improper form by
following
the
procedures
of
§ 40.205(b)(2).
(1) In such a case, you must retain
the specimen for a minimum of 5 business days from the date on which you
initiated action to correct the problem.
(2) If the problem(s) is not corrected,
you must reject the test and report the
result in accordance with § 40.97(a)(3).
(h) If the CCF is marked indicating
that a split specimen collection was
collected and if the split specimen does
not accompany the primary, has
leaked, or is otherwise unavailable for
testing, you must still test the primary
specimen and follow appropriate procedures outlined in § 40.175(b) regarding
the unavailability of the split specimen
for testing.
(1) The primary specimen and the
split specimen can be redesignated (i.e.,
Bottle B is redesignated as Bottle A,
and vice-versa) if:
(i) The primary specimen appears to
have leaked out of its sealed bottle and
the laboratory believes a sufficient
amount of urine exists in the split
specimen to conduct all appropriate
primary laboratory testing; or
(ii) The primary specimen is labeled
as Bottle B, and the split specimen as
Bottle A; or
(iii) The laboratory opens the split
specimen instead of the primary specimen, the primary specimen remains
sealed, and the laboratory believes a
sufficient amount of urine exists in the

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Office of the Secretary of Transportation
split specimen to conduct all appropriate primary laboratory testing; or
(iv) The primary specimen seal is
broken but the split specimen remains
sealed and the laboratory believes a
sufficient amount of urine exists in the
split specimen to conduct all appropriate primary laboratory testing.
(2) In situations outlined in paragraph (g)(1) of this section, the laboratory shall mark through the ‘‘A’’ and
write ‘‘B,’’ then initial and date the
change. A corresponding change shall
be made to the other bottle by marking
through the ‘‘B’’ and writing ‘‘A,’’ and
initialing and dating the change.
(i) A notation shall be made on Copy
1 of the CCF (Step 5a) and on any laboratory internal chain of custody documents, as appropriate, for any fatal or
correctable flaw.
[65 FR 79526, Dec. 19, 2000, as amended at 66
FR 41951, Aug. 9, 2001; 71 FR 49384, Aug. 23,
2006; 73 FR 35970, June 25, 2008; 75 FR 59107,
Sept. 27, 2010; 82 FR 52244, Nov 13, 2017]

§ 40.87
§ 40.85 What drugs do laboratories test
for?
As a laboratory, you must test for
the following five drugs or classes of
drugs in a DOT drug test. You must not
test ‘‘DOT specimens’’ for any other
drugs.
(a) Marijuana metabolites.
(b) Cocaine metabolites.
(c) Amphetamines.
(d) Opioids.
(e) Phencyclidine (PCP).
[82 FR 52244, Nov. 13, 2017]

§ 40.87 What are the cutoff concentrations for drug tests?
(a) As a laboratory, you must use the
cutoff concentrations displayed in the
following table for initial and confirmatory drug tests. All cutoff concentrations are expressed in nanograms per
milliliter (ng/mL). The table follows:
Confirmatory test cutoff concentration

Initial test analyte

Initial test cutoff 1

Confirmatory test analyte

Marijuana metabolites (THCA) 2 ..
Cocaine
metabolite
(Benzoylecgonine).
Codeine/ .......................................
Morphine
Hydrocodone/ ...............................
Hydromorphone
Oxycodone/ ..................................
Oxymorphone
6-Acetylmorphine .........................
Phencyclidine ...............................
Amphetamine/ ..............................
Methamphetamine
MDMA 4/MDA 5 .............................

50 ng/mL3 ...................................
150 ng/mL 3 ................................

THCA ..........................................
Benzoylecgonine ........................

15 ng/mL.
100 ng/mL.

2000 ng/mL ................................

Codeine ......................................
Morphine ....................................
Hydrocodone ..............................
Hydromorphone ..........................
Oxycodone .................................
Oxymorphone .............................
6-Acetylmorphine .......................
Phencyclidine .............................
Amphetamine .............................
Methamphetamine ......................
MDMA ........................................
MDA ...........................................

2000 ng/mL.
2000 ng/mL.
100 ng/mL.
100 ng/mL.
100 ng/mL.
100 ng/mL.
10 ng/mL.
25 ng/mL.
250 ng/mL.
250 ng/mL.
250 ng/mL.
250 ng/mL.

300 ng/mL ..................................
100 ng/mL ..................................
10 ng/mL ....................................
25 ng/mL ....................................
500 ng/mL ..................................
500 ng/mL ..................................

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1 For 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. At least one analyte within the group must have a concentration equal to or greater than the initial test cutoff or, alternatively, the sum of the analytes present (i.e., equal to or greater than the laboratory’s validated limit of quantification) must be
equal to or greater than the initial test cutoff.
2 An immunoassay must be calibrated with the target analyte, D-9-tetrahydrocannabinol-9-carboxylic acid (THCA).
3 Alternate technology (THCA and Benzoylecgonine): When using an alternate technology initial test for the specific target
analytes of THCA and Benzoylecgonine, the laboratory must use the same cutoff for the initial and confirmatory tests (i.e., 15 ng/
mL for THCA and 100ng/mL for Benzoylecgonine).
4 Methylenedioxymethamphetamine (MDMA).
5 Methylenedioxyamphetamine (MDA).

(b) On an initial drug test, you must
report a result below the cutoff concentration as negative. If the result is
at or above the cutoff concentration,
you must conduct a confirmation test.
(c) On a confirmation drug test, you
must report a result below the cutoff

concentration as negative and a result
at or above the cutoff concentration as
confirmed positive.

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§ 40.89

49 CFR Subtitle A (10–1–21 Edition)

(d) You must report quantitative values for morphine or codeine at 15,000
ng/mL or above.
[65 FR 79526, Dec. 19, 2000, as amended at 75
FR 49862, Aug. 16, 2010; 77 FR 26473, May 4,
2012; 82 FR 52244, Nov. 13, 2017]

§ 40.89 What is validity testing, and
are laboratories required to conduct it?
(a) Specimen validity testing is the
evaluation of the specimen to determine if it is consistent with normal
human urine. The purpose of validity
testing is to determine whether certain
adulterants or foreign substances were
added to the urine, if the urine was diluted, or if the specimen was substituted.
(b) As a laboratory, you must conduct validity testing.

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[65 FR 79526, Dec. 19, 2000, as amended at 66
FR 41951, Aug. 9, 2001; 73 FR 35970, June 25,
2008]

§ 40.91 What validity tests must laboratories conduct on primary specimens?
As a laboratory, when you conduct
validity testing under § 40.89, you must
conduct it in accordance with the requirements of this section.
(a) You must determine the creatinine concentration on each primary
specimen. You must also determine its
specific gravity if you find the creatinine concentration to be less than 20
mg/dL.
(b) You must determine the pH of
each primary specimen.
(c) You must perform one or more validity tests for oxidizing adulterants on
each primary specimen.
(d) You must perform additional validity tests on the primary specimen
when the following conditions are observed:
(1) Abnormal physical characteristics;
(2) Reactions or responses characteristic of an adulterant obtained
during initial or confirmatory drug
tests (e.g., non-recovery of internal
standards, unusual response); or
(3) Possible unidentified interfering
substance or adulterant.
(e) If you determine that the specimen is invalid and HHS guidelines direct you to contact the MRO, you must

contact the MRO and together decide if
testing the primary specimen by another HHS certified laboratory would
be useful in being able to report a positive or adulterated test result.
[65 FR 79526, Dec. 19, 2000, as amended at 69
FR 64867, Nov. 9, 2004]

§ 40.93 What criteria do laboratories
use to establish that a specimen is
dilute or substituted?
(a) As a laboratory, you must consider the primary specimen to be dilute
when:
(1) The creatinine concentration is
greater than or equal to 2 mg/dL but
less than 20 mg/dL, and
(2) The specific gravity is greater
than 1.0010 but less than 1.0030 on a single aliquot.
(b) As a laboratory, you must consider the primary specimen to be substituted when the creatinine concentration is less than 2 mg/dL and the
specific gravity is less than or equal to
1.0010 or greater than or equal to 1.0200
on both the initial and confirmatory
creatinine tests and on both the initial
and confirmatory specific gravity tests
on two separate aliquots.
[69 FR 64867, Nov. 9, 2004]

§ 40.95 What are the adulterant cutoff
concentrations for initial and confirmation tests?
(a) As a laboratory, you must use the
cutoff concentrations for the initial
and confirmation adulterant testing as
required by the HHS Mandatory Guidelines and you must use two separate
aliquots—one for the initial test and
another for the confirmation test.
(b) As a laboratory, you must report
results at or above the cutoffs (or for
pH, at or above or below the values, as
appropriate) as adulterated and provide
the numerical value that supports the
adulterated result.
[73 FR 35970, June 25, 2008]

§ 40.96 What criteria do laboratories
use to establish that a specimen is
invalid?
(a) As a laboratory, you must use the
invalid test result criteria for the initial and confirmation testing as required by the HHS Mandatory Guidelines, and you must use two separate

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Office of the Secretary of Transportation
aliquots—one for the initial test and
another for the confirmation test.
(b) As a laboratory, for a specimen
having an invalid result for one of the
reasons outlined in the HHS Mandatory Guidelines, you must contact the
MRO to discuss whether sending the
specimen to another HHS certified laboratory for testing would be useful in
being able to report a positive or adulterated result.
(c) As a laboratory, you must report
invalid results in accordance with the
invalid test result criteria as required
by the HHS Guidelines and provide the
numerical value that supports the invalid result, where appropriate, such as
pH.
(d) As a laboratory, you must report
the reason a test result is invalid.

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[73 FR 35970, June 25, 2008]

§ 40.97 What do laboratories report
and how do they report it?
(a) As a laboratory, you must report
the results for each primary specimen.
The result of a primary specimen will
fall into one of the following three categories. However, as a laboratory, you
must report the actual results (and not
the categories):
(1) Category 1: Negative Results. As a
laboratory, when you find a specimen
to be negative, you must report the
test result as being one of the following, as appropriate:
(i) Negative, or
(ii) Negative-dilute, with numerical
values for creatinine and specific gravity.
(2) Category 2: Non-negative Results.
As a laboratory, when you find a specimen to be non-negative, you must report the test result as being one or
more of the following, as appropriate:
(i) Positive, with drug(s)/metabolite(s) noted, with numerical values for
the drug(s) or drug metabolite(s).
(ii) Positive-dilute, with drug(s)/metabolite(s) noted, with numerical values for the drug(s) or drug metabolite(s) and with numerical values for
creatinine and specific gravity;
(iii) Adulterated, with adulterant(s)
noted, with confirmatory test values
(when applicable), and with remark(s);
(iv) Substituted, with confirmatory
test values for creatinine and specific
gravity; or

§ 40.97
(v) Invalid result, with remark(s).
Laboratories will report actual values
for pH results.
(3) Category 3: Rejected for Testing.
As a laboratory, when you reject a
specimen for testing, you must report
the result as being Rejected for Testing, with remark(s).
(b) As a laboratory, you must report
laboratory results directly, and only,
to the MRO at his or her place of business. You must not report results to or
through the DER or a service agent
(e.g., C/TPA).
(1) Negative results: You must fax,
courier, mail, or electronically transmit a legible image or copy of the
fully-completed Copy 1 of the CCF
which has been signed by the certifying
scientist, or you may provide the laboratory results report electronically
(i.e., computer data file).
(i) If you elect to provide the laboratory results report, you must include
the following elements, as a minimum,
in the report format:
(A) Laboratory name and address;
(B) Employer’s name (you may include I.D. or account number);
(C) Medical review officer’s name;
(D) Specimen I.D. number;
(E) Donor’s SSN or employee I.D.
number, if provided;
(F) Reason for test, if provided;
(G) Collector’s name and telephone
number;
(H) Date of the collection;
(I) Date received at the laboratory;
(J) Date certifying scientist released
the results;
(K) Certifying scientist’s name;
(L) Results (e.g., positive, adulterated) as listed in paragraph (a) of this
section; and
(M) Remarks section, with an explanation of any situation in which a correctable flaw has been corrected.
(ii) You may release the laboratory
results report only after review and approval by the certifying scientist. It
must reflect the same test result information as contained on the CCF signed
by the certifying scientist. The information contained in the laboratory results report may not contain information that does not appear on the CCF.
(iii) The results report may be transmitted through any means that ensures accuracy and confidentiality.

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§ 40.99

49 CFR Subtitle A (10–1–21 Edition)

You, as the laboratory, together with
the MRO, must ensure that the information is adequately protected from
unauthorized access or release, both
during transmission and in storage.
(2) Non-negative and Rejected for
Testing results: You must fax, courier,
mail, or electronically transmit a legible image or copy of the fully-completed Copy 1 of the CCF that has been
signed by the certifying scientist. In
addition, you may provide the electronic laboratory results report following the format and procedures set
forth in paragraphs (b)(1)(i) and (ii) of
this section.
(c) In transmitting laboratory results
to the MRO, you, as the laboratory, together with the MRO, must ensure that
the information is adequately protected from unauthorized access or release, both during transmission and in
storage. If the results are provided by
fax, the fax connection must have a
fixed telephone number accessible only
to authorized individuals.
(d) You must transmit test results to
the MRO in a timely manner, preferably the same day that review by the
certifying scientist is completed.
(e)(1) You must provide quantitative
values for confirmed positive drug test
results to the MRO.
(2) You must provide the numerical
values that support the adulterated
(when applicable) or substituted result,
without a request from the MRO.
(3) You must also provide to the MRO
numerical values for creatinine and
specific gravity for the negative-dilute
test result, without a request from the
MRO.
(f) You must provide quantitative
values for confirmed opiate results for
morphine or codeine at 15,000 ng/mL or
above, even if the MRO has not requested quantitative values for the test
result.

kpayne on VMOFRWIN702 with $$_JOB

[65 FR 79526, Dec. 19, 2000, as amended at 66
FR 41951, Aug. 9, 2001; 68 FR 31626, May 28,
2003; 69 FR 64867, Nov. 9, 2004; 73 FR 35970,
June 25, 2008; 75 FR 49862, Aug. 16, 2010; 75 FR
59107, Sept. 27, 2010; 77 FR 26473, May 4, 2012]

§ 40.99 How long does the laboratory
retain specimens after testing?
(a) As a laboratory testing the primary specimen, you must retain a
specimen that was reported with posi-

tive, adulterated, substituted, or invalid results for a minimum of one
year.
(b) You must keep such a specimen in
secure, long-term, frozen storage in accordance with HHS requirements.
(c) Within the one-year period, the
MRO, the employee, the employer, or a
DOT agency may request in writing
that you retain a specimen for an additional period of time (e.g., for the purpose of preserving evidence for litigation or a safety investigation). If you
receive such a request, you must comply with it. If you do not receive such
a request, you may discard the specimen at the end of the year.
(d) If you have not sent the split
specimen to another laboratory for
testing, you must retain the split specimen for an employee’s test for the
same period of time that you retain the
primary specimen and under the same
storage conditions.
(e) As the laboratory testing the split
specimen, you must meet the requirements of paragraphs (a) through (d) of
this section with respect to the split
specimen.
§ 40.101 What relationship may a laboratory have with an MRO?
(a) As a laboratory, you may not
enter into any relationship with an
MRO that creates a conflict of interest
or the appearance of a conflict of interest with the MRO’s responsibilities for
the employer. You may not derive any
financial benefit by having an employer use a specific MRO.
(b) The following are examples of relationships between laboratories and
MROs that the Department regards as
creating conflicts of interest, or the appearance of such conflicts. This following list of examples is not intended
to be exclusive or exhaustive:
(1) The laboratory employs an MRO
who reviews test results produced by
the laboratory;
(2) The laboratory has a contract or
retainer with the MRO for the review
of test results produced by the laboratory;
(3) The laboratory designates which
MRO the employer is to use, gives the
employer a slate of MROs from which
to choose, or recommends certain
MROs;

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Office of the Secretary of Transportation
(4) The laboratory gives the employer
a discount or other incentive to use a
particular MRO;
(5) The laboratory has its place of
business co-located with that of an
MRO or MRO staff who review test results produced by the laboratory; or
(6) The laboratory permits an MRO,
or an MRO’s organization, to have a financial interest in the laboratory.
§ 40.107

Who may inspect laboratories?

As a laboratory, you must permit an
inspection, with or without prior notice, by ODAPC, a DOT agency, or a
DOT-regulated employer that contracts with the laboratory for drug
testing under the DOT drug testing
program, or the designee of such an
employer.
§ 40.109 What documentation must the
laboratory keep, and for how long?
(a) As a laboratory, you must retain
all records pertaining to each employee
urine specimen for a minimum of two
years.
(b) As a laboratory, you must also
keep for two years employer-specific
data required in § 40.111.
(c) Within the two-year period, the
MRO, the employee, the employer, or a
DOT agency may request in writing
that you retain the records for an additional period of time (e.g., for the purpose of preserving evidence for litigation or a safety investigation). If you
receive such a request, you must comply with it. If you do not receive such
a request, you may discard the records
at the end of the two-year period.

kpayne on VMOFRWIN702 with $$_JOB

§ 40.111 When and how must a laboratory disclose statistical summaries
and other information it maintains?
(a) As a laboratory, you must transmit an aggregate statistical summary,
by employer, of the data listed in Appendix B to this part to the employer
on a semi-annual basis.
(1) The summary must not reveal the
identity of any employee.
(2) In order to avoid sending data
from which it is likely that information about an employee’s test result
can be readily inferred, you must not
send a summary if the employer has
fewer than five aggregate tests results.

§ 40.113
(3) The summary must be sent by
January 20 of each year for July 1
through December 31 of the prior year.
(4) The summary must also be sent
by July 20 of each year for January 1
through June 30 of the current year.
(b) When the employer requests a
summary in response to an inspection,
audit, or review by a DOT agency, you
must provide it unless the employer
had fewer than five aggregate test results. In that case, you must send the
employer a report indicating that not
enough testing was conducted to warrant a summary. You may transmit the
summary or report by hard copy, fax,
or other electronic means.
(c) You must also release information
to appropriate parties as provided in
§§ 40.329 and 40.331.
(d) As a laboratory, you must transmit an aggregate statistical summary
of the data listed in Appendix C to this
part to DOT on a semi-annual basis.
The summary must be sent by January
31 of each year for July 1 through December 31 of the prior year; it must be
sent by July 31 of each year for January 1 through June 30 of the current
year.
[65 FR 79526, Dec. 19, 2000, as amended at 73
FR 35971, June 25, 2008]

§ 40.113 Where is other information
concerning laboratories found in
this regulation?
You can find more information concerning laboratories in several sections
of this part:
§ 40.3—Definition.
§ 40.13—Prohibition on making specimens
available for other purposes.
§ 40.31—Conflicts of interest concerning collectors.
§ 40.47—Laboratory rejections of test for improper form.
§ 40.125—Conflicts of interest concerning
MROs.
§ 40.175—Role of first laboratory in split specimen tests.
§ 40.177—Role of second laboratory in split
specimen tests (drugs).
§ 40.179—Role of second laboratory in split
specimen tests (adulterants).
§ 40.181—Role of second laboratory in split
specimen tests (substitution).
§§ 40.183–40.185—Transmission of split specimen test results to MRO.
§§ 40.201–40.205—Role in correcting errors.
§ 40.329—Release of information to employees.

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§ 40.121

49 CFR Subtitle A (10–1–21 Edition)

§ 40.331—Limits on release of information.
§ 40.355—Role with respect to other service
agents.

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Subpart G—Medical Review Officers and the Verification
Process
§ 40.121 Who is qualified to act as an
MRO?
To be qualified to act as an MRO in
the DOT drug testing program, you
must meet each of the requirements of
this section:
(a) Credentials. You must be a licensed physician (Doctor of Medicine
or Osteopathy). If you are a licensed
physician in any U.S., Canadian, or
Mexican jurisdiction and meet the
other requirements of this section, you
are authorized to perform MRO services with respect to all covered employees, wherever they are located. For
example, if you are licensed as an M.D.
in one state or province in the U.S.,
Canada, or Mexico, you are not limited
to performing MRO functions in that
state or province, and you may perform
MRO functions for employees in other
states or provinces without becoming
licensed to practice medicine in the
other jurisdictions.
(b) Basic knowledge. You must be
knowledgeable in the following areas:
(1) You must be knowledgeable about
and have clinical experience in controlled substances abuse disorders, including detailed knowledge of alternative medical explanations for laboratory confirmed drug test results.
(2) You must be knowledgeable about
issues relating to adulterated and substituted specimens as well as the possible medical causes of specimens having an invalid result.
(3) You must be knowledgeable about
this part, the DOT MRO Guidelines,
and the DOT agency regulations applicable to the employers for whom you
evaluate drug test results, and you
must keep current on any changes to
these materials. You must subscribe to
the ODAPC list-serve at https://
www.transportation.gov/odapc/get-odapcemail-updates. DOT agency regulations,
DOT MRO Guidelines, and other materials are available from ODAPC (Department of Transportation, 1200 New
Jersey Avenue SE, Washington, DC

20590, 202–366–3784), or on the ODAPC
Web site (http://www.transportation.gov/
odapc).
(c) Qualification training. You must
receive qualification training meeting
the requirements of this paragraph (c).
(1) Qualification training must provide instruction on the following subjects:
(i) Collection procedures for urine
specimens;
(ii) Chain of custody, reporting, and
recordkeeping;
(iii) Interpretation of drug and validity tests results;
(iv) The role and responsibilities of
the MRO in the DOT drug testing program;
(v) The interaction with other participants in the program (e.g., DERs,
SAPs); and
(vi) Provisions of this part and DOT
agency rules applying to employers for
whom you review test results, including changes and updates to this part
and DOT agency rules, guidance, interpretations, and policies affecting the
performance of MRO functions, as well
as issues that MROs confront in carrying out their duties under this part
and DOT agency rules.
(2) Following your completion of
qualification training under paragraph
(c)(1) of this section, you must satisfactorily complete an examination administered by a nationally-recognized MRO
certification board or subspecialty
board for medical practitioners in the
field of medical review of DOT-mandated drug tests. The examination
must comprehensively cover all the
elements of qualification training listed in paragraph (c)(1) of this section.
(3) You must meet the requirements
of paragraphs (a), (b), and (c) of this
section before you begin to perform
MRO functions.
(d) Requalification training. During
each five-year period from the date on
which you satisfactorily completed the
examination under paragraph (c)(2) of
this section, you must complete requalification training.
(1) This requalification training must
meet the requirements of the qualification training under paragraph (c)(1) of
this section.

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Office of the Secretary of Transportation
(2) Following your completion of requalification training, you must satisfactorily complete an examination administered by a nationally-recognized
MRO certification board or subspecialty board for medical practitioners in the field of medical review of
DOT-mandated drug tests. The examination must comprehensively cover
all the elements of qualification training listed in paragraph (c)(1) of this
section.
(e) Documentation. You must maintain documentation showing that you
currently meet all requirements of this
section. You must provide this documentation on request to DOT agency
representatives and to employers and
C/TPAs who are using or negotiating to
use your services.

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[65 FR 79526, Dec. 19, 2000, as amended at 66
FR 41951, Aug. 9, 2001; 75 FR 49862, Aug. 16,
2010; 82 FR 52245, Nov. 13, 2017]

§ 40.123 What are the MRO’s responsibilities in the DOT drug testing
program?
As an MRO, you have the following
basic responsibilities:
(a) Acting as an independent and impartial ‘‘gatekeeper’’ and advocate for
the accuracy and integrity of the drug
testing process.
(b) Providing a quality assurance review of the drug testing process for the
specimens under your purview. This includes, but is not limited to:
(1) Ensuring the review of the CCF on
all specimen collections for the purposes of determining whether there is a
problem that may cause a test to be
cancelled (see §§ 40.199–40.203). As an
MRO, you are not required to review
laboratory internal chain of custody
documentation. No one is permitted to
cancel a test because you have not reviewed this documentation;
(2) Providing feedback to employers,
collection sites and laboratories regarding performance issues where necessary; and
(3) Reporting to and consulting with
the ODAPC or a relevant DOT agency
when you wish DOT assistance in resolving any program issue. As an employer or service agent, you are prohibited from limiting or attempting to
limit the MRO’s access to DOT for this
purpose and from retaliating in any

§ 40.127
way against an MRO for discussing
drug testing issues with DOT.
(c) You must determine whether
there is a legitimate medical explanation for confirmed positive, adulterated, substituted, and invalid drug
tests results from the laboratory.
(d) While you provide medical review
of employees’ test results, this part
does not deem that you have established a doctor-patient relationship
with the employees whose tests you review.
(e) You must act to investigate and
correct problems where possible and
notify appropriate parties (e.g., HHS,
DOT, employers, service agents) where
assistance is needed, (e.g., cancelled or
problematic tests, incorrect results).
(f) You must ensure the timely flow
of test results and other information to
employers.
(g) You must protect the confidentiality of the drug testing information.
(h) You must perform all your functions in compliance with this part and
other DOT agency regulations.
[65 FR 79526, Dec. 19, 2000, as amended at 82
FR 52245, Nov. 13, 2017]

§ 40.125 What relationship may
MRO have with a laboratory?

As an MRO, you may not enter into
any relationship with an employer’s
laboratory that creates a conflict of interest or the appearance of a conflict of
interest with your responsibilities to
that employer. You may not derive any
financial benefit by having an employer use a specific laboratory. For
examples of relationships between laboratories and MROs that the Department views as creating a conflict of interest or the appearance of such a conflict, see § 40.101(b).
§ 40.127 What are the MRO’s functions
in reviewing negative test results?
As the MRO, you must do the following with respect to negative drug
test results you receive from a laboratory, prior to verifying the result and
releasing it to the DER:
(a) Review Copy 2 of the CCF to determine if there are any fatal or correctable errors that may require you to
initiate corrective action or to cancel
the test (see §§ 40.199 and 40.203).

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§ 40.129

49 CFR Subtitle A (10–1–21 Edition)

(b) Review the negative laboratory
test result and ensure that it is consistent with the information contained
on the CCF.
(c) Before you report a negative test
result, you must have in your possession the following documents:
(1) Copy 2 of the CCF, a legible copy
of it, or any other CCF copy containing
the employee’s signature; and
(2) A legible copy (fax, photocopy,
image) of Copy 1 of the CCF or the
electronic laboratory results report
that conveys the negative laboratory
test result.
(d) If the copy of the documentation
provided to you by the collector or laboratory appears unclear, you must request that the collector or laboratory
send you a legible copy.
(e) On Copy 2 of the CCF, place a
check mark in the ‘‘Negative’’ box
(Step 6), provide your name, and sign,
initial, or stamp and date the
verification statement.
(f) Report the result in a confidential
manner (see §§ 40.163–40.167).
(g) Staff under your direct, personal
supervision may perform the administrative functions of this section for
you, but only you can cancel a test. If
you cancel a laboratory-confirmed negative result, check the ‘‘Test Cancelled’’ box (Step 6) on Copy 2 of the
CCF, make appropriate annotation in
the ‘‘Remarks’’ line, provide your
name, and sign, initial or stamp and
date the verification statement.
(1) On specimen results that are reviewed by your staff, you are responsible for assuring the quality of their
work.
(2) You are required to personally review at least 5 percent of all CCFs reviewed by your staff on a quarterly
basis, including all results that required a corrective action. However,
you need not review more than 500 negative results in any quarter.
(3) Your review must, as a minimum,
include the CCF, negative laboratory
test result, any accompanying corrective documents, and the report sent to
the employer. You must correct any errors that you discover. You must take
action as necessary to ensure compliance by your staff with this part and
document your corrective action. You
must attest to the quality assurance

review by initialing the CCFs that you
review.
(4) You must make these CCFs easily
identifiable and retrievable by you for
review by DOT agencies.
[65 FR 79526, Dec. 19, 2000, as amended at 66
FR 41951, Aug. 9, 2001]

§ 40.129 What are the MRO’s functions
in reviewing laboratory confirmed
non-negative drug test results?
(a) As the MRO, you must do the following with respect to confirmed positive, adulterated, substituted, or invalid drug tests you receive from a laboratory, before you verify the result
and release it to the DER:
(1) Review Copy 2 of the CCF to determine if there are any fatal or correctable errors that may require you to
cancel the test (see §§ 40.199 and 40.203).
Staff under your direct, personal supervision may conduct this administrative
review for you, but only you may
verify or cancel a test.
(2) Review Copy 1 of the CCF and ensure that it is consistent with the information contained on Copy 2, that
the test result is legible, and that the
certifying scientist signed the form.
You are not required to review any
other documentation generated by the
laboratory during their analysis or
handling of the specimen (e.g., the laboratory internal chain of custody).
(3) If the copy of the documentation
provided to you by the collector or laboratory appears unclear, you must request that the collector or laboratory
send you a legible copy.
(4) Except in the circumstances
spelled out in § 40.133 , conduct a
verification interview. This interview
must include direct contact in person
or by telephone between you and the
employee. You may initiate the
verification process based on the laboratory results report.
(5) Verify the test result, consistent
with the requirements of §§ 40.135
through 40.145, 40.159, and 40.160, as:
(i) Negative; or
(ii) Cancelled; or
(iii) Positive, and/or refusal to test
because of adulteration or substitution.
(b) Before you report a verified negative, positive, test cancelled, refusal to

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Office of the Secretary of Transportation
test because of adulteration or substitution, you must have in your possession the following documents:
(1) Copy 2 of the CCF, a legible copy
of it, or any other CCF copy containing
the employee’s signature; and
(2) A legible copy (fax, photocopy,
image) of Copy 1 of the CCF, containing the certifying scientist’s signature.
(c) With respect to verified positive
test results, place a checkmark in the
‘‘Positive’’ box in Step 6 on Copy 2 of
the CCF, indicate the drug(s)/metabolite(s) verified positive, and sign and
date the verification statement.
(d) If you cancel a laboratory confirmed positive, adulterated, substituted, or invalid drug test report,
check the ‘‘test cancelled’’ box (Step 6)
on Copy 2 of the CCF, make appropriate annotation in the ‘‘Remarks’’
line, sign, provide your name, and date
the verification statement.
(e) Report the result in a confidential
manner (see §§ 40.163–40.167).
(f) With respect to adulteration or
substitution test results, check the
‘‘refusal to test because:’’ box (Step 6)
on Copy 2 of the CCF, check the
‘‘Adulterated’’ or ‘‘Substituted’’ box,
as appropriate, make appropriate annotation in the ‘‘Remarks’’ line, sign and
date the verification statement.
(g) As the MRO, your actions concerning reporting confirmed positive,
adulterated, or substituted results to
the employer before you have completed the verification process are also
governed by the stand-down provisions
of § 40.21 .
(1) If an employer has a stand-down
policy that meets the requirements of
§ 40.21 , you may report to the DER
that you have received an employee’s
laboratory confirmed positive, adulterated, or substituted test result, consistent with the terms of the waiver
the employer received. You must not
provide any further details about the
test result (e.g., the name of the drug
involved).
(2) If the employer does not have a
stand-down policy that meets the requirements of § 40.21, you must not inform the employer that you have received an employee’s laboratory confirmed positive, adulterated, or substituted test result until you verify the

§ 40.131
test result. For example, as an MRO
employed directly by a company, you
must not tell anyone on the company’s
staff or management that you have received an employee’s laboratory confirmed test result.
[65 FR 79526, Dec. 19, 2000, as amended at 66
FR 41952, Aug. 9, 2001; 73 FR 35971, June 25,
2008; 75 FR 59107, Sept. 27, 2010]

§ 40.131 How does the MRO or DER notify an employee of the verification
process after receiving laboratory
confirmed non-negative drug test
results?
(a) When, as the MRO, you receive a
confirmed positive, adulterated, substituted, or invalid test result from the
laboratory, you must contact the employee directly (i.e., actually talk to
the employee), on a confidential basis,
to determine whether the employee
wants to discuss the test result. In
making this contact, you must explain
to the employee that, if he or she declines to discuss the result, you will
verify the test as positive or as a refusal to test because of adulteration or
substitution, as applicable.
(b) As the MRO, staff under your personal supervision may conduct this initial contact for you.
(1) This staff contact must be limited
to scheduling the discussion between
you and the employee and explaining
the consequences of the employee’s declining to speak with you (i.e., that the
MRO will verify the test without input
from the employee). If the employee
declines to speak with you, the staff
person must document the employee’s
decision, including the date and time.
(2) A staff person must not gather
any medical information or information concerning possible explanations
for the test result.
(3) A staff person may advise an employee to have medical information
(e.g., prescriptions, information forming the basis of a legitimate medical
explanation for a confirmed positive
test result) ready to present at the
interview with the MRO.
(4) Since you are required to speak
personally with the employee, face-toface or on the phone, your staff must
not inquire if the employee wishes to
speak with you.

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§ 40.133

49 CFR Subtitle A (10–1–21 Edition)

(c) As the MRO, you or your staff
must make reasonable efforts to reach
the employee at the day and evening
telephone numbers listed on the CCF.
Reasonable efforts include, as a minimum, three attempts, spaced reasonably over a 24-hour period, to reach the
employee at the day and evening telephone numbers listed on the CCF. If
you or your staff cannot reach the employee directly after making these efforts, you or your staff must take the
following steps:
(1) Document the efforts you made to
contact the employee, including dates
and times. If both phone numbers are
incorrect (e.g., disconnected, wrong
number), you may take the actions
listed in paragraph (c)(2) of this section
without waiting the full 24-hour period.
(2) Contact the DER, instructing the
DER to contact the employee.
(i) You must simply direct the DER
to inform the employee to contact you.
(ii) You must not inform the DER
that the employee has a confirmed
positive, adulterated, substituted, or
invalid test result.
(iii) You must document the dates
and times of your attempts to contact
the DER, and you must document the
name of the DER you contacted and
the date and time of the contact.
(d) As the DER, you must attempt to
contact the employee immediately,
using procedures that protect, as much
as possible, the confidentiality of the
MRO’s request that the employee contact the MRO. If you successfully contact the employee (i.e., actually talk
to the employee), you must document
the date and time of the contact, and
inform the MRO. You must inform the
employee that he or she should contact
the MRO immediately. You must also
inform the employee of the consequences of failing to contact the
MRO within the next 72 hours (see
§ 40.133(a)(2)).
(1) As the DER, you must not inform
anyone else working for the employer
that you are seeking to contact the
employee on behalf of the MRO.
(2) If, as the DER, you have made all
reasonable efforts to contact the employee but failed to do so, you may
place the employee on temporary medically unqualified status or medical
leave. Reasonable efforts include, as a

minimum, three attempts, spaced reasonably over a 24-hour period, to reach
the employee at the day and evening
telephone numbers listed on the CCF.
(i) As the DER, you must document
the dates and times of these efforts.
(ii) If, as the DER, you are unable to
contact the employee within this 24hour period, you must leave a message
for the employee by any practicable
means (e.g., voice mail, e-mail, letter)
to contact the MRO and inform the
MRO of the date and time of this attempted contact.
[65 FR 79526, Dec. 19, 2000, as amended at 66
FR 41952, Aug. 9, 2001; 68 FR 31626, May 28,
2003; 69 FR 64867, Nov. 9, 2004]

§ 40.133 Without interviewing the employee, under what circumstances
may the MRO verify a test result as
positive, or as a refusal to test because of adulteration or substitution, or as cancelled because the
test was invalid?
(a) As the MRO, you normally may
verify a confirmed positive test (for
any drug or drug metabolite, including
opiates), or as a refusal to test because
of adulteration or substitution, only
after interviewing the employee as provided in §§ 40.135–40.145 . However, there
are three circumstances in which you
may verify such a result without an
interview:
(1) You may verify a test result as a
positive or refusal to test, as applicable, if the employee expressly declines
the opportunity to discuss the test
with you. You must maintain complete
documentation of this occurrence, including notation of informing, or attempting to inform, the employee of
the consequences of not exercising the
option to speak with the you.
(2) You may verify a test result as a
positive or refusal to test, as applicable, if the DER has successfully made
and documented a contact with the employee and instructed the employee to
contact you and more than 72 hours
have passed since the time the DER
contacted the employee.
(3) You may verify a test result as a
positive or refusal to test, as applicable, if neither you nor the DER, after
making and documenting all reasonable efforts, has been able to contact
the employee within ten days of the
date on which the MRO receives the

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Office of the Secretary of Transportation
confirmed test result from the laboratory.
(b) As the MRO, you may verify an
invalid test result as cancelled (with
instructions to recollect immediately
under direct observation) without
interviewing the employee, as provided
at § 40.159:
(1) If the employee expressly declines
the opportunity to discuss the test
with you;
(2) If the DER has successfully made
and documented a contact with the employee and instructed the employee to
contact you and more than 72 hours
have passed since the time the DER
contacted the employee; or
(3) If neither you nor the DER, after
making and documenting all reasonable efforts, has been able to contact
the employee within ten days of the
date on which you received the confirmed invalid test result from the laboratory.
(c) As the MRO, after you verify a
test result as a positive or as a refusal
to test under this section, you must
document the date and time and reason, following the instructions in
§ 40.163. For a cancelled test due to an
invalid result under this section, you
must follow the instructions in
§ 40.159(a)(5).
(d) As the MRO, after you have
verified a test result under this section
and reported the result to the DER,
you must allow the employee to
present information to you within 60
days of the verification to document
that serious illness, injury, or other
circumstances unavoidably precluded
contact with the MRO and/or DER in
the times provided. On the basis of
such information, you may reopen the
verification, allowing the employee to
present information concerning whether there is a legitimate medical explanation of the confirmed test result.

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[65 FR 79526, Dec. 19, 2000, as amended at 73
FR 35971, June 25, 2008]

§ 40.135 What does the MRO tell the
employee at the beginning of the
verification interview?
(a) As the MRO, you must tell the
employee that the laboratory has determined that the employee’s test result was positive, adulterated, substituted, or invalid, as applicable. You

§ 40.135
must also tell the employee of the
drugs for which his or her specimen
tested positive, or the basis for the
finding of adulteration or substitution.
(b) You must explain the verification
interview process to the employee and
inform the employee that your decision
will be based on information the employee provides in the interview.
(c) You must explain that, if further
medical evaluation is needed for the
verification process, the employee
must comply with your request for this
evaluation and that failure to do so is
equivalent of expressly declining to
discuss the test result.
(d) As the MRO, you must warn an
employee who has a confirmed positive, adulterated, substituted or invalid test that you are required to provide to third parties drug test result
information and medical information
affecting the performance of safetysensitive duties that the employee
gives you in the verification process
without the employee’s consent (see
§ 40.327).
(1) You must give this warning to the
employee before obtaining any medical
information as part of the verification
process.
(2) For purposes of this paragraph (d),
medical information includes information on medications or other substances affecting the performance of
safety-sensitive duties that the employee reports using or medical conditions the employee reports having.
(3) For purposes of this paragraph (d),
the persons to whom this information
may be provided include the employer,
a SAP evaluating the employee as part
of the return to duty process (see
§ 40.293(g)), DOT, another Federal safety agency (e.g., the NTSB), or any state
safety agency as required by state law.
(e) You must also advise the employee that, before informing any third
party about any medication the employee is using pursuant to a legally
valid prescription consistent with the
Controlled Substances Act, you will
allow 5 business days from the date you
report the verified negative result for
the employee to have the prescribing
physician contact you to determine if
the medication can be changed to one

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§ 40.137

49 CFR Subtitle A (10–1–21 Edition)

that does not make the employee medically unqualified or does not pose a significant safety risk. If, in your reasonable medical judgment, a medical qualification issue or a significant safety
risk remains after you communicate
with the employee’s prescribing physician or after 5 business days, whichever
is shorter, you must follow § 40.327. If,
as the MRO, you receive information
that eliminates the medical qualification issue or significant safety risk,
you must transmit this information to
any third party to whom you previously provided information under
§ 40.327.
[65 FR 79526, Dec. 19, 2000, as amended at 66
FR 41952, Aug. 9, 2001; 82 FR 52245, Nov. 13,
2017]

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§ 40.137 On what basis does the MRO
verify test results involving marijuana,
cocaine,
amphetamines,
semi-synthetic opioids, or PCP?
(a) As the MRO, you must verify a
confirmed positive test result for marijuana, cocaine, amphetamines, semisynthetic opioids (i.e., hydrocodone,
hydromorphone,
oxycodone,
and
oxymorphone), and/or PCP unless the
employee presents a legitimate medical explanation for the presence of the
drug(s)/metabolite(s) in his or her system. In determining whether an employee’s legally valid prescription consistent with the Controlled Substances
Act for a substance in these categories
constitutes a legitimate medical explanation, you must not question whether
the prescribing physician should have
prescribed the substance.
(b) You must offer the employee an
opportunity to present a legitimate
medical explanation in all cases.
(c) The employee has the burden of
proof that a legitimate medical explanation exists. The employee must
present information meeting this burden at the time of the verification
interview. As the MRO, you have discretion to extend the time available to
the employee for this purpose for up to
five days before verifying the test result, if you determine that there is a
reasonable basis to believe that the
employee will be able to produce relevant evidence concerning a legitimate
medical explanation within that time.

(d) If you determine that there is a
legitimate medical explanation, you
must verify the test result as negative.
Otherwise, you must verify the test result as positive.
(e) In determining whether a legitimate medical explanation exists, you
may consider the employee’s use of a
medication from a foreign country.
You must exercise your professional
judgment consistently with the following principles:
(1) There can be a legitimate medical
explanation only with respect to a substance that is obtained legally in a foreign country.
(2) There can be a legitimate medical
explanation only with respect to a substance that has a legitimate medical
use. Use of a drug of abuse (e.g., heroin,
PCP, marijuana) or any other substance (see § 40.151(f) and (g)) that cannot be viewed as having a legitimate
medical use can never be the basis for
a legitimate medical explanation, even
if the substance is obtained legally in a
foreign country.
(3) Use of the substance can form the
basis of a legitimate medical explanation only if it is used consistently
with its proper and intended medical
purpose.
(4) Even if you find that there is a legitimate medical explanation under
this paragraph (e) and verify a test
negative, you may have a responsibility to raise fitness-for-duty considerations with the employer (see
§ 40.327).
[65 FR 79526, Dec. 19, 2000, as amended at 82
FR 52245, Nov. 13, 2017]

§ 40.139 On what basis does the MRO
verify test results involving 6-acetylmorphine, codeine, and morphine?
As the MRO, you must proceed as follows when you receive a laboratory
confirmed positive opiate result:
(a) If the laboratory confirms the
presence of 6-acetylmorphine (6–AM) in
the specimen, you must verify the test
result positive.
(b) In the absence of 6–AM, if the laboratory confirms the presence of either
morphine or codeine at 15,000 ng/mL or
above, you must verify the test result
positive unless the employee presents a
legitimate medical explanation for the

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Office of the Secretary of Transportation
presence of the drug or drug metabolite
in his or her system, as in the case of
other drugs (see § 40.137). Consumption
of food products (e.g., poppy seeds)
must not be considered a legitimate
medical explanation for the employee
having morphine or codeine at these
concentrations.
(c) For all other codeine and morphine positive results, you must verify
a confirmed positive test result only if
you determine that there is clinical
evidence, in addition to the urine test,
of unauthorized use of any opium, opiate, or opium derivative (i.e., morphine, codeine, or heroin).
(1) As an MRO, it is your responsibility to use your best professional and
ethical judgement and discretion to determine whether there is clinical evidence of unauthorized use of opiates.
Examples of information that you may
consider in making this judgement include, but are not limited to, the following:
(i) Recent needle tracks;
(ii) Behavioral and psychological
signs of acute opiate intoxication or
withdrawal;
(iii) Clinical history of unauthorized
use recent enough to have produced the
laboratory test result;
(iv) Use of a medication from a foreign country. See § 40.137(e) for guidance on how to make this determination.
(2) In order to establish the clinical
evidence referenced in paragraphs
(c)(1)(i) and (ii) of this section, personal
observation of the employee is essential.
(i) Therefore, you, as the MRO, must
conduct, or cause another physician to
conduct, a face-to-face examination of
the employee.
(ii) No face-to-face examination is
needed in establishing the clinical evidence referenced in paragraph (c)(1)(iii)
or (iv) of this section.
(3) To be the basis of a verified positive result for codeine or morphine, the
clinical evidence you find must concern a drug that the laboratory found
in the specimen. (For example, if the
test confirmed the presence of codeine,
and the employee admits to unauthorized use of hydrocodone, you must not
verify the test positive for codeine. The

§ 40.141
admission must be for the substance
that was found through the actual drug
test.)
(4) As the MRO, you have the burden
of establishing that there is clinical
evidence of unauthorized use of opiates
referenced in this paragraph (c). If you
cannot make this determination (e.g.,
there is not sufficient clinical evidence
or history), you must verify the test as
negative. The employee does not need
to show you that a legitimate medical
explanation exists if no clinical evidence is established.
[77 FR 26473, May 4, 2012, as amended at 82
FR 52245, Nov. 13, 2017]

§ 40.141 How does the MRO obtain information for the verification decision?
As the MRO, you must do the following as you make the determinations
needed for a verification decision:
(a) You must conduct a medical
interview. You must review the employee’s medical history and any other
relevant biomedical factors presented
to you by the employee. You may direct the employee to undergo further
medical evaluation by you or another
physician.
(b) If the employee asserts that the
presence of a drug or drug metabolite
in his or her specimen results from
taking prescription medication (i.e., a
legally valid prescription consistent
with the Controlled Substances Act),
you must review and take all reasonable and necessary steps to verify the
authenticity of all medical records the
employee provides. You may contact
the employee’s physician or other relevant medical personnel for further information. You may request an HHScertified laboratory with validated protocols (see § 40.81(c)) to conduct testing
for D,L stereoisomers of amphetamine
and methamphetamine or testing for
tetrahydrocannabivarin (THC- V) when
verifying lab results, as you determine
necessary.
[65 FR 79526, Dec. 19, 2000, as amended at 82
FR 52245, Nov. 13, 2017]

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§ 40.143
§ 40.143

49 CFR Subtitle A (10–1–21 Edition)
[Reserved]

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§ 40.145 On what basis does the MRO
verify test results involving adulteration or substitution?
(a) As an MRO, when you receive a
laboratory report that a specimen is
adulterated or substituted, you must
treat that report in the same way you
treat the laboratory’s report of a confirmed positive for a drug or drug metabolite.
(b) You must follow the same procedures used for verification of a confirmed positive test for a drug or drug
metabolite (see §§ 40.129–40.135, 40.141,
40.151), except as otherwise provided in
this section.
(c) In the verification interview, you
must explain the laboratory findings to
the employee and address technical
questions or issues the employee may
raise.
(d) You must offer the employee the
opportunity to present a legitimate
medical explanation for the laboratory
findings with respect to presence of the
adulterant in, or the creatinine and
specific gravity findings for, the specimen.
(e) The employee has the burden of
proof that there is a legitimate medical explanation.
(1) To meet this burden in the case of
an adulterated specimen, the employee
must demonstrate that the adulterant
found by the laboratory entered the
specimen through physiological means.
(2) To meet this burden in the case of
a substituted specimen, the employee
must demonstrate that he or she did
produce or could have produced urine
through physiological means, meeting
the creatinine concentration criterion
of less than 2 mg/dL and the specific
gravity criteria of less than or equal to
1.0010 or greater than or equal to 1.0200
(see § 40.93(b)).
(3) The employee must present information meeting this burden at the
time of the verification interview. As
the MRO, you have discretion to extend the time available to the employee for this purpose for up to five
days before verifying the specimen, if
you determine that there is a reasonable basis to believe that the employee
will be able to produce relevant evi-

dence supporting a legitimate medical
explanation within that time.
(f) As the MRO or the employer, you
are not responsible for arranging, conducting, or paying for any studies, examinations or analyses to determine
whether a legitimate medical explanation exists.
(g) As the MRO, you must exercise
your best professional judgment in deciding whether the employee has established a legitimate medical explanation.
(1) If you determine that the employee’s explanation does not present a reasonable basis for concluding that there
may be a legitimate medical explanation, you must report the test to the
DER as a verified refusal to test because of adulteration or substitution,
as applicable.
(2) If you believe that the employee’s
explanation may present a reasonable
basis for concluding that there is a legitimate medical explanation, you
must direct the employee to obtain,
within the five-day period set forth in
paragraph (e)(3) of this section, a further medical evaluation. This evaluation must be performed by a licensed
physician (the ‘‘referral physician’’),
acceptable to you, with expertise in the
medical issues raised by the employee’s
explanation. (The MRO may perform
this evaluation if the MRO has appropriate expertise.)
(i) As the MRO or employer, you are
not responsible for finding or paying a
referral physician. However, on request
of the employee, you must provide reasonable assistance to the employee’s
efforts to find such a physician. The
final choice of the referral physician is
the employee’s, as long as the physician is acceptable to you.
(ii) As the MRO, you must consult
with the referral physician, providing
guidance to him or her concerning his
or her responsibilities under this section. As part of this consultation, you
must provide the following information
to the referral physician:
(A) That the employee was required
to take a DOT drug test, but the laboratory reported that the specimen was
adulterated or substituted, which is
treated as a refusal to test;

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Office of the Secretary of Transportation
(B) The consequences of the appropriate DOT agency regulation for refusing to take the required drug test;
(C) That the referral physician must
agree to follow the requirements of
paragraphs (g)(3) through (g)(4) of this
section; and
(D) That the referral physician must
provide you with a signed statement of
his or her recommendations.
(3) As the referral physician, you
must evaluate the employee and consider any evidence the employee presents concerning the employee’s medical explanation. You may conduct additional tests to determine whether
there is a legitimate medical explanation. Any additional urine tests
must be performed in an HHS-certified
laboratory.
(4) As the referral physician, you
must then make a written recommendation to the MRO about
whether the MRO should determine
that there is a legitimate medical explanation. As the MRO, you must seriously consider and assess the referral
physician’s recommendation in deciding whether there is a legitimate medical explanation.
(5) As the MRO, if you determine
that there is a legitimate medical explanation, you must cancel the test
and inform ODAPC in writing of the
determination and the basis for it (e.g.,
referral physician’s findings, evidence
produced by the employee).
(6) As the MRO, if you determine
that there is not a legitimate medical
explanation, you must report the test
to the DER as a verified refusal to test
because of adulteration or substitution.
(h) The following are examples of
types of evidence an employee could
present to support an assertion of a legitimate medical explanation for a substituted result.
(1) Medically valid evidence demonstrating that the employee is capable of physiologically producing urine
meeting the creatinine and specific
gravity criteria of § 40.93(b).
(i) To be regarded as medically valid,
the evidence must have been gathered
using appropriate methodology and
controls to ensure its accuracy and reliability.

§ 40.149
(ii) Assertion by the employee that
his or her personal characteristics (e.g.,
with respect to race, gender, weight,
diet, working conditions) are responsible for the substituted result does
not, in itself, constitute a legitimate
medical explanation. To make a case
that there is a legitimate medical explanation, the employee must present
evidence showing that the cited personal characteristics actually result in
the physiological production of urine
meeting the creatinine and specific
gravity criteria of § 40.93(b).
(2) Information from a medical evaluation under paragraph (g) of this section that the individual has a medical
condition that has been demonstrated
to cause the employee to physiologically produce urine meeting the creatinine and specific gravity criteria of
§ 40.93(b).
(i) A finding or diagnosis by the physician that an employee has a medical
condition, in itself, does not constitute
a legitimate medical explanation.
(ii) To establish there is a legitimate
medical explanation, the employee
must demonstrate that the cited medical condition actually results in the
physiological production of urine meeting the creatinine and specific gravity
criteria of § 40.93(b).
[65 FR 79526, Dec. 19, 2000, as amended at 68
FR 31626, May 28, 2003; 69 FR 64867, Nov. 9,
2004]

§ 40.147

[Reserved]

§ 40.149 May the MRO change a
verified drug test result?
(a) As the MRO, you may change a
verified test result only in the following situations:
(1) When you have reopened a
verification that was done without an
interview with an employee (see
§ 40.133(d)).
(2) If you receive information, not
available to you at the time of the
original verification, demonstrating
that the laboratory made an error in
identifying (e.g., a paperwork mistake)
or testing (e.g., a false positive or negative) the employee’s primary or split
specimen. For example, suppose the
laboratory originally reported a positive test result for Employee X and a
negative result for Employee Y. You

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§ 40.151

49 CFR Subtitle A (10–1–21 Edition)

verified the test results as reported to
you. Then the laboratory notifies you
that it mixed up the two test results,
and X was really negative and Y was
really positive. You would change X’s
test result from positive to negative
and contact Y to conduct a verification
interview.
(3) If, within 60 days of the original
verification decision—
(i) You receive information that
could not reasonably have been provided to you at the time of the decision
demonstrating that there is a legitimate medical explanation for the presence of drug(s)/metabolite(s) in the employee’s specimen; or
(ii) You receive credible new or additional evidence that a legitimate medical explanation for an adulterated or
substituted result exists.

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Example to paragraph (a)(3): If the employee’s physician provides you a valid prescription that he or she failed to find at the time
of the original verification, you may change
the test result from positive to negative if
you conclude that the prescription provides
a legitimate medical explanation for the
drug(s)/ metabolite(s) in the employee’s specimen.

(4) If you receive the information in
paragraph (a)(3) of this section after
the 60-day period, you must consult
with ODAPC prior to changing the result.
(5) When you have made an administrative error and reported an incorrect
result.
(b) If you change the result, you
must immediately notify the DER in
writing, as provided in §§ 40.163–40.165.
(c) You are the only person permitted
to change a verified test result, such as
a verified positive test result or a determination that an individual has refused to test because of adulteration or
substitution. This is because, as the
MRO, you have the sole authority
under this part to make medical determinations leading to a verified test
(e.g., a determination that there was or
was not a legitimate medical explanation for a laboratory test result).
For example, an arbitrator is not permitted to overturn the medical judgment of the MRO that the employee
failed to present a legitimate medical
explanation for a positive, adulterated,

or substituted test result of his or her
specimen.
[65 FR 79526, Dec. 19, 2000, as amended at 66
FR 41952, Aug. 9, 2001; 73 FR 35971, June 25,
2008]

§ 40.151 What are MROs prohibited
from
doing
as
part
of
the
verification process?
As an MRO, you are prohibited from
doing the following as part of the
verification process:
(a) You must not consider any evidence from tests of urine samples or
other body fluids or tissues (e.g., blood
or hair samples) that are not collected
or tested in accordance with this part.
For example, if an employee tells you
he went to his own physician, provided
a urine specimen, sent it to a laboratory, and received a negative test result or a DNA test result questioning
the identity of his DOT specimen, you
are required to ignore this test result.
(b) It is not your function to make
decisions about factual disputes between the employee and the collector
concerning matters occurring at the
collection site that are not reflected on
the CCF (e.g., concerning allegations
that the collector left the area or left
open urine containers where other people could access them).
(c) It is not your function to determine whether the employer should
have directed that a test occur. For example, if an employee tells you that
the employer misidentified her as the
subject of a random test, or directed
her to take a reasonable suspicion or
post-accident test without proper
grounds under a DOT agency drug or
alcohol regulation, you must inform
the employee that you cannot play a
role in deciding these issues.
(d) It is not your function to consider
explanations of confirmed positive,
adulterated, or substituted test results
that would not, even if true, constitute
a legitimate medical explanation. For
example, an employee may tell you
that someone slipped amphetamines
into her drink at a party, that she unknowingly
ingested
a
marijuana
brownie, or that she traveled in a
closed car with several people smoking
crack. MROs are unlikely to be able to
verify the facts of such passive or unknowing ingestion stories. Even if true,

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Office of the Secretary of Transportation
such stories do not present a legitimate
medical
explanation.
Consequently, you must not declare a test
as negative based on an explanation of
this kind.
(e) You must not verify a test negative based on information that a physician recommended that the employee
use a drug listed in Schedule I of the
Controlled Substances Act. (e.g., under
a state law that purports to authorize
such recommendations, such as the
‘‘medical marijuana’’ laws that some
states have adopted).
(f) You must not accept an assertion
of consumption or other use of a hemp
or other non-prescription marijuanarelated product as a basis for verifying
a marijuana test negative. You also
must not accept such an explanation
related to consumption of coca teas as
a basis for verifying a cocaine test result as negative. Consuming or using
such a product is not a legitimate medical explanation.
(g) You must not accept an assertion
that there is a legitimate medical explanation for the presence of PCP, 6–
AM, MDMA, MDA, or MDEA in a specimen.
(h) You must not accept, as a legitimate medical explanation for an adulterated specimen, an assertion that
soap, bleach, or glutaraldehyde entered
a specimen through physiological
means. There are no physiological
means through which these substances
can enter a specimen.
(i) You must not accept, as a legitimate medical explanation for a substituted specimen, an assertion that an
employee can produce urine with no detectable creatinine. There are no physiological means through which a person can produce a urine specimen having this characteristic.

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[65 FR 79526, Dec. 19, 2000, as amended at 66
FR 41952, Aug. 9, 2001; 75 FR 49863, Aug. 16,
2010]

§ 40.153 How does the MRO notify employees of their right to a test of the
split specimen?
(a) As the MRO, when you have
verified a drug test as positive for a
drug or drug metabolite, or as a refusal
to test because of adulteration or substitution, you must notify the employee of his or her right to have the

§ 40.155
split specimen tested. You must also
notify the employee of the procedures
for requesting a test of the split specimen.
(b) You must inform the employee
that he or she has 72 hours from the
time you provide this notification to
him or her to request a test of the split
specimen.
(c) You must tell the employee how
to contact you to make this request.
You must provide telephone numbers
or other information that will allow
the employee to make this request. As
the MRO, you must have the ability to
receive the employee’s calls at all
times during the 72 hour period (e.g., by
use of an answering machine with a
‘‘time stamp’’ feature when there is no
one in your office to answer the phone).
(d) You must tell the employee that
if he or she makes this request within
72 hours, the employer must ensure
that the test takes place, and that the
employee is not required to pay for the
test from his or her own funds before
the test takes place. You must also tell
the employee that the employer may
seek reimbursement for the cost of the
test (see § 40.173).
(e) You must tell the employee that
additional tests of the specimen e.g.,
DNA tests) are not authorized.
§ 40.155 What does the MRO do when a
negative or positive test result is
also dilute?
(a) When the laboratory reports that
a specimen is dilute, you must, as the
MRO, report to the DER that the specimen, in addition to being negative or
positive, is dilute.
(b) You must check the ‘‘dilute’’ box
(Step 6) on Copy 2 of the CCF.
(c) When you report a dilute specimen to the DER, you must explain to
the DER the employer’s obligations
and choices under § 40.197, to include
the requirement for an immediate
recollection under direct observation if
the creatinine concentration of a negative-dilute specimen was greater than
or equal to 2mg/dL but less than or
equal to 5mg/dL.
(d) If the employee’s recollection
under direct observation, in paragraph
(c) of this section, results in another
negative-dilute, as the MRO, you must:

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§ 40.157

49 CFR Subtitle A (10–1–21 Edition)

(1) Review the CCF to ensure that
there is documentation that the recollection was directly observed.
(2) If the CCF documentation shows
that the recollection was directly observed as required, report this result to
the DER as a negative-dilute result.
(3) If CCF documentation indicates
that the recollection was not directly
observed as required, do not report a
result but again explain to the DER
that there must be an immediate recollection under direct observation.
[65 FR 79526, Dec. 19, 2000, as amended at 66
FR 41952, Aug. 9, 2001; 68 FR 31626, May 28,
2003; 69 FR 64867, Nov. 9, 2004; 73 FR 35971,
June 25, 2008]

§ 40.157

[Reserved]

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§ 40.159 What does the MRO do when a
drug test result is invalid?
(a) As the MRO, when the laboratory
reports that the test result is an invalid result, you must do the following:
(1) Discuss the laboratory results
with a certifying scientist to determine
if the primary specimen should be tested at another HHS certified laboratory.
If the laboratory did not contact you
as required by §§ 40.91(e) and 40.96(c),
you must contact the laboratory.
(2) If you and the laboratory have determined that no further testing is necessary, contact the employee and inform the employee that the specimen
was invalid. In contacting the employee, use the procedures set forth in
§ 40.131.
(3) After explaining the limits of disclosure (see §§ 40.135(d) and 40.327), you
must determine if the employee has a
medical explanation for the invalid result. You must inquire about the medications the employee may have taken.
(4) If the employee gives an explanation that is acceptable, you must:
(i) Place a check mark in the ‘‘Test
Cancelled’’ box (Step 6) on Copy 2 of
the CCF and enter ‘‘Invalid Result’’
and ‘‘direct observation collection not
required’’ on the ‘‘Remarks’’ line.
(ii) Report to the DER that the test
is cancelled, the reason for cancellation, and that no further action is required unless a negative test result is
required (i.e., pre-employment, returnto-duty, or follow-up tests).

(iii) If a negative test result is required and the medical explanation
concerns a situation in which the employee has a permanent or long-term
medical condition that precludes him
or her from providing a valid specimen,
as the MRO, you must follow the procedures outlined at § 40.160 for determining if there is clinical evidence
that the individual is an illicit drug
user.
(5) If the employee is unable to provide an explanation and/or a valid prescription for a medication that interfered with the immunoassay test but
denies having adulterated the specimen, you must:
(i) Place a check mark in the ‘‘Test
Cancelled’’ box (Step 6) on Copy 2 of
the CCF and enter ‘‘Invalid Result’’
and ‘‘direct observation collection required’’ on the ‘‘Remarks’’ line.
(ii) Report to the DER that the test
is cancelled, the reason for cancellation, and that a second collection must
take place immediately under direct
observation.
(iii) Instruct the employer to ensure
that the employee has the minimum
possible advance notice that he or she
must go to the collection site.
(6) When the test result is invalid because pH is greater than or equal to 9.0
but less than or equal to 9.5 and the
employee has no other medical explanation for the pH, you should consider
whether there is evidence of elapsed
time and increased temperature that
could account for the pH value.
(i) You are authorized to consider the
temperature conditions that were likely to have existed between the time of
collection and transportation of the
specimen to the laboratory, and the
length of time between the specimen
collection and arrival at the laboratory.
(ii) You may talk with the collection
site and laboratory to discuss time and
temperature issues, including any pertinent information regarding specimen
storage.
(iii) If you determine that time and
temperature account for the pH value,
you must cancel the test and take no
further action, as provided at paragraph (a)(4) of this section.
(iv) If you determine that time and
temperature fail to account for the pH

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kpayne on VMOFRWIN702 with $$_JOB

Office of the Secretary of Transportation
value, you must cancel the test and direct another collection under direct observation, as provided at paragraph
(a)(5) of this section.
(b) You may only report an invalid
test result when you are in possession
of a legible copy of Copy 1 of the CCF.
In addition, you must have Copy 2 of
the CCF, a legible copy of it, or any
other copy of the CCF containing the
employee’s signature.
(c) If the employee admits to having
adulterated or substituted the specimen, you must, on the same day, write
and sign your own statement of what
the employee told you. You must then
report a refusal to test in accordance
with § 40.163 .
(d) If the employee admits to using a
drug, you must, on the same day, write
and sign your own statement of what
the employee told you. You must then
report that admission to the DER for
appropriate action under DOT Agency
regulations. This test will be reported
as cancelled with the reason noted.
(e) If the employee’s recollection (required at paragraph (a)(5) of this section) results in another invalid result
for the same reason as reported for the
first specimen, as the MRO, you must:
(1) Review the CCF to ensure that
there is documentation that the recollection was directly observed.
(2) If the CCF review indicates that
the recollection was directly observed
as required, document that the employee had another specimen with an
invalid result for the same reason.
(3) Follow the recording and reporting procedures at (a)(4)(i) and (ii) of
this section.
(4) If a negative result is required
(i.e., pre-employment, return-to-duty,
or follow-up tests), follow the procedures at § 40.160 for determining if there
is clinical evidence that the individual
is an illicit drug user.
(5) If the recollection was not directly observed as required, do not report a result but again explain to the
DER that there must be an immediate
recollection under direct observation.
(f) If the employee’s recollection (required at paragraph (a)(5) of this section) results in another invalid result
for a different reason than that reported for the first specimen, as the
MRO, you must:

§ 40.160
(1) Review the CCF to ensure that
there is documentation that the recollection was directly observed.
(2) If the CCF review indicates that
the recollection was directly observed
as required, document that the employee had another specimen with an
invalid result for a different reason.
(3) As the MRO, you should not contact the employee to discuss the result,
but rather direct the DER to conduct
an immediate recollection under direct
observation without prior notification
to the employee.
(4) If the CCF documentation indicates that the recollection was not directly observed as required, do not report a result but again explain to the
DER that there must be an immediate
recollection under direct observation.
(g) If, as the MRO, you receive a laboratory invalid result in conjunction
with a positive, adulterated, and/or
substituted result and you verify any
of those results as being a positive and/
or refusal to test, you do not report the
invalid result unless the split specimen
fails to reconfirm the result(s) of the
primary specimen.
[65 FR 79526, Dec. 19, 2000, as amended at 73
FR 35972, June 25, 2008; 75 FR 49863, Aug. 16,
2010]

§ 40.160 What does the MRO do when a
valid test result cannot be produced
and a negative result is required?
(a) If a valid test result cannot be
produced and a negative result is required, (under § 40.159 (a)(5)(iii) and
(e)(4)), as the MRO, you must determine if there is clinical evidence that
the individual is currently an illicit
drug user. You must make this determination by personally conducting, or
causing to be conducted, a medical
evaluation. In addition, if appropriate,
you may also consult with the employee’s physician to gather information
you need to reach this determination.
(b) If you do not personally conduct
the medical evaluation, as the MRO,
you must ensure that one is conducted
by a licensed physician acceptable to
you.
(c) For purposes of this section, the
MRO or the physician conducting the
evaluation may conduct an alternative

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§ 40.161

49 CFR Subtitle A (10–1–21 Edition)

test (e.g., blood) as part of the medically appropriate procedures in determining clinical evidence of drug use.
(d) If the medical evaluation reveals
no clinical evidence of drug use, as the
MRO, you must report this to the employer as a negative test result with
written notations regarding the medical examination. The report must also
state why the medical examination was
required (i.e., either the basis for the
determination that a permanent or
long-term medical condition exists or
because the recollection under direct
observation resulted in another invalid
result for the same reason, as appropriate) and for the determination that
no signs and symptoms of drug use
exist.
(1) Check ‘‘Negative’’ (Step 6) on the
CCF.
(2) Sign and date the CCF.
(e) If the medical evaluation reveals
clinical evidence of drug use, as the
MRO, you must report the result to the
employer as a cancelled test with written notations regarding the results of
the medical examination. The report
must also state why the medical examination was required (i.e., either the
basis for the determination that a permanent or long-term medical condition
exists or because the recollection under
direct observation resulted in another
invalid result for the same reason, as
appropriate) and state the reason for
the determination that signs and
symptoms of drug use exist. Because
this is a cancelled test, it does not
serve the purpose of an actual negative
test result (i.e., the employer is not authorized to allow the employee to begin
or resume performing safety-sensitive
functions, because a negative test result is needed for that purpose).

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[73 FR 35972, June 25, 2008]

§ 40.161 What does the MRO do when a
drug test specimen is rejected for
testing?
As the MRO, when the laboratory reports that the specimen is rejected for
testing (e.g., because of a fatal or uncorrected flaw), you must do the following:
(a) Place a check mark in the ‘‘Test
Cancelled’’ box (Step 6) on Copy 2 of
the CCF and enter the reason on the
‘‘Remarks’’ line.

(b) Report to the DER that the test is
cancelled and the reason for cancellation, and that no further action is required unless a negative test is required (e.g., in the case of a pre-employment, return-to-duty, or follow-up
test).
(c) You may only report a test cancelled because of a rejected for testing
test result when you are in possession
of a legible copy of Copy 1 of the CCF.
In addition, you must have Copy 2 of
the CCF, a legible copy of it, or any
other copy of the CCF containing the
employee’s signature.
§ 40.162 What must MROs do with multiple verified results for the same
testing event?
(a) If the testing event is one in
which there was one specimen collection with multiple verified non-negative results, as the MRO, you must report them all to the DER. For example,
if you verified the specimen as being
positive for marijuana and cocaine and
as being a refusal to test because the
specimen was also adulterated, as the
MRO, you should report the positives
and the refusal to the DER.
(b) If the testing event was one in
which two separate specimen collections (e.g., a specimen out of temperature range and the subsequent observed
collection) were sent to the laboratory,
as the MRO, you must:
(1) If both specimens were verified
negative, report the result as negative.
(2) If either of the specimens was
verified negative and the other was
verified as one or more non-negative(s),
report the non-negative result(s) only.
For example, if you verified one specimen as negative and the other as a refusal to test because the second specimen was substituted, as the MRO you
should report only the refusal to the
DER.
(i) If the first specimen is reported as
negative, but the result of the second
specimen has not been reported by the
laboratory, as the MRO, you should
hold—not report—the result of the first
specimen until the result of the second
specimen is received.
(ii) If the first specimen is reported
as non-negative, as the MRO, you
should report the result immediately

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Office of the Secretary of Transportation
and not wait to receive the result of
the second specimen.
(3) If both specimens were verified
non-negative, report all of the non-negative results. For example, if you
verified one specimen as positive and
the other as a refusal to test because
the specimen was adulterated, as the
MRO, you should report the positive
and the refusal results to the DER.
(c) As an exception to paragraphs (a)
and (b) of this section, as the MRO, you
must follow procedures at § 40.159(g)
when any verified non-negative result
is also invalid.

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[73 FR 35972, June 25, 2008, as amended at 82
FR 52245, Nov. 13, 2017]

§ 40.163 How does the MRO report
drug test results?
(a) As the MRO, it is your responsibility to report all drug test results to
the employer.
(b) You may use a signed or stamped
and dated legible photocopy of Copy 2
of the CCF to report test results.
(c) If you do not report test results
using Copy 2 of the CCF for this purpose, you must provide a written report (e.g., a letter) for each test result.
This report must, as a minimum, include the following information:
(1) Full name, as indicated on the
CCF, of the employee tested;
(2) Specimen ID number from the
CCF and the donor SSN or employee ID
number;
(3) Reason for the test, if indicated
on the CCF (e.g., random, post-accident);
(4) Date of the collection;
(5) Date you received Copy 2 of the
CCF;
(6) Result of the test (i.e., positive,
negative, dilute, refusal to test, test
cancelled) and the date the result was
verified by the MRO;
(7) For verified positive tests, the
drug(s)/metabolite(s) for which the test
was positive;
(8) For cancelled tests, the reason for
cancellation; and
(9) For refusals to test, the reason for
the refusal determination (e.g., in the
case of an adulterated test result, the
name of the adulterant).
(d) As an exception to the reporting
requirements of paragraph (b) and (c)
of this section, the MRO may report

§ 40.165
negative results using an electronic
data file.
(1) If you report negatives using an
electronic data file, the report must
contain, as a minimum, the information specified in paragraph (c) of this
section, as applicable for negative test
results.
(2) In addition, the report must contain your name, address, and phone
number, the name of any person other
than you reporting the results, and the
date the electronic results report is released.
(e) You must retain a signed or
stamped and dated copy of Copy 2 of
the CCF in your records. If you do not
use Copy 2 for reporting results, you
must maintain a copy of the signed or
stamped and dated letter in addition to
the signed or stamped and dated Copy
2. If you use the electronic data file to
report negatives, you must maintain a
retrievable copy of that report in a format suitable for inspection and auditing by a DOT representative.
(f) You must not use Copy 1 of the
CCF to report drug test results.
(g) You must not provide quantitative values to the DER or C/TPA
for drug or validity test results. However, you must provide the test information in your possession to a SAP
who consults with you (see § 40.293(g)).
(h) You must maintain reports and
records related to negatives and cancelled results for one year; you must
maintain reports and records related to
positives and refusals for five years,
unless otherwise specified by applicable DOT agency regulations.
[66 FR 41952, Aug. 9, 2001, as amended at 75
FR 49863, Aug. 16, 2010; 75 FR 59107, Sept. 27,
2010; 76 FR 59578, Sept. 27, 2011]

§ 40.165 To whom does the MRO transmit reports of drug test results?
(a) As the MRO, you must report all
drug test results to the DER, except in
the circumstances provided for in
§ 40.345 .
(b) If the employer elects to receive
reports of results through a C/TPA,
acting as an intermediary as provided
in § 40.345 , you must report the results
through the designated C/TPA.

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§ 40.167

49 CFR Subtitle A (10–1–21 Edition)

§ 40.167 How are MRO reports of drug
results transmitted to the employer?
As the MRO or C/TPA who transmits
drug test results to the employer, you
must comply with the following requirements:
(a) You must report the results in a
confidential manner.
(b) You must transmit to the DER on
the same day the MRO verifies the result or the next business day all
verified positive test results, results requiring an immediate collection under
direct observation, adulterated or substituted specimen results, and other refusals to test.
(1) Direct telephone contact with the
DER is the preferred method of immediate reporting. Follow up your phone
call with appropriate documentation
(see § 40.163).
(2) You are responsible for identifying yourself to the DER, and the
DER must have a means to confirm
your identification.
(3) The MRO’s report that you transmit to the employer must contain all
of the information required by § 40.163 .
(c) You must transmit the MRO’s report(s) of verified tests to the DER so
that the DER receives it within two
days of verification by the MRO.
(1) You must fax, courier, mail, or
electronically transmit a legible image
or copy of either the signed or stamped
and dated Copy 2 or the written report
(see § 40.163(b) and (c)).
(2) Negative results reported electronically (i.e., computer data file) do
not require an image of Copy 2 or the
written report.
(d) In transmitting test results, you
or the C/TPA and the employer must
ensure the security of the transmission
and limit access to any transmission,
storage, or retrieval systems.
(e) MRO reports are not subject to
modification or change by anyone
other than the MRO, as provided in
§ 40.149(c).

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[65 FR 79526, Dec. 19, 2000, as amended at 66
FR 41953, Aug. 9, 2001]

§ 40.169 Where is other information
concerning the role of MROs and
the verification process found in
this regulation?
You can find more information concerning the role of MROs in several
sections of this part:
§ 40.3—Definition.
§§ 40.47–40.49—Correction of form and kit errors.
§ 40.67—Role in direct observation and other
atypical test situations.
§ 40.83—Laboratory handling of fatal and correctable flaws.
§ 40.97—Laboratory handling of test results
and quantitative values.
§ 40.99—Authorization of longer laboratory
retention of specimens.
§ 40.101—Relationship
with
laboratories;
avoidance of conflicts of interest.
§ 40.171—Request for test of split specimen.
§ 40.187—Action concerning split specimen
test results.
§ 40.193—Role in ‘‘shy bladder’’ situations.
§ 40.195—Role in cancelling tests.
§§ 40.199–40.203—Documenting errors in tests.
§ 40.327—Confidentiality and release of information.
§ 40.347—Transfer of records.
§ 40.353—Relationships with service agents.
[65 FR 79526, Dec. 19, 2000, as amended at 82
FR 52245, Nov. 13, 2017]

Subpart H—Split Specimen Tests
§ 40.171 How does an employee request
a test of a split specimen?
(a) As an employee, when the MRO
has notified you that you have a
verified positive drug test and/or refusal to test because of adulteration or
substitution, you have 72 hours from
the time of notification to request a
test of the split specimen. The request
may be verbal or in writing. If you
make this request to the MRO within
72 hours, you trigger the requirements
of this section for a test of the split
specimen. There is no split specimen
testing for an invalid result.
(b)(1) If, as an employee, you have
not requested a test of the split specimen within 72 hours, you may present
to the MRO information documenting
that serious injury, illness, lack of actual notice of the verified test result,
inability to contact the MRO (e.g.,
there was no one in the MRO’s office
and the answering machine was not

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Office of the Secretary of Transportation
working), or other circumstances unavoidably prevented you from making
a timely request.
(2) As the MRO, if you conclude from
the employee’s information that there
was a legitimate reason for the employee’s failure to contact you within
72 hours, you must direct that the test
of the split specimen take place, just as
you would when there is a timely request.
(c) When the employee makes a timely request for a test of the split specimen under paragraphs (a) and (b) of
this section, you must, as the MRO,
immediately provide written notice to
the laboratory that tested the primary
specimen, directing the laboratory to
forward the split specimen to a second
HHS-certified laboratory. You must
also document the date and time of the
employee’s request.

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[65 FR 79526, Dec. 19, 2000, as amended at 73
FR 35972, June 25, 2008]

§ 40.173 Who is responsible for paying
for the test of a split specimen?
(a) As the employer, you are responsible for making sure (e.g., by establishing appropriate accounts with laboratories for testing split specimens)
that the MRO, first laboratory, and
second laboratory perform the functions noted in §§ 40.175–40.185 in a timely manner, once the employee has
made a timely request for a test of the
split specimen.
(b) As the employer, you must not
condition your compliance with these
requirements on the employee’s direct
payment to the MRO or laboratory or
the employee’s agreement to reimburse
you for the costs of testing. For example, if you ask the employee to pay for
some or all of the cost of testing the
split specimen, and the employee is unwilling or unable to do so, you must
ensure that the test takes place in a
timely manner, even though this
means that you pay for it.
(c) As the employer, you may seek
payment or reimbursement of all or
part of the cost of the split specimen
from the employee (e.g., through your
written company policy or a collective
bargaining agreement). This part takes
no position on who ultimately pays the
cost of the test, so long as the employer ensures that the testing is con-

§ 40.175
ducted as required and the results released appropriately.
§ 40.175 What steps does the first laboratory take with a split specimen?
(a) As the laboratory at which the
primary and split specimen first arrive,
you must check to see whether the
split specimen is available for testing.
(b) If the split specimen is unavailable or appears insufficient, you must
then do the following:
(1) Continue the testing process for
the primary specimen as you would
normally. Report the results for the
primary specimen without providing
the MRO information regarding the unavailable split specimen.
(2) Upon receiving a letter from the
MRO instructing you to forward the
split specimen to another laboratory
for testing, report to the MRO that the
split specimen is unavailable for testing. Provide as much information as
you can about the cause of the unavailability.
(c) As the laboratory that tested the
primary specimen, you are not authorized to open the split specimen under
any circumstances (except when the
split specimen is redesignated as provided in § 40.83).
(d) When you receive written notice
from the MRO instructing you to send
the split specimen to another HHS-certified laboratory, you must forward the
following items to the second laboratory:
(1) The split specimen in its original
specimen bottle, with the seal intact;
(2) A copy of the MRO’s written request; and
(3) A copy of Copy 1 of the CCF,
which identifies the drug(s)/metabolite(s) or the validity criteria to be
tested for.
(e) You must not send to the second
laboratory any information about the
identity of the employee. Inadvertent
disclosure does not, however, cause a
fatal flaw.
(f) This subpart does not prescribe
who gets to decide which HHS-certified
laboratory is used to test the split
specimen. That decision is left to the
parties involved.

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§ 40.177

49 CFR Subtitle A (10–1–21 Edition)

§ 40.177 What does the second laboratory do with the split specimen
when it is tested to reconfirm the
presence of a drug or drug metabolite?
(a) As the laboratory testing the split
specimen, you must test the split specimen for the drug(s)/drug metabolite(s)
detected in the primary specimen.
(b) You must conduct this test without regard to the cutoff concentrations
of § 40.87.
(c) If the test fails to reconfirm the
presence of the drug(s)/drug metabolite(s) that were reported positive in
the primary specimen, you must conduct validity tests in an attempt to determine the reason for being unable to
reconfirm the presence of the drug(s)/
metabolite(s). You should conduct the
same validity tests as you would conduct on a primary specimen set forth
in § 40.91.
(d) In addition, if the test fails to reconfirm the presence of the drug(s)/
drug metabolite(s) reported in the primary specimen, you may send the specimen or an aliquot of it for testing at
another HHS-certified laboratory that
has the capability to conduct another
reconfirmation test.
[65 FR 79526, Dec. 19, 2000, as amended at 73
FR 35972, June 25, 2008]

§ 40.179 What does the second laboratory do with the split specimen
when it is tested to reconfirm an
adulterated test result?

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(a) As the laboratory testing the split
specimen, you must test the split specimen for the adulterant detected in the
primary specimen, using the confirmatory test for the adulterant and using
criteria in § 40.95 and confirmatory cutoff levels required by the HHS Mandatory Guidelines.
(b) In addition, if the test fails to reconfirm the adulterant result reported
in the primary specimen, you may send
the specimen or an aliquot of it for
testing at another HHS-certified laboratory that has the capability to conduct another reconfirmation test.
[73 FR 35973, June 25, 2008]

§ 40.181 What does the second laboratory do with the split specimen
when it is tested to reconfirm a substituted test result?
As the laboratory testing the split
specimen, you must test the split specimen using the confirmatory tests for
creatinine and specific gravity, and
using the confirmatory criteria set
forth in § 40.93(b).
[73 FR 35973, June 25, 2008]

§ 40.183 What information do laboratories report to MROs regarding
split specimen results?
(a) As the laboratory responsible for
testing the split specimen, you must
report split specimen test results by
checking the ‘‘Reconfirmed’’ box and/or
the ‘‘Failed to Reconfirm’’ box (Step
5(b)) on Copy 1 of the CCF, as appropriate, and by providing clarifying remarks using current HHS Mandatory
Guidelines requirements.
(b) As the laboratory certifying scientist, enter your name, sign, and date
the CCF.
[65 FR 79526, Dec. 19, 2000, as amended at 73
FR 35972, June 25, 2008]

§ 40.185 Through what methods and to
whom must a laboratory report
split specimen results?
(a) As the laboratory testing the split
specimen, you must report laboratory
results directly, and only, to the MRO
at his or her place of business. You
must not report results to or through
the DER or another service agent (e.g.,
a C/TPA).
(b) You must fax, courier, mail, or
electronically transmit a legible image
or copy of the fully-completed Copy 1
of the CCF, which has been signed by
the certifying scientist.
(c) You must transmit the laboratory
result to the MRO immediately, preferably on the same day or next business day as the result is signed and released.
§ 40.187 What does the MRO do with
split specimen laboratory results?
As the MRO, the split specimen laboratory results you receive will fall
into five categories. You must take the
following action, as appropriate, when
a laboratory reports split specimen results to you.

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Office of the Secretary of Transportation
(a) Category 1: The laboratory reconfirmed one or more of the primary
specimen results. As the MRO, you
must report to the DER and the employee the result(s) that was/were reconfirmed.
(1) In the case of a reconfirmed positive test(s) for drug(s) or drug metabolite(s), the positive is the final result.
(2) In the case of a reconfirmed adulterated or substituted result, the refusal to test is the final result.
(3) In the case of a combination positive and refusal to test results, the
final result is both positive and refusal
to test.
(b) Category 2: The laboratory failed
to reconfirm all of the primary specimen results because, as appropriate,
drug(s)/drug metabolite(s) were not detected; adulteration criteria were not
met; and/or substitution criteria were
not met. As the MRO, you must report
to the DER and the employee that the
test must be cancelled.
(1) As the MRO, you must inform
ODAPC of the failure to reconfirm
using the format in Appendix D to this
part.
(2) In a case where the split failed to
reconfirm because the substitution criteria were not met and the split specimen creatinine concentration was
equal to or greater than 2mg/dL but
less than or equal to 5mg/dL, as the
MRO, you must, in addition to step
(b)(1) of this paragraph, direct the DER
to ensure the immediate collection of
another specimen from the employee
under direct observation, with no notice given to the employee of this collection requirement until immediately
before the collection.
(3) In a case where the split failed to
reconfirm and the primary specimen’s
result was also invalid, direct the DER
to ensure the immediate collection of
another specimen from the employee
under direct observation, with no notice given to the employee of this collection requirement until immediately
before the collection.
(c) Category 3: The laboratory failed
to reconfirm all of the primary specimen results, and also reported that the
split specimen was invalid, adulterated, and/or substituted.
(1) In the case where the laboratory
failed to reconfirm all of the primary

§ 40.187
specimen results and the split was reported as invalid, as the MRO, you
must:
(i) Report to the DER and the employee that the test must be cancelled
and the reason for the cancellation.
(ii) Direct the DER to ensure the immediate collection of another specimen
from the employee under direct observation, with no notice given to the employee of this collection requirement
until immediately before the collection.
(iii) Inform ODAPC of the failure to
reconfirm using the format in Appendix D to this part.
(2) In the case where the laboratory
failed to reconfirm any of the primary
specimen results, and the split was reported as adulterated and/or substituted, as the MRO, you must:
(i) Contact the employee and inform
the employee that the laboratory has
determined that his or her split specimen is adulterated and/or substituted,
as appropriate.
(ii) Follow the procedures of § 40.145
to determine if there is a legitimate
medical explanation for the laboratory
finding of adulteration and/or substitution, as appropriate.
(iii) If you determine that there is a
legitimate medical explanation for the
adulterated and/or substituted test result, report to the DER and the employee that the test must be cancelled;
and inform ODAPC of the failure to reconfirm using the format in Appendix
D to this part.
(iv) If you determine that there is
not a legitimate medical explanation
for the adulterated and/or substituted
test result, you must take the following steps:
(A) Report the test to the DER and
the employee as a verified refusal to
test. Inform the employee that he or
she has 72 hours to request a test of the
primary specimen to determine if the
adulterant found in the split specimen
is also present in the primary specimen
and/or to determine if the primary
specimen meets appropriate substitution criteria.
(B) Except when the request is for a
test of the primary specimen and is
being made to the laboratory that tested the primary specimen, follow the

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§ 40.189

49 CFR Subtitle A (10–1–21 Edition)

procedures of §§ 40.153, 40.171, 40.173,
40.179, 40.181, and 40.185, as appropriate.
(C) As the laboratory that tests the
primary specimen to reconfirm the
presence of the adulterant found in the
split specimen and/or to determine that
the primary specimen meets appropriate substitution criteria, report
your result to the MRO on a photocopy
(faxed, mailed, scanned, couriered) of
Copy 1 of the CCF.
(D) If the test of the primary specimen reconfirms the adulteration and/or
substitution finding of the split specimen, as the MRO you must report the
result as a refusal to test as provided
in paragraph (a)(2) of this section.
(E) If the test of the primary specimen fails to reconfirm the adulteration
and/or substitution finding of the split
specimen, as the MRO you must cancel
the test, following procedures in paragraph (b) of this section.
(d) Category 4: The laboratory failed
to reconfirm one or more but not all of
the primary specimen results, and also
reported that the split specimen was
invalid,
adulterated,
and/or
substituted. As the MRO, in the case
where the laboratory reconfirmed one
or more of the primary specimen result(s), you must follow procedures in
paragraph (a) of this section and:
(1) Report that the split was also reported as being invalid, adulterated,
and/or substituted (as appropriate).
(2) Inform the DER to take action
only on the reconfirmed result(s).
(e) Category 5: The split specimen was
not available for testing or there was
no split laboratory available to test
the specimen. As the MRO, you must:
(1) Report to the DER and the employee that the test must be cancelled
and the reason for the cancellation;
(2) Direct the DER to ensure the immediate recollection of another specimen from the employee under direct
observation, with no notice given to
the employee of this collection requirement until immediately before the collection; and
(3) Notify ODAPC of the failure to reconfirm using the format in appendix D
to this part.
(f) For all split specimen results, as
the MRO you must in Step 7 of Copy 2
of the CCF:

(1) Report split specimen test results
by checking the ‘‘Reconfirmed’’ box
and/or the ‘‘Failed to Reconfirm’’ box,
or the ‘‘Test Cancelled’’ box, as appropriate.
(2), Enter your name, sign, and date.
(3) Send a legible copy of Copy 2 of
the CCF (or a signed and dated letter,
see § 40.163) to the employer and keep a
copy for your records. Transmit the
document as provided in § 40.167.
[73 FR 35973, June 25, 2008, as amended at 75
FR 59108, Sept. 27, 2010]

§ 40.189 Where is other information
concerning split specimens found in
this regulation?
You can find more information concerning split specimens in several sections of this part:
§ 40.3—Definition.
§ 40.65—Quantity of split specimen.
§ 40.67—Directly observed test when split
specimen is unavailable.
§§ 40.71–40.73—Collection process for split
specimens.
§ 40.83—Laboratory accessioning of split
specimens.
§ 40.99—Laboratory retention of split specimens.
§ 40.153—MRO notice to employees on tests of
split specimen.
§§ 40.193 and 40.201—MRO actions on insufficient or unavailable split specimens.
APPENDIX D TO PART 40—REPORT FORMAT FOR
SPLIT SPECIMEN FAILURE TO RECONFIRM.
[65 FR 79526, Dec. 19, 2000, as amended at 82
FR 52245, Nov. 13, 2017]

Subpart I—Problems in Drug Tests
§ 40.191 What is a refusal to take a
DOT drug test, and what are the
consequences?
(a) As an employee, you have refused
to take a drug test if you:
(1) Fail to appear for any test (except
a pre-employment test) within a reasonable time, as determined by the employer, consistent with applicable DOT
agency regulations, after being directed to do so by the employer. This
includes the failure of an employee (including an owner-operator) to appear
for a test when called by a C/TPA (see
§ 40.61(a));
(2) Fail to remain at the testing site
until the testing process is complete; Provided, That an employee who leaves the
testing site before the testing process

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Office of the Secretary of Transportation
commences (see § 40.63 (c)) for a pre-employment test is not deemed to have
refused to test;
(3) Fail to provide a urine specimen
for any drug test required by this part
or DOT agency regulations; Provided,
That an employee who does not provide
a urine specimen because he or she has
left the testing site before the testing
process commences (see § 40.63 (c)) for a
pre-employment test is not deemed to
have refused to test;
(4) In the case of a directly observed
or monitored collection in a drug test,
fail to permit the observation or monitoring of your provision of a specimen
(see §§ 40.67(l) and 40.69(g));
(5) Fail to provide a sufficient
amount of urine when directed, and it
has been determined, through a required medical evaluation, that there
was no adequate medical explanation
for the failure (see § 40.193(d)(2));
(6) Fail or decline to take an additional drug test the employer or collector has directed you to take (see, for
instance, § 40.197(b));
(7) Fail to undergo a medical examination or evaluation, as directed by
the MRO as part of the verification
process, or as directed by the DER
under § 40.193(d). In the case of a preemployment drug test, the employee is
deemed to have refused to test on this
basis only if the pre-employment test
is conducted following a contingent
offer of employment. If there was no
contingent offer of employment, the
MRO will cancel the test; or
(8) Fail to cooperate with any part of
the testing process (e.g., refuse to
empty pockets when directed by the
collector, behave in a confrontational
way that disrupts the collection process, fail to wash hands after being directed to do so by the collector).
(9) For an observed collection, fail to
follow the observer’s instructions to
raise your clothing above the waist,
lower clothing and underpants, and to
turn around to permit the observer to
determine if you have any type of prosthetic or other device that could be
used to interfere with the collection
process.
(10) Possess or wear a prosthetic or
other device that could be used to
interfere with the collection process.

§ 40.191
(11) Admit to the collector or MRO
that you adulterated or substituted the
specimen.
(b) As an employee, if the MRO reports that you have a verified adulterated or substituted test result, you
have refused to take a drug test.
(c) As an employee, if you refuse to
take a drug test, you incur the consequences specified under DOT agency
regulations for a violation of those
DOT agency regulations.
(d) As a collector or an MRO, when
an employee refuses to participate in
the part of the testing process in which
you are involved, you must terminate
the portion of the testing process in
which you are involved, document the
refusal on the CCF (including, in the
case of the collector, printing the employee’s name on Copy 2 of the CCF),
immediately notify the DER by any
means (e.g., telephone or secure fax
machine) that ensures that the refusal
notification is immediately received.
As a referral physician (e.g., physician
evaluating a ‘‘shy bladder’’ condition
or a claim of a legitimate medical explanation in a validity testing situation), you must notify the MRO, who in
turn will notify the DER.
(1) As the collector, you must note
the refusal in the ‘‘Remarks’’ line
(Step 2), and sign and date the CCF.
(2) As the MRO, you must note the
refusal by checking the ‘‘Refusal to
Test’’ box in Step 6 on Copy 2 of the
CCF, checking whether the specimen
was adulterated or substituted and, if
adulterated, noting the adulterant/reason. If there was another reason for the
refusal, check ‘‘Other’’ in Step 6 on
Copy 2 of the CCF, and note the reason
next to the ‘‘Other’’ box and on the
‘‘Remarks’’ lines, as needed. You must
then sign and date the CCF.
(e) As an employee, when you refuse
to take a non-DOT test or to sign a
non-DOT form, you have not refused to
take a DOT test. There are no consequences under DOT agency regulations for refusing to take a non-DOT
test.
[65 FR 79526, Dec. 19, 2000, as amended at 66
FR 41953, Aug. 9, 2001; 68 FR 31626, May 28,
2003; 71 FR 49384, Aug. 23, 2006; 73 FR 35974,
June 25, 2008; 75 FR 59108, Sept. 27, 2010]

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§ 40.193

49 CFR Subtitle A (10–1–21 Edition)

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§ 40.193 What happens when an employee does not provide a sufficient
amount of urine for a drug test?
(a) This section prescribes procedures
for situations in which an employee
does not provide a sufficient amount of
urine to permit a drug test (i.e., 45 mL
of urine).
(b) As the collector, you must do the
following:
(1) Discard the insufficient specimen,
except where the insufficient specimen
was out of temperature range or
showed evidence of adulteration or
tampering (see § 40.65(b) and (c)).
(2) Urge the employee to drink up to
40 ounces of fluid, distributed reasonably through a period of up to three
hours, or until the individual has provided a sufficient urine specimen,
whichever occurs first. It is not a refusal to test if the employee declines to
drink. Document on the Remarks line
of the CCF (Step 2), and inform the employee of, the time at which the threehour period begins and ends.
(3) If the employee refuses to make
the attempt to provide a new urine
specimen or leaves the collection site
before the collection process is complete, you must discontinue the collection, note the fact on the ‘‘Remarks’’
line of the CCF (Step 2), and immediately notify the DER. This is a refusal to test.
(4) If the employee has not provided a
sufficient specimen within three hours
of the first unsuccessful attempt to
provide the specimen, you must discontinue the collection, note the fact
on the ‘‘Remarks’’ line of the CCF
(Step 2), and immediately notify the
DER. You must also discard any specimen the employee previously provided
to include any specimen that is ‘‘out of
temperature range’’ or shows signs of
tampering. In the remarks section of
the CCF that you will distribute to the
MRO and DER, note the fact that the
employee provided an ‘‘out of temperature range specimen’’ or ‘‘specimen
that shows signs of tampering’’ and
that it was discarded because the employee did not provide a second sufficient specimen.
(5) Send Copy 2 of the CCF to the
MRO and Copy 4 to the DER. You must
send or fax these copies to the MRO

and DER within 24 hours or the next
business day.
(c) As the DER, when the collector
informs you that the employee has not
provided a sufficient amount of urine
(see paragraph (b)(4) of this section),
you must, after consulting with the
MRO, direct the employee to obtain,
within five days, an evaluation from a
licensed physician, acceptable to the
MRO, who has expertise in the medical
issues raised by the employee’s failure
to provide a sufficient specimen. (The
MRO may perform this evaluation if
the MRO has appropriate expertise.)
(1) As the MRO, if another physician
will perform the evaluation, you must
provide the other physician with the
following information and instructions:
(i) That the employee was required to
take a DOT drug test, but was unable
to provide a sufficient amount of urine
to complete the test;
(ii) The consequences of the appropriate DOT agency regulation for refusing to take the required drug test;
(iii) That the referral physician must
agree to follow the requirements of
paragraphs (d) through (g) of this section.
(2) [Reserved]
(d) As the referral physician conducting this evaluation, you must recommend that the MRO make one of the
following determinations:
(1) A medical condition has, or with a
high degree of probability could have,
precluded the employee from providing
a sufficient amount of urine. As the
MRO, if you accept this recommendation, you must:
(i) Check ‘‘Test Cancelled’’ (Step 6)
on the CCF; and
(ii) Sign and date the CCF.
(2) There is not an adequate basis for
determining that a medical condition
has, or with a high degree of probability could have, precluded the employee from providing a sufficient
amount of urine. As the MRO, if you
accept this recommendation, you must:
(i) Check the ‘‘Refusal to Test’’ box
and ‘‘Other’’ box in Step 6 on Copy 2 of
the CCF and note the reason next to
the ‘‘Other’’ box and on the ‘‘Remarks’’
lines, as needed.
(ii) Sign and date the CCF.

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Office of the Secretary of Transportation
(e) For purposes of this paragraph, a
medical condition includes an ascertainable physiological condition (e.g., a
urinary system dysfunction) or a medically documented pre-existing psychological disorder, but does not include
unsupported assertions of ‘‘situational
anxiety’’ or dehydration.
(f) As the referral physician making
the evaluation, after completing your
evaluation, you must provide a written
statement of your recommendations
and the basis for them to the MRO.
You must not include in this statement
detailed information on the employee’s
medical condition beyond what is necessary to explain your conclusion.
(g) If, as the referral physician making this evaluation in the case of a preemployment test, you determine that
the employee’s medical condition is a
serious and permanent or long-term
disability that is highly likely to prevent the employee from providing a
sufficient amount of urine for a very
long or indefinite period of time, you
must set forth your determination and
the reasons for it in your written statement to the MRO. As the MRO, upon
receiving such a report, you must follow the requirements of § 40.195, where
applicable.
(h) As the MRO, you must seriously
consider and assess the referral physician’s recommendations in making
your determination about whether the
employee has a medical condition that
has, or with a high degree of probability could have, precluded the employee from providing a sufficient
amount of urine. You must report your
determination to the DER in writing as
soon as you make it.
(i) As the employer, when you receive
a report from the MRO indicating that
a test is cancelled as provided in paragraph (d)(1) of this section, you take no
further action with respect to the employee. The employee remains in the
random testing pool.

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[65 FR 79526, Dec. 19, 2000, as amended at 66
FR 41953, Aug. 9, 2001; 75 FR 59108, Sept. 27,
2010; 82 FR 52245, Nov. 13, 2017]

§ 40.195
§ 40.195 What happens when an individual is unable to provide a sufficient amount of urine for a pre-employment follow-up or return-toduty test because of a permanent or
long-term medical condition?
(a) This section concerns a situation
in which an employee has a medical
condition that precludes him or her
from providing a sufficient specimen
for a pre-employment follow-up or return-to-duty test and the condition involves a permanent or long-term disability. As the MRO in this situation,
you must do the following:
(1) You must determine if there is
clinical evidence that the individual is
an illicit drug user. You must make
this determination by personally conducting, or causing to be conducted, a
medical evaluation and through consultation with the employee’s physician and/or the physician who conducted the evaluation under § 40.193(d).
(2) If you do not personally conduct
the medical evaluation, you must ensure that one is conducted by a licensed physician acceptable to you.
(3) For purposes of this section, the
MRO or the physician conducting the
evaluation may conduct an alternative
test (e.g., blood) as part of the medically appropriate procedures in determining clinical evidence of drug use.
(b) If the medical evaluation reveals
no clinical evidence of drug use, as the
MRO, you must report the result to the
employer as a negative test with written notations regarding results of both
the
evaluation
conducted
under
§ 40.193(d) and any further medical examination. This report must state the
basis for the determination that a permanent or long-term medical condition
exists, making provision of a sufficient
urine specimen impossible, and for the
determination that no signs and symptoms of drug use exist.
(1) Check ‘‘Negative’’ (Step 6) on the
CCF.
(2) Sign and date the CCF.
(c) If the medical evaluation reveals
clinical evidence of drug use, as the
MRO, you must report the result to the
employer as a cancelled test with written notations regarding results of both
the
evaluation
conducted
under
§ 40.193(d) and any further medical examination. This report must state that

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§ 40.197

49 CFR Subtitle A (10–1–21 Edition)

a permanent or long-term medical condition exists, making provision of a
sufficient urine specimen impossible,
and state the reason for the determination that signs and symptoms of drug
use exist. Because this is a cancelled
test, it does not serve the purposes of a
negative test (i.e., the employer is not
authorized to allow the employee to
begin or resume performing safety-sensitive functions, because a negative
test is needed for that purpose).
(d) For purposes of this section, permanent or long-term medical conditions are those physiological, anatomic, or psychological abnormalities
documented as being present prior to
the attempted collection, and considered not amenable to correction or
cure for an extended period of time, if
ever.
(1) Examples would include destruction (any cause) of the glomerular filtration system leading to renal failure;
unrepaired traumatic disruption of the
urinary tract; or a severe psychiatric
disorder focused on genito-urinary
matters.
(2) Acute or temporary medical conditions, such as cystitis, urethritis or
prostatitis, though they might interfere with collection for a limited period
of time, cannot receive the same exceptional consideration as the permanent
or long-term conditions discussed in
paragraph (d)(1) of this section.

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[65 FR 79526, Dec. 19, 2000, as amended at 66
FR 41953, Aug. 9, 2001]

§ 40.197 What happens when an employer receives a report of a dilute
specimen?
(a) As the employer, if the MRO informs you that a positive drug test was
dilute, you simply treat the test as a
verified positive test. You must not direct the employee to take another test
based on the fact that the specimen
was dilute.
(b) As an employer, if the MRO informs you that a negative test was dilute, take the following action:
(1) If the MRO directs you to conduct
a recollection under direct observation
(i.e., because the creatinine concentration of the specimen was equal to or
greater than 2mg/dL, but less than or
equal to 5 mg/dL (see § 40.155(c)), you
must do so immediately.

(2) Otherwise (i.e., if the creatinine
concentration of the dilute specimen is
greater than 5 mg/dL), you may, but
are not required to, direct the employee to take another test immediately.
(i) Such recollections must not be
collected under direct observation, unless there is another basis for use of direct observation (see § 40.67 (b) and (c)).
(ii) You must treat all employees the
same for this purpose. For example,
you must not retest some employees
and not others. You may, however, establish different policies for different
types of tests (e.g., conduct retests in
pre-employment situations, but not in
random test situations). You must inform your employees in advance of
your decisions on these matters.
(c) The following provisions apply to
all tests you direct an employee to
take under paragraph (b) of this section:
(1) You must ensure that the employee is given the minimum possible
advance notice that he or she must go
to the collection site;
(2) You must treat the result of the
test you directed the employee to take
under paragraph (b) of this section—
and not a prior test—as the test result
of record, on which you rely for purposes of this part;
(3) If the result of the test you directed the employee to take under
paragraph (b)(1) of this section is also
negative and dilute, you are not permitted to make the employee take an
additional test because the result was
dilute.
(4) If the result of the test you directed the employee to take under
paragraph (b)(2) of this section is also
negative and dilute, you are not permitted to make the employee take an
additional test because the result was
dilute. Provided, however, that if the
MRO directs you to conduct a recollection under direct observation under
paragraph (b)(1) of this section, you
must immediately do so.
(5) If the employee declines to take a
test you directed him or her to take
under paragraph (b) of this section, the

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Office of the Secretary of Transportation
employee has refused the test for purposes of this part and DOT agency regulations.
[68 FR 31626, May 28, 2003, as amended at 69
FR 64867, Nov. 9, 2004; 73 FR 35974, June 25,
2008]

§ 40.199 What problems always cause a
drug test to be cancelled?
(a) As the MRO, when the laboratory
discovers a ‘‘fatal flaw’’ during its
processing of incoming specimens (see
§ 40.83), the laboratory will report to
you that the specimen has been ‘‘Rejected for Testing’’ (with the reason
stated). You must always cancel such a
test.
(b) The following are ‘‘fatal flaws’’:
(1) There is no CCF;
(2) In cases where a specimen has
been collected, there is no specimen
submitted with the CCF;
(3) There is no printed collector’s
name and no collector’s signature;
(4) Two separate collections are performed using one CCF;
(5) The specimen ID numbers on the
specimen bottle and the CCF do not
match;
(6) The specimen bottle seal is broken
or shows evidence of tampering (and a
split specimen cannot be re-designated,
see § 40.83(h)); or
(7) Because of leakage or other
causes, there is an insufficient amount
of urine in the primary specimen bottle
for analysis and the specimens cannot
be re-designated (see § 40.83(h)).
(c) You must report the result as provided in § 40.161.

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[65 FR 79526, Dec. 19, 2000, as amended at 82
FR 52245, Nov. 13, 2017]

§ 40.201 What problems always cause a
drug test to be cancelled and may
result in a requirement for another
collection?
As the MRO, you must cancel a drug
test when a laboratory reports that
any of the following problems have occurred. You must inform the DER that
the test was cancelled. You must also
direct the DER to ensure that an additional collection occurs immediately,
if required by the applicable procedures
specified in paragraphs (a) through (e)
of this section.
(a) The laboratory reports an ‘‘Invalid Result.’’ You must follow applica-

§ 40.203
ble procedures in § 40.159 (recollection
under direct observation may be required).
(b) The laboratory reports the result
as ‘‘Rejected for Testing.’’ You must
follow applicable procedures in § 40.161
(a recollection may be required).
(c) The laboratory reports that the
split specimen failed to reconfirm all of
the primary specimen results because
the drug(s)/drug metabolite(s) were not
detected; adulteration criteria were
not met; and/or substitution criteria
were not met. You must follow the applicable procedures in § 40.187(b)—no
recollection is required in this case,
unless the split specimen creatinine
concentration for a substituted primary specimen was greater than or
equal to 2mg/dL but less than or equal
to 5mg/ dL, or the primary specimen
had an invalid result which was not reported to the DER. Both these cases require recollection under direct observation.
(d) The laboratory reports that the
split specimen failed to reconfirm all of
the primary specimen results, and that
the split specimen was invalid. You
must
follow
the
procedures
in
§ 40.187(c)(1)—recollection under direct
observation is required in this case.
(e) The laboratory reports that the
split specimen failed to reconfirm all of
the primary specimen results because
the split specimen was not available
for testing or there was no split laboratory available to test the specimen.
You must follow the applicable procedures in § 40.187(e)—recollection under
direct observation is required in this
case.
(f) The examining physician has determined that there is an acceptable
medical explanation of the employee’s
failure to provide a sufficient amount
of urine. You must follow applicable
procedures in § 40.193(d)(1) (no recollection is required in this case).
[65 FR 79526, Dec. 19, 2000, as amended at 73
FR 35974, June 25, 2008]

§ 40.203 What problems cause a drug
test to be cancelled unless they are
corrected?
(a) As the MRO, when a laboratory
discovers a ‘‘correctable flaw’’ during
its processing of incoming specimens

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§ 40.205

49 CFR Subtitle A (10–1–21 Edition)

(see § 40.83), the laboratory will attempt to correct it. If the laboratory is
unsuccessful in this attempt, it will report to you that the specimen has been
‘‘Rejected for Testing’’ (with the reason stated).
(b) The following is a ‘‘correctable
flaw’’ that laboratories must attempt
to correct: The collector’s signature is
omitted on the certification statement
on the CCF.
(c) As the MRO, when you discover a
‘‘correctable flaw’’ during your review
of the CCF, you must cancel the test
unless the flaw is corrected.
(d) The following are correctable
flaws that you must attempt to correct:
(1) The employee’s signature is omitted from the certification statement,
unless the employee’s failure or refusal
to sign is noted on the ‘‘Remarks’’ line
of the CCF.
(2) The certifying scientist’s signature is omitted on Copy 1 of the CCF
for a positive, adulterated, substituted,
or invalid test result.
(3) The collector uses a non-Federal
form or an expired CCF for the test.
This flaw may be corrected through the
procedure set forth in § 40.205(b)(2), provided that the collection testing process has been conducted in accordance
with the procedures in this part in an
HHS-certified laboratory.

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[65 FR 79526, Dec. 19, 2000, as amended at 66
FR 41954, Aug. 9, 2001; 75 FR 59108, Sept. 27,
2010; 76 FR 59578, Sept. 27, 2011; 82 FR 52246,
Nov. 13, 2017]

§ 40.205 How are drug test problems
corrected?
(a) As a collector, you have the responsibility of trying to successfully
complete a collection procedure for
each employee.
(1) If, during or shortly after the collection process, you become aware of
any event that prevents the completion
of a valid test or collection (e.g., a procedural or paperwork error), you must
try to correct the problem promptly, if
doing so is practicable. You may conduct another collection as part of this
effort.
(2) If another collection is necessary,
you must begin the new collection procedure as soon as possible, using a new
CCF and a new collection kit.

(b) If, as a collector, laboratory,
MRO, employer, or other person implementing these drug testing regulations, you become aware of a problem
that can be corrected (see § 40.203), but
which has not already been corrected
under paragraph (a) of this section, you
must take all practicable action to correct the problem so that the test is not
cancelled.
(1) If the problem resulted from the
omission of required information, you
must, as the person responsible for providing that information, supply in
writing the missing information and a
statement that it is true and accurate.
For example, suppose you are a collector, and you forgot to make a notation on the ‘‘Remarks’’ line of the CCF
that the employee did not sign the certification. You would, when the problem is called to your attention, supply
a signed statement that the employee
failed or refused to sign the certification and that your statement is true
and accurate. You must supply this information on the same business day on
which you are notified of the problem,
transmitting it by fax or courier.
(2) If the problem is the use of a nonFederal form or an expired Federal
form, you must provide a signed statement (i.e., a memorandum for the
record). It must state that the incorrect form contains all the information
needed for a valid DOT drug test, and
that the incorrect form was used inadvertently or as the only means of conducting a test, in circumstances beyond your control. The statement must
also list the steps you have taken to
prevent future use of non-Federal
forms or expired Federal forms for DOT
tests. For this flaw to be corrected, the
test of the specimen must have occurred at a HHS-certified laboratory
where it was tested consistent with the
requirements of this part. You must
supply this information on the same
business day on which you are notified
of the problem, transmitting it by fax
or courier.
(3) You must maintain the written
documentation of a correction with the
CCF.
(4) You must mark the CCF in such a
way (e.g., stamp noting correction) as
to make it obvious on the face of the
CCF that you corrected the flaw.

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Office of the Secretary of Transportation
(c) If the correction does not take
place, as the MRO you must cancel the
test.
[65 FR 79526, Dec. 19, 2000, as amended at 66
FR 41954, Aug. 9, 2001]

§ 40.207 What is the effect of a cancelled drug test?
(a) A cancelled drug test is neither
positive nor negative.
(1) As an employer, you must not attach to a cancelled test the consequences of a positive test or other
violation of a DOT drug testing regulation (e.g., removal from a safety-sensitive position).
(2) As an employer, you must not use
a cancelled test for the purposes of a
negative test to authorize the employee to perform safety-sensitive
functions (i.e., in the case of a pre-employment, return-to-duty, or follow-up
test).
(3) However, as an employer, you
must not direct a recollection for an
employee because a test has been cancelled, except in the situations cited in
paragraph (a)(2) of this section or other
provisions of this part that require another test to be conducted (e.g.,
§§ 40.159(a)(5) and 40.187(b)(2), (c)(1), and
(e).
(b) A cancelled test does not count
toward compliance with DOT requirements (e.g., being applied toward the
number of tests needed to meet the employer’s minimum random testing
rate).
(c) A cancelled DOT test does not
provide a valid basis for an employer to
conduct a non-DOT test (i.e., a test
under company authority).

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[65 FR 79526, Dec. 19, 2000, as amended at 73
FR 35975, June 25, 2008]

§ 40.208 What problem requires corrective action but does not result in
the cancellation of a test?
(a) If, as a laboratory, collector, employer, or other person implementing
the DOT drug testing program, you become aware that the specimen temperature on the CCF was not checked
and the ‘‘Remarks’’ line did not contain an entry regarding the temperature being out of range, you must take
corrective action, including securing a
memorandum for the record explaining
the problem and taking appropriate ac-

§ 40.209
tion to ensure that the problem does
not recur.
(b) This error does not result in the
cancellation of the test.
(c) As an employer or service agent,
this error, even though not sufficient
to cancel a drug test result, may subject you to enforcement action under
DOT agency regulations or Subpart R
of this part.
[66 FR 41954, Aug. 9, 2001]

§ 40.209 What procedural problems do
not result in the cancellation of a
test and do not require correction?
(a) As a collector, laboratory, MRO,
employer or other person administering the drug testing process, you
must document any errors in the testing process of which you become aware,
even if they are not considered problems that will cause a test to be cancelled as listed in this subpart. Decisions about the ultimate impact of
these errors will be determined by
other administrative or legal proceedings, subject to the limitations of
paragraph (b) of this section.
(b) No person concerned with the
testing process may declare a test cancelled based on an error that does not
have a significant adverse effect on the
right of the employee to have a fair
and accurate test. Matters that do not
result in the cancellation of a test include, but are not limited to, the following:
(1) A minor administrative mistake
(e.g., the omission of the employee’s
middle initial, a transposition of numbers in the employee’s social security
number, the omission of the DOT Agency in Step 1–D of the CCF.)
(2) An error that does not affect employee protections under this part (e.g.,
the collector’s failure to add bluing
agent to the toilet bowl, which adversely affects only the ability of the
collector to detect tampering with the
specimen by the employee);
(3) The collection of a specimen by a
collector who is required to have been
trained (see § 40.33), but who has not
met this requirement;
(4) A delay in the collection process
(see § 40.61(a));
(5) Verification of a test result by an
MRO who has the basic credentials to
be qualified as an MRO (see § 40.121(a)

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§ 40.210

49 CFR Subtitle A (10–1–21 Edition)

through (b)) but who has not met training and/or documentation requirements
(see § 40.121(c) through (e));
(6) The failure to directly observe or
monitor a collection that the rule requires or permits to be directly observed or monitored, or the unauthorized use of direct observation or monitoring for a collection;
(7) The fact that a test was conducted
in a facility that does not meet the requirements of § 40.41;
(8) If the specific name of the courier
on the CCF is omitted or erroneous;
(9) Personal identifying information
is inadvertently contained on the CCF
(e.g., the employee signs his or her
name on Copy 1); or
(10) Claims that the employee was
improperly selected for testing.
(c) As an employer or service agent,
these types of errors, even though not
sufficient to cancel a drug test result,
may subject you to enforcement action
under DOT agency regulations or action under Subpart R of this part.
[65 FR 79526, Dec. 19, 2000, as amended at 66
FR 41954, Aug. 9, 2001; 75 FR 59108, Sept. 27,
2010]

§ 40.210 Are drug tests other than
urine permitted under the regulations?
No. Drug tests other than on urine
specimens are not authorized for testing under this part. Only urine specimens screened and confirmed at HHS
certified laboratories (see § 40.81) are
allowed for drug testing under this
part. Point-of-collection urine testing
or instant tests are not authorized.
[82 FR 52246, Nov. 13, 2017]

Subpart J—Alcohol Testing
Personnel

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§ 40.211 Who
tests?

conducts

DOT

alcohol

(a) Screening test technicians (STTs)
and breath alcohol technicians (BATs)
meeting their respective requirements
of this subpart are the only people authorized to conduct DOT alcohol tests.
(b) An STT can conduct only alcohol
screening tests, but a BAT can conduct
alcohol screening and confirmation
tests.

(c) As a BAT- or STT-qualified immediate supervisor of a particular employee, you may not act as the STT or
BAT when that employee is tested, unless no other STT or BAT is available
and DOT agency regulations do not
prohibit you from doing so.
§ 40.213 What training requirements
must STTs and BATs meet?
To be permitted to act as a BAT or
STT in the DOT alcohol testing program, you must meet each of the requirements of this section:
(a) You must be knowledgeable about
the alcohol testing procedures in this
part and the current DOT guidance.
Procedures and guidance are available
from ODAPC (Department of Transportation, 1200 New Jersey Avenue SE.,
Washington, DC 20590, 202–366–3784, or
on the ODAPC Web site, http://
www.transportation.gov/odapc).
You
must keep current on any changes to
these materials. You must subscribe to
the ODAPC list-serve at (https://
www.transportation.gov/odapc/get-odapcemail-updates).
(b) Qualification training. You must
receive qualification training meeting
the requirements of this paragraph (b).
(1) Qualification training must be in
accordance with the DOT Model BAT
or STT Course, as applicable. The DOT
Model Courses are available from
ODAPC (Department of Transportation, 1200 New Jersey Avenue, SE.,
Washington DC, 20590, 202–366–3784, or
on the ODAPC web site, http://
www.dot.gov/ost/dapc). The training can
also be provided using a course of instruction equivalent to the DOT Model
Courses. On request, ODAPC will review BAT and STT instruction courses
for equivalency.
(2) Qualification training must include training to proficiency in using
the alcohol testing procedures of this
part and in the operation of the particular alcohol testing device(s) (i.e.,
the ASD(s) or EBT(s)) you will be
using.
(3) The training must emphasize that
you are responsible for maintaining the
integrity of the testing process, ensuring the privacy of employees being
tested, and avoiding conduct or statements that could be viewed as offensive
or inappropriate.

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Office of the Secretary of Transportation
(4) The instructor must be an individual who has demonstrated necessary
knowledge, skills, and abilities by regularly conducting DOT alcohol tests as
an STT or BAT, as applicable, for a period of at least a year, who has conducted STT or BAT training, as applicable, under this part for a year, or
who has successfully completed a
‘‘train the trainer’’ course.
(c) Initial Proficiency Demonstration.
Following your completion of qualification training under paragraph (b) of
this section, you must demonstrate
proficiency in alcohol testing under
this part by completing seven consecutive error-free mock tests (BATs) or
five
consecutive
error-free
tests
(STTs).
(1) Another person must monitor and
evaluate your performance, in person
or by a means that provides real-time
observation and interaction between
the instructor and trainee, and attest
in writing that the mock collections
are ‘‘error-free.’’ This person must be
an individual who meets the requirements of paragraph (b)(4) of this section.
(2) These tests must use the alcohol
testing devices (e.g., EBT(s) or ASD(s))
that you will use as a BAT or STT.
(3) If you are an STT who will be
using an ASD that indicates readings
by changes, contrasts, or other readings in color, you must demonstrate as
part of the mock test that you are able
to discern changes, contrasts, or readings correctly.
(d) You must meet the requirements
of paragraphs (b) and (c) of this section
before you begin to perform STT or
BAT functions.
(e) Refresher training. No less frequently than every five years from the
date on which you satisfactorily complete the requirements of paragraphs
(b) and (c) of this section, you must
complete refresher training that meets
all the requirements of paragraphs (b)
and (c) of this section.
(f) Error Correction Training. If you
make a mistake in the alcohol testing
process that causes a test to be cancelled (i.e., a fatal or uncorrected flaw),
you must undergo error correction
training. This training must occur
within 30 days of the date you are noti-

§ 40.213
fied of the error that led to the need for
retraining.
(1) Error correction training must be
provided and your proficiency documented in writing by a person who
meets the requirements of paragraph
(b)(4) of this section.
(2) Error correction training is required to cover only the subject matter
area(s) in which the error that caused
the test to be cancelled occurred.
(3) As part of the error correction
training, you must demonstrate your
proficiency in the alcohol testing procedures of this part by completing
three consecutive error-free mock
tests. The mock tests must include one
uneventful scenario and two scenarios
related to the area(s) in which your
error(s) occurred. The person providing
the training must monitor and evaluate your performance and attest in
writing that the mock tests were errorfree.
(g) Documentation. You must maintain documentation showing that you
currently meet all requirements of this
section. You must provide this documentation on request to DOT agency
representatives and to employers and
C/TPAs who are negotiating to use
your services.
(h) Other persons who may serve as
BATs or STTs. (1) Anyone meeting the
requirements of this section to be a
BAT may act as an STT, provided that
the individual has demonstrated initial
proficiency in the operation of the ASD
that he or she is using, as provided in
paragraph (c) of this section.
(2) Law enforcement officers who
have been certified by state or local
governments to conduct breath alcohol
testing are deemed to be qualified as
BATs. They are not required to also
complete the training requirements of
this section in order to act as BATs. In
order for a test conducted by such an
officer to be accepted under DOT alcohol testing requirements, the officer
must have been certified by a state or
local government to use the EBT or
ASD that was used for the test.
[65 FR 79526, Dec. 19, 2000, as amended at 66
FR 41954, Aug. 9, 2001; 75 FR 5244, Feb. 2, 2010;
82 FR 52246, Nov. 13, 2017]

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§ 40.215

49 CFR Subtitle A (10–1–21 Edition)

§ 40.215 What information about the
DER do employers have to provide
to BATs and STTs?
As an employer, you must provide to
the STTs and BATs the name and telephone number of the appropriate DER
(and C/TPA, where applicable) to contact about any problems or issues that
may arise during the testing process.
§ 40.217 Where is other information on
the role of STTs and BATs found in
this regulation?
You can find other information on
the role and functions of STTs and
BATs in the following sections of this
part:
§ 40.3—Definitions.
§ 40.223—Responsibility for supervising employees being tested.
§§ 40.225–40.227—Use of the alcohol testing
form.
§§ 40.241–40.245—Screening test procedures
with ASDs and EBTs.
§§ 40.251–40.255—Confirmation
test
procedures.
§ 40.261—Refusals to test.
§§ 40.263–40.265—Insufficient saliva or breath.
§ 40.267—Problems requiring cancellation of
tests.
§§ 40.269–40.271—Correcting problems in tests.

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Subpart K—Testing Sites, Forms,
Equipment and Supplies Used
in Alcohol Testing
§ 40.221 Where does an alcohol test
take place?
(a) A DOT alcohol test must take
place at an alcohol testing site meeting
the requirements of this section.
(b) If you are operating an alcohol
testing site, you must ensure that it
meets the security requirements of
§ 40.223.
(c) If you are operating an alcohol
testing site, you must ensure that it
provides visual and aural privacy to
the employee being tested, sufficient to
prevent unauthorized persons from seeing or hearing test results.
(d) If you are operating an alcohol
testing site, you must ensure that it
has all needed personnel, materials,
equipment, and facilities to provide for
the collection and analysis of breath
and/or saliva samples, and a suitable
clean surface for writing.
(e) If an alcohol testing site fully
meeting all the visual and aural pri-

vacy requirements of paragraph (c) is
not readily available, this part allows a
reasonable suspicion or post-accident
test to be conducted at a site that partially meets these requirements. In
this case, the site must afford visual
and aural privacy to the employee to
the greatest extent practicable.
(f) An alcohol testing site can be in a
medical facility, a mobile facility (e.g.,
a van), a dedicated collection facility,
or any other location meeting the requirements of this section.
§ 40.223 What steps must be taken to
protect the security of alcohol testing sites?
(a) If you are a BAT, STT, or other
person operating an alcohol testing
site, you must prevent unauthorized
personnel from entering the testing
site.
(1) The only people you are to treat
as authorized persons are employees
being tested, BATs, STTs, and other alcohol testing site workers, DERs, employee representatives authorized by
the employer (e.g., on the basis of employer policy or labor-management
agreement), and DOT agency representatives.
(2) You must ensure that all persons
are under the supervision of a BAT or
STT at all times when permitted into
the site.
(3) You may remove any person who
obstructs, interferes with, or causes
unnecessary delay in the testing process.
(b) As the BAT or STT, you must not
allow any person other than you, the
employee, or a DOT agency representative to actually witness the testing
process (see §§ 40.241–40.255).
(c) If you are operating an alcohol
testing site, you must ensure that
when an EBT or ASD is not being used
for testing, you store it in a secure
place.
(d) If you are operating an alcohol
testing site, you must ensure that no
one other than BATs or other employees of the site have access to the site
when an EBT is unsecured.
(e) As a BAT or STT, to avoid distraction that could compromise security, you are limited to conducting an
alcohol test for only one employee at a
time.

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Office of the Secretary of Transportation

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(1) When an EBT screening test on an
employee indicates an alcohol concentration of 0.02 or higher, and the
same EBT will be used for the confirmation test, you are not allowed to
use the EBT for a test on another employee before completing the confirmation test on the first employee.
(2) As a BAT who will conduct both
the screening and the confirmation
test, you are to complete the entire
screening and confirmation process on
one employee before starting the
screening process on another employee.
(3) You are not allowed to leave the
alcohol testing site while the testing
process for a given employee is in
progress, except to notify a supervisor
or contact a DER for assistance in the
case an employee or other person who
obstructs, interferes with, or unnecessarily delays the testing process.
§ 40.225 What form is used for an alcohol test?
(a) The DOT Alcohol Testing Form
(ATF) must be used for every DOT alcohol test. The ATF must be a threepart carbonless manifold form. The
ATF is found in Appendix G to this
part. You may view this form on the
ODAPC
web
site
(http://
www.transportation.gov/odapc).
(b) As an employer in the DOT alcohol testing program, you are not permitted to modify or revise the ATF except as follows:
(1) You may include other information needed for billing purposes, outside the boundaries of the form.
(2) You may use a ATF directly generated by an EBT which omits the
space for affixing a separate printed result to the ATF, provided the EBT
prints the result directly on the ATF.
(3) You may use an ATF that has the
employer’s name, address, and telephone number preprinted. In addition,
a C/TPA’s name, address, and telephone
number may be included, to assist with
negative results.
(4) You may use an ATF in which all
pages are printed on white paper. You
may modify the ATF by using colored
paper, or have clearly discernable borders or designation statements on Copy
2 and Copy 3. When colors are used,
they must be green for Copy 2 and blue
for Copy 3.

§ 40.229
(5) As a BAT or STT, you may add,
on the ‘‘Remarks’’ line of the ATF, the
name of the DOT agency under whose
authority the test occurred.
(6) As a BAT or STT, you may use a
ATF that has your name, address, and
telephone number preprinted, but
under no circumstances can your signature be preprinted.
(c) As an employer, you may use an
equivalent foreign-language version of
the ATF approved by ODAPC. You may
use such a non-English language form
only in a situation where both the employee and BAT/STT understand and
can use the form in that language.
[65 FR 79526, Dec. 19, 2000, as amended at 66
FR 41954, Aug. 9, 2001; 75 FR 8529, Feb. 25,
2010; 75 FR 13009, Mar. 18, 2010; 82 FR 52246,
Nov. 13, 2017]

§ 40.227 May employers use the ATF
for non-DOT tests, or non-DOT
forms for DOT tests?
(a) No, as an employer, BAT, or STT,
you are prohibited from using the ATF
for non-DOT alcohol tests. You are also
prohibited from using non-DOT forms
for DOT alcohol tests. Doing either
subjects you to enforcement action
under DOT agency regulations.
(b) If the STT or BAT, either by mistake, or as the only means to conduct
a test under difficult circumstances
(e.g., post-accident test with insufficient time to obtain the ATF), uses a
non-DOT form for a DOT test, the use
of a non-DOT form does not, in and of
itself, require the employer or service
agent to cancel the test. However, in
order for the test to be considered
valid, a signed statement must be obtained from the STT or BAT in accordance with § 40.271(b) .
§ 40.229 What devices are used to conduct alcohol screening tests?
ASDs listed on ODAPC’s Web page
for ‘‘Approved Screening Devices to
Measure Alcohol in Bodily Fluids’’ and
EBTs listed on ODAPC’s Web page for
‘‘Approved Evidential Breath Measurement Devices’’ are the only devices you
are allowed to use to conduct alcohol
screening tests under this part. You
may use an ASD for DOT alcohol tests
only if there are instructions for its
use in this part. An ASD can be used
only for screening tests for alcohol,

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§ 40.231

49 CFR Subtitle A (10–1–21 Edition)

and must not be used for confirmation
tests.
[82 FR 52246, Nov. 13, 2017]

§ 40.231 What devices are used to conduct alcohol confirmation tests?
(a) EBTs on ODAPC’s Web page for
‘‘Approved Evidential Breath Measurement Devices’’ that meet the requirements of paragraph (b) of this section
are the only devices you may use to
conduct alcohol confirmation tests
under this part.
(b) To conduct a confirmation test,
you must use an EBT that has the following capabilities:
(1) Provides a printed triplicate result (or three consecutive identical
copies of a result) of each breath test;
(2) Assigns a unique number to each
completed test, which the BAT and employee can read before each test and
which is printed on each copy of the result;
(3) Prints, on each copy of the result,
the manufacturer’s name for the device, its serial number, and the time of
the test;
(4) Distinguishes alcohol from acetone at the 0.02 alcohol concentration
level;
(5) Tests an air blank; and
(6) Performs an external calibration
check.

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[65 FR 79526, Dec. 19, 2000, as amended at 82
FR 52246, Nov. 13, 2017]

§ 40.233 What are the requirements for
proper use and care of EBTs?
(a) As an EBT manufacturer, you
must submit, for NHTSA approval, a
quality assurance plan (QAP) for your
EBT before ODAPC places the EBT on
its Web page for ‘‘Approved Evidential
Breath Measurement Devices.’’
(1) Your QAP must specify the methods used to perform external calibration checks on the EBT, the tolerances
within which the EBT is regarded as
being in proper calibration, and the intervals at which these checks must be
performed. In designating these intervals, your QAP must take into account
factors like frequency of use, environmental conditions (e.g., temperature,
humidity, altitude) and type of operation (e.g., stationary or mobile).
(2) Your QAP must also specify the
inspection, maintenance, and calibra-

tion requirements and intervals for the
EBT.
(b) As the manufacturer, you must
include, with each EBT, instructions
for its use and care consistent with the
QAP.
(c) As the user of the EBT (e.g., employer, service agent), you must do the
following:
(1) You must follow the manufacturer’s instructions (see paragraph (b) of
this section), including performance of
external calibration checks at the intervals the instructions specify.
(2) In conducting external calibration
checks, you must use only calibration
devices appearing on NHTSA’s CPL for
‘‘Calibrating Units for Breath Alcohol
Tests.’’
(3) If an EBT fails an external check
of calibration, you must take the EBT
out of service. You may not use the
EBT again for DOT alcohol testing
until it is repaired and passes an external calibration check.
(4) You must maintain records of the
inspection, maintenance, and calibration
of
EBTs
as
provided
in
§ 40.333(a)(3).
(5) You must ensure that inspection,
maintenance, and calibration of the
EBT are performed by its manufacturer
or a maintenance representative certified either by the manufacturer or by
a state health agency or other appropriate state agency.
[65 FR 79526, Dec. 19, 2000, as amended at 82
FR 52246, Nov. 13, 2017]

§ 40.235 What are the requirements for
proper use and care of ASDs?
(a) As an ASD manufacturer, you
must submit, for NHTSA approval, a
QAP for your ASD before NHTSA approves it and ODAPC places the device
on its Web page for ‘‘Approved Screening Devices to Measure Alcohol in Bodily Fluids’’. Your QAP must specify the
methods used for quality control
checks, temperatures at which the
ASD must be stored and used, the shelf
life of the device, and environmental
conditions (e.g., temperature, altitude,
humidity) that may affect the ASD’s
performance.
(b) As a manufacturer, you must include with each ASD instructions for
its use and care consistent with the

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Office of the Secretary of Transportation
QAP. The instructions must include directions on the proper use of the ASD,
and, where applicable the time within
which the device must be read, and the
manner in which the reading is made.
(c) As the user of the ADS (e.g., employer, STT), you must follow the QAP
instructions.
(d) You are not permitted to use an
ASD that does not pass the specified
quality control checks or that has
passed its expiration date.
(e) As an employer, with respect to
breath ASDs, you must also follow the
device use and care requirements of
§ 40.233 .
[65 FR 79526, Dec. 19, 2000, as amended at 82
FR 52246, Nov. 13, 2017]

Subpart L—Alcohol Screening
Tests

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§ 40.241 What are the first steps in any
alcohol screening test?
As the BAT or STT you will take the
following steps to begin all alcohol
screening tests, regardless of the type
of testing device you are using:
(a) When a specific time for an employee’s test has been scheduled, or the
collection site is at the employee’s
worksite, and the employee does not
appear at the collection site at the
scheduled time, contact the DER to determine the appropriate interval within which the DER has determined the
employee is authorized to arrive. If the
employee’s arrival is delayed beyond
that time, you must notify the DER
that the employee has not reported for
testing. In a situation where a C/TPA
has notified an owner/operator or other
individual employee to report for testing and the employee does not appear,
the C/TPA must notify the employee
that he or she has refused to test.
(b) Ensure that, when the employee
enters the alcohol testing site, you
begin the alcohol testing process without undue delay. For example, you
must not wait because the employee
says he or she is not ready or because
an authorized employer or employee
representative is delayed in arriving.
(1) If the employee is also going to
take a DOT drug test, you must, to the
greatest extent practicable, ensure
that the alcohol test is completed be-

§ 40.243
fore the urine collection process begins.
(2) If the employee needs medical attention (e.g., an injured employee in an
emergency medical facility who is required to have a post-accident test), do
not delay this treatment to conduct a
test.
(c) Require the employee to provide
positive identification. You must see a
photo ID issued by the employer (other
than in the case of an owner-operator
or other self-employer individual) or a
Federal, state, or local government
(e.g., a driver’s license). You may not
accept faxes or photocopies of identification. Positive identification by an
employer representative (not a coworker or another employee being tested) is also acceptable. If the employee
cannot produce positive identification,
you must contact a DER to verify the
identity of the employee.
(d) If the employee asks, provide your
identification to the employee. Your
identification must include your name
and your employer’s name but is not
required to include your picture, address, or telephone number.
(e) Explain the testing procedure to
the employee, including showing the
employee the instructions on the back
of the ATF.
(f) Complete Step 1 of the ATF.
(g) Direct the employee to complete
Step 2 on the ATF and sign the certification. If the employee refuses to sign
this certification, you must document
this refusal on the ‘‘Remarks’’ line of
the ATF and immediately notify the
DER. This is a refusal to test.
§ 40.243 What is the procedure for an
alcohol screening test using an EBT
or non-evidential breath ASD?
As the BAT or STT, you must take
the following steps:
(a) Select, or allow the employee to
select, an individually wrapped or
sealed mouthpiece from the testing
materials.
(b) Open the individually wrapped or
sealed mouthpiece in view of the employee and insert it into the device in
accordance with the manufacturer’s instructions.
(c) Instruct the employee to blow
steadily and forcefully into the mouthpiece for at least six seconds or until

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§ 40.245

49 CFR Subtitle A (10–1–21 Edition)

the device indicates that an adequate
amount of breath has been obtained.
(d) Show the employee the displayed
test result.
(e) If the device is one that prints the
test number, testing device name and
serial number, time, and result directly
onto the ATF, you must check to ensure that the information has been
printed correctly onto the ATF.
(f) If the device is one that prints the
test number, testing device name and
serial number, time and result, but on
a separate printout rather than directly onto the ATF, you must affix
the printout of the information to the
designated space on the ATF with tamper-evident tape or use a self-adhesive
label that is tamper-evident.
(g) If the device is one that does not
print the test number, testing device
name and serial number, time, and result, or it is a device not being used
with a printer, you must record this information in Step 3 of the ATF.

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§ 40.245 What is the procedure for an
alcohol screening test using a saliva
ASD or a breath tube ASD?
(a) As the STT or BAT, you must
take the following steps when using
the saliva ASD:
(1) Check the expiration date on the
device or on the package containing
the device and show it to the employee.
You may not use the device after its
expiration date.
(2) Open an individually wrapped or
sealed package containing the device
in the presence of the employee.
(3) Offer the employee the opportunity to use the device. If the employee uses it, you must instruct the
employee to insert it into his or her
mouth and use it in a manner described
by the device’s manufacturer.
(4) If the employee chooses not to use
the device, or in all cases in which a
new test is necessary because the device did not activate (see paragraph
(a)(7) of this section), you must insert
the device into the employee’s mouth
and gather saliva in the manner described by the device’s manufacturer.
You must wear single-use examination
or similar gloves while doing so and
change them following each test.
(5) When the device is removed from
the employee’s mouth, you must follow

the manufacturer’s instructions regarding necessary next steps in ensuring that the device has activated.
(6)(i) If you were unable to successfully follow the procedures of paragraphs (a)(3) through (a)(5) of this section (e.g., the device breaks, you drop
the device on the floor), you must discard the device and conduct a new test
using a new device.
(ii) The new device you use must be
one that has been under your control
or that of the employee before the test.
(iii) You must note on the ‘‘Remarks’’ line of the ATF the reason for
the new test. (Note: You may continue
using the same ATF with which you
began the test.)
(iv) You must offer the employee the
choice of using the device or having
you use it unless the employee, in the
opinion of the STT or BAT, was responsible (e.g., the employee dropped the
device) for the new test needing to be
conducted.
(v) If you are unable to successfully
follow the procedures of paragraphs
(a)(3) through (a)(5) of this section on
the new test, you must end the collection and put an explanation on the
‘‘Remarks’’ line of the ATF.
(vi) You must then direct the employee to take a new test immediately,
using an EBT for the screening test.
(7) If you are able to successfully follow the procedures of paragraphs (a)(3)–
(a)(5) of this section, but the device
does not activate, you must discard the
device and conduct a new test, in the
same manner as provided in paragraph
(a)(6) of this section. In this case, you
must place the device into the employee’s mouth to collect saliva for the new
test.
(8) You must read the result displayed on the device no sooner than
the device’s manufacturer instructs. In
all cases the result displayed must be
read within 15 minutes of the test. You
must then show the device and it’s
reading to the employee and enter the
result on the ATF.
(9) You must never re-use devices,
swabs, gloves or other materials used
in saliva testing.
(10) You must note the fact that you
used a saliva ASD in Step 3 of the ATF.

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Office of the Secretary of Transportation
(b) As the STT or BAT, you must
take the following steps when using
the breath tube ASD:
(1) Check the expiration date on the
detector device and the electronic analyzer or on the package containing the
device and the analyzer and show it to
the employee. You must not use the device or the analyzer after their expiration date. You must not use an analyzer which is not specifically pre-calibrated for the device being used in the
collection.
(2) Remove the device from the package and secure an inflation bag onto
the appropriate end of the device, as directed by the manufacturer on the device’s instructions.
(3) Break the tube’s ampoule in the
presence of the employee.
(4) Offer the employee the opportunity to use the device. If the employee chooses to use (e.g. hold) the device, instruct the employee to blow
forcefully and steadily into the blowing
end of device until the inflation bag
fills with air (approximately 12 seconds).
(5) If the employee chooses not to
hold the device, you must hold it and
provide the use instructions in paragraph (b)(4) of this section.
(6) When the employee completes the
breath process, take the device from
the employee (or if you were holding it,
remove it from the employee’s mouth),
remove the inflation bag, and prepare
the device to be read by the analyzer in
accordance with the manufacturer’s directions.
(7)(i) If you were unable to successfully follow the procedures of paragraphs (b)(4) through (b)(6) of this section (e.g., the device breaks apart, the
employee did not fill the inflation bag),
you must discard the device and conduct a new test using a new one.
(ii) The new device you use must be
one that has been under your control
or that of the employer before the test.
(iii) You must note on the ‘‘Remarks’’ line of the ATF the reason for
the new test. (Note: You may continue
using the same ATF with which you
began the test.)
(iv) You must offer the employee the
choice of holding the device or having
you hold it unless the employee, in the
your opinion, was responsible (e.g., the

§ 40.247
employee failed to fill the inflation
bag) for the new test needing to be conducted.
(v) If you are unable to successfully
follow the procedures of paragraphs
(b)(4) through (b)(6) of this section on
the new test, you must end the collection and put an explanation on the
‘‘Remarks’’ line of the ATF.
(vi) You must then direct the employee to take a new test immediately,
using another type of ASD (e.g., saliva
device) or an EBT.
(8) If you were able to successfully
follow the procedures of paragraphs
(b)(4) through (b)(6) of this section and
after having waited the required
amount of time directed by the manufacturer for the detector device to incubate, you must place the device in
the analyzer in accordance with the
manufacturer’s directions. The result
must be read from the analyzer no earlier then the required incubation time
of the device. In all cases, the result
must be read within 15 minutes of the
test.
(9) You must follow the manufacturer’s instructions for determining the
result of the test. You must show the
analyzer result to the employee and
record the result on Step 3 of the ATF.
(10) You must never re-use detector
devices or any gloves used in breath
tube testing. The inflation bag must be
voided of air following removal from a
device. Inflation bags and electronic
analyzers may be re-used but only in
accordance with the manufacturer’s directions.
(11) You must note the fact that you
used a breath tube device in Step 3 of
the ATF.
[67 FR 61522, Oct. 1, 2002, as amended at 72 FR
1299, Jan. 11, 2007]

§ 40.247 What procedures does the BAT
or STT follow after a screening test
result?
(a) If the test result is an alcohol
concentration of less than 0.02, as the
BAT or STT, you must do the following:
(1) Sign and date Step 3 of the ATF;
and
(2) Transmit the result to the DER in
a confidential manner, as provided in
§ 40.255 .

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§ 40.251

49 CFR Subtitle A (10–1–21 Edition)

(b) If the test result is an alcohol
concentration of 0.02 or higher, as the
BAT or STT, you must direct the employee to take a confirmation test.
(1) If you are the BAT who will conduct the confirmation test, you must
then conduct the test using the procedures beginning at § 40.251 .
(2) If you are not the BAT who will
conduct the confirmation test, direct
the employee to take a confirmation
test, sign and date Step 3 of the ATF,
and give the employee Copy 2 of the
ATF.
(3) If the confirmation test will be
performed at a different site from the
screening test, you must take the following additional steps:
(i) Advise the employee not to eat,
drink, put anything (e.g., cigarette,
chewing gum) into his or her mouth, or
belch;
(ii) Tell the employee the reason for
the
waiting
period
required
by
§ 40.251(a) (i.e., to prevent an accumulation of mouth alcohol from leading to
an artificially high reading);
(iii) Explain that following your instructions concerning the waiting period is to the employee’s benefit;
(iv) Explain that the confirmation
test will be conducted at the end of the
waiting period, even if the instructions
have not been followed;
(v) Note on the ‘‘Remarks’’ line of
the ATF that the waiting period instructions were provided;
(vi) Instruct the person accompanying the employee to carry a copy
of the ATF to the BAT who will perform the confirmation test; and
(vii) Ensure that you or another
BAT, STT, or employer representative
observe the employee as he or she is
transported to the confirmation testing site. You must direct the employee
not to attempt to drive a motor vehicle
to the confirmation testing site.
(c) If the screening test is invalid,
you must, as the BAT or STT, tell the
employee the test is cancelled and note
the problem on the ‘‘Remarks’’ line of
the ATF. If practicable, repeat the
testing process (see § 40.271).

Subpart M—Alcohol Confirmation
Tests
§ 40.251 What are the first steps in an
alcohol confirmation test?
As the BAT for an alcohol confirmation test, you must follow these steps
to begin the confirmation test process:
(a) You must carry out a requirement
for a waiting period before the confirmation test, by taking the following
steps:
(1) You must ensure that the waiting
period lasts at least 15 minutes, starting with the completion of the screening test. After the waiting period has
elapsed, you should begin the confirmation test as soon as possible, but not
more than 30 minutes after the completion of the screening test.
(i) If the confirmation test is taking
place at a different location from the
screening test (see § 40.247(b)(3)) the
time of transit between sites counts toward the waiting period if the STT or
BAT who conducted the screening test
provided the waiting period instructions.
(ii) If you cannot verify, through review of the ATF, that waiting period
instructions were provided, then you
must carry out the waiting period requirement.
(iii) You or another BAT or STT, or
an employer representative, must observe the employee during the waiting
period.
(2) Concerning the waiting period,
you must tell the employee:
(i) Not to eat, drink, put anything
(e.g., cigarette, chewing gum) into his
or her mouth, or belch;
(ii) The reason for the waiting period
(i.e., to prevent an accumulation of
mouth alcohol from leading to an artificially high reading);
(iii) That following your instructions
concerning the waiting period is to the
employee’s benefit; and
(iv) That the confirmation test will
be conducted at the end of the waiting
period, even if the instructions have
not been followed.
(3) If you become aware that the employee has not followed the instructions, you must note this on the ‘‘Remarks’’ line of the ATF.

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Office of the Secretary of Transportation
(b) If you did not conduct the screening test for the employee, you must require positive identification of the employee, explain the confirmation procedures, and use a new ATF. You must
note on the ‘‘Remarks’’ line of the ATF
that a different BAT or STT conducted
the screening test.
(c) Complete Step 1 of the ATF.
(d) Direct the employee to complete
Step 2 on the ATF and sign the certification. If the employee refuses to sign
this certification, you must document
this refusal on the ‘‘Remarks’’ line of
the ATF and immediately notify the
DER. This is a refusal to test.
(e) Even if more than 30 minutes have
passed since the screening test result
was obtained, you must begin the confirmation test procedures in § 40.253,
not another screening test.
(f) You must note on the ‘‘Remarks’’
line of the ATF the time that elapsed
between the two events, and if the confirmation test could not begin within
30 minutes of the screening test, the
reason why.
(g) Beginning the confirmation test
procedures after the 30 minutes have
elapsed does not invalidate the screening or confirmation tests, but it may
constitute a regulatory violation subject to DOT agency sanction.

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§ 40.253 What are the procedures for
conducting an alcohol confirmation
test?
As the BAT conducting an alcohol
confirmation test, you must follow
these steps in order to complete the
confirmation test process:
(a) In the presence of the employee,
you must conduct an air blank on the
EBT you are using before beginning the
confirmation test and show the reading
to the employee.
(1) If the reading is 0.00, the test may
proceed. If the reading is greater than
0.00, you must conduct another air
blank.
(2) If the reading on the second air
blank is 0.00, the test may proceed. If
the reading is greater than 0.00, you
must take the EBT out of service.
(3) If you take an EBT out of service
for this reason, no one may use it for
testing until the EBT is found to be
within tolerance limits on an external
check of calibration.

§ 40.255
(4) You must proceed with the test of
the employee using another EBT, if one
is available.
(b) You must open a new individually
wrapped or sealed mouthpiece in view
of the employee and insert it into the
device in accordance with the manufacturer’s instructions.
(c) You must ensure that you and the
employee read the unique test number
displayed on the EBT.
(d) You must instruct the employee
to blow steadily and forcefully into the
mouthpiece for at least six seconds or
until the device indicates that an adequate amount of breath has been obtained.
(e) You must show the employee the
result displayed on the EBT.
(f) You must show the employee the
result and unique test number that the
EBT prints out either directly onto the
ATF or onto a separate printout.
(g) If the EBT provides a separate
printout of the result, you must attach
the printout to the designated space on
the ATF with tamper-evident tape, or
use a self-adhesive label that is tamper-evident.
[65 FR 79526, Dec. 19, 2000, as amended at 66
FR 41954, Aug. 9, 2001]

§ 40.255 What happens next after the
alcohol confirmation test result?
(a) After the EBT has printed the result of an alcohol confirmation test,
you must, as the BAT, take the following additional steps:
(1) Sign and date Step 3 of the ATF.
(2) If the alcohol confirmation test
result is lower than 0.02, nothing further is required of the employee. As the
BAT, you must sign and date Step 3 of
the ATF.
(3) If the alcohol confirmation test
result is 0.02 or higher, direct the employee to sign and date Step 4 of the
ATF. If the employee does not do so,
you must note this on the ‘‘Remarks’’
line of the ATF. However, this is not
considered a refusal to test.
(4) If the test is invalid, tell the employee the test is cancelled and note
the problem on the ‘‘Remarks’’ line of
the ATF. If practicable, conduct a retest. (see § 40.271).
(5) Immediately transmit the result
directly to the DER in a confidential
manner.

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§ 40.261

49 CFR Subtitle A (10–1–21 Edition)

(i) You may transmit the results
using Copy 1 of the ATF, in person, by
telephone, or by electronic means. In
any case, you must immediately notify
the DER of any result of 0.02 or greater
by any means (e.g., telephone or secure
fax machine) that ensures the result is
immediately received by the DER. You
must not transmit these results
through C/TPAs or other service
agents.
(ii) If you do not make the initial
transmission in writing, you must follow up the initial transmission with
Copy 1 of the ATF.
(b) As an employer, you must take
the following steps with respect to the
receipt and storage of alcohol test result information:
(1) If you receive any test results
that are not in writing (e.g., by telephone or electronic means), you must
establish a mechanism to establish the
identity of the BAT sending you the results.
(2) You must store all test result information in a way that protects confidentiality.

Subpart N—Problems in Alcohol
Testing

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§ 40.261 What is a refusal to take an alcohol test, and what are the consequences?
(a) As an employee, you are considered to have refused to take an alcohol
test if you:
(1) Fail to appear for any test (except
a pre-employment test) within a reasonable time, as determined by the employer, consistent with applicable DOT
agency regulations, after being directed to do so by the employer. This
includes the failure of an employee (including an owner-operator) to appear
for a test when called by a C/TPA (see
§ 40.241(a));
(2) Fail to remain at the testing site
until the testing process is complete;
Provided, That an employee who leaves
the testing site before the testing process commences (see § 40.243(a)) for a
pre-employment test is not deemed to
have refused to test;
(3) Fail to provide an adequate
amount of saliva or breath for any alcohol test required by this part or DOT

agency regulations; Provided, That an
employee who does not provide an adequate amount of breath or saliva because he or she has left the testing site
before the testing process commences
(see § 40.243(a)) for a pre-employment
test is not deemed to have refused to
test;
(4) Fail to provide a sufficient breath
specimen, and the physician has determined, through a required medical
evaluation, that there was no adequate
medical explanation for the failure (see
§ 40.265(c));
(5) Fail to undergo a medical examination or evaluation, as directed by
the employer as part of the insufficient
breath
procedures
outlined
at
§ 40.265(c);
(6) Fail to sign the certification at
Step 2 of the ATF (see §§ 40.241(g) and
40.251(d)); or
(7) Fail to cooperate with any part of
the testing process.
(b) As an employee, if you refuse to
take an alcohol test, you incur the
same consequences specified under
DOT agency regulations for a violation
of those DOT agency regulations.
(c) As a BAT or an STT, or as the
physician evaluating a ‘‘shy lung’’ situation, when an employee refuses to test
as provided in paragraph (a) of this section, you must terminate the portion
of the testing process in which you are
involved, document the refusal on the
ATF (or in a separate document which
you cause to be attached to the form),
immediately notify the DER by any
means (e.g., telephone or secure fax
machine) that ensures the refusal notification is immediately received. You
must make this notification directly to
the DER (not using a C/TPA as an
intermediary).
(d) As an employee, when you refuse
to take a non-DOT test or to sign a
non-DOT form, you have not refused to
take a DOT test. There are no consequences under DOT agency regulations for such a refusal.
[65 FR 79526, Dec. 19, 2000, as amended at 66
FR 41954, Aug. 9, 2001]

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Office of the Secretary of Transportation
§ 40.263 What happens when an employee is unable to provide a sufficient amount of saliva for an alcohol screening test?
(a) As the STT, you must take the
following steps if an employee is unable to provide sufficient saliva to
complete a test on a saliva screening
device (e.g., the employee does not provide sufficient saliva to activate the
device).
(1) You must conduct a new screening
test using a new screening device.
(2) If the employee refuses to make
the attempt to complete the new test,
you must discontinue testing, note the
fact on the ‘‘Remarks’’ line of the ATF,
and immediately notify the DER. This
is a refusal to test.
(3) If the employee has not provided a
sufficient amount of saliva to complete
the new test, you must note the fact on
the ‘‘Remarks’’ line of the ATF and immediately notify the DER.
(b) As the DER, when the STT informs you that the employee has not
provided a sufficient amount of saliva
(see paragraph (a)(3) of this section),
you must immediately arrange to administer an alcohol test to the employee using an EBT or other breath
testing device.

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§ 40.265 What happens when an employee is unable to provide a sufficient amount of breath for an alcohol test?
(a) If an employee does not provide a
sufficient amount of breath to permit a
valid breath test, you must take the
steps listed in this section.
(b) As the BAT or STT, you must instruct the employee to attempt again
to provide a sufficient amount of
breath and about the proper way to do
so.
(1) If the employee refuses to make
the attempt, you must discontinue the
test, note the fact on the ‘‘Remarks’’
line of the ATF, and immediately notify the DER. This is a refusal to test.
(2) If the employee again attempts
and fails to provide a sufficient amount
of breath, you may provide another opportunity to the employee to do so if
you believe that there is a strong likelihood that it could result in providing
a sufficient amount of breath.

§ 40.265
(3) When the employee’s attempts
under paragraph (b)(2) of this section
have failed to produce a sufficient
amount of breath, you must note the
fact on the ‘‘Remarks’’ line of the ATF
and immediately notify the DER.
(4) If you are using an EBT that has
the capability of operating manually,
you may attempt to conduct the test
in manual mode.
(5) If you are qualified to use a saliva
ASD and you are in the screening test
stage, you may change to a saliva ASD
only to complete the screening test.
(c) As the employer, when the BAT or
STT informs you that the employee
has not provided a sufficient amount of
breath, you must direct the employee
to obtain, within five days, an evaluation from a licensed physician who is
acceptable to you and who has expertise in the medical issues raised by the
employee’s failure to provide a sufficient specimen.
(1) You are required to provide the
physician who will conduct the evaluation with the following information
and instructions:
(i) That the employee was required to
take a DOT breath alcohol test, but
was unable to provide a sufficient
amount of breath to complete the test;
(ii) The consequences of the appropriate DOT agency regulation for refusing to take the required alcohol test;
(iii) That the physician must provide
you with a signed statement of his or
her conclusions; and
(iv) That the physician, in his or her
reasonable medical judgment, must
base those conclusions on one of the
following determinations:
(A) A medical condition has, or with
a high degree of probability could have,
precluded the employee from providing
a sufficient amount of breath. The physician must not include in the signed
statement detailed information on the
employee’s medical condition. In this
case, the test is cancelled.
(B) There is not an adequate basis for
determining that a medical condition
has, or with a high degree of probability could have, precluded the employee from providing a sufficient
amount of breath. This constitutes a
refusal to test.
(C) For purposes of paragraphs
(c)(1)(iv)(A) and (B) of this section, a

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§ 40.267

49 CFR Subtitle A (10–1–21 Edition)

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medical condition includes an ascertainable physiological condition (e.g., a
respiratory system dysfunction) or a
medically
documented
pre-existing
psychological disorder, but does not include unsupported assertions of ‘‘situational anxiety’’ or hyperventilation.
(2) As the physician making the evaluation, after making your determination, you must provide a written statement of your conclusions and the basis
for them to the DER directly (and not
through a C/TPA acting as an
itermediary). You must not include in
this statement detailed information on
the employee’s medical condition beyond what is necessary to explain your
conclusion.
(3) Upon receipt of the report from
the examining physician, as the DER
you must immediately inform the employee and take appropriate action
based upon your DOT agency regulations.
§ 40.267 What problems always cause
an alcohol test to be cancelled?
As an employer, a BAT, or an STT,
you must cancel an alcohol test if any
of the following problems occur. These
are ‘‘fatal flaws.’’ You must inform the
DER that the test was cancelled and
must be treated as if the test never occurred. These problems are:
(a) In the case of a screening test
conducted on a saliva ASD or a breath
tube ASD:
(1) The STT or BAT reads the result
either sooner than or later than the
time allotted by the manufacturer and
this Part (see § 40.245(a)(8) for the saliva
ASD and § 40.245(b)(8) for the breath
tube ASD).
(2) The saliva ASD does not activate
(see § 40.245(a)(7); or
(3) The device is used for a test after
the expiration date printed on the device or on its package (see § 40.245(a)(1)
for the saliva ASD and § 40.245(b)(1) for
the breath tube ASD).
(4) The breath tube ASD is tested
with an analyzer which has not been
pre-calibrated for that device’s specific
lot (see § 40.245(b)(1)).
(b) In the case of a screening or confirmation test conducted on an EBT,
the sequential test number or alcohol
concentration displayed on the EBT is
not the same as the sequential test

number or alcohol concentration on
the printed result (see § 40.253(c), (e)
and (f)).
(c) In the case of a confirmation test:
(1) The BAT conducts the confirmation test before the end of the minimum 15-minute waiting period (see
§ 40.251(a)(1));
(2) The BAT does not conduct an air
blank before the confirmation test (see
§ 40.253(a));
(3) There is not a 0.00 result on the
air blank conducted before the confirmation test (see § 40.253(a)(1) and (2));
(4) The EBT does not print the result
(see § 40.253(f)); or
(5) The next external calibration
check of the EBT produces a result
that differs by more than the tolerance
stated in the QAP from the known
value of the test standard. In this case,
every result of 0.02 or above obtained
on the EBT since the last valid external calibration check is cancelled (see
§ 40.233(a)(1) and (c)(3)).
[65 FR 79526, Dec. 19, 2000, as amended at 67
FR 61522, Oct. 1, 2002; 71 FR 49384, Aug. 23,
2006; 72 FR 1299, Jan. 11, 2007]

§ 40.269 What problems cause an alcohol test to be cancelled unless they
are corrected?
As a BAT or STT, or employer, you
must cancel an alcohol test if any of
the following problems occur, unless
they are corrected. These are ‘‘correctable flaws.’’ These problems are:
(a) The BAT or STT does not sign the
ATF (see §§ 40.247(a)(1) and 40.255(a)(1)).
(b) The BAT or STT fails to note on
the ‘‘Remarks’’ line of the ATF that
the employee has not signed the ATF
after the result is obtained (see
§ 40.255(a)(3)).
(c) The BAT or STT uses a non-DOT
form for the test (see § 40.225(a)).
[65 FR 79526, Dec. 19, 2000, as amended at 71
FR 49384, Aug. 23, 2006]

§ 40.271 How are alcohol testing problems corrected?
(a) As a BAT or STT, you have the
responsibility of trying to complete
successfully an alcohol test for each
employee.
(1) If, during or shortly after the testing process, you become aware of any
event that will cause the test to be
cancelled (see § 40.267), you must try to

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Office of the Secretary of Transportation
correct the problem promptly, if practicable. You may repeat the testing
process as part of this effort.
(2) If repeating the testing process is
necessary, you must begin a new test
as soon as possible. You must use a new
ATF, a new sequential test number,
and, if needed, a new ASD and/or a new
EBT. It is permissible to use additional
technical capabilities of the EBT (e.g.,
manual operation) if you have been
trained to do so in accordance with
§ 40.213(c) .
(3) If repeating the testing process is
necessary, you are not limited in the
number of attempts to complete the
test, provided that the employee is
making a good faith effort to comply
with the testing process.
(4) If another testing device is not
available for the new test at the testing site, you must immediately notify
the DER and advise the DER that the
test could not be completed. As the
DER who receives this information,
you must make all reasonable efforts
to ensure that the test is conducted at
another testing site as soon as possible.
(b) If, as an STT, BAT, employer or
other service agent administering the
testing process, you become aware of a
‘‘correctable flaw’’ (see § 40.269) that
has not already been corrected, you
must take all practicable action to correct the problem so that the test is not
cancelled.
(1) If the problem resulted from the
omission of required information, you
must, as the person responsible for providing that information, supply in
writing the missing information and a
signed statement that it is true and accurate. For example, suppose you are a
BAT and you forgot to make a notation on the ‘‘Remarks’’ line of the ATF
that the employee did not sign the certification. You would, when the problem is called to your attention, supply
a signed statement that the employee
failed or refused to sign the certification after the result was obtained,
and that your signed statement is true
and accurate.
(2) If the problem is the use of a nonDOT form, you must, as the person responsible for the use of the incorrect
form, certify in writing that the incorrect form contains all the information
needed for a valid DOT alcohol test.

§ 40.275
You must also provide a signed statement that the incorrect form was used
inadvertently or as the only means of
conducting a test, in circumstances beyond your control, and the steps you
have taken to prevent future use of
non-DOT forms for DOT tests. You
must supply this information on the
same business day on which you are
notified of the problem, transmitting it
by fax or courier.
(c) If you cannot correct the problem,
you must cancel the test.
§ 40.273 What is the effect of a cancelled alcohol test?
(a) A cancelled alcohol test is neither
positive nor negative.
(1) As an employer, you must not attach to a cancelled test the consequences of a test result that is 0.02 or
greater (e.g., removal from a safetysensitive position).
(2) As an employer, you must not use
a cancelled test in a situation where an
employee needs a test result that is
below 0.02 (e.g., in the case of a returnto-duty or follow-up test to authorize
the employee to perform safety-sensitive functions).
(3) As an employer, you must not direct a recollection for an employee because a test has been cancelled, except
in the situations cited in paragraph
(a)(2) of this section or other provisions
of this part.
(b) A cancelled test does not count
toward compliance with DOT requirements, such as a minimum random
testing rate.
(c) When a test must be cancelled, if
you are the BAT, STT, or other person
who determines that the cancellation
is necessary, you must inform the affected DER within 48 hours of the cancellation.
(d) A cancelled DOT test does not
provide a valid basis for an employer to
conduct a non-DOT test (i.e., a test
under company authority).
§ 40.275 What is the effect of procedural problems that are not sufficient to cancel an alcohol test?
(a) As an STT, BAT, employer, or a
service agent administering the testing
process, you must document any errors
in the testing process of which you become aware, even if they are not ‘‘fatal

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§ 40.277

49 CFR Subtitle A (10–1–21 Edition)

flaws’’ or ‘‘correctable flaws’’ listed in
this subpart. Decisions about the ultimate impact of these errors will be determined by administrative or legal
proceedings, subject to the limitation
of paragraph (b) of this section.
(b) No person concerned with the
testing process may declare a test cancelled based on a mistake in the process that does not have a significant adverse effect on the right of the employee to a fair and accurate test. For
example, it is inconsistent with this
part to cancel a test based on a minor
administrative mistake (e.g., the omission of the employee’s middle initial)
or an error that does not affect employee protections under this part. Nor
does the failure of an employee to sign
in Step 4 of the ATF result in the cancellation of the test. Nor is a test to be
cancelled on the basis of a claim by an
employee that he or she was improperly selected for testing.
(c) As an employer, these errors, even
though not sufficient to cancel an alcohol test result, may subject you to enforcement action under DOT agency
regulations.
§ 40.277 Are alcohol tests other than
saliva or breath permitted under
these regulations?
No, other types of alcohol tests (e,g.,
blood and urine) are not authorized for
testing done under this part. Only saliva or breath for screening tests and
breath for confirmation tests using approved devices are permitted.

Subpart O—Substance Abuse Professionals and the Return-toDuty Process

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§ 40.281 Who is qualified to act as a
SAP?
To be permitted to act as a SAP in
the DOT drug and alcohol testing program, you must meet each of the requirements of this section:
(a) Credentials. You must have one of
the following credentials:
(1) You are a licensed physician (Doctor of Medicine or Osteopathy);
(2) You are a licensed or certified social worker;
(3) You are a licensed or certified
psychologist;

(4) You are a licensed or certified employee assistance professional;
(5) You are a state-licensed or certified marriage and family therapist;
or
(6) You are a drug and alcohol counselor certified by an organization listed
at https://www.transportation.gov/odapc/
sap.
(b) Basic knowledge. You must be
knowledgeable in the following areas:
(1) You must be knowledgeable about
and have clinical experience in the diagnosis and treatment of alcohol and
controlled
substances-related
disorders.
(2) You must be knowledgeable about
the SAP function as it relates to employer interests in safety-sensitive duties.
(3) You must be knowledgeable about
this part, the DOT agency regulations
applicable to the employers for whom
you evaluate employees, and the DOT
SAP Guidelines. You must keep current on any changes to these materials.
You must subscribe to the ODAPC listserve at https://www.transportation.gov/
odapc/get-odapc-email-updates.
DOT
agency regulations, DOT SAP Guidelines, and other materials are available
from ODAPC (Department of Transportation, 1200 New Jersey Avenue SE.,
Washington DC, 20590 (202–366–3784), or
on the ODAPC Web site (http://
www.transportation.gov/odapc).
(c) Qualification training. You must
receive qualification training meeting
the requirements of this paragraph (c).
(1) Qualification training must provide instruction on the following subjects:
(i) Background, rationale, and coverage of the Department’s drug and alcohol testing program;
(ii) 49 CFR Part 40 and DOT agency
drug and alcohol testing rules;
(iii) Key DOT drug testing requirements, including collections, laboratory testing, MRO review, and problems in drug testing;
(iv) Key DOT alcohol testing requirements, including the testing process,
the role of BATs and STTs, and problems in alcohol tests;
(v) SAP qualifications and prohibitions;

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Office of the Secretary of Transportation
(vi) The role of the SAP in the return-to-duty process, including the initial employee evaluation, referrals for
education and/or treatment, the followup evaluation, continuing treatment
recommendations, and the follow-up
testing plan;
(vii) SAP consultation and communication with employers, MROs, and
treatment providers;
(viii) Reporting and recordkeeping
requirements;
(ix) Issues that SAPs confront in carrying out their duties under the program.
(2) Following your completion of
qualification training under paragraph
(c)(1) of this section, you must satisfactorily complete an examination administered by a nationally-recognized professional or training organization. The
examination must comprehensively
cover all the elements of qualification
training listed in paragraph (c)(1) of
this section.
(3) You must meet the requirements
of paragraphs (a), (b), and (c) of this
section before you begin to perform
SAP functions.
(d) Continuing education. During each
three-year period from the date on
which you satisfactorily complete the
examination under paragraph (c)(2) of
this section, you must complete continuing education consisting of at least
12 professional development hours (e.g.,
CEUs) relevant to performing SAP
functions.
(1) This continuing education must
include material concerning new technologies, interpretations, recent guidance, rule changes, and other information about developments in SAP practice, pertaining to the DOT program,
since the time you met the qualification training requirements of this section.
(2) Your continuing education activities must include documentable assessment tools to assist you in determining
whether you have adequately learned
the material.
(e) Documentation. You must maintain documentation showing that you
currently meet all requirements of this
section. You must provide this documentation on request to DOT agency
representatives and to employers and

§ 40.287
C/TPAs who are using or
plating using your services.

[65 FR 79526, Dec. 19, 2000, as amended at 69
FR 3022, Jan. 22, 2004; 71 FR 49384; Aug. 23,
2006; 71 FR 55347, Sept. 22, 2006; 82 FR 52246,
Nov. 13, 2017]

§ 40.283 How does a certification organization obtain recognition for its
members as SAPs?
(a) If you represent a certification organization that wants DOT to authorize its certified drug and alcohol counselors to be added to § 40.281(a)(6), you
may submit a written petition to DOT
requesting a review of your petition for
inclusion.
(b) You must obtain the National
Commission for Certifying Agencies
(NCCA) accreditation before DOT will
act on your petition.
(c) You must also meet the minimum
requirements of Appendix E to this
part before DOT will act on your petition.
[65 FR 79526, Dec. 19, 2000, as amended at 71
FR 49384, Aug. 23, 2006]

§ 40.285 When is a SAP evaluation required?
(a) As an employee, when you have
violated DOT drug and alcohol regulations, you cannot again perform any
DOT safety-sensitive duties for any
employer until and unless you complete the SAP evaluation, referral, and
education/treatment process set forth
in this subpart and in applicable DOT
agency regulations. The first step in
this process is a SAP evaluation.
(b) For purposes of this subpart, a
verified positive DOT drug test result,
a DOT alcohol test with a result indicating an alcohol concentration of 0.04
or greater, a refusal to test (including
by adulterating or substituting a urine
specimen) or any other violation of the
prohibition on the use of alcohol or
drugs under a DOT agency regulation
constitutes a DOT drug and alcohol
regulation violation.
§ 40.287 What information is an employer required to provide concerning SAP services to an employee who has a DOT drug and alcohol regulation violation?
As an employer, you must provide to
each employee (including an applicant

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§ 40.289

49 CFR Subtitle A (10–1–21 Edition)

or new employee) who violates a DOT
drug and alcohol regulation a listing of
SAPs readily available to the employee
and acceptable to you, with names, addresses, and telephone numbers. You
cannot charge the employee any fee for
compiling or providing this list. You
may provide this list yourself or
through a C/TPA or other service
agent.

(5) Providing the employee and employer with recommendations for continuing education and/or treatment.
(b) As a SAP, you are not an advocate for the employer or employee.
Your function is to protect the public
interest in safety by professionally
evaluating the employee and recommending appropriate education/treatment, follow-up tests, and aftercare.

§ 40.289 Are employers required to
provide SAP and treatment services
to employees?
(a) As an employer, you are not required to provide a SAP evaluation or
any subsequent recommended education or treatment for an employee
who has violated a DOT drug and alcohol regulation.
(b) However, if you offer that employee an opportunity to return to a
DOT safety-sensitive duty following a
violation, you must, before the employee again performs that duty, ensure that the employee receives an
evaluation by a SAP meeting the requirements of § 40.281 and that the employee successfully complies with the
SAP’s evaluation recommendations.
(c) Payment for SAP evaluations and
services is left for employers and employees to decide and may be governed
by existing management-labor agreements and health care benefits.

§ 40.293 What is the SAP’s function in
conducting the initial evaluation of
an employee?

§ 40.291 What is the role of the SAP in
the evaluation, referral, and treatment process of an employee who
has violated DOT agency drug and
alcohol testing regulations?
(a) As a SAP, you are charged with:
(1) Making a face-to-face clinical assessment and evaluation to determine
what assistance is needed by the employee to resolve problems associated
with alcohol and/or drug use;
(2) Referring the employee to an appropriate education and/or treatment
program;
(3) Conducting a face-to-face followup evaluation to determine if the employee has actively participated in the
education and/or treatment program
and has demonstrated successful compliance with the initial assessment and
evaluation recommendations;
(4) Providing the DER with a followup drug and/or alcohol testing plan for
the employee; and

As a SAP, for every employee who
comes to you following a DOT drug and
alcohol regulation violation, you must
accomplish the following:
(a) Provide a comprehensive face-toface assessment and clinical evaluation.
(b) Recommend a course of education
and/or treatment with which the employee must demonstrate successful
compliance prior to returning to DOT
safety-sensitive duty.
(1) You must make such a recommendation for every individual who
has violated a DOT drug and alcohol
regulation.
(2) You must make a recommendation for education and/or treatment
that will, to the greatest extent possible, protect public safety in the event
that the employee returns to the performance of safety-sensitive functions.
(c) Appropriate education may include, but is not limited to, self-help
groups (e.g., Alcoholics Anonymous)
and community lectures, where attendance can be independently verified, and
bona fide drug and alcohol education
courses.
(d) Appropriate treatment may include, but is not limited to, in-patient
hospitalization,
partial
in-patient
treatment, out-patient counseling programs, and aftercare.
(e) You must provide a written report
directly to the DER highlighting your
specific recommendations for assistance (see § 40.311(c)).
(f) For purposes of your role in the
evaluation process, you must assume
that a verified positive test result has
conclusively established that the employee committed a DOT drug and alcohol regulation violation. You must
not take into consideration in any

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Office of the Secretary of Transportation
way, as a factor in determining what
your recommendation will be, any of
the following:
(1) A claim by the employee that the
test was unjustified or inaccurate;
(2) Statements by the employee that
attempt to mitigate the seriousness of
a violation of a DOT drug or alcohol
regulation (e.g., related to assertions of
use of hemp oil, ‘‘medical marijuana’’
use, ‘‘contact positives,’’ poppy seed ingestion, job stress); or
(3) Personal opinions you may have
about the justification or rationale for
drug and alcohol testing.
(g) In the course of gathering information for purposes of your evaluation
in the case of a drug-related violation,
you may consult with the MRO. As the
MRO, you are required to cooperate
with the SAP and provide available information the SAP requests. It is not
necessary to obtain the consent of the
employee to provide this information.
§ 40.295 May employees or employers
seek a second SAP evaluation if
they disagree with the first SAP’s
recommendations?
(a) As an employee with a DOT drug
and alcohol regulation violation, when
you have been evaluated by a SAP, you
must not seek a second SAP’s evaluation in order to obtain another recommendation.
(b) As an employer, you must not
seek a second SAP’s evaluation if the
employee has already been evaluated
by a qualified SAP. If the employee,
contrary to paragraph (a) of this section, has obtained a second SAP evaluation, as an employer you may not
rely on it for any purpose under this
part.

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§ 40.297 Does anyone have the authority to change a SAP’s initial evaluation?
(a) Except as provided in paragraph
(b) of this section, no one (e.g., an employer, employee, a managed-care provider, any service agent) may change
in any way the SAP’s evaluation or
recommendations for assistance. For
example, a third party is not permitted
to make more or less stringent a SAP’s
recommendation by changing the
SAP’s evaluation or seeking another
SAP’s evaluation.

§ 40.299
(b) The SAP who made the initial
evaluation may modify his or her initial evaluation and recommendations
based on new or additional information
(e.g., from an education or treatment
program).
§ 40.299 What is the SAP’s role and
what are the limits on a SAP’s discretion in referring employees for
education and treatment?
(a) As a SAP, upon your determination of the best recommendation for assistance, you will serve as a referral
source to assist the employee’s entry
into an education and/or treatment
program.
(b) To prevent the appearance of a
conflict of interest, you must not refer
an employee requiring assistance to
your private practice or to a person or
organization from which you receive
payment or to a person or organization
in which you have a financial interest.
You are precluded from making referrals to entities with which you are financially associated.
(c) There are four exceptions to the
prohibitions contained in paragraph (b)
of this section. You may refer an employee to any of the following providers of assistance, regardless of your
relationship with them:
(1) A public agency (e.g., treatment
facility) operated by a state, county, or
municipality;
(2) The employer or a person or organization under contract to the employer to provide alcohol or drug treatment and/or education services (e.g.,
the employer’s contracted treatment
provider);
(3) The sole source of therapeutically
appropriate treatment under the employee’s health insurance program
(e.g., the single substance abuse in-patient treatment program made available by the employee’s insurance coverage plan); or
(4) The sole source of therapeutically
appropriate
treatment
reasonably
available to the employee (e.g., the
only treatment facility or education
program reasonably located within the
general commuting area).

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§ 40.301

49 CFR Subtitle A (10–1–21 Edition)

§ 40.301 What is the SAP’s function in
the follow-up evaluation of an employee?
(a) As a SAP, after you have prescribed assistance under § 40.293, you
must re-evaluate the employee to determine if the employee has successfully carried out your education and/or
treatment recommendations.
(1) This is your way to gauge for the
employer the employee’s ability to
demonstrate
successful
compliance
with the education and/or treatment
plan.
(2) Your evaluation may serve as one
of the reasons the employer decides to
return the employee to safety-sensitive
duty.
(b) As the SAP making the follow-up
evaluation determination, you must:
(1) Confer with or obtain appropriate
documentation from the appropriate
education and/or treatment program
professionals where the employee was
referred; and
(2) Conduct a face-to-face clinical
interview with the employee to determine if the employee demonstrates
successful compliance with your initial
evaluation recommendations.
(c) (1) If the employee has demonstrated successful compliance, you
must provide a written report directly
to the DER highlighting your clinical
determination that the employee has
done so with your initial evaluation
recommendation (see § 40.311(d)).
(2) You may determine that an employee has successfully demonstrated
compliance even though the employee
has not yet completed the full regimen
of education and/or treatment you recommended or needs additional assistance. For example, if the employee has
successfully completed the 30-day inpatient program you prescribed, you
may make a ‘‘successful compliance’’
determination even though you conclude that the employee has not yet
completed the out-patient counseling
you recommended or should continue
in an aftercare program.
(d)(1) As the SAP, if you believe, as a
result of the follow-up evaluation, that
the employee has not demonstrated
successful compliance with your recommendations, you must provide written notice directly to the DER (see
§ 40.311(e)).

(2) As an employer who receives the
SAP’s written notice that the employee has not successfully complied
with the SAP’s recommendations, you
must not return the employee to the
performance of safety-sensitive duties.
(3) As the SAP, you may conduct additional follow-up evaluation(s) if the
employer determines that doing so is
consistent
with
the
employee’s
progress as you have reported it and
with the employer’s policy and/or
labor-management agreements.
(4) As the employer, following a SAP
report that the employee has not demonstrated successful compliance, you
may take personnel action consistent
with your policy and/or labor-management agreements.
§ 40.303 What happens if the SAP believes the employee needs additional treatment, aftercare, or support group services even after the
employee returns to safety-sensitive
duties?
(a) As a SAP, if you believe that ongoing services (in addition to follow-up
tests) are needed to assist an employee
to maintain sobriety or abstinence
from drug use after the employee resumes the performance of safety-sensitive duties, you must provide recommendations for these services in
your follow-up evaluation report (see
§ 40.311(d)(10)).
(b) As an employer receiving a recommendation for these services from a
SAP, you may, as part of a return-toduty agreement with the employee, require the employee to participate in
the recommended services. You may
monitor and document the employee’s
participation in the recommended services. You may also make use of SAP
and employee assistance program
(EAP) services in assisting and monitoring employees’ compliance with
SAP recommendations. Nothing in this
section permits an employer to fail to
carry out its obligations with respect
to follow-up testing (see § 40.309).
(c) As an employee, you are obligated
to comply with the SAP’s recommendations for these services. If
you fail or refuse to do so, you may be
subject to disciplinary action by your
employer.

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§ 40.305 How does the return-to-duty
process conclude?
(a) As the employer, if you decide
that you want to permit the employee
to return to the performance of safetysensitive functions, you must ensure
that the employee takes a return-toduty test. This test cannot occur until
after the SAP has determined that the
employee has successfully complied
with prescribed education and/or treatment. The employee must have a negative drug test result and/or an alcohol
test with an alcohol concentration of
less than 0.02 before resuming performance of safety-sensitive duties.
(b) As an employer, you must not return an employee to safety-sensitive
duties until the employee meets the
conditions of paragraph (a) of this section. However, you are not required to
return an employee to safety-sensitive
duties because the employee has met
these conditions. That is a personnel
decision that you have the discretion
to make, subject to collective bargaining agreements or other legal requirements.
(c) As a SAP or MRO, you must not
make a ‘‘fitness for duty’’ determination as part of this re-evaluation unless
required to do so under an applicable
DOT agency regulation. It is the employer, rather than you, who must decide whether to put the employee back
to work in a safety-sensitive position.
§ 40.307 What is the SAP’s function in
prescribing the employee’s followup tests?
(a) As a SAP, for each employee who
has committed a DOT drug or alcohol
regulation violation, and who seeks to
resume the performance of safety-sensitive functions, you must establish a
written follow-up testing plan. You do
not establish this plan until after you
determine that the employee has successfully complied with your recommendations for education and/or
treatment.
(b) You must present a copy of this
plan directly to the DER (see
§ 40.311(d)(9)).
(c) You are the sole determiner of the
number and frequency of follow-up
tests and whether these tests will be
for drugs, alcohol, or both, unless otherwise directed by the appropriate DOT

§ 40.307
agency regulation. For example, if the
employee had a positive drug test, but
your evaluation or the treatment program professionals determined that the
employee had an alcohol problem as
well, you should require that the employee have follow-up tests for both
drugs and alcohol.
(d) However, you must, at a minimum, direct that the employee be subject to six unannounced follow-up tests
in the first 12 months of safety-sensitive duty following the employee’s
return to safety-sensitive functions.
(1) You may require a greater number
of follow-up tests during the first 12month period of safety-sensitive duty
(e.g., you may require one test a month
during the 12-month period; you may
require two tests per month during the
first 6-month period and one test per
month during the final 6-month period).
(2) You may also require follow-up
tests during the 48 months of safetysensitive duty following this first 12month period.
(3) You are not to establish the actual dates for the follow-up tests you
prescribe. The decision on specific
dates to test is the employer’s.
(4) As the employer, you must not
impose additional testing requirements
(e.g., under company authority) on the
employee that go beyond the SAP’s follow-up testing plan.
(e) The requirements of the SAP’s
follow-up testing plan ‘‘follow the employee’’ to subsequent employers or
through breaks in service.
Example 1 to paragraph (e): The employee
returns to duty with Employer A. Two
months afterward, after completing the first
two of six follow-up tests required by the
SAP’s plan, the employee quits his job with
Employer A and begins to work in a similar
position for Employer B. The employee remains obligated to complete the four additional tests during the next 10 months of
safety-sensitive duty, and Employer B is responsible for ensuring that the employee
does so. Employer B learns of this obligation
through the inquiry it makes under § 40.25.
Example 2 to paragraph (e): The employee
returns to duty with Employer A. Three
months later, after the employee completes
the first two of six follow-up tests required
by the SAP’s plan, Employer A lays the employee off for economic or seasonal employment reasons. Four months later, Employer

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§ 40.309

49 CFR Subtitle A (10–1–21 Edition)

A recalls the employee. Employer A must ensure that the employee completes the remaining four follow-up tests during the next
nine months.

(f) As the SAP, you may modify the
determinations you have made concerning follow-up tests. For example,
even if you recommended follow-up
testing beyond the first 12-months, you
can terminate the testing requirement
at any time after the first year of testing. You must not, however, modify
the requirement that the employee
take at least six follow-up tests within
the first 12 months after returning to
the performance of safety-sensitive
functions.
§ 40.309 What are the employer’s responsibilities with respect to the
SAP’s directions for follow-up tests?
(a) As the employer, you must carry
out the SAP’s follow-up testing requirements. You may not allow the
employee to continue to perform safety-sensitive functions unless follow-up
testing is conducted as directed by the
SAP.
(b) You should schedule follow-up
tests on dates of your own choosing,
but you must ensure that the tests are
unannounced with no discernable pattern as to their timing, and that the
employee is given no advance notice.
(c) You cannot substitute any other
tests (e.g., those carried out under the
random testing program) conducted on
the employee for this follow-up testing
requirement.
(d) You cannot count a follow-up test
that has been cancelled as a completed
test. A cancelled follow-up test must be
recollected.

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§ 40.311 What are the requirements
concerning SAP reports?
(a) As the SAP conducting the required evaluations, you must send the
written reports required by this section
in writing directly to the DER and not
to a third party or entity for forwarding to the DER (except as provided
in § 40.355(e)). You may, however, forward the document simultaneously to
the DER and to a C/TPA.
(b) As an employer, you must ensure
that you receive SAP written reports
directly from the SAP performing the
evaluation and that no third party or

entity changed the SAP’s report in any
way.
(c) The SAP’s written report, following an initial evaluation that determines what level of assistance is needed to address the employee’s drug and/
or alcohol problems, must be on the
SAP’s own letterhead (and not the letterhead of another service agent)
signed and dated by the SAP, and must
contain the following delineated items:
(1) Employee’s name and SSN;
(2) Employer’s name and address;
(3) Reason for the assessment (specific violation of DOT regulations and
violation date);
(4) Date(s) of the assessment;
(5) SAP’s education and/or treatment
recommendation; and
(6) SAP’s telephone number.
(d) The SAP’s written report concerning a follow-up evaluation that determines the employee has demonstrated successful compliance must
be on the SAP’s own letterhead (and
not the letterhead of another service
agent), signed by the SAP and dated,
and must contain the following items:
(1) Employee’s name and SSN;
(2) Employer’s name and address;
(3) Reason for the initial assessment
(specific violation of DOT regulations
and violation date);
(4) Date(s) of the initial assessment
and synopsis of the treatment plan;
(5) Name of practice(s) or service(s)
providing the recommended education
and/or treatment;
(6) Inclusive dates of employee’s program participation;
(7) Clinical characterization of employee’s program participation;
(8) SAP’s clinical determination as to
whether the employee has demonstrated successful compliance;
(9) Follow-up testing plan;
(10) Employee’s continuing care
needs
with
specific
treatment,
aftercare, and/or support group services
recommendations; and
(11) SAP’s telephone number.
(e) The SAP’s written report concerning a follow-up evaluation that determines the employee has not demonstrated successful compliance must
be on the SAP’s own letterhead (and
not the letterhead of another service
agent), signed by the SAP and dated,
and must contain the following items:

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Office of the Secretary of Transportation
(1) Employee’s name and SSN;
(2) Employer’s name and address;
(3) Reason for the initial assessment
(specific DOT violation and date);
(4) Date(s) of initial assessment and
synopsis of treatment plan;
(5) Name of practice(s) or service(s)
providing the recommended education
and/or treatment;
(6) Inclusive dates of employee’s program participation;
(7) Clinical characterization of employee’s program participation;
(8) Date(s) of the first follow-up evaluation;
(9) Date(s) of any further follow-up
evaluation the SAP has scheduled;
(10) SAP’s clinical reasons for determining that the employee has not demonstrated successful compliance; and
(11) SAP’s telephone number.
(f) As a SAP, you must also provide
these written reports directly to the
employee if the employee has no current employer and to the gaining DOT
regulated employer in the event the
employee obtains another transportation industry safety-sensitive position.
(g) As a SAP, you are to maintain
copies of your reports to employers for
5 years, and your employee clinical
records in accordance with Federal,
state, and local laws regarding record
maintenance, confidentiality, and release of information. You must make
these records available, on request, to
DOT agency representatives (e.g., inspectors conducting an audit or safety
investigation) and representatives of
the NTSB in an accident investigation.
(h) As an employer, you must maintain your reports from SAPs for 5 years
from the date you received them.
§ 40.313 Where is other information on
SAP functions and the return-toduty process found in this regulation?

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You can find other information on
the role and functions of SAPs in the
following sections of this part:
§ 40.3—Definition.
§ 40.347—Service agent assistance with SAPrequired follow-up testing.
§ 40.355—Transmission of SAP reports.
§ 40.329(c)—Making SAP reports available to
employees on request.

§ 40.323
APPENDIX E TO PART 40—SAP EQUIVALENCY
REQUIREMENTS FOR CERTIFICATION ORGANIZATIONS.

Subpart P—Confidentiality and
Release of Information
§ 40.321 What is the general confidentiality rule for drug and alcohol test
information?
Except as otherwise provided in this
subpart, as a service agent or employer
participating in the DOT drug or alcohol testing process, you are prohibited
from releasing individual test results
or medical information about an employee to third parties without the employee’s specific written consent.
(a) A ‘‘third party’’ is any person or
organization to whom other subparts of
this regulation do not explicitly authorize or require the transmission of
information in the course of the drug
or alcohol testing process.
(b) ‘‘Specific written consent’’ means
a statement signed by the employee
that he or she agrees to the release of
a particular piece of information to a
particular, explicitly identified, person
or organization at a particular time.
‘‘Blanket releases,’’ in which an employee agrees to a release of a category
of information (e.g., all test results) or
to release information to a category of
parties (e.g., other employers who are
members of a C/TPA, companies to
which the employee may apply for employment), are prohibited under this
part.
§ 40.323 May program participants release drug or alcohol test information in connection with legal proceedings?
(a) As an employer, you may release
information pertaining to an employee’s drug or alcohol test without the
employee’s consent in certain legal
proceedings.
(1) These proceedings include a lawsuit (e.g., a wrongful discharge action),
grievance (e.g., an arbitration concerning disciplinary action taken by
the employer), or administrative proceeding (e.g., an unemployment compensation hearing) brought by, or on
behalf of, an employee and resulting
from a positive DOT drug or alcohol
test or a refusal to test (including, but

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§ 40.325

49 CFR Subtitle A (10–1–21 Edition)

not limited to, adulterated or substituted test results).
(2) These proceedings also include a
criminal or civil action resulting from
an employee’s performance of safetysensitive duties, in which a court of
competent jurisdiction determines that
the drug or alcohol test information
sought is relevant to the case and
issues an order directing the employer
to produce the information. For example, in personal injury litigation following a truck or bus collision, the
court could determine that a post-accident drug test result of an employee is
relevant to determining whether the
driver or the driver’s employer was
negligent. The employer is authorized
to respond to the court’s order to
produce the records.
(b) In such a proceeding, you may release the information to the decisionmaker in the proceeding (e.g., the court
in a lawsuit). You may release the information only with a binding stipulation that the decisionmaker to whom
it is released will make it available
only to parties to the proceeding.
(c) If you are a service agent, and the
employer requests its employee’s drug
or alcohol testing information from
you to use in a legal proceeding as authorized in paragraph (a) of this section (e.g., the laboratory’s data package), you must provide the requested
information to the employer.
(d) As an employer or service agent,
you must immediately notify the employee in writing of any information
you release under this section.

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§ 40.325

[Reserved]

§ 40.327 When must the MRO report
medical information gathered in
the verification process?
(a) As the MRO, you must, except as
provided in paragraph (c) of this section, report drug test results and medical information you learned as part of
the verification process to third parties
without the employee’s consent if you
determine, in your reasonable medical
judgment, that:
(1) The information is likely to result
in the employee being determined to be
medically unqualified under an applicable DOT agency regulation; or
(2) The information indicates that
continued performance by the em-

ployee of his or her safety-sensitive
function is likely to pose a significant
safety risk.
(b) The third parties to whom you are
authorized to provide information by
this section include the employer, a
physician or other health care provider
responsible for determining the medical qualifications of the employee
under an applicable DOT agency safety
regulation, a SAP evaluating the employee as part of the return to duty
process (see § 40.293(g)), a DOT agency,
or the National Transportation Safety
Board in the course of an accident investigation.
(c) If the law of a foreign country
(e.g., Canada) prohibits you from providing medical information to the employer, you may comply with that prohibition.
§ 40.329 What information must laboratories, MROs, and other service
agents release to employees?
(a) As an MRO or service agent you
must provide, within 10 business days
of receiving a written request from an
employee, copies of any records pertaining to the employee’s use of alcohol and/or drugs, including records of
the employee’s DOT-mandated drug
and/or alcohol tests. You may charge
no more than the cost of preparation
and reproduction for copies of these
records.
(b) As a laboratory, you must provide, within 10 business days of receiving a written request from an employee, and made through the MRO,
the records relating to the results of
the employee’s drug test (i.e., laboratory report and data package). You
may charge no more than the cost of
preparation and reproduction for copies
of these records.
(c) As a SAP, you must make available to an employee, on request, a copy
of all SAP reports (see § 40.311). However, you must redact follow-up testing
information from the report before providing it to the employee.
[65 FR 79526, Dec. 19, 2000, as amended at 66
FR 41954, Aug. 9, 2001]

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§ 40.331 To what additional parties
must employers and service agents
release information?
As an employer or service agent you
must release information under the following circumstances:
(a) If you receive a specific, written
consent from an employee authorizing
the release of information about that
employee’s drug or alcohol tests to an
identified person, you must provide the
information to the identified person.
For example, as an employer, when you
receive a written request from a former
employee to provide information to a
subsequent employer, you must do so.
In providing the information, you must
comply with the terms of the employee’s consent.
(b) If you are an employer, you must,
upon request of DOT agency representatives, provide the following:
(1) Access to your facilities used for
this part and DOT agency drug and alcohol program functions.
(2) All written, printed, and computer-based drug and alcohol program
records and reports (including copies of
name-specific records or reports), files,
materials, data, documents/documentation, agreements, contracts, policies,
and statements that are required by
this part and DOT agency regulations.
You must provide this information at
your principal place of business in the
time required by the DOT agency.
(3) All items in paragraph (b)(2) of
this section must be easily accessible,
legible, and provided in an organized
manner. If electronic records do not
meet these standards, they must be
converted to printed documentation
that meets these standards.
(c) If you are a service agent, you
must, upon request of DOT agency representatives, provide the following:
(1) Access to your facilities used for
this part and DOT agency drug and alcohol program functions.
(2) All written, printed, and computer-based drug and alcohol program
records and reports (including copies of
name-specific records or reports), files,
materials, data, documents/documentation, agreements, contracts, policies,
and statements that are required by
this part and DOT agency regulations.
You must provide this information at

§ 40.331
your principal place of business in the
time required by the DOT agency.
(3) All items in paragraph (c)(2) of
this section must be easily accessible,
legible, and provided in an organized
manner. If electronic records do not
meet these standards, they must be
converted to printed documentation
that meets these standards.
(d) If requested by the National
Transportation Safety Board as part of
an accident investigation, you must
provide information concerning postaccident tests administered after the
accident.
(e) If requested by a Federal, state or
local safety agency with regulatory authority over you or the employee, you
must provide drug and alcohol test
records concerning the employee.
(f) Except as otherwise provided in
this part, as a laboratory you must not
release or provide a specimen or a part
of a specimen to a requesting party,
without first obtaining written consent
from ODAPC. DNA testing and other
types of identity testing are not authorized and ODAPC will not give permission for such testing. If a party
seeks a court order directing you to release a specimen or part of a specimen
contrary to any provision of this part,
you must take necessary legal steps to
contest the issuance of the order (e.g.,
seek to quash a subpoena, citing the requirements of § 40.13). This part does
not require you to disobey a court
order, however.
(g) Notwithstanding any other provision of this Part, as an employer of
Commercial Motor Vehicle (CMV) drivers holding commercial driving licenses (CDLs) or as a third party administrator for owner-operator CMV
drivers with CDLs, you are authorized
to comply with State laws requiring
you to provide to State CDL licensing
authorities information about all violations of DOT drug and alcohol testing
rules (including positive tests and refusals) by any CMV driver holding a
CDL.
[65 FR 79526, Dec. 19, 2000, as amended at 66
FR 41955, Aug. 9, 2001; 73 FR 33737, June 13,
2008; 82 FR 52247, Nov. 13, 2017]

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§ 40.333

49 CFR Subtitle A (10–1–21 Edition)

§ 40.333 What records must employers
keep?

rapid and readily auditable manner, at
the request of DOT agency personnel.

(a) As an employer, you must keep
the following records for the following
periods of time:
(1) You must keep the following
records for five years:
(i) Records of alcohol test results indicating an alcohol concentration of
0.02 or greater;
(ii) Records of verified positive drug
test results;
(iii) Documentation of refusals to
take required alcohol and/or drug tests
(including substituted or adulterated
drug test results);
(iv) SAP reports; and
(v) All follow-up tests and schedules
for follow-up tests.
(2) You must keep records for three
years of information obtained from
previous employers under § 40.25 concerning drug and alcohol test results of
employees.
(3) You must keep records of the inspection, maintenance, and calibration
of EBTs, for two years.
(4) You must keep records of negative
and cancelled drug test results and alcohol test results with a concentration
of less than 0.02 for one year.
(b) You do not have to keep records
related to a program requirement that
does not apply to you (e.g., a maritime
employer who does not have a DOTmandated random alcohol testing program need not maintain random alcohol testing records).
(c) You must maintain the records in
a location with controlled access.
(d) A service agent may maintain
these records for you. However, you
must ensure that you can produce
these records at your principal place of
business in the time required by the
DOT agency. For example, as a motor
carrier, when an FMCSA inspector requests your records, you must ensure
that you can provide them within two
business days.
(e) If you store records electronically, where permitted by this part,
you must ensure that the records are
easily accessible, legible, and formatted and stored in an organized
manner. If electronic records do not
meet these criteria, you must convert
them to printed documentation in a

[65 FR 79526, Dec. 19, 2000, as amended at 66
FR 41955, Aug. 9, 2001]

Subpart Q—Roles and
Responsibilities of Service Agents
§ 40.341 Must service agents comply
with DOT drug and alcohol testing
requirements?
(a) As a service agent, the services
you provide to transportation employers must meet the requirements of this
part and the DOT agency drug and alcohol testing regulations.
(b) If you do not comply, DOT may
take action under the Public Interest
Exclusions procedures of this part (see
Subpart R of this part) or applicable
provisions of other DOT agency regulations.
§ 40.343 What tasks may a service
agent perform for an employer?
As a service agent, you may perform
for employers the tasks needed to comply with DOT agency drug and alcohol
testing regulations, subject to the requirements and limitations of this
part.
§ 40.345 In what circumstances may a
C/TPA act as an intermediary in the
transmission of drug and alcohol
testing information to employers?
(a) As a C/TPA or other service
agent, you may act as an intermediary
in the transmission of drug and alcohol
testing
information
in
the
circumstances specified in this section
only if the employer chooses to have
you do so. Each employer makes the
decision about whether to receive some
or all of this information from you,
acting as an intermediary, rather than
directly from the service agent who
originates the information (e.g., an
MRO or BAT).
(b) The specific provisions of this
part concerning which you may act as
an intermediary are listed in Appendix
F to this part. These are the only situations in which you may act as an
intermediary. You are prohibited from
doing so in all other situations.
(c) In every case, you must ensure
that, in transmitting information to
employers, you meet all requirements

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Office of the Secretary of Transportation
(e.g., concerning confidentiality and
timing) that would apply if the service
agent originating the information (e.g.,
an MRO or collector) sent the information directly to the employer. For example, if you transmit drug testing results from MROs to DERs, you must
transmit each drug test result to the
DER in compliance with the MRO requirements set forth in § 40.167 .
§ 40.347 What functions may C/TPAs
perform with respect to administering testing?
As a C/TPA, except as otherwise specified in this part, you may perform the
following functions for employers concerning random selection and other selections for testing.
(a) You may operate random testing
programs for employers and may assist
(i.e., through contracting with laboratories or collection sites, conducting
collections) employers with other
types of testing (e.g., pre-employment,
post-accident, reasonable suspicion, return-to-duty, and follow-up).
(b) You may combine employees from
more than one employer or one transportation industry in a random pool if
permitted by all the DOT agency drug
and alcohol testing regulations involved.
(1) If you combine employees from
more than one transportation industry,
you must ensure that the random testing rate is at least equal to the highest
rate required by each DOT agency.
(2) Employees not covered by DOT
agency regulations may not be part of
the same random pool with DOT covered employees.
(c) You may assist employers in ensuring that follow-up testing is conducted in accordance with the plan established by the SAP. However, neither
you nor the employer are permitted to
randomly select employees from a
‘‘follow-up pool’’ for follow-up testing.

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§ 40.349 What records may a service
agent receive and maintain?
(a) Except where otherwise specified
in this part, as a service agent you may
receive and maintain all records concerning DOT drug and alcohol testing
programs, including positive, negative,
and refusal to test individual test results. You do not need the employee’s

§ 40.349
consent to receive and maintain these
records.
(b) You may maintain all information needed for operating a drug/alcohol program (e.g., CCFs, ATFs, names
of employees in random pools, random
selection lists, copies of notices to employers of selected employees) on behalf of an employer.
(c) If a service agent originating drug
or alcohol testing information, such as
an MRO or BAT, sends the information
directly to the DER, he or she may also
provide
the
information
simultaneously to you, as a C/TPA or other
service agent who maintains this information for the employer.
(d) If you are serving as an intermediary in transmitting information
that is required to be provided to the
employer, you must ensure that it
reaches the employer in the same time
periods required elsewhere in this part.
(e) You must ensure that you can
make available to the employer within
two business days any information the
employer is asked to produce by a DOT
agency representative.
(f) On request of an employer, you
must, at any time on the request of an
employer, transfer immediately all
records pertaining to the employer and
its employees to the employer or to
any other service agent the employer
designates. You must carry out this
transfer as soon as the employer requests it. You are not required to obtain employee consent for this transfer. You must not charge more than
your reasonable administrative costs
for conducting this transfer. You may
not charge a fee for the release of these
records.
(g) If you are planning to go out of
business or your organization will be
bought by or merged with another organization, you must immediately notify all employers and offer to transfer
all records pertaining to the employer
and its employees to the employer or
to any other service agent the employer designates. You must carry out
this transfer as soon as the employer
requests it. You are not required to obtain employee consent for this transfer. You must not charge more than
your reasonable administrative costs
for conducting this transfer. You may

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§ 40.351

49 CFR Subtitle A (10–1–21 Edition)

not charge a fee for the release of these
records.
[65 FR 79526, Dec. 19, 2000, as amended at 66
FR 41955, Aug. 9, 2001]

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§ 40.351 What confidentiality requirements apply to service agents?
Except where otherwise specified in
this part, as a service agent the following confidentiality requirements
apply to you:
(a) When you receive or maintain
confidential information about employees (e.g., individual test results),
you must follow the same confidentiality regulations as the employer
with respect to the use and release of
this information.
(b) You must follow all confidentiality and records retention requirements applicable to employers.
(c) You may not provide individual
test results or other confidential information to another employer without a
specific, written consent from the employee. For example, suppose you are a
C/TPA that has employers X and Y as
clients. Employee Jones works for X,
and you maintain Jones’ drug and alcohol test for X. Jones wants to change
jobs and work for Y. You may not inform Y of the result of a test conducted
for X without having a specific, written
consent from Jones. Likewise, you may
not provide this information to employer Z, who is not a C/TPA member,
without this consent.
(d) You must not use blanket consent
forms authorizing the release of employee testing information.
(e) You must establish adequate confidentiality and security measures to
ensure that confidential employee
records are not available to unauthorized persons. This includes protecting
the physical security of records, access
controls, and computer security measures to safeguard confidential data in
electronic data bases.
§ 40.353 What principles govern the
interaction between MROs and
other service agents?
As a service agent other than an
MRO (e.g., a C/TPA), the following
principles govern your interaction with
MROs:
(a) You may provide MRO services to
employers, directly or through con-

tract, if you meet all applicable provisions of this part.
(b) If you employ or contract for an
MRO, the MRO must perform duties
independently
and
confidentially.
When you have a relationship with an
MRO, you must structure the relationship to ensure that this independence
and confidentiality are not compromised. Specific means (including
both physical and operational measures, as appropriate) to separate MRO
functions and other service agent functions are essential.
(c) Only your staff who are actually
under the day-to-day supervision and
control of an MRO with respect to
MRO functions may perform these
functions. This does not mean that
those staff may not perform other
functions at other times. However, the
designation of your staff to perform
MRO functions under MRO supervision
must be limited and not used as a subterfuge to circumvent confidentiality
and other requirements of this part and
DOT agency regulations. You must ensure that MRO staff operate under controls sufficient to ensure that the independence and confidentiality of the
MRO process are not compromised.
(d) Like other MROs, an MRO you
employ or contract with must personally conduct verification interviews
with employees and must personally
make all verification decisions. Consequently, your staff cannot perform
these functions.
§ 40.355 What limitations apply to the
activities of service agents?
As a service agent, you are subject to
the following limitations concerning
your activities in the DOT drug and alcohol testing program.
(a) You must not require an employee to sign a consent, release, waiver of liability, or indemnification
agreement with respect to any part of
the drug or alcohol testing process covered by this part (including, but not
limited to, collections, laboratory testing, MRO, and SAP services). No one
may do so on behalf of a service agent.
(b) You must not act as an intermediary in the transmission of drug
test results from the laboratory to the
MRO. That is, the laboratory may not
send results to you, with you in turn

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Office of the Secretary of Transportation
sending them to the MRO for
verification. For example, a practice in
which the laboratory transmits results
to your computer system, and you then
assign the results to a particular MRO,
is not permitted.
(c) You must not transmit drug test
results directly from the laboratory to
the employer (by electronic or other
means) or to a service agent who forwards them to the employer. All confirmed laboratory results must be processed by the MRO before they are released to any other party.
(d) You must not act as an intermediary in the transmission of alcohol
test results of 0.02 or higher from the
STT or BAT to the DER.
(e) Except as provided in paragraph
(f) of this section, you must not act as
an intermediary in the transmission of
individual SAP reports to the actual
employer. That is, the SAP may not
send such reports to you, with you in
turn sending them to the actual employer. However, you may maintain individual SAP summary reports and follow-up testing plans after they are sent
to the DER, and the SAP may transmit
such reports to you simultaneously
with sending them to the DER.
(f) As an exception to paragraph (e)
of this section, you may act as an
intermediary in the transmission of
SAP report from the SAP to an owneroperator or other self-employed individual.
(g) Except as provided in paragraph
(h) of this section, you must not make
decisions to test an employee based
upon reasonable suspicion, post-accident, return-to-duty, and follow-up determination criteria. These are duties
the actual employer cannot delegate to
a C/TPA. You may, however, provide
advice and information to employers
regarding these testing issues and how
the employer should schedule required
testing.
(h) As an exception to paragraph (g)
of this section, you may make decisions to test an employee based upon
reasonable suspicion, post-accident, return-to-duty, and follow-up determination criteria with respect to an owneroperator or other self-employed individual.
(i) Except as provided in paragraph
(j) of this section, you must not make

§ 40.355
a determination that an employee has
refused a drug or alcohol test. This is a
non-delegable duty of the actual employer. You may, however, provide advice and information to employers regarding refusal-to-test issues.
(j) As an exception to paragraph (i) of
this section, you may make a determination that an employee has refused
a drug or alcohol test, if:
(1) You schedule a required test for
an owner-operator or other self-employed individual, and the individual
fails to appear for the test without a
legitimate reason; or
(2) As an MRO, you determine that
an individual has refused to test on the
basis of adulteration or substitution.
(k) You must not act as a DER. For
example, while you may be responsible
for transmitting information to the
employer about test results, you must
not act on behalf of the employer in actions to remove employees from safetysensitive duties.
(l) In transmitting documents to laboratories, you must ensure that you
send to the laboratory that conducts
testing only Copy 1 of the CCF. You
must not transmit other copies of the
CCF or any ATFs to the laboratory.
(m) You must not impose conditions
or requirements on employers that
DOT regulations do not authorize. For
example, as a C/TPA serving employers
in the pipeline or motor carrier industry, you must not require employers to
have provisions in their DOT plans
that PHMSA or FMCSA regulations do
not require.
(n) You must not intentionally delay
the transmission of drug or alcohol
testing-related documents concerning
actions you have performed, because of
a payment dispute or other reasons.
Example 1 to paragraph (n): A laboratory
that has tested a specimen must not delay
transmitting the documentation of the test
result to an MRO because of a billing or payment dispute with the MRO or a C/TPA.
Example 2 to paragraph (n): An MRO or SAP
who has interviewed an employee must not
delay sending a verified test result or SAP
report to the employer because of such a dispute with the employer or employee.
Example 3 to paragraph (n): A collector who
has performed a urine specimen collection
must not delay sending the drug specimen
and CCF to the laboratory because of a payment or other dispute with the laboratory or
a C/TPA.

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§ 40.361

49 CFR Subtitle A (10–1–21 Edition)

Example 4 to paragraph (n): A BAT who has
conducted an alcohol test must not delay
sending test result information to an employer or C/TPA because of a payment or
other dispute with the employer or C/TPA.

(o) While you must follow the DOT
agency regulations, the actual employer remains accountable to DOT for
compliance, and your failure to implement any aspect of the program as required in this part and other applicable
DOT agency regulations makes the employer subject to enforcement action
by the Department.
[65 FR 79526, Dec. 19, 2000, as amended at 66
FR 41955, Aug. 9, 2001; 71 FR 49384, Aug. 23,
2006; 75 FR 59108, Sept. 27, 2010]

Subpart R—Public Interest
Exclusions

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§ 40.361 What is the purpose of a public interest exclusion (PIE)?
(a) To protect the public interest, including protecting transportation employers and employees from serious
noncompliance with DOT drug and alcohol testing rules, the Department’s
policy is to ensure that employers conduct business only with responsible
service agents.
(b) The Department therefore uses
PIEs to exclude from participation in
DOT’s drug and alcohol testing program any service agent who, by serious
noncompliance with this part or other
DOT agency drug and alcohol testing
regulations, has shown that it is not
currently acting in a responsible manner.
(c) A PIE is a serious action that the
Department takes only to protect the
public interest. We intend to use PIEs
only to remedy situations of serious
noncompliance. PIEs are not used for
the purpose of punishment.
(d) Nothing in this subpart precludes
a DOT agency or the Inspector General
from taking other action authorized by
its regulations with respect to service
agents or employers that violate its
regulations.
§ 40.363 On what basis may the Department issue a PIE?
(a) If you are a service agent, the Department may issue a PIE concerning
you if we determine that you have
failed or refused to provide drug or al-

cohol testing services consistent with
the requirements of this part or a DOT
agency drug and alcohol regulation.
(b) The Department also may issue a
PIE if you have failed to cooperate
with DOT agency representatives concerning inspections, complaint investigations, compliance and enforcement
reviews, or requests for documents and
other information about compliance
with this part or DOT agency drug and
alcohol regulations.
§ 40.365 What is the Department’s policy concerning starting a PIE proceeding?
(a) It is the Department’s policy to
start a PIE proceeding only in cases of
serious, uncorrected noncompliance
with the provisions of this part, affecting such matters as safety, the outcomes of test results, privacy and confidentiality, due process and fairness
for employees, the honesty and integrity of the testing program, and cooperation with or provision of information to DOT agency representatives.
(b) The following are examples of the
kinds of serious noncompliance that, as
a matter of policy, the Department
views as appropriate grounds for starting a PIE proceeding. These examples
are not intended to be an exhaustive or
exclusive list of the grounds for starting a PIE proceeding. We intend them
to illustrate the level of seriousness
that the Department believes supports
starting a PIE proceeding. The examples follow:
(1) For an MRO, verifying tests positive without interviewing the employees as required by this part or providing MRO services without meeting
the qualifications for an MRO required
by this part;
(2) For a laboratory, refusing to provide information to the Department,
an employer, or an employee as required by this part; failing or refusing
to conduct a validity testing program
when required by this part; or a pattern or practice of testing errors that
result in the cancellation of tests. (As
a general matter of policy, the Department does not intend to initiate a PIE
proceeding concerning a laboratory
with respect to matters on which HHS
initiates certification actions under its
laboratory guidelines.);

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Office of the Secretary of Transportation
(3) For a collector, a pattern or practice of directly observing collections
when doing so is unauthorized, or failing or refusing to directly observe collections when doing so is mandatory;
(4) For collectors, BATs, or STTs, a
pattern or practice of using forms,
testing equipment, or collection kits
that do not meet the standards in this
part;
(5) For a collector, BAT, or STT, a
pattern or practice of ‘‘fatal flaws’’ or
other significant uncorrected errors in
the collection process;
(6) For a laboratory, MRO or C/TPA,
failing or refusing to report tests results as required by this part or DOT
agency regulations;
(7) For a laboratory, falsifying, concealing, or destroying documentation
concerning any part of the drug testing
process, including, but not limited to,
documents in a ‘‘litigation package’’;
(8) For SAPs, providing SAP services
while not meeting SAP qualifications
required by this part or performing
evaluations without face-to-face interviews;
(9) For any service agent, maintaining a relationship with another party
that constitutes a conflict of interest
under this part (e.g., a laboratory that
derives a financial benefit from having
an employer use a specific MRO);
(10) For any service agent, falsely
representing that the service agent or
its activities is approved or certified by
the Department or a DOT agency (such
representation includes, but is not limited to, the use of a Department or
DOT agency logo, title, or emblem).
(11) For any service agent, disclosing
an employee’s test result information
to any party this part or a DOT agency
regulation does not authorize, including by obtaining a ‘‘blanket’’ consent
from employees or by creating a data
base from which employers or others
can retrieve an employee’s DOT test
results without the specific consent of
the employee;
(12) For any service agent, interfering or attempting to interfere with
the ability of an MRO to communicate
with the Department, or retaliating
against an MRO for communicating
with the Department;
(13) For any service agent, directing
or recommending that an employer fail

§ 40.371
or refuse to implement any provision of
this part; or
(14) With respect to noncompliance
with a DOT agency regulation, conduct
that affects important provisions of
Department-wide concern (e.g., failure
to properly conduct the selection process for random testing).
[65 FR 79526, Dec. 19, 2000, as amended at 82
FR 52247, Nov. 13, 2017]

§ 40.367 Who
ceeding?

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pro-

The following DOT officials may initiate a PIE proceeding:
(a) The drug and alcohol program
manager of a DOT agency;
(b) An official of ODAPC, other than
the Director; or
(c) The designee of any of these officials.
§ 40.369 What is the discretion of an
initiating official in starting a PIE
proceeding?
(a) Initiating officials have broad discretion in deciding whether to start a
PIE proceeding.
(b) In exercising this discretion, the
initiating official must consider the
Department’s policy regarding the seriousness of the service agent’s conduct
(see § 40.365) and all information he or
she has obtained to this point concerning the facts of the case. The initiating official may also consider the
availability of the resources needed to
pursue a PIE proceeding.
(c) A decision not to initiate a PIE
proceeding does not necessarily mean
that the Department regards a service
agent as being in compliance or that
the Department may not use other applicable remedies in a situation of noncompliance.
§ 40.371 On what information does an
initiating official rely in deciding
whether to start a PIE proceeding?
(a) An initiating official may rely on
credible information from any source
as the basis for starting a PIE proceeding.
(b) Before sending a correction notice
(see § 40.373), the initiating official informally contacts the service agent to
determine if there is any information
that may affect the initiating official’s

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§ 40.373

49 CFR Subtitle A (10–1–21 Edition)

determination about whether it is necessary to send a correction notice. The
initiating official may take any information resulting from this contact
into account in determining whether to
proceed under this subpart.
§ 40.373 Before starting a PIE proceeding, does the initiating official
give the service agent an opportunity to correct problems?
(a) If you are a service agent, the initiating official must send you a correction notice before starting a PIE proceeding.
(b) The correction notice identifies
the specific areas in which you must
come into compliance in order to avoid
being subject to a PIE proceeding.
(c) If you make and document
changes needed to come into compliance in the areas listed in the correction notice to the satisfaction of the
initiating official within 60 days of the
date you receive the notice, the initiating official does not start a PIE proceeding. The initiating official may
conduct appropriate fact finding to
verify that you have made and maintained satisfactory corrections. When
he or she is satisfied that you are in
compliance, the initiating official
sends you a notice that the matter is
concluded.

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§ 40.375 How does the initiating official start a PIE proceeding?
(a) As a service agent, if your compliance matter is not correctable (see
§ 40.373(a)), or if have not resolved compliance
matters
as
provided
in
§ 40.373(c), the initiating official starts
a PIE proceeding by sending you a notice of proposed exclusion (NOPE). The
NOPE contains the initiating official’s
recommendations
concerning
the
issuance of a PIE, but it is not a decision by the Department to issue a PIE.
(b) The NOPE includes the following
information:
(1) A statement that the initiating
official is recommending that the Department issue a PIE concerning you;
(2) The factual basis for the initiating official’s belief that you are not
providing drug and/or alcohol testing
services to DOT-regulated employers
consistent with the requirements of
this part or are in serious noncompli-

ance with a DOT agency drug and alcohol regulation;
(3) The factual basis for the initiating official’s belief that your noncompliance has not been or cannot be
corrected;
(4) The initiating official’s recommendation for the scope of the PIE;
(5) The initiating official’s recommendation for the duration of the
PIE; and
(6) A statement that you may contest
the issuance of the proposed PIE, as
provided in § 40.379.
(c) The initiating official sends a
copy of the NOPE to the ODAPC Director at the same time he or she sends
the NOPE to you.
§ 40.377 Who decides whether to issue
a PIE?
(a) The ODAPC Director, or his or
her designee, decides whether to issue a
PIE. If a designee is acting as the decisionmaker, all references in this subpart to the Director refer to the designee.
(b) To ensure his or her impartiality,
the Director plays no role in the initiating official’s determination about
whether to start a PIE proceeding.
(c) There is a ‘‘firewall’’ between the
initiating official and the Director.
This means that the initiating official
and the Director are prohibited from
having any discussion, contact, or exchange of information with one another about the matter, except for documents and discussions that are part of
the record of the proceeding.
§ 40.379 How do you
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(a) If you receive a NOPE, you may
contest the issuance of the PIE.
(b) If you want to contest the proposed PIE, you must provide the Director information and argument in opposition to the proposed PIE in writing,
in person, and/or through a representative. To contest the proposed PIE, you
must take one or more of the steps listed in this paragraph (b) within 30 days
after you receive the NOPE.
(1) You may request that the Director dismiss the proposed PIE without
further proceedings, on the basis that

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Office of the Secretary of Transportation
it does not concern serious noncompliance with this part or DOT agency regulations, consistent with the Department’s policy as stated in § 40.365.
(2) You may present written information and arguments, consistent with
the provisions of § 40.381, contesting the
proposed PIE.
(3) You may arrange with the Director for an informal meeting to present
your information and arguments.
(c) If you do not take any of the actions listed in paragraph (b) of this section within 30 days after you receive
the NOPE, the matter proceeds as an
uncontested case. In this event, the Director makes his or her decision based
on the record provided by the initiating official (i.e., the NOPE and any
supporting information or testimony)
and any additional information the Director obtains.
§ 40.381 What information do you
present to contest the proposed
issuance of a PIE?
(a) As a service agent who wants to
contest a proposed PIE, you must
present at least the following information to the Director:
(1) Specific facts that contradict the
statements contained in the NOPE (see
§ 40.375(b)(2) and (3)). A general denial is
insufficient to raise a genuine dispute
over facts material to the issuance of a
PIE;
(2) Identification of any existing, proposed or prior PIE; and
(3) Identification of your affiliates, if
any.
(b) You may provide any information
and arguments you wish concerning
the proposed issuance, scope and duration of the PIE (see § 40.375(b)(4) and
(5)).
(c) You may provide any additional
relevant information or arguments
concerning any of the issues in the
matter.

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§ 40.383 What procedures apply if you
contest the issuance of a PIE?
(a) DOT conducts PIE proceedings in
a fair and informal manner. The Director may use flexible procedures to
allow you to present matters in opposition. The Director is not required to
follow formal rules of evidence or pro-

§ 40.387
cedure in creating the record of the
proceeding.
(b) The Director will consider any information or argument he or she determines to be relevant to the decision on
the matter.
(c) You may submit any documentary evidence you want the Director to
consider. In addition, if you have arranged an informal meeting with the
Director, you may present witnesses
and confront any person the initiating
official presents as a witness against
you.
(d) In cases where there are material
factual issues in dispute, the Director
or his or her designee may conduct additional fact-finding.
(e) If you have arranged a meeting
with the Director, the Director will
make a transcribed record of the meeting available to you on your request.
You must pay the cost of transcribing
and copying the meeting record.
§ 40.385 Who bears the burden of proof
in a PIE proceeding?
(a) As the proponent of issuing a PIE,
the initiating official bears the burden
of proof.
(b) This burden is to demonstrate, by
a preponderance of the evidence, that
the service agent was in serious noncompliance with the requirements of
this part for drug and/or alcohol testing-related services or with the requirements of another DOT agency
drug and alcohol testing regulation.
§ 40.387 What matters does the Director decide concerning a proposed
PIE?
(a) Following the service agent’s response (see § 40.379(b)) or, if no response
is received, after 30 days have passed
from the date on which the service
agent received the NOPE, the Director
may take one of the following steps:
(1) In response to a request from the
service agent (see § 40.379(b)(1)) or on
his or her own motion, the Director
may dismiss a PIE proceeding if he or
she determines that it does not concern
serious noncompliance with this part
or DOT agency regulations, consistent
with the Department’s policy as stated
in § 40.365.
(i) If the Director dismisses a proposed PIE under this paragraph (a), the

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§ 40.389

49 CFR Subtitle A (10–1–21 Edition)

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action is closed with respect to the
noncompliance alleged in the NOPE.
(ii) The Department may initiate a
new PIE proceeding against you on the
basis of different or subsequent conduct that is in noncompliance with this
part or other DOT drug and alcohol
testing rules.
(2) If the Director determines that
the initiating official’s submission does
not have complete information needed
for a decision, the Director may remand the matter to the initiating official. The initiating official may resubmit the matter to the Director when
the needed information is complete. If
the basis for the proposed PIE has
changed, the initiating official must
send an amended NOPE to the service
agent.
(b) The Director makes determinations concerning the following matters
in any PIE proceeding that he or she
decides on the merits:
(1) Any material facts that are in dispute;
(2) Whether the facts support issuing
a PIE;
(3) The scope of any PIE that is
issued; and
(4) The duration of any PIE that is
issued.
§ 40.389 What factors may the Director
consider?
This section lists examples of the
kind of mitigating and aggravating
factors that the Director may consider
in determining whether to issue a PIE
concerning you, as well as the scope
and duration of a PIE. This list is not
exhaustive or exclusive. The Director
may consider other factors if appropriate in the circumstances of a particular case. The list of examples follows:
(a) The actual or potential harm that
results or may result from your noncompliance;
(b) The frequency of incidents and/or
duration of the noncompliance;
(c) Whether there is a pattern or
prior history of noncompliance;
(d) Whether the noncompliance was
pervasive within your organization, including such factors as the following:
(1) Whether and to what extent your
organization planned, initiated, or carried out the noncompliance;

(2) The positions held by individuals
involved in the noncompliance, and
whether your principals tolerated their
noncompliance; and
(3) Whether you had effective standards of conduct and control systems
(both with respect to your own organization and any contractors or affiliates) at the time the noncompliance
occurred;
(e) Whether you have demonstrated
an appropriate compliance disposition,
including such factors as the following:
(1) Whether you have accepted responsibility for the noncompliance and
recognize the seriousness of the conduct that led to the cause for issuance
of the PIE;
(2) Whether you have cooperated
fully with the Department during the
investigation. The Director may consider when the cooperation began and
whether you disclosed all pertinent information known to you;
(3) Whether you have fully investigated the circumstances of the noncompliance forming the basis for the
PIE and, if so, have made the result of
the investigation available to the Director;
(4) Whether you have taken appropriate disciplinary action against the
individuals responsible for the activity
that constitutes the grounds for
issuance of the PIE; and
(5) Whether your organization has
taken appropriate corrective actions or
remedial measures, including implementing actions to prevent recurrence;
(f) With respect to noncompliance
with a DOT agency regulation, the degree to which the noncompliance affects matters common to the DOT drug
and alcohol testing program;
(g) Other factors appropriate to the
circumstances of the case.
§ 40.391

What is the scope of a PIE?

(a) The scope of a PIE is the Department’s determination about the divisions, organizational elements, types of
services, affiliates, and/or individuals
(including direct employees of a service
agent and its contractors) to which a
PIE applies.
(b) If, as a service agent, the Department issues a PIE concerning you, the

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Office of the Secretary of Transportation
PIE applies to all your divisions, organizational elements, and types of services that are involved with or affected
by the noncompliance that forms the
factual basis for issuing the PIE.
(c) In the NOPE (see § 40.375(b)(4)), the
initiating official sets forth his or her
recommendation for the scope of the
PIE. The proposed scope of the PIE is
one of the elements of the proceeding
that the service agent may contest (see
§ 40.381(b)) and about which the Director makes a decision (see § 40.387(b)(3)).
(d) In recommending and deciding
the scope of the PIE, the initiating official and Director, respectively, must
take into account the provisions of
paragraphs (e) through (j) of this section.
(e) The pervasiveness of the noncompliance within a service agent’s organization (see § 40.389(d)) is an important consideration in determining the
scope of a PIE. The appropriate scope
of a PIE grows broader as the pervasiveness of the noncompliance increases.
(f) The application of a PIE is not
limited to the specific location or employer at which the conduct that forms
the factual basis for issuing the PIE
was discovered.
(g) A PIE applies to your affiliates, if
the affiliate is involved with or affected by the conduct that forms the
factual basis for issuing the PIE.
(h) A PIE applies to individuals who
are officers, employees, directors,
shareholders, partners, or other individuals associated with your organization in the following circumstances:
(1) Conduct forming any part of the
factual basis of the PIE occurred in
connection with the individual’s performance of duties by or on behalf of
your organization; or
(2) The individual knew of, had reason to know of, approved, or acquiesced
in such conduct. The individual’s acceptance of benefits derived from such
conduct is evidence of such knowledge,
acquiescence, or approval.
(i) If a contractor to your organization is solely responsible for the conduct that forms the factual basis for a
PIE, the PIE does not apply to the
service agent itself unless the service
agent knew or should have known

§ 40.391
about the conduct and did not take action to correct it.
(j) PIEs do not apply to drug and alcohol testing that DOT does not regulate.
(k) The following examples illustrate
how the Department intends the provisions of this section to work:
Example 1 to § 40.391. Service Agent P provides a variety of drug testing services. P’s
SAP services are involved in a serious violation of this Part 40. However, P’s other services fully comply with this part, and P’s
overall management did not plan or concur
in the noncompliance, which in fact was contrary to P’s articulated standards. Because
the noncompliance was isolated in one area
of the organization’s activities, and did not
pervade the entire organization, the scope of
the PIE could be limited to SAP services.
Example 2 to § 40.391. Service Agent Q provides a similar variety of services. The conduct forming the factual basis for a PIE concerns collections for a transit authority. As
in Example 1, the noncompliance is not pervasive throughout Q’s organization. The PIE
would apply to collections at all locations
served by Q, not just the particular transit
authority or not just in the state in which
the transit authority is located.
Example 3 to § 40.391. Service Agent R provides a similar array of services. One or more
of the following problems exists: R’s activities in several areas—collections, MROs,
SAPs, protecting the confidentiality of information—are involved in serious noncompliance; DOT determines that R’s management knew or should have known about
serious noncompliance in one or more areas,
but management did not take timely corrective action; or, in response to an inquiry
from DOT personnel, R’s management refuses to provide information about its operations. In each of these three cases, the
scope of the PIE would include all aspects of
R’s services.
Example 4 to § 40.391. Service Agent W provides only one kind of service (e.g., laboratory or MRO services). The Department
issues a PIE concerning these services. Because W only provides this one kind of service, the PIE necessarily applies to all its operations.
Example 5 to § 40.391. Service Agent X, by
exercising reasonably prudent oversight of
its collection contractor, should have known
that the contractor was making numerous
‘‘fatal flaws’’ in tests. Alternatively, X received a correction notice pointing out these
problems in its contractor’s collections. In
neither case did X take action to correct the
problem. X, as well as the contractor, would
be subject to a PIE with respect to collections.

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§ 40.393

49 CFR Subtitle A (10–1–21 Edition)

Example 6 to § 40.391. Service Agent Y could
not reasonably have known that one of its
MROs was regularly failing to interview employees before verifying tests positive. When
it received a correction notice, Y immediately dismissed the erring MRO. In this
case, the MRO would be subject to a PIE but
Y would not.
Example 7 to § 40.391. The Department issues
a PIE with respect to Service Agent Z. Z provides services for DOT-regulated transportation employers, a Federal agency under
the HHS-regulated Federal employee testing
program, and various private businesses and
public agencies that DOT does not regulate.
The PIE applies only to the DOT-regulated
transportation employers with respect to
their DOT-mandated testing, not to the Federal agency or the other public agencies and
private businesses. The PIE does not prevent
the non-DOT regulated entities from continuing to use Z’s services.

§ 40.393 How long does a PIE stay in
effect?
(a) In the NOPE (see § 40.375(b)(5)),
the initiating official proposes the duration of the PIE. The duration of the
PIE is one of the elements of the proceeding that the service agent may
contest (see § 40.381(b)) and about which
the Director makes a decision (see
§ 40.387(b)(4)).
(b) In deciding upon the duration of
the PIE, the Director considers the seriousness of the conduct on which the
PIE is based and the continued need to
protect employers and employees from
the service agent’s noncompliance. The
Director considers factors such as
those listed in § 40.389 in making this
decision.
(c) The duration of a PIE will be between one and five years, unless the Director reduces its duration under
§ 40.407.

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§ 40.395 Can you settle a PIE proceeding?
At any time before the Director’s decision, you and the initiating official
can, with the Director’s concurrence,
settle a PIE proceeding.
§ 40.397 When does the Director make
a PIE decision?
The Director makes his or her decision within 60 days of the date when
the record of a PIE proceeding is complete (including any meeting with the
Director and any additional fact-finding that is necessary). The Director

may extend this period for good cause
for additional periods of up to 30 days.
§ 40.399 How does the Department notify service agents of its decision?
If you are a service agent involved in
a PIE proceeding, the Director provides
you written notice as soon as he or she
makes a PIE decision. The notice includes the following elements:
(a) If the decision is not to issue a
PIE, a statement of the reasons for the
decision, including findings of fact
with respect to any material factual
issues that were in dispute.
(b) If the decision is to issue a PIE—
(1) A reference to the NOPE;
(2) A statement of the reasons for the
decision, including findings of fact
with respect to any material factual
issues that were in dispute;
(3) A statement of the scope of the
PIE; and
(4) A statement of the duration of the
PIE.
§ 40.401 How does the Department notify employers and the public about
a PIE?
(a) The Department maintains a document called the ‘‘List of Excluded
Drug and Alcohol Service Agents.’’
This document may be found on the
Department’s
web
site
(http://
www.transportation.gov/odapc) . You
may also request a copy of the document from ODAPC.
(b) When the Director issues a PIE,
he or she adds to the List the name and
address of the service agent, and any
other persons or organizations, to
whom the PIE applies and information
about the scope and duration of the
PIE.
(c) When a service agent ceases to be
subject to a PIE, the Director removes
this information from the List.
(d) The Department also publishes a
FEDERAL REGISTER notice to inform
the public on any occasion on which a
service agent is added to or taken off
the List.
[65 FR 79526, Dec. 19, 2000, as amended at 82
FR 52247, Nov. 13, 2017]

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Office of the Secretary of Transportation
§ 40.403 Must a service agent notify its
clients when the Department issues
a PIE?
(a) As a service agent, if the Department issues a PIE concerning you, you
must notify each of your DOT-regulated employer clients, in writing,
about the issuance, scope, duration,
and effect of the PIE. You may meet
this requirement by sending a copy of
the Director’s PIE decision or by a separate notice. You must send this notice
to each client within three business
days of receiving from the Department
the notice provided for in § 40.399(b).
(b) As part of the notice you send
under paragraph (a) of this section, you
must offer to transfer immediately all
records pertaining to the employer and
its employees to the employer or to
any other service agent the employer
designates. You must carry out this
transfer as soon as the employer requests it.
[65 FR 79526, Dec. 19, 2000, as amended at 66
FR 41955, Aug. 9, 2001]

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§ 40.405 May the Federal courts review
PIE decisions?
The Director’s decision is a final administrative action of the Department.
Like all final administrative actions of
Federal agencies, the Director’s decision is subject to judicial review under
the Administrative Procedure Act (5
U.S.C. 551 et. seq).
§ 40.407 May a service agent ask to
have a PIE reduced or terminated?
(a) Yes, as a service agent concerning
whom the Department has issued a
PIE, you may request that the Director
terminate a PIE or reduce its duration
and/or scope. This process is limited to
the issues of duration and scope. It is
not an appeal or reconsideration of the
decision to issue the PIE.
(b) Your request must be in writing
and supported with documentation.
(c) You must wait at least nine
months from the date on which the Director issued the PIE to make this request.
(d) The initiating official who was
the proponent of the PIE may provide
information and arguments concerning
your request to the Director.
(e) If the Director verifies that the
sources of your noncompliance have

§ 40.409
been eliminated and that all drug or alcohol testing-related services you
would provide to DOT-regulated employers will be consistent with the requirements of this part, the Director
may issue a notice terminating or reducing the PIE.
§ 40.409 What does the issuance of a
PIE mean to transportation employers?
(a) As an employer, you are deemed
to have notice of the issuance of a PIE
when it appears on the List mentioned
in § 40.401(a) or the notice of the PIE
appears in the FEDERAL REGISTER as
provided in § 40.401(d). You should
check this List to ensure that any
service agents you are using or planning to use are not subject to a PIE.
(b) As an employer who is using a
service agent concerning whom a PIE
is issued, you must stop using the services of the service agent no later than
90 days after the Department has published the decision in the FEDERAL
REGISTER or posted it on its web site.
You may apply to the ODAPC Director
for an extension of 30 days if you demonstrate that you cannot find a substitute service agent within 90 days.
(c) Except during the period provided
in paragraph (b) of this section, you
must not, as an employer, use the services of a service agent that are covered
by a PIE that the Director has issued
under this subpart. If you do so, you
are in violation of the Department’s
regulations and subject to applicable
DOT agency sanctions (e.g., civil penalties, withholding of Federal financial
assistance).
(d) You also must not obtain drug or
alcohol testing services through a contractor or affiliate of the service agent
to whom the PIE applies.
Example to paragraph (d): Service Agent R
was subject to a PIE with respect to SAP
services. As an employer, not only must you
not use R’s own SAP services, but you also
must not use SAP services you arrange
through R, such as services provided by a
subcontractor or affiliate of R or a person or
organization that receives financial gain
from its relationship with R.

(e) This section’s prohibition on
using the services of a service agent
concerning which the Director has
issued a PIE applies to employers in all

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§ 40.411

49 CFR Subtitle A (10–1–21 Edition)

industries subject to DOT drug and alcohol testing regulations.
Example to paragraph (e): The initiating official for a PIE was the FAA drug and alcohol program manager, and the conduct forming the basis of the PIE pertained to the
aviation industry. As a motor carrier, transit authority, pipeline, railroad, or maritime
employer, you are also prohibited from using
the services of the service agent involved in
connection with the DOT drug and alcohol
testing program.

(f) The issuance of a PIE does not result in the cancellation of drug or alcohol tests conducted using the service
agent involved before the issuance of
the Director’s decision or up to 90 days
following its publication in the FEDERAL REGISTER or posting on the Department’s web site, unless otherwise
specified in the Director’s PIE decision
or the Director grants an extension as
provided in paragraph (b) of this
section.
Example to paragraph (f): The Department
issues a PIE concerning Service Agent N on
September 1. All tests conducted using N’s
services before September 1, and through November 30, are valid for all purposes under
DOT drug and alcohol testing regulations,
assuming they meet all other regulatory requirements.

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§ 40.411 What is the role of the DOT Inspector General’s office?
(a) Any person may bring concerns
about waste, fraud, or abuse on the
part of a service agent to the attention
of the DOT Office of Inspector General.
(b) In appropriate cases, the Office of
Inspector General may pursue criminal
or civil remedies against a service
agent.
(c) The Office of Inspector General
may provide factual information to
other DOT officials for use in a PIE
proceeding.
§ 40.413 How are notices sent to service agents?
(a) If you are a service agent, DOT
sends notices to you, including correction notices, notices of proposed exclusion, decision notices, and other notices, in any of the ways mentioned in
paragraph (b) or (c) of this section.
(b) DOT may send a notice to you,
your identified counsel, your agent for
service of process, or any of your partners, officers, directors, owners, or

joint venturers to the last known
street address, fax number, or e-mail
address. DOT deems the notice to have
been received by you if sent to any of
these persons.
(c) DOT considers notices to be received by you—
(1) When delivered, if DOT mails the
notice to the last known street address, or five days after we send it if
the letter is undeliverable;
(2) When sent, if DOT sends the notice by fax or five days after we send it
if the fax is undeliverable; or
(3) When delivered, if DOT sends the
notice by e-mail or five days after DOT
sends it if the e-mail is undeliverable.

APPENDIX A TO PART 40—DOT
STANDARDS FOR URINE COLLECTION KITS
The Collection Kit Contents
1. Collection Container
a. Single-use container, made of plastic,
large enough to easily catch and hold at
least 55 mL of urine voided from the body.
b. Must have graduated volume markings
clearly noting levels of 45 mL and above.
c. Must have a temperature strip providing
graduated temperature readings 32–38 °C/90–
100 °F, that is affixed or can be affixed at a
proper level on the outside of the collection
container. Other methodologies (e.g., temperature device built into the wall of the
container) are acceptable provided the temperature measurement is accurate and such
that there is no potential for contamination
of the specimen.
d. Must be individually wrapped in a sealed
plastic bag or shrink wrapping; or must have
a peelable, sealed lid or other easily visible
tamper-evident system.
e. May be made available separately at collection sites to address shy bladder situations when several voids may be required to
complete the testing process.
2. Plastic Specimen Bottles
a. Each bottle must be large enough to
hold at least 35 mL; or alternatively, they
may be two distinct sizes of specimen bottles
provided that the bottle designed to hold the
primary specimen holds at least 35 mL of
urine and the bottle designed to hold the
split specimen holds at least 20 mL.
b. Must have screw-on or snap-on caps that
prevent seepage of the urine from the bottles
during shipment.
c. Must have markings clearly indicating
the appropriate levels (30 mL for the primary
specimen and 15 mL for the split) of urine
that must be poured into the bottles.

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Office of the Secretary of Transportation
d. Must be designed so that the required
tamper-evident bottle seals made available
on the CCF fit with no damage to the seal
when the employee initials it nor with the
chance that the seal overlap would conceal
printed information.
e. Must be wrapped (with caps) together in
a sealed plastic bag or shrink wrapping separate from the collection container; or must
be wrapped (with cap) individually in sealed
plastic bags or shrink wrapping; or must
have peelable, sealed lid or other easily visible tamper-evident system.
f. Plastic material must be leach resistant.
3. Leak-Resistant Plastic Bag
a. Must have two sealable compartments
or pouches which are leak-resistant; one
large enough to hold two specimen bottles
and the other large enough to hold the CCF
paperwork.
b. The sealing methodology must be such
that once the compartments are sealed, any
tampering or attempts to open either compartment will be evident.
4. Absorbent material
Each kit must contain enough absorbent
material to absorb the entire contents of
both specimen bottles. Absorbent material
must be designed to fit inside the leak-resistant plastic bag pouch into which the
specimen bottles are placed.
5. Shipping Container
a. Must be designed to adequately protect
the specimen bottles from shipment damage
in the transport of specimens from the collection site to the laboratory (e.g., standard
courier box, small cardboard box, plastic
container).
b. May be made available separately at collection sites rather than being part of an actual kit sent to collection sites.
c. A shipping container is not necessary if
a laboratory courier hand-delivers the specimen bottles in the plastic leak-proof bags
from the collection site to the laboratory.

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APPENDIX B TO PART 40—DOT DRUGTESTING SEMI-ANNUAL LABORATORY
REPORT TO EMPLOYERS
The following items are required on each
laboratory report:
Reporting Period: (inclusive dates)
Laboratory Identification: (name and address)
Employer Identification: (name; may include
Billing Code or ID code)
C/TPA Identification: (where applicable;
name and address)
1. Specimen Results Reported (total number)
By Test Reason
(a) Pre-employment (number)
(b) Post-Accident (number)
(c) Random (number)
(d) Reasonable Suspicion/Cause (number)
(e) Return-to-Duty (number)

Pt. 40, App. C
(f) Follow-up (number)
(g) Type of Test Not Noted on CCF (number)
2. Specimens Reported
(a) Negative (number)
(b) Negative and Dilute (number)
3. Specimens Reported as Rejected for Testing (total number)
By Reason
(a) Fatal flaw (number)
(b) Uncorrected Flaw (number)
4. Specimens Reported as Positive (total
number) By Drug
(a) Marijuana Metabolite (number)
(b) Cocaine Metabolite (number)
(c) Opioids (number)
(1) Codeine (number)
(2) Morphine (number)
(3) 6–AM (number)
(4) Hydrocodone (number)
(5) Hydromorphone (number)
(6) Oxycodone (number)
(7) Oxymorphone (number)
(d) Phencyclidine (number)
(e) Amphetamines (number)
(1) Amphetamine (number)
(2) Methamphetamine (number)
(3) MDMA (number)
(4) MDA (number)
5. Adulterated (number)
6. Substituted (number)
7. Invalid Result (number)
[82 FR 52247, Nov. 13, 2017]

APPENDIX C TO PART 40—DOT DRUGTESTING SEMI-ANNUAL LABORATORY
REPORT TO DOT
Mail, fax, or email to:
U.S. Department of Transportation, Office of
Drug and Alcohol Policy and Compliance,
W62–300, 1200 New Jersey Avenue SE.,
Washington, DC 20590, Fax: (202) 366–3897,
Email: [email protected].
The following items are required on each
report:
Reporting Period: (inclusive dates)
Laboratory Identification: (name and address)
1. DOT Specimen Results Reported (total
number)
2. Negative Results Reported (total number)
Negative (number)
Negative-Dilute (number)
3. Rejected for Testing Results Reported
(total number)
By Reason
(a) Fatal flaw (number)
(b) Uncorrected Flaw (number)
4. Positive Results Reported (total number)
By Drug
(a) Marijuana Metabolite (number)
(b) Cocaine Metabolite (number)
(c) Opioids (number)
(1) Codeine (number)
(2) Morphine (number)

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Pt. 40, App. D

49 CFR Subtitle A (10–1–21 Edition)

(3) 6–AM (number)
(4) Hydrocodone (number)
(5) Hydromorphone (number)
(6) Oxycodone (number)
(7) Oxymorphone (number)
(d) Phencyclidine (number)
(e) Amphetamines (number)
(1) Amphetamine (number)
(2) Methamphetamine (number)
(3) MDMA (number)
(4) MDA (number)
5. Adulterated Results Reported (total number)
By Reason (number)
6. Substituted Results Reported (total number)
7. Invalid Results Reported (total number)
By Reason (number)
[82 FR 52247, Nov. 13, 2017]

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APPENDIX D TO PART 40—REPORT FORMAT: SPLIT SPECIMEN FAILURE TO
RECONFIRM
Mail, fax, or submit electronically to:
U.S. Department of Transportation, Office of
Drug and Alcohol Policy and Compliance,
W62–300, 1200 New Jersey Avenue SE.,
Washington, DC 20590, Fax: (202) 366–
3897.Submit
Electronically:
https://
www.transportation.gov/content/split-specimen-cancellation-notification-49-cfr-part40187-appendix-d
The following items are required on each
report:
1. MRO name, address, phone number, and
fax number.
2. Collection site name, address, and phone
number.
3. Date of collection.
4. Specimen I.D. number.
5. Laboratory accession number.
6. Primary specimen laboratory name, address, and phone number.
7. Date result reported or certified by primary laboratory.
8. Split specimen laboratory name, address, and phone number.
9. Date split specimen result reported or
certified by split specimen laboratory.
10. Primary specimen results (e.g., name of
drug, adulterant) in the primary specimen.
11. Reason for split specimen failure-to-reconfirm result (e.g., drug or adulterant not
present, specimen invalid, split not collected, insufficient volume).
12. Actions taken by the MRO (e.g., notified employer of failure to reconfirm and requirement for recollection).
13. Additional information explaining the
reason for cancellation.
14. Name of individual submitting the report (if not the MRO)
[82 FR 52247, Nov. 13, 2017]

APPENDIX E TO PART 40—SAP EQUIVALENCY REQUIREMENTS FOR CERTIFICATION ORGANIZATIONS
1. Experience: Minimum requirements are
for three years of full-time supervised experience or 6,000 hours of supervised experience
as an alcoholism and/or drug abuse counselor. The supervision must be provided by a
licensed or certified practitioner. Supervised
experience is important if the individual is
to be considered a professional in the field of
alcohol and drug abuse evaluation and counseling.
2. Education: There exists a requirement of
270 contact hours of education and training
in alcoholism and/or drug abuse or related
training. These hours can take the form of
formal education, in-service training, and
professional development courses. Part of
any professional counselor’s development is
participation in formal and non-formal education opportunities within the field.
3. Continuing Education: The certified counselor must receive at least 40–60 hours of
continuing education units (CEU) during
each two year period. These CEUs are important to the counselor’s keeping abreast of
changes and improvements in the field.
4. Testing: A passing score on a national
test is a requirement. The test must accurately measure the application of the knowledge, skills, and abilities possessed by the
counselor. The test establishes a national
standard that must be met to practice.
5. Testing Validity: The certification examination must be reviewed by an independent
authority for validity (examination reliability and relationship to the knowledge,
skills, and abilities required by the counseling field). The reliability of the exam is
paramount if counselor attributes are to be
accurately measured. The examination passing score point must be placed at an appropriate minimal level score as gauged by statistically reliable methodology.
6. Measurable Knowledge Base: The certification process must be based upon measurable knowledge possessed by the applicant
and verified through collateral data and testing. That level of knowledge must be of sufficient quantity to ensure a high quality of
SAP evaluation and referral services.
7. Measurable Skills Base: The certification
process must be based upon measurable
skills possessed by the applicant and verified
through collateral data and testing. That
level of skills must be of sufficient quality to
ensure a high quality of SAP evaluation and
referral services.
8. Quality Assurance Plan: The certification
agency must ensure that a means exists to
determine that applicant records are verified
as being true by the certification staff. This
is an important check to ensure that true information is being accepted by the certifying
agency.

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Office of the Secretary of Transportation
9. Code of Ethics: Certified counselors must
pledge to adhere to an ethical standard for
practice. It must be understood that code
violations could result in de-certification.
These standards are vital in maintaining the
integrity of practitioners. High ethical
standards are required to ensure quality of
client care and confidentiality of client information as well as to guard against inappropriate referral practices.
10. Re-certification Program: Certification is
not just a one-time event. It is a continuing
privilege with continuing requirements.
Among these are continuing education, continuing state certification, and concomitant
adherence to the code of ethics. Re-certification serves as a protector of client interests by removing poor performers from the
certified practice.
11. Fifty State Coverage: Certification must
be available to qualified counselors in all 50
states and, therefore, the test must be available to qualified applicants in all 50 states.
Because many companies are multi-state operators, consistency in SAP evaluation quality and opportunities is paramount. The test
need not be given in all 50 states but should
be accessible to candidates from all states.
12. National Commission for Certifying Agencies (NCCA) Accreditation: Having NCCA accreditation is a means of demonstrating to
the Department of Transportation that your
certification has been reviewed by a panel of
impartial experts that have determined that
your examination(s) has met stringent and
appropriate testing standards.

APPENDIX F TO PART 40—DRUG AND ALCOHOL TESTING INFORMATION THAT
C/TPAS MAY TRANSMIT TO EMPLOY-

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ERS

1. If you are a C/TPA, you may, acting as
an intermediary, transmit the information
in the following sections of this part to the
DER for an employer, if the employer chooses to have you do so. These are the only
items that you are permitted to transmit to
the employer as an intermediary. The use of
C/TPA intermediaries is prohibited in all
other cases, such as transmission of laboratory drug test results to MROs, the transmission of medical information from MROs
to employers, the transmission of SAP reports to employers, the transmission of positive alcohol test results, and the transmission of medical information from MROs
to employers.
2. In every case, you must ensure that, in
transmitting the information, you meet all
requirements (e.g., concerning confidentiality and timing) that would apply if the
party originating the information (e.g., an
MRO or collector) sent the information directly to the employer. For example, if you
transmit MROs’ drug testing results to
DERs, you must transmit each drug test re-

Pt. 40, App. F
sult to the DER in compliance with the requirements for MROs set forth in § 40.167.
DRUG TESTING INFORMATION
§ 40.25: Previous two years’ test results
§ 40.35: Notice to collectors of contact information for DER
§ 40.61(a): Notification to DER that an employee is a ‘‘no show’’ for a drug test
§ 40.63(e): Notification to DER of a collection
under direct observation
§ 40.65(b)(6) and (7) and (c)(2) and (3): Notification to DER of a refusal to provide a
specimen or an insufficient specimen
§ 40.73(a)(9): Transmission of CCF copies to
DER (However, MRO copy of CCF must
be sent by collector directly to the MRO,
not through the C/TPA.)
§ 40.111(a): Transmission of laboratory statistical report to employer
§ 40.127(f): Report of test results to DER
§§ 40.127(g), 40.129(d), 40.159(a)(4)(ii); 40.161(b):
Reports to DER that test is cancelled
§ 40.129 (d): Report of test results to DER
§ 40.129(g)(1): Report to DER of confirmed
positive test in stand-down situation
§§ 40.149(b): Report to DER of changed test result
§ 40.155(a): Report to DER of dilute specimen
§ 40.167(b) and (c): Reports of test results to
DER
§ 40.187(a)–(e) Reports to DER concerning the
reconfirmation of tests
§ 40.191(d): Notice to DER concerning refusals
to test
§ 40.193(b)(3): Notification to DER of refusal
in shy bladder situation
§ 40.193(b)(4): Notification to DER of insufficient specimen
§ 40.193(b)(5): Transmission of CCF copies to
DER (not to MRO)
§ 40.199: Report to DER of cancelled test and
direction to DER for additional collection
§ 40.201: Report to DER of cancelled test
ALCOHOL TESTING INFORMATION
§ 40.215: Notice to BATs and STTs of contact
information for DER
§ 40.241(b)(1): Notification to DER that an
employee is a ‘‘no show’’ for an alcohol
test
§ 40.247(a)(2): Transmission of alcohol screening test results only when the test result
is less than 0.02
§ 40.255(a)(4): Transmission of alcohol confirmation test results only when the test
result is less than 0.02
§ 40.263(a)(3) and 263(b)(3): Notification of insufficient saliva and failure to provide
sufficient amount of breath
[65 FR 79526, Dec. 19, 2000, as amended at 66
FR 41955, Aug. 9, 2001; 73 FR 35975, June 25,
2008]

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Pt. 40, App. G

49 CFR Subtitle A (10–1–21 Edition)
APPENDIX G TO PART 40—ALCOHOL TESTING FORM

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The following form is the alcohol testing form required for use in the DOT alcohol testing
program beginning January 1, 2011. Employers are authorized to use the form effective February 25, 2010.

Pt. 40, App. G

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49 CFR Subtitle A (10–1–21 Edition)

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Pt. 40, App. G

Pt. 40, App. G

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Pt. 40, App. G

49 CFR Subtitle A (10–1–21 Edition)

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[75 FR 8529, Feb. 25, 2010, as amended at 75 FR 13009, Mar. 18, 2010; 75 FR 38423, July 2, 2010]

Office of the Secretary of Transportation

Pt. 40, App. H

APPENDIX H TO PART 40—DOT DRUG AND ALCOHOL TESTING MANAGEMENT
INFORMATION SYSTEM (MIS) DATA COLLECTION FORM

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The following form is the MIS Data Collection form required for use to report calendar year
MIS data. The instructions for this form are found at https://www.transportation.gov/odapc.

Pt. 41

49 CFR Subtitle A (10–1–21 Edition)

[84 FR 16773, Apr. 23, 2019]

PART 41—SEISMIC SAFETY
Sec.
41.100 Purpose and applicability.
41.105 Definitions.
41.110 New DOT owned buildings and additions to buildings.
41.115 New buildings to be leased for DOT
occupancy.
41.117 Buildings built with Federal assistance.
41.119 DOT regulated buildings.
41.120 Acceptable model codes.
41.125 Judicial review.

§ 41.105

Definitions.

As used in this part—
Operating Administration includes the
Office of the Secretary.
DOT means the U.S. Department of
Transportation.

SOURCE: 58 FR 32871, June 14, 1993, unless
otherwise noted.

§ 41.110 New DOT owned buildings
and additions to buildings.

§ 41.100 Purpose and applicability.
(a) This part implements the provisions of 49 U.S.C. 7701 et seq. and Executive Order (E.O.) 12699, ‘‘Seismic Safety
of Federal and Federally-Assisted or
Regulated New Building Construction’’
(3 CFR, 1990 Comp., p. 269). Under the
Executive Order the DOT is given the
responsibility for developing and implementing its own mission-appropriate and cost-effective regulations
governing seismic safety.
(b) This part applies to new DOT
owned buildings and to new DOT
leased, assisted and regulated buildings. The purpose of this part is to reduce risk to lives of the building occupants, improve the capabilities of es-

(a) DOT Operating Administrations
responsible for the design and construction of new DOT Federally owned
buildings will ensure that each building is designed and constructed in accord with the seismic design and construction standards set out in § 41.120 of
this part.
(b) This section pertains to all building projects for which development of
detailed plans and specifications was
initiated after January 5, 1990. It applies to additions to existing buildings
as well as to new buildings. It applies
worldwide.
(c) For DOT Federally owned buildings, a certification of compliance with
the seismic design and construction requirements of this part is required

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AUTHORITY: 42 U.S.C. 7701 et seq.; 49 U.S.C.
322; E.O. 12699, 3 CFR, 1990 Comp., p. 269.

sential buildings to function during or
after an earthquake, and to reduce
earthquake losses of public buildings
and investments.
(c) This part may be further implemented by the DOT Operating Administrations.