TheIn followingthis definitionspart, applythe toterms listed in this partsection have the following meanings:
AirAdulterated blankspecimen. A readingspecimen 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 EBTabnormal concentration of ambientan airendogenous containingsubstance.
Affiliate. noPersons alcoholare 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 useconfirmation test. TheA consumptionsubsequent of
test
any
using
beverage
an EBT
,
mixture
following
a screening test with a result of 0.02
or
preparation
greater
,
including
that
any
provides
medication,
quantitative
containing
data
about the
alcohol
concentration
.
Aliquot
Alcohol screening device (ASD)
. A
portion
breath
of
or
a
saliva
specimen
device,
used
other
than an EBT, that is approved by the National Highway Traffic Safety Administration (NHTSA) and appears on ODAPC's Web page
for
testing
“Approved Screening Devices to Measure Alcohol in Bodily Fluids” because it conforms to the model specifications from NHTSA
.
Blind
Alcohol
sample
screening
or
test.
blind
An
performance
analytic
test
procedure
to determine whether an employee may have a prohibited concentration of alcohol in a breath or saliva
specimen.
Alcohol
testing site.
A
urine
place
specimen
selected
submitted
by
to
the
a
employer
laboratory
where
employees present themselves
for
quality
the
control
purpose
testing
of
purposes,
providing
with
breath
a
or
fictitious
saliva
identifier,
for
so
an
that
alcohol
the
test.
Alcohol
laboratory
use.
cannot
The
distinguish
drinking
it
or
from
swallowing
employee
of
specimens
any beverage
,
and
liquid
which
mixture
is
or
spiked
preparation
with
(including
known
any
quantities
medication),
containing alcohol.
Aliquot. A fractional part
of
specific
a
drugs
specimen
or
used
which
for
testing. It
is
blank
taken as a sample representing the whole specimen.
Alternate specimen. An authorized specimen
,
containing
other
no
than
drugs
the type of specimen previously collected or attempted to be collected
.
Breath Alcohol Technician (BAT).
An
A
individual
person
who instructs and assists
individuals
employees
in the alcohol testing process and operates an
EBT
evidential breath testing device
.
Canceled
Cancelled
or invalid
test.
In
A
drug
testing,
or
alcohol test that has
a
drug
problem
test
identified
that
cannot be or
has
not
been
declared
corrected,
invalid
or
by
which
a
this
Medical
part
Review
otherwise
Officer
requires to be cancelled
. A
canceled
cancelled
test is neither a positive nor a negative test.
Chain
For
of
purposes
custody.
of
The
this
procedure
part,
used
a
to
sample
document
that
the
has
handling
been
of
rejected
the
for
urine
testing
specimen
by
from
a
the
laboratory
time
is
the
treated
employee
gives
the
same
specimen
as
to
a
the
canceled
collector
test
until the specimen is destroyed
.
In
This
alcohol
procedure
testing,
uses
a
the
test
Federal
that
Drug
is
Testing
deemed
Custody
to
and
be
Control
invalid
Form
under
(CCF)
§
as
40
approved by the Office of Management and Budget
.
79
Collection container
.
It
A
is
container
neither
used
a
to
positive
collect
nor
a
negative test
specimen
.
Chain
Collection
of custody
site
.
Procedures
A
to
place
account
selected
by the employer where employees present themselves
for the
integrity
purpose
of
each
providing
urine
a
or
specimen
blood
for
specimen
a
by
drug
tracking
test.
Collector.
its
A
handling
person
and
who
storage
instructs
from
and
point
assists
of
employees
specimen
at
a
collection
to
site,
final
who
disposition
receives
and makes an initial inspection
of the specimen
.
With
provided
respect
by
to
those
drug testing
employees
,
these
and
procedures
who
shall
initiates
require
and
that
completes
an
the
appropriate
CCF.
Commercial
drug
Driver's
testing
License
custody
Drug
form
and
(see
Alcohol
§
Clearinghouse
40.23
(
a
Clearinghouse
)
)
.
be
A
used
database,
from
administered
time
by
of
the
collection
Federal
to
Motor
receipt
Carrier
by
Safety
the
Administration,
laboratory
containing
and
records
that
of
upon
commercial
receipt
motor
by
vehicle
the
drivers'
laboratory
violations
an
of
appropriate
controlled
laboratory
substances
chain
and
of
alcohol
custody
testing
form(s)
program
account(s)
requirements,
for
as
the
set
sample
forth
or
in
sample
part
aliquots
382
within
of
the
this
laboratory
title, as well as their return-to-duty status
.
Collection
Confirmatory
container
drug test
. A
container
second
into
analytical
which
procedure
the
performed
employee
on
urinates
a
to
different
provide
aliquot
of
the
urine
original
sample
specimen
used
to
for
identify
and quantify
a
specific
drug
test
or drug metabolite
.
Collection
Confirmatory
site
validity test
. A
place
second
designated
test
by
performed
the
on
employer
a
where
different
individuals
aliquot
present
of
themselves
the
for
original
the
urine
purpose
specimen
of
to
providing
further
support
a
specimen
validity
of
test
their
result.
Confirmed
urine
drug
to
test.
be
A
analyzed
confirmation
for
test
the
result
presence
received
of
by
drugs
an MRO from a laboratory
.
Collection
Consortium/Third-party
site
administrator
person
(C/TPA)
. A
person
service
who
agent
instructs
that
and
provides
assists
or
individuals
coordinates
at
the
provision of
a
collection
variety
site
of
drug
and
who
alcohol
receives
testing
and
services
makes
to
a
employers.
screening
C/TPAs
examination
typically
perform administrative tasks concerning the operation
of the
urine
employers'
specimen
drug
provided
and
by
alcohol
those
testing
individuals
programs
.
Confirmation
(or
This
confirmatory)
term
test.
includes,
In
but
drug
is
testing
not limited to
,
a
groups
second
of
analytical
employers
procedure
who
join together
to
identify
administer,
as a single entity,
the
presence
DOT
drug and alcohol testing programs
of
a
its
specific
members.
drug
C/TPAs
or
are
metabolite
not
that
“employers”
is
for
independent
purposes
of
the
this
screening
part.
Continuing
test
education.
and
Training
that
for
uses
substance
a
abuse
different
professionals
technique
(SAPs)
and
who
chemical
have
principle
completed
from
qualification
that
training
of
and
the
are
screening
performing
test
SAP
in
functions,
order
designed
to
ensure
keep
reliability
SAPs
current on changes
and
accuracy
developments in the DOT drug and alcohol testing program
.
Cutoff.
(Gas
The
chromatography/mass
analytical
spectrometry
value
(
GC/MS
e.g., drug or drug metabolite concentration
)
is
used
as
the
only
decision
authorized
point
confirmation
to
method
determine
for
a
cocaine
result (e.g.
,
marijuana
negative
,
opiates
positive
,
amphetamines
adulterated
,
and
invalid,
phencyclidine.
or substituted
)
In
or
alcohol
the
need for further
testing
,
.
Designated
a
employer
second
representative
test,
(DER).
following
An
a
employee
screening
authorized
test
by
with
the
a
employer
result
to
of
take
0.02
immediate
action(s) to remove employees from safety-sensitive duties,
or
greater
cause employees to be removed from these covered duties
,
that
and
provides
to
quantitative
make
data
required
of
decisions
alcohol
in
concentration
the testing and evaluation processes
.
DHHS.
The
Department
DER
of
also
Health
receives
and
test
Human
results
Services
and
or
other
any
communications
designee
for
of
the
Secretary
employer
,
Department
consistent
with the requirements
of
Health
this
and
part.
Human
Service
Services
agents cannot act as DERs
.
DOT
Dilute
agency
specimen
.
An
A
agency
urine
of
specimen
the
with
United
creatinine
States
and
Department
specific
of
gravity
Transportation
values
administering
that
regulations
are
related
lower
to
than
drug
expected
or
for
alcohol
human
testing
urine.
DOT
,
including
The
the
Department,
United
DOT
States
Agency.
Coast
These
Guard
terms
(for
encompass
drug
all
testing
DOT
purposes
agencies,
only)
including
,
but not limited to,
the Federal Aviation Administration
(FAA)
, the Federal Railroad Administration
(FRA)
, the Federal
Highway
Motor
Carrier Safety
Administration
(FMCSA)
, the Federal Transit Administration
(FTA)
, the
Research
National
Highway Traffic Safety Administration (NHTSA), the Pipeline
and
Special
Hazardous
Programs
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.
An
Any
individual
person
who is
designated in a DOT agency regulation as subject to drug testing and/or alcohol testing.
As
The
used
term
in
includes
this
individuals
part
currently
“employee”
performing
includes
safety-sensitive
an
functions
applicant
designated
in DOT agency regulations and applicants
for employment
subject to pre-employment testing
.
“Employee”
For
and
purposes
“individual”
of
or
drug
“individual
testing
to
under
be
this
tested”
part,
have
the
term employee has
the same meaning
for
as
purposes
the
term “donor” as found on CCF and related guidance materials produced by the Department
of
this
Health
part
and Human Services
.
Employer.
An
A
person or
entity employing one or more employees
that
(including
an individual who
is
self-employed)
subject to DOT agency regulations requiring compliance with this part.
As
The
used
term
in
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
,
employer
collectors,
includes
and
screening test technicians (STTs) following
an
industry
error
consortium
that
or
resulted
joint
in
enterprise
the
comprised
cancellation
of
two
a
drug
or
more
alcohol
employing
test.
entities
Error correction training must be provided in person or by a means that provides real-time observation and interaction between the instructor and trainee
.
EBT
Evidential
(or
Breath
evidential
Testing
breath
Device
testing device
(EBT
).
An
A
EBT
device
that is
approved by the National Highway Traffic Safety Administration (NHTSA) for the evidential testing of breath
at the.02
and
.04
placed
alcohol
concentrations, and appears
on
NHTSA
ODAPC
's
“Conforming
Web
Products
page
List
for
of
“Approved
Evidential Breath Measurement Devices”
(CPL),
because
it conforms with the model specifications available from NHTSA.
HHS. The Department of Health
and
identified
Human
on
Services
or any designee of
the
CPL
Secretary,
as
Department
conforming
of
Health and Human Services.
Initial drug test. The first 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 specimen is adulterated, diluted, substituted, or invalid.
Invalid result. The result reported by an HHS-certified in accordance
with the
model
criteria
specifications
established
available
by
from
HHS
when a positive, negative, adulterated, or substituted result cannot be established for a specific drug or specimen validity test.
Laboratory. Any U.S. laboratory certified by HHS under
the National
Highway
Laboratory
Traffic
Certification
Safety
Program
Administration
as meeting the minimum standards set by HHS; or
,
Office
in
the case
of
Alcohol
foreign
laboratories, a laboratory approved for participation by DOT under this part.
Limit of Detection (LOD). The lowest concentration at which the analyte (e.g., drug or drug metabolite) can be identified.
Limit of Quantitation (LOQ). For quantitative assays, the lowest concentration at which the identity
and
State
concentration
Programs
of the analyte (e
.
g., drug or drug metabolite) can be accurately established.
Medical Review Officer (MRO). A
licensed
person
physician
who
(medical
is
doctor
a
or
licensed
doctor
physician
of
and
osteopathy)
who
is
responsible for receiving
and reviewing
laboratory results generated by an employer's drug testing program
who
and
has
evaluating
knowledge
medical
of
explanations
substance
for
abuse
certain
disorders
drug
and
test
has
results.
Negative
appropriate
result.
medical
The
training
result
reported by an HHS-certified laboratory
to
interpret
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
evaluate
the
an
specimen
individual's
is
confirmed
a
valid specimen.
Non-negative specimen. A specimen that is reported as adulterated, substituted,
positive
test
(for
result
drug(s)
together
or
with
drug
his
metabolite(s)),
or
her
invalid.
Office
medical
of
history
Drug
and
any
Alcohol
other
Policy
relevant
and
biomedical
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
.
Screening
Oral
test
fluid
(
specimen. A specimen that is collected from an employee's oral cavity and is a combination of physiological fluids produced primarily by the salivary glands. An oral fluid specimen is considered to be a direct observation collection for all purposes 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,
an
the
immunoassay
specimen
screen
bottle
that is opened and tested by a first laboratory
to
eliminate
determine
whether the employee has a drug or drug metabolite in his or her system; and for the purpose of specimen validity testing. The primary specimen is the portion of the donor's subdivided specimen designated as the primary (
“
negative
A
”
)
urine
specimen
specimens
by
the collector to distinguish it
from
further
the
analysis
split (“B”) specimen, as defined in this section
.
Positive
In
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.
,
an
classroom
analytic
instruction,
procedure
internet
application, CD-ROM, video).
Reconfirmed. The result reported for a split (Bottle B) specimen when the second HHS-certified laboratory corroborates the original result reported for the primary (Bottle A) specimen.
Refresher Training. The training required periodically for qualified collectors, BATs, and STTs
to
determine
review
whether
basic
an
requirements
employee
and
provide instruction concerning changes in technology (e.g., new testing methods that
may
have
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
prohibited
specimen
concentration
because
of
alcohol
a
in
fatal
flaw or
a
breath
correctable
specimen
flaw that is not corrected
.
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.
Shipping
Service
container
agent
.
A
Any
container
person
capable
or
entity, other than an employee
of
being
the
secured
employer,
who provides services to employers and/or employees in connection
with
a
DOT
tamper-evident
drug
seal
and
that
alcohol
testing requirements. This includes, but
is
used
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
transfer
purposes
of
one
this
or
part.
Shipping
more
container.
urine
A
container that is used for transporting and protecting
specimen
bottle(s)
bottles
and associated
documentation
documents
from the collection site to the laboratory.
Specimen
.
Fluid, breath, or other material collected from an employee at the collection site for the purpose of a drug or alcohol test.
Specimen
bottle. The bottle that, after being
labeled
sealed
and
sealed
labeled
according to the procedures in this part, is used to
transmit
hold
a
urine
primary
sample
(“A”)
or split (“B”) specimen during transportation
to the laboratory.
In the context of oral fluid testing, it may be referred to as a “vial,” “tube,” or “bottle.”
Substance
Split
abuse
specimen.
professional
In drug testing, the specimen that is sent to a first laboratory and stored with its original seal intact, and which is transported to a second laboratory for retesting at the employee's request following MRO verification of the primary specimen as positive, adulterated or substituted
.
Split
specimen collection.
A
licensed
collection
physician
in
which the single specimen collected is divided into two separate specimen bottles, the primary specimen
(
Medical
Bottle
Doctor
A)
and the split specimen (Bottle B).
SSN
or
Doctor
Employee
of
ID
Osteopathy
No. This number serves as a unique identifier that must be used on the Federal Drug Testing Custody and Control Form (CCF
)
;
or
Alcohol Testing Form (ATF) for
a
licensed
donor,
on the MRO's reports, on SAP reports,
or
certified
on
psychologist
other documents that are required under this part. For all purposes of this part
,
social
this
worker
term means: only the Commercial Driver's License (CDL) Number and State of issuance for drivers tested under the authority of the Federal Motor Carrier Safety Administration (FMCSA); and
,
for all drivers and other safety-sensitive employees tested under the authority of the other DOT agencies, this can be the individual's actual Social Security Number, a unique identifier issued by the employer, a State-issued identification card number, a State-issued driver's license number (including a CDL number)
or
any other State-issued or federally-issued identification number.
Stand-down. The practice of temporarily removing an
employee
assistance
from
professional;
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
addiction
adulterated
counselor
test,
(certified
or
by
a
substituted test, before
the
National
MRO
Association
has
completed verification
of
Alcoholism
the
and
test
Drug
result.
Substance
Abuse
Counselors
Professional
Certification
(SAP).
Commission
A
or
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. An employee's specimen not consistent with a normal human specimen, as determined
by
the
HHS
International
(e.g.,
Certification
a
Reciprocity
urine
Consortium/Alcohol
specimen,
&
with
Other
creatinine
Drug
and
Abuse
specific gravity values that are so diminished, or so divergent that they are not consistent with normal human urine
).
Undiluted
All
(neat)
oral fluid. An oral fluid specimen to which no other solid or liquid has been added. For example: A collection device that uses a diluent (or other component, process, or method that modifies the volume of the testable specimen)
must
have
collect
knowledge
at
least 1 mL
of
and
undiluted
clinical
(neat)
experience
oral
in
fluid.
Urine
specimen. Urine collected from an employee at
the
diagnosis
collection
and
site
treatment
for
the purpose
of
alcohol
a
and
drug
controlled
test.
Verified
substances
test. A drug test result or validity testing result from an HHS
-
related
certified
disorders
laboratory that has undergone review and final determination by the MRO
.
[
59
65
FR
7354
79526
,
Feb
Dec
.
15
19
,
1994
2000
, as amended at
59
66
FR
43000
41950
, Aug.
19
9
,
1994
2001
;
61
71
FR
37224
49384
,
July
Aug.
17
23
,
1996
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; 88 FR 27636, May 2, 2023
]
RegulusPipeline research