**Subpart A - Administrative Provisions**

**§ 40.3   What do the terms used in this regulation mean?**

In this part, the terms listed in this section have the following
meanings:

[Adulterated specimen]{.underline}. A urine specimen containing a
substance that is not a normal constituent or containing an endogenous
substance at a concentration that is not a normal physiological
concentration.

[Affiliate]{.underline}. 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]{.underline}. 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]{.underline}. The intoxicating agent in beverage alcohol, ethyl
alcohol or other low molecular weight alcohols, including methyl or
isopropyl alcohol.

[Alcohol concentration.]{.underline} 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]{.underline}. 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.

[Alcohol screening device (ASD]{.underline}). A breath or saliva device,
other than an EBT, that is approved by the National Highway Traffic
Safety Administration (NHTSA) and placed on a conforming products list
(CPL) for such devices.

[Alcohol screening test]{.underline}. An analytic procedure to determine
whether an employee may have a prohibited concentration of alcohol in a
breath or saliva specimen.

[Alcohol testing site]{.underline}. A place selected by the employer
where employees present themselves for the purpose of providing breath
or saliva for an alcohol test.

[Alcohol use]{.underline}. The drinking or swallowing of any beverage,
liquid mixture or preparation (including any medication), containing
alcohol.

[Aliquot.]{.underline} A fractional part of a specimen used for testing.
It is taken as a sample representing the whole specimen.

[Blind specimen or blind performance test specimen]{.underline}. A
specimen submitted to a laboratory for quality control testing purposes,
with a fictitious identifier, so that the laboratory cannot distinguish
it from an employee specimen.

[Breath Alcohol Technician (BAT.]{.underline} A person who instructs and
assists employees in the alcohol testing process and operates an
evidential breath testing device.

[Cancelled test]{.underline}. 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]{.underline}. 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).

[Collection container]{.underline}. A container into which the employee
urinates to provide the specimen for a drug test.

[Collection site]{.underline}. A place selected by the employer where
employees present themselves for the purpose of providing a urine
specimen for a drug test.

[Collector]{.underline}. 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.]{.underline} A second analytical procedure to
identify the presence of a specific drug or metabolite which is
independent of the initial test and which uses a different technique and
chemical principle from that of the initial test in order to ensure
reliability and accuracy. (Gas chromatography/ mass spectrometry (GC/MS)
is the only authorized confirmation method for cocaine, marijuana,
opiates, amphetamines, and phencyclidine).

[Confirmatory validity test]{.underline}. A second test performed on a
different aliquot of the original urine specimen to further support a
validity test result.

[Confirmed drug test]{.underline}. A confirmation test result received
by an MRO from a laboratory.

[Consortium/Third-party administrator (C/TPA).]{.underline} 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]{.underline}. Training for medical review officers
(MROs) and substance abuse professionals (SAPs) who have completed
qualification training and are performing MRO or SAP functions, designed
to keep MROs and SAPs current on changes and developments in the DOT
drug and alcohol testing program.

[Designated employer representative (DER]{.underline}). 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]{.underline}. A urine specimen with creatinine and
specific gravity values that are lower than expected for human urine.

[DOT, The Department, DOT agency]{.underline}. These terms encompass all
DOT agencies, including, but not limited to, the United States Coast
Guard (USCG), the Federal Aviation Administration (FAA), the Federal
Railroad Administration (FRA), the Federal Motor Carrier Safety
Administration (FMCSA), 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). These terms include any designee of a DOT agency.

[Drugs]{.underline}. The drugs for which tests are required under this
part and DOT agency regulations are marijuana, cocaine, amphetamines,
phencyclidine (PCP), and opiates.

[Employee]{.underline}. 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]{.underline}. 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]{.underline}. 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).]{.underline} A device approved
by NHTSA for the evidential testing of breath at the .02 and .04 alcohol
concentrations, placed on NHTSA\'s Conforming Products List (CPL) for
"Evidential Breath Measurement Devices" and identified on the CPL as
conforming with the model specifications available from NHTSA\'s Traffic
Safety Program.

[HHS.]{.underline} 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)]{.underline}.
An immunoassay test to eliminate "negative" urine specimens from further
consideration and to identify the presumptively positive specimens that
require confirmation or further testing.

[Initial validity test]{.underline}. The first test used to determine if
a urine specimen is adulterated, diluted, or substituted.

[Invalid result]{.underline}. 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.]{.underline} 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. (The HHS Mandatory Guidelines for Federal Workplace Drug Testing
Programs are available on the internet at
http://www.health.org/workpl.htm or from the Division of Workplace
Programs, 1 Choke Cherry Road, Room 2-1035, Rockville, MD 20857)

[Limit of Detection (LOD)]{.underline}. The lowest concentration at
which an analyte can be reliably shown to be present under defined
conditions.

[Medical Review Officer (MRO)]{.underline}. 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 and evaluating
medical explanations for certain drug test results.

[Non-negative specimen.]{.underline} 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]{.underline}).
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.]{.underline} 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]{.underline}. 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.

[Qualification Training.]{.underline} 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).

[Refresher Training]{.underline}. 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).

[Screening Drug Test.]{.underline} See Initial drug test definition
above.

[Screening Test Technician (STT]{.underline}). A person who instructs
and assists employees in the alcohol testing process and operates an
ASD.

[Secretary]{.underline}. The Secretary of Transportation or the
Secretary\'s designee.

[Service agent]{.underline}. Any person or entity, other than an
employee of the employer, who provides services specified under this
part 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 the qualifications set forth in applicable
sections of this part. Service agents are not employers for purposes of
this part.

[Shipping container]{.underline}. A container that is used for
transporting and protecting urine specimen bottles and associated
documents from the collection site to the laboratory.

[Specimen bottle]{.underline}. 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]{.underline}. 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.

[Stand-down]{.underline}. 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]{.underline}). 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]{.underline}. 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]{.underline}. A drug test result or validity testing
result from an HHS-certified laboratory that has undergone review and
final determination by the MRO.

\[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41950, Aug. 9, 2001;
71 FR 49384, August 23, 2006; 71 FR 55347, Sept. 22, 2006; 73 FR 35969,
June 25, 2008\]