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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,
safety-sensitive transportation employees (including self-employed
individuals, contractors and volunteers as covered by 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 regulation
In this part, the terms listed in this section have the following
Adulterated specimen. A specimen that contains a substance that
is not expected to be present in human urine, or contains a substance
expected to be present but is at a concentration so high that
it is not consistent with human urine.
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 ofSubpart
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
Alcohol. The intoxicating agent in beverage alcohol, ethyl alcohol
or other low molecular weight alcohols, including methyl or isopropyl
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.
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 placed on a conforming products
list (CPL) for such devices.
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
Blind specimen or blind performance test specimen. 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). 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).
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.
Confirmation (or confirmatory) drug test. A second analytical
procedure performed on a urine specimen to identify and quantify
the presence of a specific drug or drug metabolite.
Confirmation (or confirmatory) validity test. A second test
performed on a urine specimen to further support a validity test
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 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). 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 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 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
Research and Special Programs Administration (RSPA), and the Office
of the Secretary (OST). These terms include any designee of a
Drugs. The drugs for which tests are required under this part
and DOT agency regulations are marijuana, cocaine, amphetamines,
phencyclidine (PCP), and opiates.
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
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
Evidential Breath Testing Device (EBT). 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. The Department of Health and Human Services or any designee
of the Secretary, Department of Health and Human Services.
Initial drug test. The test used to differentiate a negative
specimen from one that requires further testing for drugs or drug
Initial validity test. The first test used to determine if a
specimen is adulterated, diluted, or substituted.
Invalid drug test. The result of a drug test for a urine specimen
that contains an unidentified adulterant or an unidentified interfering
substance, has abnormal physical characteristics, or has an endogenous
substance at an abnormal concentration that prevents the laboratory
from completing 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.
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 and evaluating
medical explanations for certain drug test results.
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.
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.
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).
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).
Screening Test Technician (STT). A person who instructs and
assists employees in the alcohol testing process and operates
Secretary. The Secretary of Transportation or the Secretary's
Service agent. 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. 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
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,
Substituted specimen. A specimen with creatinine and specific
gravity values that are so diminished that they are not consistent
with 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.
§40.5 Who issues authoritative interpretations of
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 exemption to the following
Department of Transportation
Deputy Assistant General Counsel
for Regulation and Enforcement
400 7th Street, SW., Room 10424
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.
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