[Code of Federal Regulations]

[Title 49, Volume 1]

[Revised as of October 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 49CFR40.3]



[Page 631-634]

 

                        TITLE 49--TRANSPORTATION

 

          Subtitle A--Office of the Secretary of Transportation

 

PART 40_PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING 

PROGRAMS--Table of Contents

 

                   Subpart A_Administrative Provisions

 

Sec. 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. 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 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.

    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 alcohol.

    Blind specimen or blind performance test specimen. A specimen 

submitted to a laboratory for quality control testing



[[Page 632]]



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 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 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 DOT agency.

    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



[[Page 633]]



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 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 

metabolites.

    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. (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, 5600 Fishers Lane, Rockwall II Building, Suite 815, 

Rockville, MD 20857.)

    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).



[[Page 634]]



    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 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 test result.

    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 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.



[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41950, Aug. 9, 2001]