§ 40.3 What do the terms used in this part mean?

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 oftest anyusing beveragean EBT, mixturefollowing a screening test with a result of 0.02 or preparationgreater, includingthat anyprovides medication,quantitative containingdata about the alcohol concentration.
AliquotAlcohol screening device (ASD). A portionbreath ofor asaliva specimendevice, usedother 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.
BlindAlcohol samplescreening ortest. blindAn performanceanalytic testprocedure to determine whether an employee may have a prohibited concentration of alcohol in a breath or saliva specimen.
Alcohol testing site. A urineplace specimenselected submittedby tothe aemployer laboratorywhere employees present themselves for qualitythe controlpurpose testingof purposes,providing withbreath aor fictitioussaliva identifier,for soan thatalcohol thetest.
Alcohol laboratoryuse. cannotThe distinguishdrinking itor fromswallowing employeeof specimensany beverage, andliquid whichmixture isor spikedpreparation with(including knownany quantitiesmedication), containing alcohol.
Aliquot. A fractional part of specifica drugsspecimen orused whichfor testing. It is blanktaken as a sample representing the whole specimen.
Alternate specimen. An authorized specimen, containingother nothan drugsthe type of specimen previously collected or attempted to be collected.
Breath Alcohol Technician (BAT). AnA individualperson who instructs and assists individualsemployees in the alcohol testing process and operates an EBT.
Canceledevidential orbreath invalidtesting device.
Cancelled test. InA drug testing,or alcohol test that has a drugproblem testidentified that cannot be or has not been declaredcorrected, invalidor bywhich athis Medicalpart Reviewotherwise Officerrequires to be cancelled. A canceledcancelled test is neither a positive nor a negative test.
Chain Forof purposescustody. ofThe thisprocedure part,used ato sampledocument thatthe hashandling beenof rejectedthe forurine testingspecimen byfrom athe laboratorytime isthe treatedemployee gives the samespecimen asto athe canceledcollector testuntil the specimen is destroyed. InThis alcoholprocedure testing,uses athe testFederal thatDrug isTesting deemedCustody toand beControl invalidForm under(CCF) §as 40approved by the Office of Management and Budget.79
Collection container. ItA iscontainer neitherused ato positivecollect nor a negative testspecimen.
ChainCollection of custodysite. ProceduresA toplace accountselected by the employer where employees present themselves for the integritypurpose of eachproviding urinea orspecimen bloodfor specimena bydrug trackingtest.
Collector. itsA handlingperson andwho storageinstructs fromand pointassists ofemployees specimenat a collection tosite, finalwho dispositionreceives and makes an initial inspection of the specimen. Withprovided respectby tothose drug testingemployees, theseand procedureswho shallinitiates requireand thatcompletes anthe appropriateCCF.
Commercial drugDriver's testingLicense custodyDrug formand (seeAlcohol §Clearinghouse 40.23(aClearinghouse)). beA useddatabase, fromadministered timeby ofthe collectionFederal toMotor receiptCarrier bySafety theAdministration, laboratorycontaining andrecords thatof uponcommercial receiptmotor byvehicle thedrivers' laboratoryviolations anof appropriatecontrolled laboratorysubstances chainand ofalcohol custodytesting form(s)program account(s)requirements, foras theset sampleforth orin samplepart aliquots382 withinof thethis laboratorytitle, as well as their return-to-duty status.
CollectionConfirmatory containerdrug test. A containersecond intoanalytical whichprocedure theperformed employeeon urinatesa todifferent providealiquot of the urineoriginal samplespecimen usedto foridentify and quantify a specific drug testor drug metabolite.
CollectionConfirmatory sitevalidity test. A placesecond designatedtest byperformed theon employera wheredifferent individualsaliquot presentof themselvesthe fororiginal theurine purposespecimen ofto providingfurther support a specimenvalidity oftest theirresult.
Confirmed urinedrug totest. beA analyzedconfirmation fortest theresult presencereceived ofby drugsan MRO from a laboratory.
CollectionConsortium/Third-party siteadministrator person(C/TPA). A personservice whoagent instructsthat andprovides assistsor individualscoordinates atthe provision of a collectionvariety siteof drug and whoalcohol receivestesting andservices makesto aemployers. screeningC/TPAs examinationtypically perform administrative tasks concerning the operation of the urineemployers' specimendrug providedand byalcohol thosetesting individualsprograms.
Confirmation (orThis confirmatory)term test.includes, Inbut drugis testingnot limited to, agroups secondof analyticalemployers procedurewho join together to identifyadminister, as a single entity, the presenceDOT drug and alcohol testing programs of aits specificmembers. drugC/TPAs orare metabolitenot that“employers” isfor independentpurposes of thethis screeningpart.
Continuing testeducation. andTraining thatfor usessubstance aabuse differentprofessionals technique(SAPs) andwho chemicalhave principlecompleted fromqualification thattraining ofand theare screeningperforming testSAP infunctions, orderdesigned to ensurekeep reliabilitySAPs current on changes and accuracydevelopments in the DOT drug and alcohol testing program.
Cutoff. (GasThe chromatography/massanalytical spectrometryvalue (GC/MSe.g., drug or drug metabolite concentration) isused as the onlydecision authorizedpoint confirmationto methoddetermine fora cocaineresult (e.g., marijuananegative, opiatespositive, amphetaminesadulterated, andinvalid, phencyclidine.or substituted) Inor alcoholthe need for further testing,.
Designated aemployer secondrepresentative test,(DER). followingAn aemployee screeningauthorized testby withthe aemployer resultto oftake 0.02immediate action(s) to remove employees from safety-sensitive duties, or greatercause employees to be removed from these covered duties, thatand providesto quantitativemake datarequired ofdecisions alcoholin concentrationthe testing and evaluation processes.
DHHS. The DepartmentDER ofalso Healthreceives andtest Humanresults Servicesand orother anycommunications designeefor of the Secretaryemployer, Departmentconsistent with the requirements of Healththis andpart. HumanService Servicesagents cannot act as DERs.
DOTDilute agencyspecimen. AnA agencyurine ofspecimen thewith Unitedcreatinine Statesand Departmentspecific ofgravity Transportationvalues administeringthat regulationsare relatedlower tothan drugexpected orfor alcoholhuman testingurine.
DOT, includingThe theDepartment, UnitedDOT StatesAgency. CoastThese Guardterms (forencompass drugall testingDOT purposesagencies, only)including, but not limited to, the Federal Aviation Administration (FAA), the Federal Railroad Administration (FRA), the Federal HighwayMotor Carrier Safety Administration (FMCSA), the Federal Transit Administration (FTA), the ResearchNational Highway Traffic Safety Administration (NHTSA), the Pipeline and SpecialHazardous ProgramsMaterials 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. AnAny individualperson who is designated in a DOT agency regulation as subject to drug testing and/or alcohol testing. AsThe usedterm inincludes thisindividuals partcurrently “employee”performing includessafety-sensitive anfunctions applicantdesignated in DOT agency regulations and applicants for employment subject to pre-employment testing. “Employee”For andpurposes “individual”of ordrug “individualtesting tounder bethis tested”part, havethe term employee has the same meaning foras purposesthe term “donor” as found on CCF and related guidance materials produced by the Department of thisHealth partand Human Services.
Employer. AnA 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. AsThe usedterm inincludes 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, employercollectors, includesand screening test technicians (STTs) following an industryerror consortiumthat orresulted jointin enterprisethe comprisedcancellation of twoa drug or morealcohol employing entitiestest.
EBT (Error correction training must be provided in person or evidentialby breatha testingmeans device)that provides real-time observation and interaction between the instructor and trainee.
Evidential AnBreath 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 placed.04 alcohol concentrations, and appears on NHTSAODAPC's “ConformingWeb Productspage Listfor of“Approved Evidential Breath Measurement Devices” (CPL),because it conforms with the model specifications available from NHTSA.
HHS. The Department of Health and identifiedHuman onServices or any designee of the CPLSecretary, asDepartment conformingof 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 modelcriteria specificationsestablished availableby fromHHS 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 HighwayLaboratory TrafficCertification SafetyProgram Administrationas meeting the minimum standards set by HHS; or, Officein the case of Alcoholforeign 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 Stateconcentration Programsof the analyte (e.g., drug or drug metabolite) can be accurately established.
Medical Review Officer (MRO). A licensedperson physicianwho (medicalis doctora orlicensed doctorphysician ofand osteopathy)who is responsible for receiving and reviewing laboratory results generated by an employer's drug testing program whoand hasevaluating knowledgemedical ofexplanations substancefor abusecertain disordersdrug andtest hasresults.
Negative appropriateresult. medicalThe trainingresult reported by an HHS-certified laboratory to interpretan 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 evaluatethe anspecimen individual'sis confirmeda valid specimen.
Non-negative specimen. A specimen that is reported as adulterated, substituted, positive test(for resultdrug(s) togetheror withdrug hismetabolite(s)), or herinvalid.
Office medicalof historyDrug and anyAlcohol otherPolicy relevantand biomedicalCompliance (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.
ScreeningOral testfluid (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, anthe immunoassayspecimen screenbottle that is opened and tested by a first laboratory to eliminatedetermine 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 (“negativeA”) urinespecimen specimensby the collector to distinguish it from furtherthe analysissplit (“B”) specimen, as defined in this section.
Positive Inresult. 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., anclassroom analyticinstruction, procedureinternet 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 determinereview whetherbasic anrequirements employeeand provide instruction concerning changes in technology (e.g., new testing methods that may havebe 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 prohibitedspecimen concentrationbecause of alcohola infatal flaw or a breathcorrectable specimenflaw 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.
ShippingService containeragent. AAny containerperson capableor entity, other than an employee of beingthe securedemployer, who provides services to employers and/or employees in connection with aDOT tamper-evidentdrug sealand thatalcohol testing requirements. This includes, but is usednot 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 transferpurposes of onethis orpart.
Shipping morecontainer. urineA container that is used for transporting and protecting specimen bottle(s)bottles and associated documentationdocuments 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 labeledsealed and sealedlabeled according to the procedures in this part, is used to transmithold a urineprimary 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.”
SubstanceSplit abusespecimen. professionalIn 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 licensedcollection physicianin which the single specimen collected is divided into two separate specimen bottles, the primary specimen (MedicalBottle DoctorA) and the split specimen (Bottle B).
SSN or DoctorEmployee ofID OsteopathyNo. 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 licenseddonor, on the MRO's reports, on SAP reports, or certifiedon psychologistother documents that are required under this part. For all purposes of this part, socialthis workerterm 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 assistancefrom 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 addictionadulterated counselortest, (certifiedor bya substituted test, before the NationalMRO Associationhas completed verification of Alcoholismthe andtest Drugresult.
Substance Abuse CounselorsProfessional Certification(SAP). CommissionA orperson 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 theHHS International(e.g., Certificationa Reciprocityurine Consortium/Alcoholspecimen, &with Othercreatinine Drugand Abusespecific 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 havecollect knowledgeat least 1 mL of andundiluted clinical(neat) experienceoral influid.
Urine specimen. Urine collected from an employee at the diagnosiscollection andsite treatmentfor the purpose of alcohola anddrug controlledtest.
Verified substancestest. A drug test result or validity testing result from an HHS-relatedcertified disorderslaboratory that has undergone review and final determination by the MRO.
[5965 FR 735479526, FebDec. 1519, 19942000, as amended at 5966 FR 4300041950, Aug. 199, 19942001; 6171 FR 3722449384, JulyAug. 1723, 19962006; 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]