49 cfr part 40 - procedures for transportation … · 2019-04-26 · 49 cfr part 40 - procedures...

49 CFR PART 40 - PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG & ALCOHOL TESTING PROGRAMS

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Reprinted by SAPLIST.COM as a study aidfor the continuing education and training of

Substance Abuse Professionals (SAPs).

This version of 49 CFR Part 40 is an abridgedversion of the complete regulation. It containsthe sections of the regulations that are relevant toSAPlist U’s continuing education module andrequired quiz. SAPs are encouraged to have acopy of the complete regulation for their ownuse. A copy can be obtained by going to:https://www.transportation.gov/odapc andclicking on “Regulations and Interpretations”.

Subpart A - Administrative Provisions§ 40.1 Who does this regulation cover?§ 40.3 What do the terms used in this part

mean?§ 40.5 Who issues authoritative

interpretations of this regulation?§ 40.7 How can you get an exemption from a

requirement in this regulation?

Subpart B -Employer Responsibilities§ 40.11 What are the general responsibilities

of employers under this regulation?§ 40.13 How do DOT drug and alcohol tests

relate to non-DOT tests?§ 40.14 What collection information must

employers provide to collectors?§ 40.15 May an employer use a service agent

to meet DOT drug and alcohol testingrequirements?

§ 40.17 Is an employer responsible forobtaining information from its serviceagents?

§ 40.21 May an employer stand down anemployee before the MRO hascompleted the verification process?

§ 40.23 What actions do employers take afterreceiving verified test results?

§ 40.25 Must an employer check on the drugand alcohol testing record ofemployees it is intending to use toperform safety-sensitive duties?

§ 40.26 What form must an employer use toreport Management InformationSystem (MIS) data to a DOT agency?

§ 40.27 May an employer require anemployee to sign a consent or releasein connection with the DOT drug andalcohol testing program?

§ 40.29 Where is other information onemployer responsibilities found in thisregulation?

Subpart C - Urine Collection Personnel§ 40.31 Who may collect urine specimens for

DOT drug testing?§ 40.33 What training requirements must a

collector meet?§ 40.35 What information about the DER

must employers provide to collectors?§ 40.37 Where is other information on the role

of collectors found in this regulation?

Subpart D - Collection Sites, Forms,Equipment and Supplies Used in DOTUrine Collections§ 40.41 Where does a urine collection for a

DOT drug test take place?§ 40.43 What steps must operators of

collection sites take to protect thesecurity and integrity of urinecollections?

§ 40.45 What form is used to document aDOT urine collection?

§ 40.47 May employers use the CCF for non-Federal collections or non-Federalforms for DOT collections?

§ 40.49 What materials are used to collecturine specimens?

§ 40.51 What materials are used to send urinespecimens to the laboratory?

Subpart E - Urine Specimen Collections§ 40.61 What are the preliminary steps in the

collection process?§ 40.63 What steps does the collector take in

the collection process before theemployee provides a urine specimen?

§ 40.65 What does the collector check forwhen the employee presents aspecimen?

§ 40.67 When and how is a directly observedcollection conducted?

§ 40.69 How is a monitored collectionconducted?

§ 40.71 How does the collector prepare thespecimens?

§ 40.73 How is the collection processcompleted?

Subpart F - Drug Testing Laboratories§ 40.81 What laboratories may be used for

DOT drug testing?§ 40.83 How do laboratories process incoming

specimens?§ 40.85 What drugs do laboratories test for?§ 40.87 What are the cutoff concentrations for

initial and confirmation tests?§ 40.89 What is validity testing, and are

laboratories required to conduct it?§ 40.91 What validity tests must laboratories

conduct on primary specimens?§ 40.93 What criteria do laboratories use to

establish that a specimen is dilute orsubstituted?

§ 40.95 What are the adulterant cutoffconcentrations for initial andconfirmation tests?

§ 40.96 What criteria do laboratories use toestablish that a specimen is invalid?

§ 40.97 What do laboratories report and howdo they report it?

§ 40.99 How long does the laboratory retainspecimens after testing?

§ 40.101 What relationship may a laboratoryhave with an MRO?

§ 40.103 What are the requirements forsubmitting blind specimens to alaboratory?

§ 40.105 What happens if the laboratory reportsa result different from that expectedfor a blind specimen?

§ 40.107 Who may inspect laboratories?§ 40.109 What documentation must the

laboratory keep, and for how long?§ 40.111 When and how must a laboratory

disclose statistical summaries andother information it maintains?

§ 40.113 Where is other informationconcerning laboratories found in thisregulation?

Subpart G - Medical Review Officers andthe Verification Process§ 40.121 Who is qualified to act as an MRO?

§ 40.123 What are the MRO's responsibilitiesin the DOT drug testing program?

§ 40.125 What relationship may an MRO havewith a laboratory?

§ 40.127 What are the MRO's functions inreviewing negative test results?

§ 40.129 What are the MRO's functions inreviewing laboratory confirmed non-negative drug test results?

§ 40.131 How does the MRO or DER notify anemployee of the verification processafter receiving laboratory confirmednon-negative drug test results?

§ 40.133 Without interviewing the employee,under what circumstances may theMRO verify a test as positive, or as arefusal to test because of adulterationor substitution, or as cancelledbecause the test was invalid?

§ 40.135 What does the MRO tell the employeeat the beginning of the verificationinterview?

§ 40.137 On what basis does the MRO verifytest results involving marijuana,cocaine, amphetamines, or PCP?

§ 40.139 On what basis does the MRO verifytest results involving opiates?

§ 40.141 How does the MRO obtaininformation for the verificationdecision?

§ 40.145 On what basis does the MRO verifytest results involving adulteration orsubstitution?

§ 40.149 May the MRO change a verified drugtest result?

§ 40.151 What are MROs prohibited fromdoing as part of the verificationprocess?

§ 40.153 How does the MRO notify employeesof their right to a test of the splitspecimen?

§ 40.155 What does the MRO do when anegative or positive test result is alsodilute?

§ 40.159 What does the MRO do when a drugtest result is invalid?

§ 40.160 What does the MRO do when a validtest result cannot be produced and anegative result is required?

§ 40.162 What must MROs do with multipleverified results for the same testingevent?

§ 40.163 How does the MRO report drug testresults?

§ 40.165 To whom does the MRO transmitreports of drug test results?

§ 40.167 How are MRO reports of drug resultstransmitted to the employer?

§ 40.169 Where is other informationconcerning the role of MROs and theverification process found in thisregulation?

Subpart H - Split Specimen Tests§ 40.171 How does an employee request a test

of a split specimen?§ 40.173 Who is responsible for paying for the

test of a split specimen?§ 40.175 What steps does the first laboratory

take with a split specimen?§ 40.177 What does the second laboratory do

with the split specimen when it istested to reconfirm the presence of adrug or drug metabolite?


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§ 40.179 What does the second laboratory dowith the split specimen when it istested to reconfirm an adulterated testresult?

§ 40.181 What does the second laboratory dowith the split specimen when it istested to reconfirm a substituted testresult?

§ 40.183 What information do laboratoriesreport to MROs regarding splitspecimen results?

§ 40.185 Through what methods and to whommust a laboratory report splitspecimen results?

§ 40.187 What does the MRO do with splitspecimen laboratory results?

§ 40.189 Where is other informationconcerning split specimens found inthis regulation?

Subpart I - Problems in Drug Tests§ 40.191 What is a refusal to take a DOT drug

test, and what are the consequences?§ 40.193 What happens when an employee

does not provide a sufficient amountof urine for a drug test?

§ 40.195 What happens when an individual isunable to provide a sufficient amountof urine for a pre-employment follow-up or return-to-duty test because of apermanent or long-term medicalcondition?

§ 40.197 What happens when an employerreceives a report of a dilute specimen?

§ 40.199 What problems always cause a drugtest to be cancelled?

§ 40.201 What problems always cause a drugtest to be cancelled and may result ina requirement for another collection?

§ 40.203 What problems cause a drug test tobe cancelled unless they arecorrected?

§ 40.205 How are drug test problemscorrected?

§ 40.207 What is the effect of a cancelled drugtest?

§ 40.208 What problem requires correctiveaction but does not result in thecancellation of a test?

§ 40.209 What procedural problems do notresult in the cancellation of a test anddo not require corrective action?

Subpart J - Alcohol Testing Personnel§ 40.211 Who conducts DOT alcohol tests?§ 40.213 What training requirements must

STTs and BATs meet?§ 40.215 What information about the DER do

employers have to provide to BATsand STTs?

§ 40.217 Where is other information on the roleof STTs and BATs found in thisregulation?

Subpart K - Testing Sites, Forms,Equipment and Supplies Used in AlcoholTesting§ 40.221 Where does an alcohol test take

place?§ 40.223 What steps must be taken to protect

the security of alcohol testing sites?§ 40.225 What form is used for an alcohol test?

§ 40.227 May employers use the ATF for non-DOT tests, or non-DOT forms forDOT tests?

§ 40.229 What devices are used to conductalcohol screening tests?

§ 40.231 What devices are used to conductalcohol confirmation tests?

§ 40.233 What are the requirements for properuse and care of EBTs?

§ 40.235 What are the requirements for properuse and care of ASDs?

Subpart L - Alcohol Screening Tests§ 40.241 What are the first steps in any alcohol

screening test?§ 40.243 What is the procedure for an alcohol

screening test using an EBT or non-evidential breath ASD?

§ 40.245 What is the procedure for an alcoholscreening test using a saliva ASD or abreath tube ASD?

§ 40.247 What procedures does the BAT orSTT follow after a screening testresult?

Subpart M - Alcohol Confirmation Tests§ 40.251 What are the first steps in an alcohol

confirmation test?§ 40.253 What are the procedures for

conducting an alcohol confirmationtest?

§ 40.255 What happens next after the alcoholconfirmation test result?

Subpart N - Problems in Alcohol Testing§ 40.261 What is a refusal to take an alcohol

test, and what are the consequences?§ 40.263 What happens when an employee is

unable to provide a sufficient amountof saliva for an alcohol screening test?

§ 40.265 What happens when an employee isunable to provide a sufficient amountof breath for an alcohol test?

§ 40.267 What problems always cause analcohol test to be cancelled?

§ 40.269 What problems cause an alcohol testto be cancelled unless they arecorrected?

§ 40.271 How are alcohol testing problemscorrected?

§ 40.273 What is the effect of a cancelledalcohol test?

§ 40.275 What is the effect of proceduralproblems that are not sufficient tocancel an alcohol test?

§ 40.277 Are alcohol tests other than saliva orbreath permitted under theseregulations?

Subpart O - Substance AbuseProfessionals and the Return-to-DutyProcess§ 40.281 Who is qualified to act as a SAP?§ 40.283 How does a certification organization

obtain recognition for its members asSAPs?

§ 40.285 When is a SAP evaluation required?§ 40.287 What information is an employer

required to provide concerning SAPservices to an employee who has aDOT drug and alcohol regulationviolation?

§ 40.289 Are employers required to provideSAP and treatment services toemployees?

§ 40.291 What is the role of the SAP in theevaluation, referral, and treatmentprocess of an employee who hasviolated DOT agency drug andalcohol testing regulations?

§ 40.293 What is the SAP's function inconducting the initial evaluation of anemployee?

§ 40.295 May employees or employers seek asecond SAP evaluation if theydisagree with the first SAP'srecommendations?

§ 40.297 Does anyone have the authority tochange a SAP's initial evaluation?

§ 40.299 What is the SAP's role and what arethe limits on a SAP's discretion inreferring employees for education andtreatment?

§ 40.301 What is the SAP's function in thefollow-up evaluation of an employee?

§ 40.303 What happens if the SAP believes theemployee needs additional treatment,aftercare, or support group serviceseven after the employee returns tosafety-sensitive duties?

§ 40.305 How does the return-to-duty processconclude?

§ 40.307 What is the SAP's function inprescribing the employee's follow-uptests?

§ 40.309 What are the employer'sresponsibilities with respect to theSAP's directions for follow-up tests?

§ 40.311 What are the requirements concerningSAP reports?

§ 40.313 Where is other information on SAPfunctions and the return-to-dutyprocess found in this regulation?

Subpart P - Confidentiality and Release ofInformation§ 40.321 What is the general confidentiality

rule for drug and alcohol testinformation?

§ 40.323 May program participants releasedrug or alcohol test information inconnection with legal proceedings?

§ 40.327 When must the MRO report medicalinformation gathered in theverification process?

§ 40.329 What information must laboratories,MROs, and other service agentsrelease to employees?

§ 40.331 To what additional parties mustemployers and service agents releaseinformation?

§ 40.333 What records must employers keep?

Subpart Q - Roles and Responsibilities ofService Agents§ 40.341 Must service agents comply with

DOT drug and alcohol testingrequirements?

§ 40.343 What tasks may a service agentperform for an employer?

§ 40.345 In what circumstances may a C/TPAact as an intermediary in thetransmission of drug and alcoholtesting information to employers?

§ 40.347 What functions may C/TPAs performwith respect to administering testing?

§ 40.349 What records may a service agentreceive and maintain?


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§ 40.351 What confidentiality requirementsapply to service agents?

§ 40.353 What principles govern the interactionbetween MROs and other serviceagents?

§ 40.355 What limitations apply to theactivities of service agents?

Subpart R - Public Interest Exclusions§ 40.361 What is the purpose of a public

interest exclusion (PIE)?§ 40.363 On what basis may the Department

issue a PIE?§ 40.365 What is the Department's policy

concerning starting a PIE proceeding?§ 40.367 Who initiates a PIE proceeding?§ 40.369 What is the discretion of an initiating

official in starting a PIE proceeding?§ 40.371 On what information does an

initiating official rely in decidingwhether to start a PIE proceeding?

§ 40.373 Before starting a PIE proceeding, doesthe initiating official give the serviceagent an opportunity to correctproblems?

§ 40.375 How does the initiating official start aPIE proceeding?

§ 40.377 Who decides whether to issue a PIE?§ 40.379 How do you contest the issuance of a

PIE?§ 40.381 What information do you present to

contest the proposed issuance of aPIE?

§ 40.383 What procedures apply if you contestthe issuance of a PIE?

§ 40.385 Who bears the burden of proof in aPIE proceeding?

§ 40.387 What matters does the Director decideconcerning a proposed PIE?

§ 40.389 What factors may the Directorconsider?

§ 40.391 What is the scope of a PIE?

§ 40.393 How long does a PIE stay in effect?§ 40.395 Can you settle a PIE proceeding?§ 40.397 When does the Director make a PIE

decision?§ 40.399 How does the Department notify

service agents of its decision?§ 40.401 How does the Department notify

employers and the public about a PIE?§ 40.403 Must a service agent notify its clients

when the Department issues a PIE?§ 40.405 May the Federal courts review PIE

decisions?§ 40.407 May a service agent ask to have a PIE

reduced or terminated?§ 40.409 What does the issuance of a PIE mean

to transportation employers?§ 40.411 What is the role of the DOT Inspector

General's office?§ 40.413 How are notices sent to service

agents?


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Subpart A -Administrative Provisions

§ 40.1Who does this regulation cover?(a) This part tells all parties who conduct drug

and alcohol tests required by Department ofTransportation (DOT) agency regulationshow to conduct these tests and whatprocedures to use.

(b) This part concerns the activities oftransportation employers, safety-sensitivetransportation employees (including self-employed individuals, contractors andvolunteers as covered by DOT agencyregulations), and service agents.

(c) Nothing in this part is intended to supersedeor conflict with the implementation of theFederal Railroad Administration's post-accident testing program (see 49 CFR219.200).

§ 40.3What do the terms used in this partmean?In this part, the terms listed in this section havethe following meanings:Adulterated specimen. A specimen that has been

altered, as evidenced by test resultsshowing either a substance that is not anormal constituent for that type ofspecimen or showing an abnormalconcentration of an endogenous substance.

Affiliate. Persons are affiliates of one another if,directly or indirectly, one controls or hasthe power to control the other, or a thirdparty controls or has the power to controlboth. Indicators of control include, but arenot limited to: interlocking management orownership; shared interest among familymembers; shared facilities or equipment; orcommon use of employees. Following theissuance of a public interest exclusion, anorganization having the same or similarmanagement, ownership, or principalemployees as the service agent concerningwhom a public interest exclusion is in effectis regarded as an affiliate. This definition isused in connection with the public interestexclusion procedures of Subpart R of thispart.

Air blank. In evidential breath testing devices(EBTs) using gas chromatographytechnology, a reading of the device'sinternal standard. In all other EBTs, areading of ambient air containing noalcohol.

Alcohol. The intoxicating agent in beveragealcohol, ethyl alcohol or other lowmolecular weight alcohols, includingmethyl or isopropyl alcohol.

Alcohol concentration. The alcohol in a volumeof breath expressed in terms of grams ofalcohol per 210 liters of breath as indicatedby a breath test under this part.

Alcohol confirmation test. A subsequent testusing an EBT, following a screening testwith a result of 0.02 or greater, thatprovides quantitative data about the alcoholconcentration.

Alcohol screening device (ASD). A breath orsaliva device, other than an EBT, that isapproved by the National Highway TrafficSafety Administration (NHTSA) and placed

on a conforming products list (CPL) forsuch devices.

Alcohol screening test. An analytic procedure todetermine whether an employee may have aprohibited concentration of alcohol in abreath or saliva specimen.

Alcohol testing site. A place selected by theemployer where employees presentthemselves for the purpose of providingbreath or saliva for an alcohol test.

Alcohol use. The drinking or swallowing of anybeverage, liquid mixture or preparation(including any medication), containingalcohol.

Aliquot. A fractional part of a specimen used fortesting. It is taken as a sample representingthe whole specimen.

Blind specimen or blind performance testspecimen. A specimen submitted to alaboratory for quality control testingpurposes, with a fictitious identifier, so thatthe laboratory cannot distinguish it from anemployee specimen.

Breath Alcohol Technician (BAT). A personwho instructs and assists employees in thealcohol testing process and operates anevidential breath testing device.

Cancelled test. A drug or alcohol test that has aproblem identified that cannot be or has notbeen corrected, or which this part otherwiserequires to be cancelled. A cancelled test isneither a positive nor a negative test.

Chain of custody. The procedure used todocument the handling of the urinespecimen from the time the employee givesthe specimen to the collector until thespecimen is destroyed. This procedure usesthe Federal Drug Testing Custody andControl Form (CCF) as approved by theOffice of Management and Budget.

Collection container. A container into which theemployee urinates to provide the specimenfor a drug test.

Collection site. A place selected by the employerwhere employees present themselves for thepurpose of providing a urine specimen for adrug test.

Collector. A person who instructs and assistsemployees at a collection site, who receivesand makes an initial inspection of thespecimen provided by those employees, andwho initiates and completes the CCF.

Confirmatory drug test. A second analyticalprocedure performed on a different aliquotof the original specimen to identify andquantify the presence of a specific drug ordrug metabolite.

Confirmatory validity test. A second testperformed on different aliquot of theoriginal urine specimen to further support avalidity test result.

Confirmed drug test. A confirmation test resultreceived by an MRO from a laboratory.

Consortium/Third-party administrator (C/TPA).A service agent that provides or coordinatesthe provision of a variety of drug andalcohol testing services to employers.C/TPAs typically perform administrativetasks concerning the operation of theemployers' drug and alcohol testingprograms. This term includes, but is notlimited to, groups of employers who jointogether to administer, as a single entity, theDOT drug and alcohol testing programs of

its members. C/TPAs are not “employers”for purposes of this part.

Continuing education. Training substance abuseprofessionals (SAPs) who have completedqualification training and are performingSAP functions, designed to keep SAPscurrent on changes and developments in theDOT drug and alcohol testing program.

Designated employer representative (DER). Anemployee authorized by the employer totake immediate action(s) to removeemployees from safety-sensitive duties, orcause employees to be removed from thesecovered duties, and to make requireddecisions in the testing and evaluationprocesses. The DER also receives testresults and other communications for theemployer, consistent with the requirementsof this part. Service agents cannot act asDERs.

Dilute specimen. A urine specimen withcreatinine and specific gravity values thatare lower than expected for human urine.

DOT, The Department, DOT agency. Theseterms encompass all DOT agencies,including, but not limited to, the UnitedStates Coast Guard (USCG), the FederalAviation Administration (FAA), the FederalRailroad Administration (FRA), the FederalMotor Carrier Safety Administration(FMCSA), the Federal TransitAdministration (FTA), the NationalHighway Traffic Safety Administration(NHTSA), the Pipeline and HazardousMaterials Safety Administration (PHMSA),and the Office of the Secretary (OST).These terms include any designee of a DOTagency.

Drugs. The drugs for which tests are requiredunder this part and DOT agency regulationsare marijuana, cocaine, amphetamines,phencyclidine (PCP), and opiates.

Employee. Any person who is designated in aDOT agency regulation as subject to drugtesting and/or alcohol testing. The termincludes individuals currently performingsafety-sensitive functions designated inDOT agency regulations and applicants foremployment subject to pre-employmenttesting. For purposes of drug testing underthis part, the term employee has the samemeaning as the term “donor” as found onCCF and related guidance materialsproduced by the Department of Health andHuman Services.

Employer. A person or entity employing one ormore employees (including an individualwho is self-employed) subject to DOTagency regulations requiring compliancewith this part. The term includes anemployer's officers, representatives, andmanagement personnel. Service agents arenot employers for the purposes of this part.

Error Correction Training. Training provided toBATs, collectors, and screening testtechnicians (STTs) following an error thatresulted in the cancellation of a drug oralcohol test. Error correction training mustbe provided in person or by a means thatprovides real-time observation andinteraction between the instructor andtrainee.

Evidential Breath Testing Device (EBT). Adevice approved by NHTSA for the


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evidential testing of breath at the .02 and.04 alcohol concentrations, placed onNHTSA's Conforming Products List (CPL)for “Evidential Breath MeasurementDevices” and identified on the CPL asconforming with the model specificationsavailable from NHTSA's Traffic SafetyProgram.

HHS. The Department of Health and HumanServices or any designee of the Secretary,Department of Health and Human Services.

Initial drug test. (also known as a Screening drugtest). The test used to differentiate anegative specimen from one that requiresfurther testing for drugs or drugmetabolites.

Initial specimen validity test. The first test usedto determine if a urine specimen isadulterated, diluted, substituted or invalid.

Invalid drug test. The result reported by alaboratory for a urine specimen thatcontains an unidentified adulterant, containsan unidentified interfering substance, has anabnormal physical characteristic, or has anendogenous substance at an abnormalconcentration that prevents the laboratoryfrom completing testing or obtaining a validdrug test result.

Laboratory. Any U.S. laboratory certified byHHS under the National LaboratoryCertification Program as meeting theminimum standards of Subpart C of theHHS Mandatory Guidelines for FederalWorkplace Drug Testing Programs; or, inthe case of foreign laboratories, a laboratoryapproved for participation by DOT underthis part.

Limit of Detection (LOD). The lowestconcentration at which a measurand can beidentified, but (for quantitative assays) theconcentration cannot be accuratelycalculated.

Limit of Quantitation. For quantitative assays,the lowest concentration at which theidentity and concentration of the measurandcan be accurately established

Medical Review Officer (MRO). A person who isa licensed physician and who is responsiblefor receiving and reviewing laboratoryresults generated by an employer's drugtesting program and evaluating medicalexplanations for certain drug test results.

Negative result. The result reported by an HHS-certified laboratory to an MRO when aspecimen contains no drug or theconcentration of the drug is less than thecutoff concentration for the drug or drugclass and the specimen is a valid specimen.

Non-negative specimen. A urine specimen that isreported as adulterated, substituted, positive(for drug(s) or drug metabolite(s)), and/orinvalid

Office of Drug and Alcohol Policy andCompliance (ODAPC). The office in theOffice of the Secretary, DOT, that isresponsible for coordinating drug andalcohol testing program matters within theDepartment and providing informationconcerning the implementation of this part.

Oxidizing adulterant. A substance that acts aloneor in combination with other substances tooxidize drugs or drug metabolites toprevent the detection of the drug or drug

metabolites, or affects the reagents in eitherthe initial or confirmatory drug test.

Positive result. The result reported by an HHS-certified laboratory when a specimencontains a drug or drug metabolite equal toor greater than the cutoff concentrations

Primary specimen. In drug testing, the urinespecimen bottle that is opened and tested bya first laboratory to determine whether theemployee has a drug or drug metabolite inhis or her system; and for the purpose ofvalidity testing. The primary specimen isdistinguished from the split specimen,defined in this section.

Qualification Training. The training required inorder for a collector, BAT, MRO, SAP, orSTT to be qualified to perform theirfunctions in the DOT drug and alcoholtesting program. Qualification training maybe provided by any appropriate means (e.g.,classroom instruction, internet application,CD–ROM, video).

Reconfirmed. The result reported for a splitspecimen when the second laboratory isable to corroborate the original resultreported for the primary specimen.

Refresher Training. The training requiredperiodically for qualified collectors, BATs,and STTs to review basic requirements andprovide instruction concerning changes intechnology (e.g., new testing methods thatmay be authorized) and amendments,interpretations, guidance, and issuesconcerning this part and DOT agency drugand alcohol testing regulations. Refreshertraining can be provided by any appropriatemeans (e.g., classroom instruction, internetapplication, CD–ROM, video).

Rejected for testing. The result reported by anHHS-certified laboratory when no tests areperformed for a specimen because of a fatalflaw or a correctable flaw that is notcorrected

Screening Drug Test. See Initial drug testdefinition above.

Screening Test Technician (STT). A person whoinstructs and assists employees in thealcohol testing process and operates anASD.

Secretary. The Secretary of Transportation or theSecretary's designee.

Service agent. Any person or entity, other than anemployee of the employer, who providesservices specified under this part toemployers and/or employees in connectionwith DOT drug and alcohol testingrequirements. This includes, but is notlimited to, collectors, BATs and STTs,laboratories, MROs, substance abuseprofessionals, and C/TPAs. To act asservice agents, persons and organizationsmust meet the qualifications set forth inapplicable sections of this part. Serviceagents are not employers for purposes ofthis part.

Shipping container. A container that is used fortransporting and protecting urine specimenbottles and associated documents from thecollection site to the laboratory.

Specimen bottle. The bottle that, after beingsealed and labeled according to theprocedures in this part, is used to hold theurine specimen during transportation to thelaboratory.

Split specimen. In drug testing, a part of the urinespecimen that is sent to a first laboratoryand retained unopened, and which istransported to a second laboratory in theevent that the employee requests that it betested following a verified positive test ofthe primary specimen or a verifiedadulterated or substituted test result.

Split-specimen collection. A collection in whichthe urine collected is divided into twoseparate specimen bottles, the primaryspecimen (Bottle A) and the split specimen(Bottle B).

Stand-down. The practice of temporarilyremoving an employee from theperformance of safety-sensitive functionsbased only on a report from a laboratory tothe MRO of a confirmed positive test for adrug or drug metabolite, an adulterated test,or a substituted test, before the MRO hascompleted verification of the test result.

Substance Abuse Professional (SAP). A personwho evaluates employees who haveviolated a DOT drug and alcohol regulationand makes recommendations concerningeducation, treatment, follow-up testing, andaftercare.

Substituted specimen. A urine specimen withcreatinine and specific gravity values thatare so diminished or so divergent that theyare not consistent with normal human urine.

Verified test. A drug test result or validity testingresult from an HHS-certified laboratory thathas undergone review and finaldetermination by the MRO.

[65 FR 79526, Dec. 19, 2000, as amended at 66FR 41950, Aug. 9, 2001, 71 FR 49384, Aug. 23,2006; 71 FR 55347, Sept. 22, 2006; 73 FR35959, June 25, 2008; 75 FR 49861, August 16,2010, 76 FR 59577, Sept 27, 2011; 80 FR 19553,April 13, 2015]

§ 40.5Who issues authoritativeinterpretations of this regulation?

ODAPC and the DOT Office of General Counsel(OGC) provide written interpretations of theprovisions of this part. These written DOTinterpretations are the only official andauthoritative interpretations concerning theprovisions of this part. DOT agencies mayincorporate ODAPC/OGC interpretations inwritten guidance they issue concerning drug andalcohol testing matters. Only Part 40interpretations issued after August 1, 2001, areconsidered valid.

§ 40.7How can you get an exemption froma requirement in this regulation?(a) If you want an exemption from any provision

of this part, you must request it in writingfrom the Office of the Secretary ofTransportation, under the provisions andstandards of 49 CFR part 5. You must sendrequests for an exemption to the followingaddress: Department of Transportation,Deputy Assistant General Counsel forRegulation and Enforcement, 400 7thStreet, SW., Room 10424, Washington, DC20590.

(b) Under the standards of 49 CFR part 5, wewill grant the request only if the requestdocuments special or exceptional


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circumstances, not likely to be generallyapplicable and not contemplated inconnection with the rulemaking thatestablished this part, that make yourcompliance with a specific provision of thispart impracticable.

(c) If we grant you an exemption, you mustagree to take steps we specify to complywith the intent of the provision from whichan exemption is granted.

(d) We will issue written responses to allexemption requests.

Subpart B -Employer Responsibilities

§ 40.11What are the general responsibilitiesof employers under this regulation?(a) As an employer, you are responsible for

meeting all applicable requirements andprocedures of this part.

(b) You are responsible for all actions of yourofficials, representatives, and agents(including service agents) in carrying outthe requirements of the DOT agencyregulations.

(c) All agreements and arrangements, writtenor unwritten, between and amongemployers and service agents concerningthe implementation of DOT drug andalcohol testing requirements are deemed, asa matter of law, to require compliance withall applicable provisions of this part andDOT agency drug and alcohol testingregulations. Compliance with theseprovisions is a material term of all suchagreements and arrangements.

§ 40.13How do DOT drug and alcohol testsrelate to non-DOT tests?(a) DOT tests must be completely separate

from non-DOT tests in all respects.(b) DOT tests must take priority and must be

conducted and completed before a non-DOT test is begun. For example, you mustdiscard any excess urine left over from aDOT test and collect a separate void for thesubsequent non-DOT test.

(c) Except as provided in paragraph (d) of thissection, you must not perform any tests onDOT urine or breath specimens other thanthose specifically authorized by this part orDOT agency regulations. For example, youmay not test a DOT urine specimen foradditional drugs, and a laboratory isprohibited from making a DOT urinespecimen available for a DNA test or othertypes of specimen identity testing.

(d) The single exception to paragraph (c) ofthis section is when a DOT drug testcollection is conducted as part of a physicalexamination required by DOT agencyregulations. It is permissible to conductrequired medical tests related to thisphysical examination (e.g., for glucose) onany urine remaining in the collectioncontainer after the drug test urinespecimens have been sealed into thespecimen bottles.

(e) No one is permitted to change or disregardthe results of DOT tests based on the resultsof non-DOT tests. For example, as an

employer you must not disregard a verifiedpositive DOT drug test result because theemployee presents a negative test resultfrom a blood or urine specimen collected bythe employee's physician or a DNA testresult purporting to question the identity ofthe DOT specimen.

(f) As an employer, you must not use the CCFor the ATF in your non-DOT drug andalcohol testing programs. This prohibitionincludes the use of the DOT forms withreferences to DOT programs and agenciescrossed out. You also must always use theCCF and ATF for all your DOT-mandateddrug and alcohol tests.

§ 40.14What collection information mustemployers provide to collectors?

As an employer, or an employer’s serviceagent—for example a C/TPA, you must ensurethe collector has the following information whenconducting a urine specimen collection for you:(a) Full name of the employee being tested.(b) Employee SSN or ID number.(c) Laboratory name and address (can be pre-

printed on the CCF).(d) Employer name, address, phone number,

and fax number (can be pre-printed on theCCF at Step 1-A).

(e) DER information required at §40.35 of thispart.

(f) MRO name, address, phone number, andfax number (can be pre-printed on the CCFat Step 1-B).

(g) The DOT Agency which regulates theemployee’s safety-sensitive duties (thecheckmark can be pre-printed in theappropriate box on the CCF at Step 1-D).

(h) Test reason, as appropriate: Pre-employment; Random; ReasonableSuspicion/Reasonable Cause; Post-Accident; Return-to-Duty; and Follow-up.

(i) Whether the test is to be observed or not(see §40.67 of this part).

(j) (Optional) C/TPA name, address, phone,and fax number (can be pre-printed on theCCF).

[65 FR 79526, Dec. 19, 2000, Sept. 27, 2010]

§ 40.15May an employer use a service agentto meet DOT drug and alcoholtesting requirements?(a) As an employer, you may use a service

agent to perform the tasks needed tocomply with this part and DOT agency drugand alcohol testing regulations, consistentwith the requirements of Subpart Q andother applicable provisions of this part.

(b) As an employer, you are responsible forensuring that the service agents you usemeet the qualifications set forth in this part(e.g., §40.121 for MROs). You may requireservice agents to show you documentationthat they meet the requirements of this part(e.g., documentation of MRO qualificationsrequired by §40.121(e)).

(c) You remain responsible for compliancewith all applicable requirements of this partand other DOT drug and alcohol testingregulations, even when you use a serviceagent. If you violate this part or other DOTdrug and alcohol testing regulationsbecause a service agent has not provided

services as our rules require, a DOT agencycan subject you to sanctions. Your goodfaith use of a service agent is not a defensein an enforcement action initiated by a DOTagency in which your allegednoncompliance with this part or a DOTagency drug and alcohol regulation mayhave resulted from the service agent'sconduct.

(d) As an employer, you must not permit aservice agent to act as your DER.

[65 FR 79526, Dec.19, 2000, as amended at 75FR 59107, September 27, 2010]

§ 40.17Is an employer responsible forobtaining information from itsservice agents?

Yes, as an employer, you are responsible forobtaining information required by this part fromyour service agents. This is true whether or notyou choose to use a C/TPA as an intermediary intransmitting information to you. For example,suppose an applicant for a safety-sensitive jobtakes a pre-employment drug test, but there is asignificant delay in your receipt of the test resultfrom an MRO or C/TPA. You must not assumethat “no news is good news” and permit theapplicant to perform safety-sensitive dutiesbefore receiving the result. This is a violation ofthe Department's regulations.

§ 40.21May an employer stand down anemployee before the MRO hascompleted the verification process?(a) As an employer, you are prohibited from

standing employees down, exceptconsistent with a waiver a DOT agencygrants under this section.

(b) You may make a request to the concernedDOT agency for a waiver from theprohibition of paragraph (a) of this section.Such a waiver, if granted, permits you tostand an employee down following theMRO's receipt of a laboratory report of aconfirmed positive test for a drug or drugmetabolite, an adulterated test, or asubstituted test pertaining to the employee.

(1) For this purpose, the concerned DOTagency is the one whose drug andalcohol testing rules apply to themajority of the covered employees inyour organization. The concerned DOTagency uses its applicable procedures forconsidering requests for waivers.

(2) Before taking action on a waiver request,the concerned DOT agency coordinateswith other DOT agencies that regulatethe employer's other covered employees.

(3) The concerned DOT agency provides awritten response to each employer thatpetitions for a waiver, setting forth thereasons for the agency's decision on thewaiver request.

(c) Your request for a waiver must include, as aminimum, the following elements:

(1) Information about your organization:(i) Your determination that standing

employees down is necessary forsafety in your organization and astatement of your basis for it,including any data on safety problemsor incidents that could have been


7

prevented if a stand-down procedurehad been in place;

(ii) Data showing the number ofconfirmed laboratory positive,adulterated, and substituted testresults for your employees over thetwo calendar years preceding yourwaiver request, and the number andpercentage of those test results thatwere verified positive, adulterated, orsubstituted by the MRO;

(iii) Information about the work situationof the employees subject to stand-down, including a description of thesize and organization of the unit(s) inwhich the employees work, theprocess through which employees willbe informed of the stand-down,whether there is an in-house MRO,and whether your organization has amedical disqualification or stand-down policy for employees insituations other than drug and alcoholtesting; and

(iv) A statement of which DOT agenciesregulate your employees.

(2) Your proposed written company policyconcerning stand-down, which mustinclude the following elements:

(i) Your assurance that you willdistribute copies of your writtenpolicy to all employees that it covers;

(ii) Your means of ensuring that noinformation about the confirmedpositive, adulterated, or substitutedtest result or the reason for theemployee's temporary removal fromperformance of safety-sensitivefunctions becomes available, directlyor indirectly, to anyone in yourorganization (or subsequently toanother employer) other than theemployee, the MRO and the DER;

(iii) Your means of ensuring that allcovered employees in a particular jobcategory in your organization aretreated the same way with respect tostand-down;

(iv) Your means of ensuring that acovered employee will be subject tostand-down only with respect to theactual performance of safety-sensitiveduties;

(v) Your means of ensuring that you willnot take any action adverselyaffecting the employee's pay andbenefits pending the completion of theMRO's verification process. Thisincludes continuing to pay theemployee during the period of thestand-down in the same way youwould have paid him or her had he orshe not been stood down;

(vi) Your means of ensuring that theverification process will commenceno later than the time an employee istemporarily removed from theperformance of safety-sensitivefunctions and that the period of stand-down for any employee will notexceed five days, unless you areinformed in writing by the MRO thata longer period is needed to completethe verification process; and

(vii) Your means of ensuring that, in theevent that the MRO verifies the testnegative or cancels it—

(A) You return the employeeimmediately to the performance ofsafety-sensitive duties;

(B) The employee suffers no adversepersonnel or financialconsequences as a result; and

(C) You maintain no individuallyidentifiable record that theemployee had a confirmedlaboratory positive, adulterated, orsubstituted test result (i.e., youmaintain a record of the test only asa negative or cancelled test).

(d) The Administrator of the concerned DOTagency, or his or her designee, may grant awaiver request only if he or she determinesthat, in the context of your organization,there is a high probability that theprocedures you propose will effectivelyenhance safety and protect the interests ofemployees in fairness and confidentiality.

(1) The Administrator, or his or herdesignee, may impose any conditions heor she deems appropriate on the grant ofa waiver.

(2) The Administrator, or his or herdesignee, may immediately suspend orrevoke the waiver if he or she determinesthat you have failed to protect effectivelythe interests of employees in fairness andconfidentiality, that you have failed tocomply with the requirements of thissection, or that you have failed tocomply with any other conditions theDOT agency has attached to the waiver.

(e) You must not stand employees down in theabsence of a waiver, or inconsistent withthe terms of your waiver. If you do, you arein violation of this part and DOT agencydrug testing regulations, and you are subjectto enforcement action by the DOT agencyjust as you are for other violations of thispart and DOT agency rules.

§ 40.23What actions do employers take afterreceiving verified test results?a) As an employer who receives a verified

positive drug test result, you mustimmediately remove the employee involvedfrom performing safety-sensitive functions.You must take this action upon receivingthe initial report of the verified positive testresult. Do not wait to receive the writtenreport or the result of a split specimen test.

(b) As an employer who receives a verifiedadulterated or substituted drug test result,you must consider this a refusal to test andimmediately remove the employee involvedfrom performing safety-sensitive functions.You must take this action on receiving theinitial report of the verified adulterated orsubstituted test result. Do not wait toreceive the written report or the result of asplit specimen test.

(c) As an employer who receives an alcoholtest result of 0.04 or higher, you mustimmediately remove the employee involvedfrom performing safety-sensitive functions.If you receive an alcohol test result of0.02—0.039, you must temporarily removethe employee involved from performing

safety-sensitive functions, as provided inapplicable DOT agency regulations. Do notwait to receive the written report of theresult of the test.

(d) As an employer, when an employee has averified positive, adulterated, or substitutedtest result, or has otherwise violated a DOTagency drug and alcohol regulation, youmust not return the employee to theperformance of safety-sensitive functionsuntil or unless the employee successfullycompletes the return-to-duty process ofSubpart O of this part.

(e) As an employer who receives a drug testresult indicating that the employee'sspecimen was dilute, take action asprovided in §40.197.

(f) As an employer who receives a drug testresult indicating that the employee's urinespecimen was cancelled because it wasinvalid and that a second collection musttake place under direct observation—

(1) You must immediately direct theemployee to provide a new specimenunder direct observation.

(2) You must not attach consequences to thefinding that the test was invalid otherthan collecting a new specimen underdirect observation.

(3) You must not give any advance notice ofthis test requirement to the employee.

(4) You must instruct the collector to noteon the CCF the same reason (e.g.random test, post-accident test) and DOTAgency (e.g., check DOT and FMCSA)as for the original collection.

(5) You must ensure that the collectorconducts the collection under directobservation.

(g) As an employer who receives a cancelledtest result when a negative result is required(e.g., pre-employment, return-to-duty, orfollow-up test), you must direct theemployee to provide another specimenimmediately.

(h) As an employer, you may also be requiredto take additional actions required by DOTagency regulations (e.g., FAA rules requiresome positive drug tests to be reported tothe Federal Air Surgeon).

(i) As an employer, you must not alter a drugor alcohol test result transmitted to you byan MRO, BAT, or C/TPA.

[65 FR 79526, Dec. 19, 2000, as amended at 71FR 49384, Aug. 23, 2006; 73 FR 35970, June 25,2008; September 27, 2010]

§ 40.25Must an employer check on the drugand alcohol testing record ofemployees it is intending to use toperform safety-sensitive duties?(a) Yes, as an employer, you must, after

obtaining an employee's written consent,request the information about the employeelisted in paragraph (b) of this section. Thisrequirement applies only to employeesseeking to begin performing safety-sensitive duties for you for the first time(i.e., a new hire, an employee transfers intoa safety-sensitive position). If the employeerefuses to provide this written consent, youmust not permit the employee to performsafety-sensitive functions.


8

(b) You must request the information listed inthis paragraph (b) from DOT-regulatedemployers who have employed theemployee during any period during the twoyears before the date of the employee'sapplication or transfer:

(1) Alcohol tests with a result of 0.04 orhigher alcohol concentration;

(2) Verified positive drug tests;(3) Refusals to be tested (including verified

adulterated or substituted drug testresults);

(4) Other violations of DOT agency drugand alcohol testing regulations; and

(5) With respect to any employee whoviolated a DOT drug and alcoholregulation, documentation of theemployee's successful completion ofDOT return-to-duty requirements(including follow-up tests). If theprevious employer does not haveinformation about the return-do-dutyprocess (e.g., an employer who did nothire an employee who tested positive ona pre-employment test), you must seek toobtain this information from theemployee.

(c) The information obtained from a previousemployer includes any drug or alcohol testinformation obtained from previousemployers under this section or otherapplicable DOT agency regulations.

(d) If feasible, you must obtain and review thisinformation before the employee firstperforms safety-sensitive functions. If thisis not feasible, you must obtain and reviewthe information as soon as possible.However, you must not permit theemployee to perform safety-sensitivefunctions after 30 days from the date onwhich the employee first performed safety-sensitive functions, unless you haveobtained or made and documented a goodfaith effort to obtain this information.

(e) If you obtain information that the employeehas violated a DOT agency drug andalcohol regulation, you must not use theemployee to perform safety-sensitivefunctions unless you also obtaininformation that the employee hassubsequently complied with the return-to-duty requirements of Subpart O of this partand DOT agency drug and alcoholregulations.

(f) You must provide to each of the employersfrom whom you request information underparagraph (b) of this section written consentfor the release of the information cited inparagraph (a) of this section.

(g) The release of information under thissection must be in any written form (e.g.,fax, e-mail, letter) that ensuresconfidentiality. As the previous employer,you must maintain a written record of theinformation released, including the date, theparty to whom it was released, and asummary of the information provided.

(h) If you are an employer from whominformation is requested under paragraph(b) of this section, you must, afterreviewing the employee's specific, writtenconsent, immediately release the requestedinformation to the employer making theinquiry.

(i) As the employer requesting the informationrequired under this section, you mustmaintain a written, confidential record ofthe information you obtain or of the goodfaith efforts you made to obtain theinformation. You must retain thisinformation for three years from the date ofthe employee's first performance of safety-sensitive duties for you.

(j) As the employer, you must also ask theemployee whether he or she has testedpositive, or refused to test, on any pre-employment drug or alcohol testadministered by an employer to which theemployee applied for, but did not obtain,safety-sensitive transportation workcovered by DOT agency drug and alcoholtesting rules during the past two years. Ifthe employee admits that he or she had apositive test or a refusal to test, you mustnot use the employee to perform safety-sensitive functions for you, until and unlessthe employee documents successfulcompletion of the return-to-duty process(see paragraphs (b)(5) and (e) of thissection).

§ 40.26What form must an employer use toreport Management InformationSystem (MIS) data to a DOT agency?As an employer, when you are required to reportMIS data to a DOT agency, you must use theform and instructions at appendix H to part 40.You must submit the MIS report in accordancewith rule requirements (e.g., dates forsubmission; selection of companies required tosubmit, and method of reporting) established bythe DOT agency regulating your operation.[68 FR 43952, July 25, 2003]

§ 40.27May an employer require anemployee to sign a consent orrelease in connection with the DOTdrug and alcohol testing program?No, as an employer, you must not require anemployee to sign a consent, release, waiver ofliability, or indemnification agreement withrespect to any part of the drug or alcohol testingprocess covered by this part (including, but notlimited to, collections, laboratory testing, MROand SAP services).[66 FR 41950, Aug. 9, 2001]

§ 40.29Where is other information onemployer responsibilities found inthis regulation?You can find other information on theresponsibilities of employers in the followingsections of this part:§40.3 Definition.§40.35 Information about DERs that

employers must provide collectors.§40.45 Modifying CCFs, Use of foreign-

language CCFs.§40.47 Use of non-Federal forms for DOT

tests or Federal CCFs for non-DOTtests.

§40.67 Requirements for direct observation.§§40.103–40.105

Blind specimen requirements.§40. 173 Responsibility to ensure test of split

specimen.

§40.193 Action in “shy bladder” situations.§40.197 Actions following report of a dilute

specimen.§40.207 Actions following a report of a

cancelled drug test.§40.209 Actions following and consequences

of non-fatal flaws in drug tests.§40.215 Information about DERs that

employers must provide BATs andSTTs.

§40.225 Modifying ATFs; use of foreign-language ATFs.

§40.227 Use of non-DOT forms for DOT testsor DOT ATFs for non-DOT tests.

§40.235 (c) and (d) responsibility to followinstructions for ASDs.

§40.255 (b) receipt and storage of alcohol testinformation.

§40.265 (c)–(e)actions in “shy lung” situations.

§40.267 Cancellation of alcohol tests.§40.271 Actions in “correctable flaw”

situations in alcohol tests.§40.273 Actions following cancelled tests in

alcohol tests.§40.275 Actions in “non-fatal flaw” situations

in alcohol tests.§§40.287–40.289

Responsibilities concerning SAPservices.

§§40.295–40.297Prohibition on seeking second SAPevaluation or changing SAPrecommendation.

§40.303 Responsibilities concerning aftercarerecommendations.

§40.305 Responsibilities concerning return-to-duty decision.

§40.309 Responsibilities concerning follow-uptests.

§40.321 General confidentiality requirement.§40.323 Release of confidential information in

litigation.§40.331 Other circumstances for the release of

confidential information.§40.333 Record retention requirements.§40.345 Choice of who reports drug testing

information to employers.[65 FR 79526, Dec. 19, 2000. Redesignated at 66FR 41950, Aug. 9, 2001]

Subpart C - Urine CollectionPersonnel

Subpart DCollection Sites, Forms,Equipment and Supplies Used inDOT Urine Collections

§ 40.47May employers use the CCF for non-Federal collections or non-Federalforms for DOT collections?(a) No, as an employer, you are prohibited

from using the CCF for non-Federal urinecollections. You are also prohibited fromusing non-Federal forms for DOT urinecollections. Doing either subjects you toenforcement action under DOT agencyregulations.

(b) (1) In the rare case where the collector,either by mistake or as the only means to


9

conduct a test under difficultcircumstances (e.g., post-accident orreasonable suspicion test withinsufficient time to obtain the CCF), usesa non-Federal form for a DOTcollection, the use of a non-Federal formdoes not present a reason for thelaboratory to reject the specimen fortesting or for an MRO to cancel theresult.

(2) The use of the non-Federal form is a“correctable flaw.” As an MRO, tocorrect the problem you must follow theprocedures of §40.205(b) (2).

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

Subpart E -Urine Specimen Collections

§ 40.67When and how is a directly observedcollection conducted?(a) As an employer, you must direct an

immediate collection under directobservation with no advance notice to theemployee, if:

(1) The laboratory reported to the MRO thata specimen is invalid, and the MROreported to you that there was not anadequate medical explanation for theresult;

(2) The MRO reported to you that theoriginal positive, adulterated, orsubstituted result had to be cancelledbecause the test of the split specimencould not be performed; or

(3) The laboratory reported to the MRO thatthe specimen was negative-dilute with acreatinine concentration greater than orequal to 2 mg/dL but less than or equalto 5 mg/dL, and the MRO reported thespecimen to you as negative-dilute andthat a second collection must take placeunder direct observation (see§40.197(b)(1)).

(b) As an employer, you must direct acollection under direct observation of anemployee if the drug test is a return-to-dutytest or a follow-up test.

(c) As a collector, you must immediatelyconduct a collection under directobservation if:

(1) You are directed by the DER to do so(see paragraphs (a) and (b) of thissection); or

(2) You observed materials brought to thecollection site or the employee's conductclearly indicates an attempt to tamperwith a specimen (see §§40.61(f)(5)(i)and 40.63(e)); or

(3) The temperature on the originalspecimen was out of range (see§40.65(b)(5)); or (4) The originalspecimen appeared to have beentampered with (see §40.65(c)(1)).

(d)(1) As the employer, you must explain to theemployee the reason for a directlyobserved collection under paragraph (a)or (b) of this section.

(2) As the collector, you must explain to theemployee the reason, if known, underthis part for a directly observed

collection under paragraphs (c)(1)through (3) of this section.

(e) As the collector, you must complete a newCCF for the directly observed collection.

1) You must mark the “reason for test”block (Step 1) the same as for the firstcollection.

(2) You must check the “Observed, (EnterRemark)” box and enter the reason (see§40.67(b)) in the “Remarks” line (Step2).

(f) In a case where two sets of specimens arebeing sent to the laboratory because ofsuspected tampering with the specimen atthe collection site, enter on the “Remarks”line of the CCF (Step 2) for each specimena notation to this effect (e.g., collection 1 of2, or 2 of 2) and the specimen ID number ofthe other specimen.

(g) As the collector, you must ensure that theobserver is the same gender as theemployee. You must never permit anopposite gender person to act as theobserver. The observer can be a differentperson from the collector and need not be aqualified collector.

(h) As the collector, if someone else is toobserve the collection (e.g., in order toensure a same gender observer), you mustverbally instruct that person to followprocedures at paragraphs (i) and (j) of thissection. If you, the collector, are theobserver, you too must follow theseprocedures.

(i) As the observer, you must request theemployee to raise his or her shirt, blouse, ordress/skirt, as appropriate, above the waist;and lower clothing and underpants to showyou, by turning around, that they do nothave a prosthetic device. After you havedetermined that the employee does not havesuch a device, you may permit theemployee to return clothing to its properposition for observed urination.

(j) As the observer, you must watch theemployee urinate into the collectioncontainer. Specifically, you are to watch theurine go from the employee's body into thecollection container.

(k) As the observer but not the collector, youmust not take the collection container fromthe employee, but you must observe thespecimen as the employee takes it to thecollector.

(l) As the collector, when someone else hasacted as the observer, you must include theobserver's name in the “Remarks” line ofthe CCF (Step 2).

(m) As the employee, if you decline to allow adirectly observed collection required orpermitted under this section to occur, this isa refusal to test.

(n) As the collector, when you learn that adirectly observed collection should havebeen collected but was not, you mustinform the employer that it must direct theemployee to have an immediate recollectionunder direct observation.

[65 FR 79526, Dec. 19, 2000, as amended at 66FR 41950, Aug. 9, 2001; 68 FR 31626, May 28,2003; 69 FR 64867, Nov.9, 2004; 73 FR 35970,June 25, 2008; 73 FR 70283, November 20,2008; 74 FR 37949, July 30, 2009]

§ 40.69How is a monitored collectionconducted?(a) As the collector, you must secure the room

being used for the monitored collection sothat no one except the employee and themonitor can enter it until after the collectionhas been completed.

(b) As the collector, you must ensure that themonitor is the same gender as theemployee, unless the monitor is a medicalprofessional (e.g., nurse, doctor, physician'sassistant, technologist, or technicianlicensed or certified to practice in thejurisdiction in which the collection takesplace). The monitor can be a differentperson from the collector and need not be aqualified collector.

(c) As the collector, if someone else is tomonitor the collection (e.g., in order toensure a same-gender monitor), you mustverbally instruct that person to follow theprocedures of paragraphs (d) and (e) of thissection. If you, the collector, are themonitor, you must follow these procedures.

(d) As the monitor, you must not watch theemployee urinate into the collectioncontainer. If you hear sounds or make otherobservations indicating an attempt totamper with a specimen, there must be anadditional collection under directobservation (see §§40.63(e), 40.65(c), and40.67(b)).

(e) As the monitor, you must ensure that theemployee takes the collection containerdirectly to the collector as soon as theemployee has exited the enclosure.

(f) As the collector, when someone else hasacted as the monitor, you must note thatperson's name in the “Remarks” line of theCCF (Step 2).

(g) As the employee being tested, if youdecline to permit a collection authorizedunder this section to be monitored, it is arefusal to test.


Subpart F - Drug TestingLaboratories

§ 40.81What laboratories may be used forDOT drug testing?(a) As a drug testing laboratory located in the

U.S., you are permitted to participate inDOT drug testing only if you are certifiedby HHS under the National LaboratoryCertification Program (NLCP) for alltesting required under this part.

(b) As a drug testing laboratory located inCanada or Mexico which is not certified byHHS under the NLCP, you are permitted toparticipate in DOT drug testing only if:

(1) The DOT, based on a writtenrecommendation from HHS, hasapproved your laboratory as meetingHHS laboratory certification standards ordeemed your laboratory fully equivalentto a laboratory meeting HHS laboratorycertification standards for all testingrequired under this part; or

(2) The DOT, based on a writtenrecommendation from HHS, has


10

recognized a Canadian or Mexicancertifying organization as havingequivalent laboratory certificationstandards and procedures to those ofHHS, and the Canadian or Mexicancertifying organization has certified yourlaboratory under those equivalentstandards and procedures.

(c) As a laboratory participating in the DOTdrug testing program, you must complywith the requirements of this part. Youmust also comply with all applicablerequirements of HHS in testing DOTspecimens, whether or not the HHSrequirements are explicitly stated in thispart.

(d) If DOT determines that you are innoncompliance with this part, you could besubject to PIE proceedings under Subpart Rof this part. If the Department issues a PIEwith respect to you, you are ineligible toparticipate in the DOT drug testing programeven if you continue to meet therequirements of paragraph (a) or (b) of thissection.

§ 40.83How do laboratories processincoming specimens?As the laboratory, you must do the followingwhen you receive a DOT specimen:(a) You are authorized to receive only Copy 1

of the CCF. You are not authorized toreceive other copies of the CCF or anycopies of the alcohol testing form.

(b) You must comply with applicableprovisions of the HHS Guidelinesconcerning accessioning and processingurine drug specimens.

(c) You must inspect each specimen and CCFfor the following “fatal flaws:”

(1) The specimen ID numbers on thespecimen bottle and the CCF do notmatch;

(2) The specimen bottle seal is broken orshows evidence of tampering, unless asplit specimen can be redesignated (seeparagraph (h) of this section);

(3) The collector's printed name andsignature are omitted from the CCF; and

(4) There is an insufficient amount of urinein the primary bottle for analysis, unlessthe specimens can be redesignated (seeparagraph (h) of this section).

(d) When you find a specimen meeting thecriteria of paragraph (c) of this section, youmust document your findings and stop thetesting process. Report the result inaccordance with §40.97(a)(3).

(e) You must inspect each CCF for thepresence of the collector's signature on thecertification statement in Step 4 of the CCF.Upon finding that the signature is omitted,document the flaw and continue the testingprocess.

(1) In such a case, you must retain thespecimen for a minimum of 5 businessdays from the date on which youinitiated action to correct the flaw.

(2) You must then attempt to correct theflaw by following the procedures of§40.205(b)(1).

(3) If the flaw is not corrected, report theresult as rejected for testing inaccordance with §40.97(a)(3).

(f) If you determine that the specimentemperature was not checked and the“Remarks” line did not contain an entryregarding the temperature being outside ofrange, you must then attempt to correct theproblem by following the procedures of§40.208.

(1) In such a case, you must continue yourefforts to correct the problem for fivebusiness days, before you report theresult.

(2) When you have obtained the correction,or five business days have elapsed,report the result in accordance with§40.97(a).

(g) If you determine that a CCF that fails tomeet the requirements of §40.45(a) (e.g., anon-Federal form or an expired Federalform was used for the collection), you mustattempt to correct the use of the improperform by following the procedures of§40.205(b) (2).

(1) In such a case, you must retain thespecimen for a minimum of 5 businessdays from the date on which youinitiated action to correct the problem.

(2) If the problem(s) is not corrected, youmust reject the test and report the resultin accordance with §40.97(a)(3).

(h) If the CCF is marked indicating that a splitspecimen collection was collected and if thesplit specimen does not accompany theprimary, has leaked, or is otherwiseunavailable for testing, you must still testthe primary specimen and followappropriate procedures outlined in§40.175(b) regarding the unavailability ofthe split specimen for testing.

(1) The primary specimen and the splitspecimen can be redesignated (i.e.,Bottle B is redesignated as Bottle A, andvice-versa) if:

(i) The primary specimen appears tohave leaked out of its sealed bottleand the laboratory believes asufficient amount of urine exists in thesplit specimen to conduct allappropriate primary laboratorytesting; or

(ii) The primary specimen is labeled asBottle B, and the split specimen asBottle A; or

(iii) The laboratory opens the splitspecimen instead of the primaryspecimen, the primary specimenremains sealed, and the laboratorybelieves a sufficient amount of urineexists in the split specimen to conductall appropriate primary laboratorytesting; or

(iv) The primary specimen seal is brokenbut the split specimen remains sealedand the laboratory believes asufficient amount of urine exists in thesplit specimen to conduct allappropriate primary laboratorytesting.

(2) In situations outlined in paragraph (g)(1)of this section, the laboratory shall markthrough the “A” and write “B,” theninitial and date the change. Acorresponding change shall be made tothe other bottle by marking through the“B” and writing “A,” and initialing anddating the change.

(i) A notation shall be made on Copy 1of the CCF (Step 5a) and on anylaboratory internal chain of custodydocuments, as appropriate, for anyfatal or correctable flaw.

[65 FR 79526, Dec. 19, 2000, as amended at 66FR 41951, Aug. 9, 2001; 71 FR 49384, Aug. 23,2006; 73 FR 35970, June 25, 2008; 75 FR 59107,September 27, 2010]

§ 40.85What drugs do laboratories test for?As a laboratory, you must test for the followingfive drugs or classes of drugs in a DOT drug test.You must not test “DOT specimens” for anyother drugs.(a) Marijuana metabolites.(b) Cocaine metabolites.(c) Amphetamines.(d) Opiate metabolites.(e) Phencyclidine (PCP).

§ 40.87What are the cutoff concentrations for drug tests?(a) As a laboratory, you must use the cutoff concentrations displayed in the following table for initial and confirmation drug tests. All cutoff

concentrations are expressed in nanograms per milliliter (ng/mL). The table follows:

Initial test analyte Initial test cutoff concentration Confirmatory test analyte Confirmatory test cutoff concentration

Marijuana metabolites 50 ng/mL THCA 1 15 ng/mL

Cocaine metabolites 150 ng/mL Benzoylecgonine 100 ng/mL

Opiate metabolites


11

Codeine / Morphine 2 2,000 ng/mL Codeine 2,000 ng/mL

Morphine 2,000 ng/mL

6-Acetylmorphine 10 ng/mL 6-Acetylmorphine 10 ng/mL

Phencyclidine 25 ng/mL Phencyclidine 25 ng/mL

Amphetamines 3

AMP/MAMP 4 500 ng/mL Amphetamine 250 ng/mL

Methamphetamine 5 250 ng/mL

MDMA 6 500 ng/mL MDMA 250 ng/mL

MDA 7 250 ng/mL

MDEA 8 250 ng/mL

1 Delta-9-tetrahydrocannabinol-9-carboxylic acid (THCA).2 Morphine is the target analyte for codeine/morphine testing.3 Either a single initial test kit or multiple initial test kits may be used provided the single test kit detects each target analyteindependently atthe specified cutoff.4 Methamphetamine is the target analyte for amphetamine/methamphetamine testing.5 To be reported positive for methamphetamine, a specimen must also contain amphetamine at a concentration equal to or greaterthan 100ng/mL.6 Methylenedioxymethamphetamine (MDMA).7 Methylenedioxyamphetamine (MDA).8 Methylenedioxyethylamphetamine (MDEA

(b) On an initial drug test, you must report a result below the cutoff concentration as negative. If the result is at or above the cutoff concentration,you must conduct a confirmation test.(c) On a confirmation drug test, you must report a result below the cutoff concentration as negative and a result at or above the cutoffconcentration as confirmed positive.(d) You must report quantitative values for morphine or codeine at 15,000 ng/mL or above.[65 FR 79526, Dec. 19, 2000, as amended at 75 FR 49862, August 16, 2010; FR 26473, May 4, 2012]

§ 40.89What is validity testing, and arelaboratories required to conduct it?(a) Specimen validity testing is the evaluation

of the specimen to determine if it isconsistent with normal human urine. Thepurpose of validity testing is to determinewhether certain adulterants or foreignsubstances were added to the urine, if theurine was diluted, or if the specimen wassubstituted.

(b) As a laboratory, you must conduct validitytesting.

[65 FR 79526, Dec. 19, 2000, as amended at 66FR 41951, Aug. 9, 2001, 73 FR 35970, June 25,2008]

§ 40.97What do laboratories report and howdo they report it?(a) As a laboratory, you must report the results

for each primary specimen. The result of aprimary specimen will fall into one of thefollowing three categories. However, as alaboratory, you must report the actualresults (and not the categories):

(1) Category 1: Negative Results. As alaboratory, when you find a specimen tobe negative, you must report the testresult as being one of the following, asappropriate:

(i) Negative, or(ii) Negative-dilute, with numerical values

for creatinine and specific gravity.(2) Category 2: Non-negative Results. As a

laboratory, when you find a specimen to

be non-negative, you must report the testresult as being one or more of thefollowing, as appropriate:

(i) Positive, with drug(s)/metabolite(s)noted, with numerical values for thedrug(s) or drug metabolites(s).

(ii) Positive-dilute, with drug(s)/metabolite(s) noted, with numericalvalues for the drug(s) or drugmetabolite(s) and with numericalvalues for creatinine and specificgravity;

(iii) Adulterated, with adulterant(s) noted,with confirmatory test values (whenapplicable), and with remarks(s);

(iv) Substituted, with confirmatory testvalues for creatinine and specificgravity; or

(v) Invalid result, with remark(s).Laboratories will report actual valuesfor pH results

(3) Category 3: Rejected for Testing. As alaboratory, when you reject a specimenfor testing, you must report the result asbeing Rejected for Testing, withremark(s).

(b) As a laboratory, you must report laboratoryresults directly, and only, to the MRO at hisor her place of business. You must notreport results to or through the DER or aservice agent (e.g., C/TPA).

(1) Negative results: You must fax, courier,mail, or electronically transmit a legibleimage or copy of the fully-completedCopy 1 of the CCF which has beensigned by the certifying scientist, or you

may provide the laboratory results reportelectronically (i.e., computer data file).

(i) If you elect to provide the laboratoryresults report, you must include thefollowing elements, as a minimum, inthe report format:

(A) Laboratory name and address;(B) Employer's name (you may include

I.D. or account number);(C) Medical review officer's name;(D) Specimen I.D. number;(E) Donor's SSN or employee I.D.

number, if provided;(F) Reason for test, if provided;(G) Collector's name and telephone

number;(H) Date of the collection;(I) Date received at the laboratory;(J) Date certifying scientist released

the results;(K) Certifying scientist's name;(L) Results (e.g., positive, adulterated)

as listed in paragraph (a) of thissection; and

(M) Remarks section, with anexplanation of any situation inwhich a correctable flaw has beencorrected.

(ii) You may release the laboratory resultsreport only after review and approvalby the certifying scientist. It mustreflect the same test result informationas contained on the CCF signed by thecertifying scientist. The informationcontained in the laboratory results


12

report may not contain informationthat does not appear on the CCF.

(iii) The results report may be transmittedthrough any means that ensuresaccuracy and confidentiality. You, asthe laboratory, together with theMRO, must ensure that theinformation is adequately protectedfrom unauthorized access or release,both during transmission and instorage.

(2) Non-negative and Rejected for Testingresults: You must fax, courier, mail, orelectronically transmit a legible image orcopy of the fully-completed Copy 1 ofthe CCF that has been signed by thecertifying scientist. In addition, you mayprovide the electronic laboratory resultsreport following the format andprocedures set forth in paragraphs(b)(1)(i) and (ii) of this section.

(c) In transmitting laboratory results to theMRO, you, as the laboratory, together withthe MRO, must ensure that the informationis adequately protected from unauthorizedaccess or release, both during transmissionand in storage. If the results are provided byfax, the fax connection must have a fixedtelephone number accessible only toauthorized individuals.

(d) You must transmit test results to the MROin a timely manner, preferably the same daythat review by the certifying scientist iscompleted.

(e) (1) You must provide quantitative values forconfirmed positive drug test results tothe MRO.

(2) You must provide numerical values thatsupport the adulterated (whenapplicable) or substituted result, withouta request from the MRO.

(3) You must also provide the MROnumerical values for creatinine andspecific gravity for the negative-dilutetest result, without a request from theMRO.

(f) You must provide quantitative values forconfirmed opiate results for morphine orcodeine at 15,000 ng/mL or above, even ifthe MRO has not requested quantitativevalues for the test result.

[65 FR 79526, Dec. 19, 2000, as amended at 66FR 41951, Aug. 9, 2001; 68 FR 31626, May 28,2003; 69 FR 64867, Nov.9, 2004, 73 FR 35970,June 25, 2008; 75 FR 59107, 75 FR 49862,August 16, 2010; September 27, 2010, 77 FR26473, May 4, 2012]

Subpart G - Medical ReviewOfficers and the VerificationProcess

§ 40.131How does the MRO or DER notify anemployee of the verification processafter receiving laboratory confirmednon-negative test results?(a) When, as the MRO, you receive a

confirmed positive, adulterated, substituted,or invalid test result from the laboratory,you must contact the employee directly(i.e., actually talk to the employee), on aconfidential basis, to determine whether the

employee wants to discuss the test result. Inmaking this contact, you must explain tothe employee that, if he or she declines todiscuss the result, you will verify the test aspositive or as a refusal to test because ofadulteration or substitution, as applicable.

(b) As the MRO, staff under your personalsupervision may conduct this initial contactfor you.

(1) This staff contact must be limited toscheduling the discussion between youand the employee and explaining theconsequences of the employee'sdeclining to speak with you (i.e., that theMRO will verify the test without inputfrom the employee). If the employeedeclines to speak with you, the staffperson must document the employee'sdecision, including the date and time.

(2) A staff person must not gather anymedical information or informationconcerning possible explanations for thetest result.

(3) A staff person may advise an employeeto have medical information (e.g.,prescriptions, information forming thebasis of a legitimate medical explanationfor a confirmed positive test result) readyto present at the interview with theMRO.

(4) Since you are required to speakpersonally with the employee, face-to-face or on the phone, your staff must notinquire if the employee wishes to speakwith you.

(c) As the MRO, you or your staff must makereasonable efforts to reach the employee atthe day and evening telephone numberslisted on the CCF. Reasonable effortsinclude, as a minimum, three attempts,spaced reasonably over a 24-hour period, toreach the employee at the day and eveningtelephone numbers listed on the CCF. Ifyou or your staff cannot reach the employeedirectly after making these efforts, you oryour staff must take the following steps:

(1) Document the efforts you made tocontact the employee, including datesand times. If both phone numbers areincorrect (e.g., disconnected, wrongnumber), you may take the actions listedin paragraph (c)(2) of this sectionwithout waiting the full 24-hour period.

(2) Contact the DER, instructing the DER tocontact the employee.

(i) You must simply direct the DER toinform the employee to contact you.

(ii) You must not inform the DER that theemployee has a confirmed positive,adulterated, substituted, or invalid testresult.

(iii) You must document the dates andtimes of your attempts to contact theDER, and you must document thename of the DER you contacted andthe date and time of the contact.

(d) As the DER, you must attempt to contactthe employee immediately, usingprocedures that protect, as much aspossible, the confidentiality of the MRO'srequest that the employee contact the MRO.If you successfully contact the employee(i.e., actually talk to the employee), youmust document the date and time of the

contact, and inform the MRO. You mustinform the employee that he or she shouldcontact the MRO immediately. You mustalso inform the employee of theconsequences of failing to contact the MROwithin the next 72 hours (see§40.133(a)(2)).

(1) As the DER, you must not informanyone else working for the employerthat you are seeking to contact theemployee on behalf of the MRO.

(2) If, as the DER, you have made allreasonable efforts to contact theemployee but failed to do so, you mayplace the employee on temporarymedically unqualified status or medicalleave. Reasonable efforts include, as aminimum, three attempts, spacedreasonably over a 24-hour period, toreach the employee at the day andevening telephone numbers listed on theCCF.

(i) As the DER, you must document thedates and times of these efforts.

(ii) If, as the DER, you are unable tocontact the employee within this 24-hour period, you must leave amessage for the employee by anypracticable means (e.g., voice mail, e-mail, letter) to contact the MRO andinform the MRO of the date and timeof this attempted contact.

[65 FR 79526, Dec. 19, 2000, as amended at 66FR 41952, Aug. 9, 2001; 68 FR 31626, May 28,2003; 69 FR 64867, Nov.9, 2004; 73 FR 35971,June 25, 2008]

§ 40.135What does the MRO tell theemployee at the beginning of theverification interview?(a) As the MRO, you must tell the employee

that the laboratory has determined that theemployee's test result was positive,adulterated, substituted, or invalid, asapplicable. You must also tell the employeeof the drugs for which his or her specimentested positive, or the basis for the findingof adulteration or substitution.

(b) You must explain the verification interviewprocess to the employee and inform theemployee that your decision will be basedon information the employee provides inthe interview.

(c) You must explain that, if further medicalevaluation is needed for the verificationprocess, the employee must comply withyour request for this evaluation and thatfailure to do so is equivalent of expresslydeclining to discuss the test result.

(d) As the MRO, you must warn an employeewho has a confirmed positive, adulterated,substituted or invalid test that you arerequired to provide to third parties drug testresult information and medical informationaffecting the performance of safety-sensitive duties that the employee gives youin the verification process without theemployee's consent (see §40.327).

(1) You must give this warning to theemployee before obtaining any medicalinformation as part of the verificationprocess.

(2) For purposes of this paragraph (d),medical information includes


13

information on medications or othersubstances affecting the performance ofsafety-sensitive duties that the employeereports using or medical conditions theemployee reports having.

(3) For purposes of this paragraph (d), thepersons to whom this information maybe provided include the employer, a SAPevaluating the employee as part of thereturn to duty process (see §40.293(g)),DOT, another Federal safety agency(e.g., the NTSB), or any state safetyagency as required by state law.

(e) You must also advise the employee that,after informing any third party about anymedication the employee is using pursuantto a legally valid prescription under theControlled Substances Act, you will allow 5days for the employee to have theprescribing physician contact you todetermine if the medication can be changedto one that does not make the employeemedically unqualified or does not pose asignificant safety risk. If, as an MRO, youreceive such information from theprescribing physician, you must transmitthis information to any third party to whomyou previously provided information aboutthe safety risks of the employee's othermedication.


§ 40.163How does the MRO report drug testresults?(a) As the MRO, it is your responsibility to

report all drug test results to the employer.(b) You may use a signed or stamped and dated

legible photocopy of Copy 2 of the CCF toreport test results.

(c) If you do not report test results using Copy2 of the CCF for this purpose, you mustprovide a written report (e.g., a letter) foreach test result. This report must, as aminimum, include the followinginformation:

(1) Full name, as indicated on the CCF, ofthe employee tested;

(2) Specimen ID number from the CCF andthe donor SSN or employee ID number;

(3) Reason for the test, if indicated on theCCF (e.g., random, post-accident);

(4) Date of the collection;(5) Date you received Copy 2 of the CCF;(6) Result of the test (i.e., positive, negative,

dilute, refusal to test, test cancelled) andthe date the result was verified by theMRO;

7) For verified positive tests, thedrug(s)/metabolite(s) for which the testwas positive;

(8) For cancelled tests, the reason forcancellation; and

(9) For refusals to test, the reason for therefusal determination (e.g., in the case ofan adulterated test result, the name of theadulterant).

(d) As an exception to the reportingrequirements of paragraph (b) and (c) ofthis section, the MRO may report negativeresults using an electronic data file.

(1) If you report negatives using anelectronic data file, the report mustcontain, as a minimum, the information

specified in paragraph (c) of this section,as applicable for negative test results.

(2) In addition, the report must contain yourname, address, and phone number, thename of any person other than youreporting the results, and the date theelectronic results report is released.

(e) You must retain a signed or stamped anddated copy of Copy 2 of the CCF in yourrecords. If you do not use Copy 2 forreporting results, you must maintain a copyof the signed or stamped and dated letter inaddition to the signed or stamped and datedCopy 2. If you use the electronic data file toreport negatives, you must maintain aretrievable copy of that report in a formatsuitable for inspection and auditing by aDOT representative.

(f) You must not use Copy 1 of the CCF toreport drug test results.

(g) You must not provide quantitative values tothe DER or C/TPA for drug or validity testresults. However, you must provide the testinformation in your possession to a SAPwho consults with you (see §40.293(g)).

(h) You must maintain reports and recordsrelated to negatives and cancelled resultsfor one year; you must maintain reports andrecords related to positives and refusals forfive years, unless otherwise specified byapplicable DOT agency regulations.

[66 FR 41952, Aug. 9, 2001, as amended 75 FR49863; August 16, 2010; 75 FR 59107,September 27, 2010, 76 FR 59578, Sep 27, 2011]

§ 40.165To whom does the MRO transmitreports of drug test results?(a) As the MRO, you must report all drug test

results to the DER, except in thecircumstances provided for in §40.345.

(b) If the employer elects to receive reports ofresults through a C/TPA, acting as anintermediary as provided in §40.345, youmust report the results through thedesignated C/TPA.

§ 40.167How are MRO reports of drug resultstransmitted to the employer?As the MRO or C/TPA who transmits drug testresults to the employer, you must comply withthe following requirements:(a) You must report the results in a confidential

manner.(b) You must transmit to the DER on the same

day the MRO verifies the result or the nextbusiness day all verified positive testresults, results requiring an immediatecollection under direct observation,adulterated or substituted specimen results,and other refusals to test.

(1) Direct telephone contact with the DER isthe preferred method of immediatereporting. Follow up your phone callwith appropriate documentation (see§40.163).

(2) You are responsible for identifyingyourself to the DER, and the DER musthave a means to confirm youridentification.

(3) The MRO's report that you transmit tothe employer must contain all of theinformation required by §40.163.

(c) You must transmit the MRO's report(s) ofverified tests to the DER so that the DERreceives it within two days of verificationby the MRO.

(1) You must fax, courier, mail, orelectronically transmit a legible image orcopy of either the signed or stamped anddated Copy 2 or the written report (see§40.163(b) and (c)).

(2) Negative results reported electronically(i.e., computer data file) do not requirean image of Copy 2 or the written report.

(d) In transmitting test results, you or theC/TPA and the employer must ensure thesecurity of the transmission and limit accessto any transmission, storage, or retrievalsystems.

(e) MRO reports are not subject tomodification or change by anyone otherthan the MRO, as provided in §40.149(c).


§ 40.169Where is other informationconcerning the role of MROs and theverification process found in thisregulation?You can find more information concerning therole of MROs in several sections of this part:§40.3 Definition.§§40.47–40.49 Correction of form and kit errors.§40.67 Role in direct observation and other

atypical test situations.§40.83 Laboratory handling of fatal and

correctable flaws.§40.97 Laboratory handling of test results

and quantitative values.§40.99 Authorization of longer laboratory

retention of specimens.§40.101 Relationship with laboratories;

avoidance of conflicts of interest.§40.105 Notification of discrepancies in blind

specimen results.§40.171 Request for test of split specimen.§40.187 Action concerning split specimen test

results.§40.193 Role in “shy bladder” situations.§40.195 Role in cancelling tests.§40.199–40.203 Documenting errors in tests.§40.327 Confidentiality and release of

information.§40.347 Transfer of records.§40.353 Relationships with service agents.

Subpart H - Split Specimen Tests

§ 40.171How does an employee request atest of a split specimen?(a) As an employee, when the MRO has

notified you that you have a verifiedpositive drug test and/or refusal to testbecause of adulteration or substitution, youhave 72 hours from the time of notificationto request a test of the split specimen. Therequest may be verbal or in writing. If youmake this request to the MRO within 72hours, you trigger the requirements of thissection for a test of the split specimen.There is no split specimen testing for aninvalid result.

(b) (1) If, as an employee, you have notrequested a test of the split specimen


14

within 72 hours, you may present to theMRO information documenting thatserious injury, illness, lack of actualnotice of the verified test result, inabilityto contact the MRO (e.g., there was noone in the MRO's office and theanswering machine was not working), orother circumstances unavoidablyprevented you from making a timelyrequest.

(2) As the MRO, if you conclude from theemployee's information that there was alegitimate reason for the employee'sfailure to contact you within 72 hours,you must direct that the test of the splitspecimen take place, just as you wouldwhen there is a timely request.

(c) When the employee makes a timely requestfor a test of the split specimen underparagraphs (a) and (b) of this section, youmust, as the MRO, immediately providewritten notice to the laboratory that testedthe primary specimen, directing thelaboratory to forward the split specimen toa second HHS-certified laboratory. Youmust also document the date and time of theemployee's request.

[65 FR 79526, Dec. 19, 2000, as amended at 73FR 35973, June 25, 2008]

§ 40.173Who is responsible for paying for thetest of a split specimen?(a) As the employer, you are responsible for

making sure (e.g., by establishingappropriate accounts with laboratories fortesting split specimens) that the MRO, firstlaboratory, and second laboratory performthe functions noted in §§40.175–40.185 in atimely manner, once the employee hasmade a timely request for a test of the splitspecimen.

(b) As the employer, you must not conditionyour compliance with these requirementson the employee's direct payment to theMRO or laboratory or the employee'sagreement to reimburse you for the costs oftesting. For example, if you ask theemployee to pay for some or all of the costof testing the split specimen, and theemployee is unwilling or unable to do so,you must ensure that the test takes place ina timely manner, even though this meansthat you pay for it.

(c) As the employer, you may seek payment orreimbursement of all or part of the cost ofthe split specimen from the employee (e.g.,through your written company policy or acollective bargaining agreement). This parttakes no position on who ultimately paysthe cost of the test, so long as the employerensures that the testing is conducted asrequired and the results releasedappropriately.

Subpart I—Problems in DrugTests

§ 40.191What is a refusal to take a DOT drugtest, and what are theconsequences?

(a) As an employee, you have refused to take adrug test if you:

(1) Fail to appear for any test (except a pre-employment test) within a reasonabletime, as determined by the employer,consistent with applicable DOT agencyregulations, after being directed to do soby the employer. This includes thefailure of an employee (including anowner-operator) to appear for a testwhen called by a C/TPA (see §40.61(a));

(2) Fail to remain at the testing site until thetesting process is complete; Provided,That an employee who leaves the testingsite before the testing processcommences (see §40.63 (c)) for a pre-employment test is not deemed to haverefused to test;

(3) Fail to provide a urine specimen for anydrug test required by this part or DOTagency regulations; Provided, That anemployee who does not provide a urinespecimen because he or she has left thetesting site before the testing processcommences (see §40.63 (c)) for a pre-employment test is not deemed to haverefused to test;

(4) In the case of a directly observed ormonitored collection in a drug test, failto permit the observation or monitoringof your provision of a specimen (see§§40.67(l) and 40.69(g));

(5) Fail to provide a sufficient amount ofurine when directed, and it has beendetermined, through a required medicalevaluation, that there was no adequatemedical explanation for the failure (see§40.193(d)(2));

(6) Fail or decline to take an additional drugtest the employer or collector hasdirected you to take (see, for instance,§40.197(b));

(7) Fail to undergo a medical examination orevaluation, as directed by the MRO aspart of the verification process, or asdirected by the DER under §40.193(d).In the case of a pre-employment drugtest, the employee is deemed to haverefused to test on this basis only if thepre-employment test is conductedfollowing a contingent offer ofemployment. If there was no contingentoffer of employment, the MRO willcancel the test; or

(8) Fail to cooperate with any part of thetesting process (e.g., refuse to emptypockets when directed by the collector,behave in a confrontational way thatdisrupts the collection process, fail towash hands after being directed to do soby the collector).

(9) For an observed collection, fail to followthe observer’s instructions to raise yourclothing above the waist, lower clothingand underpants, and to turn around topermit the observer to determine if youhave any type of prosthetic or otherdevice that could be used to interferewith the collection process.

(10) Possess or wear a prosthetic or otherdevice that could be used to interferewith the collection process.

(11) Admit to the collector or MRO that youadulterated or substituted the specimen.

(b) As an employee, if the MRO reports thatyou have a verified adulterated orsubstituted test result, you have refused totake a drug test.

(c) As an employee, if you refuse to take adrug test, you incur the consequencesspecified under DOT agency regulations fora violation of those DOT agencyregulations.

(d) As a collector or an MRO, when anemployee refuses to participate in the partof the testing process in which you areinvolved, you must terminate the portion ofthe testing process in which you areinvolved, document the refusal on the CCF(including, in the case of the collector,printing the employee's name on Copy 2 ofthe CCF), immediately notify the DER byany means (e.g., telephone or secure faxmachine) that ensures that the refusalnotification is immediately received. As areferral physician (e.g., physicianevaluating a “shy bladder” condition or aclaim of a legitimate medical explanation ina validity testing situation), you must notifythe MRO, who in turn will notify the DER.

(1) As the collector, you must note therefusal in the “Remarks” line (Step 2),and sign and date the CCF.

(2) As the MRO, you must note the refusalby checking the “Refusal to Test” box inStep 6 on Copy 2 of the CCF, checkingwhether the specimen was adulterated orsubstituted and, if adulterated, nothingthe adulterant/reason. If there wasanother reason for the refusal, check“Other” in Step 6 on Copy 2 of the CCF,and note the reason next to the “Other”box and on the “remarks” lines, asneeded. You must then sign and date theCCF.

(e) As an employee, when you refuse to take anon-DOT test or to sign a non-DOT form,you have not refused to take a DOT test.There are no consequences under DOTagency regulations for refusing to take anon-DOT test.

[65 FR 79526, Dec. 19, 2000, as amended at 66FR 41953, Aug. 9, 2001; 68 FR 31626, May 28,2003, June 25, 2008; 75 FR 59108, September27, 2010]

§ 40.193What happens when an employeedoes not provide a sufficient amountof urine for a drug test?(a) This section prescribes procedures for

situations in which an employee does notprovide a sufficient amount of urine topermit a drug test (i.e., 45 mL of urine).

(b) As the collector, you must do the following:(1) Discard the insufficient specimen, except

where the insufficient specimen was outof temperature range or showed evidenceof adulteration or tampering (see§40.65(b) and (c)).

(2) Urge the employee to drink up to 40ounces of fluid, distributed reasonablythrough a period of up to three hours, oruntil the individual has provided asufficient urine specimen, whicheveroccurs first. It is not a refusal to test ifthe employee declines to drink.Document on the Remarks line of theCCF (Step 2), and inform the employee


15

of, the time at which the three-hourperiod begins and ends.

(3) If the employee refuses to make theattempt to provide a new urine specimenor leaves the collection site before thecollection process is complete, you mustdiscontinue the collection, note the facton the “Remarks” line of the CCF (Step2), and immediately notify the DER.This is a refusal to test.

(4) If the employee has not provided asufficient specimen within three hours ofthe first unsuccessful attempt to providethe specimen, you must discontinue thecollection, note the fact on the“Remarks” line of the CCF (Step 2), andimmediately notify the DER.

(5) Send Copy 2 of the CCF to the MROand Copy 4 to the DER. You must sendor fax these copies to the MRO and DERwithin 24 hours or the next business day.

(c) As the DER, when the collector informsyou that the employee has not provided asufficient amount of urine (see paragraph(b)(4) of this section), you must, afterconsulting with the MRO, direct theemployee to obtain, within five days, anevaluation from a licensed physician,acceptable to the MRO, who has expertisein the medical issues raised by theemployee's failure to provide a sufficientspecimen. (The MRO may perform thisevaluation if the MRO has appropriateexpertise.)

(1) As the MRO, if another physician willperform the evaluation, you mustprovide the other physician with thefollowing information and instructions:

(i) That the employee was required totake a DOT drug test, but was unableto provide a sufficient amount of urineto complete the test;

(ii) The consequences of the appropriateDOT agency regulation for refusing totake the required drug test;

(iii) That the referral physician must agreeto follow the requirements ofparagraphs (d) through (g) of thissection.

(2) [Reserved](d) As the referral physician conducting this

evaluation, you must recommend that theMRO make one of the followingdeterminations:

(1) A medical condition has, or with a highdegree of probability could have,precluded the employee from providinga sufficient amount of urine. As theMRO, if you accept thisrecommendation, you must:

(i) Check “Test Cancelled” (Step 6) onthe CCF; and

(ii) Sign and date the CCF.(2) There is not an adequate basis for

determining that a medical condition has,or with a high degree of probabilitycould have, precluded the employeefrom providing a sufficient amount ofurine. As the MRO, if you accept thisrecommendation, you must:

(i) Check the “Refusal to Test” box and“Other” box in Step 6 on Copy 2 ofthe CCF and note the reason next to

the “Other” box and on the“Remarks” lines, as needed.

(e) For purposes of this paragraph, amedical condition includes anascertainable physiological condition(e.g., a urinary system dysfunction) ora medically documented pre-existingpsychological disorder, but does notinclude unsupported assertions of“situational anxiety” or dehydration.

(f) As the referral physician making theevaluation, after completing yourevaluation, you must provide a writtenstatement of your recommendationsand the basis for them to the MRO.You must not include in this statementdetailed information on theemployee's medical condition beyondwhat is necessary to explain yourconclusion.

(g) If, as the referral physician makingthis evaluation in the case of a pre-employment test, you determine thatthe employee's medical condition is aserious and permanent or long-termdisability that is highly likely toprevent the employee from providinga sufficient amount of urine for a verylong or indefinite period of time, youmust set forth your determination andthe reasons for it in your writtenstatement to the MRO. As the MRO,upon receiving such a report, youmust follow the requirements of§40.195, where applicable.

(h) As the MRO, you must seriouslyconsider and assess the referralphysician's recommendations inmaking your determination aboutwhether the employee has a medicalcondition that has, or with a highdegree of probability could have,precluded the employee fromproviding a sufficient amount ofurine. You must report yourdetermination to the DER in writingas soon as you make it.

(i) As the employer, when you receive areport from the MRO indicating that atest is cancelled as provided inparagraph (d)(1) of this section, youtake no further action with respect tothe employee. The employee remainsin the random testing pool.

[65 FR 79526, Dec. 19, 2000, as amended at 66FR 41953, Aug. 9, 2001; 75 FR 59108,September 27, 2010]

§ 40.195What happens when an individual isunable to provide a sufficientamount of urine for a pre-employment follow-up or return-to-duty test because of a permanent orlong-term medical condition?(a) This section concerns a situation in which

an employee has a medical condition thatprecludes him or her from providing asufficient specimen for a pre-employmentfollow-up or return-to-duty test and thecondition involves a permanent or long-term disability. As the MRO in thissituation, you must do the following:

(1) You must determine if there is clinicalevidence that the individual is an illicitdrug user. You must make thisdetermination by personally conducting,or causing to be conducted, a medicalevaluation and through consultation withthe employee's physician and/or thephysician who conducted the evaluationunder §40.193(d).

(2) If you do not personally conduct themedical evaluation, you must ensure thatone is conducted by a licensed physicianacceptable to you.

(3) For purposes of this section, the MRO orthe physician conducting the evaluationmay conduct an alternative test (e.g.,blood) as part of the medicallyappropriate procedures in determiningclinical evidence of drug use.

(b) If the medical evaluation reveals no clinicalevidence of drug use, as the MRO, youmust report the result to the employer as anegative test with written notationsregarding results of both the evaluationconducted under §40.193(d) and any furthermedical examination. This report must statethe basis for the determination that apermanent or long-term medical conditionexists, making provision of a sufficienturine specimen impossible, and for thedetermination that no signs and symptomsof drug use exist.

(1) Check “Negative” (Step 6) on the CCF.(2) Sign and date the CCF.

(c) If the medical evaluation reveals clinicalevidence of drug use, as the MRO, youmust report the result to the employer as acancelled test with written notationsregarding results of both the evaluationconducted under §40.193(d) and any furthermedical examination. This report must statethat a permanent or long-term medicalcondition exists, making provision of asufficient urine specimen impossible, andstate the reason for the determination thatsigns and symptoms of drug use exist.Because this is a cancelled test, it does notserve the purposes of a negative test (i.e.,the employer is not authorized to allow theemployee to begin or resume performingsafety-sensitive functions, because anegative test is needed for that purpose).

(d) For purposes of this section, permanent orlong-term medical conditions are thosephysiological, anatomic, or psychologicalabnormalities documented as being presentprior to the attempted collection, andconsidered not amenable to correction orcure for an extended period of time, if ever.

(1) Examples would include destruction(any cause) of the glomerular filtrationsystem leading to renal failure;unrepaired traumatic disruption of theurinary tract; or a severe psychiatricdisorder focused on genito-urinarymatters.

(2) Acute or temporary medical conditions,such as cystitis, urethritis or prostatitis,though they might interfere withcollection for a limited period of time,cannot receive the same exceptionalconsideration as the permanent or long-term conditions discussed in paragraph(d)(1) of this section.


16


§ 40.197What happens when an employerreceives a report of a dilutespecimen?(a) As the employer, if the MRO informs you

that a positive drug test was dilute, yousimply treat the test as a verified positivetest. You must not direct the employee totake another test based on the fact that thespecimen was dilute.

(b) As an employer, if the MRO informs youthat a negative test was dilute, take thefollowing action:

(1) If the MRO directs you to conduct arecollection under direct observation(i.e., because the creatinine concentrationof the specimen was equal to or greaterthan 2mg/dL, but less than or equal to 5mg/dL (see §40.155(c)), you must do soimmediately.

(2) Otherwise (i.e., if the creatinineconcentration of the dilute specimen isgreater than 5 mg/dL), you may, but arenot required to, direct the employee totake another test immediately.

(i) Such recollections must not becollected under direct observation,unless there is another basis for use ofdirect observation (see §40.67 (b) and(c)).

(ii) You must treat all employees thesame for this purpose. For example,you must not retest some employeesand not others. You may, however,establish different policies fordifferent types of tests (e.g., conductretests in pre-employment situations,but not in random test situations). Youmust inform your employees inadvance of your decisions on thesematters.

(c) The following provisions apply to all testsyou direct an employee to take underparagraph (b) of this section:

(1) You must ensure that the employee isgiven the minimum possible advancenotice that he or she must go to thecollection site;

(2) You must treat the result of the test youdirected the employee to take underparagraph (b) of this section—and not aprior test—as the test result of record, onwhich you rely for purposes of this part;

(3) If the result of the test you directed theemployee to take under paragraph (b)(1)of this section is also negative and dilute,you are not permitted to make theemployee take an additional test becausethe result was dilute.

(4) If the result of the test you directed theemployee to take under paragraph (b)(2)of this section is also negative and dilute,you are not permitted to make theemployee take an additional test becausethe result was dilute. Provided, however,that if the MRO directs you to conduct arecollection under direct observationunder paragraph (b)(1) of this section,you must immediately do so.

(5) If the employee declines to take a testyou directed him or her to take underparagraph (b) of this section, the

employee has refused the test forpurposes of this part and DOT agencyregulations

[68 FR 31626, May 28, 2003; 69 FR 64867,Nov.9, 2004; 73 FR 35974, June 25, 2008]

§ 40.199What problems always cause a drugtest to be cancelled?(a) As the MRO, when the laboratory discovers

a “fatal flaw” during its processing ofincoming specimens (see §40.83), thelaboratory will report to you that thespecimen has been “Rejected for Testing”(with the reason stated). You must alwayscancel such a test.

(b) The following are “fatal flaws”:(1) There is no printed collector's name and

no collector's signature;(2) The specimen ID numbers on the

specimen bottle and the CCF do notmatch;

(3) The specimen bottle seal is broken orshows evidence of tampering (and a splitspecimen cannot be redesignated, see§40.83(g)); and

(4) Because of leakage or other causes, thereis an insufficient amount of urine in theprimary specimen bottle for analysis andthe specimens cannot be redesignated(see §40.83(g)).

(c) You must report the result as provided in§40.161.

§ 40.201What problems always cause a drugtest to be cancelled and may resultin a requirement for anothercollection?As the MRO, you must cancel a drug test when alaboratory reports that any of the followingproblems have occurred. You must inform theDER that the test was cancelled. You must alsodirect the DER to ensure that an additionalcollection occurs immediately, if required by theapplicable procedures specified in paragraphs (a)through (e) of this section.(a) The laboratory reports an “Invalid Result.”

You must follow applicable procedures in§40.159 (recollection under directobservation may be required).

(b) The laboratory reports the result as“Rejected for Testing.” You must followapplicable procedures in §40.161 (arecollection may be required).

(c) The laboratory reports that the splitspecimen failed to reconfirm all of theprimary specimen results because thedrug(s)/drug metabolite(s) were notdetected; adulteration criteria were not met;and/ or substitution criteria were not met.You must follow the applicable proceduresin § 40.187(b) – no recollection is requiredin this case, unless the split specimencreatinine concentration for a substitutedprimary specimen was greater than or equalto 2mg/dL but less than or equal to 5mg/dL, or the primary specimen had an invalidresult which was not reported to the DER.Both these cases require recollection underdirect observation

(d) The laboratory reports that the splitspecimen failed to reconfirm all of theprimary specimen results, and that the splitspecimen was invalid. You must follow the

procedures in § 40.187(c)(1) – recollectionunder direct observation is required in thiscase.

(e) The laboratory reports that the splitspecimen failed to reconfirm all of theprimary specimen results because the splitspecimen was not available for testing orthere was no split laboratory available totest the specimen. You must follow theapplicable procedures in § 40.187(e) –recollection under direct observation isrequired in this case.

(f) The examining physician has determinedthat there is an acceptable medicalexplanation of the employee's failure toprovide a sufficient amount of urine. Youmust follow applicable procedures in§40.193(d)(1) (no recollection is required inthis case).


§ 40.203What problems cause a drug test tobe cancelled unless they arecorrected?(a) As the MRO, when a laboratory discovers a

“correctable flaw” during its processing ofincoming specimens (see §40.83), thelaboratory will attempt to correct it. If thelaboratory is unsuccessful in this attempt, itwill report to you that the specimen hasbeen “Rejected for Testing” (with thereason stated).

(b) The following is a “correctable flaw” thatlaboratories must attempt to correct: Thecollector's signature is omitted on thecertification statement on the CCF.

(c) As the MRO, when you discover a“correctable flaw” during your review ofthe CCF, you must cancel the test unless theflaw is corrected.

(d) The following are correctable flaws thatyou must attempt to correct:

(1) The employee's signature is omittedfrom the certification statement, unlessthe employee's failure or refusal to signis noted on the “Remarks” line of theCCF.

(2) The certifying scientist's signature isomitted on Copy 1 of the CCF for apositive, adulterated, substituted, orinvalid test result.

(3) The collector uses a non-Federal form oran expired CCF for the test. This flawmay be corrected through the procedureset forth in §40.205(b)(2), provided thatthe collection testing process has beenconducted in accordance with theprocedures of this part in an HHS-certified laboratory. During the periodOctober 1, 2010-November 30, 2011,you are not required to cancel a testbecause of the use of an old CCF.Beginning December 1, 2011, if theproblem is not corrected, you mustcancel the test.

[65 FR 79526, Dec. 19, 2000, as amended at 66FR 41954, Aug. 9, 2001; 75 FR 59108,September 27, 2010; 76 FR 59578, Sep 27, 2011]

§ 40.205How are drug test problemscorrected?


17

(a) As a collector, you have the responsibilityof trying to successfully complete acollection procedure for each employee.

(1) If, during or shortly after the collectionprocess, you become aware of any eventthat prevents the completion of a validtest or collection (e.g., a procedural orpaperwork error), you must try to correctthe problem promptly, if doing so ispracticable. You may conduct anothercollection as part of this effort.

(2) If another collection is necessary, youmust begin the new collection procedureas soon as possible, using a new CCFand a new collection kit.

(b) If, as a collector, laboratory, MRO,employer, or other person implementingthese drug testing regulations, you becomeaware of a problem that can be corrected(see §40.203 ), but which has not alreadybeen corrected under paragraph (a) of thissection, you must take all practicable actionto correct the problem so that the test is notcancelled.

(1) If the problem resulted from theomission of required information, youmust, as the person responsible forproviding that information, supply inwriting the missing information and astatement that it is true and accurate. Forexample, suppose you are a collector,and you forgot to make a notation on the“Remarks” line of the CCF that theemployee did not sign the certification.You would, when the problem is calledto your attention, supply a signedstatement that the employee failed orrefused to sign the certification and thatyour statement is true and accurate. Youmust supply this information on the samebusiness day on which you are notifiedof the problem, transmitting it by fax orcourier.

(2) If the problem is the use of a non-Federalform or an expired Federal form, youmust provide a signed statement (i.e., amemorandum for the record). It muststate that the incorrect form contains allthe information needed for a valid DOTdrug test, and that the incorrect form wasused inadvertently or as the only meansof conducting a test, in circumstancesbeyond your control. The statement mustalso list the steps you have taken toprevent future use of non-Federal formsor expired Federal forms for DOT tests.For this flaw to be corrected, the test ofthe specimen must have occurred at aHHS-certified laboratory where it wastested consistent with the requirementsof this part. You must supply thisinformation on the same business day onwhich you are notified of the problem,transmitting it by fax or courier.

(3) You must maintain the writtendocumentation of a correction with theCCF.

(4) You must mark the CCF in such a way(e.g., stamp noting correction) as tomake it obvious on the face of the CCFthat you corrected the flaw.

(c) If the correction does not take place, as theMRO you must cancel the test.


§ 40.207What is the effect of a cancelled drugtest?(a) A cancelled drug test is neither positive nor

negative.(1) As an employer, you must not attach to a

cancelled test the consequences of apositive test or other violation of a DOTdrug testing regulation (e.g., removalfrom a safety-sensitive position).

(2) As an employer, you must not use acancelled test for the purposes of anegative test to authorize the employeeto perform safety-sensitive functions(i.e., in the case of a pre-employment,return-to-duty, or follow-up test).

(3) However, as an employer, you must notdirect a recollection for an employeebecause a test has been cancelled, exceptin the situations cited in paragraph (a)(2)of this section or other provisions of thispart that require another test to beconducted (e.g., §§40.159(a)(5) and40.187(b)(2), (c)(1), and (e)).

(b) A cancelled test does not count towardcompliance with DOT requirements (e.g.,being applied toward the number of testsneeded to meet the employer's minimumrandom testing rate).

(c) A cancelled DOT test does not provide avalid basis for an employer to conduct anon-DOT test (i.e., a test under companyauthority).


§ 40.208What problem requires correctiveaction but does not result in thecancellation of a test?(a) If, as a laboratory, collector, employer, or

other person implementing the DOT drugtesting program, you become aware that thespecimen temperature on the CCF was notchecked and the “Remarks” line did notcontain an entry regarding the temperaturebeing out of range, you must take correctiveaction, including securing a memorandumfor the record explaining the problem andtaking appropriate action to ensure that theproblem does not recur.

(b) This error does not result in the cancellationof the test.

(c) As an employer or service agent, this error,even though not sufficient to cancel a drugtest result, may subject you to enforcementaction under DOT agency regulations orSubpart R of this part.

[66 FR 41954, Aug. 9, 2001]

§ 40.209What procedural problems do notresult in the cancellation of a testand do not require corrective action?(a) As a collector, laboratory, MRO, employer

or other person administering the drugtesting process, you must document anyerrors in the testing process of which youbecome aware, even if they are notconsidered problems that will cause a test tobe cancelled as listed in this subpart.

Decisions about the ultimate impact ofthese errors will be determined by otheradministrative or legal proceedings, subjectto the limitations of paragraph (b) of thissection.

(b) No person concerned with the testingprocess may declare a test cancelled basedon an error that does not have a significantadverse effect on the right of the employeeto have a fair and accurate test. Matters thatdo not result in the cancellation of a testinclude, but are not limited to, thefollowing:

(1) A minor administrative mistake (e.g., theomission of the employee's middleinitial, a transposition of numbers in theemployee's social security number, theomission of the DOT Agency in Step 1-D of the CCF);

(2) An error that does not affect employeeprotections under this part (e.g., thecollector's failure to add bluing agent tothe toilet bowl, which adversely affectsonly the ability of the collector to detecttampering with the specimen by theemployee);

(3) The collection of a specimen by acollector who is required to have beentrained (see §40.33), but who has notmet this requirement;

(4) A delay in the collection process (see§40.61(a));

(5) Verification of a test result by an MROwho has the basic credentials to bequalified as an MRO (see §40.121(a)through (b)) but who has not mettraining and/or documentationrequirements (see §40.121(c) through(e));

(6) The failure to directly observe ormonitor a collection that the rule requiresor permits to be directly observed ormonitored, or the unauthorized use ofdirect observation or monitoring for acollection;

(7) The fact that a test was conducted in afacility that does not meet therequirements of §40.41;

(8) If the specific name of the courier on theCCF is omitted or erroneous;

(9) Personal identifying information isinadvertently contained on the CCF (e.g.,the employee signs his or her name onCopy 1); or

(10) Claims that the employee wasimproperly selected for testing.

(c) As an employer or service agent, thesetypes of errors, even though not sufficientto cancel a drug test result, may subject youto enforcement action under DOT agencyregulations or action under Subpart R ofthis part.


Subpart J - Alcohol TestingPersonnel

§ 40.211Who conducts DOT alcohol tests?(a) Screening test technicians (STTs) and

breath alcohol technicians (BATs) meetingtheir respective requirements of this subpart


18

are the only people authorized to conductDOT alcohol tests.

(b) An STT can conduct only alcohol screeningtests, but a BAT can conduct alcoholscreening and confirmation tests.

(c) As a BAT- or STT-qualified immediatesupervisor of a particular employee, youmay not act as the STT or BAT when thatemployee is tested, unless no other STT orBAT is available and DOT agencyregulations do not prohibit you from doingso.

§ 40.213What training requirements mustSTTs and BATs meet?To be permitted to act as a BAT or STT in theDOT alcohol testing program, you must meeteach of the requirements of this section:(a) Basic information. You must be

knowledgeable about the alcohol testingprocedures in this part and the current DOTguidance. These documents andinformation are available from ODAPC(Department of Transportation, 400 7thStreet, SW., Room 10403, Washington DC,20590, 202–366–3784, or on the ODAPCweb site, http://www.dot.gov/ost/dapc)).

(b) Qualification training. You must receivequalification training meeting therequirements of this paragraph (b).

(1) Qualification training must be inaccordance with the DOT Model BAT orSTT Course, as applicable. The DOTModel Courses are available fromODAPC (Department of Transportation,400 7th Street, SW., Room 10403,Washington DC, 20590, 202–366–3784,or on the ODAPC web site,http://www.dot.gov/ost/dapc). Thetraining can also be provided using acourse of instruction equivalent to theDOT Model Courses. On request,ODAPC will review BAT and STTinstruction courses for equivalency.

(2) Qualification training must includetraining to proficiency in using thealcohol testing procedures of this partand in the operation of the particularalcohol testing device(s) (i.e., theASD(s) or EBT(s)) you will be using.

(3) The training must emphasize that you areresponsible for maintaining the integrityof the testing process, ensuring theprivacy of employees being tested, andavoiding conduct or statements thatcould be viewed as offensive orinappropriate.

(4) The instructor must be an individual whohas demonstrated necessary knowledge,skills, and abilities by regularlyconducting DOT alcohol tests as an STTor BAT, as applicable, for a period of atleast a year, who has conducted STT orBAT training, as applicable, under thispart for a year, or who has successfullycompleted a “train the trainer” course.

(c) Initial Proficiency Demonstration.Following your completion of qualificationtraining under paragraph (b) of this section,you must demonstrate proficiency inalcohol testing under this part bycompleting seven consecutive error-freemock tests (BATs) or five consecutiveerror-free tests (STTs).

(1) Another person must monitor andevaluate your performance, in person orby a means that provides real-timeobservation and interaction between theinstructor and trainee, and attest inwriting that the mock collections are“error-free.” This person must be anindividual who meets the requirementsof paragraph (b)(4) of this section.

(2) These tests must use the alcohol testingdevices (e.g., EBT(s) or ASD(s)) thatyou will use as a BAT or STT.

(3) If you are an STT who will be using anASD that indicates readings by changes,contrasts, or other readings in color, youmust demonstrate as part of the mocktest that you are able to discern changes,contrasts, or readings correctly.

(d) Schedule for qualification training andinitial proficiency demonstration. Thefollowing is the schedule for qualificationtraining and the initial proficiencydemonstration you must meet:

(1) If you became a BAT or STT beforeAugust 1, 2001, you were required tohave met the requirements set forth inparagraphs (b) and (c) of thissection, and you do not have to meetthem again.

(2) If you become a BAT or STT on or afterAugust 1, 2001, you must meet therequirements of paragraphs (b) and (c) ofthis section before you begin to performBAT or STT functions.

(e) Refresher training. No less frequently thanevery five years from the date on which yousatisfactorily complete the requirements ofparagraphs (b) and (c) of this section, youmust complete refresher training that meetsall the requirements of paragraphs (b) and(c) of this section. If you are a BAT or STTwho completed qualification training beforeJanuary 1, 1998, you are not required tocomplete refresher training until January 1,2003.

(f) Error Correction Training. If you make amistake in the alcohol testing process thatcauses a test to be cancelled (i.e., a fatal oruncorrected flaw), you must undergo errorcorrection training. This training mustoccur within 30 days of the date you arenotified of the error that led to the need forretraining.

(1) Error correction training must beprovided and your proficiencydocumented in writing by a person whomeets the requirements of paragraph(b)(4) of this section.

(2) Error correction training is required tocover only the subject matter area(s) inwhich the error that caused the test to becancelled occurred.

(3) As part of the error correction training,you must demonstrate your proficiencyin the alcohol testing procedures of thispart by completing three consecutiveerror-free mock tests. The mock testsmust include one uneventful scenarioand two scenarios related to the area(s)in which your error(s) occurred. Theperson providing the training mustmonitor and evaluate your performanceand attest in writing that the mock testswere error-free.

(g) Documentation. You must maintaindocumentation showing that you currentlymeet all requirements of this section. Youmust provide this documentation on requestto DOT agency representatives and toemployers and C/TPAs who are negotiatingto use your services.

(h) Other persons who may serve as BATs orSTTs.

(1) Anyone meeting the requirements of thissection to be a BAT may act as an STT,provided that the individual hasdemonstrated initial proficiency in theoperation of the ASD that he or she isusing, as provided in paragraph (c) ofthis section.

(2) Law enforcement officers who havebeen certified by state or localgovernments to conduct breath alcoholtesting are deemed to be qualified asBATs. They are not required to alsocomplete the training requirements ofthis section in order to act as BATs. Inorder for a test conducted by such anofficer to be accepted under DOTalcohol testing requirements, the officermust have been certified by a state orlocal government to use the EBT or ASDthat was used for the test.


§ 40.215What information about the DER doemployers have to provide to BATsand STTs?As an employer, you must provide to the STTsand BATs the name and telephone number of theappropriate DER (and C/TPA, where applicable)to contact about any problems or issues that mayarise during the testing process.

Subpart K - Testing Sites, Forms,Equipment and Supplies Used inAlcohol Testing

Subpart L—Alcohol ScreeningTests

§ 40.243What is the procedure for an alcoholscreening test using an EBT or non-evidential breath ASD?As the BAT or STT, you must take the followingsteps:(a) Select, or allow the employee to select, an

individually wrapped or sealed mouthpiecefrom the testing materials.

(b) Open the individually wrapped or sealedmouthpiece in view of the employee andinsert it into the device in accordance withthe manufacturer's instructions.

(c) Instruct the employee to blow steadily andforcefully into the mouthpiece for at leastsix seconds or until the device indicates thatan adequate amount of breath has beenobtained.

(d) Show the employee the displayed testresult.

(e) If the device is one that prints the testnumber, testing device name and serialnumber, time, and result directly onto theATF, you must check to ensure that the


19

information has been printed correctly ontothe ATF.

(f) If the device is one that prints the testnumber, testing device name and serialnumber, time and result, but on a separateprintout rather than directly onto the ATF,you must affix the printout of theinformation to the designated space on theATF with tamper-evident tape or use a self-adhesive label that is tamper-evident.

(g) If the device is one that does not print thetest number, testing device name and serialnumber, time, and result, or it is a devicenot being used with a printer, you mustrecord this information in Step 3 of theATF.

§ 40.245What is the procedure for an alcoholscreening test using a saliva ASD ora breath tube ASD?(a) As the STT or BAT, you must take the

following steps when using the saliva ASD:(1) Check the expiration date on the device

or on the package containing the deviceand show it to the employee. You maynot use the device after its expirationdate.

(2) Open an individually wrapped or sealedpackage containing the device in thepresence of the employee.

(3) Offer the employee the opportunity touse the device. If the employee uses it,you must instruct the employee to insertit into his or her mouth and use it in amanner described by the device'smanufacturer.

(4) If the employee chooses not to use thedevice, or in all cases in which a new testis necessary because the device did notactivate (see paragraph (a)(7) of thissection), you must insert the device intothe employee's mouth and gather salivain the manner described by the device'smanufacturer. You must wear single-useexamination or similar gloves whiledoing so and change them followingeach test.

(5) When the device is removed from theemployee's mouth, you must follow themanufacturer's instructions regardingnecessary next steps in ensuring that thedevice has activated.

(6) (i) If you were unable to successfullyfollow the procedures of paragraphs(a)(3) through (a)(5) of this section(e.g., the device breaks, you drop thedevice on the floor), you must discardthe device and conduct a new testusing a new device.

(ii) The new device you use must be onethat has been under your control orthat of the employee before the test.

(iii) You must note on the “Remarks” lineof the ATF the reason for the newtest. (Note: You may continue usingthe same ATF with which you beganthe test.)

(iv) You must offer the employee thechoice of using the device or havingyou use it unless the employee, in theopinion of the STT or BAT, wasresponsible (e.g., the employeedropped the device) for the new testneeding to be conducted.

(v) If you are unable to successfullyfollow the procedures of paragraphs(a)(3) through (a)(5) of this section onthe new test, you must end thecollection and put an explanation onthe “Remarks” line of the ATF.

(vi) You must then direct the employee totake a new test immediately, using anEBT for the screening test.

(7) If you are able to successfully follow theprocedures of paragraphs (a)(3)—(a)(5)of this section, but the device does notactivate, you must discard the device andconduct a new test, in the same manneras provided in paragraph (a)(6) of thissection. In this case, you must place thedevice into the employee's mouth tocollect saliva for the new test.

(8) You must read the result displayed onthe device no sooner than the device'smanufacturer instructs. In all cases theresult displayed must be read within 15minutes of the test. You must then showthe device and it's reading to theemployee and enter the result on theATF.

(9) You must never re-use devices, swabs,gloves or other materials used in salivatesting.

(10) You must note the fact that you used asaliva ASD in Step 3 of the ATF.

(b) As the STT or BAT, you must take thefollowing steps when using the breath tubeASD:

(1) Check the expiration date on the deviceor on the detector device and theelectronic analyzer or on the packagecontaining the device and show it to theemployee. You must not use the deviceor the analyzer after their expiration date.You must not use an analyzer which isnot specifically pre-calibrated for thedevice being used in the collection.

(2) Remove a device from the package andsecure an inflation bag onto theappropriate end of the device, as directedby the manufacturer on the device’sinstructions.

(3) Break the tube's ampule in the presenceof the employee.

(4) Offer the employee the opportunity touse the device. If the employee choosesto use (e.g. hold) the device, instruct theemployee to blow forcefully and steadilyinto the blowing end of device until theinflation bag fills with air(approximately 12 seconds).

(5) If the employee chooses not to hold thedevice, you must hold it and provide theuse instructions in paragraph (b)(4) ofthis section.

(6) When the employee completes the breathprocess, take the device from theemployee (or if you were holding it,remove it from the employee’s mouth),remove the inflation bag, and prepare thedevice to be read by the analyzer inaccordance with the manufacturer’sdirections.

(7) (i) If you were unable to successfullyfollow the procedures of paragraphs(b)(4) through (b)(6) of this section(e.g., the device breaks apart, theemployee did not fill the inflation

bag), you must discard the device andconduct a new test using a new one.

(ii) The new device you use must be onethat has been under your control orthat of the employer before the test.

(iii) You must note on the “Remarks” lineof the ATF the reason for the newtest. (Note: You may continue usingthe same ATF with which you beganthe test.)

(iv) You must offer the employee thechoice of holding the device or havingyou hold it unless the employee, in theyour opinion, was responsible (e.g.,the employee failed to fill the inflationbag) for the new test needing to beconducted.

(v) If you are unable to successfullyfollow the procedures of paragraphs(b)(4) through (b)(6) of this section onthe new test, you must end thecollection and put an explanation onthe “Remarks” line of the ATF.

(vi) You must then direct the employee totake a new test immediately, usinganother type of ASD (e.g., salivadevice) or an EBT.

(8) If you were able to successfully followthe procedures of paragraphs (b)(4)through (b)(6) of this section and afterhaving waited the required amount oftime directed by the manufacturer for thedetector device to incubate, you mustplace the device in the analyzer inaccordance with the manufacturer’sdirections. The result must be read fromthe analyzer no earlier than the requiredincubation time of the device. In allcases, the result must be read within 15minutes of the test.

(9) You must follow the manufacturer'sinstructions for determining the result ofthe test. You must show the analyzerresult to the employee and record theresult on Step 3 of the ATF.

(10) You must never re-use detector devicesor any gloves used in breath tube testing.The inflation bag must be voided of airfollowing removal from a device.Inflation bags and electronic analyzersmay be re-used but only in accordancewith the manufacturer’s directions.

(11) You must note the fact that you used abreath tube device in Step 3 of the ATF.

[67 FR 61522, Oct. 1, 2002, as amended at 72 FR1299, Jan. 11, 2007; 75 FR 8526,February25, 2010]

Subpart M - Alcohol ConfirmationTests

Subpart N - Problems in AlcoholTesting

§ 40.261What is a refusal to take an alcoholtest, and what are theconsequences?(a) As an employee, you are considered to have

refused to take an alcohol test if you:(1) Fail to appear for any test (except a pre-

employment test) within a reasonabletime, as determined by the employer,


20

consistent with applicable DOT agencyregulations, after being directed to do soby the employer. This includes thefailure of an employee (including anowner-operator) to appear for a testwhen called by a C/TPA (see§40.241(a));

(2) Fail to remain at the testing site until thetesting process is complete; Provided,That an employee who leaves the testingsite before the testing processcommences (see §40.243(a)) for a pre-employment test is not deemed to haverefused to test;

(3) Fail to provide an adequate amount ofsaliva or breath for any alcohol testrequired by this part or DOT agencyregulations; Provided, That an employeewho does not provide an adequateamount of breath or saliva because he orshe has left the testing site before thetesting process commences (see§40.243(a)) for a pre-employment test isnot deemed to have refused to test;

(4) Fail to provide a sufficient breathspecimen, and the physician hasdetermined, through a required medicalevaluation, that there was no adequatemedical explanation for the failure (see§40.265(c));

(5) Fail to undergo a medical examination orevaluation, as directed by the employeras part of the insufficient breathprocedures outlined at §40.265(c);

(6) Fail to sign the certification at Step 2 ofthe ATF (see §§40.241(g) and40.251(d)); or

(7) Fail to cooperate with any part of thetesting process.

(b) As an employee, if you refuse to take analcohol test, you incur the sameconsequences specified under DOT agencyregulations for a violation of those DOTagency regulations.

(c) As a BAT or an STT, or as the physicianevaluating a “shy lung” situation, when anemployee refuses to test as provided inparagraph (a) of this section, you mustterminate the portion of the testing processin which you are involved, document therefusal on the ATF (or in a separatedocument which you cause to be attached tothe form), immediately notify the DER byany means (e.g., telephone or secure faxmachine) that ensures the refusalnotification is immediately received. Youmust make this notification directly to theDER (not using a C/TPA as anintermediary).

(d) As an employee, when you refuse to take anon-DOT test or to sign a non-DOT form,you have not refused to take a DOT test.There are no consequences under DOTagency regulations for such a refusal.


§ 40.263What happens when an employee isunable to provide a sufficientamount of saliva for an alcoholscreening test?(a) As the STT, you must take the following

steps if an employee is unable to provide

sufficient saliva to complete a test on asaliva screening device (e.g., the employeedoes not provide sufficient saliva to activatethe device).

(1) You must conduct a new screening testusing a new screening device.

(2) If the employee refuses to make theattempt to complete the new test, youmust discontinue testing, note the fact onthe “Remarks” line of the ATF, andimmediately notify the DER. This is arefusal to test.

(3) If the employee has not provided asufficient amount of saliva to completethe new test, you must note the fact onthe “Remarks” line of the ATF andimmediately notify the DER.

(b) As the DER, when the STT informs youthat the employee has not provided asufficient amount of saliva (see paragraph(a)(3) of this section), you mustimmediately arrange to administer analcohol test to the employee using an EBTor other breath testing device.

§ 40.265What happens when an employee isunable to provide a sufficientamount of breath for an alcohol test?(a) If an employee does not provide a sufficient

amount of breath to permit a valid breathtest, you must take the steps listed in thissection.

(b) As the BAT or STT, you must instruct theemployee to attempt again to provide asufficient amount of breath and about theproper way to do so.

(1) If the employee refuses to make theattempt, you must discontinue the test,note the fact on the “Remarks” line ofthe ATF, and immediately notify theDER. This is a refusal to test.

(2) If the employee again attempts and failsto provide a sufficient amount of breath,you may provide another opportunity tothe employee to do so if you believe thatthere is a strong likelihood that it couldresult in providing a sufficient amount ofbreath.

(3) When the employee's attempts underparagraph (b)(2) of this section havefailed to produce a sufficient amount ofbreath, you must note the fact on the“Remarks” line of the ATF andimmediately notify the DER.

(4) If you are using an EBT that has thecapability of operating manually, youmay attempt to conduct the test inmanual mode.

(5) If you are qualified to use a saliva ASDand you are in the screening test stage,you may change to a saliva ASD only tocomplete the screening test.

(c) As the employer, when the BAT or STTinforms you that the employee has notprovided a sufficient amount of breath, youmust direct the employee to obtain, withinfive days, an evaluation from a licensedphysician who is acceptable to you and whohas expertise in the medical issues raised bythe employee's failure to provide asufficient specimen.

(1) You are required to provide thephysician who will conduct the

evaluation with the followinginformation and instructions:

(i) That the employee was required totake a DOT breath alcohol test, butwas unable to provide a sufficientamount of breath to complete the test;

(ii) The consequences of the appropriateDOT agency regulation for refusing totake the required alcohol test;

(iii) That the physician must provide youwith a signed statement of his or herconclusions; and

(iv) That the physician, in his or herreasonable medical judgment, mustbase those conclusions on one of thefollowing determinations:

(A) A medical condition has, or with ahigh degree of probability couldhave, precluded the employee fromproviding a sufficient amount ofbreath. The physician must notinclude in the signed statementdetailed information on theemployee's medical condition. Inthis case, the test is cancelled.

(B) There is not an adequate basis fordetermining that a medicalcondition has, or with a highdegree of probability could have,precluded the employee fromproviding a sufficient amount ofbreath. This constitutes a refusal totest.

(C) For purposes of paragraphs(c)(1)(iv)(A) and (B) of thissection, a medical conditionincludes an ascertainablephysiological condition (e.g., arespiratory system dysfunction) ora medically documented pre-existing psychological disorder, butdoes not include unsupportedassertions of “situational anxiety”or hyperventilation.

(2) As the physician making the evaluation,after making your determination, youmust provide a written statement of yourconclusions and the basis for them to theDER directly (and not through a C/TPAacting as an intermediary). You must notinclude in this statement detailedinformation on the employee's medicalcondition beyond what is necessary toexplain your conclusion.

(3) Upon receipt of the report from theexamining physician, as the DER youmust immediately inform the employeeand take appropriate action based uponyour DOT agency regulations.

§ 40.267What problems always cause analcohol test to be cancelled?As an employer, a BAT, or an STT, you mustcancel an alcohol test if any of the followingproblems occur. These are “fatal flaws.” Youmust inform the DER that the test was cancelledand must be treated as if the test never occurred.These problems are:(a) In the case of a screening test conducted on

a saliva ASD or a breath tube ASD:(1) The STT or BAT reads the result either

sooner than or later than the time allottedby the manufacturer and this Part (see


21

§40.245(a)(8) for the saliva ASD and§40.245(b)(8) for the breath tube ASD).

(2) The saliva ASD does not activate (see§40.245(a)(7); or

(3) The device is used for a test after theexpiration date printed on the device oron its package (see §40.245(a)(1) for thesaliva ASD and §40.245(b)(1) for thebreath tube ASD).

(4) The breath tube ASD is tested with ananalyzer which has not been pre-calibrated for that device’s specific lot(see §40.245(b)(1)).

(b) In the case of a screening or confirmationtest conducted on an EBT, the sequentialtest number or alcohol concentrationdisplayed on the EBT is not the same as thesequential test number or alcoholconcentration on the printed result (see§40.253(c), (e) and (f)).

(c) In the case of a confirmation test:(1) The BAT conducts the confirmation test

before the end of the minimum 15-minute waiting period (see§40.251(a)(1));

(2) The BAT does not conduct an air blankbefore the confirmation test (see§40.253(a));

(3) There is not a 0.00 result on the air blankconducted before the confirmation test(see §40.253(a)(1) and (2));

(4) The EBT does not print the result (see§40.253(f)); or

(5) The next external calibration check ofthe EBT produces a result that differs bymore than the tolerance stated in theQAP from the known value of the teststandard. In this case, every result of0.02 or above obtained on the EBT sincethe last valid external calibration checkis cancelled (see §40.233(a)(1) and(c)(3)).

[65 FR 79526, Dec. 19, 2000, as amended at 67FR 61522, Oct. 1, 2002, February 25, 2010]

§ 40.269What problems cause an alcohol testto be cancelled unless they arecorrected?As a BAT or STT, or employer, you must cancelan alcohol test if any of the following problemsoccur, unless they are corrected. These are“correctable flaws.” These problems are:(a) The BAT or STT does not sign the ATF

(see §§40.247(a)(1) and 40.255(a)(1)).(b) The BAT or STT fails to note on the

“Remarks” line of the ATF that theemployee has not signed the ATF after theresult is obtained (see §40.255(a)(2)).

(c) The BAT or STT uses a non-DOT form forthe test (see §40.225(a)).

§ 40.271How are alcohol testing problemscorrected?(a) As a BAT or STT, you have the

responsibility of trying to completesuccessfully an alcohol test for eachemployee.

(1) If, during or shortly after the testingprocess, you become aware of any eventthat will cause the test to be cancelled(see §40.267 ), you must try to correctthe problem promptly, if practicable.

You may repeat the testing process aspart of this effort.

(2) If repeating the testing process isnecessary, you must begin a new test assoon as possible. You must use a newATF, a new sequential test number, and,if needed, a new ASD and/or a newEBT. It is permissible to use additionaltechnical capabilities of the EBT (e.g.,manual operation if you have beentrained to do so in accordance with§40.213(c).

(3) If repeating the testing process isnecessary, you are not limited in thenumber of attempts to complete the test,provided that the employee is making agood faith effort to comply with thetesting process.

(4) If another testing device is not availablefor the new test at the testing site, youmust immediately notify the DER andadvise the DER that the test could not becompleted. As the DER who receivesthis information, you must make allreasonable efforts to ensure that the testis conducted at another testing site assoon as possible.

(b) If, as an STT, BAT, employer or otherservice agent administering the testingprocess, you become aware of a“correctable flaw” (see §40.269 ) that hasnot already been corrected, you must takeall practicable action to correct the problemso that the test is not cancelled.

(1) If the problem resulted from theomission of required information, youmust, as the person responsible forproviding that information, supply inwriting the missing information and asigned statement that it is true andaccurate. For example, suppose you are aBAT and you forgot to make a notationon the “Remarks” line of the ATF thatthe employee did not sign thecertification. You would, when theproblem is called to your attention,supply a signed statement that theemployee failed or refused to sign thecertification after the result wasobtained, and that your signed statementis true and accurate.

(2) If the problem is the use of a non-DOTform, you must, as the personresponsible for the use of the incorrectform, certify in writing that the incorrectform contains all the information neededfor a valid DOT alcohol test. You mustalso provide a signed statement that theincorrect form was used inadvertently oras the only means of conducting a test, incircumstances beyond your control, andthe steps you have taken to preventfuture use of non-DOT forms for DOTtests. You must supply this informationon the same business day on which youare notified of the problem, transmittingit by fax or courier.

(c) If you cannot correct the problem, you mustcancel the test.

§ 40.273What is the effect of a cancelledalcohol test?(a) A cancelled alcohol test is neither positive

nor negative.

(1) As an employer, you must not attach to acancelled test the consequences of a testresult that is 0.02 or greater (e.g.,removal from a safety-sensitiveposition).

(2) As an employer, you must not use acancelled test in a situation where anemployee needs a test result that isbelow 0.02 (e.g., in the case of a return-to-duty or follow-up test to authorize theemployee to perform safety-sensitivefunctions).

(3) As an employer, you must not direct arecollection for an employee because atest has been cancelled, except in thesituations cited in paragraph (a)(2) ofthis section or other provisions of thispart.

(b) A cancelled test does not count towardcompliance with DOT requirements, suchas a minimum random testing rate.

(c) When a test must be cancelled, if you arethe BAT, STT, or other person whodetermines that the cancellation isnecessary, you must inform the affectedDER within 48 hours of the cancellation.

(d) A cancelled DOT test does not provide avalid basis for an employer to conduct anon-DOT test (i.e., a test under companyauthority).

§ 40.275What is the effect of proceduralproblems that are not sufficient tocancel an alcohol test?(a) As an STT, BAT, employer, or a service

agent administering the testing process, youmust document any errors in the testingprocess of which you become aware, evenif they are not “fatal flaws” or “correctableflaws” listed in this subpart. Decisionsabout the ultimate impact of these errorswill be determined by administrative orlegal proceedings, subject to the limitationof paragraph (b) of this section.

(b) No person concerned with the testingprocess may declare a test cancelled basedon a mistake in the process that does nothave a significant adverse effect on theright of the employee to a fair and accuratetest. For example, it is inconsistent with thispart to cancel a test based on a minoradministrative mistake (e.g., the omissionof the employee's middle initial) or an errorthat does not affect employee protectionsunder this part. Nor does the failure of anemployee to sign in Step 4 of the ATFresult in the cancellation of the test. Nor is atest to be cancelled on the basis of a claimby an employee that he or she wasimproperly selected for testing.

(c) As an employer, these errors, even thoughnot sufficient to cancel an alcohol testresult, may subject you to enforcementaction under DOT agency regulations.

§ 40.277Are alcohol tests other than saliva orbreath permitted under theseregulations?No, other types of alcohol tests (e.g., blood andurine) are not authorized for testing done underthis part. Only saliva or breath for screening testsand breath for confirmation tests using approveddevices are permitted.


22

Subpart O - Substance AbuseProfessionals and the Return-to-Duty Process

§ 40.281Who is qualified to act as a SAP?To be permitted to act as a SAP in the DOT drugtesting program, you must meet each of therequirements of this section:(a) Credentials. You must have one of the

following credentials:(1) You are a licensed physician (Doctor of

Medicine or Osteopathy);(2) You are a licensed or certified social

worker;(3) You are a licensed or certified

psychologist;(4) You are a licensed or certified employee

assistance professional;(5) You are a state-licensed or certified

marriage and family therapist; or(6) You are a drug and alcohol counselor

certified by the National Association ofAlcoholism and Drug Abuse CounselorsCertification Commission (NAADAC);or by the International CertificationReciprocity Consortium/Alcohol andOther Drug Abuse (ICRC); or by theNational Board for Certified Counselors,Inc. and Affiliates/Master AddictionsCounselor (NBCC).

(b) Basic knowledge. You must beknowledgeable in the following areas:

(1) You must be knowledgeable about andhave clinical experience in the diagnosisand treatment of alcohol and controlledsubstances-related disorders.

(2) You must be knowledgeable about theSAP function as it relates to employerinterests in safety-sensitive duties.

(3) You must be knowledgeable about thispart, the DOT agency regulationsapplicable to the employers for whomyou evaluate employees, and the DOTSAP Guidelines, and you keep currenton any changes to these materials. Thesedocuments are available from ODAPC(Department of Transportation, 400 7thStreet, SW., Room 10403, WashingtonDC, 20590 (202–366–3784), or on theODAPC web site(http://www.dot.gov/ost/dapc).

(c) Qualification training. You must receivequalification training meeting therequirements of this paragraph (c).

(1) Qualification training must provideinstruction on the following subjects:

(i) Background, rationale, and coverageof the Department's drug and alcoholtesting program;

(ii) 49 CFR Part 40 and DOT agency drugand alcohol testing rules;

(iii) Key DOT drug testing requirements,including collections, laboratorytesting, MRO review, and problems indrug testing;

(iv) Key DOT alcohol testingrequirements, including the testingprocess, the role of BATs and STTs,and problems in alcohol tests;

(v) SAP qualifications and prohibitions;(vi) The role of the SAP in the return-to-

duty process, including the initialemployee evaluation, referrals for

education and/or treatment, thefollow-up evaluation, continuingtreatment recommendations, and thefollow-up testing plan;

(vii) SAP consultation and communicationwith employers, MROs, and treatmentproviders;

(viii) Reporting and recordkeepingrequirements;

(ix) Issues that SAPs confront in carryingout their duties under the program.

(2) Following your completion ofqualification training under paragraph(c)(1) of this section, you mustsatisfactorily complete an examinationadministered by a nationally-recognizedprofessional or training organization.The examination must comprehensivelycover all the elements of qualificationtraining listed in paragraph (c)(1) of thissection.

(3) The following is the schedule forqualification training you must meet:

(i) If you became a SAP before August 1,2001, you must meet the qualificationtraining requirement no later thanDecember 31, 2003.

(ii) If you become a SAP between August1, 2001, and December 31, 2003, youmust meet the qualification trainingrequirement no later than December31, 2003.

(iii) If you become a SAP on or afterJanuary 1, 2004, you must meet thequalification training requirementbefore you begin to perform SAPfunctions.

(d) Continuing education. During each three-year period from the date on which yousatisfactorily complete the examinationunder paragraph (c)(2) of this section, youmust complete continuing educationconsisting of at least 12 professionaldevelopment hours (e.g., CEUs) relevant toperforming SAP functions.

(1) This continuing education must includematerial concerning new technologies,interpretations, recent guidance, rulechanges, and other information aboutdevelopments in SAP practice,pertaining to the DOT program, since thetime you met the qualification trainingrequirements of this section.

(2) Your continuing education activitiesmust include documentable assessmenttools to assist you in determiningwhether you have adequately learned thematerial.

(e) Documentation. You must maintaindocumentation showing that you currentlymeet all requirements of this section. Youmust provide this documentation on requestto DOT agency representatives and toemployers and C/TPAs who are using orcontemplating using your services.

[65 FR 79526, Dec. 19, 2000, as amended at 69FR 3022, Jan. 22, 2004]

§ 40.283How does a certification organizationobtain recognition for its membersas SAPs?(a) If you represent a certification organization

that wants DOT to authorize its certifieddrug and alcohol counselors to be added to

§40.281(a)(6), you may submit a writtenpetition to DOT requesting a review of yourpetition for inclusion.

(b) You must obtain the National Commissionfor Certifying Agencies (NCCA)accreditation before DOT will act on yourpetition.

(c) You must also meet the minimumrequirements of Appendix E to this partbefore DOT will act on your petition.

§ 40.285When is a SAP evaluation required?(a) As an employee, when you have violated

DOT drug and alcohol regulations, youcannot again perform any DOT safety-sensitive duties for any employer until andunless you complete the SAP evaluation,referral, and education/treatment process setforth in this subpart and in applicable DOTagency regulations. The first step in thisprocess is a SAP evaluation.

(b) For purposes of this subpart, a verifiedpositive DOT drug test result, a DOTalcohol test with a result indicating analcohol concentration of 0.04 or greater, arefusal to test (including by adulterating orsubstituting a urine specimen) or any otherviolation of the prohibition on the use ofalcohol or drugs under a DOT agencyregulation constitutes a DOT drug andalcohol regulation violation.

§ 40.287What information is an employerrequired to provide concerning SAPservices to an employee who has aDOT drug and alcohol regulationviolation?As an employer, you must provide to eachemployee (including an applicant or newemployee) who violates a DOT drug and alcoholregulation a listing of SAPs readily available tothe employee and acceptable to you, with names,addresses, and telephone numbers. You cannotcharge the employee any fee for compiling orproviding this list. You may provide this listyourself or through a C/TPA or other serviceagent.

§ 40.289Are employers required to provideSAP and treatment services toemployees?(a) As an employer, you are not required to

provide a SAP evaluation or anysubsequent recommended education ortreatment for an employee who has violateda DOT drug and alcohol regulation.

(b) However, if you offer that employee anopportunity to return to a DOT safety-sensitive duty following a violation, youmust, before the employee again performsthat duty, ensure that the employee receivesan evaluation by a SAP meeting therequirements of §40.281 and that theemployee successfully complies with theSAP's evaluation recommendations.

(c) Payment for SAP evaluations and servicesis left for employers and employees todecide and may be governed by existingmanagement-labor agreements and healthcare benefits.


23

§ 40.291What is the role of the SAP in theevaluation, referral, and treatmentprocess of an employee who hasviolated DOT agency drug andalcohol testing regulations?(a) As a SAP, you are charged with:

(1) Making a face-to-face clinicalassessment and evaluation to determinewhat assistance is needed by theemployee to resolve problems associatedwith alcohol and/or drug use;

(2) Referring the employee to an appropriateeducation and/or treatment program;

(3) Conducting a face-to-face follow-upevaluation to determine if the employeehas actively participated in the educationand/or treatment program and hasdemonstrated successful compliancewith the initial assessment andevaluation recommendations;

(4) Providing the DER with a follow-updrug and/or alcohol testing plan for theemployee; and

(5) Providing the employee and employerwith recommendations for continuingeducation and/or treatment.

(b) As a SAP, you are not an advocate for theemployer or employee. Your function is toprotect the public interest in safety byprofessionally evaluating the employee andrecommending appropriateeducation/treatment, follow-up tests, andaftercare.

§ 40.293What is the SAP's function inconducting the initial evaluation ofan employee?As a SAP, for every employee who comes to youfollowing a DOT drug and alcohol regulationviolation, you must accomplish the following:(a) Provide a comprehensive face-to-face

assessment and clinical evaluation.(b) Recommend a course of education and/or

treatment with which the employee mustdemonstrate successful compliance prior toreturning to DOT safety-sensitive duty.

(1) You must make such a recommendationfor every individual who has violated aDOT drug and alcohol regulation.

(2) You must make a recommendation foreducation and/or treatment that will, tothe greatest extent possible, protectpublic safety in the event that theemployee returns to the performance ofsafety-sensitive functions.

(c) Appropriate education may include, but isnot limited to, self-help groups (e.g.,Alcoholics Anonymous) and communitylectures, where attendance can beindependently verified, and bona fide drugand alcohol education courses.

(d) Appropriate treatment may include, but isnot limited to, in-patient hospitalization,partial in-patient treatment, out-patientcounseling programs, and aftercare.

(e) You must provide a written report directlyto the DER highlighting your specificrecommendations for assistance (see§40.311(c)).

(f) For purposes of your role in the evaluationprocess, you must assume that a verifiedpositive test result has conclusively

established that the employee committed aDOT drug and alcohol regulation violation.You must not take into consideration in anyway, as a factor in determining what yourrecommendation will be, any of thefollowing:

(1) A claim by the employee that the testwas unjustified or inaccurate;

(2) Statements by the employee that attemptto mitigate the seriousness of a violationof a DOT drug or alcohol regulation(e.g., related to assertions of use of hempoil, “medical marijuana” use, “contactpositives,” poppy seed ingestion, jobstress); or

(3) Personal opinions you may have aboutthe justification or rationale for drug andalcohol testing.

(g) In the course of gathering information forpurposes of your evaluation in the case of adrug-related violation, you may consultwith the MRO. As the MRO, you arerequired to cooperate with the SAP andprovide available information the SAPrequests. It is not necessary to obtain theconsent of the employee to provide thisinformation.

§ 40.295May employees or employers seek asecond SAP evaluation if theydisagree with the first SAP'srecommendations?(a) As an employee with a DOT drug and

alcohol regulation violation, when you havebeen evaluated by a SAP, you must notseek a second SAP's evaluation in order toobtain another recommendation.

(b) As an employer, you must not seek asecond SAP's evaluation if the employeehas already been evaluated by a qualifiedSAP. If the employee, contrary toparagraph (a) of this section, has obtained asecond SAP evaluation, as an employer youmay not rely on it for any purpose underthis part.

§ 40.297Does anyone have the authority tochange a SAP's initial evaluation?(a) Except as provided in paragraph (b) of this

section, no one (e.g., an employer,employee, a managed-care provider, anyservice agent) may change in any way theSAP's evaluation or recommendations forassistance. For example, a third party is notpermitted to make more or less stringent aSAP's recommendation by changing theSAP's evaluation or seeking another SAP'sevaluation.

(b) The SAP who made the initial evaluationmay modify his or her initial evaluation andrecommendations based on new oradditional information (e.g., from aneducation or treatment program).

§ 40.299What is the SAP's role and what arethe limits on a SAP's discretion inreferring employees for educationand treatment?(a) As a SAP, upon your determination of the

best recommendation for assistance, youwill serve as a referral source to assist the

employee's entry into a education and/ortreatment program.

(b) To prevent the appearance of a conflict ofinterest, you must not refer an employeerequiring assistance to your private practiceor to a person or organization from whichyou receive payment or to a person ororganization in which you have a financialinterest. You are precluded from makingreferrals to entities with which you arefinancially associated.

(c) There are four exceptions to theprohibitions contained in paragraph (b) ofthis section. You may refer an employee toany of the following providers ofassistance, regardless of your relationshipwith them:

(1) A public agency (e.g., treatment facility)operated by a state, county, ormunicipality;

(2) The employer or a person ororganization under contract to theemployer to provide alcohol or drugtreatment and/or education services (e.g.,the employer's contracted treatmentprovider);

(3) The sole source of therapeuticallyappropriate treatment under theemployee's health insurance program(e.g., the single substance abuse in-patient treatment program madeavailable by the employee's insurancecoverage plan); or

(4) The sole source of therapeuticallyappropriate treatment reasonablyavailable to the employee (e.g., the onlytreatment facility or education programreasonably located within the generalcommuting area).

§ 40.301What is the SAP's function in thefollow-up evaluation of anemployee?(a) As a SAP, after you have prescribed

assistance under §40.293, you must re-evaluate the employee to determine if theemployee has successfully carried out youreducation and/or treatmentrecommendations.

(1) This is your way to gauge for theemployer the employee's ability todemonstrate successful compliance withthe education and/or treatment plan.

(2) Your evaluation may serve as one of thereasons the employer decides to returnthe employee to safety-sensitive duty.

(b) As the SAP making the follow-upevaluation determination, you must:

(1) Confer with or obtain appropriatedocumentation from the appropriateeducation and/or treatment programprofessionals where the employee wasreferred; and

(2) Conduct a face-to-face clinical interviewwith the employee to determine if theemployee demonstrates successfulcompliance with your initial evaluationrecommendations.

(c) (1) If the employee has demonstratedsuccessful compliance, you must providea written report directly to the DERhighlighting your clinical determinationthat the employee has done so with your


24

initial evaluation recommendation (see§40.311(d)).

(2) You may determine that an employeehas successfully demonstratedcompliance even though the employeehas not yet completed the full regimen ofeducation and/or treatment yourecommended or needs additionalassistance. For example, if the employeehas successfully completed the 30-dayin-patient program you prescribed, youmay make a “successful compliance”determination even though you concludethat the employee has not yet completedthe out-patient counseling yourecommended or should continue in anaftercare program.

(d) (1) As the SAP, if you believe, as a result ofthe follow-up evaluation, that theemployee has not demonstratedsuccessful compliance with yourrecommendations, you must providewritten notice directly to the DER (see§40.311(e)).

(2) As an employer who receives the SAP'swritten notice that the employee has notsuccessfully complied with the SAP'srecommendations, you must not returnthe employee to the performance ofsafety-sensitive duties.

(3) As the SAP, you may conduct additionalfollow-up evaluation(s) if the employerdetermines that doing so is consistentwith the employee's progress as you havereported it and with the employer'spolicy and/or labor-managementagreements.

(4) As the employer, following a SAP reportthat the employee has not demonstratedsuccessful compliance, you may takepersonnel action consistent with yourpolicy and/or labor-managementagreements.

§ 40.303What happens if the SAP believesthe employee needs additionaltreatment, aftercare, or supportgroup services even after theemployee returns to safety-sensitiveduties?(a) As a SAP, if you believe that ongoing

services (in addition to follow-up tests) areneeded to assist an employee to maintainsobriety or abstinence from drug use afterthe employee resumes the performance ofsafety-sensitive duties, you must providerecommendations for these services in yourfollow-up evaluation report (see§40.311(d)(10)).

(b) As an employer receiving arecommendation for these services from aSAP, you may, as part of a return-to-dutyagreement with the employee, require theemployee to participate in therecommended services. You may monitorand document the employee's participationin the recommended services. You may alsomake use of SAP and employee assistanceprogram (EAP) services in assisting andmonitoring employees' compliance withSAP recommendations. Nothing in thissection permits an employer to fail to carry

out its obligations with respect to follow-uptesting (see §40.309 ).

(c) As an employee, you are obligated tocomply with the SAP's recommendationsfor these services. If you fail or refuse to doso, you may be subject to disciplinaryaction by your employer.

§ 40.305How does the return-to-duty processconclude?(a) As the employer, if you decide that you

want to permit the employee to return to theperformance of safety-sensitive functions,you must ensure that the employee takes areturn-to-duty test. This test cannot occuruntil after the SAP has determined that theemployee has successfully complied withprescribed education and/or treatment. Theemployee must have a negative drug testresult and/or an alcohol test with an alcoholconcentration of less than 0.02 beforeresuming performance of safety-sensitiveduties.

(b) As an employer, you must not return anemployee to safety-sensitive duties until theemployee meets the conditions of paragraph(a) of this section. However, you are notrequired to return an employee to safety-sensitive duties because the employee hasmet these conditions. That is a personneldecision that you have the discretion tomake, subject to collective bargainingagreements or other legal requirements.

(c) As a SAP or MRO, you must not make a“fitness for duty” determination as part ofthis re-evaluation unless required to do sounder an applicable DOT agencyregulation. It is the employer, rather thanyou, who must decide whether to put theemployee back to work in a safety-sensitiveposition.

§ 40.307What is the SAP's function inprescribing the employee's follow-uptests?(a) As a SAP, for each employee who has

committed a DOT drug or alcoholregulation violation, and who seeks toresume the performance of safety-sensitivefunctions, you must establish a writtenfollow-up testing plan. You do not establishthis plan until after you determine that theemployee has successfully complied withyour recommendations for education and/ortreatment.

(b) You must present a copy of this plandirectly to the DER (see §40.311(d)(9)).

(c) You are the sole determiner of the numberand frequency of follow-up tests andwhether these tests will be for drugs,alcohol, or both, unless otherwise directedby the appropriate DOT agency regulation.For example, if the employee had a positivedrug test, but your evaluation or thetreatment program professionals determinedthat the employee had an alcohol problemas well, you should require that theemployee have follow-up tests for bothdrugs and alcohol.

(d) However, you must, at a minimum, directthat the employee be subject to sixunannounced follow-up tests in the first 12months of safety-sensitive duty following

the employee's return to safety-sensitivefunctions.

(1) You may require a greater number offollow-up tests during the first 12-monthperiod of safety-sensitive duty (e.g., youmay require one test a month during the12-month period; you may require twotests per month during the first 6-monthperiod and one test per month during thefinal 6-month period).

(2) You may also require follow-up testsduring the 48 months of safety-sensitiveduty following this first 12-monthperiod.

(3) You are not to establish the actual datesfor the follow-up tests you prescribe.The decision on specific dates to test isthe employer's.

(4) As the employer, you must not imposeadditional testing requirements (e.g.,under company authority) on theemployee that go beyond the SAP'sfollow-up testing plan.

(e) The requirements of the SAP's follow-uptesting plan “follow the employee” tosubsequent employers or through breaks inservice.

Example 1 to Paragraph (e):The employee returns to duty with EmployerA. Two months afterward, after completingthe first two of six follow-up tests required bythe SAP's plan, the employee quits his jobwith Employer A and begins to work in asimilar position for Employer B. Theemployee remains obligated to complete thefour additional tests during the next 10 monthsof safety-sensitive duty, and Employer B isresponsible for ensuring that the employeedoes so. Employer B learns of this obligationthrough the inquiry it makes under §40.25.

Example 2 to Paragraph (e):The employee returns to duty with EmployerA. Three months later, after the employeecompletes the first two of six follow-up testsrequired by the SAP's plan, Employer A laysthe employee off for economic or seasonalemployment reasons. Four months later,Employer A recalls the employee. EmployerA must ensure that the employee completesthe remaining four follow-up tests during thenext nine months.

(f) As the SAP, you may modify thedeterminations you have made concerningfollow-up tests. For example, even if yourecommended follow-up testing beyond thefirst 12-months, you can terminate thetesting requirement at any time after thefirst year of testing. You must not,however, modify the requirement that theemployee take at least six follow-up testswithin the first 12 months after returning tothe performance of safety-sensitivefunctions.

§ 40.309What are the employer'sresponsibilities with respect to theSAP's directions for follow-uptests?

(a) As the employer, you must carry out theSAP's follow-up testing requirements. Youmay not allow the employee to continue toperform safety-sensitive functions unless


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follow-up testing is conducted as directedby the SAP.

(b) You should schedule follow-up tests ondates of your own choosing, but you mustensure that the tests are unannounced withno discernable pattern as to their timing,and that the employee is given no advancenotice.

(c) You cannot substitute any other tests (e.g.,those carried out under the random testingprogram) conducted on the employee forthis follow-up testing requirement.

(d) You cannot count a follow-up test that hasbeen cancelled as a completed test. Acancelled follow-up test must berecollected.

§ 40.311What are the requirementsconcerning SAP reports?(a) As the SAP conducting the required

evaluations, you must send the writtenreports required by this section in writingdirectly to the DER and not to a third partyor entity for forwarding to the DER (exceptas provided in §40.355(e)). You may,however, forward the documentsimultaneously to the DER and to a C/TPA.

(b) As an employer, you must ensure that youreceive SAP written reports directly fromthe SAP performing the evaluation and thatno third party or entity changed the SAP'sreport in any way.

(c) The SAP's written report, following aninitial evaluation that determines what levelof assistance is needed to address theemployee's drug and/or alcohol problems,must be on the SAP's own letterhead (andnot the letterhead of another service agent)signed and dated by the SAP, and mustcontain the following delineated items:

(1) Employee's name and SSN;(2) Employer's name and address;(3) Reason for the assessment (specific

violation of DOT regulations andviolation date);

(4) Date(s) of the assessment;(5) SAP's education and/or treatment

recommendation; and(6) SAP's telephone number.

(d) The SAP's written report concerning afollow-up evaluation that determines theemployee has demonstrated successfulcompliance must be on the SAP's ownletterhead (and not the letterhead of anotherservice agent), signed by the SAP anddated, and must contain the followingitems:

(1) Employee's name and SSN;(2) Employer's name and address;(3) Reason for the initial assessment

(specific violation of DOT regulationsand violation date);

(4) Date(s) of the initial assessment andsynopsis of the treatment plan;

(5) Name of practice(s) or service(s)providing the recommended educationand/or treatment;

(6) Inclusive dates of employee's programparticipation;

(7) Clinical characterization of employee'sprogram participation;

(8) SAP's clinical determination as towhether the employee has demonstratedsuccessful compliance;

(9) Follow-up testing plan;(10) Employee's continuing care needs with

specific treatment, aftercare, and/orsupport group servicesrecommendations; and

(11) SAP's telephone number.(e) The SAP's written report concerning a

follow-up evaluation that determines theemployee has not demonstrated successfulcompliance must be on the SAP's ownletterhead (and not the letterhead of anotherservice agent), signed by the SAP anddated, and must contain the followingitems:

(1) Employee's name and SSN;(2) Employer's name and address;(3) Reason for the initial assessment

(specific DOT violation and date);(4) Date(s) of initial assessment and

synopsis of treatment plan;(5) Name of practice(s) or service(s)

providing the recommended educationand/or treatment;

(6) Inclusive dates of employee's programparticipation;

(7) Clinical characterization of employee'sprogram participation;

(8) Date(s) of the first follow-up evaluation;(9) Date(s) of any further follow-up

evaluation the SAP has scheduled;(10) SAP's clinical reasons for determining

that the employee has not demonstratedsuccessful compliance; and

(11) SAP's telephone number.(f) As a SAP, you must also provide these

written reports directly to the employee ifthe employee has no current employer andto the gaining DOT regulated employer inthe event the employee obtains anothertransportation industry safety-sensitiveposition.

(g) As a SAP, you are to maintain copies ofyour reports to employers for 5 years, andyour employee clinical records inaccordance with Federal, state, and locallaws regarding record maintenance,confidentiality, and release of information.You must make these records available, onrequest, to DOT agency representatives(e.g., inspectors conducting an audit orsafety investigation) and representatives ofthe NTSB in an accident investigation.

(h) As an employer, you must maintain yourreports from SAPs for 5 years from the dateyou received them.

§ 40.313Where is other information on SAPfunctions and the return-to-dutyprocess found in this regulation?You can find other information on the role andfunctions of SAPs in the following sections ofthis part:§40.3 Definition.§40.347 Service agent assistance with SAP-

required follow-up testing.§40.355 Transmission of SAP reports.§40.329(c) Making SAP reports available to

employees on request.Appendix E to Part 40

SAP Equivalency Requirements forCertification Organizations.

Subpart P - Confidentiality andRelease of Information

§ 40.321What is the general confidentialityrule for drug and alcohol testinformation?Except as otherwise provided in this subpart, as aservice agent or employer participating in theDOT drug or alcohol testing process, you areprohibited from releasing individual test resultsor medical information about an employee tothird parties without the employee's specificwritten consent.(a) A “third party” is any person or

organization to whom other subparts of thisregulation do not explicitly authorize orrequire the transmission of information inthe course of the drug or alcohol testingprocess.

(b) “Specific written consent” means astatement signed by the employee that he orshe agrees to the release of a particularpiece of information to a particular,explicitly identified, person or organizationat a particular time. “Blanket releases,” inwhich an employee agrees to a release of acategory of information (e.g., all testresults) or to release information to acategory of parties (e.g., other employerswho are members of a C/TPA, companiesto which the employee may apply foremployment), are prohibited under this part.

§ 40.323May program participants releasedrug or alcohol test information inconnection with legal proceedings?(a) As an employer, you may release

information pertaining to an employee'sdrug or alcohol test without the employee'sconsent in certain legal proceedings.

(1) These proceedings include a lawsuit(e.g., a wrongful discharge action),grievance (e.g., an arbitration concerningdisciplinary action taken by theemployer), or administrative proceeding(e.g., an unemployment compensationhearing) brought by, or on behalf of, anemployee and resulting from a positiveDOT drug or alcohol test or a refusal totest (including, but not limited to,adulterated or substituted test results).

(2) These proceedings also include acriminal or civil action resulting from anemployee's performance of safety-sensitive duties, in which a court ofcompetent jurisdiction determines thatthe drug or alcohol test informationsought is relevant to the case and issuesan order directing the employer toproduce the information. For example, inpersonal injury litigation following atruck or bus collision, the court coulddetermine that a post-accident drug testresult of an employee is relevant todetermining whether the driver or thedriver's employer was negligent. Theemployer is authorized to respond to thecourt's order to produce the records.

(b) In such a proceeding, you may release theinformation to the decisionmaker in theproceeding (e.g., the court in a lawsuit).You may release the information only with


26

a binding stipulation that the decisionmakerto whom it is released will make it availableonly to parties to the proceeding.

(c) If you are a service agent, and the employerrequests its employee's drug or alcoholtesting information from you to use in alegal proceeding as authorized in paragraph(a) of this section (e.g., the laboratory's datapackage), you must provide the requestedinformation to the employer.

(d) As an employer or service agent, you mustimmediately notify the employee in writingof any information you release under thissection.

§ 40.327When must the MRO report medicalinformation gathered in theverification process?(a) As the MRO, you must, except as provided

in paragraph (c) of this section, report drugtest results and medical information youlearned as part of the verification process tothird parties without the employee's consentif you determine, in your reasonablemedical judgment, that:

(1) The information is likely to result in theemployee being determined to bemedically unqualified under anapplicable DOT agency regulation; or

(2) The information indicates that continuedperformance by the employee of his orher safety-sensitive function is likely topose a significant safety risk.

(b) The third parties to whom you areauthorized to provide information by thissection include the employer, a physician orother health care provider responsible fordetermining the medical qualifications ofthe employee under an applicable DOTagency safety regulation, a SAP evaluatingthe employee as part of the return to dutyprocess (see §40.293(g)), a DOT agency, orthe National Transportation Safety Board inthe course of an accident investigation.

(c) If the law of a foreign country (e.g.,Canada) prohibits you from providingmedical information to the employer, youmay comply with that prohibition.

§ 40.329What information must laboratories,MROs, and other service agentsrelease to employees?(a) As an MRO or service agent you must

provide, within 10 business days ofreceiving a written request from anemployee, copies of any records pertainingto the employee's use of alcohol and/ordrugs, including records of the employee'sDOT-mandated drug and/or alcohol tests.You may charge no more than the cost ofpreparation and reproduction for copies ofthese records.

(b) As a laboratory, you must provide, within10 business days of receiving a writtenrequest from an employee, and madethrough the MRO, the records relating tothe results of the employee's drug test (i.e.,laboratory report and data package). Youmay charge no more than the cost ofpreparation and reproduction for copies ofthese records.

(c) As a SAP, you must make available to anemployee, on request, a copy of all SAP

reports (see §40.311). However, you mustredact follow-up testing information fromthe report before providing it to theemployee.


§ 40.331 To what additionalparties must employers and serviceagents release information?As an employer or service agent you must releaseinformation under the following circumstances:(a) If you receive a specific, written consent

from an employee authorizing the release ofinformation about that employee's drug oralcohol tests to an identified person, youmust provide the information to theidentified person. For example, as anemployer, when you receive a writtenrequest from a former employee to provideinformation to a subsequent employer, youmust do so. In providing the information,you must comply with the terms of theemployee's consent.

(b) If you are an employer, you must, uponrequest of DOT agency representatives,provide the following:

(1) Access to your facilities used for thispart and DOT agency drug and alcoholprogram functions.

(2) All written, printed, and computer-baseddrug and alcohol program records andreports (including copies of name-specific records or reports), files,materials, data,documents/documentation, agreements,contracts, policies, and statements thatare required by this part and DOTagency regulations. You must providethis information at your principal placeof business in the time required by theDOT agency.

(3) All items in paragraph (b)(2) of thissection must be easily accessible,legible, and provided in an organizedmanner. If electronic records do not meetthese standards, they must be convertedto printed documentation that meetsthese standards.

(c) If you are a service agent, you must, uponrequest of DOT agency representatives,provide the following:

(1) Access to your facilities used for thispart and DOT agency drug and alcoholprogram functions.

(2) All written, printed, and computer-baseddrug and alcohol program records andreports (including copies of name-specific records or reports), files,materials, data,documents/documentation, agreements,contracts, policies, and statements thatare required by this part and DOTagency regulations. You must providethis information at your principal placeof business in the time required by theDOT agency.

(3) All items in paragraph (c)(2) of thissection must be easily accessible,legible, and provided in an organizedmanner. If electronic records do not meetthese standards, they must be convertedto printed documentation that meetsthese standards.

(d) If requested by the National TransportationSafety Board as part of an accidentinvestigation, you must provide informationconcerning post-accident tests administeredafter the accident.

(e) If requested by a Federal, state or localsafety agency with regulatory authorityover you or the employee, you mustprovide drug and alcohol test recordsconcerning the employee.

(f) Except as otherwise provided in this part, asa laboratory you must not release or providea specimen or a part of a specimen to arequesting party, without first obtainingwritten consent from ODAPC. If a partyseeks a court order directing you to releasea specimen or part of a specimen contraryto any provision of this part, you must takenecessary legal steps to contest the issuanceof the order (e.g., seek to quash a subpoena,citing the requirements of §40.13 ). Thispart does not require you to disobey a courtorder, however.

(g) Notwithstanding any other provision of thisPart, as an employer of Commercial MotorVehicle (CMV) drivers holding commercialdriving licenses (CDLs) or as a third partyadministrator for owner-operator CMVdrivers with CDLs, you are authorized tocomply with State laws requiring you toprovide to State CDL licensing authoritiesinformation about all violations of DOTdrug and alcohol testing rules (includingpositive tests and refusals) by any CMVdriver holding a CDL.

[65 FR 79526, Dec. 19, 2000, as amended at 66FR 41955, Aug. 9, 2001; 73 FR 33737, June 13,2008, February 25, 2010]

§ 40.333What records must employers keep?(a) As an employer, you must keep the

following records for the following periodsof time:

(1) You must keep the following records forfive years:

(i) Records of alcohol test resultsindicating an alcohol concentration of0.02 or greater;

(ii) Records of verified positive drug testresults;

(iii) Documentation of refusals to takerequired alcohol and/or drug tests(including substituted or adulterateddrug test results);

(iv) SAP reports; and(v) All follow-up tests and schedules for

follow-up tests.(2) You must keep records for three years of

information obtained from previousemployers under §40.25 concerning drugand alcohol test results of employees.

(3) You must keep records of the inspection,maintenance, and calibration of EBTs,for two years.

(4) You must keep records of negative andcancelled drug test results and alcoholtest results with a concentration of lessthan 0.02 for one year.

(b) You do not have to keep records related to aprogram requirement that does not apply toyou (e.g., a maritime employer who doesnot have a DOT-mandated random alcoholtesting program need not maintain randomalcohol testing records).


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(c) You must maintain the records in a locationwith controlled access.

(d) A service agent may maintain these recordsfor you. However, you must ensure that youcan produce these records at your principalplace of business in the time required by theDOT agency. For example, as a motorcarrier, when an FMCSA inspector requestsyour records, you must ensure that you canprovide them within two business days.

(e) If you store records electronically, wherepermitted by this part, you must ensure thatthe records are easily accessible, legible,and formatted and stored in an organizedmanner. If electronic records do not meetthese criteria, you must convert them toprinted documentation in a rapid andreadily auditable manner, at the request ofDOT agency personnel.


Subpart Q - Roles andResponsibilities of ServiceAgents

§ 40.341Must service agents comply withDOT drug and alcohol testingrequirements?(a) As a service agent, the services you provide

to transportation employers must meet therequirements of this part and the DOTagency drug and alcohol testing regulations.

(b) If you do not comply, DOT may take actionunder the Public Interest Exclusionsprocedures of this part (see Subpart R ofthis part) or applicable provisions of otherDOT agency regulations.

§ 40.343What tasks may a service agentperform for an employer?

As a service agent, you may perform foremployers the tasks needed to comply with DOTagency drug and alcohol testing regulations,subject to the requirements and limitations of thispart.

§ 40.345In what circumstances may a C/TPAact as an intermediary in thetransmission of drug and alcoholtesting information to employers?(a) As a C/TPA or other service agent, you

may act as an intermediary in thetransmission of drug and alcohol testinginformation in the circumstances specifiedin this section only if the employer choosesto have you do so. Each employer makesthe decision about whether to receive someor all of this information from you, actingas an intermediary, rather than directly fromthe service agent who originates theinformation (e.g., an MRO or BAT).

(b) The specific provisions of this partconcerning which you may act as anintermediary are listed in Appendix F tothis part. These are the only situations inwhich you may act as an intermediary. Youare prohibited from doing so in all othersituations.

(c) In every case, you must ensure that, intransmitting information to employers, you

meet all requirements (e.g., concerningconfidentiality and timing) that would applyif the service agent originating theinformation (e.g., an MRO or collector)sent the information directly to theemployer. For example, if you transmitdrug testing results from MROs to DERs,you must transmit each drug test result tothe DER in compliance with the MROrequirements set forth in §40.167.

§ 40.347What functions may C/TPAs performwith respect to administeringtesting?As a C/TPA, except as otherwise specified in thispart, you may perform the following functionsfor employers concerning random selection andother selections for testing.(a) You may operate random testing programs

for employers and may assist (i.e., throughcontracting with laboratories or collectionsites, conducting collections) employerswith other types of testing (e.g., pre-employment, post-accident, reasonablesuspicion, return-to-duty, and follow-up).

(b) You may combine employees from morethan one employer or one transportationindustry in a random pool if permitted byall the DOT agency drug and alcoholtesting regulations involved.

(1) If you combine employees from morethan one transportation industry, youmust ensure that the random testing rateis at least equal to the highest raterequired by each DOT agency.

(2) Employees not covered by DOT agencyregulations may not be part of the samerandom pool with DOT coveredemployees.

(c) You may assist employers in ensuring thatfollow-up testing is conducted inaccordance with the plan established by theSAP. However, neither you nor theemployer are permitted to randomly selectemployees from a “follow-up pool” forfollow-up testing.

§ 40.349What records may a service agentreceive and maintain?(a) Except where otherwise specified in this

part, as a service agent you may receive andmaintain all records concerning DOT drugand alcohol testing programs, includingpositive, negative, and refusal to testindividual test results. You do not need theemployee's consent to receive and maintainthese records.

(b) You may maintain all information neededfor operating a drug/alcohol program (e.g.,CCFs, ATFs, names of employees inrandom pools, random selection lists,copies of notices to employers of selectedemployees) on behalf of an employer.

(c) If a service agent originating drug oralcohol testing information, such as anMRO or BAT, sends the informationdirectly to the DER, he or she may alsoprovide the information simultaneously toyou, as a C/TPA or other service agent whomaintains this information for theemployer.

(d) If you are serving as an intermediary intransmitting information that is required to

be provided to the employer, you mustensure that it reaches the employer in thesame time periods required elsewhere inthis part.

(e) You must ensure that you can makeavailable to the employer within twobusiness days any information the employeris asked to produce by a DOT agencyrepresentative.

(f) On request of an employer, you must, atany time on the request of an employer,transfer immediately all records pertainingto the employer and its employees to theemployer or to any other service agent theemployer designates. You must carry outthis transfer as soon as the employerrequests it. You are not required to obtainemployee consent for this transfer. Youmust not charge more than your reasonableadministrative costs for conducting thistransfer. You may not charge a fee for therelease of these records.

(g) If you are planning to go out of business oryour organization will be bought by ormerged with another organization, youmust immediately notify all employers andoffer to transfer all records pertaining to theemployer and its employees to theemployer or to any other service agent theemployer designates. You must carry outthis transfer as soon as the employerrequests it. You are not required to obtainemployee consent for this transfer. Youmust not charge more than your reasonableadministrative costs for conducting thistransfer. You may not charge a fee for therelease of these records.


§ 40.351What confidentiality requirementsapply to service agents?Except where otherwise specified in this part, asa service agent the following confidentialityrequirements apply to you:(a) When you receive or maintain confidential

information about employees (e.g.,individual test results), you must follow thesame confidentiality regulations as theemployer with respect to the use and releaseof this information.

(b) You must follow all confidentiality andrecords retention requirements applicable toemployers.

(c) You may not provide individual test resultsor other confidential information to anotheremployer without a specific, writtenconsent from the employee. For example,suppose you are a C/TPA that hasemployers X and Y as clients. EmployeeJones works for X, and you maintain Jones'drug and alcohol test for X. Jones wants tochange jobs and work for Y. You may notinform Y of the result of a test conductedfor X without having a specific, writtenconsent from Jones. Likewise, you may notprovide this information to employer Z,who is not a C/TPA member, without thisconsent.

(d) You must not use blanket consent formsauthorizing the release of employee testinginformation.

(e) You must establish adequate confidentialityand security measures to ensure that


28

confidential employee records are notavailable to unauthorized persons. Thisincludes protecting the physical security ofrecords, access controls, and computersecurity measures to safeguard confidentialdata in electronic data bases.

§ 40.353What principles govern theinteraction between MROs and otherservice agents?As a service agent other than an MRO (e.g., aC/TPA), the following principles govern yourinteraction with MROs:(a) You may provide MRO services to

employers, directly or through contract, ifyou meet all applicable provisions of thispart.

(b) If you employ or contract for an MRO, theMRO must perform duties independentlyand confidentially. When you have arelationship with an MRO, you muststructure the relationship to ensure that thisindependence and confidentiality are notcompromised. Specific means (includingboth physical and operational measures, asappropriate) to separate MRO functions andother service agent functions are essential.

(c) Only your staff who are actually under theday-to-day supervision and control of anMRO with respect to MRO functions mayperform these functions. This does notmean that those staff may not perform otherfunctions at other times. However, thedesignation of your staff to perform MROfunctions under MRO supervision must belimited and not used as a subterfuge tocircumvent confidentiality and otherrequirements of this part and DOT agencyregulations. You must ensure that MROstaff operate under controls sufficient toensure that the independence andconfidentiality of the MRO process are notcompromised.

(d) Like other MROs, an MRO you employ orcontract with must personally conductverification interviews with employees andmust personally make all verificationdecisions. Consequently, your staff cannotperform these functions.

§ 40.355What limitations apply to theactivities of service agents?As a service agent, you are subject to thefollowing limitations concerning your activitiesin the DOT drug and alcohol testing program.(a) You must not require an employee to sign a

consent, release, waiver of liability, orindemnification agreement with respect toany part of the drug or alcohol testingprocess covered by this part (including, butnot limited to, collections, laboratorytesting, MRO, and SAP services). No onemay do so on behalf of a service agent.

(b) You must not act as an intermediary in thetransmission of drug test results from thelaboratory to the MRO. That is, thelaboratory may not send results to you, withyou in turn sending them to the MRO forverification. For example, a practice inwhich the laboratory transmits results toyour computer system, and you then assignthe results to a particular MRO, is notpermitted.

(c) You must not transmit drug test resultsdirectly from the laboratory to the employer(by electronic or other means) or to aservice agent who forwards them to theemployer. All confirmed laboratory resultsmust be processed by the MRO before theyare released to any other party.

(d) You must not act as an intermediary in thetransmission of alcohol test results of 0.02or higher from the STT or BAT to the DER.

(e) Except as provided in paragraph (f) of thissection, you must not act as an intermediaryin the transmission of individual SAPreports to the actual employer. That is, theSAP may not send such reports to you, withyou in turn sending them to the actualemployer. However, you may maintainindividual SAP summary reports andfollow-up testing plans after they are sent tothe DER, and the SAP may transmit suchreports to you simultaneously with sendingthem to the DER.

(f) As an exception to paragraph (e) of thissection, you may act as an intermediary inthe transmission of SAP report from theSAP to an owner-operator or other self-employed individual.

(g) Except as provided in paragraph (h) of thissection, you must not make decisions to testan employee based upon reasonablesuspicion, post-accident, return-to-duty, andfollow-up determination criteria. These areduties the actual employer cannot delegateto a C/TPA. You may, however, provideadvice and information to employersregarding these testing issues and how theemployer should schedule required testing.

(h) As an exception to paragraph (g) of thissection, you may make decisions to test anemployee based upon reasonable suspicion,post-accident, return-to-duty, and follow-updetermination criteria with respect to anowner-operator or other self-employedindividual.

(i) Except as provided in paragraph (j) of thissection, you must not make a determinationthat an employee has refused a drug oralcohol test. This is a non-delegable duty ofthe actual employer. You may, however,provide advice and information toemployers regarding refusal-to-test issues.

(j) As an exception to paragraph (i) of thissection, you may make a determination thatan employee has refused a drug or alcoholtest, if:

(1) You schedule a required test for anowner-operator or other self-employedindividual, and the individual fails toappear for the test without a legitimatereason; or

(2) As an MRO, you determine that anindividual has refused to test on the basisof adulteration or substitution.

(k) You must not act as a DER. For example,while you may be responsible fortransmitting information to the employerabout test results, you must not act onbehalf of the employer in actions to removeemployees from safety-sensitive duties.

(l) In transmitting documents to laboratories,you must ensure that you send to thelaboratory that conducts testing only Copy1 of the CCF. You must not transmit other

copies of the CCF or any ATFs to thelaboratory.

(m) You must not impose conditions orrequirements on employers that DOTregulations do not authorize. For example,as a C/TPA serving employers in thepipeline or motor carrier industry, you mustnot require employers to have provisions intheir DOT plans that PHMSA or FMCSAregulations do not require.

(n) You must not intentionally delay thetransmission of drug or alcohol testing-related documents concerning actions youhave performed, because of a paymentdispute or other reasons.

Example 1 to Paragraph (n):A laboratory that has tested a specimen mustnot delay transmitting the documentation ofthe test result to an MRO because of a billingor payment dispute with the MRO or aC/TPA.

Example 2 to Paragraph (n):An MRO or SAP who has interviewed anemployee must not delay sending a verifiedtest result or SAP report to the employerbecause of such a dispute with the employer oremployee.

Example 3 to Paragraph (n):

A collector who has performed a urinespecimen collection must not delay sendingthe drug specimen and CCF to the laboratorybecause of a payment or other dispute with thelaboratory or a C/TPA.

Example 4 to Paragraph (n):

A BAT who has conducted an alcohol testmust not delay sending test result informationto an employer or C/TPA because of apayment or other dispute with the employer orC/TPA.

(o) While you must follow the DOT agencyregulations, the actual employer remainsaccountable to DOT for compliance, andyour failure to implement any aspect of theprogram as required in this part and otherapplicable DOT agency regulations makesthe employer subject to enforcement actionby the Department.


Subpart R - Public InterestExclusions

49 cfr part 40 - procedures for transportation … · 2019-04-26 · 49 cfr part 40 - procedures...

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