**TITLE 49: TRANSPORTATION**

PART 40 - PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL
TESTING PROGRAMS

Reprinted by the Department of Transportation, Drug and Alcohol Policy
and Compliance Office,

400 7^th^ St., SW, Washington, DC 20590 (202) 366-3784

[**Subpart A - Administrative Provisions**](#49:1.0.1.1.27.1)

§ 40.1   Who does this regulation cover?\
§ 40.3   What do the terms used in this regulation 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**](#49:1.0.1.1.27.2)

[§ 40.11   What are the general responsibilities of employers under this
regulation?](#49:1.0.1.1.27.2.22.1)\
[§ 40.13   How do DOT drug and alcohol tests relate to non-DOT
tests?](#49:1.0.1.1.27.2.22.2)\
[§ 40.15   May an employer use a service agent to meet DOT drug and
alcohol testing requirements?](#49:1.0.1.1.27.2.22.3)\
[§ 40.17   Is an employer responsible for obtaining information from its
service agents?](#49:1.0.1.1.27.2.22.4)\
[§ 40.19   \[Reserved\]](#49:1.0.1.1.27.2.22.5)\
[§ 40.21   May an employer stand down an employee before the MRO has
completed the verification process?](#49:1.0.1.1.27.2.22.6)\
[§ 40.23   What actions do employers take after receiving verified test
results?](#49:1.0.1.1.27.2.22.7)\
[§ 40.25   Must an employer check on the drug and alcohol testing record
of employees it is intending to use to perform safety-sensitive
duties?](#49:1.0.1.1.27.2.22.8)\
[§ 40.26   What form must an employer use to report Management
Information System (MIS) data to a DOT agency?](#49:1.0.1.1.27.2.22.9)\
[§ 40.27   May an employer require an employee to sign a consent or
release in connection with the DOT drug and alcohol testing
program?](#49:1.0.1.1.27.2.22.10)\
[§ 40.29   Where is other information on employer responsibilities found
in this regulation?](#49:1.0.1.1.27.2.22.11)

[**Subpart C - Urine Collection Personnel**](#49:1.0.1.1.27.3)

[§ 40.31   Who may collect urine specimens for DOT drug
testing?](#49:1.0.1.1.27.3.22.1)\
[§ 40.33   What training requirements must a collector
meet?](#49:1.0.1.1.27.3.22.2)\
[§ 40.35   What information about the DER must employers provide to
collectors?](#49:1.0.1.1.27.3.22.3)\
[§ 40.37   Where is other information on the role of collectors found in
this regulation?](#49:1.0.1.1.27.3.22.4)

[**Subpart D - Collection Sites, Forms, Equipment and Supplies Used in
DOT Urine Collections**](#49:1.0.1.1.27.4)

[§ 40.41   Where does a urine collection for a DOT drug test take
place?](#49:1.0.1.1.27.4.22.1)\
[§ 40.43   What steps must operators of collection sites take to protect
the security and integrity of urine
collections?](#49:1.0.1.1.27.4.22.2)\
[§ 40.45   What form is used to document a DOT urine
collection?](#49:1.0.1.1.27.4.22.3)\
[§ 40.47   May employers use the CCF for non-Federal collections or
non-Federal forms for DOT collections?](#49:1.0.1.1.27.4.22.4)\
[§ 40.49   What materials are used to collect urine
specimens?](#49:1.0.1.1.27.4.22.5)\
[§ 40.51   What materials are used to send urine specimens to the
laboratory?](#49:1.0.1.1.27.4.22.6)

[**Subpart E - Urine Specimen Collections**](#49:1.0.1.1.27.5)

[§ 40.61   What are the preliminary steps in the collection
process?](#49:1.0.1.1.27.5.22.1)\
[§ 40.63   What steps does the collector take in the collection process
before the employee provides a urine specimen?](#49:1.0.1.1.27.5.22.2)\
[§ 40.65   What does the collector check for when the employee presents
a specimen?](#49:1.0.1.1.27.5.22.3)\
[§ 40.67   When and how is a directly observed collection
conducted?](#49:1.0.1.1.27.5.22.4)\
[§ 40.69   How is a monitored collection
conducted?](#49:1.0.1.1.27.5.22.5)\
[§ 40.71   How does the collector prepare the
specimens?](#49:1.0.1.1.27.5.22.6)\
[§ 40.73   How is the collection process
completed?](#49:1.0.1.1.27.5.22.7)

[**Subpart F - Drug Testing Laboratories**](#49:1.0.1.1.27.6)

[§ 40.81   What laboratories may be used for DOT drug
testing?](#49:1.0.1.1.27.6.22.1)\
[§ 40.83   How do laboratories process incoming
specimens?](#49:1.0.1.1.27.6.22.2)\
[§ 40.85   What drugs do laboratories test for?](#49:1.0.1.1.27.6.22.3)\
[§ 40.87   What are the cutoff concentrations for initial and
confirmation tests?](#49:1.0.1.1.27.6.22.4)\
[§ 40.89   What is validity testing, and are laboratories required to
conduct it?](#49:1.0.1.1.27.6.22.5)\
[§ 40.91   What validity tests must laboratories conduct on primary
specimens?](#49:1.0.1.1.27.6.22.6)\
[§ 40.93   What criteria do laboratories use to establish that a
specimen is dilute or substituted?](#49:1.0.1.1.27.6.22.7)\
[§ 40.95   What criteria do laboratories use to establish that a
specimen is adulterated?](#49:1.0.1.1.27.6.22.8)\
[§ 40.97   What do laboratories report and how do they report
it?](#49:1.0.1.1.27.6.22.9)\
[§ 40.99   How long does the laboratory retain specimens after
testing?](#49:1.0.1.1.27.6.22.10)\
[§ 40.101 What relationship may a laboratory have with an
MRO?](#49:1.0.1.1.27.6.22.11)\
[§ 40.103 What are the requirements for submitting blind specimens to a
laboratory?](#49:1.0.1.1.27.6.22.12)\
[§ 40.105 What happens if the laboratory reports a result different from
that expected for a blind specimen?](#49:1.0.1.1.27.6.22.13)\
[§ 40.107  Who may inspect laboratories?](#49:1.0.1.1.27.6.22.14)\
[§ 40.109  What documentation must the laboratory keep, and for how
long?](#49:1.0.1.1.27.6.22.15)\
[§ 40.111  When and how must a laboratory disclose statistical summaries
and other information it maintains?](#49:1.0.1.1.27.6.22.16)\
[§ 40.113  Where is other information concerning laboratories found in
this regulation?](#49:1.0.1.1.27.6.22.17)

[**Subpart G - Medical Review Officers and the Verification
Process**](#49:1.0.1.1.27.7)

[§ 40.121   Who is qualified to act as an MRO?](#49:1.0.1.1.27.7.22.1)\
[§ 40.123   What are the MRO\'s responsibilities in the DOT drug testing
program?](#49:1.0.1.1.27.7.22.2)\
[§ 40.125   What relationship may an MRO have with a
laboratory?](#49:1.0.1.1.27.7.22.3)\
[§ 40.127   What are the MRO\'s functions in reviewing negative test
results?](#49:1.0.1.1.27.7.22.4)\
[§ 40.129   What are the MRO\'s functions in reviewing laboratory
confirmed positive, adulterated, substituted, or invalid drug test
results?](#49:1.0.1.1.27.7.22.5)\
[§ 40.131   How does the MRO or DER notify an employee of the
verification process after a confirmed positive, adulterated,
substituted, or invalid test result?](#49:1.0.1.1.27.7.22.6)\
[§ 40.133   Under what circumstances may the MRO verify a test as
positive, or as a refusal to test because of adulteration or
substitution, without interviewing the
employee?](#49:1.0.1.1.27.7.22.7)\
[§ 40.135   What does the MRO tell the employee at the beginning of the
verification interview?](#49:1.0.1.1.27.7.22.8)\
[§ 40.137   On what basis does the MRO verify test results involving
marijuana, cocaine, amphetamines, or PCP?](#49:1.0.1.1.27.7.22.9)\
[§ 40.139   On what basis does the MRO verify test results involving
opiates?](#49:1.0.1.1.27.7.22.10)\
[§ 40.141   How does the MRO obtain information for the verification
decision?](#49:1.0.1.1.27.7.22.11)\
[§ 40.143   \[Reserved\]](#49:1.0.1.1.27.7.22.12)\
[§ 40.145   On what basis does the MRO verify test results involving
adulteration or substitution?](#49:1.0.1.1.27.7.22.13)\
[§ 40.147   \[Reserved\]](#49:1.0.1.1.27.7.22.14)\
[§ 40.149   May the MRO change a verified positive drug test result or
refusal to test?](#49:1.0.1.1.27.7.22.15)\
[§ 40.151   What are MROs prohibited from doing as part of the
verification process?](#49:1.0.1.1.27.7.22.16)\
[§ 40.153   How does the MRO notify employees of their right to a test
of the split specimen?](#49:1.0.1.1.27.7.22.17)\
[§ 40.155   What does the MRO do when a negative or positive test result
is also dilute?](#49:1.0.1.1.27.7.22.18)\
[§ 40.157   \[Reserved\]](#49:1.0.1.1.27.7.22.19)\
[§ 40.159   What does the MRO do when a drug test result is
invalid?](#49:1.0.1.1.27.7.22.20)\
[§ 40.161   What does the MRO do when a drug test specimen is rejected
for testing?](#49:1.0.1.1.27.7.22.21)\
[§ 40.163   How does the MRO report drug test
results?](#49:1.0.1.1.27.7.22.22)\
[§ 40.165   To whom does the MRO transmit reports of drug test
results?](#49:1.0.1.1.27.7.22.23)\
[§ 40.167   How are MRO reports of drug results transmitted to the
employer?](#49:1.0.1.1.27.7.22.24)\
[§ 40.169   Where is other information concerning the role of MROs and
the verification process found in this
regulation?](#49:1.0.1.1.27.7.22.25)

[**Subpart H - Split Specimen Tests**](#49:1.0.1.1.27.8)

[§ 40.171   How does an employee request a test of a split
specimen?](#49:1.0.1.1.27.8.22.1)\
[§ 40.173   Who is responsible for paying for the test of a split
specimen?](#49:1.0.1.1.27.8.22.2)\
[§ 40.175   What steps does the first laboratory take with a split
specimen?](#49:1.0.1.1.27.8.22.3)\
[§ 40.177   What does the second laboratory do with the split specimen
when it is tested to reconfirm the presence of a drug or drug
metabolite?](#49:1.0.1.1.27.8.22.4)\
[§ 40.179   What does the second laboratory do with the split specimen
when it is tested to reconfirm an adulterated test
result?](#49:1.0.1.1.27.8.22.5)\
[§ 40.181   What does the second laboratory do with the split specimen
when it is tested to reconfirm a substituted test
result?](#49:1.0.1.1.27.8.22.6)\
[§ 40.183   What information do laboratories report to MROs regarding
split specimen results?](#49:1.0.1.1.27.8.22.7)\
[§ 40.185   Through what methods and to whom must a laboratory report
split specimen results?](#49:1.0.1.1.27.8.22.8)\
[§ 40.187   What does the MRO do with split specimen laboratory
results?](#49:1.0.1.1.27.8.22.9)\
[§ 40.189   Where is other information concerning split specimens found
in this regulation?](#49:1.0.1.1.27.8.22.10)

[**Subpart I - Problems in Drug Tests**](#49:1.0.1.1.27.9)

[§ 40.191   What is a refusal to take a DOT drug test, and what are the
consequences?](#49:1.0.1.1.27.9.22.1)\
[§ 40.193   What happens when an employee does not provide a sufficient
amount of urine for a drug test?](#49:1.0.1.1.27.9.22.2)\
[§ 40.195   What happens when an individual is unable to provide a
sufficient amount of urine for a pre-employment follow-up or
return-to-duty test because of a permanent or long-term medical
condition?](#49:1.0.1.1.27.9.22.3)\
[§ 40.197   What happens when an employer receives a report of a dilute
specimen?](#49:1.0.1.1.27.9.22.4)\
[§ 40.199   What problems always cause a drug test to be
cancelled?](#49:1.0.1.1.27.9.22.5)\
[§ 40.201   What problems always cause a drug test to be cancelled and
may result in a requirement for another
collection?](#49:1.0.1.1.27.9.22.6)\
[§ 40.203 What problems cause a drug test to be cancelled unless they
are corrected?](#49:1.0.1.1.27.9.22.7)\
[§ 40.205  How are drug test problems
corrected?](#49:1.0.1.1.27.9.22.8)\
[§ 40.207   What is the effect of a cancelled drug
test?](#49:1.0.1.1.27.9.22.9)\
[§ 40.208   What problem requires corrective action but does not result
in the cancellation of a test?](#49:1.0.1.1.27.9.22.10)\
[§ 40.209   What procedural problems do not result in the cancellation
of a test and do not require collection?](#49:1.0.1.1.27.9.22.11)

[**Subpart J - Alcohol Testing Personnel**](#49:1.0.1.1.27.10)

[§ 40.211   Who conducts DOT alcohol tests?](#49:1.0.1.1.27.10.22.1)\
[§ 40.213   What training requirements must STTs and BATs
meet?](#49:1.0.1.1.27.10.22.2)\
[§ 40.215   What information about the DER do employers have to provide
to BATs and STTs?](#49:1.0.1.1.27.10.22.3)\
[§ 40.217   Where is other information on the role of STTs and BATs
found in this regulation?](#49:1.0.1.1.27.10.22.4)

[**Subpart K - Testing Sites, Forms, Equipment and Supplies Used in
Alcohol Testing**](#49:1.0.1.1.27.11)

[§ 40.221   Where does an alcohol test take
place?](#49:1.0.1.1.27.11.22.1)\
[§ 40.223   What steps must be taken to protect the security of alcohol
testing sites?](#49:1.0.1.1.27.11.22.2)\
[§ 40.225   What form is used for an alcohol
test?](#49:1.0.1.1.27.11.22.3)\
[§ 40.227   May employers use the ATF for non-DOT tests, or non-DOT
forms for DOT tests?](#49:1.0.1.1.27.11.22.4)\
[§ 40.229   What devices are used to conduct alcohol screening
tests?](#49:1.0.1.1.27.11.22.5)\
[§ 40.231   What devices are used to conduct alcohol confirmation
tests?](#49:1.0.1.1.27.11.22.6)\
[§ 40.233   What are the requirements for proper use and care of
EBTs?](#49:1.0.1.1.27.11.22.7)\
[§ 40.235   What are the requirements for proper use and care of
ASDs?](#49:1.0.1.1.27.11.22.8)

[**Subpart L - Alcohol Screening Tests**](#49:1.0.1.1.27.12)

[§ 40.241   What are the first steps in any alcohol screening
test?](#49:1.0.1.1.27.12.22.1)\
[§ 40.243   What is the procedure for an alcohol screening test using an
EBT or non-evidential breath ASD?](#49:1.0.1.1.27.12.22.2)\
[§ 40.245   What is the procedure for an alcohol screening test using a
saliva ASD or a breath tube ASD?](#49:1.0.1.1.27.12.22.3)\
[§ 40.247   What procedures does the BAT or STT follow after a screening
test result?](#49:1.0.1.1.27.12.22.4)

[**Subpart M - Alcohol Confirmation Tests**](#49:1.0.1.1.27.13)

[§ 40.251   What are the first steps in an alcohol confirmation
test?](#49:1.0.1.1.27.13.22.1)\
[§ 40.253   What are the procedures for conducting an alcohol
confirmation test?](#49:1.0.1.1.27.13.22.2)\
[§ 40.255   What happens next after the alcohol confirmation test
result?](#49:1.0.1.1.27.13.22.3)

[**Subpart N - Problems in Alcohol Testing**](#49:1.0.1.1.27.14)

[§ 40.261   What is a refusal to take an alcohol test, and what are the
consequences?](#49:1.0.1.1.27.14.22.1)\
[§ 40.263   What happens when an employee is unable to provide a
sufficient amount of saliva for an alcohol screening
test?](#49:1.0.1.1.27.14.22.2)\
[§ 40.265   What happens when an employee is unable to provide a
sufficient amount of breath for an alcohol
test?](#49:1.0.1.1.27.14.22.3)\
[§ 40.267   What problems always cause an alcohol test to be
cancelled?](#49:1.0.1.1.27.14.22.4)\
[§ 40.269   What problems cause an alcohol test to be cancelled unless
they are corrected?](#49:1.0.1.1.27.14.22.5)\
[§ 40.271   How are alcohol testing problems
corrected?](#49:1.0.1.1.27.14.22.6)\
[§ 40.273   What is the effect of a cancelled alcohol
test?](#49:1.0.1.1.27.14.22.7)\
[§ 40.275   What is the effect of procedural problems that are not
sufficient to cancel an alcohol test?](#49:1.0.1.1.27.14.22.8)\
[§ 40.277   Are alcohol tests other than saliva or breath permitted
under these regulations?](#49:1.0.1.1.27.14.22.9)

[**Subpart O - Substance Abuse Professionals and the Return-to-Duty
Process**](#49:1.0.1.1.27.15)

[§ 40.281   Who is qualified to act as a SAP?](#49:1.0.1.1.27.15.22.1)\
[§ 40.283   How does a certification organization obtain recognition for
its members as SAPs?](#49:1.0.1.1.27.15.22.2)\
[§ 40.285   When is a SAP evaluation required?](#49:1.0.1.1.27.15.22.3)\
[§ 40.287   What information is an employer required to provide
concerning SAP services to an employee who has a DOT drug and alcohol
regulation violation?](#49:1.0.1.1.27.15.22.4)\
[§ 40.289   Are employers required to provide SAP and treatment services
to employees?](#49:1.0.1.1.27.15.22.5)\
[§ 40.291   What is the role of the SAP in the evaluation, referral, and
treatment process of an employee who has violated DOT agency drug and
alcohol testing regulations?](#49:1.0.1.1.27.15.22.6)\
[§ 40.293   What is the SAP\'s function in conducting the initial
evaluation of an employee?](#49:1.0.1.1.27.15.22.7)\
[§ 40.295   May employees or employers seek a second SAP evaluation if
they disagree with the first SAP\'s
recommendations?](#49:1.0.1.1.27.15.22.8)\
[§ 40.297   Does anyone have the authority to change a SAP\'s initial
evaluation?](#49:1.0.1.1.27.15.22.9)\
[§ 40.299   What is the SAP\'s role and what are the limits on a SAP\'s
discretion in referring employees for education and
treatment?](#49:1.0.1.1.27.15.22.10)\
[§ 40.301   What is the SAP\'s function in the follow-up evaluation of
an employee?](#49:1.0.1.1.27.15.22.11)\
[§ 40.303   What happens if the SAP believes the employee needs
additional treatment, aftercare, or support group services even after
the employee returns to safety-sensitive
duties?](#49:1.0.1.1.27.15.22.12)\
[§ 40.305   How does the return-to-duty process
conclude?](#49:1.0.1.1.27.15.22.13)\
[§ 40.307   What is the SAP\'s function in prescribing the employee\'s
follow-up tests?](#49:1.0.1.1.27.15.22.14)\
[§ 40.309   What are the employer\'s responsibilities with respect to
the SAP\'s directions for follow-up tests?](#49:1.0.1.1.27.15.22.15)\
[§ 40.311   What are the requirements concerning SAP
reports?](#49:1.0.1.1.27.15.22.16)\
[§ 40.313   Where is other information on SAP functions and the
return-to-duty process found in this
regulation?](#49:1.0.1.1.27.15.22.17)

[**Subpart P - Confidentiality and Release of
Information**](#49:1.0.1.1.27.16)

[§ 40.321   What is the general confidentiality rule for drug and
alcohol test information?](#49:1.0.1.1.27.16.22.1)\
[§ 40.323   May program participants release drug or alcohol test
information in connection with legal
proceedings?](#49:1.0.1.1.27.16.22.2)\
[§ 40.325   \[Reserved\]](#49:1.0.1.1.27.16.22.3)\
[§ 40.327   When must the MRO report medical information gathered in the
verification process?](#49:1.0.1.1.27.16.22.4)\
[§ 40.329   What information must laboratories, MROs, and other service
agents release to employees?](#49:1.0.1.1.27.16.22.5)\
[§ 40.331   To what additional parties must employers and service agents
release information?](#49:1.0.1.1.27.16.22.6)\
[§ 40.333   What records must employers keep?](#49:1.0.1.1.27.16.22.7)

[**Subpart Q - Roles and Responsibilities of Service
Agents**](#49:1.0.1.1.27.17)

[§ 40.341   Must service agents comply with DOT drug and alcohol testing
requirements?](#49:1.0.1.1.27.17.22.1)\
[§ 40.343   What tasks may a service agent perform for an
employer?](#49:1.0.1.1.27.17.22.2)\
[§ 40.345   In what circumstances may a C/TPA act as an intermediary in
the transmission of drug and alcohol testing information to
employers?](#49:1.0.1.1.27.17.22.3)\
[§ 40.347   What functions may C/TPAs perform with respect to
administering testing?](#49:1.0.1.1.27.17.22.4)\
[§ 40.349   What records may a service agent receive and
maintain?](#49:1.0.1.1.27.17.22.5)\
[§ 40.351   What confidentiality requirements apply to service
agents?](#49:1.0.1.1.27.17.22.6)\
[§ 40.353   What principles govern the interaction between MROs and
other service agents?](#49:1.0.1.1.27.17.22.7)\
[§ 40.355   What limitations apply to the activities of service
agents?](#49:1.0.1.1.27.17.22.8)

[**Subpart R - Public Interest Exclusions**](#49:1.0.1.1.27.18)

[§ 40.361   What is the purpose of a public interest exclusion
(PIE)?](#49:1.0.1.1.27.18.22.1)\
[§ 40.363   On what basis may the Department issue a
PIE?](#49:1.0.1.1.27.18.22.2)\
[§ 40.365   What is the Department\'s policy concerning starting a PIE
proceeding?](#49:1.0.1.1.27.18.22.3)\
[§ 40.367   Who initiates a PIE proceeding?](#49:1.0.1.1.27.18.22.4)\
[§ 40.369   What is the discretion of an initiating official in starting
a PIE proceeding?](#49:1.0.1.1.27.18.22.5)\
[§ 40.371   On what information does an initiating official rely in
deciding whether to start a PIE proceeding?](#49:1.0.1.1.27.18.22.6)\
[§ 40.373   Before starting a PIE proceeding, does the initiating
official give the service agent an opportunity to correct
problems?](#49:1.0.1.1.27.18.22.7)\
[§ 40.375   How does the initiating official start a PIE
proceeding?](#49:1.0.1.1.27.18.22.8)\
[§ 40.377   Who decides whether to issue a
PIE?](#49:1.0.1.1.27.18.22.9)\
[§ 40.379   How do you contest the issuance of a
PIE?](#49:1.0.1.1.27.18.22.10)\
[§ 40.381   What information do you present to contest the proposed
issuance of a PIE?](#49:1.0.1.1.27.18.22.11)\
[§ 40.383   What procedures apply if you contest the issuance of a
PIE?](#49:1.0.1.1.27.18.22.12)\
[§ 40.385   Who bears the burden of proof in a PIE
proceeding?](#49:1.0.1.1.27.18.22.13)\
[§ 40.387   What matters does the Director decide concerning a proposed
PIE?](#49:1.0.1.1.27.18.22.14)\
[§ 40.389   What factors may the Director
consider?](#49:1.0.1.1.27.18.22.15)\
[§ 40.391   What is the scope of a PIE?](#49:1.0.1.1.27.18.22.16)\
[§ 40.393   How long does a PIE stay in
effect?](#49:1.0.1.1.27.18.22.17)\
[§ 40.395   Can you settle a PIE proceeding?](#49:1.0.1.1.27.18.22.18)\
[§ 40.397   When does the Director make a PIE
decision?](#49:1.0.1.1.27.18.22.19)\
[§ 40.399   How does the Department notify service agents of its
decision?](#49:1.0.1.1.27.18.22.20)\
[§ 40.401   How does the Department notify employers and the public
about a PIE?](#49:1.0.1.1.27.18.22.21)\
[§ 40.403   Must a service agent notify its clients when the Department
issues a PIE?](#49:1.0.1.1.27.18.22.22)\
[§ 40.405   May the Federal courts review PIE
decisions?](#49:1.0.1.1.27.18.22.23)\
[§ 40.407   May a service agent ask to have a PIE reduced or
terminated?](#49:1.0.1.1.27.18.22.24)\
[§ 40.409   What does the issuance of a PIE mean to transportation
employers?](#49:1.0.1.1.27.18.22.25)\
[§ 40.411   What is the role of the DOT Inspector General\'s
office?](#49:1.0.1.1.27.18.22.26)\
[§ 40.413   How are notices sent to service
agents?](#49:1.0.1.1.27.18.22.27)

[Appendix A to Part 40---DOT Standards for Urine Collection
Kits](#49:1.0.1.1.27.18.22.28.28)\
[Appendix B to Part 40---DOT Drug Testing Semi-Annual Laboratory
Report](#49:1.0.1.1.27.18.22.28.29)\
[Appendix C to Part 40 \[Reserved\]](#49:1.0.1.1.27.18.22.28.30)\
[Appendix D to Part 40---Report Format: Split Specimen Failure to
Reconfirm](#49:1.0.1.1.27.18.22.28.31)\
[Appendix E to Part 40---SAP Equivalency Requirements for Certification
Organizations](#49:1.0.1.1.27.18.22.28.32)\
[Appendix F to Part 40---Drug and Alcohol Testing Information that
C/TPAs May Transmit to Employers](#49:1.0.1.1.27.18.22.28.33)\
[Appendix G to Part 40---Alcohol Testing
Form](#49:1.0.1.1.27.18.22.28.34)\
[Appendix H to Part 40---DOT Drug and Alcohol Testing Management
Information System (MIS) Data Collection
Form](#49:1.0.1.1.27.18.22.28.35)

**Authority:   49 U.S.C. 102, 301, 322, 5331, 20140, 31306, and 45101 et
seq.**

**Source:   65 FR 79526, Dec. 19, 2000, unless otherwise noted.**

**Subpart A - Administrative Provisions**

**§ 40.1   Who does this regulation cover**?

\(a\) This part tells all parties who conduct drug and alcohol tests
required by Department of Transportation (DOT) agency regulations how to
conduct these tests and what procedures to use.

\(b\) This part concerns the activities of transportation employers,
safety-sensitive transportation employees (including self-employed
individuals, contractors and volunteers as covered by DOT agency
regulations), and service agents.

\(c\) Nothing in this part is intended to supersede or conflict with the
implementation of the Federal Railroad Administration\'s post-accident
testing program (see 49 CFR 219.200).

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

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

[Adulterated specimen]{.underline}. A specimen that contains a substance
that is not expected to be present in human urine, or contains a
substance expected to be present but is at a concentration so high that
it is not consistent with human urine.

[Affiliate]{.underline}. Persons are affiliates of one another if,
directly or indirectly, one controls or has the power to control the
other, or a third party controls or has the power to control both.
Indicators of control include, but are not limited to: interlocking
management or ownership; shared interest among family members; shared
facilities or equipment; or common use of employees. Following the
issuance of a public interest exclusion, an organization having the same
or similar management, ownership, or principal employees as the service
agent concerning whom a public interest exclusion is in effect is
regarded as an affiliate. This definition is used in connection with the
public interest exclusion procedures of Subpart R of this part.

[Air blank]{.underline}. In evidential breath testing devices (EBTs)
using gas chromatography technology, a reading of the device\'s internal
standard. In all other EBTs, a reading of ambient air containing no
alcohol.

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

[Alcohol concentration.]{.underline} The alcohol in a volume of breath
expressed in terms of grams of alcohol per 210 liters of breath as
indicated by a breath test under this part.

[Alcohol confirmation test]{.underline}. A subsequent test using an EBT,
following a screening test with a result of 0.02 or greater, that
provides quantitative data about the alcohol concentration.

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

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

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

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

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

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

[Cancelled test]{.underline}. A drug or alcohol test that has a problem
identified that cannot be or has not been corrected, or which this part
otherwise requires to be cancelled. A cancelled test is neither a
positive nor a negative test.

[Chain of custody]{.underline}. The procedure used to document the
handling of the urine specimen from the time the employee gives the
specimen to the collector until the specimen is destroyed. This
procedure uses the Federal Drug Testing Custody and Control Form (CCF).

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

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

[Collector]{.underline}. A person who instructs and assists employees at
a collection site, who receives and makes an initial inspection of the
specimen provided by those employees, and who initiates and completes
the CCF.

[Confirmation (or confirmatory) drug test.]{.underline} A second
analytical procedure performed on a urine specimen to identify and
quantify the presence of a specific drug or drug metabolite.

[Confirmation (or confirmatory) validity test]{.underline}. A second
test performed on a urine specimen to further support a validity test
result.

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

[Consortium/Third-party administrator (C/TPA).]{.underline} A service
agent that provides or coordinates the provision of a variety of drug
and alcohol testing services to employers. C/TPAs typically perform
administrative tasks concerning the operation of the employers\' drug
and alcohol testing programs. This term includes, but is not limited to,
groups of employers who join together to administer, as a single entity,
the DOT drug and alcohol testing programs of its members. C/TPAs are not
"employers" for purposes of this part.

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

[Designated employer representative (DER]{.underline}). An employee
authorized by the employer to take immediate action(s) to remove
employees from safety-sensitive duties, or cause employees to be removed
from these covered duties, and to make required decisions in the testing
and evaluation processes. The DER also receives test results and other
communications for the employer, consistent with the requirements of
this part. Service agents cannot act as DERs.

[Dilute specimen.]{.underline} A specimen with creatinine and specific
gravity values that are lower than expected for human urine.

[DOT, The Department, DOT agency]{.underline}. These terms encompass all
DOT agencies, including, but not limited to, the United States Coast
Guard (USCG), the Federal Aviation Administration (FAA), the Federal
Railroad Administration (FRA), the Federal Motor Carrier Safety
Administration (FMCSA), the Federal Transit Administration (FTA), the
National Highway Traffic Safety Administration (NHTSA), the Research and
Special Programs Administration (RSPA), and the Office of the Secretary
(OST). These terms include any designee of a DOT agency.

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

[Employee]{.underline}. Any person who is designated in a DOT agency
regulation as subject to drug testing and/or alcohol testing. The term
includes individuals currently performing safety-sensitive functions
designated in DOT agency regulations and applicants for employment
subject to pre-employment testing. For purposes of drug testing under
this part, the term employee has the same meaning as the term "donor" as
found on CCF and related guidance materials produced by the Department
of Health and Human Services.

[Employer]{.underline}. A person or entity employing one or more
employees (including an individual who is self-employed) subject to DOT
agency regulations requiring compliance with this part. The term
includes an employer\'s officers, representatives, and management
personnel. Service agents are not employers for the purposes of this
part.

[Error Correction Training]{.underline}. Training provided to BATs,
collectors, and screening test technicians (STTs) following an error
that resulted in the cancellation of a drug or alcohol test. Error
correction training must be provided in person or by a means that
provides real-time observation and interaction between the instructor
and trainee.

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

[HHS.]{.underline} The Department of Health and Human Services or any
designee of the Secretary, Department of Health and Human Services.

[Initial drug test]{.underline}. The test used to differentiate a
negative specimen from one that requires further testing for drugs or
drug metabolites.

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

[Invalid drug test]{.underline}. The result of a drug test for a urine
specimen that contains an unidentified adulterant or an unidentified
interfering substance, has abnormal physical characteristics, or has an
endogenous substance at an abnormal concentration that prevents the
laboratory from completing or obtaining a valid drug test result.

[Laboratory.]{.underline} Any U.S. laboratory certified by HHS under the
National Laboratory Certification Program as meeting the minimum
standards of Subpart C of the HHS Mandatory Guidelines for Federal
Workplace Drug Testing Programs; or, in the case of foreign
laboratories, a laboratory approved for participation by DOT under this
part. (The HHS Mandatory Guidelines for Federal Workplace Drug Testing
Programs are available on the internet at
http://www.health.org/workpl.htm or from the Division of Workplace
Programs, 5600 Fishers Lane, Rockwall II Building, Suite 815, Rockville,
MD 20857.)

[Medical Review Officer (MRO).]{.underline} A person who is a licensed
physician and who is responsible for receiving and reviewing laboratory
results generated by an employer\'s drug testing program and evaluating
medical explanations for certain drug test results.

[Office of Drug and Alcohol Policy and Compliance (ODAPC]{.underline}).
The office in the Office of the Secretary, DOT, that is responsible for
coordinating drug and alcohol testing program matters within the
Department and providing information concerning the implementation of
this part.

[Primary specimen]{.underline}. In drug testing, the urine specimen
bottle that is opened and tested by a first laboratory to determine
whether the employee has a drug or drug metabolite in his or her system;
and for the purpose of validity testing. The primary specimen is
distinguished from the split specimen, defined in this section.

[Qualification Training.]{.underline} The training required in order for
a collector, BAT, MRO, SAP, or STT to be qualified to perform their
functions in the DOT drug and alcohol testing program. Qualification
training may be provided by any appropriate means (e.g., classroom
instruction, internet application, CD--ROM, video).

[Refresher Training]{.underline}. The training required periodically for
qualified collectors, BATs, and STTs to review basic requirements and
provide instruction concerning changes in technology (e.g., new testing
methods that may be authorized) and amendments, interpretations,
guidance, and issues concerning this part and DOT agency drug and
alcohol testing regulations. Refresher training can be provided by any
appropriate means (e.g., classroom instruction, internet application,
CD--ROM, video).

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

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

[Service agent]{.underline}. Any person or entity, other than an
employee of the employer, who provides services specified under this
part to employers and/or employees in connection with DOT drug and
alcohol testing requirements. This includes, but is not limited to,
collectors, BATs and STTs, laboratories, MROs, substance abuse
professionals, and C/TPAs. To act as service agents, persons and
organizations must meet the qualifications set forth in applicable
sections of this part. Service agents are not employers for purposes of
this part.

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

[Specimen bottle]{.underline}. The bottle that, after being sealed and
labeled according to the procedures in this part, is used to hold the
urine specimen during transportation to the laboratory.

[Split specimen]{.underline}. In drug testing, a part of the urine
specimen that is sent to a first laboratory and retained unopened, and
which is transported to a second laboratory in the event that the
employee requests that it be tested following a verified positive test
of the primary specimen or a verified adulterated or substituted test
result.

[Stand-down]{.underline}. The practice of temporarily removing an
employee from the performance of safety-sensitive functions based only
on a report from a laboratory to the MRO of a confirmed positive test
for a drug or drug metabolite, an adulterated test, or a substituted
test, before the MRO has completed verification of the test result.

[Substance Abuse Professional (SAP]{.underline}). A person who evaluates
employees who have violated a DOT drug and alcohol regulation and makes
recommendations concerning education, treatment, follow-up testing, and
aftercare.

[Substituted specimen]{.underline}. A specimen with creatinine and
specific gravity values that are so diminished that they are not
consistent with human urine.

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

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

**§ 40.5   Who issues authoritative interpretations of this
regulation?**

ODAPC and the DOT Office of General Counsel (OGC) provide written
interpretations of the provisions of this part. These written DOT
interpretations are the only official and authoritative interpretations
concerning the provisions of this part. DOT agencies may incorporate
ODAPC/OGC interpretations in written guidance they issue concerning drug
and alcohol testing matters. Only Part 40 interpretations issued after
August 1, 2001, are considered valid.

**§ 40.7   How can you get an exemption from a requirement in this
regulation?**

\(a\) If you want an exemption from any provision of this part, you must
request it in writing from the Office of the Secretary of
Transportation, under the provisions and standards of 49 CFR part 5. You
must send requests for an exemption to the following address: Department
of Transportation, Deputy Assistant General Counsel for Regulation and
Enforcement, 400 7th Street, SW., Room 10424, Washington, DC 20590.

\(b\) Under the standards of 49 CFR part 5, we will grant the request
only if the request documents special or exceptional circumstances, not
likely to be generally applicable and not contemplated in connection
with the rulemaking that established this part, that make your
compliance with a specific provision of this part impracticable.

\(c\) If we grant you an exemption, you must agree to take steps we
specify to comply with the intent of the provision from which an
exemption is granted.

\(d\) We will issue written responses to all exemption requests.

**Subpart B - Employer Responsibilities**

**§ 40.11   What are the general responsibilities of employers under
this regulation?**

\(a\) As an employer, you are responsible for meeting all applicable
requirements and procedures of this part.

\(b\) You are responsible for all actions of your officials,
representatives, and agents (including service agents) in carrying out
the requirements of the DOT agency regulations.

\(c\) All agreements and arrangements, written or unwritten, between and
among employers and service agents concerning the implementation of DOT
drug and alcohol testing requirements are deemed, as a matter of law, to
require compliance with all applicable provisions of this part and DOT
agency drug and alcohol testing regulations. Compliance with these
provisions is a material term of all such agreements and arrangements.

**§ 40.13   How do DOT drug and alcohol tests relate 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 must discard any excess
urine left over from a DOT test and collect a separate void for the
subsequent non-DOT test.

\(c\) Except as provided in paragraph (d) of this section, you must not
perform any tests on DOT urine or breath specimens other than those
specifically authorized by this part or DOT agency regulations. For
example, you may not test a DOT urine specimen for additional drugs, and
a laboratory is prohibited from making a DOT urine specimen available
for a DNA test or other types of specimen identity testing.

\(d\) The single exception to paragraph (c) of this section is when a
DOT drug test collection is conducted as part of a physical examination
required by DOT agency regulations. It is permissible to conduct
required medical tests related to this physical examination (e.g., for
glucose) on any urine remaining in the collection container after the
drug test urine specimens have been sealed into the specimen bottles.

\(e\) No one is permitted to change or disregard the results of DOT
tests based on the results of non-DOT tests. For example, as an employer
you must not disregard a verified positive DOT drug test result because
the employee presents a negative test result from a blood or urine
specimen collected by the employee\'s physician or a DNA test result
purporting to question the identity of the DOT specimen.

\(f\) As an employer, you must not use the CCF or the ATF in your
non-DOT drug and alcohol testing programs. This prohibition includes the
use of the DOT forms with references to DOT programs and agencies
crossed out. You also must always use the CCF and ATF for all your
DOT-mandated drug and alcohol tests.

**§ 40.15   May an employer use a service agent to meet DOT drug and
alcohol testing requirements?**

\(a\) As an employer, you may use a service agent to perform the tasks
needed to comply with this part and DOT agency drug and alcohol testing
regulations, consistent with the requirements of Subpart Q and other
applicable provisions of this part.

\(b\) As an employer, you are responsible for ensuring that the service
agents you use meet the qualifications set forth in this part (e.g.,
§40.121 for MROs). You may require service agents to show you
documentation that they meet the requirements of this part (e.g.,
documentation of MRO qualifications required by §40.121(e)).

\(c\) You remain responsible for compliance with all applicable
requirements of this part and other DOT drug and alcohol testing
regulations, even when you use a service agent. If you violate this part
or other DOT drug and alcohol testing regulations because a service
agent has not provided services as our rules require, a DOT agency can
subject you to sanctions. Your good faith use of a service agent is not
a defense in an enforcement action initiated by a DOT agency in which
your alleged noncompliance with this part or a DOT agency drug and
alcohol regulation may have resulted from the service agent\'s conduct.

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

**§ 40.17   Is an employer responsible for obtaining information from
its service agents?**

Yes, as an employer, you are responsible for obtaining information
required by this part from your service agents. This is true whether or
not you choose to use a C/TPA as an intermediary in transmitting
information to you. For example, suppose an applicant for a
safety-sensitive job takes a pre-employment drug test, but there is a
significant delay in your receipt of the test result from an MRO or
C/TPA. You must not assume that "no news is good news" and permit the
applicant to perform safety-sensitive duties before receiving the
result. This is a violation of the Department\'s regulations.

**§ 40.19   \[Reserved\]**

**§ 40.21   May an employer stand down an employee before the MRO has
completed the verification process?**

\(a\) As an employer, you are prohibited from standing employees down,
except consistent with a waiver a DOT agency grants under this section.

\(b\) You may make a request to the concerned DOT agency for a waiver
from the prohibition of paragraph (a) of this section. Such a waiver, if
granted, permits you to stand an employee down following the MRO\'s
receipt of a laboratory report of a confirmed positive test for a drug
or drug metabolite, an adulterated test, or a substituted test
pertaining to the employee.

\(1\) For this purpose, the concerned DOT agency is the one whose drug
and alcohol testing rules apply to the majority of the covered employees
in your organization. The concerned DOT agency uses its applicable
procedures for considering requests for waivers.

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

\(3\) The concerned DOT agency provides a written response to each
employer that petitions for a waiver, setting forth the reasons for the
agency\'s decision on the waiver request.

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

\(1\) Information about your organization:

\(i\) Your determination that standing employees down is necessary for
safety in your organization and a statement of your basis for it,
including any data on safety problems or incidents that could have been
prevented if a stand-down procedure had been in place;

\(ii\) Data showing the number of confirmed laboratory positive,
adulterated, and substituted test results for your employees over the
two calendar years preceding your waiver request, and the number and
percentage of those test results that were verified positive,
adulterated, or substituted by the MRO;

\(iii\) Information about the work situation of the employees subject to
stand-down, including a description of the size and organization of the
unit(s) in which the employees work, the process through which employees
will be informed of the stand-down, whether there is an in-house MRO,
and whether your organization has a medical disqualification or
stand-down policy for employees in situations other than drug and
alcohol testing; and

\(iv\) A statement of which DOT agencies regulate your employees.

\(2\) Your proposed written company policy concerning stand-down, which
must include the following elements:

\(i\) Your assurance that you will distribute copies of your written
policy to all employees that it covers;

\(ii\) Your means of ensuring that no information about the confirmed
positive, adulterated, or substituted test result or the reason for the
employee\'s temporary removal from performance of safety-sensitive
functions becomes available, directly or indirectly, to anyone in your
organization (or subsequently to another employer) other than the
employee, the MRO and the DER;

\(iii\) Your means of ensuring that all covered employees in a
particular job category in your organization are treated the same way
with respect to stand-down;

\(iv\) Your means of ensuring that a covered employee will be subject to
stand-down only with respect to the actual performance of
safety-sensitive duties;

\(v\) Your means of ensuring that you will not take any action adversely
affecting the employee\'s pay and benefits pending the completion of the
MRO\'s verification process. This includes continuing to pay the
employee during the period of the stand-down in the same way you would
have paid him or her had he or she not been stood down;

\(vi\) Your means of ensuring that the verification process will
commence no later than the time an employee is temporarily removed from
the performance of safety-sensitive functions and that the period of
stand-down for any employee will not exceed five days, unless you are
informed in writing by the MRO that a longer period is needed to
complete the verification process; and

\(vii\) Your means of ensuring that, in the event that the MRO verifies
the test negative or cancels it---

\(A\) You return the employee immediately to the performance of
safety-sensitive duties;

\(B\) The employee suffers no adverse personnel or financial
consequences as a result; and

\(C\) You maintain no individually identifiable record that the employee
had a confirmed laboratory positive, adulterated, or substituted test
result (i.e., you maintain a record of the test only as a negative or
cancelled test).

\(d\) The Administrator of the concerned DOT agency, or his or her
designee, may grant a waiver request only if he or she determines that,
in the context of your organization, there is a high probability that
the procedures you propose will effectively enhance safety and protect
the interests of employees in fairness and confidentiality.

\(1\) The Administrator, or his or her designee, may impose any
conditions he or she deems appropriate on the grant of a waiver.

\(2\) The Administrator, or his or her designee, may immediately suspend
or revoke the waiver if he or she determines that you have failed to
protect effectively the interests of employees in fairness and
confidentiality, that you have failed to comply with the requirements of
this section, or that you have failed to comply with any other
conditions the DOT agency has attached to the waiver.

\(e\) You must not stand employees down in the absence of a waiver, or
inconsistent with the terms of your waiver. If you do, you are in
violation of this part and DOT agency drug testing regulations, and you
are subject to enforcement action by the DOT agency just as you are for
other violations of this part and DOT agency rules.

**§ 40.23   What actions do employers take after receiving verified test
results?**

a\) As an employer who receives a verified positive drug test result,
you must immediately remove the employee involved from performing
safety-sensitive functions. You must take this action upon receiving the
initial report of the verified positive test result. Do not wait to
receive the written report or the result of a split specimen test.

\(b\) As an employer who receives a verified adulterated or substituted
drug test result, you must consider this a refusal to test and
immediately remove the employee involved from performing
safety-sensitive functions. You must take this action on receiving the
initial report of the verified adulterated or substituted test result.
Do not wait to receive the written report or the result of a split
specimen test.

\(c\) As an employer who receives an alcohol test result of 0.04 or
higher, you must immediately remove the employee involved from
performing safety-sensitive functions. If you receive an alcohol test
result of 0.02---0.39, you must temporarily remove the employee involved
from performing safety-sensitive functions, as provided in applicable
DOT agency regulations. Do not wait to receive the written report of the
result of the test.

\(d\) As an employer, when an employee has a verified positive,
adulterated, or substituted test result, or has otherwise violated a DOT
agency drug and alcohol regulation, you must not return the employee to
the performance of safety-sensitive functions until or unless the
employee successfully completes the return-to-duty process of Subpart O
of this part.

\(e\) As an employer who receives a drug test result indicating that the
employee\'s specimen was dilute, take action as provided in §40.197.

\(f\) As an employer who receives a drug test result indicating that the
employee\'s specimen was invalid and that a second collection must take
place under direct observation---

\(1\) You must immediately direct the employee to provide a new specimen
under direct observation.

\(2\) You must not attach consequences to the finding that the test was
invalid other than collecting a new specimen under direct observation.

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

\(4\) You must instruct the collector to note on the CCF the same reason
(e.g. random test, post-accident test) as for the original collection.

\(g\) As an employer who receives a cancelled test result when a
negative result is required (e.g., pre-employment, return-to-duty, or
follow-up test), you must direct the employee to provide another
specimen immediately.

\(h\) As an employer, you may also be required to take additional
actions required by DOT agency regulations (e.g., FAA rules require some
positive drug tests to be reported to the Federal Air Surgeon).

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

**§ 40.25   Must an employer check on the drug and alcohol testing
record of employees it is intending to use to perform safety-sensitive
duties?**

\(a\) Yes, as an employer, you must, after obtaining an employee\'s
written consent, request the information about the employee listed in
paragraph (b) of this section. This requirement applies only to
employees seeking to begin performing safety-sensitive duties for you
for the first time (i.e., a new hire, an employee transfers into a
safety-sensitive position). If the employee refuses to provide this
written consent, you must not permit the employee to perform
safety-sensitive functions.

\(b\) You must request the information listed in this paragraph (b) from
DOT-regulated employers who have employed the employee during any period
during the two years before the date of the employee\'s application or
transfer:

\(1\) Alcohol tests with a result of 0.04 or higher alcohol
concentration;

\(2\) Verified positive drug tests;

\(3\) Refusals to be tested (including verified adulterated or
substituted drug test results);

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

\(5\) With respect to any employee who violated a DOT drug and alcohol
regulation, documentation of the employee\'s successful completion of
DOT return-to-duty requirements (including follow-up tests). If the
previous employer does not have information about the return-do-duty
process (e.g., an employer who did not hire an employee who tested
positive on a pre-employment test), you must seek to obtain this
information from the employee.

\(c\) The information obtained from a previous employer includes any
drug or alcohol test information obtained from previous employers under
this section or other applicable DOT agency regulations.

\(d\) If feasible, you must obtain and review this information before
the employee first performs safety-sensitive functions. If this is not
feasible, you must obtain and review the information as soon as
possible. However, you must not permit the employee to perform
safety-sensitive functions after 30 days from the date on which the
employee first performed safety-sensitive functions, unless you have
obtained or made and documented a good faith effort to obtain this
information.

\(e\) If you obtain information that the employee has violated a DOT
agency drug and alcohol regulation, you must not use the employee to
perform safety-sensitive functions unless you also obtain information
that the employee has subsequently complied with the return-to-duty
requirements of Subpart O of this part and DOT agency drug and alcohol
regulations.

\(f\) You must provide to each of the employers from whom you request
information under paragraph (b) of this section written consent for the
release of the information cited in paragraph (a) of this section.

\(g\) The release of information under this section must be in any
written form (e.g., fax, e-mail, letter) that ensures confidentiality.
As the previous employer, you must maintain a written record of the
information released, including the date, the party to whom it was
released, and a summary of the information provided.

\(h\) If you are an employer from whom information is requested under
paragraph (b) of this section, you must, after reviewing the employee\'s
specific, written consent, immediately release the requested information
to the employer making the inquiry.

\(i\) As the employer requesting the information required under this
section, you must maintain a written, confidential record of the
information you obtain or of the good faith efforts you made to obtain
the information. You must retain this information for three years from
the date of the employee\'s first performance of safety-sensitive duties
for you.

\(j\) As the employer, you must also ask the employee whether he or she
has tested positive, or refused to test, on any pre-employment drug or
alcohol test administered by an employer to which the employee applied
for, but did not obtain, safety-sensitive transportation work covered by
DOT agency drug and alcohol testing rules during the past two years. If
the employee admits that he or she had a positive test or a refusal to
test, you must not use the employee to perform safety-sensitive
functions for you, until and unless the employee documents successful
completion of the return-to-duty process (see paragraphs (b)(5) and (e)
of this section).

**§ 40.26   What form must an employer use to report Management
Information System (MIS) data to a DOT agency?**

As an employer, when you are required to report MIS data to a DOT
agency, you must use the form and instructions at appendix H to part 40.
You must submit the MIS report in accordance with rule requirements
(e.g., dates for submission; selection of companies required to submit,
and method of reporting) established by the DOT agency regulating your
operation.

\[68 FR 43952, July 25, 2003\]

**§ 40.27   May an employer require an employee to sign a consent or
release in connection with the DOT drug and alcohol testing program?**

No, as an employer, you must not require an employee to sign a consent,
release, waiver of liability, or indemnification agreement with respect
to any part of the drug or alcohol testing process covered by this part
(including, but not limited to, collections, laboratory testing, MRO and
SAP services).

\[66 FR 41950, Aug. 9, 2001\]

**§ 40.29   Where is other information on employer responsibilities
found in this regulation?**

You can find other information on the responsibilities of employers in
the following sections 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-DOT tests.
>
> §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 and
> STTs.
>
> §40.225---Modifying ATFs; use of foreign-language ATFs.
>
> §40.227---Use of non-DOT forms for DOT tests or DOT ATFs for non-DOT
> tests.
>
> §40.235 (c) and (d)---responsibility to follow instructions for ASDs.
>
> §40.255 (b)---receipt and storage of alcohol test information.
>
> §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 SAP services.
>
> §§40.295--40.297---Prohibition on seeking second SAP evaluation or
> changing SAP recommendation.
>
> §40.303---Responsibilities concerning aftercare recommendations.
>
> §40.305---Responsibilities concerning return-to-duty decision.
>
> §40.309---Responsibilities concerning follow-up tests.
>
> §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.
>
> \[65 FR 79526, Dec. 19, 2000. Redesignated at 66 FR 41950, Aug. 9,
> 2001\]

**Subpart C - Urine Collection Personnel**

**§ 40.31   Who may collect urine specimens for DOT drug testing?**

\(a\) Collectors meeting the requirements of this subpart are the only
persons authorized to collect urine specimens for DOT drug testing.

\(b\) A collector must meet training requirements of §40.33.

\(c\) As the immediate supervisor of an employee being tested, you may
not act as the collector when that employee is tested, unless no other
collector is available and you are permitted to do so under DOT agency
drug and alcohol regulations.

\(d\) You must not act as the collector for the employee being tested if
you work for a HHS-certified laboratory (e.g., as a technician or
accessioner) and could link the employee with a urine specimen, drug
testing result, or laboratory report.

**§ 40.33   What training requirements must a collector meet?**

To be permitted to act as a collector in the DOT drug testing program,
you must meet each of the requirements of this section:

\(a\) [Basic information.]{.underline} You must be knowledgeable about
this part, the current "DOT Urine Specimen Collection Procedures
Guidelines," and DOT agency regulations applicable to the employers for
whom you perform collections, and you must keep current on any changes
to these materials. The DOT Urine Specimen Collection Procedures
Guidelines document is available from ODAPC (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).

\(b\) [Qualification training]{.underline}. You must receive
qualification training meeting the requirements of this paragraph.
Qualification training must provide instruction on the following
subjects:

\(1\) All steps necessary to complete a collection correctly and the
proper completion and transmission of the CCF;

\(2\) "Problem" collections (e.g., situations like "shy bladder" and
attempts to tamper with a specimen);

\(3\) Fatal flaws, correctable flaws, and how to correct problems in
collections; and

\(4\) The collector\'s responsibility for maintaining the integrity of
the collection process, ensuring the privacy of employees being tested,
ensuring the security of the specimen, and avoiding conduct or
statements that could be viewed as offensive or inappropriate;

\(c\) [Initial Proficiency Demonstration]{.underline}. Following your
completion of qualification training under paragraph (b) of this
section, you must demonstrate proficiency in collections under this part
by completing five consecutive error-free mock collections.

\(1\) The five mock collections must include two uneventful collection
scenarios, one insufficient quantity of urine scenario, one temperature
out of range scenario, and one scenario in which the employee refuses to
sign the CCF and initial the specimen bottle tamper-evident seal.

\(2\) Another person must monitor and evaluate your performance, in
person or by a means that provides real-time observation and interaction
between the instructor and trainee, and attest in writing that the mock
collections are "error-free." This person must be a qualified collector
who has demonstrated necessary knowledge, skills, and abilities by---

i\) Regularly conducting DOT drug test collections for a period of at
least a year;

\(ii\) Conducting collector training under this part for a year; or

\(iii\) Successfully completing a "train the trainer" course.

\(d\) [Schedule for qualification training and initial proficiency
demonstration]{.underline}. The following is the schedule for
qualification training and the initial proficiency demonstration you
must meet:

\(1\) If you became a collector before August 1, 2001, and you have
already met the requirements of paragraphs (b) and (c) of this section,
you do not have to meet them again.

\(2\) If you became a collector before August 1, 2001, and have yet to
meet the requirements of paragraphs (b) and (c) of this section, you
must do so no later than January 31, 2003.

\(3\) If you become a collector on or after August 1, 2001, you must
meet the requirements of paragraphs (b) and (c) of this section before
you begin to perform collector functions.

\(e\) [Refresher training]{.underline}. No less frequently than every
five years from the date on which you satisfactorily complete the
requirements of paragraphs (b) and (c) of this section, you must
complete refresher training that meets all the requirements of
paragraphs (b) and (c) of this section.

\(f\) [Error Correction Training.]{.underline} If you make a mistake in
the collection process that causes a test to be cancelled (i.e., a fatal
or uncorrected flaw), you must undergo error correction training. This
training must occur within 30 days of the date you are notified of the
error that led to the need for retraining.

\(1\) Error correction training must be provided and your proficiency
documented in writing by a person who meets the requirements of
paragraph (c)(2) of this section.

\(2\) Error correction training is required to cover only the subject
matter area(s) in which the error that caused the test to be cancelled
occurred.

\(3\) As part of the error correction training, you must demonstrate
your proficiency in the collection procedures of this part by completing
three consecutive error-free mock collections. The mock collections must
include one uneventful scenario and two scenarios related to the area(s)
in which your error(s) occurred. The person providing the training must
monitor and evaluate your performance and attest in writing that the
mock collections were "error-free."

\(g\) [Documentation.]{.underline} You must maintain documentation
showing that you currently meet all requirements of this section. You
must provide this documentation on request to DOT agency representatives
and to employers and C/TPAs who are using or negotiating to use your
services.

\[65 FR 79526, Dec 19, 2000; 66 FR 3885, Jan. 17, 2001, as amended at 66
FR 41950, Aug. 9, 2001\]

**§ 40.35   What information about the DER must employers provide to
collectors?**

As an employer, you must provide to collectors the name and telephone
number of the appropriate DER (and C/TPA, where applicable) to contact
about any problems or issues that may arise during the testing process.

**§ 40.37   Where is other information on the role of collectors found
in this regulation?**

You can find other information on the role and functions of collectors
in the following sections of this part:

> §40.3---Definition.
>
> §40.43---Steps to prepare and secure collection sites.
>
> §§40.45--40.47---Use of CCF.
>
> §§40.49--40.51---Use of collection kit and shipping materials.
>
> §§40.61--40.63---Preliminary steps in collections.
>
> §40.65---Role in checking specimens.
>
> §40.67---Role in directly observed collections.
>
> §40.69---Role in monitored collections.
>
> §40.71---Role in split specimen collections.
>
> §40.73---Chain of custody completion and finishing the collection
> process.
>
> §40.103---Processing blind specimens.
>
> §40.191---Action in case of refusals to take test.
>
> §40.193---Action in "shy bladder" situations.
>
> §40.199--40.205---Collector errors in tests, effects, and means of
> correction.

**Subpart D - Collection Sites, Forms, Equipment and Supplies Used in
DOT Urine Collections**

**§ 40.41   Where does a urine collection for a DOT drug test take
place?**

\(a\) A urine collection for a DOT drug test must take place in a
collection site meeting the requirements of this section.

\(b\) If you are operating a collection site, you must ensure that it
meets the security requirements of §40.43.

\(c\) If you are operating a collection site, you must have all
necessary personnel, materials, equipment, facilities and supervision to
provide for the collection, temporary storage, and shipping of urine
specimens to a laboratory, and a suitable clean surface for writing.

\(d\) Your collection site must include a facility for urination
described in either paragraph (e) or paragraph (f) of this section.

\(e\) The first, and preferred, type of facility for urination that a
collection site may include is a single-toilet room, having a
full-length privacy door, within which urination can occur.

\(1\) No one but the employee may be present in the room during the
collection, except for the observer in the event of a directly observed
collection.

\(2\) You must have a source of water for washing hands, that, if
practicable, should be external to the closed room where urination
occurs. If an external source is not available, you may meet this
requirement by securing all sources of water and other substances that
could be used for adulteration and substitution (e.g., water faucets,
soap dispensers) and providing moist towelettes outside the closed room.

\(f\) The second type of facility for urination that a collection site
may include is a multistall restroom.

\(1\) Such a site must provide substantial visual privacy (e.g., a
toilet stall with a partial-length door) and meet all other applicable
requirements of this section.

\(2\) If you use a multi-stall restroom, you must either---

\(i\) Secure all sources of water and other substances that could be
used for adulteration and substitution (e.g., water faucets, soap
dispensers) and place bluing agent in all toilets or secure the toilets
to prevent access; or

\(ii\) Conduct all collections in the facility as monitored collections
(see §40.69 for procedures). This is the only circumstance in which you
may conduct a monitored collection.

\(3\) No one but the employee may be present in the multistall restroom
during the collection, except for the monitor in the event of a
monitored collection or the observer in the event of a directly observed
collection.

\(g\) A collection site may be in a medical facility, a mobile facility
(e.g., a van), a dedicated collection facility, or any other location
meeting the requirements of this section.

**§ 40.43   What steps must operators of collection sites take to
protect the security and integrity of urine collections?**

\(a\) Collectors and operators of collection sites must take the steps
listed in this section to prevent unauthorized access that could
compromise the integrity of collections.

\(b\) As a collector, you must do the following before each collection
to deter tampering with specimens:

\(1\) Secure any water sources or otherwise make them unavailable to
employees (e.g., turn off water inlet, tape handles to prevent opening
faucets);

\(2\) Ensure that the water in the toilet is blue;

\(3\) Ensure that no soap, disinfectants, cleaning agents, or other
possible adulterants are present;

\(4\) Inspect the site to ensure that no foreign or unauthorized
substances are present;

\(5\) Tape or otherwise secure shut any movable toilet tank , or put
bluing in the tank;

6\) Ensure that undetected access (e.g., through a door not in your
view) is not possible;

\(7\) Secure areas and items (e.g., ledges, trash receptacles, paper
towel holders, under-sink areas) that appear suitable for concealing
contaminants; and

\(8\) Recheck items in paragraphs (b)(1) through (7) of this section
following each collection to ensure the site\'s continued integrity.

\(c\) If the collection site uses a facility normally used for other
purposes, like a public rest room or hospital examining room, you must,
as a collector, also ensure before the collection that:

\(1\) Access to collection materials and specimens is effectively
restricted; and

\(2\) The facility is secured against access during the procedure to
ensure privacy to the employee and prevent distraction of the collector.
Limited-access signs must be posted.

\(d\) As a collector, you must take the following additional steps to
ensure security during the collection process:

\(1\) To avoid distraction that could compromise security, you are
limited to conducting a collection for only one employee at a time.
However, during the time one employee is in the period for drinking
fluids in a "shy bladder" situation (see §40.193(b)), you may conduct a
collection for another employee.

\(2\) To the greatest extent you can, keep an employee\'s collection
container within view of both you and the employee between the time the
employee has urinated and the specimen is sealed.

\(3\) Ensure you are the only person in addition to the employee who
handles the specimen before it is poured into the bottles and sealed
with tamper-evident seals.

\(4\) In the time between when the employee gives you the specimen and
when you seal the specimen, remain within the collection site.

\(5\) Maintain personal control over each specimen and CCF throughout
the collection process.

\(e\) If you are operating a collection site, you must implement a
policy and procedures to prevent unauthorized personnel from entering
any part of the site in which urine specimens are collected or stored.

\(1\) Only employees being tested, collectors and other collection site
workers, DERs, employee and employer representatives authorized by the
employer (e.g., employer policy, collective bargaining agreement), and
DOT agency representatives are authorized persons for purposes of this
paragraph (e).

\(2\) Except for the observer in a directly observed collection or the
monitor in the case of a monitored collection, you must not permit
anyone to enter the urination facility in which employees provide
specimens.

3\) You must ensure that all authorized persons are under the
supervision of a collector at all times when permitted into the site.

\(4\) You or the collector may remove any person who obstructs,
interferes with, or causes a delay in the collection process.

\(f\) If you are operating a collection site, you must minimize the
number of persons handling specimens.

**§ 40.45   What form is used to document a DOT urine collection?**

\(a\) The Federal Drug Testing Custody and Control Form (CCF) must be
used to document every urine collection required by the DOT drug testing
program. The CCF must be a five-part carbonless manifold form. You may
view this form on the Department\'s web site
(http://www.dot.gov/ost/dapc) or the HHS web site
(http://www.workplace.samhsa.gov).

\(b\) You must not use a non-Federal form or an expired Federal form to
conduct a DOT urine collection. As a laboratory, C/TPA or other party
that provides CCFs to employers, collection sites, or other customers,
you must not provide copies of an expired Federal form to these
participants. You must also affirmatively notify these participants that
they must not use an expired Federal form (e.g., that beginning August
1, 2001, they may not use the old 7-part Federal CCF for DOT urine
collections).

\(c\) As a participant in the DOT drug testing program, you are not
permitted to modify or revise the CCF except as follows:

\(1\) You may include, in the area outside the border of the form, other
information needed for billing or other purposes necessary to the
collection process.

\(2\) The CCF must include the names, addresses, telephone numbers and
fax numbers of the employer and the MRO, which may be preprinted, typed,
or handwritten. The MRO information must include the specific
physician\'s name and address, as opposed to only a generic clinic,
health care organization, or company name. This information is required,
and it is prohibited for an employer, collector, service agent or any
other party to omit it. In addition, a C/TPA\'s name, address, fax
number, and telephone number may be included, but is not required. The
employer may use a C/TPA\'s address in place of its own, but must
continue to include its name, telephone number, and fax number.

\(3\) As an employer, you may add the name of the DOT agency under whose
authority the test occurred as part of the employer information.

\(4\) As a collector, you may use a CCF with your name, address,
telephone number, and fax number preprinted, but under no circumstances
may you sign the form before the collection event.

\(d\) Under no circumstances may the CCF transmit personal identifying
information about an employee (other than a social security number (SSN)
or other employee identification (ID) number) to a laboratory.

\(e\) As an employer, you may use an equivalent foreign-language version
of the CCF approved by ODAPC. You may use such a non-English language
form only in a situation where both the employee and collector
understand and can use the form in that language.

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

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

\(a\) No, as an employer, you are prohibited from using the CCF for
non-Federal urine collections. You are also prohibited from using
non-Federal forms for DOT urine collections. Doing either subjects you
to enforcement action under DOT agency regulations.

\(b\) (1) In the rare case where the collector, either by mistake or as
the only means to conduct a test under difficult circumstances (e.g.,
post-accident or reasonable suspicion test with insufficient time to
obtain the CCF), uses a non-Federal form for a DOT collection, the use
of a non-Federal form does not present a reason for the laboratory to
reject the specimen for testing or for an MRO to cancel the result.

\(2\) The use of the non-Federal form is a "correctable flaw." As an
MRO, to correct the problem you must follow the procedures of
§40.205(b)(2).

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

**§ 40.49   What materials are used to collect urine specimens?**

For each DOT drug test, you must use a collection kit meeting the
requirements of Appendix A of this part.

**§ 40.51   What materials are used to send urine specimens to the
laboratory?**

\(a\) Except as provided in paragraph (b) of this section, you must use
a shipping container that adequately protects the specimen bottles from
shipment damage in the transport of specimens from the collection site
to the laboratory.

\(b\) You are not required to use a shipping container if a laboratory
courier hand-delivers the specimens from the collection site to the
laboratory.

**Subpart E - Urine Specimen Collections**

**§ 40.61   What are the preliminary steps in the collection process?**

As the collector, you must take the following steps before actually
beginning a collection:

\(a\) When a specific time for an employee\'s test has been scheduled,
or the collection site is at the employee\'s work site, and the employee
does not appear at the collection site at the scheduled time, contact
the DER to determine the appropriate interval within which the DER has
determined the employee is authorized to arrive. If the employee\'s
arrival is delayed beyond that time, you must notify the DER that the
employee has not reported for testing. In a situation where a C/TPA has
notified an owner/operator or other individual employee to report for
testing and the employee does not appear, the C/TPA must notify the
employee that he or she has refused to test (see §40.191(a)(1)).

\(b\) Ensure that, when the employee enters the collection site, you
begin the testing process without undue delay. For example, you must not
wait because the employee says he or she is not ready or is unable to
urinate or because an authorized employer or employee representative is
delayed in arriving.

\(1\) If the employee is also going to take a DOT alcohol test, you
must, to the greatest extent practicable, ensure that the alcohol test
is completed before the urine collection process begins.

*[Example to Paragraph (b)(1]{.underline}):*   An employee enters the
test site for both a drug and an alcohol test. Normally, the collector
would wait until the BAT had completed the alcohol test process before
beginning the drug test process. However, there are some situations in
which an exception to this normal practice would be reasonable. One such
situation might be if several people were waiting for the BAT to conduct
alcohol tests, but a drug testing collector in the same facility were
free. Someone waiting might be able to complete a drug test without
unduly delaying his or her alcohol test. Collectors and BATs should work
together, however, to ensure that post-accident and reasonable suspicion
alcohol tests happen as soon as possible (e.g., by moving the employee
to the head of the line for alcohol tests).

\(2\) If the employee needs medical attention (e.g., an injured employee
in an emergency medical facility who is required to have a post-accident
test), do not delay this treatment to collect a specimen.

\(3\) You must not collect, by catheterization or other means, urine
from an unconscious employee to conduct a drug test under this part. Nor
may you catheterize a conscious employee. However, you must inform an
employee who normally voids through self-catheterization that the
employee is required to provide a specimen in that manner.

\(4\) If, as an employee, you normally void through
self-catheterization, and decline to do so, this constitutes a refusal
to test.

\(c\) Require the employee to provide positive identification. You must
see a photo ID issued by the employer (other than in the case of an
owner-operator or other self-employed individual) or a Federal, state,
or local government (e.g., a driver\'s license). You may not accept
faxes or photocopies of identification. Positive identification by an
employer representative (not a co-worker or another employee being
tested) is also acceptable. If the employee cannot produce positive
identification, you must contact a DER to verify the identity of the
employee.

\(d\) If the employee asks, provide your identification to the employee.
Your identification must include your name and your employer\'s name,
but does not have to include your picture, address, or telephone number.

\(e\) Explain the basic collection procedure to the employee, including
showing the employee the instructions on the back of the CCF.

\(f\) Direct the employee to remove outer clothing (e.g., coveralls,
jacket, coat, hat) that could be used to conceal items or substances
that could be used to tamper with a specimen. You must also direct the
employee to leave these garments and any briefcase, purse, or other
personal belongings with you or in a mutually agreeable location. You
must advise the employee that failure to comply with your directions
constitutes a refusal to test.

\(1\) If the employee asks for a receipt for any belongings left with
you, you must provide one.

\(2\) You must allow the employee to keep his or her wallet.

\(3\) You must not ask the employee to remove other clothing (e.g.,
shirts, pants, dresses, underwear), to remove all clothing, or to change
into a hospital or examination gown (unless the urine collection is
being accomplished simultaneously with a DOT agency-authorized medical
examination).

\(4\) You must direct the employee to empty his or her pockets and
display the items in them to ensure that no items are present which
could be used to adulterate the specimen. If nothing is there that can
be used to adulterate a specimen, the employee can place the items back
into his or her pockets. As the employee, you must allow the collector
to make this observation.

\(5\) If, in your duties under paragraph (f)(4) of this section, you
find any material that could be used to tamper with a specimen, you
must:

\(i\) Determine if the material appears to be brought to the collection
site with the intent to alter the specimen, and, if it is, conduct a
directly observed collection using direct observation procedures (see
§40.67); or

\(ii\) Determine if the material appears to be inadvertently brought to
the collection site (e.g., eye drops), secure and maintain it until the
collection process is completed and conduct a normal (i.e., unobserved)
collection.

\(g\) You must instruct the employee not to list medications that he or
she is currently taking on the CCF. (The employee may make notes of
medications on the back of the employee copy of the form for his or her
own convenience, but these notes must not be transmitted to anyone
else.)

**§ 40.63   What steps does the collector take in the collection process
before the employee provides a urine specimen?**

As the collector, you must take the following steps before the employee
provides the urine specimen:

\(a\) Complete Step 1 of the CCF.

\(b\) Instruct the employee to wash and dry his or her hands at this
time. You must tell the employee not to wash his or her hands again
until after delivering the specimen to you. You must not give the
employee any further access to water or other materials that could be
used to adulterate or dilute a specimen.

\(c\) Select, or allow the employee to select, an individually wrapped
or sealed collection container from collection kit materials. Either you
or the employee, with both of you present, must unwrap or break the seal
of the collection container. You must not unwrap or break the seal on
any specimen bottle at this time. You must not allow the employee to
take anything from the collection kit into the room used for urination
except the collection container.

\(d\) Direct the employee to go into the room used for urination,
provide a specimen of at least 45 mL, not flush the toilet, and return
to you with the specimen as soon as the employee has completed the void.

\(1\) Except in the case of an observed or a monitored collection (see
§§40.67 and 40.69 ), neither you nor anyone else may go into the room
with the employee.

\(2\) As the collector, you may set a reasonable time limit for voiding.

\(e\) You must pay careful attention to the employee during the entire
collection process to note any conduct that clearly indicates an attempt
to tamper with a specimen (e.g., substitute urine in plain view or an
attempt to bring into the collection site an adulterant or urine
substitute). If you detect such conduct, you must require that a
collection take place immediately under direct observation (see §40.67 )
and note the conduct and the fact that the collection was observed in
the "Remarks" line of the CCF (Step 2). You must also, as soon as
possible, inform the DER and collection site supervisor that a
collection took place under direct observation and the reason for doing
so.

**§ 40.65   What does the collector check for when the employee presents
a specimen?**

As a collector, you must check the following when the employee gives the
collection container to you:

\(a\) [Sufficiency of specimen]{.underline}. You must check to ensure
that the specimen contains at least 45 mL of urine.

\(1\) If it does not, you must follow "shy bladder" procedures (see
§40.193(b)).

\(2\) When you follow "shy bladder" procedures, you must discard the
original specimen, unless another problem (i.e., temperature out of
range, signs of tampering) also exists.

\(3\) You are never permitted to combine urine collected from separate
voids to create a specimen.

\(4\) You must discard any excess urine.

\(b\) [Temperature.]{.underline} You must check the temperature of the
specimen no later than four minutes after the employee has given you the
specimen.

\(1\) The acceptable temperature range is 32--38 °C/90--100 °F.

\(2\) You must determine the temperature of the specimen by reading the
temperature strip attached to the collection container.

\(3\) If the specimen temperature is within the acceptable range, you
must mark the "Yes" box on the CCF (Step 2).

\(4\) If the specimen temperature is outside the acceptable range, you
must mark the "No" box and enter in the "Remarks" line (Step 2) your
findings about the temperature.

\(5\) If the specimen temperature is outside the acceptable range, you
must immediately conduct a new collection using direct observation
procedures (see §40.67).

\(6\) In a case where a specimen is collected under direct observation
because of the temperature being out of range, you must process both the
original specimen and the specimen collected using direct observation
and send the two sets of specimens to the laboratory. This is true even
in a case in which the original specimen has insufficient volume but the
temperature is out of range. You must also, as soon as possible, inform
the DER and collection site supervisor that a collection took place
under direct observation and the reason for doing so.

\(7\) In a case where the employee refuses to provide another specimen
(see §40.191(a)(3)) or refuses to provide another specimen under direct
observation (see §40.191(a)(4)), you must notify the DER. As soon as you
have notified the DER, you must discard any specimen the employee has
provided previously during the collection procedure.

\(c\) [Signs of tampering]{.underline}. You must inspect the specimen
for unusual color, presence of foreign objects or material, or other
signs of tampering (e.g., if you notice any unusual odor).

\(1\) If it is apparent from this inspection that the employee has
tampered with the specimen (e.g., blue dye in the specimen, excessive
foaming when shaken, smell of bleach), you must immediately conduct a
new collection using direct observation procedures (see §40.67 ).

\(2\) In a case where a specimen is collected under direct observation
because of showing signs of tampering, you must process both the
original specimen and the specimen collected using direct observation
and send the two sets of specimens to the laboratory. This is true even
in a case in which the original specimen has insufficient volume but it
shows signs of tampering. You must also, as soon as possible, inform the
DER and collection site supervisor that a collection took place under
direct observation and the reason for doing so.

\(3\) In a case where the employee refuses to provide a specimen under
direct observation (see §40.191(a)(4)), you must discard any specimen
the employee provided previously during the collection procedure. Then
you must notify the DER as soon as practicable.

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

**§ 40.67   When and how is a directly observed collection conducted?**

\(a\) As an employer, you must direct an immediate collection under
direct observation with no advance notice to the employee, if:

\(1\) The laboratory reported to the MRO that a specimen is invalid, and
the MRO reported to you that there was not an adequate medical
explanation for the result;

\(2\) The MRO reported to you that the original positive, adulterated,
or substituted result had to be cancelled because the test of the split
specimen could not be performed; or

\(3\) The laboratory reported to the MRO that the specimen was
substituted with a creatinine concentration greater than or equal to 2
mg/dL and less than or equal to 5 mg/dL and the MRO reported the
specimen to you as negative and dilute (see §§40.145(a)(1) and 40.197).

\(b\) As an employer, you may direct a collection under direct
observation of an employee if the drug test is a return-to-duty test or
a follow-up test.

\(c\) As a collector, you must immediately conduct a collection under
direct observation if:

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

\(2\) You observed materials brought to the collection site or the
employee\'s conduct clearly indicates an attempt to tamper with a
specimen (see §§40.61(f)(5)(i) and 40.63(e)); or

\(3\) The temperature on the original specimen was out of range (see
§40.65(b)(5)); or (4) The original specimen appeared to have been
tampered with (see §40.65(c)(1)).

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

\(2\) As the collector, you must explain to the employee the reason, if
known, under this part for a directly observed collection under
paragraphs (c)(1) through (3) of this section.

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

\(1\) You must mark the "reason for test" block (Step 1) the same as for
the first collection.

\(2\) You must check the "Observed, (Enter Remark)" box and enter the
reason (see §40.67(b)) in the "Remarks" line (Step 2).

\(f\) In a case where two sets of specimens are being sent to the
laboratory because of suspected tampering with the specimen at the
collection site, enter on the "Remarks" line of the CCF (Step 2) for
each specimen a notation to this effect (e.g., collection 1 of 2, or 2
of 2) and the specimen ID number of the other specimen.

\(g\) As the collector, you must ensure that the observer is the same
gender as the employee. You must never permit an opposite gender person
to act as the observer. The observer can be a different person from the
collector and need not be a qualified collector.

\(h\) As the collector, if someone else is to observe the collection
(e.g., in order to ensure a same gender observer), you must verbally
instruct that person to follow procedures at paragraphs (i) and (j) of
this section. If you, the collector, are the observer, you too must
follow these procedures.

\(i\) As the observer, you must watch the employee urinate into the
collection container. Specifically, you are to watch the urine go from
the employee\'s body into the collection container.

\(j\) As the observer but not the collector, you must not take the
collection container from the employee, but you must observe the
specimen as the employee takes it to the collector.

\(k\) As the collector, when someone else has acted as the observer, you
must include the observer\'s name in the "Remarks" line of the CCF (Step
2).

\(l\) As the employee, if you decline to allow a directly observed
collection required or permitted under this section to occur, this is a
refusal to test.

\(m\) As the collector, when you learn that a directly observed
collection should have been collected but was not, you must inform the
employer that it must direct the employee to have an immediate
recollection under direct observation.

\[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41950, Aug. 9, 2001;
68 FR 31626, May 28, 2003\]

**§ 40.69   How is a monitored collection conducted?**

\(a\) As the collector, you must secure the room being used for the
monitored collection so that no one except the employee and the monitor
can enter it until after the collection has been completed.

\(b\) As the collector, you must ensure that the monitor is the same
gender as the employee, unless the monitor is a medical professional
(e.g., nurse, doctor, physician\'s assistant, technologist, or
technician licensed or certified to practice in the jurisdiction in
which the collection takes place). The monitor can be a different person
from the collector and need not be a qualified collector.

\(c\) As the collector, if someone else is to monitor the collection
(e.g., in order to ensure a same-gender monitor), you must verbally
instruct that person to follow the procedures of paragraphs (d) and (e)
of this section. If you, the collector, are the monitor, you must follow
these procedures.

\(d\) As the monitor, you must not watch the employee urinate into the
collection container. If you hear sounds or make other observations
indicating an attempt to tamper with a specimen, there must be an
additional collection under direct observation (see §§40.63(e),
40.65(c), and 40.67(b)).

\(e\) As the monitor, you must ensure that the employee takes the
collection container directly to the collector as soon as the employee
has exited the enclosure.

\(f\) As the collector, when someone else has acted as the monitor, you
must note that person\'s name in the "Remarks" line of the CCF (Step 2).

\(g\) As the employee being tested, if you decline to permit a
collection authorized under this section to be monitored, it is a
refusal to test.

\[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41951, Aug. 9, 2001\]

**§ 40.71   How does the collector prepare the specimens?**

\(a\) All collections under DOT agency drug testing regulations must be
split specimen collections.

\(b\) As the collector, you must take the following steps, in order,
after the employee brings the urine specimen to you. You must take these
steps in the presence of the employee.

\(1\) Check the box on the CCF (Step 2) indicating that this was a split
specimen collection.

\(2\) You, not the employee, must first pour at least 30 mL of urine
from the collection container into one specimen bottle, to be used for
the primary specimen.

\(3\) You, not the employee, must then pour at least 15 mL of urine from
the collection container into the second specimen bottle to be used for
the split specimen.

\(4\) You, not the employee, must place and secure (i.e., tighten or
snap) the lids/caps on the bottles.

\(5\) You, not the employee, must seal the bottles by placing the
tamper-evident bottle seals over the bottle caps/lids and down the sides
of the bottles.

\(6\) You, not the employee, must then write the date on the
tamper-evident bottle seals.

\(7\) You must then ensure that the employee initials the tamper-evident
bottle seals for the purpose of certifying that the bottles contain the
specimens he or she provided. If the employee fails or refuses to do so,
you must note this in the "Remarks" line of the CCF (Step 2) and
complete the collection process.

\(8\) You must discard any urine left over in the collection container
after both specimen bottles have been appropriately filled and sealed.
There is one exception to this requirement: you may use excess urine to
conduct clinical tests (e.g., protein, glucose) if the collection was
conducted in conjunction with a physical examination required by a DOT
agency regulation. Neither you nor anyone else may conduct further
testing (such as adulteration testing) on this excess urine and the
employee has no legal right to demand that the excess urine be turned
over to the employee.

\[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41951, Aug. 9, 2001\]

**§ 40.73   How is the collection process completed?**

\(a\) As the collector, you must do the following things to complete the
collection process. You must complete the steps called for in paragraphs
(a)(1) through (a)(7) of this section in the employee\'s presence.

\(1\) Direct the employee to read and sign the certification statement
on Copy 2 (Step 5) of the CCF and provide date of birth, printed name,
and day and evening contact telephone numbers. If the employee refuses
to sign the CCF or to provide date of birth, printed name, or telephone
numbers, you must note this in the "Remarks" line (Step 2) of the CCF,
and complete the collection. If the employee refuses to fill out any
information, you must, as a minimum, print the employee\'s name in the
appropriate place.

\(2\) Complete the chain of custody on the CCF (Step 5) by printing your
name (note: you may pre-print your name), recording the time and date of
the collection, signing the statement, and entering the name of the
delivery service transferring the specimen to the laboratory,

\(3\) Ensure that all copies of the CCF are legible and complete.

\(4\) Remove Copy 5 of the CCF and give it to the employee.

\(5\) Place the specimen bottles and Copy 1 of the CCF in the
appropriate pouches of the plastic bag.

\(6\) Secure both pouches of the plastic bag.

\(7\) Advise the employee that he or she may leave the collection site.

\(8\) To prepare the sealed plastic bag containing the specimens and CCF
for shipment you must:

\(i\) Place the sealed plastic bag in a shipping container (e.g.,
standard courier box) designed to minimize the possibility of damage
during shipment. (More than one sealed plastic bag can be placed into a
single shipping container if you are doing multiple collections.)

\(ii\) Seal the container as appropriate.

\(iii\) If a laboratory courier hand-delivers the specimens from the
collection site to the laboratory, prepare the sealed plastic bag for
shipment as directed by the courier service.

\(9\) Send Copy 2 of the CCF to the MRO and Copy 4 to the DER. You must
fax or otherwise transmit these copies to the MRO and DER within 24
hours or during the next business day. Keep Copy 3 for at least 30 days,
unless otherwise specified by applicable DOT agency regulations.

\(b\) As a collector or collection site, you must ensure that each
specimen you collect is shipped to a laboratory as quickly as possible,
but in any case within 24 hours or during the next business day.

**Subpart F - Drug Testing Laboratories**

**§ 40.81   What laboratories may be used for DOT drug testing?**

\(a\) As a drug testing laboratory located in the U.S., you are
permitted to participate in DOT drug testing only if you are certified
by HHS under the National Laboratory Certification Program (NLCP) for
all testing required under this part.

\(b\) As a drug testing laboratory located in Canada or Mexico which is
not certified by HHS under the NLCP, you are permitted to participate in
DOT drug testing only if:

\(1\) The DOT, based on a written recommendation from HHS, has approved
your laboratory as meeting HHS laboratory certification standards or
deemed your laboratory fully equivalent to a laboratory meeting HHS
laboratory certification standards for all testing required under this
part; or

\(2\) The DOT, based on a written recommendation from HHS, has
recognized a Canadian or Mexican certifying organization as having
equivalent laboratory certification standards and procedures to those of
HHS, and the Canadian or Mexican certifying organization has certified
your laboratory under those equivalent standards and procedures.

\(c\) As a laboratory participating in the DOT drug testing program, you
must comply with the requirements of this part. You must also comply
with all applicable requirements of HHS in testing DOT specimens,
whether or not the HHS requirements are explicitly stated in this part.

\(d\) If DOT determines that you are in noncompliance with this part,
you could be subject to PIE proceedings under Subpart R of this part. If
the Department issues a PIE with respect to you, you are ineligible to
participate in the DOT drug testing program even if you continue to meet
the requirements of paragraph (a) or (b) of this section.

**§ 40.83   How do laboratories process incoming specimens?**

As the laboratory, you must do the following when you receive a DOT
specimen:

\(a\) You are authorized to receive only the laboratory copy of the CCF.
You are not authorized to receive other copies of the CCF nor any copies
of the alcohol testing form.

\(b\) You must comply with applicable provisions of the HHS Guidelines
concerning accessioning and processing urine drug specimens.

\(c\) You must inspect each specimen and CCF for the following "fatal
flaws:"

\(1\) The specimen ID numbers on the specimen bottle and the CCF do not
match;

\(2\) The specimen bottle seal is broken or shows evidence of tampering,
unless a split specimen can be redesignated (see paragraph (g) of this
section);

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

\(4\) There is an insufficient amount of urine in the primary bottle for
analysis, unless the specimens can be redesignated (see paragraph (g) of
this section).

\(d\) When you find a specimen meeting the criteria of paragraph (c) of
this section, you must document your findings and stop the testing
process. Report the result in accordance with §40.97(a)(3) .

\(e\) You must inspect each CCF for the presence of the collector\'s
signature on the certification statement in Step 4 of the CCF. Upon
finding that the signature is omitted, document the flaw and continue
the testing process.

\(1\) In such a case, you must retain the specimen for a minimum of 5
business days from the date on which you initiated action to correct the
flaw.

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

\(3\) If the flaw is not corrected, report the result as rejected for
testing in accordance with §40.97(a)(3).

\(f\) If you determine that the specimen temperature was not checked and
the "Remarks" line did not contain an entry regarding the temperature
being outside of range, you must then attempt to correct the problem by
following the procedures of §40.208.

\(1\) In such a case, you must continue your efforts to correct the
problem for five business days, before you report the result.

\(2\) 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 to meet the requirements of
§40.45(a) (e.g., a non-Federal form or an expired Federal form was used
for the collection), you must attempt to correct the use of the improper
form by following the procedures of §40.205(b)(2).

\(1\) In such a case, you must retain the specimen for a minimum of 5
business days from the date on which you initiated action to correct the
problem.

\(2\) During the period August 1--October 31, 2001, you are not required
to reject a test conducted on an expired Federal CCF because this
problem is not corrected. Beginning November 1, 2001, if the problem(s)
is not corrected, you must reject the test and report the result in
accordance with §40.97(a)(3).

\(h\) If the CCF is marked indicating that a split specimen collection
was collected and if the split specimen does not accompany the primary,
has leaked, or is otherwise unavailable for testing, you must still test
the primary specimen and follow appropriate procedures outlined in
§40.175(b) regarding the unavailability of the split specimen for
testing.

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

\(i\) The primary specimen appears to have leaked out of its sealed
bottle and the laboratory believes a sufficient amount of urine exists
in the split specimen to conduct all appropriate primary laboratory
testing; or

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

\(iii\) The laboratory opens the split specimen instead of the primary
specimen, the primary specimen remains sealed, and the laboratory
believes a sufficient amount of urine exists in the split specimen to
conduct all appropriate primary laboratory testing; or

\(iv\) The primary specimen seal is broken but the split specimen
remains sealed and the laboratory believes a sufficient amount of urine
exists in the split specimen to conduct all appropriate primary
laboratory testing.

\(2\) In situations outlined in paragraph (g)(1) of this section, the
laboratory shall mark through the "A" and write "B," then initial and
date the change. A corresponding change shall be made to the other
bottle by marking through the "B" and writing "A," and initialing and
dating the change.

\(i\) A notation shall be made on Copy 1 of the CCF (Step 5a) and on any
laboratory internal chain of custody documents, as appropriate, for any
fatal or correctable flaw.

\[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41951, Aug. 9, 2001\]

**§ 40.85   What drugs do laboratories test for?**

As a laboratory, you must test for the following five drugs or classes
of drugs in a DOT drug test. You must not test "DOT specimens" for any
other drugs.

\(a\) Marijuana metabolites.

\(b\) Cocaine metabolites.

\(c\) Amphetamines.

\(d\) Opiate metabolites.

\(e\) Phencyclidine (PCP).

**§ 40.87   What are the cutoff concentrations for initial and
confirmation 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:

+-------------------------+--------------------+----------------------+
| **Type of Drug or       | > **Initial Test** | **Confirmation       |
| Metabolite**            |                    | Test**               |
+-------------------------+--------------------+----------------------+
| (1) Marijuana           | > 50               | > 15                 |
|     metabolities        |                    |                      |
|                         |                    |                      |
| \(i\)                   |                    |                      |
| Delta-9-tetrahydr       |                    |                      |
| ocannabinol-9-caroxylic |                    |                      |
| acid (THC)              |                    |                      |
+-------------------------+--------------------+----------------------+
| \(2\) Cocaine           | > 300              | > 150                |
| metabolities            |                    |                      |
|                         |                    |                      |
| (Benzoylecgonine)       |                    |                      |
+-------------------------+--------------------+----------------------+
| \(3\) Phencyclidine     | > 25               | > 25                 |
| (PCP)                   |                    |                      |
+-------------------------+--------------------+----------------------+
| \(4\) Amphetamines      | > 1000             | > 500                |
|                         |                    |                      |
| \(i\) Amphetamine       |                    | 500 (Specimen must   |
|                         |                    | also                 |
| \(ii\) Methamphetamine  |                    |                      |
|                         |                    | contain amphetamine  |
|                         |                    |                      |
|                         |                    | at a concentration   |
|                         |                    | of                   |
|                         |                    |                      |
|                         |                    | greater than or      |
|                         |                    | equal                |
|                         |                    |                      |
|                         |                    | to 200 ng/mL.        |
+-------------------------+--------------------+----------------------+
| \(5\) Opiate            | > 2000             | > 2000               |
| metabolities            |                    | >                    |
|                         |                    | > 2000               |
| \(i\) Codeine           |                    | >                    |
|                         |                    | > 10                 |
| \(ii\) Morphine         |                    |                      |
|                         |                    | Test for 6-AM in the |
| \(iii\) 6acety1morphine |                    |                      |
|                         |                    | specimen. Conduct    |
|                         |                    | this test only       |
|                         |                    |                      |
|                         |                    | when specimen        |
|                         |                    | contains morphine    |
|                         |                    |                      |
|                         |                    | at a concentration   |
|                         |                    | greater than         |
|                         |                    |                      |
|                         |                    | or equal to 2000     |
|                         |                    | ng/mL.               |
+-------------------------+--------------------+----------------------+

\(b\) 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 cutoff
concentration as confirmed positive.

\(d\) You must report quantitative values for morphine or codeine at
15,000 ng/mL or above.

**§ 40.89   What is validity testing, and are laboratories required to
conduct it?**

\(a\) Specimen validity testing is the evaluation of the specimen to
determine if it is consistent with normal human urine. The purpose of
validity testing is to determine whether certain adulterants or foreign
substances were added to the urine, if the urine was diluted, or if the
specimen was substituted.

\(b\) As a laboratory, you are authorized to conduct validity testing.

\[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41951, Aug. 9, 2001\]

**§ 40.91   What validity tests must laboratories conduct on primary
specimens?**

As a laboratory, when you conduct validity testing under §40.89, you
must conduct it in accordance with the requirements of this section.

\(a\) You must test each primary specimen for creatinine. You must also
determine its specific gravity if you find that the creatinine
concentration is less than 20 mg/dL.

\(b\) You must measure the pH of each primary specimen.

\(c\) You must test each primary specimen to determine if it contains
substances that may be used to adulterate the specimen. Your tests must
have the capability of determining whether any substance identified in
current HHS requirements or specimen validity guidance is present in the
specimen.

\(d\) If you suspect the presence of an interfering substance/adulterant
that could make a test result invalid, but you are unable to identify it
(e.g., a new adulterant), you must, as the first laboratory, send the
specimen to another HHS certified laboratory that has the capability of
doing so.

\(e\) If you identify a substance in a specimen that appears to be an
adulterant, but which is not listed in current HHS requirements or
guidance, you must report the finding in writing to ODAPC and the
Division of Workplace Programs, HHS, within three business days. You
must also complete testing of the specimen for drugs, to the extent
technically feasible.

\(f\) You must conserve as much as possible of the specimen for possible
future testing.

**§ 40.93   What criteria do laboratories use to establish that a
specimen is dilute or substituted?**

\(a\) As a laboratory you must consider the primary specimen to be
dilute if the creatinine concentration is less than 20 mg/dL and the
specific gravity is less than 1.003, unless the criteria for a
substituted specimen are met.

\(b\) As a laboratory you must consider the primary specimen to be
substituted if the creatinine concentration is less than or equal to 5
mg/dL and the specific gravity is less than or equal to 1.001 or greater
than or equal to 1.020.

**§ 40.95   What criteria do laboratories use to establish that a
specimen is adulterated?**

\(a\) As a laboratory, you must consider the primary specimen to be
adulterated if you determine that---

\(1\) A substance that is not expected to be present in human urine is
identified in the specimen;

\(2\) A substance that is expected to be present in human urine is
identified at a concentration so high that it is not consistent with
human urine; or

\(3\) The physical characteristics of the specimen are outside the
normal expected range for human urine.

\(b\) In making your determination under paragraph (a) of this section,
you must apply the criteria in current HHS requirements or specimen
validity guidance.

**§ 40.97   What do laboratories report and how do they report it?**

\(a\) As a laboratory, you must report the results for each primary
specimen tested as one or more of the following:

\(1\) Negative;

\(2\) Negative---dilute;

\(3\) Rejected for testing, with remark(s);

\(4\) Positive, with drug(s)/metabolite(s) noted;

\(5\) Positive, with drug(s)/metabolite(s) noted---dilute;

\(6\) Adulterated, with remark(s);

\(7\) Substituted, with quantitative values for creatinine and specific
gravity, and remarks; or

\(8\) Invalid result, with remark(s).

\(b\) As a laboratory, you must report laboratory results directly, and
only, to the MRO at his or her place of business. You must not report
results to or through the DER or a service agent (e.g., C/TPA).

\(1\) [Negative results]{.underline}: You must fax, courier, mail, or
electronically transmit a legible image or copy of the fully-completed
Copy 1 of the CCF which has been signed by the certifying scientist, or
you may provide the laboratory results report electronically (i.e.,
computer data file).

\(i\) If you elect to provide the laboratory results report, you must
include the following elements, as a minimum, in the 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 this section; and

\(M\) Remarks section, with an explanation of any situation in which a
correctable flaw has been corrected.

\(ii\) You may release the laboratory results report only after review
and approval by the certifying scientist. It must reflect the same test
result information as contained on the CCF signed by the certifying
scientist. The information contained in the laboratory results report
may not contain information that does not appear on the CCF.

\(iii\) The results report may be transmitted through any means that
ensures accuracy and confidentiality. You, as the laboratory, together
with the MRO, must ensure that the information is adequately protected
from unauthorized access or release, both during transmission and in
storage.

\(2\) [Non-negative results]{.underline}: You must fax, courier, mail,
or electronically transmit a legible image or copy of the
fully-completed Copy 1 of the CCF that has been signed by the certifying
scientist. In addition, you may provide the electronic laboratory
results report following the format and procedures set forth in
paragraphs (b)(1)(i) and (ii) of this section.

\(c\) In transmitting laboratory results to the MRO, you, as the
laboratory, together with the MRO, must ensure that the information is
adequately protected from unauthorized access or release, both during
transmission and in storage. If the results are provided by fax, the fax
connection must have a fixed telephone number accessible only to
authorized individuals.

\(d\) You must transmit test results to the MRO in a timely manner,
preferably the same day that review by the certifying scientist is
completed.

(e)(1) You must provide quantitative values for confirmed positive drug
and adulterated test results to the MRO when the MRO requests you to do
so in writing. The MRO\'s request may be either a general request
covering all such results you send to the MRO or a specific case-by-case
request.

\(2\) You must also provide to the MRO quantitative values for
creatinine and specific gravity for all substituted test results when
the result is above your detection limit. If the result is not above
your detection limit, you must report "creatinine not detected" to the
MRO. You must make these reports for in all cases of substituted tests,
without a request from the MRO.

\(f\) You must provide quantitative values for confirmed opiate results
for morphine or codeine at 15,000 ng/mL or above, even if the MRO has
not requested quantitative values for the test result.

\[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41951, Aug. 9, 2001;
68 FR 31626, May 28, 2003\]

**§ 40.99   How long does the laboratory retain specimens after
testing?**

\(a\) As a laboratory testing the primary specimen, you must retain a
specimen that was reported with positive, adulterated, substituted, or
invalid results for a minimum of one year.

\(b\) You must keep such a specimen in secure, long-term, frozen storage
in accordance with HHS requirements.

\(c\) Within the one-year period, the MRO, the employee, the employer,
or a DOT agency may request in writing that you retain a specimen for an
additional period of time (e.g., for the purpose of preserving evidence
for litigation or a safety investigation). If you receive such a
request, you must comply with it. If you do not receive such a request,
you may discard the specimen at the end of the year.

\(d\) If you have not sent the split specimen to another laboratory for
testing, you must retain the split specimen for an employee\'s test for
the same period of time that you retain the primary specimen and under
the same storage conditions.

> \(e\) As the laboratory testing the split specimen, you must meet the
> requirements of paragraphs (a) through (d) of this section with
> respect to the split specimen.

**§ 40.101   What relationship may a laboratory have with an MRO?**

\(a\) As a laboratory, you may not enter into any relationship with an
MRO that creates a conflict of interest or the appearance of a conflict
of interest with the MRO\'s responsibilities for the employer. You may
not derive any financial benefit by having an employer use a specific
MRO.

\(b\) The following are examples of relationships between laboratories
and MROs that the Department regards as creating conflicts of interest,
or the appearance of such conflicts. This following list of examples is
not intended to be exclusive or exhaustive:

\(1\) The laboratory employs an MRO who reviews test results produced by
the laboratory;

\(2\) The laboratory has a contract or retainer with the MRO for the
review of test results produced by the laboratory;

\(3\) The laboratory designates which MRO the employer is to use, gives
the employer a slate of MROs from which to choose, or recommends certain
MROs;

\(4\) The laboratory gives the employer a discount or other incentive to
use a particular MRO;

\(5\) The laboratory has its place of business co-located with that of
an MRO or MRO staff who review test results produced by the laboratory;
or

\(6\) The laboratory permits an MRO, or an MRO\'s organization, to have
a financial interest in the laboratory.

**§ 40.103   What are the requirements for submitting blind specimens to
a laboratory?**

\(a\) As an employer or C/TPA with an aggregate of 2000 or more
DOT-covered employees, you must send blind specimens to laboratories you
use. If you have an aggregate of fewer than 2000 DOT-covered employees,
you are not required to provide blind specimens.

\(b\) To each laboratory to which you send at least 100 specimens in a
year, you must transmit a number of blind specimens equivalent to one
percent of the specimens you send to that laboratory, up to a maximum of
50 blind specimens in each quarter (i.e., January--March, April--June,
July--September, October--December). As a C/TPA, you must apply this
percentage to the total number of DOT-covered employees\' specimens you
send to the laboratory. Your blind specimen submissions must be evenly
spread throughout the year. The following examples illustrate how this
requirement works:

*[Example 1 to Paragraph (b]{.underline}).*   You send 2500 specimens to
Lab X in Year 1. In this case, you would send 25 blind specimens to Lab
X in Year 1. To meet the even distribution requirement, you would send 6
in each of three quarters and 7 in the other.

*[Example 2 to Paragraph (b]{.underline}).*   You send 2000 specimens to
Lab X and 1000 specimens to Lab Y in Year 1. In this case, you would
send 20 blind specimens to Lab X and 10 to Lab Y in Year 1. The even
distribution requirement would apply in a similar way to that described
in Example 1.

*[Example 3 to Paragraph (b]{.underline}).*   Same as Example 2, except
that you also send 20 specimens to Lab Z. In this case, you would send
blind specimens to Labs X and Y as in Example 2. You would not have to
send any blind specimens to Lab Z, because you sent fewer than 100
specimens to Lab Z.

*[Example 4 to Paragraph (b).]{.underline}*   You are a C/TPA sending
2000 specimens to Lab X in Year 1. These 2000 specimens represent 200
small employers who have an average of 10 covered employees each. In
this case you---not the individual employers---send 20 blind specimens
to Lab X in Year 1, again ensuring even distribution. The individual
employers you represent are not required to provide any blind specimens
on their own.

*[Example 5 to Paragraph (b]{.underline}).*   You are a large C/TPA that
sends 40,000 specimens to Lab Y in Year 1. One percent of that figure is
400. However, the 50 blind specimen per quarter "cap" means that you
need send only 50 blind specimens per quarter, rather than the 100 per
quarter you would have to send to meet the one percent rate. Your annual
total would be 200, rather than 400, blind specimens.

\(c\) Approximately 75 percent of the specimens you submit must be blank
(i.e., containing no drugs, nor adulterated or substituted).
Approximately 15 percent must be positive for one or more of the five
drugs involved in DOT tests, and approximately 10 percent must either be
adulterated with a substance cited in HHS guidance or substituted (i.e.,
having specific gravity and creatinine meeting the criteria of
§40.93(b)).

\(1\) The blind specimens that you submit that contain drugs, that are
adulterated with a substance cited in HHS guidance, or that are
substituted must be validated as to their contents by the supplier using
initial and confirmatory tests.

\(2\) The supplier must provide information regarding the shelf life of
the blind specimens.

\(3\) If the blind specimen is drug positive, the concentration of drug
it contains must be between 1.5 and 2 times the initial drug test cutoff
concentration.

\(4\) If the blind specimen is adulterated with nitrite, the
concentration of nitrite it contains must be between 1.5 and 2 times the
initial validity test cutoff concentration.

\(5\) If the blind specimen is adulterated by altering pH, the pH must
be less than or equal to 2, or greater than or equal to 12.

\(6\) If the blind specimen is substituted, the creatinine must be less
than or equal to 2, and the specific gravity must be 1.000.

\(d\) You must ensure that each blind specimen is indistinguishable to
the laboratory from a normal specimen.

\(1\) You must submit blind specimens to the laboratory using the same
channels (e.g., via a regular collection site) through which employees\'
specimens are sent to the laboratory.

\(2\) You must ensure that the collector uses a CCF, places fictional
initials on the specimen bottle label/seal, indicates for the MRO on
Copy 2 that the specimen is a blind specimen, and discards Copies 4 and
5 (employer and employee copies).

\(3\) You must ensure that all blind specimens include split specimens.

**§ 40.105   What happens if the laboratory reports a result different
from that expected for a blind specimen?**

\(a\) If you are an employer, MRO, or C/TPA who submits a blind
specimen, and if the result reported to the MRO is different from the
result expected, you must investigate the discrepancy.

\(b\) If the unexpected result is a false negative, you must provide the
laboratory with the expected results (obtained from the supplier of the
blind specimen), and direct the laboratory to determine the reason for
the discrepancy.

\(c\) If the unexpected result is a false positive, you must provide the
laboratory with the expected results (obtained from the supplier of the
blind specimen), and direct the laboratory to determine the reason for
the discrepancy. You must also notify ODAPC of the discrepancy by
telephone (202--366--3784) or e-mail (addresses are listed on the ODAPC
web site, http://www.dot.gov/ost/dapc). ODAPC will notify HHS who will
take appropriate action.

**§ 40.107   Who may inspect laboratories?**

As a laboratory, you must permit an inspection, with or without prior
notice, by ODAPC, a DOT agency, or a DOT-regulated employer that
contracts with the laboratory for drug testing under the DOT drug
testing program, or the designee of such an employer.

**§ 40.109   What documentation must the laboratory keep, and for how
long?**

\(a\) As a laboratory, you must retain all records pertaining to each
employee urine specimen for a minimum of two years.

\(b\) As a laboratory, you must also keep for two years
employer-specific data required in §40.111.

\(c\) Within the two-year period, the MRO, the employee, the employer,
or a DOT agency may request in writing that you retain the records for
an additional period of time (e.g., for the purpose of preserving
evidence for litigation or a safety investigation). If you receive such
a request, you must comply with it. If you do not receive such a
request, you may discard the records at the end of the two-year period.

**§ 40.111   When and how must a laboratory disclose statistical
summaries and other information it maintains?**

\(a\) As a laboratory, you must transmit an aggregate statistical
summary, by employer, of the data listed in Appendix B to this part to
the employer on a semi-annual basis.

\(1\) The summary must not reveal the identity of any employee.

\(2\) In order to avoid sending data from which it is likely that
information about an employee\'s test result can be readily inferred,
you must not send a summary if the employer has fewer than five
aggregate tests results.

\(3\) The summary must be sent by January 20 of each year for July 1
through December 31 of the prior year.

\(4\) The summary must also be sent by July 20 of each year for January
1 through June 30 of the current year.

\(b\) When the employer requests a summary in response to an inspection,
audit, or review by a DOT agency, you must provide it unless the
employer had fewer than five aggregate test results. In that case, you
must send the employer a report indicating that not enough testing was
conducted to warrant a summary. You may transmit the summary or report
by hard copy, fax, or other electronic means.

\(c\) You must also release information to appropriate parties as
provided in §§40.329 and 40.331.

**§ 40.113   Where is other information concerning laboratories found in
this regulation?**

You can find more information concerning laboratories in several
sections of this part:

§40.3---Definition.

§40.13---Prohibition on making specimens available for other purposes.

§40.31---Conflicts of interest concerning collectors.

§40.47---Laboratory rejections of test for improper form.

§40.125---Conflicts of interest concerning MROs.

§40.175---Role of first laboratory in split specimen tests.

§40.177---Role of second laboratory in split specimen tests (drugs).

§40.179---Role of second laboratory in split specimen tests
(adulterants).

§40.181---Role of second laboratory in split specimen tests
(substitution).

§§40.183--40.185---Transmission of split specimen test results to MRO.

§§40.201--40.205---Role in correcting errors.

§40.329---Release of information to employees.

§40.331---Limits on release of information.

§40.355---Role with respect to other service agents.

**Subpart G - Medical Review Officers and the Verification Process**

**§ 40.121   Who is qualified to act as an MRO?**

To be qualified to act as an MRO in the DOT drug testing program, you
must meet each of the requirements of this section:

\(a\) [Credentials]{.underline}. You must be a licensed physician
(Doctor of Medicine or Osteopathy). If you are a licensed physician in
any U.S., Canadian, or Mexican jurisdiction and meet the other
requirements of this section, you are authorized to perform MRO services
with respect to all covered employees, wherever they are located. For
example, if you are licensed as an M.D. in one state or province in the
U.S., Canada, or Mexico, you are not limited to performing MRO functions
in that state or province, and you may perform MRO functions for
employees in other states or provinces without becoming licensed to
practice medicine in the other jurisdictions.

\(b\) [Basic knowledge]{.underline}. You must be knowledgeable in the
following areas:

\(1\) You must be knowledgeable about and have clinical experience in
controlled substances abuse disorders, including detailed knowledge of
alternative medical explanations for laboratory confirmed drug test
results.

\(2\) You must be knowledgeable about issues relating to adulterated and
substituted specimens as well as the possible medical causes of
specimens having an invalid result.

\(3\) You must be knowledgeable about this part, the DOT MRO Guidelines,
and the DOT agency regulations applicable to the employers for whom you
evaluate drug test results, and you must keep current on any changes to
these materials. The DOT MRO Guidelines document is available from ODAPC
(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)).

\(c\) [Qualification training]{.underline}. You must receive
qualification training meeting the requirements of this paragraph (c).

\(1\) Qualification training must provide instruction on the following
subjects:

\(i\) Collection procedures for urine specimens;

\(ii\) Chain of custody, reporting, and recordkeeping;

\(iii\) Interpretation of drug and validity tests results;

\(iv\) The role and responsibilities of the MRO in the DOT drug testing
program;

\(v\) The interaction with other participants in the program (e.g.,
DERs, SAPs); and

\(vi\) Provisions of this part and DOT agency rules applying to
employers for whom you review test results, including changes and
updates to this part and DOT agency rules, guidance, interpretations,
and policies affecting the performance of MRO functions, as well as
issues that MROs confront in carrying out their duties under this part
and DOT agency rules.

\(2\) Following your completion of qualification training under
paragraph (c)(1) of this section, you must satisfactorily complete an
examination administered by a nationally-recognized MRO certification
board or subspecialty board for medical practitioners in the field of
medical review of DOT-mandated drug tests. The examination must
comprehensively cover all the elements of qualification training listed
in paragraph (c)(1) of this section.

\(3\) The following is the schedule for qualification training you must
meet:

\(i\) If you became an MRO before August 1, 2001, and have already met
the qualification training requirement, you do not have to meet it
again.

\(ii\) If you became an MRO before August 1, 2001, but have not yet met
the qualification training requirement, you must do so no later than
January 31, 2003.

\(iii\) If you become an MRO on or after August 1, 2001, you must meet
the qualification training requirement before you begin to perform MRO
functions.

\(d\) [Continuing Education]{.underline}. During each three-year period
from the date on which you satisfactorily complete the examination under
paragraph (c)(2) of this section, you must complete continuing education
consisting of at least 12 professional development hours (e.g.,
Continuing Education Medical Units) relevant to performing MRO
functions.

\(1\) This continuing education must include material concerning new
technologies, interpretations, recent guidance, rule changes, and other
information about developments in MRO practice, pertaining to the DOT
program, since the time you met the qualification training requirements
of this section.

\(2\) Your continuing education activities must include assessment tools
to assist you in determining whether you have adequately learned the
material.

\(3\) If you are an MRO who completed the qualification training and
examination requirements prior to August 1, 2001, you must complete your
first increment of 12 CEU hours before August 1, 2004.

\(e\) [Documentation]{.underline}. You must maintain documentation
showing that you currently meet all requirements of this section. You
must provide this documentation on request to DOT agency representatives
and to employers and C/TPAs who are using or negotiating to use your
services.

\[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41951, Aug. 9, 2001\]

**§ 40.123   What are the MRO\'s responsibilities in the DOT drug
testing program?**

As an MRO, you have the following basic responsibilities:

\(a\) Acting as an independent and impartial "gatekeeper" and advocate
for the accuracy and integrity of the drug testing process.

\(b\) Providing a quality assurance review of the drug testing process
for the specimens under your purview. This includes, but is not limited
to:

\(1\) Ensuring the review of the CCF on all specimen collections for the
purposes of determining whether there is a problem that may cause a test
to be cancelled (see §§40.199--40.203 ). As an MRO, you are not required
to review laboratory internal chain of custody documentation. No one is
permitted to cancel a test because you have not reviewed this
documentation;

\(2\) Providing feedback to employers, collection sites and laboratories
regarding performance issues where necessary; and

\(3\) Reporting to and consulting with the ODAPC or a relevant DOT
agency when you wish DOT assistance in resolving any program issue. As
an employer or service agent, you are prohibited from limiting or
attempting to limit the MRO\'s access to DOT for this purpose and from
retaliating in any way against an MRO for discussing drug testing issues
with DOT.

\(c\) You must determine whether there is a legitimate medical
explanation for confirmed positive, adulterated, substituted, and
invalid drug tests results from the laboratory.

\(d\) While you provide medical review of employees\' test results, this
part does not deem that you have established a doctor-patient
relationship with the employees whose tests you review.

\(e\) You must act to investigate and correct problems where possible
and notify appropriate parties (e.g., HHS, DOT, employers, service
agents) where assistance is needed, (e.g., cancelled or problematic
tests, incorrect results, problems with blind specimens).

\(f\) You must ensure the timely flow of test results and other
information to employers.

\(g\) You must protect the confidentiality of the drug testing
information.

\(h\) You must perform all your functions in compliance with this part
and other DOT agency regulations.

**§ 40.125   What relationship may an MRO have with a laboratory?**

As an MRO, you may not enter into any relationship with an employer\'s
laboratory that creates a conflict of interest or the appearance of a
conflict of interest with your responsibilities to that employer. You
may not derive any financial benefit by having an employer use a
specific laboratory. For examples of relationships between laboratories
and MROs that the Department views as creating a conflict of interest or
the appearance of such a conflict, see §40.101(b).

**§ 40.127   What are the MRO\'s functions in reviewing negative test
results?**

As the MRO, you must do the following with respect to negative drug test
results you receive from a laboratory, prior to verifying the result and
releasing it to the DER:

\(a\) Review Copy 2 of the CCF to determine if there are any fatal or
correctable errors that may require you to initiate corrective action or
to cancel the test (see §§40.199 and 40.203).

\(b\) Review the negative laboratory test result and ensure that it is
consistent with the information contained on the CCF.

\(c\) Before you report a negative test result, you must have in your
possession the following documents:

\(1\) Copy 2 of the CCF, a legible copy of it, or any other CCF copy
containing the employee\'s signature; and

\(2\) A legible copy (fax, photocopy, image) of Copy 1 of the CCF or the
electronic laboratory results report that conveys the negative
laboratory test result.

\(d\) If the copy of the documentation provided to you by the collector
or laboratory appears unclear, you must request that the collector or
laboratory send you a legible copy.

\(e\) On Copy 2 of the CCF, place a check mark in the "Negative" box
(Step 6), provide your name, and sign, initial, or stamp and date the
verification statement.

\(f\) Report the result in a confidential manner (see §§40.163--40.167).

\(g\) Staff under your direct, personal supervision may perform the
administrative functions of this section for you, but only you can
cancel a test. If you cancel a laboratory-confirmed negative result,
check the "Test Cancelled" box (Step 6) on Copy 2 of the CCF, make
appropriate annotation in the "Remarks" line, provide your name, and
sign, initial or stamp and date the verification statement.

\(1\) On specimen results that are reviewed by your staff, you are
responsible for assuring the quality of their work.

\(2\) You are required to personally review at least 5 percent of all
CCFs reviewed by your staff on a quarterly basis, including all results
that required a corrective action. However, you need not review more
than 500 negative results in any quarter.

\(3\) Your review must, as a minimum, include the CCF, negative
laboratory test result, any accompanying corrective documents, and the
report sent to the employer. You must correct any errors that you
discover. You must take action as necessary to ensure compliance by your
staff with this part and document your corrective action. You must
attest to the quality assurance review by initialing the CCFs that you
review.

\(4\) You must make these CCFs easily identifiable and retrievable by
you for review by DOT agencies.

\[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41951, Aug. 9, 2001\]

**§ 40.129   What are the MRO\'s functions in reviewing laboratory
confirmed positive, adulterated, substituted, or invalid drug test
results?**

\(a\) As the MRO, you must do the following with respect to confirmed
positive, adulterated, substituted, or invalid drug tests you receive
from a laboratory, before you verify the result and release it to the
DER:

\(1\) Review Copy 2 of the CCF to determine if there are any fatal or
correctable errors that may require you to cancel the test (see §§40.199
and 40.203). Staff under your direct, personal supervision may conduct
this administrative review for you, but only you may verify or cancel a
test.

\(2\) Review Copy 1 of the CCF and ensure that it is consistent with the
information contained on Copy 2, that the test result is legible, and
that the certifying scientist signed the form. You are not required to
review any other documentation generated by the laboratory during their
analysis or handling of the specimen (e.g., the laboratory internal
chain of custody).

\(3\) If the copy of the documentation provided to you by the collector
or laboratory appears unclear, you must request that the collector or
laboratory send you a legible copy.

\(4\) Except in the circumstances spelled out in §40.133 , conduct a
verification interview. This interview must include direct contact in
person or by telephone between you and the employee. You may initiate
the verification process based on the laboratory results report.

\(5\) Verify the test result as either negative, positive, test
cancelled, or refusal to test because of adulteration or substitution,
consistent with the requirements of §§40.135--40.145 and 40.159 .

\(b\) Before you report a verified negative, positive, test cancelled,
refusal to test because of adulteration or substitution, you must have
in your possession the following documents:

\(1\) Copy 2 of the CCF, a legible copy of it, or any other CCF copy
containing the employee\'s signature; and

\(2\) A legible copy (fax, photocopy, image) of Copy 1 of the CCF,
containing the certifying scientist\'s signature.

\(c\) With respect to verified positive test results, place a check mark
in the "Positive" box (Step 6) on Copy 2 of the CCF, indicate the
drug(s)/ metabolite(s) detected on the "Remarks" line, sign and date the
verification statement.

\(d\) If you cancel a laboratory confirmed positive, adulterated,
substituted, or invalid drug test report, check the "test cancelled" box
(Step 6) on Copy 2 of the CCF, make appropriate annotation in the
"Remarks" line, sign, provide your name, and date the verification
statement.

\(e\) Report the result in a confidential manner (see §§40.163--40.167
).

\(f\) With respect to adulteration or substitution test results, check
the "refusal to test because:" box (Step 6) on Copy 2 of the CCF, check
the "Adulterated" or "Substituted" box, as appropriate, make appropriate
annotation in the "Remarks" line, sign and date the verification
statement.

\(g\) As the MRO, your actions concerning reporting confirmed positive,
adulterated, or substituted results to the employer before you have
completed the verification process are also governed by the stand-down
provisions of §40.21 .

\(1\) If an employer has a stand-down policy that meets the requirements
of §40.21 , you may report to the DER that you have received an
employee\'s laboratory confirmed positive, adulterated, or substituted
test result, consistent with the terms of the waiver the employer
received. You must not provide any further details about the test result
(e.g., the name of the drug involved).

\(2\) If the employer does not have a stand-down policy that meets the
requirements of §40.21 , you must not inform the employer that you have
received an employee\'s laboratory confirmed positive, adulterated, or
substituted test result until you verify the test result. For example,
as an MRO employed directly by a company, you must not tell anyone on
the company\'s staff or management that you have received an employee\'s
laboratory confirmed test result.

\[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41952, Aug. 9, 2001\]

**§ 40.131   How does the MRO or DER notify an employee of the
verification process after a confirmed positive, adulterated,
substituted, or invalid test result?**

\(a\) When, as the MRO, you receive a confirmed positive, adulterated,
substituted with a creatinine concentration of less than 2 mg/dL, or
invalid test result from the laboratory, you must contact the employee
directly (i.e., actually talk to the employee), on a confidential basis,
to determine whether the employee wants to discuss the test result. In
making this contact, you must explain to the employee that, if he or she
declines to discuss the result, you will verify the test as positive or
as a refusal to test because of adulteration or substitution, as
applicable.

\(b\) As the MRO, staff under your personal supervision may conduct this
initial contact for you.

\(1\) This staff contact must be limited to scheduling the discussion
between you and the employee and explaining the consequences of the
employee\'s declining to speak with you (i.e., that the MRO will verify
the test without input from the employee). If the employee declines to
speak with you, the staff person must document the employee\'s decision,
including the date and time.

\(2\) A staff person must not gather any medical information or
information concerning possible explanations for the test result.

\(3\) A staff person may advise an employee to have medical information
(e.g., prescriptions, information forming the basis of a legitimate
medical explanation for a confirmed positive test result) ready to
present at the interview with the MRO.

\(4\) Since you are required to speak personally with the employee,
face-to-face or on the phone, your staff must not inquire if the
employee wishes to speak with you.

\(c\) As the MRO, you or your staff must make reasonable efforts to
reach the employee at the day and evening telephone numbers listed on
the CCF. Reasonable efforts include, as a minimum, three attempts,
spaced reasonably over a 24-hour period, to reach the employee at the
day and evening telephone numbers listed on the CCF. If you or your
staff cannot reach the employee directly after making these efforts, you
or your staff must take the following steps:

\(1\) Document the efforts you made to contact the employee, including
dates and times. If both phone numbers are incorrect (e.g.,
disconnected, wrong number), you may take the actions listed in
paragraph (c)(2) of this section without waiting the full 24-hour
period.

\(2\) Contact the DER, instructing the DER to contact the employee.

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

\(ii\) You must not inform the DER that the employee has a confirmed
positive, adulterated, substituted, or invalid test result.

\(iii\) You must document the dates and times of your attempts to
contact the DER, and you must document the name of the DER you contacted
and the date and time of the contact.

\(d\) As the DER, you must attempt to contact the employee immediately,
using procedures that protect, as much as possible, the confidentiality
of the MRO\'s request that the employee contact the MRO. If you
successfully contact the employee (i.e., actually talk to the employee),
you must document the date and time of the contact, and inform the MRO.
You must inform the employee that he or she should contact the MRO
immediately. You must also inform the employee of the consequences of
failing to contact the MRO within the next 72 hours (see §40.133(a)(2)).

\(1\) As the DER, you must not inform anyone else working for the
employer that you are seeking to contact the employee on behalf of the
MRO.

\(2\) If, as the DER, you have made all reasonable efforts to contact
the employee but failed to do so, you may place the employee on
temporary medically unqualified status or medical leave. Reasonable
efforts include, as a minimum, three attempts, spaced reasonably over a
24-hour period, to reach the employee at the day and evening telephone
numbers listed on the CCF.

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

\(ii\) If, as the DER, you are unable to contact the employee within
this 24-hour period, you must leave a message for the employee by any
practicable means (e.g., voice mail, e-mail, letter) to contact the MRO
and inform the MRO of the date and time of this attempted contact.

\[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41952, Aug. 9, 2001;
68 FR 31626, May 28, 2003\]

**§ 40.133   Under what circumstances may the MRO verify a test as
positive, or as a refusal to test because of adulteration or
substitution, without interviewing the employee?**

\(a\) As the MRO, you normally may verify a confirmed positive test (for
any drug or drug metabolite, including opiates), or as a refusal to test
because of adulteration or substitution, only after interviewing the
employee as provided in §§40.135--40.145 . However, there are three
circumstances in which you may verify such a result without an
interview:

\(1\) You may verify a test result as a positive or refusal to test, as
applicable, if the employee expressly declines the opportunity to
discuss the test with you. You must maintain complete documentation of
this occurrence, including notation of informing, or attempting to
inform, the employee of the consequences of not exercising the option to
speak with the you.

\(2\) You may verify a test result as a positive or refusal to test, as
applicable, if the DER has successfully made and documented a contact
with the employee and instructed the employee to contact you and more
than 72 hours have passed since the time the DER contacted the employee.

\(3\) You may verify a test result as a positive or refusal to test, as
applicable, if neither you nor the DER, after making and documenting all
reasonable efforts, has been able to contact the employee within ten
days of the date on which the MRO receives the confirmed test result
from the laboratory.

\(b\) As the MRO, when you verify a test result as a positive or refusal
to test under this section, you must document the date, time and reason,
following the instructions in §40.163 .

\(c\) As the MRO, after you have verified a test result as a positive or
refusal to test under this section and reported the result to the DER,
you must allow the employee to present information to you within 60 days
of the verification documenting that serious illness, injury, or other
circumstances unavoidably precluded contact with the MRO and/or DER in
the times provided. On the basis of such information, you may reopen the
verification, allowing the employee to present information concerning
whether there is a legitimate medical explanation for the confirmed test
result.

**§ 40.135   What does the MRO tell the employee at the beginning of the
verification interview?**

\(a\) As the MRO, you must tell the employee that the laboratory has
determined that the employee\'s test result was positive, adulterated,
substituted, or invalid, as applicable. You must also tell the employee
of the drugs for which his or her specimen tested positive, or the basis
for the finding of adulteration or substitution.

\(b\) You must explain the verification interview process to the
employee and inform the employee that your decision will be based on
information the employee provides in the interview.

\(c\) You must explain that, if further medical evaluation is needed for
the verification process, the employee must comply with your request for
this evaluation and that failure to do so is equivalent of expressly
declining to discuss the test result.

\(d\) As the MRO, you must warn an employee who has a confirmed
positive, adulterated, substituted or invalid test that you are required
to provide to third parties drug test result information and medical
information affecting the performance of safety-sensitive duties that
the employee gives you in the verification process without the
employee\'s consent (see §40.327).

\(1\) You must give this warning to the employee before obtaining any
medical information as part of the verification process.

\(2\) For purposes of this paragraph (d), medical information includes
information on medications or other substances affecting the performance
of safety-sensitive duties that the employee reports using or medical
conditions the employee reports having.

\(3\) For purposes of this paragraph (d), the persons to whom this
information may be provided include the employer, a SAP evaluating the
employee as part of the return to duty process (see §40.293(g)), DOT,
another Federal safety agency (e.g., the NTSB), or any state safety
agency as required by state law.

\(e\) You must also advise the employee that, after informing any third
party about any medication the employee is using pursuant to a legally
valid prescription under the Controlled Substances Act, you will allow 5
days for the employee to have the prescribing physician contact you to
determine if the medication can be changed to one that does not make the
employee medically unqualified or does not pose a significant safety
risk. If, as an MRO, you receive such information from the prescribing
physician, you must transmit this information to any third party to whom
you previously provided information about the safety risks of the
employee\'s other medication.

\[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41952, Aug. 9, 2001\]

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

\(a\) As the MRO, you must verify a confirmed positive test result for
marijuana, cocaine, amphetamines, and/or PCP unless the employee
presents a legitimate medical explanation for the presence of the
drug(s)/metabolite(s) in his or her system.

\(b\) You must offer the employee an opportunity to present a legitimate
medical explanation in all cases.

\(c\) The employee has the burden of proof that a legitimate medical
explanation exists. The employee must present information meeting this
burden at the time of the verification interview. As the MRO, you have
discretion to extend the time available to the employee for this purpose
for up to five days before verifying the test result, if you determine
that there is a reasonable basis to believe that the employee will be
able to produce relevant evidence concerning a legitimate medical
explanation within that time.

\(d\) If you determine that there is a legitimate medical explanation,
you must verify the test result as negative. Otherwise, you must verify
the test result as positive.

\(e\) In determining whether a legitimate medical explanation exists,
you may consider the employee\'s use of a medication from a foreign
country. You must exercise your professional judgment consistently with
the following principles:

\(1\) There can be a legitimate medical explanation only with respect to
a substance that is obtained legally in a foreign country.

\(2\) There can be a legitimate medical explanation only with respect to
a substance that has a legitimate medical use. Use of a drug of abuse
(e.g., heroin, PCP, marijuana) or any other substance (see §40.151(f)
and (g)) that cannot be viewed as having a legitimate medical use can
never be the basis for a legitimate medical explanation, even if the
substance is obtained legally in a foreign country.

\(3\) Use of the substance can form the basis of a legitimate medical
explanation only if it is used consistently with its proper and intended
medical purpose.

\(4\) Even if you find that there is a legitimate medical explanation
under this paragraph (e) and verify a test negative, you may have a
responsibility to raise fitness-for-duty considerations with the
employer (see §40.327).

**§ 40.139   On what basis does the MRO verify test results involving
opiates?**

As the MRO, you must proceed as follows when you receive a laboratory
confirmed positive opiate result:

\(a\) If the laboratory detects the presence of 6-acetylmorphine (6-AM)
in the specimen, you must verify the test result positive.

\(b\) In the absence of 6-AM, if the laboratory detects the presence of
either morphine or codeine at 15,000 ng/mL or above, you must verify the
test result positive unless the employee presents a legitimate medical
explanation for the presence of the drug or drug metabolite in his or
her system, as in the case of other drugs (see §40.137). Consumption of
food products (e.g., poppy seeds) must not be considered a legitimate
medical explanation for the employee having morphine or codeine at these
concentrations.

\(c\) For all other opiate positive results, you must verify a confirmed
positive test result for opiates only if you determine that there is
clinical evidence, in addition to the urine test, of unauthorized use of
any opium, opiate, or opium derivative (i.e., morphine, heroin, or
codeine).

\(1\) As an MRO, it is your responsibility to use your best professional
and ethical judgement and discretion to determine whether there is
clinical evidence of unauthorized use of opiates. Examples of
information that you may consider in making this judgement include, but
are not limited to, the following:

\(i\) Recent needle tracks;

\(ii\) Behavioral and psychological signs of acute opiate intoxication
or withdrawal;

\(iii\) Clinical history of unauthorized use recent enough to have
produced the laboratory test result;

\(iv\) Use of a medication from a foreign country. See §40.137(e) for
guidance on how to make this determination.

\(2\) In order to establish the clinical evidence referenced in
paragraphs (c)(1)(i) and (ii) of this section, personal observation of
the employee is essential.

\(i\) Therefore, you, as the MRO, must conduct, or cause another
physician to conduct, a face-to-face examination of the employee.

> \(ii\) No face-to-face examination is needed in establishing the
> clinical evidence referenced in paragraph (c)(1)(iii) or (iv) of this
> section.

\(3\) To be the basis of a verified positive result for opiates, the
clinical evidence you find must concern a drug that the laboratory found
in the specimen. (For example, if the test confirmed the presence of
codeine, and the employee admits to unauthorized use of hydrocodone, you
do not have grounds for verifying the test positive. The admission must
be for the substance that was found).

\(4\) As the MRO, you have the burden of establishing that there is
clinical evidence of unauthorized use of opiates referenced in this
paragraph (c). If you cannot make this determination (e.g., there is not
sufficient clinical evidence or history), you must verify the test as
negative. The employee does not need to show you that a legitimate
medical explanation exists if no clinical evidence is established.

**§ 40.141   How does the MRO obtain information for the verification
decision?**

As the MRO, you must do the following as you make the determinations
needed for a verification decision:

\(a\) You must conduct a medical interview. You must review the
employee\'s medical history and any other relevant biomedical factors
presented to you by the employee. You may direct the employee to undergo
further medical evaluation by you or another physician.

\(b\) If the employee asserts that the presence of a drug or drug
metabolite in his or her specimen results from taking prescription
medication, you must review and take all reasonable and necessary steps
to verify the authenticity of all medical records the employee provides.
You may contact the employee\'s physician or other relevant medical
personnel for further information.

**§ 40.143   \[Reserved\]**

**§ 40.145   On what basis does the MRO verify test results involving
adulteration or substitution?**

\(a\) As an MRO, when you receive a laboratory report that a specimen is
adulterated or substituted, you must treat that report in the same way
you treat the laboratory\'s report of a confirmed positive test for a
drug or drug metabolite, unless the creatinine concentration for a
substituted specimen was reported by the laboratory to be equal to or
more than 2 mg/dL.

\(1\) If the laboratory has reported the creatinine concentration for a
substituted specimen as equal to or more than 2 mg/dL, you must report
the specimen to the DER as being dilute, as provided in §40.155 of this
part. Notwithstanding any other provision of this part, you must also
instruct the DER that a second collection under direct observation must
take place immediately.

\(2\) If the laboratory has reported the creatinine concentration for a
substituted specimen as less than 2 mg/dL or "creatinine not detected,"
you must follow the procedures set forth in paragraphs (b) through (h)
of this section.

\(b\) You must follow the same procedures used for verification of a
confirmed positive test for a drug or drug metabolite (see
§§40.129--40.135, 40.141, 40.151), except as otherwise provided in this
section.

\(c\) In the verification interview, you must explain the laboratory
findings to the employee and address technical questions or issues the
employee may raise.

\(d\) You must offer the employee the opportunity to present a
legitimate medical explanation for the laboratory findings with respect
to presence of the adulterant in, or the creatinine and specific gravity
findings for, the specimen.

\(e\) The employee has the burden of proof that there is a legitimate
medical explanation.

\(1\) To meet this burden in the case of an adulterated specimen, the
employee must demonstrate that the adulterant found by the laboratory
entered the specimen through physiological means.

\(2\) To meet this burden in the case of a substituted specimen, the
employee must demonstrate that he or she did produce or could have
produced urine, through physiological means, meeting criteria for
creatinine of less than 2 mg/dL and for specific gravity of less than or
equal to 1.001 or greater than or equal to 1.020.

\(3\) The employee must present information meeting this burden at the
time of the verification interview. As the MRO, you have discretion to
extend the time available to the employee for this purpose for up to
five days before verifying the specimen, if you determine that there is
a reasonable basis to believe that the employee will be able to produce
relevant evidence supporting a legitimate medical explanation within
that time.

\(f\) As the MRO or the employer, you are not responsible for arranging,
conducting, or paying for any studies, examinations or analyses to
determine whether a legitimate medical explanation exists.

\(g\) As the MRO, you must exercise your best professional judgment in
deciding whether the employee has established a legitimate medical
explanation.

\(1\) If you determine that the employee\'s explanation does not present
a reasonable basis for concluding that there may be a legitimate medical
explanation, you must report the test to the DER as a verified refusal
to test because of adulteration or substitution, as applicable.

\(2\) If you believe that the employee\'s explanation may present a
reasonable basis for concluding that there is a legitimate medical
explanation, you must direct the employee to obtain, within the five-day
period set forth in paragraph (e)(3) of this section, a further medical
evaluation. This evaluation must be performed by a licensed physician
(the "referral physician"), acceptable to you, with expertise in the
medical issues raised by the employee\'s explanation. (The MRO may
perform this evaluation if the MRO has appropriate expertise.)

\(i\) As the MRO or employer, you are not responsible for finding or
paying a referral physician. However, on request of the employee, you
must provide reasonable assistance to the employee\'s efforts to find
such a physician. The final choice of the referral physician is the
employee\'s, as long as the physician is acceptable to you.

\(ii\) As the MRO, you must consult with the referral physician,
providing guidance to him or her concerning his or her responsibilities
under this section. As part of this consultation, you must provide the
following information to the referral physician:

\(A\) That the employee was required to take a DOT drug test, but the
laboratory reported that the specimen was adulterated or substituted,
which is treated as a refusal to test;

\(B\) The consequences of the appropriate DOT agency regulation for
refusing to take the required drug test;

\(C\) That the referral physician must agree to follow the requirements
of paragraphs (g)(3) through (g)(4) of this section; and

\(D\) That the referral physician must provide you with a signed
statement of his or her recommendations.

\(3\) As the referral physician, you must evaluate the employee and
consider any evidence the employee presents concerning the employee\'s
medical explanation. You may conduct additional tests to determine
whether there is a legitimate medical explanation. Any additional urine
tests must be performed in an HHS-certified laboratory.

\(4\) As the referral physician, you must then make a written
recommendation to the MRO about whether the MRO should determine that
there is a legitimate medical explanation. As the MRO, you must
seriously consider and assess the referral physician\'s recommendation
in deciding whether there is a legitimate medical explanation.

\(5\) As the MRO, if you determine that there is a legitimate medical
explanation, you must cancel the test and inform ODAPC in writing of the
determination and the basis for it (e.g., referral physician\'s
findings, evidence produced by the employee).

\(6\) As the MRO, if you determine that there is not a legitimate
medical explanation, you must report the test to the DER as a verified
refusal to test because of adulteration or substitution.

\(h\) The following are examples of types of evidence an employee could
present to support an assertion of a legitimate medical explanation for
a substituted result.

\(1\) Medically valid evidence demonstrating that the employee is
capable of physiologically producing urine meeting the creatinine and
specific gravity criteria of §40.93(b) .

\(i\) To be regarded as medically valid, the evidence must have been
gathered using appropriate methodology and controls to ensure its
accuracy and reliability.

\(ii\) Assertion by the employee that his or her personal
characteristics (e.g., with respect to race, gender, weight, diet,
working conditions) are responsible for the substituted result does not,
in itself, constitute a legitimate medical explanation. To make a case
that there is a legitimate medical explanation, the employee must
present evidence showing that the cited personal characteristics
actually result in the physiological production of urine meeting the
creatinine and specific gravity criteria of §40.93(b) .

\(2\) Information from a medical evaluation under paragraph (g) of this
section that the individual has a medical condition that has been
demonstrated to cause the employee to physiologically produce urine
meeting the creatinine and specific gravity criteria of §40.93(b) .

\(i\) A finding or diagnosis by the physician that an employee has a
medical condition, in itself, does not constitute a legitimate medical
explanation.

\(ii\) To establish there is a legitimate medical explanation, the
employee must demonstrate that the cited medical condition actually
results in the physiological production of urine meeting the creatinine
and specific gravity criteria of §40.93(b) .

\[65 FR 79526, Dec. 19, 2000, as amended at 68 FR 31626, May 28, 2003\]

**§ 40.147   \[Reserved\]**

**§ 40.149   May the MRO change a verified positive drug test result or
refusal to test?**

\(a\) As the MRO, you may change a verified positive or refusal to test
drug test result only in the following situations:

\(1\) When you have reopened a verification that was done without an
interview with an employee (see §40.133(c)).

\(2\) If you receive information, not available to you at the time of
the original verification, demonstrating that the laboratory made an
error in identifying (e.g., a paperwork mistake) or testing (e.g., a
false positive or negative) the employee\'s primary or split specimen.
For example, suppose the laboratory originally reported a positive test
result for Employee X and a negative result for Employee Y. You verified
the test results as reported to you. Then the laboratory notifies you
that it mixed up the two test results, and X was really negative and Y
was really positive. You would change X\'s test result from positive to
negative and contact Y to conduct a verification interview.

\(3\) If, within 60 days of the original verification decision---

\(i\) You receive information that could not reasonably have been
provided to you at the time of the decision demonstrating that there is
a legitimate medical explanation for the presence of
drug(s)/metabolite(s) in the employee\'s specimen; or

\(ii\) You receive credible new or additional evidence that a legitimate
medical explanation for an adulterated or substituted result exists.

*[Example to Paragraph (a)(3]{.underline}):*   If the employee\'s
physician provides you a valid prescription that he or she failed to
find at the time of the original verification, you may change the test
result from positive to negative if you conclude that the prescription
provides a legitimate medical explanation for the drug(s)/ metabolite(s)
in the employee\'s specimen.

\(4\) If you receive the information in paragraph (a)(3) of this section
after the 60-day period, you must consult with ODAPC prior to changing
the result.

\(5\) When you have made an administrative error and reported an
incorrect result.

\(b\) If you change the result, you must immediately notify the DER in
writing, as provided in §§40.163--40.165.

\(c\) You are the only person permitted to change a verified test
result, such as a verified positive test result or a determination that
an individual has refused to test because of adulteration or
substitution. This is because, as the MRO, you have the sole authority
under this part to make medical determinations leading to a verified
test (e.g., a determination that there was or was not a legitimate
medical explanation for a laboratory test result). For example, an
arbitrator is not permitted to overturn the medical judgment of the MRO
that the employee failed to present a legitimate medical explanation for
a positive, adulterated, or substituted test result of his or her
specimen.

\[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41952, Aug. 9, 2001\]

**§ 40.151   What are MROs prohibited from doing as part of the
verification process?**

As an MRO, you are prohibited from doing the following as part of the
verification process:

\(a\) You must not consider any evidence from tests of urine samples or
other body fluids or tissues (e.g., blood or hair samples) that are not
collected or tested in accordance with this part. For example, if an
employee tells you he went to his own physician, provided a urine
specimen, sent it to a laboratory, and received a negative test result
or a DNA test result questioning the identity of his DOT specimen, you
are required to ignore this test result.

\(b\) It is not your function to make decisions about factual disputes
between the employee and the collector concerning matters occurring at
the collection site that are not reflected on the CCF (e.g., concerning
allegations that the collector left the area or left open urine
containers where other people could access them).

\(c\) It is not your function to determine whether the employer should
have directed that a test occur. For example, if an employee tells you
that the employer misidentified her as the subject of a random test, or
directed her to take a reasonable suspicion or post-accident test
without proper grounds under a DOT agency drug or alcohol regulation,
you must inform the employee that you cannot play a role in deciding
these issues.

\(d\) It is not your function to consider explanations of confirmed
positive, adulterated, or substituted test results that would not, even
if true, constitute a legitimate medical explanation. For example, an
employee may tell you that someone slipped amphetamines into her drink
at a party, that she unknowingly ingested a marijuana brownie, or that
she traveled in a closed car with several people smoking crack. MROs are
unlikely to be able to verify the facts of such passive or unknowing
ingestion stories. Even if true, such stories do not present a
legitimate medical explanation. Consequently, you must not declare a
test as negative based on an explanation of this kind.

\(e\) You must not verify a test negative based on information that a
physician recommended that the employee use a drug listed in Schedule I
of the Controlled Substances Act. (e.g., under a state law that purports
to authorize such recommendations, such as the "medical marijuana" laws
that some states have adopted).

\(f\) You must not accept an assertion of consumption or other use of a
hemp or other non-prescription marijuana-related product as a basis for
verifying a marijuana test negative. You also must not accept such an
explanation related to consumption of coca teas as a basis for verifying
a cocaine test result as negative. Consuming or using such a product is
not a legitimate medical explanation.

\(g\) You must not accept an assertion that there is a legitimate
medical explanation for the presence of PCP or 6-AM in a specimen. There
are no legitimate medical explanations for the presence of these
substances.

\(h\) You must not accept, as a legitimate medical explanation for an
adulterated specimen, an assertion that soap, bleach, or glutaraldehyde
entered a specimen through physiological means. There are no
physiological means through which these substances can enter a specimen.

\(i\) You must not accept, as a legitimate medical explanation for a
substituted specimen, an assertion that an employee can produce urine
with no detectable creatinine. There are no physiological means through
which a person can produce a urine specimen having this characteristic.

\[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41952, Aug. 9, 2001\]

**§ 40.153   How does the MRO notify employees of their right to a test
of the split specimen?**

\(a\) As the MRO, when you have verified a drug test as positive for a
drug or drug metabolite, or as a refusal to test because of adulteration
or substitution, you must notify the employee of his or her right to
have the split specimen tested. You must also notify the employee of the
procedures for requesting a test of the split specimen.

\(b\) You must inform the employee that he or she has 72 hours from the
time you provide this notification to him or her to request a test of
the split specimen.

\(c\) You must tell the employee how to contact you to make this
request. You must provide telephone numbers or other information that
will allow the employee to make this request. As the MRO, you must have
the ability to receive the employee\'s calls at all times during the 72
hour period (e.g., by use of an answering machine with a "time stamp"
feature when there is no one in your office to answer the phone).

\(d\) You must tell the employee that if he or she makes this request
within 72 hours, the employer must ensure that the test takes place, and
that the employee is not required to pay for the test from his or her
own funds before the test takes place. You must also tell the employee
that the employer may seek reimbursement for the cost of the test (see
§40.173 ).

\(e\) You must tell the employee that additional tests of the specimen
e.g., DNA tests) are not authorized.

**§ 40.155   What does the MRO do when a negative or positive test
result is also dilute?**

\(a\) When the laboratory reports that a specimen is dilute, or reports
that a specimen is substituted with a creatinine quantitation of greater
than or equal to 2 mg/dL, you must, as the MRO, report to the DER that
the specimen, in addition to being negative or positive, is dilute.

\(b\) You must check the "dilute" box (Step 6) on Copy 2 of the CCF.

\(c\) When you report a dilute specimen to the DER, you must explain to
the DER the employer\'s obligations and choices under §40.197.

\[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41952, Aug. 9, 2001;
68 FR 31626, May 28, 2003\]

**§ 40.157   \[Reserved\]**

**§ 40.159   What does the MRO do when a drug test result is invalid?**

\(a\) As the MRO, when the laboratory reports that the test result is an
invalid result, you must do the following:

\(1\) Discuss the laboratory results with a certifying scientist to
obtain more specific information.

\(2\) Contact the employee and inform the employee that the specimen was
invalid or contained an unexplained interfering substance. In contacting
the employee, use the procedures set forth in §40.131.

\(3\) After explaining the limits of disclosure (see §§40.135(d) and
40.327), you should inquire as to medications the employee may have
taken that may interfere with some immunoassay tests.

\(4\) If the employee gives an explanation that is acceptable, you must:

\(i\) Place a check mark in the "Test Cancelled" box (Step 6) on Copy 2
of the CCF and enter "Invalid Result" and "direct observation collection
not required" on the "Remarks" line.

\(ii\) Report to the DER that the test is cancelled, the reason for
cancellation, and that no further action is required unless a negative
test result is required (i.e., pre-employment, return-to-duty, or
follow-up tests).

\(5\) If the employee is unable to provide an explanation and/or a valid
prescription for a medication that interfered with the immunoassay test
but denies having adulterated the specimen, you must:

\(i\) Place a check mark in the "Test Cancelled" box (Step 6) on Copy 2
of the CCF and enter "Invalid Result" and "direct observation collection
required" on the "Remarks" line.

\(ii\) Report to the DER that the test is cancelled, the reason for
cancellation, and that a second collection must take place immediately
under direct observation.

\(iii\) Instruct the employer to ensure that the employee has the
minimum possible advance notice that he or she must go to the collection
site.

\(b\) You may only report an invalid test result when you are in
possession of a legible copy of Copy 1 of the CCF. In addition, you must
have Copy 2 of the CCF, a legible copy of it, or any other copy of the
CCF containing the employee\'s signature.

\(c\) If the employee admits to having adulterated or substituted the
specimen, you must, on the same day, write and sign your own statement
of what the employee told you. You must then report a refusal to test in
accordance with §40.163 .

**§ 40.161   What does the MRO do when a drug test specimen is rejected
for testing?**

As the MRO, when the laboratory reports that the specimen is rejected
for testing (e.g., because of a fatal or uncorrected flaw), you must do
the following:

\(a\) Place a check mark in the "Test Cancelled" box (Step 6) on Copy 2
of the CCF and enter the reason on the "Remarks" line.

\(b\) Report to the DER that the test is cancelled and the reason for
cancellation, and that no further action is required unless a negative
test is required (e.g., in the case of a pre-employment, return-to-duty,
or follow-up test).

\(c\) You may only report a test cancelled because of a rejected for
testing test result when you are in possession of a legible copy of Copy
1 of the CCF. In addition, you must have Copy 2 of the CCF, a legible
copy of it, or any other copy of the CCF containing the employee\'s
signature.

**§ 40.163   How does the MRO report drug test results?**

\(a\) 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 to report test results.

\(c\) If you do not report test results using Copy 2 of the CCF for this
purpose, you must provide a written report (e.g., a letter) for each
test result. This report must, as a minimum, include the following
information:

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

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

\(3\) Reason for the test, if indicated on the CCF (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) and the date the result was verified by the MRO;

\(7\) For verified positive tests, the drug(s)/metabolite(s) for which
the test was positive;

\(8\) For cancelled tests, the reason for cancellation; and

\(9\) For refusals to test, the reason for the refusal determination
(e.g., in the case of an adulterated test result, the name of the
adulterant).

\(d\) As an exception to the reporting requirements of paragraph (b) and
(c) of this section, the MRO may report negative results using an
electronic data file.

\(1\) If you report negatives using an electronic data file, the report
must contain, 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 your name, address, and phone
number, the name of any person other than you reporting the results, and
the date the electronic results report is released.

\(e\) You must retain a signed or stamped and dated copy of Copy 2 of
the CCF in your records. If you do not use Copy 2 for reporting results,
you must maintain a copy of the signed or stamped and dated letter in
addition to the signed or stamped and dated Copy 2. If you use the
electronic data file to report negatives, you must maintain a
retrievable copy of that report in a format suitable for inspection and
auditing by a DOT representative.

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

\(g\) You must not provide quantitative values to the DER or C/TPA for
drug or validity test results. However, you must provide the test
information in your possession to a SAP who consults with you (see
§40.293(g)).

\[66 FR 41952, Aug. 9, 2001\]

**§ 40.165   To whom does the MRO transmit reports of drug test
results?**

\(a\) As the MRO, you must report all drug test results to the DER,
except in the circumstances provided for in §40.345 .

\(b\) If the employer elects to receive reports of results through a
C/TPA, acting as an intermediary as provided in §40.345 , you must
report the results through the designated C/TPA.

**§ 40.167   How are MRO reports of drug results transmitted to the
employer?**

As the MRO or C/TPA who transmits drug test results to the employer, you
must comply with the 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 next business day all verified positive test results,
results requiring an immediate collection under direct observation,
adulterated or substituted specimen results, and other refusals to test.

\(1\) Direct telephone contact with the DER is the preferred method of
immediate reporting. Follow up your phone call with appropriate
documentation (see §40.163).

\(2\) You are responsible for identifying yourself to the DER, and the
DER must have a means to confirm your identification.

\(3\) The MRO\'s report that you transmit to the employer must contain
all of the information required by §40.163 .

\(c\) You must transmit the MRO\'s report(s) of verified tests to the
DER so that the DER receives it within two days of verification by the
MRO.

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

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

\(d\) In transmitting test results, you or the C/TPA and the employer
must ensure the security of the transmission and limit access to any
transmission, storage, or retrieval systems.

\(e\) MRO reports are not subject to modification or change by anyone
other than the MRO, as provided in §40.149(c).

\[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41953, Aug. 9, 2001\]

**§ 40.169   Where is other information concerning the role of MROs and
the verification process found in this regulation?**

You can find more information concerning the role 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**

**§ 40.171   How does an employee request a test of a split specimen?**

\(a\) As an employee, when the MRO has notified you that you have a
verified positive drug test or refusal to test because of adulteration
or substitution, you have 72 hours from the time of notification to
request a test of the split specimen. The request may be verbal or in
writing. If you make this request to the MRO within 72 hours, you
trigger the requirements of this section for a test of the split
specimen.

(b)(1) If, as an employee, you have not requested a test of the split
specimen within 72 hours, you may present to the MRO information
documenting that serious injury, illness, lack of actual notice of the
verified test result, inability to contact the MRO (e.g., there was no
one in the MRO\'s office and the answering machine was not working), or
other circumstances unavoidably prevented you from making a timely
request.

\(2\) As the MRO, if you conclude from the employee\'s information that
there was a legitimate reason for the employee\'s failure to contact you
within 72 hours, you must direct that the test of the split specimen
take place, just as you would when there is a timely request.

\(c\) When the employee makes a timely request for a test of the split
specimen under paragraphs (a) and (b) of this section, you must, as the
MRO, immediately provide written notice to the laboratory that tested
the primary specimen, directing the laboratory to forward the split
specimen to a second HHS-certified laboratory. You must also document
the date and time of the employee\'s request.

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

\(a\) As the employer, you are responsible for making sure (e.g., by
establishing appropriate accounts with laboratories for testing split
specimens) that the MRO, first laboratory, and second laboratory perform
the functions noted in §§40.175--40.185 in a timely manner, once the
employee has made a timely request for a test of the split specimen.

\(b\) As the employer, you must not condition your compliance with these
requirements on the employee\'s direct payment to the MRO or laboratory
or the employee\'s agreement to reimburse you for the costs of testing.
For example, if you ask the employee to pay for some or all of the cost
of testing the split specimen, and the employee is unwilling or unable
to do so, you must ensure that the test takes place in a timely manner,
even though this means that you pay for it.

\(c\) As the employer, you may seek payment or reimbursement of all or
part of the cost of the split specimen from the employee (e.g., through
your written company policy or a collective bargaining agreement). This
part takes no position on who ultimately pays the cost of the test, so
long as the employer ensures that the testing is conducted as required
and the results released appropriately.

**§ 40.175   What steps does the first laboratory take with a split
specimen?**

\(a\) As the laboratory at which the primary and split specimen first
arrive, you must check to see whether the split specimen is available
for testing.

\(b\) If the split specimen is unavailable or appears insufficient, you
must then do the following:

\(1\) Continue the testing process for the primary specimen as you would
normally. Report the results for the primary specimen without providing
the MRO information regarding the unavailable split specimen.

\(2\) Upon receiving a letter from the MRO instructing you to forward
the split specimen to another laboratory for testing, report to the MRO
that the split specimen is unavailable for testing. Provide as much
information as you can about the cause of the unavailability.

\(c\) As the laboratory that tested the primary specimen, you are not
authorized to open the split specimen under any circumstances (except
when the split specimen is redesignated as provided in §40.83).

\(d\) When you receive written notice from the MRO instructing you to
send the split specimen to another HHS-certified laboratory, you must
forward the following items to the second laboratory:

\(1\) The split specimen in its original specimen bottle, with the seal
intact;

\(2\) A copy of the MRO\'s written request; and

\(3\) A copy of Copy 1 of the CCF, which identifies the
drug(s)/metabolite(s) or the validity criteria to be tested for.

\(e\) You must not send to the second laboratory any information about
the identity of the employee. Inadvertent disclosure does not, however,
cause a fatal flaw.

\(f\) This subpart does not prescribe who gets to decide which
HHS-certified laboratory is used to test the split specimen. That
decision is left to the parties involved.

**§ 40.177   What does the second laboratory do with the split specimen
when it is tested to reconfirm the presence of a drug or drug
metabolite?**

\(a\) As the laboratory testing the split specimen, you must test the
split specimen for the drug(s)/drug metabolite(s) detected in the
primary specimen.

\(b\) You must conduct this test without regard to the cutoff
concentrations of §40.87 .

\(c\) If the test fails to reconfirm the presence of the drug(s)/drug
metabolite(s) that were reported positive in the primary specimen, you
must conduct validity tests in an attempt to determine the reason for
being unable to reconfirm the presence of the drug(s)/metabolite(s). You
should conduct the same validity tests as you would conduct on a primary
specimen set forth in §40.91 .

\(d\) In addition, if the test fails to reconfirm the presence of the
drugs/drugs metabolites or validity criteria that were reported in the
primary specimen, you may transmit the specimen or an aliquot of it to
another HHS-certified laboratory that will conduct another
reconfirmation test.

**§ 40.179   What does the second laboratory do with the split specimen
when it is tested to reconfirm an adulterated test result?**

As the laboratory testing the split specimen, you must test the split
specimen for the adulterant detected in the primary specimen, using the
criteria of §40.95 just as you would do for a primary specimen. The
result of the primary specimen is reconfirmed if the split specimen
meets these criteria.

**§ 40.181   What does the second laboratory do with the split specimen
when it is tested to reconfirm a substituted test result?**

As the laboratory testing the split specimen, you must test the split
specimen using the criteria of §40.93(b), just as you would do for a
primary specimen. The result of the primary specimen is reconfirmed if
the split specimen meets these criteria.

**§ 40.183   What information do laboratories report to MROs regarding
split specimen results?**

\(a\) As the laboratory responsible for testing the split specimen, you
must report split specimen test results by checking the "Reconfirmed"
box or the "Failed to Reconfirm" box (Step 5(b)) on Copy 1 of the CCF.

\(b\) If you check the "Failed to Reconfirm" box, one of the following
statements must be included (as appropriate) on the "Reason" line (Step
5(b)):

\(1\) "Drug(s)/Drug Metabolite(s) Not Detected."

\(2\) "Adulterant not found within criteria."

\(3\) "Specimen not consistent with substitution criteria \[specify
creatinine, specific gravity, or both\]"

\(4\) "Specimen not available for testing."

\(c\) As the laboratory certifying scientist, enter your name, sign, and
date the CCF.

**§ 40.185   Through what methods and to whom must a laboratory report
split specimen results?**

\(a\) As the laboratory testing the split specimen, you must report
laboratory results directly, and only, to the MRO at his or her place of
business. You must not report results to or through the DER or another
service agent (e.g., a C/TPA).

\(b\) You must fax, courier, mail, or electronically transmit a legible
image or copy of the fully-completed Copy 1 of the CCF, which has been
signed by the certifying scientist.

\(c\) You must transmit the laboratory result to the MRO immediately,
preferably on the same day or next business day as the result is signed
and released.

**§ 40.187   What does the MRO do with split specimen laboratory
results?**

As an MRO, you must take the following actions when a laboratory reports
the following results of split specimen tests:

\(a\) Reconfirmed. (1) In the case of a reconfirmed positive test for a
drug or drug metabolite, report the reconfirmation to the DER and the
employee.

\(2\) In the case of a reconfirmed adulterated or substituted result,
report to the DER and the employee that the specimen was adulterated or
substituted, either of which constitutes a refusal to test. Therefore,
"refusal to test" is the final result.

\(3\) In the case of a reconfirmed substituted result, in which the
creatinine concentration for the primary specimen was less than 2 mg/dL
and the creatinine concentration of the split specimen is between 2 and
5 mg/DL, inclusive, report the result to the employer as "dilute" and
instruct the employer to conduct an immediate recollection under direct
observation.

\(b\) Failed to Reconfirm: Drug(s)/Drug Metabolite(s) Not Detected. (1)
Report to the DER and the employee that both tests must be cancelled.

\(2\) Using the format in Appendix D to this part, inform ODAPC of the
failure to reconfirm.

\(c\) Failed to Reconfirm: Adulteration or Substitution (as appropriate)
Criteria Not Met. (1) Report to the DER and the employee that both tests
must be cancelled.

\(2\) Using the format in Appendix D to this part, inform ODAPC of the
failure to reconfirm.

\(d\) Failed to Reconfirm: Specimen not Available for Testing. (1)
Report to the DER and the employee that both tests must be cancelled and
the reason for cancellation.

\(2\) Direct the DER to ensure the immediate collection of another
specimen from the employee under direct observation, with no notice
given to the employee of this collection requirement until immediately
before the collection.

\(3\) Using the format in Appendix D to this part, notify ODAPC of the
failure to reconfirm.

\(e\) Failed to Reconfirm: Specimen Results Invalid. (1) Report to the
DER and the employee that both tests must be cancelled and the reason
for cancellation.

\(2\) Direct the DER to ensure the immediate collection of another
specimen from the employee under direct observation, with no notice
given to the employee of this collection requirement until immediately
before the collection.

\(3\) Using the format in Appendix D to this part, notify ODAPC of the
failure to reconfirm.

\(f\) Failed to Reconfirm: Split Specimen Adulterated. (1) Contact the
employee and inform the employee that the laboratory has determined that
his or her split specimen is adulterated.

\(2\) Follow the procedures of §40.145 to determine if there is a
legitimate medical explanation for the laboratory finding of
adulteration.

\(3\) If you determine that there is a legitimate medical explanation
for the adulterated test result, report to the DER and the employee that
the test is cancelled. Using the format in Appendix D to this part,
notify ODAPC of the result.

\(4\) If you determine that there is not a legitimate medical
explanation for the adulterated test result, take the following steps:

\(i\) Report the test to the DER and the employee as a verified refusal
to test. Inform the employee that he or she has 72 hours to request a
test of the primary specimen to determine if the adulterant found in the
split specimen also is present in the primary specimen.

\(ii\) Except that the request is for a test of the primary specimen and
is being made to the laboratory that tested the primary specimen, follow
the procedures of §§40.153, 40.171, 40.173, 40.179, and 40.185.

\(iii\) As the laboratory that tests the primary specimen to reconfirm
the presence of the adulterant found in the split specimen, report your
result to the MRO on a photocopy (faxed, mailed, scanned, couriered) of
Copy 1 of the CCF .

\(iv\) If the test of the primary specimen reconfirms the adulteration
finding of the split specimen, as the MRO you must report the test
result as a refusal as provided in §40.187(a)(2).

\(v\) If the test of the primary specimen fails to reconfirm the
adulteration finding of the split specimen, as the MRO you cancel the
test. Follow the procedures of paragraph (e) of this section in this
situation.

\(g\) Enter your name, sign and date (Step 7) of Copy 2 of the CCF.

\(h\) Send a legible copy of Copy 2 of the CCF (or a signed and dated
letter, see §40.163 ) to the employer and keep a copy for your records.
Transmit the document as provided in §40.167.

\[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41953, Aug. 9, 2001;
68 FR 31626, May 28, 2003\]

**§ 40.189   Where is other information concerning split specimens found
in this regulation?**

You can find more information concerning split specimens in several
sections of this part:

> §40.3---Definition.
>
> §40.65---Quantity of split specimen.
>
> §40.67---Directly observed test when split specimen is unavailable.
>
> §§40.71--40.73---Collection process for split specimens.
>
> §40.83---Laboratory accessioning of split specimens.
>
> §40.99---Laboratory retention of split specimens.
>
> §40.103---Blind split specimens.
>
> §40.153---MRO notice to employees on tests of split specimen.
>
> §§40.193 and 40.201---MRO actions on insufficient or unavailable split
> specimens.
>
> Appendix D to Part 40---Report format for split specimen failure to
> reconfirm.

**Subpart I---Problems in Drug Tests**

**§ 40.191   What is a refusal to take a DOT drug test, and what are the
consequences?**

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

\(1\) Fail to appear for any test (except a pre-employment test) within
a reasonable time, as determined by the employer, consistent with
applicable DOT agency regulations, after being directed to do so by the
employer. This includes the failure of an employee (including an
owner-operator) to appear for a test when called by a C/TPA (see
§40.61(a));

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

\(3\) Fail to provide a urine specimen for any drug test required by
this part or DOT agency regulations; Provided, That an employee who does
not provide a urine specimen because he or she has left the testing site
before the testing process commences (see §40.63 (c)) for a
pre-employment test is not deemed to have refused to test;

\(4\) In the case of a directly observed or monitored collection in a
drug test, fail to permit the observation or monitoring of your
provision of a specimen (see §§40.67(l) and 40.69(g));

\(5\) Fail to provide a sufficient amount of urine when directed, and it
has been determined, through a required medical evaluation, that there
was no adequate medical explanation for the failure (see §40.193(d)(2));

\(6\) Fail or decline to take an additional drug test the employer or
collector has directed you to take (see, for instance, §40.197(b));

\(7\) Fail to undergo a medical examination or evaluation, as directed
by the MRO as part of the verification process, or as directed by the
DER under §40.193(d). In the case of a pre-employment drug test, the
employee is deemed to have refused to test on this basis only if the
pre-employment test is conducted following a contingent offer of
employment; or

\(8\) Fail to cooperate with any part of the testing process (e.g.,
refuse to empty pockets when so directed by the collector, behave in a
confrontational way that disrupts the collection process).

\(b\) As an employee, if the MRO reports that you have a verified
adulterated or substituted test result, you have refused to take a drug
test.

\(c\) As an employee, if you refuse to take a drug test, you incur the
consequences specified under DOT agency regulations for a violation of
those DOT agency regulations.

\(d\) As a collector or an MRO, when an employee refuses to participate
in the part of the testing process in which you are involved, you must
terminate the portion of the testing process in which you are involved,
document the refusal on the CCF (including, in the case of the
collector, printing the employee\'s name on Copy 2 of the CCF),
immediately notify the DER by any means (e.g., telephone or secure fax
machine) that ensures that the refusal notification is immediately
received. As a referral physician (e.g., physician evaluating a "shy
bladder" condition or a claim of a legitimate medical explanation in a
validity testing situation), you must notify the MRO, who in turn will
notify the DER.

\(1\) As the collector, you must note the refusal in the "Remarks" line
(Step 2), and sign and date the CCF.

\(2\) As the MRO, you must note the refusal by checking the "refused to
test because" box (Step 6) on Copy 2 of the CCF, and add the reason on
the "Remarks" line. You must then sign and date the CCF.

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

\[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41953, Aug. 9, 2001;
68 FR 31626, May 28, 2003\]

**§ 40.193   What happens when an employee does not provide a sufficient
amount of urine for a drug test?**

\(a\) This section prescribes procedures for situations in which an
employee does not provide a sufficient amount of urine to permit 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 out of temperature range or showed evidence of adulteration
or tampering (see §40.65(b) and (c)).

\(2\) Urge the employee to drink up to 40 ounces of fluid, distributed
reasonably through a period of up to three hours, or until the
individual has provided a sufficient urine specimen, whichever occurs
first. It is not a refusal to test if the employee declines to drink.
Document on the Remarks line of the CCF (Step 2), and inform the
employee of, the time at which the three-hour period begins and ends.

\(3\) If the employee refuses to make the attempt to provide a new urine
specimen or leaves the collection site before the collection process is
complete, you must discontinue the collection, note the fact on the
"Remarks" line of the CCF (Step 2), and immediately notify the DER. This
is a refusal to test.

\(4\) If the employee has not provided a sufficient specimen within
three hours of the first unsuccessful attempt to provide the specimen,
you must discontinue the collection, note the fact on the "Remarks" line
of the CCF (Step 2), and immediately notify the DER.

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

\(c\) As the DER, when the collector informs you that the employee has
not provided a sufficient amount of urine (see paragraph (b)(4) of this
section), you must, after consulting with the MRO, direct the employee
to obtain, within five days, an evaluation from a licensed physician,
acceptable to the MRO, who has expertise in the medical issues raised by
the employee\'s failure to provide a sufficient specimen. (The MRO may
perform this evaluation if the MRO has appropriate expertise.)

\(1\) As the MRO, if another physician will perform the evaluation, you
must provide the other physician with the following information and
instructions:

\(i\) That the employee was required to take a DOT drug test, but was
unable to provide a sufficient amount of urine to complete the test;

\(ii\) The consequences of the appropriate DOT agency regulation for
refusing to take the required drug test;

\(iii\) That the referral physician must agree to follow the
requirements of paragraphs (d) through (g) of this section.

\(2\) \[Reserved\]

\(d\) As the referral physician conducting this evaluation, you must
recommend that the MRO make one of the following determinations:

\(1\) A medical condition has, or with a high degree of probability
could have, precluded the employee from providing a sufficient amount of
urine. As the MRO, if you accept this recommendation, you must:

\(i\) Check "Test Cancelled" (Step 6) on the 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 probability could have,
precluded the employee from providing a sufficient amount of urine. As
the MRO, if you accept this recommendation, you must:

\(i\) Check "Refusal to test because" (Step 6) on the CCF and enter
reason in the remarks line; and

\(ii\) Sign and date the CCF.

\(e\) For purposes of this paragraph, a medical condition includes an
ascertainable physiological condition (e.g., a urinary system
dysfunction) or a medically documented pre-existing psychological
disorder, but does not include unsupported assertions of "situational
anxiety" or dehydration.

\(f\) As the referral physician making the evaluation, after completing
your evaluation, you must provide a written statement of your
recommendations and the basis for them to the MRO. You must not include
in this statement detailed information on the employee\'s medical
condition beyond what is necessary to explain your conclusion.

\(g\) If, as the referral physician making this evaluation in the case
of a pre-employment test, you determine that the employee\'s medical
condition is a serious and permanent or long-term disability that is
highly likely to prevent the employee from providing a sufficient amount
of urine for a very long or indefinite period of time, you must set
forth your determination and the reasons for it in your written
statement to the MRO. As the MRO, upon receiving such a report, you must
follow the requirements of §40.195, where applicable.

\(h\) As the MRO, you must seriously consider and assess the referral
physician\'s recommendations in making your determination about whether
the employee has a medical condition that has, or with a high degree of
probability could have, precluded the employee from providing a
sufficient amount of urine. You must report your determination to the
DER in writing as soon as you make it.

\(i\) As the employer, when you receive a report from the MRO indicating
that a test is cancelled as provided in paragraph (d)(1) of this
section, you take no further action with respect to the employee. The
employee remains in the random testing pool.

\[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41953, Aug. 9, 2001\]

**§ 40.195   What happens when an individual is unable to provide a
sufficient amount of urine for a pre-employment follow-up or
return-to-duty test because of a permanent or long-term medical
condition?**

\(a\) This section concerns a situation in which an employee has a
medical condition that precludes him or her from providing a sufficient
specimen for a pre-employment follow-up or return-to-duty test and the
condition involves a permanent or long-term disability. As the MRO in
this situation, you must do the following:

\(1\) You must determine if there is clinical evidence that the
individual is an illicit drug user. You must make this determination by
personally conducting, or causing to be conducted, a medical evaluation
and through consultation with the employee\'s physician and/or the
physician who conducted the evaluation under §40.193(d).

\(2\) If you do not personally conduct the medical evaluation, you must
ensure that one is conducted by a licensed physician acceptable to you.

\(3\) For purposes of this section, the MRO or the physician conducting
the evaluation may conduct an alternative test (e.g., blood) as part of
the medically appropriate procedures in determining clinical evidence of
drug use.

\(b\) If the medical evaluation reveals no clinical evidence of drug
use, as the MRO, you must report the result to the employer as a
negative test with written notations regarding results of both the
evaluation conducted under §40.193(d) and any further medical
examination. This report must state the basis for the determination that
a permanent or long-term medical condition exists, making provision of a
sufficient urine specimen impossible, and for the determination that no
signs and symptoms of drug use exist.

\(1\) Check "Negative" (Step 6) on the CCF.

\(2\) Sign and date the CCF.

\(c\) If the medical evaluation reveals clinical evidence of drug use,
as the MRO, you must report the result to the employer as a cancelled
test with written notations regarding results of both the evaluation
conducted under §40.193(d) and any further medical examination. This
report must state that a permanent or long-term medical condition
exists, making provision of a sufficient urine specimen impossible, and
state the reason for the determination that signs and symptoms of drug
use exist. Because this is a cancelled test, it does not serve the
purposes of a negative test (i.e., the employer is not authorized to
allow the employee to begin or resume performing safety-sensitive
functions, because a negative test is needed for that purpose).

\(d\) For purposes of this section, permanent or long-term medical
conditions are those physiological, anatomic, or psychological
abnormalities documented as being present prior to the attempted
collection, and considered not amenable to correction or cure for an
extended period of time, if ever.

\(1\) Examples would include destruction (any cause) of the glomerular
filtration system leading to renal failure; unrepaired traumatic
disruption of the urinary tract; or a severe psychiatric disorder
focused on genito-urinary matters.

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

\[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41953, Aug. 9, 2001\]

**§ 40.197   What happens when an employer receives a report of a dilute
specimen?**

\(a\) As the employer, if the MRO informs you that a positive drug test
was dilute, you simply treat the test as a verified positive test. You
must not direct the employee to take another test based on the fact that
the specimen was dilute.

\(b\) As an employer, if the MRO informs you that a negative test was
dilute, take the following action:

\(1\) If the MRO directs you to conduct a recollection under direct
observation (i.e., because the creatinine concentration of the specimen
was equal to or greater than 2mg/dL, but less than or equal to 5 mg/dL
(see §40.145(a)(1)), you must do so immediately.

\(2\) Otherwise (i.e., if the creatinine concentration of the dilute
specimen is greater than 5 mg/dL), you may, but are not required to,
direct the employee to take another test immediately.

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

\(ii\) You must treat all employees the same for this purpose. For
example, you must not retest some employees and not others. You may,
however, establish different policies for different types of tests
(e.g., conduct retests in pre-employment situations, but not in random
test situations). You must inform your employees in advance of your
decisions on these matters.

\(c\) The following provisions apply to all tests you direct an employee
to take under paragraph (b) of this section:

\(1\) You must ensure that the employee is given the minimum possible
advance notice that he or she must go to the collection site;

\(2\) You must treat the result of the test you directed the employee to
take under paragraph (b) of this section---and not a prior test---as the
test result of record, on which you rely for purposes of this part;

\(3\) If the result of the test you directed the employee to take under
paragraph (b) of this section is also negative and dilute, you are not
permitted to make the employee take an additional test because the
result was dilute. Provided, however, that if the MRO directs you to
conduct a recollection under direct observation under paragraph (b)(1)
of this section, you must immediately do so.

\(4\) If the employee declines to take a test you directed him or her to
take under paragraph (b) of this section, the employee has refused the
test for purposes of this part and DOT agency regulations.

\[68 FR 31626, May 28, 2003\]

**§ 40.199   What problems always cause a drug test to be cancelled?**

\(a\) As the MRO, when the laboratory discovers a "fatal flaw" during
its processing of incoming specimens (see §40.83), the laboratory will
report to you that the specimen has been "Rejected for Testing" (with
the reason stated). You must always cancel 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 not
match;

\(3\) The specimen bottle seal is broken or shows evidence of tampering
(and a split specimen cannot be redesignated, see §40.83(g)); and

\(4\) Because of leakage or other causes, there is an insufficient
amount of urine in the primary specimen bottle for analysis and the
specimens cannot be redesignated (see §40.83(g)).

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

**§ 40.201 What problems always cause a drug test to be cancelled and
may result in a requirement for another collection?**

As the MRO, you must cancel a drug test when a laboratory reports that
any of the following problems have occurred. You must inform the DER
that the test was cancelled. You must also direct the DER to ensure that
an additional collection occurs immediately, if required by the
applicable 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 direct observation
may be required).

\(b\) The laboratory reports the result as "Rejected for Testing." You
must follow applicable procedures in §40.161 (a recollection may be
required).

\(c\) The laboratory\'s test of the primary specimen is positive and the
split specimen is reported by the laboratory as "Failure to Reconfirm:
Drug(s)/Drug Metabolite(s) Not Detected." You must follow applicable
procedures in §40.187(b) (no recollection is required in this case).

\(d\) The laboratory\'s test result for the primary specimen is
adulterated or substituted and the split specimen is reported by the
laboratory as "Adulterant not found within criteria," or " specimen not
consistent with substitution criteria, as applicable. You must follow
applicable procedures in §40.187(c) (no recollection is required in this
case).

\(e\) The laboratory\'s test of the primary specimen is positive,
adulterated, or substituted and the split specimen is unavailable for
testing. You must follow applicable procedures in §40.187(d)
(recollection under direct observation is required in this case).

\(f\) The examining physician has determined that there is an acceptable
medical explanation of the employee\'s failure to provide a sufficient
amount of urine. You must follow applicable procedures in §40.193(d)(1)
(no recollection is required in this case).

**§ 40.203   What problems cause a drug test to be cancelled unless they
are corrected?**

\(a\) As the MRO, when a laboratory discovers a "correctable flaw"
during its processing of incoming specimens (see §40.83), the laboratory
will attempt to correct it. If the laboratory is unsuccessful in this
attempt, it will report to you that the specimen has been "Rejected for
Testing" (with the reason stated).

\(b\) The following is a "correctable flaw" that laboratories must
attempt to correct: The collector\'s signature is omitted on the
certification statement on the CCF.

\(c\) As the MRO, when you discover a "correctable flaw" during your
review of the CCF, you must cancel the test unless the flaw is
corrected.

\(d\) The following are correctable flaws that you must attempt to
correct:

\(1\) The employee\'s signature is omitted from the certification
statement, unless the employee\'s failure or refusal to sign is noted on
the "Remarks" line of the CCF.

\(2\) The certifying scientist\'s signature is omitted on the laboratory
copy of the CCF for a positive, adulterated, substituted, or invalid
test result.

\(3\) The collector uses a non-Federal form or an expired Federal form
for the test. This flaw may be corrected through the procedure set forth
in §40.205(b)(2), provided that the collection testing process has been
conducted in accordance with the procedures of this part in an
HHS-certified laboratory. During the period August 1--October 31, 2001,
you are not required to cancel a test because of the use of an expired
Federal form. Beginning November 1, 2001, if the problem is not
corrected, you must cancel the test.

\[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41954, Aug. 9, 2001\]

**§ 40.205 How are drug test problems corrected?**

\(a\) As a collector, you have the responsibility of trying to
successfully complete a collection procedure for each employee.

\(1\) If, during or shortly after the collection process, you become
aware of any event that prevents the completion of a valid test or
collection (e.g., a procedural or paperwork error), you must try to
correct the problem promptly, if doing so is practicable. You may
conduct another collection as part of this effort.

\(2\) If another collection is necessary, you must begin the new
collection procedure as soon as possible, using a new CCF and a new
collection kit.

\(b\) If, as a collector, laboratory, MRO, employer, or other person
implementing these drug testing regulations, you become aware of a
problem that can be corrected (see §40.203 ), but which has not already
been corrected under paragraph (a) of this section, you must take all
practicable action to correct the problem so that the test is not
cancelled.

\(1\) If the problem resulted from the omission of required information,
you must, as the person responsible for providing that information,
supply in writing the missing information and a statement that it is
true and accurate. For example, suppose you are a collector, and you
forgot to make a notation on the "Remarks" line of the CCF that the
employee did not sign the certification. You would, when the problem is
called to your attention, supply a signed statement that the employee
failed or refused to sign the certification and that your statement is
true and accurate. You must supply this information on the same business
day on which you are notified of the problem, transmitting it by fax or
courier.

\(2\) If the problem is the use of a non-Federal form or an expired
Federal form, you must provide a signed statement (i.e., a memorandum
for the record). It must state that the incorrect form contains all the
information needed for a valid DOT drug test, and that the incorrect
form was used inadvertently or as the only means of conducting a test,
in circumstances beyond your control. The statement must also list the
steps you have taken to prevent future use of non-Federal forms or
expired Federal forms for DOT tests. For this flaw to be corrected, the
test of the specimen must have occurred at a HHS-certified laboratory
where it was tested consistent with the requirements of this part. You
must supply this information on the same business day on which you are
notified of the problem, transmitting it by fax or courier.

\(3\) You must maintain the written documentation of a correction with
the CCF.

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

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

\[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41954, Aug. 9, 2001\]

**§ 40.207   What is the effect of a cancelled drug test?**

\(a\) A cancelled drug test is neither positive nor negative.

\(1\) As an employer, you must not attach to a cancelled test the
consequences of a positive test or other violation of a DOT drug testing
regulation (e.g., removal from a safety-sensitive position).

\(2\) As an employer, you must not use a cancelled test for the purposes
of a negative test to authorize the employee to 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 not direct a recollection for an
employee because a test has been cancelled, except in the situations
cited in paragraph (a)(2) of this section or other provisions of this
part that require another test to be conducted (e.g., §§40.159(a)(5) and
40.187(b)).

\(b\) A cancelled test does not count toward compliance with DOT
requirements (e.g., being applied toward the number of tests needed to
meet the employer\'s minimum random testing rate).

\(c\) A cancelled DOT test does not provide a valid basis for an
employer to conduct a non-DOT test (i.e., a test under company
authority).

**§ 40.208   What problem requires corrective action but does not result
in the cancellation of a test?**

\(a\) If, as a laboratory, collector, employer, or other person
implementing the DOT drug testing program, you become aware that the
specimen temperature on the CCF was not checked and the "Remarks" line
did not contain an entry regarding the temperature being out of range,
you must take corrective action, including securing a memorandum for the
record explaining the problem and taking appropriate action to ensure
that the problem does not recur.

\(b\) This error does not result in the cancellation of the test.

\(c\) As an employer or service agent, this error, even though not
sufficient to cancel a drug test result, may subject you to enforcement
action under DOT agency regulations or Subpart R of this part.

\[66 FR 41954, Aug. 9, 2001\]

**§ 40.209   What procedural problems do not result in the cancellation
of a test and do not require collection?**

\(a\) As a collector, laboratory, MRO, employer or other person
administering the drug testing process, you must document any errors in
the testing process of which you become aware, even if they are not
considered problems that will cause a test to be cancelled as listed in
this subpart. Decisions about the ultimate impact of these errors will
be determined by other administrative or legal proceedings, subject to
the limitations of paragraph (b) of this section.

\(b\) No person concerned with the testing process may declare a test
cancelled based on an error that does not have a significant adverse
effect on the right of the employee to have a fair and accurate test.
Matters that do not result in the cancellation of a test include, but
are not limited to, the following:

\(1\) A minor administrative mistake (e.g., the omission of the
employee\'s middle initial, a transposition of numbers in the
employee\'s social security number);

\(2\) An error that does not affect employee protections under this part
(e.g., the collector\'s failure to add bluing agent to the toilet bowl,
which adversely affects only the ability of the collector to detect
tampering with the specimen by the employee);

\(3\) The collection of a specimen by a collector who is required to
have been trained (see §40.33), but who has not met this requirement;

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

\(5\) Verification of a test result by an MRO who has the basic
credentials to be qualified as an MRO (see §40.121(a) through (b)) but
who has not met training and/or documentation requirements (see
§40.121(c) through (e));

\(6\) The failure to directly observe or monitor a collection that the
rule requires or permits to be directly observed or monitored, or the
unauthorized use of direct observation or monitoring for a collection;

\(7\) The fact that a test was conducted in a facility that does not
meet the requirements of §40.41;

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

\(9\) Personal identifying information is inadvertently contained on the
CCF (e.g., the employee signs his or her name on the laboratory copy);
or

\(10\) Claims that the employee was improperly selected for testing.

\(c\) As an employer or service agent, these types of errors, even
though not sufficient to cancel a drug test result, may subject you to
enforcement action under DOT agency regulations or action under Subpart
R of this part.

\[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41954, Aug. 9, 2001\]

**Subpart J - Alcohol Testing Personnel**

**§ 40.211   Who conducts DOT alcohol tests?**

\(a\) Screening test technicians (STTs) and breath alcohol technicians
(BATs) meeting their respective requirements of this subpart are the
only people authorized to conduct DOT alcohol tests.

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

\(c\) As a BAT- or STT-qualified immediate supervisor of a particular
employee, you may not act as the STT or BAT when that employee is
tested, unless no other STT or BAT is available and DOT agency
regulations do not prohibit you from doing so.

**§ 40.213   What training requirements must STTs and BATs meet?**

To be permitted to act as a BAT or STT in the DOT alcohol testing
program, you must meet each of the requirements of this section:

\(a\) [Basic information]{.underline}. You must be knowledgeable about
the alcohol testing procedures in this part and the current DOT
guidance. These documents and information are available from ODAPC
(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)).

\(b\) [Qualification training]{.underline}. You must receive
qualification training meeting the requirements of this paragraph (b).

\(1\) Qualification training must be in accordance with the DOT Model
BAT or STT Course, as applicable. The DOT Model Courses are available
from ODAPC (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). The training can also be provided using a
course of instruction equivalent to the DOT Model Courses. On request,
ODAPC will review BAT and STT instruction courses for equivalency.

\(2\) Qualification training must include training to proficiency in
using the alcohol testing procedures of this part and in the operation
of the particular alcohol testing device(s) (i.e., the ASD(s) or EBT(s))
you will be using.

\(3\) The training must emphasize that you are responsible for
maintaining the integrity of the testing process, ensuring the privacy
of employees being tested, and avoiding conduct or statements that could
be viewed as offensive or inappropriate.

\(4\) The instructor must be an individual who has demonstrated
necessary knowledge, skills, and abilities by regularly conducting DOT
alcohol tests as an STT or BAT, as applicable, for a period of at least
a year, who has conducted STT or BAT training, as applicable, under this
part for a year, or who has successfully completed a "train the trainer"
course.

\(c\) [Initial Proficiency Demonstration]{.underline}. Following your
completion of qualification training under paragraph (b) of this
section, you must demonstrate proficiency in alcohol testing under this
part by completing seven consecutive error-free mock tests (BATs) or
five consecutive error-free tests (STTs).

\(1\) Another person must monitor and evaluate your performance, in
person or by a means that provides real-time observation and interaction
between the instructor and trainee, and attest in writing that the mock
collections are "error-free." This person must be an individual who
meets the requirements of paragraph (b)(4) of this section.

\(2\) These tests must use the alcohol testing devices (e.g., EBT(s) or
ASD(s)) that you will use as a BAT or STT.

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

\(d\) [Schedule for qualification training and initial proficiency
demonstration]{.underline}. The following is the schedule for
qualification training and the initial proficiency demonstration you
must meet:

\(1\) If you became a BAT or STT before August 1, 2001, you were
required to have met the requirements set forth in paragraphs (b) and
(c) of this section, and you do not have to meet them again.

\(2\) If you become a BAT or STT on or after August 1, 2001, you must
meet the requirements of paragraphs (b) and (c) of this section before
you begin to perform BAT or STT functions.

\(e\) [Refresher training]{.underline}. No less frequently than every
five years from the date on which you satisfactorily complete the
requirements of paragraphs (b) and (c) of this section, you must
complete refresher training that meets all the requirements of
paragraphs (b) and (c) of this section. If you are a BAT or STT who
completed qualification training before January 1, 1998, you are not
required to complete refresher training until January 1, 2003.

\(f\) [Error Correction Training]{.underline}. If you make a mistake in
the alcohol testing process that causes a test to be cancelled (i.e., a
fatal or uncorrected flaw), you must undergo error correction training.
This training must occur within 30 days of the date you are notified of
the error that led to the need for retraining.

\(1\) Error correction training must be provided and your proficiency
documented in writing by a person who meets the requirements of
paragraph (b)(4) of this section.

\(2\) Error correction training is required to cover only the subject
matter area(s) in which the error that caused the test to be cancelled
occurred.

\(3\) As part of the error correction training, you must demonstrate
your proficiency in the alcohol testing procedures of this part by
completing three consecutive error-free mock tests. The mock tests must
include one uneventful scenario and two scenarios related to the area(s)
in which your error(s) occurred. The person providing the training must
monitor and evaluate your performance and attest in writing that the
mock tests were error-free.

\(g\) [Documentation]{.underline}. You must maintain documentation
showing that you currently meet all requirements of this section. You
must provide this documentation on request to DOT agency representatives
and to employers and C/TPAs who are negotiating to use your services.

\(h\) [Other persons who may serve as BATs or STTs]{.underline}. (1)
Anyone meeting the requirements of this section to be a BAT may act as
an STT, provided that the individual has demonstrated initial
proficiency in the operation of the ASD that he or she is using, as
provided in paragraph (c) of this section.

\(2\) Law enforcement officers who have been certified by state or local
governments to conduct breath alcohol testing are deemed to be qualified
as BATs. They are not required to also complete the training
requirements of this section in order to act as BATs. In order for a
test conducted by such an officer to be accepted under DOT alcohol
testing requirements, the officer must have been certified by a state or
local government to use the EBT or ASD that was used for the test.

\[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41954, Aug. 9, 2001\]

**§ 40.215   What information about the DER do employers have to provide
to BATs and STTs?**

As an employer, you must provide to the STTs and BATs the name and
telephone number of the appropriate DER (and C/TPA, where applicable) to
contact about any problems or issues that may arise during the testing
process.

**§ 40.217   Where is other information on the role of STTs and BATs
found in this regulation?**

You can find other information on the role and functions of STTs and
BATs in the following sections of this part:

> §40.3---Definitions.
>
> §40.223---Responsibility for supervising employees being tested.
>
> §§40.225--40.227---Use of the alcohol testing form.
>
> §§40.241--40.245---Screening test procedures with ASDs and EBTs.
>
> §§40.251--40.255---Confirmation test procedures.
>
> §40.261---Refusals to test.
>
> §§40.263--40.265---Insufficient saliva or breath.
>
> §40.267---Problems requiring cancellation of tests.
>
> §§40.269--40.271---Correcting problems in tests.

**Subpart K - Testing Sites, Forms, Equipment and Supplies Used in
Alcohol Testing**

**§ 40.221   Where does an alcohol test take place?**

\(a\) A DOT alcohol test must take place at an alcohol testing site
meeting the requirements of this section.

\(b\) If you are operating an alcohol testing site, you must ensure that
it meets the security requirements of §40.223.

\(c\) If you are operating an alcohol testing site, you must ensure that
it provides visual and aural privacy to the employee being tested,
sufficient to prevent unauthorized persons from seeing or hearing test
results.

\(d\) If you are operating an alcohol testing site, you must ensure that
it has all needed personnel, materials, equipment, and facilities to
provide for the collection and analysis of breath and/or saliva samples,
and a suitable clean surface for writing.

\(e\) If an alcohol testing site fully meeting all the visual and aural
privacy requirements of paragraph (c) is not readily available, this
part allows a reasonable suspicion or post-accident test to be conducted
at a site that partially meets these requirements. In this case, the
site must afford visual and aural privacy to the employee to the
greatest extent practicable.

\(f\) An alcohol testing site can be in a medical facility, a mobile
facility (e.g., a van), a dedicated collection facility, or any other
location meeting the requirements of this section.

**§ 40.223   What steps must be taken to protect the security of alcohol
testing sites?**

\(a\) If you are a BAT, STT, or other person operating an alcohol
testing site, you must prevent unauthorized personnel from entering the
testing site.

\(1\) The only people you are to treat as authorized persons are
employees being tested, BATs, STTs, and other alcohol testing site
workers, DERs, employee representatives authorized by the employer
(e.g., on the basis of employer policy or labor-management agreement),
and DOT agency representatives.

\(2\) You must ensure that all persons are under the supervision of a
BAT or STT at all times when permitted into the site.

\(3\) You may remove any person who obstructs, interferes with, or
causes unnecessary delay in the testing process.

\(b\) As the BAT or STT, you must not allow any person other than you,
the employee, or a DOT agency representative to actually witness the
testing process (see §§40.241--40.255).

\(c\) If you are operating an alcohol testing site, you must ensure that
when an EBT or ASD is not being used for testing, you store it in a
secure place.

\(d\) If you are operating an alcohol testing site, you must ensure that
no one other than BATs or other employees of the site have access to the
site when an EBT is unsecured.

\(e\) As a BAT or STT, to avoid distraction that could compromise
security, you are limited to conducting an alcohol test for only one
employee at a time.

\(1\) When an EBT screening test on an employee indicates an alcohol
concentration of 0.02 or higher, and the same EBT will be used for the
confirmation test, you are not allowed to use the EBT for a test on
another employee before completing the confirmation test on the first
employee.

\(2\) As a BAT who will conduct both the screening and the confirmation
test, you are to complete the entire screening and confirmation process
on one employee before starting the screening process on another
employee.

\(3\) You are not allowed to leave the alcohol testing site while the
testing process for a given employee is in progress, except to notify a
supervisor or contact a DER for assistance in the case an employee or
other person who obstructs, interferes with, or unnecessarily delays the
testing process.

**§ 40.225   What form is used for an alcohol test?**

\(a\) The DOT Alcohol Testing Form (ATF) must be used for every DOT
alcohol test beginning February 1, 2002. The ATF must be a three-part
carbonless manifold form. The ATF is found in Appendix G to this part.
You may view this form on the ODAPC web site
(http://www.dot.gov/ost/dapc).

\(b\) As an employer in the DOT alcohol testing program, you are not
permitted to modify or revise the ATF except as follows:

\(1\) You may include other information needed for billing purposes,
outside the boundaries of the form.

\(2\) You may use a ATF directly generated by an EBT which omits the
space for affixing a separate printed result to the ATF, provided the
EBT prints the result directly on the ATF.

\(3\) You may use an ATF that has the employer\'s name, address, and
telephone number preprinted. In addition, a C/TPA\'s name, address, and
telephone number may be included, to assist with negative results.

\(4\) You may use an ATF in which all pages are printed on white paper.
You may modify the ATF by using colored paper, or have clearly
discernable borders or designation statements on Copy 2 and Copy 3. When
colors are used, they must be green for Copy 2 and blue for Copy 3.

\(5\) As a BAT or STT, you may add, on the "Remarks" line of the ATF,
the name of the DOT agency under whose authority the test occurred.

\(6\) As a BAT or STT, you may use a ATF that has your name, address,
and telephone number preprinted, but under no circumstances can your
signature be preprinted.

\(c\) As an employer, you may use an equivalent foreign-language version
of the ATF approved by ODAPC. You may use such a non-English language
form only in a situation where both the employee and BAT/STT understand
and can use the form in that language.

\[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41954, Aug. 9, 2001\]

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

\(a\) No, as an employer, BAT, or STT, you are prohibited from using the
ATF for non-DOT alcohol tests. You are also prohibited from using
non-DOT forms for DOT alcohol tests. Doing either subjects you to
enforcement action under DOT agency regulations.

\(b\) If the STT or BAT, either by mistake, or as the only means to
conduct a test under difficult circumstances (e.g., post-accident test
with insufficient time to obtain the ATF), uses a non-DOT form for a DOT
test, the use of a non-DOT form does not, in and of itself, require the
employer or service agent to cancel the test. However, in order for the
test to be considered valid, a signed statement must be obtained from
the STT or BAT in accordance with §40.271(b) .

**§ 40.229   What devices are used to conduct alcohol screening tests?**

EBTs and ASDs on the NHTSA conforming products lists (CPL) for
evidential and non-evidential devices are the only devices you are
allowed to use to conduct alcohol screening tests under this part. You
may use an ASD that is on the NHTSA CPL for DOT alcohol tests only if
there are instructions for its use in this part. An ASD can be used only
for screening tests for alcohol, and may not be used for confirmation
tests.

\[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41954, Aug. 9, 2001\]

**§ 40.231   What devices are used to conduct alcohol confirmation
tests?**

\(a\) EBTs on the NHTSA CPL for evidential devices that meet the
requirements of paragraph (b) of this section are the only devices you
may use to conduct alcohol confirmation tests under this part. Note
that, among devices on the CPL for EBTs, only those devices listed
without an asterisk (\*) are authorized for use in confirmation testing
in the DOT alcohol testing program.

\(b\) To conduct a confirmation test, you must use an EBT that has the
following capabilities:

\(1\) Provides a printed triplicate result (or three consecutive
identical copies of a result) of each breath test;

\(2\) Assigns a unique number to each completed test, which the BAT and
employee can read before each test and which is printed on each copy of
the result;

\(3\) Prints, on each copy of the result, the manufacturer\'s name for
the device, its serial number, and the time of the test;

\(4\) Distinguishes alcohol from acetone at the 0.02 alcohol
concentration level;

\(5\) Tests an air blank; and

\(6\) Performs an external calibration check.

**§ 40.233   What are the requirements for proper use and care of
EBTs?**

\(a\) As an EBT manufacturer, you must submit, for NHTSA approval, a
quality assurance plan (QAP) for your EBT before NHTSA places the EBT on
the CPL.

\(1\) Your QAP must specify the methods used to perform external
calibration checks on the EBT, the tolerances within which the EBT is
regarded as being in proper calibration, and the intervals at which
these checks must be performed. In designating these intervals, your QAP
must take into account factors like frequency of use, environmental
conditions (e.g., temperature, humidity, altitude) and type of operation
(e.g., stationary or mobile).

\(2\) Your QAP must also specify the inspection, maintenance, and
calibration requirements and intervals for the EBT.

\(b\) As the manufacturer, you must include, with each EBT, instructions
for its use and care consistent with the QAP.

\(c\) As the user of the EBT (e.g., employer, service agent), you must
do the following:

\(1\) You must follow the manufacturer\'s instructions (see paragraph
(b) of this section), including performance of external calibration
checks at the intervals the instructions specify.

\(2\) In conducting external calibration checks, you must use only
calibration devices appearing on NHTSA\'s CPL for "Calibrating Units for
Breath Alcohol Tests."

\(3\) If an EBT fails an external check of calibration, you must take
the EBT out of service. You may not use the EBT again for DOT alcohol
testing until it is repaired and passes an external calibration check.

\(4\) You must maintain records of the inspection, maintenance, and
calibration of EBTs as provided in §40.333(a)(2) .

\(5\) You must ensure that inspection, maintenance, and calibration of
the EBT are performed by its manufacturer or a maintenance
representative certified either by the manufacturer or by a state health
agency or other appropriate state agency.

**§ 40.235   What are the requirements for proper use and care of
ASDs?**

\(a\) As an ASD manufacturer, you must submit, for NHTSA approval, a QAP
for your ASD before NHTSA places the ASD on the CPL. Your QAP must
specify the methods used for quality control checks, temperatures at
which the ASD must be stored and used, the shelf life of the device, and
environmental conditions (e.g., temperature, altitude, humidity) that
may affect the ASD\'s performance.

\(b\) As a manufacturer, you must include with each ASD instructions for
its use and care consistent with the QAP. The instructions must include
directions on the proper use of the ASD, and, where applicable the time
within which the device must be read, and the manner in which the
reading is made.

\(c\) As the user of the ADS (e.g., employer, STT), you must follow the
QAP instructions.

\(d\) You are not permitted to use an ASD that does not pass the
specified quality control checks or that has passed its expiration date.

\(e\) As an employer, with respect to breath ASDs, you must also follow
the device use and care requirements of §40.233 .

**Subpart L---Alcohol Screening Tests**

**§ 40.241   What are the first steps in any alcohol screening test?**

As the BAT or STT you will take the following steps to begin all alcohol
screening tests, regardless of the type of testing device you are using:

\(a\) When a specific time for an employee\'s test has been scheduled,
or the collection site is at the employee\'s worksite, and the employee
does not appear at the collection site at the scheduled time, contact
the DER to determine the appropriate interval within which the DER has
determined the employee is authorized to arrive. If the employee\'s
arrival is delayed beyond that time, you must notify the DER that the
employee has not reported for testing. In a situation where a C/TPA has
notified an owner/operator or other individual employee to report for
testing and the employee does not appear, the C/TPA must notify the
employee that he or she has refused to test.

\(b\) Ensure that, when the employee enters the alcohol testing site,
you begin the alcohol testing process without undue delay. For example,
you must not wait because the employee says he or she is not ready or
because an authorized employer or employee representative is delayed in
arriving.

\(1\) If the employee is also going to take a DOT drug test, you must,
to the greatest extent practicable, ensure that the alcohol test is
completed before the urine collection process begins.

\(2\) If the employee needs medical attention (e.g., an injured employee
in an emergency medical facility who is required to have a post-accident
test), do not delay this treatment to conduct a test.

\(c\) Require the employee to provide positive identification. You must
see a photo ID issued by the employer (other than in the case of an
owner-operator or other self-employer individual) or a Federal, state,
or local government (e.g., a driver\'s license). You may not accept
faxes or photocopies of identification. Positive identification by an
employer representative (not a co-worker or another employee being
tested) is also acceptable. If the employee cannot produce positive
identification, you must contact a DER to verify the identity of the
employee.

\(d\) If the employee asks, provide your identification to the employee.
Your identification must include your name and your employer\'s name but
is not required to include your picture, address, or telephone number.

\(e\) Explain the testing procedure to the employee, including showing
the employee the instructions on the back of the ATF.

\(f\) Complete Step 1 of the ATF.

\(g\) Direct the employee to complete Step 2 on the ATF and sign the
certification. If the employee refuses to sign this certification, you
must document this refusal on the "Remarks" line of the ATF and
immediately notify the DER. This is a refusal to test.

**§ 40.243   What is the procedure for an alcohol screening test using
an EBT or non-evidential breath ASD?**

As the BAT or STT, you must take the following steps:

\(a\) Select, or allow the employee to select, an individually wrapped
or sealed mouthpiece from the testing materials.

\(b\) Open the individually wrapped or sealed mouthpiece in view of the
employee and insert it into the device in accordance with the
manufacturer\'s instructions.

\(c\) Instruct the employee to blow steadily and forcefully into the
mouthpiece for at least six seconds or until the device indicates that
an adequate amount of breath has been obtained.

\(d\) Show the employee the displayed test result.

\(e\) If the device is one that prints the test number, testing device
name and serial number, time, and result directly onto the ATF, you must
check to ensure that the information has been printed correctly onto the
ATF.

\(f\) If the device is one that prints the test number, testing device
name and serial number, time and result, but on a separate printout
rather than directly onto the ATF, you must affix the printout of the
information to the designated space on the ATF with tamper-evident tape
or use a self-adhesive label that is tamper-evident.

\(g\) If the device is one that does not print the test number, testing
device name and serial number, time, and result, or it is a device not
being used with a printer, you must record this information in Step 3 of
the ATF.

**§ 40.245   What is the procedure for an alcohol screening test using a
saliva ASD or a 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 device and show it to the employee. You may not use the
device after its expiration date.

\(2\) Open an individually wrapped or sealed package containing the
device in the presence of the employee.

\(3\) Offer the employee the opportunity to use the device. If the
employee uses it, you must instruct the employee to insert it into his
or her mouth and use it in a manner described by the device\'s
manufacturer.

\(4\) If the employee chooses not to use the device, or in all cases in
which a new test is necessary because the device did not activate (see
paragraph (a)(7) of this section), you must insert the device into the
employee\'s mouth and gather saliva in the manner described by the
device\'s manufacturer. You must wear single-use examination or similar
gloves while doing so and change them following each test.

\(5\) When the device is removed from the employee\'s mouth, you must
follow the manufacturer\'s instructions regarding necessary next steps
in ensuring that the device has activated.

(6)(i) If you were unable to successfully follow the procedures of
paragraphs (a)(3) through (a)(5) of this section (e.g., the device
breaks, you drop the device on the floor), you must discard the device
and conduct a new test using a new device.

\(ii\) The new device you use must be one that has been under your
control or that of the employee before the test.

\(iii\) You must note on the "Remarks" line of the ATF the reason for
the new test. (Note: You may continue using the same ATF with which you
began the test.)

\(iv\) You must offer the employee the choice of using the device or
having you use it unless the employee, in the opinion of the STT or BAT,
was responsible (e.g., the employee dropped the device) for the new test
needing to be conducted.

\(v\) If you are unable to successfully follow the procedures of
paragraphs (a)(3) through (a)(5) of this section on the new test, you
must end the collection and put an explanation on the "Remarks" line of
the ATF.

\(vi\) You must then direct the employee to take a new test immediately,
using an EBT for the screening test.

\(7\) If you are able to successfully follow the procedures of
paragraphs (a)(3)---(a)(5) of this section, but the device does not
activate, you must discard the device and conduct a new test, in the
same manner as provided in paragraph (a)(6) of this section. In this
case, you must place the device into the employee\'s mouth to collect
saliva for the new test.

\(8\) You must read the result displayed on the device no sooner than
the device\'s manufacturer instructs. In all cases the result displayed
must be read within 15 minutes of the test. You must then show the
device and it\'s reading to the employee and enter the result on the
ATF.

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

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

\(b\) As the STT or BAT, you must take the following steps when using
the breath tube ASD:

\(1\) Check the expiration date on the device or on the package
containing the device and show it to the employee. You must not use the
device after its expiration date.

\(2\) Remove a device from the package and break the tube\'s ampule in
the presence of the employee.

\(3\) Secure an inflation bag onto the appropriate end of the device, as
directed by the manufacturer on the device\'s instructions.

\(4\) Offer the employee the opportunity to use the device. If the
employee chooses to use (e.g. hold) the device, instruct the employee to
blow forcefully and steadily into the blowing end of device until the
inflation bag fills with air (approximately 12 seconds).

\(5\) If the employee chooses not to hold the device, you must hold it
and provide the use instructions in paragraph (b)(4) of this section.

\(6\) When the employee completes the breath process, take the device
from the employee (or if you were holding it, remove it from the
employee\'s mouth); remove the inflation bag; and either hold the device
or place it on a clean flat surface while waiting for the reading to
appear.

(7)(i) If you were unable to successfully follow the procedures of
paragraphs (b)(4) through (b)(6) of this section (e.g., the device
breaks apart, the employee did not fill the inflation bag), you must
discard the device and conduct a new test using a new one.

\(ii\) The new device you use must be one that has been under your
control or that of the employer before the test.

\(iii\) You must note on the "Remarks" line of the ATF the reason for
the new test. (Note: You may continue using the same ATF with which you
began the test.)

\(iv\) You must offer the employee the choice of holding the device or
having you hold it unless the employee, in the your opinion, was
responsible (e.g., the employee failed to fill the inflation bag) for
the new test needing to be conducted.

\(v\) If you are unable to successfully follow the procedures of
paragraphs (b)(4) through (b)(6) of this section on the new test, you
must end the collection and put an explanation on the "Remarks" line of
the ATF.

\(vi\) You must then direct the employee to take a new test immediately,
using another type of ASD (e.g., saliva device) or an EBT.

\(8\) If you were able to successfully follow the procedures of
paragraphs (b)(4) through (b)(6) of this section, you must compare the
color of the crystals in the device with the colored crystals on the
manufacturer-produced control tube no sooner than the manufacturer
instructs. In all cases color comparisons must take place within 15
minutes of the test.

\(9\) You must follow the manufacturer\'s instructions for determining
the result of the test. You must then show both the device and the
control tube side-by-side to the employee and record the result on the
ATF.

\(10\) You must never re-use devices or gloves used in breath tube
testing. The inflation bag must be voided of air following removal from
a device. One inflation bag can be used for up to 10 breath tube tests.

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

\[67 FR 61522, Oct. 1, 2002\]

**§ 40.247   What procedures does the BAT or STT follow after a
screening test result?**

\(a\) If the test result is an alcohol concentration of less than 0.02,
as the BAT or STT, you must do the following:

\(1\) Sign and date Step 3 of the ATF; and

\(2\) Transmit the result to the DER in a confidential manner, as
provided in §40.255 .

\(b\) If the test result is an alcohol concentration of 0.02 or higher,
as the BAT or STT, you must direct the employee to take a confirmation
test.

\(1\) If you are the BAT who will conduct the confirmation test, you
must then conduct the test using the procedures beginning at §40.251 .

\(2\) If you are not the BAT who will conduct the confirmation test,
direct the employee to take a confirmation test, sign and date Step 3 of
the ATF, and give the employee Copy 2 of the ATF.

\(3\) If the confirmation test will be performed at a different site
from the screening test, you must take the following additional steps:

\(i\) Advise the employee not to eat, drink, put anything (e.g.,
cigarette, chewing gum) into his or her mouth, or belch;

\(ii\) Tell the employee the reason for the waiting period required by
§40.251(a) (i.e., to prevent an accumulation of mouth alcohol from
leading to an artificially high reading);

\(iii\) Explain that following your instructions concerning the waiting
period is to the employee\'s benefit;

\(iv\) Explain that the confirmation test will be conducted at the end
of the waiting period, even if the instructions have not been followed;

\(v\) Note on the "Remarks" line of the ATF that the waiting period
instructions were provided;

\(vi\) Instruct the person accompanying the employee to carry a copy of
the ATF to the BAT who will perform the confirmation test; and

\(vii\) Ensure that you or another BAT, STT, or employer representative
observe the employee as he or she is transported to the confirmation
testing site. You must direct the employee not to attempt to drive a
motor vehicle to the confirmation testing site.

\(c\) If the screening test is invalid, you must, as the BAT or STT,
tell the employee the test is cancelled and note the problem on the
"Remarks" line of the ATF. If practicable, repeat the testing process
(see §40. 271).

**Subpart M - Alcohol Confirmation Tests**

**§ 40.251   What are the first steps in an alcohol confirmation test?**

As the BAT for an alcohol confirmation test, you must follow these steps
to begin the confirmation test process:

\(a\) You must carry out a requirement for a waiting period before the
confirmation test, by taking the following steps:

\(1\) You must ensure that the waiting period lasts at least 15 minutes,
starting with the completion of the screening test. After the waiting
period has elapsed, you should begin the confirmation test as soon as
possible, but not more than 30 minutes after the completion of the
screening test.

\(i\) If the confirmation test is taking place at a different location
from the screening test (see §40.247(b)(3)) the time of transit between
sites counts toward the waiting period if the STT or BAT who conducted
the screening test provided the waiting period instructions.

\(ii\) If you cannot verify, through review of the ATF, that waiting
period instructions were provided, then you must carry out the waiting
period requirement.

\(iii\) You or another BAT or STT, or an employer representative, must
observe the employee during the waiting period.

\(2\) Concerning the waiting period, you must tell the employee:

\(i\) Not to eat, drink, put anything (e.g., cigarette, chewing gum)
into his or her mouth, or belch;

\(ii\) The reason for the waiting period (i.e., to prevent an
accumulation of mouth alcohol from leading to an artificially high
reading);

\(iii\) That following your instructions concerning the waiting period
is to the employee\'s benefit; and

\(iv\) That the confirmation test will be conducted at the end of the
waiting period, even if the instructions have not been followed.

\(3\) If you become aware that the employee has not followed the
instructions, you must note this on the "Remarks" line of the ATF.

\(b\) If you did not conduct the screening test for the employee, you
must require positive identification of the employee, explain the
confirmation procedures, and use a new ATF. You must note on the
"Remarks" line of the ATF that a different BAT or STT conducted the
screening test.

\(c\) Complete Step 1 of the ATF.

\(d\) Direct the employee to complete Step 2 on the ATF and sign the
certification. If the employee refuses to sign this certification, you
must document this refusal on the "Remarks" line of the ATF and
immediately notify the DER. This is a refusal to test.

\(e\) Even if more than 30 minutes have passed since the screening test
result was obtained, you must begin the confirmation test procedures in
§40.253, not another screening test.

\(f\) You must note on the "Remarks" line of the ATF the time that
elapsed between the two events, and if the confirmation test could not
begin within 30 minutes of the screening test, the reason why.

\(g\) Beginning the confirmation test procedures after the 30 minutes
have elapsed does not invalidate the screening or confirmation tests,
but it may constitute a regulatory violation subject to DOT agency
sanction.

**§ 40.253   What are the procedures for conducting an alcohol
confirmation test?**

As the BAT conducting an alcohol confirmation test, you must follow
these steps in order to complete the confirmation test process:

\(a\) In the presence of the employee, you must conduct an air blank on
the EBT you are using before beginning the confirmation test and show
the reading to the employee.

\(1\) If the reading is 0.00, the test may proceed. If the reading is
greater than 0.00, you must conduct another air blank.

\(2\) If the reading on the second air blank is 0.00, the test may
proceed. If the reading is greater than 0.00, you must take the EBT out
of service.

\(3\) If you take an EBT out of service for this reason, no one may use
it for testing until the EBT is found to be within tolerance limits on
an external check of calibration.

\(4\) You must proceed with the test of the employee using another EBT,
if one is available.

\(b\) You must open a new individually wrapped or sealed mouthpiece in
view of the employee and insert it into the device in accordance with
the manufacturer\'s instructions.

\(c\) You must ensure that you and the employee read the unique test
number displayed on the EBT.

\(d\) You must instruct the employee to blow steadily and forcefully
into the mouthpiece for at least six seconds or until the device
indicates that an adequate amount of breath has been obtained.

\(e\) You must show the employee the result displayed on the EBT.

\(f\) You must show the employee the result and unique test number that
the EBT prints out either directly onto the ATF or onto a separate
printout.

\(g\) If the EBT provides a separate printout of the result, you must
attach the printout to the designated space on the ATF with
tamper-evident tape, or use a self-adhesive label that is
tamper-evident.

\[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41954, Aug. 9, 2001\]

**§ 40.255   What happens next after the alcohol confirmation test
result?**

\(a\) After the EBT has printed the result of an alcohol confirmation
test, you must, as the BAT, take the following additional steps:

\(1\) Sign and date Step 3 of the ATF.

\(2\) If the alcohol confirmation test result is lower than 0.02,
nothing further is required of the employee. As the BAT, you must sign
and date Step 3 of the ATF.

\(3\) If the alcohol confirmation test result is 0.02 or higher, direct
the employee to sign and date Step 4 of the ATF. If the employee does
not do so, you must note this on the "Remarks" line of the ATF. However,
this is not considered a refusal to test.

\(4\) If the test is invalid, tell the employee the test is cancelled
and note the problem on the "Remarks" line of the ATF. If practicable,
conduct a re-test. (see §40.271).

\(5\) Immediately transmit the result directly to the DER in a
confidential manner.

\(i\) You may transmit the results using Copy 1 of the ATF, in person,
by telephone, or by electronic means. In any case, you must immediately
notify the DER of any result of 0.02 or greater by any means (e.g.,
telephone or secure fax machine) that ensures the result is immediately
received by the DER. You must not transmit these results through C/TPAs
or other service agents.

\(ii\) If you do not make the initial transmission in writing, you must
follow up the initial transmission with Copy 1 of the ATF.

\(b\) As an employer, you must take the following steps with respect to
the receipt and storage of alcohol test result information:

\(1\) If you receive any test results that are not in writing (e.g., by
telephone or electronic means), you must establish a mechanism to
establish the identity of the BAT sending you the results.

\(2\) You must store all test result information in a way that protects
confidentiality.

**Subpart N - Problems in Alcohol Testing**

**§ 40.261   What is a refusal to take an alcohol test, and what are the
consequences?**

\(a\) 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 reasonable time, as determined by the employer, consistent with
applicable DOT agency regulations, after being directed to do so by the
employer. This includes the failure of an employee (including an
owner-operator) to appear for a test when called by a C/TPA (see
§40.241(a));

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

\(3\) Fail to provide an adequate amount of saliva or breath for any
alcohol test required by this part or DOT agency regulations; Provided,
That an employee who does not provide an adequate amount of breath or
saliva because he or she has left the testing site before the testing
process commences (see §40.243(a)) for a pre-employment test is not
deemed to have refused to test;

\(4\) Fail to provide a sufficient breath specimen, and the physician
has determined, through a required medical evaluation, that there was no
adequate medical explanation for the failure (see §40.265(c));

\(5\) Fail to undergo a medical examination or evaluation, as directed
by the employer as part of the insufficient breath procedures outlined
at §40.265(c);

\(6\) Fail to sign the certification at Step 2 of the ATF (see
§§40.241(g) and 40.251(d)); or

\(7\) Fail to cooperate with any part of the testing process.

\(b\) As an employee, if you refuse to take an alcohol test, you incur
the same consequences specified under DOT agency regulations for a
violation of those DOT agency regulations.

\(c\) As a BAT or an STT, or as the physician evaluating a "shy lung"
situation, when an employee refuses to test as provided in paragraph (a)
of this section, you must terminate the portion of the testing process
in which you are involved, document the refusal on the ATF (or in a
separate document which you cause to be attached to the form),
immediately notify the DER by any means (e.g., telephone or secure fax
machine) that ensures the refusal notification is immediately received.
You must make this notification directly to the DER (not using a C/TPA
as an intermediary).

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

\[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41954, Aug. 9, 2001\]

**§ 40.263   What happens when an employee is unable to provide a
sufficient amount of saliva for an alcohol screening 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 a saliva
screening device (e.g., the employee does not provide sufficient saliva
to activate the device).

\(1\) You must conduct a new screening test using a new screening
device.

\(2\) If the employee refuses to make the attempt to complete the new
test, you must discontinue testing, note the fact on the "Remarks" line
of the ATF, and immediately notify the DER. This is a refusal to test.

\(3\) If the employee has not provided a sufficient amount of saliva to
complete the new test, you must note the fact on the "Remarks" line of
the ATF and immediately notify the DER.

\(b\) As the DER, when the STT informs you that the employee has not
provided a sufficient amount of saliva (see paragraph (a)(3) of this
section), you must immediately arrange to administer an alcohol test to
the employee using an EBT or other breath testing device.

**§ 40.265   What happens when an employee is unable to provide a
sufficient amount of breath for an alcohol test?**

\(a\) If an employee does not provide a sufficient amount of breath to
permit a valid breath test, you must take the steps listed in this
section.

\(b\) As the BAT or STT, you must instruct the employee to attempt again
to provide a sufficient amount of breath and about the proper way to do
so.

\(1\) If the employee refuses to make the attempt, you must discontinue
the test, note the fact on the "Remarks" line of the ATF, and
immediately notify the DER. This is a refusal to test.

\(2\) If the employee again attempts and fails to provide a sufficient
amount of breath, you may provide another opportunity to the employee to
do so if you believe that there is a strong likelihood that it could
result in providing a sufficient amount of breath.

\(3\) When the employee\'s attempts under paragraph (b)(2) of this
section have failed to produce a sufficient amount of breath, you must
note the fact on the "Remarks" line of the ATF and immediately notify
the DER.

\(4\) If you are using an EBT that has the capability of operating
manually, you may attempt to conduct the test in manual mode.

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

\(c\) As the employer, when the BAT or STT informs you that the employee
has not provided a sufficient amount of breath, you must direct the
employee to obtain, within five days, an evaluation from a licensed
physician who is acceptable to you and who has expertise in the medical
issues raised by the employee\'s failure to provide a sufficient
specimen.

\(1\) You are required to provide the physician who will conduct the
evaluation with the following information and instructions:

\(i\) That the employee was required to take a DOT breath alcohol test,
but was unable to provide a sufficient amount of breath to complete the
test;

\(ii\) The consequences of the appropriate DOT agency regulation for
refusing to take the required alcohol test;

\(iii\) That the physician must provide you with a signed statement of
his or her conclusions; and

\(iv\) That the physician, in his or her reasonable medical judgment,
must base those conclusions on one of the following determinations:

\(A\) A medical condition has, or with a high degree of probability
could have, precluded the employee from providing a sufficient amount of
breath. The physician must not include in the signed statement detailed
information on the employee\'s medical condition. In this case, the test
is cancelled.

\(B\) There is not an adequate basis for determining that a medical
condition has, or with a high degree of probability could have,
precluded the employee from providing a sufficient amount of breath.
This constitutes a refusal to test.

\(C\) For purposes of paragraphs (c)(1)(iv)(A) and (B) of this section,
a medical condition includes an ascertainable physiological condition
(e.g., a respiratory system dysfunction) or a medically documented
pre-existing psychological disorder, but does not include unsupported
assertions of "situational anxiety" or hyperventilation.

\(2\) As the physician making the evaluation, after making your
determination, you must provide a written statement of your conclusions
and the basis for them to the DER directly (and not through a C/TPA
acting as an itermediary). You must not include in this statement
detailed information on the employee\'s medical condition beyond what is
necessary to explain your conclusion.

\(3\) Upon receipt of the report from the examining physician, as the
DER you must immediately inform the employee and take appropriate action
based upon your DOT agency regulations.

**§ 40.267   What problems always cause an alcohol test to be
cancelled?**

As an employer, a BAT, or an STT, you must cancel an alcohol test if any
of the following problems occur. These are "fatal flaws." You must
inform the DER that the test was cancelled and 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 allotted by the manufacturer and this Part (see §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 the expiration date printed on
the device or on its package (see §40.245(a)(1) for the saliva ASD and
§40.245(b)(1) for the breath tube ASD).

\(b\) In the case of a screening or confirmation test conducted on an
EBT, the sequential test number or alcohol concentration displayed on
the EBT is not the same as the sequential test number or alcohol
concentration 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 blank before the confirmation test
(see §40.253(a));

\(3\) There is not a 0.00 result on the air blank conducted 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 of the EBT produces a result
that differs by more than the tolerance stated in the QAP from the known
value of the test standard. In this case, every result of 0.02 or above
obtained on the EBT since the last valid external calibration check is
cancelled (see §40.233(a)(1) and (d)).

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

**§ 40.269   What problems cause an alcohol test to be cancelled unless
they are corrected?**

As a BAT or STT, or employer, you must cancel an alcohol test if any of
the following problems occur, 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
the employee has not signed the ATF after the result is obtained (see
§40.255(a)(2)).

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

**§ 40.271   How are alcohol testing problems corrected?**

\(a\) As a BAT or STT, you have the responsibility of trying to complete
successfully an alcohol test for each employee.

\(1\) If, during or shortly after the testing process, you become aware
of any event that will cause the test to be cancelled (see §40.267 ),
you must try to correct the problem promptly, if practicable. You may
repeat the testing process as part of this effort.

\(2\) If repeating the testing process is necessary, you must begin a
new test as soon as possible. You must use a new ATF, a new sequential
test number, and, if needed, a new ASD and/or a new EBT. It is
permissible to use additional technical capabilities of the EBT (e.g.,
manual operation) if you have been trained to do so in accordance with
§40.213(c) .

\(3\) If repeating the testing process is necessary, you are not limited
in the number of attempts to complete the test, provided that the
employee is making a good faith effort to comply with the testing
process.

\(4\) If another testing device is not available for the new test at the
testing site, you must immediately notify the DER and advise the DER
that the test could not be completed. As the DER who receives this
information, you must make all reasonable efforts to ensure that the
test is conducted at another testing site as soon as possible.

\(b\) If, as an STT, BAT, employer or other service agent administering
the testing process, you become aware of a "correctable flaw" (see
§40.269 ) that has not already been corrected, you must take all
practicable action to correct the problem so that the test is not
cancelled.

\(1\) If the problem resulted from the omission of required information,
you must, as the person responsible for providing that information,
supply in writing the missing information and a signed statement that it
is true and accurate. For example, suppose you are a BAT and you forgot
to make a notation on the "Remarks" line of the ATF that the employee
did not sign the certification. You would, when the problem is called to
your attention, supply a signed statement that the employee failed or
refused to sign the certification after the result was obtained, and
that your signed statement is true and accurate.

\(2\) If the problem is the use of a non-DOT form, you must, as the
person responsible for the use of the incorrect form, certify in writing
that the incorrect form contains all the information needed for a valid
DOT alcohol test. You must also provide a signed statement that the
incorrect form was used inadvertently or as the only means of conducting
a test, in circumstances beyond your control, and the steps you have
taken to prevent future use of non-DOT forms for DOT tests. You must
supply this information on the same business day on which you are
notified of the problem, transmitting it by fax or courier.

\(c\) If you cannot correct the problem, you must cancel the test.

**§ 40.273   What is the effect of a cancelled alcohol test?**

\(a\) A cancelled alcohol test is neither positive nor negative.

\(1\) As an employer, you must not attach to a cancelled test the
consequences of a test result that is 0.02 or greater (e.g., removal
from a safety-sensitive position).

\(2\) As an employer, you must not use a cancelled test in a situation
where an employee needs a test result that is below 0.02 (e.g., in the
case of a return-to-duty or follow-up test to authorize the employee to
perform safety-sensitive functions).

\(3\) As an employer, you must not direct a recollection for an employee
because a test has been cancelled, except in the situations cited in
paragraph (a)(2) of this section or other provisions of this part.

\(b\) A cancelled test does not count toward compliance with DOT
requirements, such as a minimum random testing rate.

\(c\) When a test must be cancelled, if you are the BAT, STT, or other
person who determines that the cancellation is necessary, you must
inform the affected DER within 48 hours of the cancellation.

\(d\) A cancelled DOT test does not provide a valid basis for an
employer to conduct a non-DOT test (i.e., a test under company
authority).

**§ 40.275   What is the effect of procedural problems that are not
sufficient to cancel an alcohol test?**

\(a\) As an STT, BAT, employer, or a service agent administering the
testing process, you must document any errors in the testing process of
which you become aware, even if they are not "fatal flaws" or
"correctable flaws" listed in this subpart. Decisions about the ultimate
impact of these errors will be determined by administrative or legal
proceedings, subject to the limitation of paragraph (b) of this section.

\(b\) No person concerned with the testing process may declare a test
cancelled based on a mistake in the process that does not have a
significant adverse effect on the right of the employee to a fair and
accurate test. For example, it is inconsistent with this part to cancel
a test based on a minor administrative mistake (e.g., the omission of
the employee\'s middle initial) or an error that does not affect
employee protections under this part. Nor does the failure of an
employee to sign in Step 4 of the ATF result in the cancellation of the
test. Nor is a test to be cancelled on the basis of a claim by an
employee that he or she was improperly selected for testing.

\(c\) As an employer, these errors, even though not sufficient to cancel
an alcohol test result, may subject you to enforcement action under DOT
agency regulations.

**§ 40.277   Are alcohol tests other than saliva or breath permitted
under these regulations?**

No, other types of alcohol tests (e,g., blood and urine) are not
authorized for testing done under this part. Only saliva or breath for
screening tests and breath for confirmation tests using approved devices
are permitted.

**Subpart O - Substance Abuse Professionals and the Return-to-Duty
Process**

**§ 40.281   Who is qualified to act as a SAP?**

To be permitted to act as a SAP in the DOT drug testing program, you
must meet each of the requirements of this section:

\(a\) [Credentials]{.underline}. 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;
or

\(5\) You are a drug and alcohol counselor certified by the National
Association of Alcoholism and Drug Abuse Counselors Certification
Commission (NAADAC); or by the International Certification Reciprocity
Consortium/Alcohol and Other Drug Abuse (ICRC); or by the National Board
for Certified Counselors, Inc. and Affiliates/Master Addictions
Counselor (NBCC).

\(b\) [Basic knowledge]{.underline}. You must be knowledgeable in the
following areas:

\(1\) You must be knowledgeable about and have clinical experience in
the diagnosis and treatment of alcohol and controlled substances-related
disorders.

\(2\) You must be knowledgeable about the SAP function as it relates to
employer interests in safety-sensitive duties.

\(3\) You must be knowledgeable about this part, the DOT agency
regulations applicable to the employers for whom you evaluate employees,
and the DOT SAP Guidelines, and you keep current on any changes to these
materials. These documents are available from ODAPC (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).

\(c\) [Qualification training]{.underline}. You must receive
qualification training meeting the requirements of this paragraph (c).

\(1\) Qualification training must provide instruction on the following
subjects:

\(i\) Background, rationale, and coverage of the Department\'s drug and
alcohol testing program;

\(ii\) 49 CFR Part 40 and DOT agency drug and alcohol testing rules;

\(iii\) Key DOT drug testing requirements, including collections,
laboratory testing, MRO review, and roblems in drug testing;

\(iv\) Key DOT alcohol testing requirements, including the testing
process, 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
initial employee evaluation, referrals for education and/or treatment,
the follow-up evaluation, continuing treatment recommendations, and the
follow-up testing plan;

\(vii\) SAP consultation and communication with employers, MROs, and
treatment providers;

\(viii\) Reporting and recordkeeping requirements;

\(ix\) Issues that SAPs confront in carrying out their duties under the
program.

\(2\) Following your completion of qualification training under
paragraph (c)(1) of this section, you must satisfactorily complete an
examination administered by a nationally-recognized professional or
training organization. The examination must comprehensively cover all
the elements of qualification training listed in paragraph (c)(1) of
this section.

\(3\) The following is the schedule for qualification training you must
meet:

\(i\) If you became a SAP before August 1, 2001, you must meet the
qualification training requirement no later than December 31, 2003.

\(ii\) If you become a SAP between August 1, 2001, and December 31,
2003, you must meet the qualification training requirement no later than
December 31, 2003.

\(iii\) If you become a SAP on or after January 1, 2004, you must meet
the qualification training requirement before you begin to perform SAP
functions.

\(d\) [Continuing education]{.underline}. During each three-year period
from the date on which you satisfactorily complete the examination under
paragraph (c)(2) of this section, you must complete continuing education
consisting of at least 12 professional development hours (e.g., CEUs)
relevant to performing SAP functions.

\(1\) This continuing education must include material concerning new
technologies, interpretations, recent guidance, rule changes, and other
information about developments in SAP practice, pertaining to the DOT
program, since the time you met the qualification training requirements
of this section.

\(2\) Your continuing education activities must include documentable
assessment tools to assist you in determining whether you have
adequately learned the material.

\(e\) [Documentation]{.underline}. You must maintain documentation
showing that you currently meet all requirements of this section. You
must provide this documentation on request to DOT agency representatives
and to employers and C/TPAs who are using or contemplating using your
services.

\[65 FR 79526, Dec. 19, 2000, as amended at 69 FR 3022, Jan. 22, 2004\]

**§ 40.283   How does a certification organization obtain recognition
for its members as SAPs?**

\(a\) If you represent a certification organization that wants DOT to
authorize its certified drug and alcohol counselors to be added to
§40.281(a)(5), you may submit a written petition to DOT requesting a
review of your petition for inclusion.

\(b\) You must obtain the National Commission for Certifying Agencies
(NCCA) accreditation before DOT will act on your petition.

\(c\) You must also meet the minimum requirements of Appendix E to this
part before DOT will act on your petition.

**§ 40.285   When is a SAP evaluation required?**

\(a\) As an employee, when you have violated DOT drug and alcohol
regulations, you cannot again perform any DOT safety-sensitive duties
for any employer until and unless you complete the SAP evaluation,
referral, and education/treatment process set forth in this subpart and
in applicable DOT agency regulations. The first step in this process is
a SAP evaluation.

\(b\) For purposes of this subpart, a verified positive DOT drug test
result, a DOT alcohol test with a result indicating an alcohol
concentration of 0.04 or greater, a refusal to test (including by
adulterating or substituting a urine specimen) or any other violation of
the prohibition on the use of alcohol or drugs under a DOT agency
regulation constitutes a DOT drug and alcohol regulation violation.

**§ 40.287   What information is an employer required to provide
concerning SAP services to an employee who has a DOT drug and alcohol
regulation violation?**

As an employer, you must provide to each employee (including an
applicant or new employee) who violates a DOT drug and alcohol
regulation a listing of SAPs readily available to the employee and
acceptable to you, with names, addresses, and telephone numbers. You
cannot charge the employee any fee for compiling or providing this list.
You may provide this list yourself or through a C/TPA or other service
agent.

**§ 40.289   Are employers required to provide SAP and treatment
services to employees?**

\(a\) As an employer, you are not required to provide a SAP evaluation
or any subsequent recommended education or treatment for an employee who
has violated a DOT drug and alcohol regulation.

\(b\) However, if you offer that employee an opportunity to return to a
DOT safety-sensitive duty following a violation, you must, before the
employee again performs that duty, ensure that the employee receives an
evaluation by a SAP meeting the requirements of §40.281 and that the
employee successfully complies with the SAP\'s evaluation
recommendations.

\(c\) Payment for SAP evaluations and services is left for employers and
employees to decide and may be governed by existing management-labor
agreements and health care benefits.

**§ 40.291   What is the role of the SAP in the evaluation, referral,
and treatment process of an employee who has violated DOT agency drug
and alcohol testing regulations?**

\(a\) As a SAP, you are charged with:

\(1\) Making a face-to-face clinical assessment and evaluation to
determine what assistance is needed by the employee to resolve problems
associated with alcohol and/or drug use;

\(2\) Referring the employee to an appropriate education and/or
treatment program;

\(3\) Conducting a face-to-face follow-up evaluation to determine if the
employee has actively participated in the education and/or treatment
program and has demonstrated successful compliance with the initial
assessment and evaluation recommendations;

\(4\) Providing the DER with a follow-up drug and/or alcohol testing
plan for the employee; and

\(5\) Providing the employee and employer with recommendations for
continuing education and/or treatment.

\(b\) As a SAP, you are not an advocate for the employer or employee.
Your function is to protect the public interest in safety by
professionally evaluating the employee and recommending appropriate
education/treatment, follow-up tests, and aftercare.

**§ 40.293   What is the SAP\'s function in conducting the initial
evaluation of an employee?**

As a SAP, for every employee who comes to you following a DOT drug and
alcohol regulation violation, 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 must demonstrate successful compliance prior to returning to
DOT safety-sensitive duty.

\(1\) You must make such a recommendation for every individual who has
violated a DOT drug and alcohol regulation.

\(2\) You must make a recommendation for education and/or treatment that
will, to the greatest extent possible, protect public safety in the
event that the employee returns to the performance of safety-sensitive
functions.

\(c\) Appropriate education may include, but is not limited to,
self-help groups (e.g., Alcoholics Anonymous) and community lectures,
where attendance can be independently verified, and bona fide drug and
alcohol education courses.

\(d\) Appropriate treatment may include, but is not limited to,
in-patient hospitalization, partial in-patient treatment, out-patient
counseling programs, and aftercare.

\(e\) You must provide a written report directly to the DER highlighting
your specific recommendations for assistance (see §40.311(c)).

\(f\) For purposes of your role in the evaluation process, you must
assume that a verified positive test result has conclusively established
that the employee committed a DOT drug and alcohol regulation violation.
You must not take into consideration in any way, as a factor in
determining what your recommendation will be, any of the following:

\(1\) A claim by the employee that the test was unjustified or
inaccurate;

\(2\) Statements by the employee that attempt to mitigate the
seriousness of a violation of a DOT drug or alcohol regulation (e.g.,
related to assertions of use of hemp oil, "medical marijuana" use,
"contact positives," poppy seed ingestion, job stress); or

\(3\) Personal opinions you may have about the justification or
rationale for drug and alcohol testing.

\(g\) In the course of gathering information for purposes of your
evaluation in the case of a drug-related violation, you may consult with
the MRO. As the MRO, you are required to cooperate with the SAP and
provide available information the SAP requests. It is not necessary to
obtain the consent of the employee to provide this information.

**§ 40.295   May employees or employers seek a second SAP evaluation if
they disagree with the first SAP\'s recommendations?**

\(a\) As an employee with a DOT drug and alcohol regulation violation,
when you have been evaluated by a SAP, you must not seek a second SAP\'s
evaluation in order to obtain another recommendation.

\(b\) As an employer, you must not seek a second SAP\'s evaluation if
the employee has already been evaluated by a qualified SAP. If the
employee, contrary to paragraph (a) of this section, has obtained a
second SAP evaluation, as an employer you may not rely on it for any
purpose under this part.

**§ 40.297   Does anyone have the authority to change 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, any service agent) may
change in any way the SAP\'s evaluation or recommendations for
assistance. For example, a third party is not permitted to make more or
less stringent a SAP\'s recommendation by changing the SAP\'s evaluation
or seeking another SAP\'s evaluation.

\(b\) The SAP who made the initial evaluation may modify his or her
initial evaluation and recommendations based on new or additional
information (e.g., from an education or treatment program).

**§ 40.299   What is the SAP\'s role and what are the limits on a SAP\'s
discretion in referring employees for education and treatment?**

\(a\) As a SAP, upon your determination of the best recommendation for
assistance, you will serve as a referral source to assist the
employee\'s entry into a education and/or treatment program.

\(b\) To prevent the appearance of a conflict of interest, you must not
refer an employee requiring assistance to your private practice or to a
person or organization from which you receive payment or to a person or
organization in which you have a financial interest. You are precluded
from making referrals to entities with which you are financially
associated.

\(c\) There are four exceptions to the prohibitions contained in
paragraph (b) of this section. You may refer an employee to any of the
following providers of assistance, regardless of your relationship with
them:

\(1\) A public agency (e.g., treatment facility) operated by a state,
county, or municipality;

\(2\) The employer or a person or organization under contract to the
employer to provide alcohol or drug treatment and/or education services
(e.g., the employer\'s contracted treatment provider);

> \(3\) The sole source of therapeutically appropriate treatment under
> the employee\'s health insurance program (e.g., the single substance
> abuse in-patient treatment program made available by the employee\'s
> insurance coverage plan); or

\(4\) The sole source of therapeutically appropriate treatment
reasonably available to the employee (e.g., the only treatment facility
or education program reasonably located within the general commuting
area).

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

\(a\) As a SAP, after you have prescribed assistance under §40.293, you
must re-evaluate the employee to determine if the employee has
successfully carried out your education and/or treatment
recommendations.

\(1\) This is your way to gauge for the employer the employee\'s ability
to demonstrate successful compliance with the education and/or treatment
plan.

\(2\) Your evaluation may serve as one of the reasons the employer
decides to return the employee to safety-sensitive duty.

\(b\) As the SAP making the follow-up evaluation determination, you
must:

\(1\) Confer with or obtain appropriate documentation from the
appropriate education and/or treatment program professionals where the
employee was referred; and

\(2\) Conduct a face-to-face clinical interview with the employee to
determine if the employee demonstrates successful compliance with your
initial evaluation recommendations.

\(c\) (1) If the employee has demonstrated successful compliance, you
must provide a written report directly to the DER highlighting your
clinical determination that the employee has done so with your initial
evaluation recommendation (see §40.311(d)).

\(2\) You may determine that an employee has successfully demonstrated
compliance even though the employee has not yet completed the full
regimen of education and/or treatment you recommended or needs
additional asssitance. For example, if the employee has successfully
completed the 30-day in-patient program you prescribed, you may make a
"successful compliance" determination even though you conclude that the
employee has not yet completed the out-patient counseling you
recommended or should continue in an aftercare program.

(d)(1) As the SAP, if you believe, as a result of the follow-up
evaluation, that the employee has not demonstrated successful compliance
with your recommendations, you must provide written notice directly to
the DER (see §40.311(e)).

\(2\) As an employer who receives the SAP\'s written notice that the
employee has not successfully complied with the SAP\'s recommendations,
you must not return the employee to the performance of safety-sensitive
duties.

\(3\) As the SAP, you may conduct additional follow-up evaluation(s) if
the employer determines that doing so is consistent with the employee\'s
progress as you have reported it and with the employer\'s policy and/or
labor-management agreements.

\(4\) As the employer, following a SAP report that the employee has not
demonstrated successful compliance, you may take personnel action
consistent with your policy and/or labor-management agreements.

**§ 40.303   What happens if the SAP believes the employee needs
additional treatment, aftercare, or support group services even after
the employee returns to safety-sensitive duties?**

\(a\) As a SAP, if you believe that ongoing services (in addition to
follow-up tests) are needed to assist an employee to maintain sobriety
or abstinence from drug use after the employee resumes the performance
of safety-sensitive duties, you must provide recommendations for these
services in your follow-up evaluation report (see §40.311(d)(10)).

\(b\) As an employer receiving a recommendation for these services from
a SAP, you may, as part of a return-to-duty agreement with the employee,
require the employee to participate in the recommended services. You may
monitor and document the employee\'s participation in the recommended
services. You may also make use of SAP and employee assistance program
(EAP) services in assisting and monitoring employees\' compliance with
SAP recommendations. Nothing in this section permits an employer to fail
to carry out its obligations with respect to follow-up testing (see
§40.309 ).

\(c\) As an employee, you are obligated to comply with the SAP\'s
recommendations for these services. If you fail or refuse to do so, you
may be subject to disciplinary action by your employer.

**§ 40.305   How does the return-to-duty process conclude?**

\(a\) As the employer, if you decide that you want to permit the
employee to return to the performance of safety-sensitive functions, you
must ensure that the employee takes a return-to-duty test. This test
cannot occur until after the SAP has determined that the employee has
successfully complied with prescribed education and/or treatment. The
employee must have a negative drug test result and/or an alcohol test
with an alcohol concentration of less than 0.02 before resuming
performance of safety-sensitive duties.

\(b\) As an employer, you must not return an employee to
safety-sensitive duties until the employee meets the conditions of
paragraph (a) of this section. However, you are not required to return
an employee to safety-sensitive duties because the employee has met
these conditions. That is a personnel decision that you have the
discretion to make, subject to collective bargaining agreements or other
legal requirements.

\(c\) As a SAP or MRO, you must not make a "fitness for duty"
determination as part of this re-evaluation unless required to do so
under an applicable DOT agency regulation. It is the employer, rather
than you, who must decide whether to put the employee back to work in a
safety-sensitive position.

**§ 40.307   What is the SAP\'s function in prescribing the employee\'s
follow-up tests?**

\(a\) As a SAP, for each employee who has committed a DOT drug or
alcohol regulation violation, and who seeks to resume the performance of
safety-sensitive functions, you must establish a written follow-up
testing plan. You do not establish this plan until after you determine
that the employee has successfully complied with your recommendations
for education and/or treatment.

\(b\) You must present a copy of this plan directly to the DER (see
§40.311(d)(9)).

\(c\) You are the sole determiner of the number and frequency of
follow-up tests and whether these tests will be for drugs, alcohol, or
both, unless otherwise directed by the appropriate DOT agency
regulation. For example, if the employee had a positive drug test, but
your evaluation or the treatment program professionals determined that
the employee had an alcohol problem as well, you should require that the
employee have follow-up tests for both drugs and alcohol.

\(d\) However, you must, at a minimum, direct that the employee be
subject to six unannounced follow-up tests in the first 12 months of
safety-sensitive duty following the employee\'s return to
safety-sensitive functions.

\(1\) You may require a greater number of follow-up tests during the
first 12-month period of safety-sensitive duty (e.g., you may require
one test a month during the 12-month period; you may require two tests
per month during the first 6-month period and one test per month during
the final 6-month period).

\(2\) You may also require follow-up tests during the 48 months of
safety-sensitive duty following this first 12-month period.

\(3\) You are not to establish the actual dates for the follow-up tests
you prescribe. The decision on specific dates to test is the
employer\'s.

\(4\) As the employer, you must not impose additional testing
requirements (e.g., under company authority) on the employee that go
beyond the SAP\'s follow-up testing plan.

\(e\) The requirements of the SAP\'s follow-up testing plan "follow the
employee" to subsequent employers or through breaks in service.

*[Example 1 to Paragraph (e]{.underline}):*   The employee returns to
duty with Employer A. Two months afterward, after completing the first
two of six follow-up tests required by the SAP\'s plan, the employee
quits his job with Employer A and begins to work in a similar position
for Employer B. The employee remains obligated to complete the four
additional tests during the next 10 months of safety-sensitive duty, and
Employer B is responsible for ensuring that the employee does so.
Employer B learns of this obligation through the inquiry it makes under
§40.25.

*[Example 2 to Paragraph (e)]{.underline}:*   The employee returns to
duty with Employer A. Three months later, after the employee completes
the first two of six follow-up tests required by the SAP\'s plan,
Employer A lays the employee off for economic or seasonal employment
reasons. Four months later, Employer A recalls the employee. Employer A
must ensure that the employee completes the remaining four follow-up
tests during the next nine months.

\(f\) As the SAP, you may modify the determinations you have made
concerning follow-up tests. For example, even if you recommended
follow-up testing beyond the first 12-months, you can terminate the
testing requirement at any time after the first year of testing. You
must not, however, modify the requirement that the employee take at
least six follow-up tests within the first 12 months after returning to
the performance of safety-sensitive functions.

**§ 40.309   What are the employer\'s responsibilities with respect to
the SAP\'s directions for follow-up tests?**

\(a\) As the employer, you must carry out the SAP\'s follow-up testing
requirements. You may not allow the employee to continue to perform
safety-sensitive functions unless follow-up testing is conducted as
directed by the SAP.

\(b\) You should schedule follow-up tests on dates of your own choosing,
but you must ensure that the tests are unannounced with no discernable
pattern as to their timing, and that the employee is given no advance
notice.

\(c\) You cannot substitute any other tests (e.g., those carried out
under the random testing program) conducted on the employee for this
follow-up testing requirement.

\(d\) You cannot count a follow-up test that has been cancelled as a
completed test. A cancelled follow-up test must be recollected.

**§ 40.311   What are the requirements concerning SAP reports?**

\(a\) As the SAP conducting the required evaluations, you must send the
written reports required by this section in writing directly to the DER
and not to a third party or entity for forwarding to the DER (except as
provided in §40.355(e)). You may, however, forward the document
simultaneously to the DER and to a C/TPA.

\(b\) As an employer, you must ensure that you receive SAP written
reports directly from the SAP performing the evaluation and that no
third party or entity changed the SAP\'s report in any way.

\(c\) The SAP\'s written report, following an initial evaluation that
determines what level of assistance is needed to address the employee\'s
drug and/or alcohol problems, must be on the SAP\'s own letterhead (and
not the letterhead of another service agent) signed and dated by the
SAP, and must contain 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
and violation 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 a follow-up evaluation that
determines the employee has demonstrated successful compliance must be
on the SAP\'s own letterhead (and not the letterhead of another service
agent), signed by the SAP and dated, and must contain the following
items:

\(1\) Employee\'s name and SSN;

\(2\) Employer\'s name and address;

\(3\) Reason for the initial assessment (specific violation of DOT
regulations and violation date);

\(4\) Date(s) of the initial assessment and synopsis of the treatment
plan;

\(5\) Name of practice(s) or service(s) providing the recommended
education and/or treatment;

\(6\) Inclusive dates of employee\'s program participation;

\(7\) Clinical characterization of employee\'s program participation;

\(8\) SAP\'s clinical determination as to whether the employee has
demonstrated successful compliance;

\(9\) Follow-up testing plan;

\(10\) Employee\'s continuing care needs with specific treatment,
aftercare, and/or support group services recommendations; and

\(11\) SAP\'s telephone number.

\(e\) The SAP\'s written report concerning a follow-up evaluation that
determines the employee has not demonstrated successful compliance must
be on the SAP\'s own letterhead (and not the letterhead of another
service agent), signed by the SAP and dated, and must contain the
following items:

\(1\) 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
education and/or treatment;

\(6\) Inclusive dates of employee\'s program participation;

\(7\) Clinical characterization of employee\'s program 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
demonstrated successful compliance; and

\(11\) SAP\'s telephone number.

\(f\) As a SAP, you must also provide these written reports directly to
the employee if the employee has no current employer and to the gaining
DOT regulated employer in the event the employee obtains another
transportation industry safety-sensitive position.

\(g\) As a SAP, you are to maintain copies of your reports to employers
for 5 years, and your employee clinical records in accordance with
Federal, state, and local laws regarding record maintenance,
confidentiality, and release of information. You must make these records
available, on request, to DOT agency representatives (e.g., inspectors
conducting an audit or safety investigation) and representatives of the
NTSB in an accident investigation.

\(h\) As an employer, you must maintain your reports from SAPs for 5
years from the date you received them.

**§ 40.313   Where is other information on SAP functions and the
return-to-duty process found in this regulation?**

You can find other information on the role and functions of SAPs in the
following sections of this 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 for Certification
> Organizations.

**Subpart P - Confidentiality and Release of Information**

**§ 40.321   What is the general confidentiality rule for drug and
alcohol test information?**

Except as otherwise provided in this subpart, as a service agent or
employer participating in the DOT drug or alcohol testing process, you
are prohibited from releasing individual test results or medical
information about an employee to third parties without the employee\'s
specific written consent.

\(a\) A "third party" is any person or organization to whom other
subparts of this regulation do not explicitly authorize or require the
transmission of information in the course of the drug or alcohol testing
process.

\(b\) "Specific written consent" means a statement signed by the
employee that he or she agrees to the release of a particular piece of
information to a particular, explicitly identified, person or
organization at a particular time. "Blanket releases," in which an
employee agrees to a release of a category of information (e.g., all
test results) or to release information to a category of parties (e.g.,
other employers who are members of a C/TPA, companies to which the
employee may apply for employment), are prohibited under this part.

**§ 40.323   May program participants release drug or alcohol test
information in connection with legal proceedings?**

\(a\) As an employer, you may release information pertaining to an
employee\'s drug or alcohol test without the employee\'s consent in
certain legal proceedings.

\(1\) These proceedings include a lawsuit (e.g., a wrongful discharge
action), grievance (e.g., an arbitration concerning disciplinary action
taken by the employer), or administrative proceeding (e.g., an
unemployment compensation hearing) brought by, or on behalf of, an
employee and resulting from a positive DOT drug or alcohol test or a
refusal to test (including, but not limited to, adulterated or
substituted test results).

\(2\) These proceedings also include a criminal or civil action
resulting from an employee\'s performance of safety-sensitive duties, in
which a court of competent jurisdiction determines that the drug or
alcohol test information sought is relevant to the case and issues an
order directing the employer to produce the information. For example, in
personal injury litigation following a truck or bus collision, the court
could determine that a post-accident drug test result of an employee is
relevant to determining whether the driver or the driver\'s employer was
negligent. The employer is authorized to respond to the court\'s order
to produce the records.

\(b\) In such a proceeding, you may release the information to the
decisionmaker in the proceeding (e.g., the court in a lawsuit). You may
release the information only with a binding stipulation that the
decisionmaker to whom it is released will make it available only to
parties to the proceeding.

\(c\) If you are a service agent, and the employer requests its
employee\'s drug or alcohol testing information from you to use in a
legal proceeding as authorized in paragraph (a) of this section (e.g.,
the laboratory\'s data package), you must provide the requested
information to the employer.

\(d\) As an employer or service agent, you must immediately notify the
employee in writing of any information you release under this section.

**§ 40.325   \[Reserved\]**

**§ 40.327   When must the MRO report medical information gathered in
the verification process?**

\(a\) As the MRO, you must, except as provided in paragraph (c) of this
section, report drug test results and medical information you learned as
part of the verification process to third parties without the
employee\'s consent if you determine, in your reasonable medical
judgment, that:

\(1\) The information is likely to result in the employee being
determined to be medically unqualified under an applicable DOT agency
regulation; or

\(2\) The information indicates that continued performance by the
employee of his or her safety-sensitive function is likely to pose a
significant safety risk.

\(b\) The third parties to whom you are authorized to provide
information by this section include the employer, a physician or other
health care provider responsible for determining the medical
qualifications of the employee under an applicable DOT agency safety
regulation, a SAP evaluating the employee as part of the return to duty
process (see §40.293(g)), a DOT agency, or the National Transportation
Safety Board in the course of an accident investigation.

\(c\) If the law of a foreign country (e.g., Canada) prohibits you from
providing medical information to the employer, you may comply with that
prohibition.

**§ 40.329   What information must laboratories, MROs, and other service
agents release to employees?**

\(a\) As an MRO or service agent you must provide, within 10 business
days of receiving a written request from an employee, copies of any
records pertaining to the employee\'s use of alcohol and/or drugs,
including records of the employee\'s DOT-mandated drug and/or alcohol
tests. You may charge no more than the cost of preparation and
reproduction for copies of these records.

\(b\) As a laboratory, you must provide, within 10 business days of
receiving a written request from an employee, and made through the MRO,
the records relating to the results of the employee\'s drug test (i.e.,
laboratory report and data package). You may charge no more than the
cost of preparation and reproduction for copies of these records.

\(c\) As a SAP, you must make available to an employee, on request, a
copy of all SAP reports (see §40.311). However, you must redact
follow-up testing information from the report before providing it to the
employee.

\[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41954, Aug. 9, 2001\]

**§ 40.331   To what additional parties must employers and service
agents release information?**

As an employer or service agent you must release information under the
following circumstances:

\(a\) If you receive a specific, written consent from an employee
authorizing the release of information about that employee\'s drug or
alcohol tests to an identified person, you must provide the information
to the identified person. For example, as an employer, when you receive
a written request from a former employee to provide information to a
subsequent employer, you must do so. In providing the information, you
must comply with the terms of the employee\'s consent.

\(b\) If you are an employer, you must, upon request of DOT agency
representatives, provide the following:

\(1\) Access to your facilities used for this part and DOT agency drug
and alcohol program functions.

\(2\) All written, printed, and computer-based drug and alcohol program
records and reports (including copies of name-specific records or
reports), files, materials, data, documents/documentation, agreements,
contracts, policies, and statements that are required by this part and
DOT agency regulations. You must provide this information at your
principal place of business in the time required by the DOT agency.

\(3\) All items in paragraph (b)(2) of this section must be easily
accessible, legible, and provided in an organized manner. If electronic
records do not meet these standards, they must be converted to printed
documentation that meets these standards.

\(c\) If you are a service agent, you must, upon request of DOT agency
representatives, provide the following:

\(1\) Access to your facilities used for this part and DOT agency drug
and alcohol program functions.

\(2\) All written, printed, and computer-based drug and alcohol program
records and reports (including copies of name-specific records or
reports), files, materials, data, documents/documentation, agreements,
contracts, policies, and statements that are required by this part and
DOT agency regulations. You must provide this information at your
principal place of business in the time required by the DOT agency.

\(3\) All items in paragraph (c)(2) of this section must be easily
accessible, legible, and provided in an organized manner. If electronic
records do not meet these standards, they must be converted to printed
documentation that meets these standards.

\(d\) If requested by the National Transportation Safety Board as part
of an accident investigation, you must provide information concerning
post-accident tests administered after the accident.

\(e\) If requested by a Federal, state or local safety agency with
regulatory authority over you or the employee, you must provide drug and
alcohol test records concerning the employee.

\(f\) Except as otherwise provided in this part, as a laboratory you
must not release or provide a specimen or a part of a specimen to a
requesting party, without first obtaining written consent from ODAPC. If
a party seeks a court order directing you to release a specimen or part
of a specimen contrary to any provision of this part, you must take
necessary legal steps to contest the issuance of the order (e.g., seek
to quash a subpoena, citing the requirements of §40.13 ). This part does
not require you to disobey a court order, however.

\[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41955, Aug. 9, 2001\]

**§ 40.333   What records must employers keep?**

\(a\) As an employer, you must keep the following records for the
following periods of time:

\(1\) You must keep the following records for five years:

\(i\) Records of alcohol test results indicating an alcohol
concentration of 0.02 or greater;

\(ii\) Records of verified positive drug test results;

\(iii\) Documentation of refusals to take required alcohol and/or drug
tests (including substituted or adulterated drug 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
previous employers under §40.25 concerning drug and 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 and cancelled drug test results
and alcohol test results with a concentration of less than 0.02 for one
year.

\(b\) You do not have to keep records related to a program requirement
that does not apply to you (e.g., a maritime employer who does not have
a DOT-mandated random alcohol testing program need not maintain random
alcohol testing records).

\(c\) You must maintain the records in a location with controlled
access.

\(d\) A service agent may maintain these records for you. However, you
must ensure that you can produce these records at your principal place
of business in the time required by the DOT agency. For example, as a
motor carrier, when an FMCSA inspector requests your records, you must
ensure that you can provide them within two business days.

\(e\) If you store records electronically, where permitted by this part,
you must ensure that the records are easily accessible, legible, and
formatted and stored in an organized manner. If electronic records do
not meet these criteria, you must convert them to printed documentation
in a rapid and readily auditable manner, at the request of DOT agency
personnel.

\[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41955, Aug. 9, 2001\]

**Subpart Q - Roles and Responsibilities of Service Agents**

**§ 40.341   Must service agents comply with DOT drug and alcohol
testing requirements?**

\(a\) As a service agent, the services you provide to transportation
employers must meet the requirements of this part and the DOT agency
drug and alcohol testing regulations.

\(b\) If you do not comply, DOT may take action under the Public
Interest Exclusions procedures of this part (see Subpart R of this part)
or applicable provisions of other DOT agency regulations.

**§ 40.343   What tasks may a service agent perform for an employer?**

As a service agent, you may perform for employers the tasks needed to
comply with DOT agency drug and alcohol testing regulations, subject to
the requirements and limitations of this part.

**§ 40.345   In what circumstances may a C/TPA act as an intermediary in
the transmission of drug and alcohol testing information to employers?**

\(a\) As a C/TPA or other service agent, you may act as an intermediary
in the transmission of drug and alcohol testing information in the
circumstances specified in this section only if the employer chooses to
have you do so. Each employer makes the decision about whether to
receive some or all of this information from you, acting as an
intermediary, rather than directly from the service agent who originates
the information (e.g., an MRO or BAT).

\(b\) The specific provisions of this part concerning which you may act
as an intermediary are listed in Appendix F to this part. These are the
only situations in which you may act as an intermediary. You are
prohibited from doing so in all other situations.

\(c\) In every case, you must ensure that, in transmitting information
to employers, you meet all requirements (e.g., concerning
confidentiality and timing) that would apply if the service agent
originating the information (e.g., an MRO or collector) sent the
information directly to the employer. For example, if you transmit drug
testing results from MROs to DERs, you must transmit each drug test
result to the DER in compliance with the MRO requirements set forth in
§40.167 .

**§ 40.347   What functions may C/TPAs perform with respect to
administering testing?**

As a C/TPA, except as otherwise specified in this part, you may perform
the following functions for employers concerning random selection and
other selections for testing.

\(a\) You may operate random testing programs for employers and may
assist (i.e., through contracting with laboratories or collection sites,
conducting collections) employers with other types of testing (e.g.,
pre-employment, post-accident, reasonable suspicion, return-to-duty, and
follow-up).

\(b\) You may combine employees from more than one employer or one
transportation industry in a random pool if permitted by all the DOT
agency drug and alcohol testing regulations involved.

\(1\) If you combine employees from more than one transportation
industry, you must ensure that the random testing rate is at least equal
to the highest rate required by each DOT agency.

\(2\) Employees not covered by DOT agency regulations may not be part of
the same random pool with DOT covered employees.

\(c\) You may assist employers in ensuring that follow-up testing is
conducted in accordance with the plan established by the SAP. However,
neither you nor the employer are permitted to randomly select employees
from a "follow-up pool" for follow-up testing.

**§ 40.349   What records may a service agent receive and maintain?**

\(a\) Except where otherwise specified in this part, as a service agent
you may receive and maintain all records concerning DOT drug and alcohol
testing programs, including positive, negative, and refusal to test
individual test results. You do not need the employee\'s consent to
receive and maintain these records.

\(b\) You may maintain all information needed for operating a
drug/alcohol program (e.g., CCFs, ATFs, names of employees in random
pools, random selection lists, copies of notices to employers of
selected employees) on behalf of an employer.

\(c\) If a service agent originating drug or alcohol testing
information, such as an MRO or BAT, sends the information directly to
the DER, he or she may also provide the information simultaneously to
you, as a C/TPA or other service agent who maintains this information
for the employer.

\(d\) If you are serving as an intermediary in transmitting information
that is required to be provided to the employer, you must ensure that it
reaches the employer in the same time periods required elsewhere in this
part.

\(e\) You must ensure that you can make available to the employer within
two business days any information the employer is asked to produce by a
DOT agency representative.

\(f\) On request of an employer, you must, at any time on the request of
an employer, transfer immediately all records pertaining to the employer
and its employees to the employer or to any other service agent the
employer designates. You must carry out this transfer as soon as the
employer requests it. You are not required to obtain employee consent
for this transfer. You must not charge more than your reasonable
administrative costs for conducting this transfer. You may not charge a
fee for the release of these records.

\(g\) If you are planning to go out of business or your organization
will be bought by or merged with another organization, you must
immediately notify all employers and offer to transfer all records
pertaining to the employer and its employees to the employer or to any
other service agent the employer designates. You must carry out this
transfer as soon as the employer requests it. You are not required to
obtain employee consent for this transfer. You must not charge more than
your reasonable administrative costs for conducting this transfer. You
may not charge a fee for the release of these records.

\[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41955, Aug. 9, 2001\]

**§ 40.351   What confidentiality requirements apply to service
agents?**

Except where otherwise specified in this part, as a service agent the
following confidentiality requirements apply to you:

\(a\) When you receive or maintain confidential information about
employees (e.g., individual test results), you must follow the same
confidentiality regulations as the employer with respect to the use and
release of this information.

\(b\) You must follow all confidentiality and records retention
requirements applicable to employers.

\(c\) You may not provide individual test results or other confidential
information to another employer without a specific, written consent from
the employee. For example, suppose you are a C/TPA that has employers X
and Y as clients. Employee Jones works for X, and you maintain Jones\'
drug and alcohol test for X. Jones wants to change jobs and work for Y.
You may not inform Y of the result of a test conducted for X without
having a specific, written consent from Jones. Likewise, you may not
provide this information to employer Z, who is not a C/TPA member,
without this consent.

\(d\) You must not use blanket consent forms authorizing the release of
employee testing information.

\(e\) You must establish adequate confidentiality and security measures
to ensure that confidential employee records are not available to
unauthorized persons. This includes protecting the physical security of
records, access controls, and computer security measures to safeguard
confidential data in electronic data bases.

**§ 40.353   What principles govern the interaction between MROs and
other service agents?**

As a service agent other than an MRO (e.g., a C/TPA), the following
principles govern your interaction with MROs:

\(a\) You may provide MRO services to employers, directly or through
contract, if you meet all applicable provisions of this part.

\(b\) If you employ or contract for an MRO, the MRO must perform duties
independently and confidentially. When you have a relationship with an
MRO, you must structure the relationship to ensure that this
independence and confidentiality are not compromised. Specific means
(including both physical and operational measures, as appropriate) to
separate MRO functions and other service agent functions are essential.

\(c\) Only your staff who are actually under the day-to-day supervision
and control of an MRO with respect to MRO functions may perform these
functions. This does not mean that those staff may not perform other
functions at other times. However, the designation of your staff to
perform MRO functions under MRO supervision must be limited and not used
as a subterfuge to circumvent confidentiality and other requirements of
this part and DOT agency regulations. You must ensure that MRO staff
operate under controls sufficient to ensure that the independence and
confidentiality of the MRO process are not compromised.

\(d\) Like other MROs, an MRO you employ or contract with must
personally conduct verification interviews with employees and must
personally make all verification decisions. Consequently, your staff
cannot perform these functions.

**§ 40.355   What limitations apply to the activities of service
agents?**

As a service agent, you are subject to the following limitations
concerning your activities in the DOT drug and alcohol testing program.

\(a\) You must not require an employee to sign a consent, release,
waiver of liability, or indemnification agreement with respect to any
part of the drug or alcohol testing process covered by this part
(including, but not limited to, collections, laboratory testing, MRO,
and SAP services). No one may do so on behalf of a service agent.

\(b\) You must not act as an intermediary in the transmission of drug
test results from the laboratory to the MRO. That is, the laboratory may
not send results to you, with you in turn sending them to the MRO for
verification. For example, a practice in which the laboratory transmits
results to your computer system, and you then assign the results to a
particular MRO, is not permitted.

\(c\) You must not transmit drug test results directly from the
laboratory to the employer (by electronic or other means) or to a
service agent who forwards them to the employer. All confirmed
laboratory results must be processed by the MRO before they are released
to any other party.

\(d\) You must not act as an intermediary in the transmission of alcohol
test results of 0.02 or higher from the STT or BAT to the DER.

\(e\) Except as provided in paragraph (f) of this section, you must not
act as an intermediary in the transmission of individual SAP reports to
the actual employer. That is, the SAP may not send such reports to you,
with you in turn sending them to the actual employer. However, you may
maintain individual SAP summary reports and follow-up testing plans
after they are sent to the DER, and the SAP may transmit such reports to
you simultaneously with sending them to the DER.

\(f\) As an exception to paragraph (e) of this section, you may act as
an intermediary in the transmission of SAP report from the SAP to an
owner-operator or other self-employed individual.

\(g\) Except as provided in paragraph (h) of this section, you must not
make decisions to test an employee based upon reasonable suspicion,
post-accident, return-to-duty, and follow-up determination criteria.
These are duties the actual employer cannot delegate to a C/TPA. You
may, however, provide advice and information to employers regarding
these testing issues and how the employer should schedule required
testing.

\(h\) As an exception to paragraph (g) of this section, you may make
decisions to test an employee based upon reasonable suspicion,
post-accident, return-to-duty, and follow-up determination criteria with
respect to an owner-operator or other self-employed individual.

\(i\) Except as provided in paragraph (j) of this section, you must not
make a determination that an employee has refused a drug or alcohol
test. This is a non-delegable duty of the actual employer. You may,
however, provide advice and information to employers regarding
refusal-to-test issues.

\(j\) As an exception to paragraph (i) of this section, you may make a
determination that an employee has refused a drug or alcohol test, if:

\(1\) You schedule a required test for an owner-operator or other
self-employed individual, and the individual fails to appear for the
test without a legitimate reason; or

\(2\) As an MRO, you determine that an individual has refused to test on
the basis of adulteration or substitution.

\(k\) You must not act as a DER. For example, while you may be
responsible for transmitting information to the employer about test
results, you must not act on behalf of the employer in actions to remove
employees from safety-sensitive duties.

\(l\) In transmitting documents to laboratories, you must ensure that
you send to the laboratory that conducts testing only the laboratory
copy of the CCF. You must not transmit other copies of the CCF or any
ATFs to the laboratory.

\(m\) You must not impose conditions or requirements on employers that
DOT regulations do not authorize. For example, as a C/TPA serving
employers in the pipeline or motor carrier industry, you must not
require employers to have provisions in their DOT plans that RSPA or
FMCSA regulations do not require.

\(n\) You must not intentionally delay the transmission of drug or
alcohol testing-related documents concerning actions you have performed,
because of a payment dispute or other reasons.

*[Example 1 to Paragraph (n]{.underline}):*   A laboratory that has
tested a specimen must not delay transmitting the documentation of the
test result to an MRO because of a billing or payment dispute with the
MRO or a C/TPA.

*[Example 2 to Paragraph (n]{.underline}):*   An MRO or SAP who has
interviewed an employee must not delay sending a verified test result or
SAP report to the employer because of such a dispute with the employer
or employee.

*[Example 3 to Paragraph (n]{.underline}):*   A collector who has
performed a urine specimen collection must not delay sending the drug
specimen and CCF to the laboratory because of a payment or other dispute
with the laboratory or a C/TPA.

*[Example 4 to Paragraph (n)]{.underline}:*   A BAT who has conducted an
alcohol test must not delay sending test result information to an
employer or C/TPA because of a payment or other dispute with the
employer or C/TPA.

\(o\) While you must follow the DOT agency regulations, the actual
employer remains accountable to DOT for compliance, and your failure to
implement any aspect of the program as required in this part and other
applicable DOT agency regulations makes the employer subject to
enforcement action by the Department.

\[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41955, Aug. 9, 2001\]

**Subpart R - Public Interest Exclusions**

**§ 40.361   What is the purpose of a public interest exclusion (PIE)?**

\(a\) To protect the public interest, including protecting
transportation employers and employees from serious noncompliance with
DOT drug and alcohol testing rules, the Department\'s policy is to
ensure that employers conduct business only with responsible service
agents.

\(b\) The Department therefore uses PIEs to exclude from participation
in DOT\'s drug and alcohol testing program any service agent who, by
serious noncompliance with this part or other DOT agency drug and
alcohol testing regulations, has shown that it is not currently acting
in a responsible manner.

\(c\) A PIE is a serious action that the Department takes only to
protect the public interest. We intend to use PIEs only to remedy
situations of serious noncompliance. PIEs are not used for the purpose
of punishment.

\(d\) Nothing in this subpart precludes a DOT agency or the Inspector
General from taking other action authorized by its regulations with
respect to service agents or employers that violate its regulations.

**§ 40.363   On what basis may the Department issue a PIE?**

\(a\) If you are a service agent, the Department may issue a PIE
concerning you if we determine that you have failed or refused to
provide drug or alcohol testing services consistent with the
requirements of this part or a DOT agency drug and alcohol regulation.

\(b\) The Department also may issue a PIE if you have failed to
cooperate with DOT agency representatives concerning inspections,
complaint investigations, compliance and enforcement reviews, or
requests for documents and other information about compliance with this
part or DOT agency drug and alcohol regulations.

**§ 40.365   What is the Department\'s policy concerning starting a PIE
proceeding?**

\(a\) It is the Department\'s policy to start a PIE proceeding only in
cases of serious, uncorrected noncompliance with the provisions of this
part, affecting such matters as safety, the outcomes of test results,
privacy and confidentiality, due process and fairness for employees, the
honesty and integrity of the testing program, and cooperation with or
provision of information to DOT agency representatives.

\(b\) The following are examples of the kinds of serious noncompliance
that, as a matter of policy, the Department views as appropriate grounds
for starting a PIE proceeding. These examples are not intended to be an
exhaustive or exclusive list of the grounds for starting a PIE
proceeding. We intend them to illustrate the level of seriousness that
the Department believes supports starting a PIE proceeding. The examples
follow:

\(1\) For an MRO, verifying tests positive without interviewing the
employees as required by this part or providing MRO services without
meeting the qualifications for an MRO required by this part;

\(2\) For a laboratory, refusing to provide information to the
Department, an employer, or an employee as required by this part;
failing or refusing to conduct a validity testing program when required
by this part; or a pattern or practice of testing errors that result in
the cancellation of tests. (As a general matter of policy, the
Department does not intend to initiate a PIE proceeding concerning a
laboratory with respect to matters on which HHS initiates certification
actions under its laboratory guidelines.);

\(3\) For a collector, a pattern or practice of directly observing
collections when doing so is unauthorized, or failing or refusing to
directly observe collections when doing so is mandatory;

\(4\) For collectors, BATs, or STTs, a pattern or practice of using
forms, testing equipment, or collection kits that do not meet the
standards in this part;

\(5\) For a collector, BAT, or STT, a pattern or practice of "fatal
flaws" or other significant uncorrected errors in the collection
process;

\(6\) For a laboratory, MRO or C/TPA, failing or refusing to report
tests results as required by this part or DOT agency regulations;

\(7\) For a laboratory, falsifying, concealing, or destroying
documentation concerning any part of the drug testing process,
including, but not limited to, documents in a "litigation package";

\(8\) For SAPs, providing SAP services while not meeting SAP
qualifications required by this part or performing evaluations without
face-to-face interviews;

\(9\) For any service agent, maintaining a relationship with another
party that constitutes a conflict of interest under this part (e.g., a
laboratory that derives a financial benefit from having an employer use
a specific MRO);

\(10\) For any service agent, representing falsely that the service
agent or its activities is approved or certified by the Department or a
DOT agency;

\(11\) For any service agent, disclosing an employee\'s test result
information to any party this part or a DOT agency regulation does not
authorize, including by obtaining a "blanket" consent from employees or
by creating a data base from which employers or others can retrieve an
employee\'s DOT test results without the specific consent of the
employee;

\(12\) For any service agent, interfering or attempting to interfere
with the ability of an MRO to communicate with the Department, or
retaliating against an MRO for communicating with the Department;

\(13\) For any service agent, directing or recommending that an employer
fail or refuse to implement any provision of this part; or

\(14\) With respect to noncompliance with a DOT agency regulation,
conduct that affects important provisions of Department-wide concern
(e.g., failure to properly conduct the selection process for random
testing).

**§ 40.367   Who initiates a PIE proceeding?**

The following DOT officials may initiate a PIE proceeding:

\(a\) The drug and alcohol program manager of a DOT agency;

\(b\) An official of ODAPC, other than the Director; or

\(c\) The designee of any of these officials.

**§ 40.369   What is the discretion of an initiating official in
starting a PIE proceeding?**

\(a\) Initiating officials have broad discretion in deciding whether to
start a PIE proceeding.

\(b\) In exercising this discretion, the initiating official must
consider the Department\'s policy regarding the seriousness of the
service agent\'s conduct (see §40.365) and all information he or she has
obtained to this point concerning the facts of the case. The initiating
official may also consider the availability of the resources needed to
pursue a PIE proceeding.

\(c\) A decision not to initiate a PIE proceeding does not necessarily
mean that the Department regards a service agent as being in compliance
or that the Department may not use other applicable remedies in a
situation of noncompliance.

**§ 40.371   On what information does an initiating official rely in
deciding whether to start a PIE proceeding?**

\(a\) An initiating official may rely on credible information from any
source as the basis for starting a PIE proceeding.

\(b\) Before sending a correction notice (see §40.373), the initiating
official informally contacts the service agent to determine if there is
any information that may affect the initiating official\'s determination
about whether it is necessary to send a correction notice. The
initiating official may take any information resulting from this contact
into account in determining whether to proceed under this subpart.

**§ 40.373   Before starting a PIE proceeding, does the initiating
official give the service agent an opportunity to correct problems?**

\(a\) If you are a service agent, the initiating official must send you
a correction notice before starting a PIE proceeding.

\(b\) The correction notice identifies the specific areas in which you
must come into compliance in order to avoid being subject to a PIE
proceeding.

\(c\) If you make and document changes needed to come into compliance in
the areas listed in the correction notice to the satisfaction of the
initiating official within 60 days of the date you receive the notice,
the initiating official does not start a PIE proceeding. The initiating
official may conduct appropriate fact finding to verify that you have
made and maintained satisfactory corrections. When he or she is
satisfied that you are in compliance, the initiating official sends you
a notice that the matter is concluded.

**§ 40.375   How does the initiating official start a PIE proceeding?**

\(a\) As a service agent, if your compliance matter is not correctable
(see §40.373(a)), or if have not resolved compliance matters as provided
in §40.373(c), the initiating official starts a PIE proceeding by
sending you a notice of proposed exclusion (NOPE). The NOPE contains the
initiating official\'s recommendations concerning the issuance of a PIE,
but it is not a decision by the Department to issue a PIE.

\(b\) The NOPE includes the following information:

\(1\) A statement that the initiating official is recommending that the
Department issue a PIE concerning you;

\(2\) The factual basis for the initiating official\'s belief that you
are not providing drug and/or alcohol testing services to DOT-regulated
employers consistent with the requirements of this part or are in
serious noncompliance with a DOT agency drug and alcohol regulation;

\(3\) The factual basis for the initiating official\'s belief that your
noncompliance has not been or cannot be corrected;

\(4\) The initiating official\'s recommendation for the scope of the
PIE;

\(5\) The initiating official\'s recommendation for the duration of the
PIE; and

\(6\) A statement that you may contest the issuance of the proposed PIE,
as provided in §40.379.

\(c\) The initiating official sends a copy of the NOPE to the ODAPC
Director at the same time he or she sends the NOPE to you.

**§ 40.377   Who decides whether to issue a PIE?**

\(a\) The ODAPC Director, or his or her designee, decides whether to
issue a PIE. If a designee is acting as the decisionmaker, all
references in this subpart to the Director refer to the designee.

\(b\) To ensure his or her impartiality, the Director plays no role in
the initiating official\'s determination about whether to start a PIE
proceeding.

\(c\) There is a "firewall" between the initiating official and the
Director. This means that the initiating official and the Director are
prohibited from having any discussion, contact, or exchange of
information with one another about the matter, except for documents and
discussions that are part of the record of the proceeding.

**§ 40.379   How do you contest the issuance of a PIE?**

\(a\) If you receive a NOPE, you may contest the issuance of the PIE.

\(b\) If you want to contest the proposed PIE, you must provide the
Director information and argument in opposition to the proposed PIE in
writing, in person, and/or through a representative. To contest the
proposed PIE, you must take one or more of the steps listed in this
paragraph (b) within 30 days after you receive the NOPE.

\(1\) You may request that the Director dismiss the proposed PIE without
further proceedings, on the basis that it does not concern serious
noncompliance with this part or DOT agency regulations, consistent with
the Department\'s policy as stated in §40.365.

\(2\) You may present written information and arguments, consistent with
the provisions of §40.381, contesting the proposed PIE.

\(3\) You may arrange with the Director for an informal meeting to
present your information and arguments.

\(c\) If you do not take any of the actions listed in paragraph (b) of
this section within 30 days after you receive the NOPE, the matter
proceeds as an uncontested case. In this event, the Director makes his
or her decision based on the record provided by the initiating official
(i.e., the NOPE and any supporting information or testimony) and any
additional information the Director obtains.

**§ 40.381   What information do you present to contest the proposed
issuance of a PIE?**

\(a\) As a service agent who wants to contest a proposed PIE, you must
present at least the following information to the Director:

\(1\) Specific facts that contradict the statements contained in the
NOPE (see §40.375(b)(2) and (3)). A general denial is insufficient to
raise a genuine dispute over facts material to the issuance of a PIE;

\(2\) Identification of any existing, proposed or prior PIE; and

\(3\) Identification of your affiliates, if any.

\(b\) You may provide any information and arguments you wish concerning
the proposed issuance, scope and duration of the PIE (see §40.375(b)(4)
and (5)).

\(c\) You may provide any additional relevant information or arguments
concerning any of the issues in the matter.

**§ 40.383   What procedures apply if you contest the issuance of a
PIE?**

\(a\) DOT conducts PIE proceedings in a fair and informal manner. The
Director may use flexible procedures to allow you to present matters in
opposition. The Director is not required to follow formal rules of
evidence or procedure in creating the record of the proceeding.

\(b\) The Director will consider any information or argument he or she
determines to be relevant to the decision on the matter.

\(c\) You may submit any documentary evidence you want the Director to
consider. In addition, if you have arranged an informal meeting with the
Director, you may present witnesses and confront any person the
initiating official presents as a witness against you.

\(d\) In cases where there are material factual issues in dispute, the
Director or his or her designee may conduct additional fact-finding.

\(e\) If you have arranged a meeting with the Director, the Director
will make a transcribed record of the meeting available to you on your
request. You must pay the cost of transcribing and copying the meeting
record.

**§ 40.385   Who bears the burden of proof in a PIE proceeding?**

\(a\) As the proponent of issuing a PIE, the initiating official bears
the burden of proof.

\(b\) This burden is to demonstrate, by a preponderance of the evidence,
that the service agent was in serious noncompliance with the
requirements of this part for drug and/or alcohol testing-related
services or with the requirements of another DOT agency drug and alcohol
testing regulation.

**§ 40.387   What matters does the Director decide concerning a proposed
PIE?**

\(a\) Following the service agent\'s response (see §40.379(b)) or, if no
response is received, after 30 days have passed from the date on which
the service agent received the NOPE, the Director may take one of the
following steps:

\(1\) In response to a request from the service agent (see
§40.379(b)(1)) or on his or her own motion, the Director may dismiss a
PIE proceeding if he or she determines that it does not concern serious
noncompliance with this part or DOT agency regulations, consistent with
the Department\'s policy as stated in §40.365.

\(i\) If the Director dismisses a proposed PIE under this paragraph (a),
the action is closed with respect to the noncompliance alleged in the
NOPE.

\(ii\) The Department may initiate a new PIE proceeding against you on
the basis of different or subsequent conduct that is in noncompliance
with this part or other DOT drug and alcohol testing rules.

\(2\) If the Director determines that the initiating official\'s
submission does not have complete information needed for a decision, the
Director may remand the matter to the initiating official. The
initiating official may resubmit the matter to the Director when the
needed information is complete. If the basis for the proposed PIE has
changed, the initiating official must send an amended NOPE to the
service agent.

\(b\) The Director makes determinations concerning the following matters
in any PIE proceeding that he or she decides on the merits:

\(1\) Any material facts that are in dispute;

\(2\) Whether the facts support issuing a PIE;

\(3\) The scope of any PIE that is issued; and

\(4\) The duration of any PIE that is issued.

**§ 40.389   What factors may the Director consider?**

This section lists examples of the kind of mitigating and aggravating
factors that the Director may consider in determining whether to issue a
PIE concerning you, as well as the scope and duration of a PIE. This
list is not exhaustive or exclusive. The Director may consider other
factors if appropriate in the circumstances of a particular case. The
list of examples follows:

\(a\) The actual or potential harm that results or may result from your
noncompliance;

\(b\) The frequency of incidents and/or duration of the noncompliance;

\(c\) Whether there is a pattern or prior history of noncompliance;

\(d\) Whether the noncompliance was pervasive within your organization,
including such factors as the following:

\(1\) Whether and to what extent your organization planned, initiated,
or carried out the noncompliance;

\(2\) The positions held by individuals involved in the noncompliance,
and whether your principals tolerated their noncompliance; and

\(3\) Whether you had effective standards of conduct and control systems
(both with respect to your own organization and any contractors or
affiliates) at the time the noncompliance occurred;

\(e\) Whether you have demonstrated an appropriate compliance
disposition, including such factors as the following:

\(1\) Whether you have accepted responsibility for the noncompliance and
recognize the seriousness of the conduct that led to the cause for
issuance of the PIE;

\(2\) Whether you have cooperated fully with the Department during the
investigation. The Director may consider when the cooperation began and
whether you disclosed all pertinent information known to you;

\(3\) Whether you have fully investigated the circumstances of the
noncompliance forming the basis for the PIE and, if so, have made the
result of the investigation available to the Director;

\(4\) Whether you have taken appropriate disciplinary action against the
individuals responsible for the activity that constitutes the grounds
for issuance of the PIE; and

\(5\) Whether your organization has taken appropriate corrective actions
or remedial measures, including implementing actions to prevent
recurrence;

\(f\) With respect to noncompliance with a DOT agency regulation, the
degree to which the noncompliance affects matters common to the DOT drug
and alcohol testing program;

\(g\) Other factors appropriate to the circumstances of the case.

**§ 40.391   What is the scope of a PIE?**

\(a\) The scope of a PIE is the Department\'s determination about the
divisions, organizational elements, types of services, affiliates,
and/or individuals (including direct employees of a service agent and
its contractors) to which a PIE applies.

\(b\) If, as a service agent, the Department issues a PIE concerning
you, the PIE applies to all your divisions, organizational elements, and
types of services that are involved with or affected by the
noncompliance that forms the factual basis for issuing the PIE.

\(c\) In the NOPE (see §40.375(b)(4)), the initiating official sets
forth his or her recommendation for the scope of the PIE. The proposed
scope of the PIE is one of the elements of the proceeding that the
service agent may contest (see §40.381(b)) and about which the Director
makes a decision (see §40.387(b)(3)).

\(d\) In recommending and deciding the scope of the PIE, the initiating
official and Director, respectively, must take into account the
provisions of paragraphs (e) through (j) of this section.

\(e\) The pervasiveness of the noncompliance within a service agent\'s
organization (see §40.389(d)) is an important consideration in
determining the scope of a PIE. The appropriate scope of a PIE grows
broader as the pervasiveness of the noncompliance increases.

\(f\) The application of a PIE is not limited to the specific location
or employer at which the conduct that forms the factual basis for
issuing the PIE was discovered.

\(g\) A PIE applies to your affiliates, if the affiliate is involved
with or affected by the conduct that forms the factual basis for issuing
the PIE.

\(h\) A PIE applies to individuals who are officers, employees,
directors, shareholders, partners, or other individuals associated with
your organization in the following circumstances:

\(1\) Conduct forming any part of the factual basis of the PIE occurred
in connection with the individual\'s performance of duties by or on
behalf of your organization; or

\(2\) The individual knew of, had reason to know of, approved, or
acquiesced in such conduct. The individual\'s acceptance of benefits
derived from such conduct is evidence of such knowledge, acquiescence,
or approval.

\(i\) If a contractor to your organization is solely responsible for the
conduct that forms the factual basis for a PIE, the PIE does not apply
to the service agent itself unless the service agent knew or should have
known about the conduct and did not take action to correct it.

\(j\) PIEs do not apply to drug and alcohol testing that DOT does not
regulate.

\(k\) The following examples illustrate how the Department intends the
provisions of this section to work:

*[Example 1 to §40.391]{.underline}.*   Service Agent P provides a
variety of drug testing services. P\'s SAP services are involved in a
serious violation of this Part 40. However, P\'s other services fully
comply with this part, and P\'s overall management did not plan or
concur in the noncompliance, which in fact was contrary to P\'s
articulated standards. Because the noncompliance was isolated in one
area of the organization\'s activities, and did not pervade the entire
organization, the scope of the PIE could be limited to SAP services.

*[Example 2 to §40.391]{.underline}.*   Service Agent Q provides a
similar variety of services. The conduct forming the factual basis for a
PIE concerns collections for a transit authority. As in Example 1, the
noncompliance is not pervasive throughout Q\'s organization. The PIE
would apply to collections at all locations served by Q, not just the
particular transit authority or not just in the state in which the
transit authority is located.

*[Example 3 to §40.391]{.underline}.*   Service Agent R provides a
similar array of services. One or more of the following problems exists:
R\'s activities in several areas---collections, MROs, SAPs, protecting
the confidentiality of information---are involved in serious
noncompliance; DOT determines that R\'s management knew or should have
known about serious noncompliance in one or more areas, but management
did not take timely corrective action; or, in response to an inquiry
from DOT personnel, R\'s management refuses to provide information about
its operations. In each of these three cases, the scope of the PIE would
include all aspects of R\'s services.

*[Example 4 to §40.391]{.underline}.*   Service Agent W provides only
one kind of service (e.g., laboratory or MRO services). The Department
issues a PIE concerning these services. Because W only provides this one
kind of service, the PIE necessarily applies to all its operations.

*[Example 5 to §40.391]{.underline}.*   Service Agent X, by exercising
reasonably prudent oversight of its collection contractor, should have
known that the contractor was making numerous "fatal flaws" in tests.
Alternatively, X received a correction notice pointing out these
problems in its contractor\'s collections. In neither case did X take
action to correct the problem. X, as well as the contractor, would be
subject to a PIE with respect to collections.

*[Example 6 to §40.391]{.underline}.*   Service Agent Y could not
reasonably have known that one of its MROs was regularly failing to
interview employees before verifying tests positive. When it received a
correction notice, Y immediately dismissed the erring MRO. In this case,
the MRO would be subject to a PIE but Y would not.

*[Example 7 to §40.391]{.underline}.*   The Department issues a PIE with
respect to Service Agent Z. Z provides services for DOT-regulated
transportation employers, a Federal agency under the HHS-regulated
Federal employee testing program, and various private businesses and
public agencies that DOT does not regulate. The PIE applies only to the
DOT-regulated transportation employers with respect to their
DOT-mandated testing, not to the Federal agency or the other public
agencies and private businesses. The PIE does not prevent the non-DOT
regulated entities from continuing to use Z\'s services.

**§ 40.393   How long does a PIE stay in effect?**

\(a\) In the NOPE (see §40.375(b)(5)), the initiating official proposes
the duration of the PIE. The duration of the PIE is one of the elements
of the proceeding that the service agent may contest (see §40.381(b))
and about which the Director makes a decision (see §40.387(b)(4)).

\(b\) In deciding upon the duration of the PIE, the Director considers
the seriousness of the conduct on which the PIE is based and the
continued need to protect employers and employees from the service
agent\'s noncompliance. The Director considers factors such as those
listed in §40.389 in making this decision.

c\) The duration of a PIE will be between one and five years, unless the
Director reduces its duration under §40.407.

**§ 40.395   Can you settle a PIE proceeding?**

any time before the Director\'s decision, you and the initiating
official can, with the Director\'s concurrence, settle a PIE proceeding.

**§ 40.397   When does the Director make a PIE decision?**

Director makes his or her decision within 60 days of the date when the
record of a PIE proceeding is complete (including any meeting with the
Director and any additional fact-finding that is necessary). The
Director may extend this period for good cause for additional periods of
up to 30 days.

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

you are a service agent involved in a PIE proceeding, the Director
provides you written notice as soon as he or she makes a PIE decision.
The notice includes the following elements:

\(a\) If the decision is not to issue a PIE, a statement of the reasons
for the decision, including findings of fact with respect to any
material factual issues that were in dispute.

\(b\) If the decision is to issue a PIE---

\(1\) A reference to the NOPE;

\(2\) A statement of the reasons for the decision, including findings of
fact with respect to any material factual issues that were in dispute;

\(3\) A statement of the scope of the PIE; and

\(4\) A statement of the duration of the PIE.

**§ 40.401   How does the Department notify employers and the public
about a PIE?**

\(a\) The Department maintains a document called the "List of Excluded
Drug and Alcohol Service Agents." This document may be found on the
Department\'s web site (http://www.dot.gov/ost/dapc). You may also
request a copy of the document from ODAPC.

\(b\) When the Director issues a PIE, he or she adds to the List the
name and address of the service agent, and any other persons or
organizations, to whom the PIE applies and information about the scope
and duration of the PIE.

\(c\) When a service agent ceases to be subject to a PIE, the Director
removes this information from the List.

\(d\) The Department also publishes a Federal Register notice to inform
the public on any occasion on which a service agent is added to or taken
off the List.

**§ 40.403   Must a service agent notify its clients when the Department
issues a PIE?**

\(a\) As a service agent, if the Department issues a PIE concerning you,
you must notify each of your DOT-regulated employer clients, in writing,
about the issuance, scope, duration, and effect of the PIE. You may meet
this requirement by sending a copy of the Director\'s PIE decision or by
a separate notice. You must send this notice to each client within three
business days of receiving from the Department the notice provided for
in §40.399(b).

\(b\) As part of the notice you send under paragraph (a) of this
section, you must offer to transfer immediately all records pertaining
to the employer and its employees to the employer or to any other
service agent the employer designates. You must carry out this transfer
as soon as the employer requests it.

\[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41955, Aug. 9, 2001\]

**§ 40.405   May the Federal courts review PIE decisions?**

Director\'s decision is a final administrative action of the Department.
Like all final administrative actions of Federal agencies, the
Director\'s decision is subject to judicial review under the
Administrative Procedure Act (5 U.S.C. 551 et. seq).

**§ 40.407   May a service agent ask to have a PIE reduced or
terminated?**

\(a\) Yes, as a service agent concerning whom the Department has issued
a PIE, you may request that the Director terminate a PIE or reduce its
duration and/or scope. This process is limited to the issues of duration
and scope. It is not an appeal or reconsideration of the decision to
issue the PIE.

\(b\) Your request must be in writing and supported with documentation.

\(c\) You must wait at least nine months from the date on which the
Director issued the PIE to make this request.

\(d\) The initiating official who was the proponent of the PIE may
provide information and arguments concerning your request to the
Director.

\(e\) If the Director verifies that the sources of your noncompliance
have been eliminated and that all drug or

alcohol testing-related services you would provide to DOT-regulated
employers will be consistent with the requirements of this part, the
Director may issue a notice terminating or reducing the PIE.

**§ 40.409   What does the issuance of a PIE mean to transportation
employers?**

\(a\) As an employer, you are deemed to have notice of the issuance of a
PIE when it appears on the List mentioned in §40.401(a) or the notice of
the PIE appears in the Federal Register as provided in §40.401(d). You
should check this List to ensure that any service agents you are using
or planning to use are not subject to a PIE.

\(b\) As an employer who is using a service agent concerning whom a PIE
is issued, you must s using the services of the service agent no later
than 90 days after the Department has published the decision in the
Federal Register or posted it on its web site. You may apply to the
ODAPC Director for an extension of 30 days if you demonstrate that you
cannot find a substitute service agent within 90 days.

\(c\) Except during the period provided in paragraph (b) of this
section, you must not, as an employer, use the services of a service
agent that are covered by a PIE that the Director has issued under this
subpart. If you do so, you are in violation of the Department\'s
regulations and subject to applicable DOT agency sanctions (e.g., civil
penalties, withholding of Federal financial assistance).

\(d\) You also must not obtain drug or alcohol testing services through
a contractor or affiliate of the service agent to whom the PIE applies.

*[Example to Paragraph (d]{.underline}):*   Service Agent R was subject
to a PIE with respect to SAP services. As an employer, not only must you
not use R\'s own SAP services, but you also must not use SAP services
you arrange through R, such as services provided by a subcontractor or
affiliate of R or a person or organization that receives financial gain
from its relationship with R.

\(e\) This section\'s prohibition on using the services of a service
agent concerning which the Director has issued a PIE applies to
employers in all industries subject to DOT drug and alcohol testing
regulations.

*[Example to Paragraph (e]{.underline}):*   The initiating official for
a PIE was the FAA drug and alcohol program manager, and the conduct
forming the basis of the PIE pertained to the aviation industry. As a
motor carrier, transit authority, pipeline, railroad, or maritime
employer, you are also prohibited from using the services of the service
agent involved in connection with the DOT drug and alcohol testing
program.

\(f\) The issuance of a PIE does not result in the cancellation of drug
or alcohol tests conducted using the service agent involved before the
issuance of the Director\'s decision or up to 90 days following its
publication in the Federal Register or posting on the Department\'s web
site, unless otherwise specified in the Director\'s PIE decision or the
Director grants an extension as provided in paragraph (b) of this
section.

*[Example to Paragraph]{.underline} (f):*   The Department issues a PIE
concerning Service Agent N on September 1. All tests conducted using
N\'s services before September 1, and through November 30, are valid for
all purposes under DOT drug and alcohol testing regulations, assuming
they meet all other regulatory requirements.

**§ 40.411   What is the role of the DOT Inspector General\'s office?**

\(a\) Any person may bring concerns about waste, fraud, or abuse on the
part of a service agent to the attention of the DOT Office of Inspector
General.

\(b\) In appropriate cases, the Office of Inspector General may pursue
criminal or civil remedies against a service agent.

\(c\) The Office of Inspector General may provide factual information to
other DOT officials for use in a PIE proceeding.

**§ 40.413   How are notices sent to service agents?**

\(a\) If you are a service agent, DOT sends notices to you, including
correction notices, notices of proposed exclusion, decision notices, and
other notices, in any of the ways mentioned in paragraph (b) or (c) of
this section.

\(b\) DOT may send a notice to you, your identified counsel, your agent
for service of process, or any of your partners, officers, directors,
owners, or joint venturers to the last known street address, fax number,
or e-mail address. DOT deems the notice to have been received by you if
sent to any of these persons.

\(c\) DOT considers notices to be received by you---

\(1\) When delivered, if DOT mails the notice to the last known street
address, or five days after we send it if the letter is undeliverable;

\(2\) When sent, if DOT sends the notice by fax or five days after we
send it if the fax is undeliverable; or

\(3\) When delivered, if DOT sends the notice by e-mail or five days
after DOT sends it if the e-mail is undeliverable.

**Appendix A to Part 40 - DOT Standards for Urine Collection Kits**

*[The Collection Kit Contents]{.underline}*

1\. [Collection Container]{.underline}

a\. Single-use container, made of plastic, large enough to easily catch
and hold at least 55 mL of urine voided from the body.

b\. Must have graduated volume markings clearly noting levels of 45 mL
and above.

c\. Must have a temperature strip providing graduated temperature
readings 32--38 °C/90--100 °F, that is affixed or can be affixed at a
proper level on the outside of the collection container. Other
methodologies (e.g., temperature device built into the wall of the
container) are acceptable provided the temperature measurement is
accurate and such that there is no potential for contamination of the
specimen.

d\. Must be individually wrapped in a sealed plastic bag or shrink
wrapping; or must have a peelable, sealed lid or other easily visible
tamper-evident system.

e\. May be made available separately at collection sites to address shy
bladder situations when several voids may be required to complete the
testing process.

[2. Plastic Specimen Bottles]{.underline}

a\. Each bottle must be large enough to hold at least 35 mL; or
alternatively, they may be two distinct sizes of specimen bottles
provided that the bottle designed to hold the primary specimen holds at
least 35 mL of urine and the bottle designed to hold the split specimen
holds at least 20 mL.

b\. Must have screw-on or snap-on caps that prevent seepage of the urine
from the bottles during shipment.

c\. Must have markings clearly indicating the appropriate levels (30 mL
for the primary specimen and 15 mL for the split) of urine that must be
poured into the bottles.

d\. Must be designed so that the required tamper-evident bottle seals
made available on the CCF fit with no damage to the seal when the
employee initials it nor with the chance that the seal overlap would
conceal printed information.

e\. Must be wrapped (with caps) together in a sealed plastic bag or
shrink wrapping separate from the collection container; or must be
wrapped (with cap) individually in sealed plastic bags or shrink
wrapping; or must have peelable, sealed lid or other easily visible
tamper-evident system.

f\. Plastic material must be leach resistant.

3\. [Leak-Resistant Plastic Bag]{.underline}

a\. Must have two sealable compartments or pouches which are
leak-resistant; one large enough to hold two specimen bottles and the
other large enough to hold the CCF paperwork.

b\. The sealing methodology must be such that once the compartments are
sealed, any tampering or attempts to open either compartment will be
evident.

4\. [Absorbent material]{.underline}

Each kit must contain enough absorbent material to absorb the entire
contents of both specimen bottles. Absorbent material must be designed
to fit inside the leak-resistant plastic bag pouch into which the
specimen bottles are placed.

5\. [Shipping Container]{.underline}

a\. Must be designed to adequately protect the specimen bottles from
shipment damage in the transport of specimens from the collection site
to the laboratory (e.g., standard courier box, small cardboard box,
plastic container).

b\. May be made available separately at collection sites rather than
being part of an actual kit sent to collection sites.

c\. A shipping container is not necessary if a laboratory courier
hand-delivers the specimen bottles in the plastic leak-proof bags from
the collection site to the laboratory.

**Appendix B to Part 40 - DOT Drug Testing Semi-Annual Laboratory
Report**

The following items are required on each report:

Reporting Period: (inclusive dates) Laboratory Identification: (name and
address) Employer Identification: (name; may include billing code or ID
code) C/C/TPA Identification: (where applicable; name and address)

1\. Number of specimen results reported: (total number)

By test type:

\(a\) Pre-employment testing: (number)

\(b\) Post-accident testing: (number)

\(c\) Random testing: (number)

\(d\) Reasonable suspicion/cause testing: (number)

\(e\) Return-to-duty testing: (number)

\(f\) Follow-up testing: (number)

\(g\) Type not noted on CCF: (number)

2\. Number of specimens reported as

\(a\) Negative: (total number)

\(b\) Negative-dilute: (number)

3\. Number of specimens reported as Rejected for Testing: (total number)
By reason:

\(a\) Fatal flaw: (number)

\(b\) Uncorrected flaw: (number)

4\. Number of specimens reported as Positive: (total number)

By drug:

\(a\) Marijuana Metabolite: (number)

\(b\) Cocaine Metabolite: (number)

\(c\) Opiates:

> \(1\) Codeine: (number)
>
> \(2\) Morphine: (number)
>
> \(3\) 6--AM: (number)

\(d\) Phencyclidine: (number)

\(e\) Amphetamines: (number)

> \(1\) Amphetamine: (number)
>
> \(2\) Methamphetamine: (number):

5\. Adulterated: (number)

6\. Substituted: (number)

7\. Invalid results: (number)

**Appendix C to Part 40 \[Reserved\]**

**Appendix D to Part 40 - Report Format: Split Specimen Failure to
Reconfirm**

Fax or mail to:

[Department of Transportation]{.underline},

Office of Drug and Alcohol Policy and Compliance,

400 7th Street, SW., Room 10403,

[Washington, DC 20590]{.underline}

(fax) 202--366--3897.

1\. MRO name, address, phone number, and fax number.

2\. Collection site name, address, and phone number.

3\. Date of collection.

4\. Specimen I.D. number.

5\. Laboratory accession number.

6\. Primary specimen laboratory name, address, and phone number.

7\. Date result reported or certified by primary laboratory.

8\. Split specimen laboratory name, address, and phone number.

9\. Date split specimen result reported or certified by split specimen
laboratory.

10\. Primary specimen results (e.g., name of drug, adulterant) in the
primary specimen.

> 11\. Reason for split specimen failure-to-reconfirm result (e.g., drug
> or adulterant not present, specimen invalid, split not collected,
> insufficient volume).
>
> 12\. Actions taken by the MRO (e.g., notified employer of failure to
> reconfirm and requirement for recollection).

13\. Additional information explaining the reason for cancellation.

14\. Name of individual submitting the report (if not the MRO).

**Appendix E to Part 40 - SAP Equivalency Requirements for Certification
Organizations**

1\. [Experience]{.underline}: Minimum requirements are for three years
of full-time supervised experience or 6,000 hours of supervised
experience as an alcoholism and/or drug abuse counselor. The supervision
must be provided by a licensed or certified practitioner. Supervised
experience is important if the individual is to be considered a
professional in the field of alcohol and drug abuse evaluation and
counseling.

2\. [Education]{.underline}: There exists a requirement of 270 contact
hours of education and training in alcoholism and/or drug abuse or
related training. These hours can take the form of formal education,
in-service training, and professional development courses. Part of any
professional counselor\'s development is participation in formal and
non-formal education opportunities within the field.

3\. [Continuing Education]{.underline}: The certified counselor must
receive at least 40--60 hours of continuing education units (CEU) during
each two year period. These CEUs are important to the counselor\'s
keeping abreast of changes and improvements in the field.

4\. [Testing]{.underline}: A passing score on a national test is a
requirement. The test must accurately measure the application of the
knowledge, skills, and abilities possessed by the counselor. The test
establishes a national standard that must be met to practice.

5\. [Testing Validity]{.underline}: The certification examination must
be reviewed by an independent authority for validity (examination
reliability and relationship to the knowledge, skills, and abilities
required by the counseling field). The reliability of the exam is
paramount if counselor attributes are to be accurately measured. The
examination passing score point must be placed at an appropriate minimal
level score as gauged by statistically reliable methodology.

6\. [Measurable Knowledge Base]{.underline}: The certification process
must be based upon measurable knowledge possessed by the applicant and
verified through collateral data and testing. That level of knowledge
must be of sufficient quantity to ensure a high quality of SAP
evaluation and referral services.

7\. [Measurable Skills Base]{.underline}: The certification process must
be based upon measurable skills possessed by the applicant and verified
through collateral data and testing. That level of skills must be of
sufficient quality to ensure a high quality of SAP evaluation and
referral services.

8\. [Quality Assurance Plan]{.underline}: The certification agency must
ensure that a means exists to determine that applicant records are
verified as being true by the certification staff. This is an important
check to ensure that true information is being accepted by the
certifying agency.

9\. [Code of Ethics]{.underline}: Certified counselors must pledge to
adhere to an ethical standard for practice. It must be understood that
code violations could result in de-certification. These standards are
vital in maintaining the integrity of practitioners. High ethical
standards are required to ensure quality of client care and
confidentiality of client information as well as to guard against
inappropriate referral practices.

10\. [Re-certification Program]{.underline}: Certification is not just a
one-time event. It is a continuing privilege with continuing
requirements. Among these are continuing education, continuing state
certification, and concomitant adherence to the code of ethics.
Re-certification serves as a protector of client interests by removing
poor performers from the certified practice.

11\. [Fifty State Coverage]{.underline}: Certification must be available
to qualified counselors in all 50 states and, therefore, the test must
be available to qualified applicants in all 50 states. Because many
companies are multi-state operators, consistency in SAP evaluation
quality and opportunities is paramount. The test need not be given in
all 50 states but should be accessible to candidates from all states.

12\. [National Commission for Certifying Agencies (NCCA)
Accreditation:]{.underline} Having NCCA accreditation is a means of
demonstrating to the Department of Transportation that your
certification has been reviewed by a panel of impartial experts that
have determined that your examination(s) has met stringent and
appropriate testing standards.

**Appendix F to Part 40 - Drug and Alcohol Testing Information that
C/TPAs May Transmit to Employers**

1\. If you are a C/TPA, you may, acting as an intermediary, transmit the
information in the following sections of this part to the DER for an
employer, if the employer chooses to have you do so. These are the only
items that you are permitted to transmit to the employer as an
intermediary. The use of C/TPA intermediaries is prohibited in all other
cases, such as transmission of laboratory drug test results to MROs, the
transmission of medical information from MROs to employers, the
transmission of SAP reports to employers, the transmission of positive
alcohol test results, and the transmission of medical information from
MROs to employers.

2\. In every case, you must ensure that, in transmitting the
information, you meet all requirements (e.g., concerning confidentiality
and timing) that would apply if the party originating the information
(e.g., an MRO or collector) sent the information directly to the
employer. For example, if you transmit MROs\' drug testing results to
DERs, you must transmit each drug test result to the DER in compliance
with the requirements for MROs set forth in §40.167.

*[Drug Testing Information]{.underline}*

§40.25: Previous two years\' test results

§40.35: Notice to collectors of contact information for DER

§40.61(a): Notification to DER that an employee is a "no show" for a
drug test

§40.63(e): Notification to DER of a collection under direct observation

§40.65(b)(6) and (7) and (c)(2) and (3): Notification to DER of a
refusal to provide a specimen or an insufficient specimen

§40.73(a)(9): Transmission of CCF copies to DER (However, MRO copy of
CCF must be sent by collector directly to the MRO, not through the
C/TPA.)

§40.111(a): Transmission of laboratory statistical report to employer

§40.127(f): Report of test results to DER

§§40.127(g), 40.129(d), 40.159(a)(4)(ii); 40.161(b): Reports to DER that
test is cancelled

§40.129 (d): Report of test results to DER

§40.129(g)(1): Report to DER of confirmed positive test in stand-down
situation

§§40.149(b): Report to DER of changed test result

§40.155(a): Report to DER of dilute specimen

§40.167(b) and (c): Reports of test results to DER

§40.187(a)--(f) Reports to DER concerning the reconfirmation of tests

§40.191(d): Notice to DER concerning refusals to test

§40.193(b)(3): Notification to DER of refusal in shy bladder situation

§40.193(b)(4): Notification to DER of insufficient specimen

§40.193(b)(5): Transmission of CCF copies to DER (not to MRO)

§40.199: Report to DER of cancelled test and direction to DER for
additional collection

§40.201: Report to DER of cancelled test

*[Alcohol Testing Information]{.underline}*

§40.215: Notice to BATs and STTs of contact information for DER

§40.241(b)(1): Notification to DER that an employee is a "no show" for
an alcohol test

§40.247(a)(2): Transmission of alcohol screening test results only when
the test result is less than 0.02

§40.255(a)(4): Transmission of alcohol confirmation test results only
when the test result is less than 0.02

§40.263(a)(3) and 263(b)(3): Notification of insufficient saliva and
failure to provide sufficient amount of breath

\[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41955, Aug. 9, 2001\]

**Appendix G to Part 40---Alcohol Testing Form**

The following form is the alcohol testing form required for use in the
DOT alcohol testing program beginning August 1, 2001. Use of the form is
authorized beginning January 18, 2001.

Appendix H to Part 40 - DOT Drug and Alcohol Testing Management
Information System (MIS) Data Collection Form

**U.S. DEPARTMENT OF TRANSPORTATION DRUG AND ALCOHOL TESTING MIS DATA
COLLECTION FORM**

Calendar Year Covered by this Report: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
OMB No. 2105-0529

# I. Employer:

Company Name:

Doing Business As (DBA) Name (if applicable):

#######  Address:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ E-mail: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ 

Name of Certifying Official: Signature:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

##  Telephone: (\_\_\_\_\_)\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Date Certified: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Prepared by (if different):
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Telephone: (\_\_\_\_\_)\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

C/TPA Name and Telephone (if applicable):
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
(\_\_\_\_\_)\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

## Check the DOT agency for which you are reporting MIS data; and complete the information on that same line as appropriate:

\_\_\_ FMCSA -- Motor Carrier: DOT #:
­­­\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Owner-operator: (circle
one) YES or NO Exempt (Circle One) YES or NO

\_\_\_ FAA -- Aviation: Certificate \# (if applicable):
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Plan / Registration \#
(if applicable):\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

\_\_\_ RSPA -- Pipeline: (Check) Gas Gathering\_\_ Gas Transmission\_\_
Gas Distribution\_\_ Transport Hazardous Liquids\_\_ Transport Carbon
Dioxide\_\_

\_\_\_ FRA -- Railroad: Total Number of observed/documented Part 219
"Rule G" Observations for covered employees:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

\_\_\_ USCG -- Maritime: Vessel ID \# (USCG- or State-Issued):
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
(If more than one vessel, list separately.)

\_\_\_ FTA -- Transit

**II. Covered Employees**: **(A) Enter Total Number Safety-Sensitive
Employees In All Employee Categories:**

**(B) Enter Total Number of Employee Categories**:

**(C)**

###### 

###### III. Drug Testing Data:

<table style="width:100%;">
<colgroup>
<col style="width: 16%" />
<col style="width: 8%" />
<col style="width: 6%" />
<col style="width: 6%" />
<col style="width: 6%" />
<col style="width: 6%" />
<col style="width: 6%" />
<col style="width: 6%" />
<col style="width: 6%" />
<col style="width: 6%" />
<col style="width: 6%" />
<col style="width: 6%" />
<col style="width: 6%" />
<col style="width: 4%" />
</colgroup>
<tbody>
<tr class="odd">
<td rowspan="2">Type of Test</td>
<td rowspan="2"><blockquote>
<p>Total Number Of Test Results [Should equal the sum of Columns 2, 3,
9, 10, 11, and 12]</p>
</blockquote></td>
<td rowspan="2"><blockquote>
<p>Verified Negative Results</p>
</blockquote></td>
<td rowspan="2"><blockquote>
<p>Verified Positive Results ~ For One Or More Drugs</p>
</blockquote></td>
<td rowspan="2"><blockquote>
<p>Positive For</p>
<p>Marijuana</p>
</blockquote></td>
<td rowspan="2"><blockquote>
<p>Positive For</p>
<p>Cocaine</p>
</blockquote></td>
<td rowspan="2"><blockquote>
<p>Positive For</p>
<p>PCP</p>
</blockquote></td>
<td rowspan="2"><blockquote>
<p>Positive For</p>
<p>Opiates</p>
</blockquote></td>
<td rowspan="2"><blockquote>
<p>Positive For</p>
<p>Amphetamines</p>
</blockquote></td>
<td colspan="4">Refusal Results</td>
<td rowspan="2"><blockquote>
<p>Cancelled Results</p>
</blockquote></td>
</tr>
<tr class="even">
<td><blockquote>
<p>Adulterated</p>
</blockquote></td>
<td><blockquote>
<p>Substituted</p>
</blockquote></td>
<td><blockquote>
<p>“Shy Bladder” ~ With No Medical Explanation</p>
</blockquote></td>
<td><blockquote>
<p>Other Refusals To Submit To Testing</p>
</blockquote></td>
</tr>
<tr class="odd">
<td>Pre-Employment</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>Random</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>Post-Accident</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>Reasonable Susp./Cause</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>Return-to-Duty</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>Follow-Up</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>TOTAL</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
</tbody>
</table>

**IV. Alcohol Testing Data**:

<table>
<colgroup>
<col style="width: 17%" />
<col style="width: 11%" />
<col style="width: 11%" />
<col style="width: 11%" />
<col style="width: 10%" />
<col style="width: 8%" />
<col style="width: 8%" />
<col style="width: 7%" />
<col style="width: 7%" />
<col style="width: 6%" />
</colgroup>
<tbody>
<tr class="odd">
<td rowspan="2">Type of Test</td>
<td rowspan="2"><blockquote>
<p>Total Number Of Screening Test Results [Should equal the sum of
Columns 2, 3, 7, and 8]</p>
</blockquote></td>
<td rowspan="2"><blockquote>
<p>Screening Tests With Results Below 0.02</p>
</blockquote></td>
<td rowspan="2"><blockquote>
<p>Screening Tests With Results 0.02 Or Greater</p>
</blockquote></td>
<td rowspan="2"><blockquote>
<p>Number Of Confirmation Tests Results</p>
</blockquote></td>
<td rowspan="2"><blockquote>
<p>Confirmation Tests With Results 0.02 Through 0.039</p>
</blockquote></td>
<td rowspan="2"><blockquote>
<p>Confirmation Tests With Results 0.04 Or Greater</p>
</blockquote></td>
<td colspan="2">Refusal Results</td>
<td rowspan="2"><blockquote>
<p>Cancelled Results</p>
</blockquote></td>
</tr>
<tr class="even">
<td><blockquote>
<p>“Shy Lung” ~ With No Medical Explanation</p>
</blockquote></td>
<td><blockquote>
<p>Other Refusals To Submit To Testing</p>
</blockquote></td>
</tr>
<tr class="odd">
<td>Pre-Employment</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>Random</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>Post-Accident</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>Reasonable Susp./Cause</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>Return-to-Duty</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>Follow-Up</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>TOTAL</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
</tbody>
</table>

+-----------------------------------------------------------------------+
| **PAPERWORK REDUCTION ACT NOTICE (as required by 5 CFR 1320.21)**     |
|                                                                       |
| According to the Paperwork Reduction Act of 1995, no persons are      |
| required to respond to a collection of information unless it displays |
| a valid OMB control number. The valid OMB control number for this     |
| information collection is 2105-0529. The Department of Transportation |
| estimates that the average burden for this report form is 1.5 hours.  |
| You may send comments regarding this burden estimate or any           |
| suggestions for reducing the burden to: U.S. Department of            |
| Transportation, Office of Drug and Alcohol Policy and Compliance,     |
| Room 10403, 400 Seventh Street, SW, Washington, D.C. 20590; OR Office |
| of Management and Budget, Paperwork Reduction Project, 725            |
| Seventeenth Street, NW, Washington, D.C. 20503.                       |
+-----------------------------------------------------------------------+

  -----------------------------------------------------------------------
  Title 18, USC Section 1001, makes it a criminal offense subject to a
  maximum fine of \$10,000, or imprisonment for not more than 5 years, or
  both, to knowingly and willfully make or cause to be made any false or
  fraudulent statements of representations in any matter within the
  jurisdiction of any agency of the United States.

  -----------------------------------------------------------------------

The following form and instructions must be used when an employer is
required to report MIS data to a DOT agency.

U.S. DEPARTMENT OF TRANSPORTATION

**DRUG AND ALCOHOL TESTING MIS DATA COLLECTION FORM**

**INSTRUCTION SHEET**

This Management Information System (MIS) form is made-up of four
sections: employer information; covered employees (i.e., employees
performing DOT regulated safety-sensitive duties) information; drug
testing data; and alcohol testing data. The employer information needs
only to be provided once per submission. However, you must submit a
separate page of data for each employee category for which you report
testing data. If you are preparing reports for more than one DOT agency
then you must submit DOT agency-specific forms.

Please type or print entries legibly in black ink.

***[TIP]{.underline}** \~ Read the entire instructions before starting.
Please note that USCG-regulated employers do not report alcohol test
results on the MIS form.*

**Calendar Year Covered by this Report**: Enter the appropriate year.

######## [Section I. Employer]{.underline}

######## 

######## 1. Enter your company's name, to include when applicable, your "doing business as" name; current address, city, state, and zip code; and an e-mail address, if available.

2\. Enter the printed name, signature, and complete telephone number of
the company official certifying the accuracy of the report and the date
that person certified the report as complete.

3\. If someone other than the certifying official completed the MIS
form, enter that person's name and phone number on the appropriate lines
provided.

4\. If a Consortium/Third Party Administrator (C/TPA) performs
administrative services for your drug and alcohol program operation,
enter its name and phone number on the appropriate lines provided.

5\. DOT Agency Information: Check the box next to the DOT agency for
which you are completing this MIS form. Again, if you are submitting to
multiple DOT agencies, you must use separate forms for each DOT agency.

a\. If you are completing the form for FMCSA, enter your FMCSA DOT
Number, as appropriate. In addition, you must indicate whether you are
an owner-operator (i.e., an employer who employs only himself or herself
as a driver) and whether you are exempt from providing MIS data.
Exemptions are noted in the FMCSA regulation at 382.103(d).

b\. If you are completing the form for FAA, enter your FAA Certificate
Number and FAA Antidrug Plan / Registration Number, when applicable.

c\. If you are completing the form for RSPA, check the additional box(s)
indicating your type of operation.

d\. If you are completing the form for FRA, enter the number of
observed/documented Part 219 "Rule G" Observations for covered
employees.

e\. If you are submitting the form for USCG, enter the vessel ID number.
If there is more than one number, enter the numbers separately.

######### 

######### Section II. Covered Employees

1\. In Box II-A, enter the total number of covered employees (i.e.,
employees performing DOT regulated safety-sensitive duties) who work for
your company. Then enter, in Box II-B, the total number of employee
categories that number represents. If you have employees, some of whom
perform duties under one DOT agency and others of whom perform duties
under another DOT agency, enter only the number of those employees
performing duties under the DOT agency for whom you are submitting the
form. If you have covered employees who perform multi-DOT agency
functions (e.g., an employee drives a commercial motor vehicle and
performs pipeline maintenance duties for you), count the employee only
on the MIS report for the DOT agency regulating more than 50 percent of
the employee's safety sensitive function.

\[Example: If you are submitting the information for the FRA and you
have 2000 covered employees performing duties in [all]{.underline}
FRA-covered service categories -- you would enter "2000" in the first
box (II-A) and "5" in the second box (II-B), because FRA has five
safety-sensitive employee categories and you have employees in all of
these groups. If you have 1000 employees performing safety-sensitive
duties in three FRA-covered service categories (e.g., engine service,
train service, and dispatcher/operation), you would enter "1000" in the
first box (II-A) and "3" in the second box (II-B).\]

***[TIP]{.underline}** \~ To calculate the total number of covered
employees, add the total number of covered employees eligible for
testing during each random testing selection period for the year and
divide that total by the number of random testing periods. (However, no
company will need to factor the average number of employees more often
than once per month). For instance, a company conducting random testing
quarterly needs to add the total of covered employees they had in the
random pool when each selection was made; then divide this number by 4
to obtain the yearly average number of covered employees. It is
extremely important that you place all eligible employees into these
random pools. \[As an example, if Company A had 1500 employees in the
first quarter random pool, 2250 in the second quarter, 2750 in the third
quarter; and 1500 in the fourth quarter; 1500 + 2250 + 2750 + 1500 =
8000; 8000 / 4 = 2000; the total number of covered employees for the
year would be reported as,"2000".*

*If you conduct random selections more often than once per month (e.g.,
you select daily, weekly, bi-weekly), you do not need to compute this
total number of covered employees rate more than on a once per month
basis. Therefore, employers need not compute the covered employees rate
more than 12 times per year.\]*

2\. If you are reporting multiple employee categories, enter the
specific employee category in box II-C; [and]{.underline} provide the
number of employees performing safety-sensitive duties in that specific
category.

\[Example: You are submitting data to the FTA and you have 2000 covered
employees. You have 1750 personnel performing revenue vehicle operation
and the remaining 250 are performing revenue vehicle and equipment
maintenance. When you provide vehicle operation information, you would
enter "Revenue Vehicle Operation" in the first II-C box and "1750" in
the second II-C box. When you provide data on the maintenance personnel,
you would enter "Revenue Vehicle and Equipment Maintenance" in the first
II-C box and "250" in the second II-C box.\]

***[TIP]{.underline}** \~ A separate form for each employee category
must be submitted. You may do this by filling out a single MIS form
through Section II-B and then make one copy for each additional employee
category you are reporting. \[For instance, if you are submitting the
MIS form for the FMCSA, you need only submit one form for all FMCSA
covered employees working for you -- your only category of employees is
"driver." If you are reporting testing data to the FAA and you employ
[only]{.underline} flight crewmembers, flight attendants, and aircraft
maintenance workers, you need to complete one form each for category --
three forms in all. If you are reporting to FAA and have
[all]{.underline} FAA categories of covered employees, you must submit
eight forms.\]*

*Here is a full listing of covered-employee categories:*

##### FMCSA (one category): Driver

***FAA** (eight categories): Flight Crewmember; Flight Attendant; Flight
Instructor; Aircraft Dispatcher; Aircraft Maintenance; Ground Security
Coordinator; Aviation Screener; Air Traffic Controller*

***RSPA** (one category): Operation/Maintenance/Emergency Response*

***FRA** (five categories): Engine Service; Train Service;
Dispatcher/Operation; Signal Service; Other \[Includes yardmasters,
hostlers (non-engineer craft), bridge tenders; switch tenders, and other
miscellaneous employees performing 49 CFR 228.5 (c) defined covered
service.\]*

***USCG** (one category): Crewmember*

***FTA** (five categories): Revenue Vehicle Operation; Revenue Vehicle
and Equipment Maintenance; Revenue Vehicle Control/Dispatch;
CDL/Non-Revenue Vehicle; Armed Security Personnel*

### [Section III. Drug Testing Data]{.underline}

This section summarizes the drug testing results for all covered
employees (to include applicants). The table in this section requires
drug test data by test type and by result. The categories of test types
are: Pre-Employment; Random; Post-Accident; Reasonable Suspicion /
Reasonable Cause; Return-to-Duty, and Follow-Up.

The categories of type of results are: Total Number of Test Results
\[excluding cancelled tests and blind specimens\]; Verified Negative;
Verified Positive; Positive for Marijuana; Positive for Cocaine;
Positive for PCP; Positive for Opiates; Positive for Amphetamines;
Refusals due to Adulterated, Substituted, "Shy Bladder" with No Medical
Explanation, and Other Refusals to Submit to Testing; and Cancelled
Results.

***[TIP]{.underline}** \~ Do not enter data on blind specimens submitted
to laboratories. Be sure to enter all pre-employment testing data
regardless of whether an applicant was hired or not. You do not need to
separate reasonable suspicion and reasonable cause drug testing data on
the MIS form. \[Therefore, if you conducted only reasonable suspicion
drug testing (i.e., FMCSA and FTA), enter that data; if you conducted
only reasonable cause drug testing (i.e., FAA, RSPA, and USCG); or if
you conducted both under FRA drug testing rules, simply enter the data
with no differentiation.\] For USCG, enter any "Serious Marine Incident"
testing in the Post-Accident row. For FRA, do not enter post accident
data (the FRA does not collect this data on the MIS form). Finally, you
may leave blank any row or column in which there were no results, or you
may enter "0" (zero) instead. Please note that cancelled tests are not
included in the "total number of test results" column.*

**Section III, Column 1. Total Number of Test Results** \~ This column
requires a count of the total number of test results in each testing
category during the entire reporting year. Count the number of test
results as the number of testing events resulting in negative, positive,
and refusal results. Do not count cancelled tests and blind specimens in
this total.

\[Example: A company that conducted fifty pre-employment tests would
enter "50" on the Pre-Employment row. If it conducted one hundred random
tests, "100' would be entered on the Random row. If that company did no
post-accident, reasonable suspicion, reasonable cause, return-to-duty,
or follow-up tests, those categories will be left blank or zeros
entered.\]

**Section III, Column 2. Verified Negative Results** \~ This column
requires a count of the number of tests in each testing category that
the Medical Review Officer (MRO) reported as negative. Do not count a
negative-dilute result if, subsequently, the employee underwent a second
collection; the second test is the test of record.

\[Example: If forty-seven of the company's fifty pre-employment tests
were reported negative, "47" would be entered in Column 2 on the
Pre-Employment row. If ninety of the company's one hundred random test
results were reported negative, "90" would be entered in Column 2 on the
Random row. Because the company did no other testing, those other
categories would be left blank or zeros entered.\]

**Section III, Column 3. Verified Positive Results \~ For One Or More
Drugs** \~ This column requires a count of the number of tests in each
testing category that the MRO reported as positive for one or more
drugs. When the MRO reports a test positive for two drugs, it would
count as one positive test.

\[Example: If one of the fifty pre-employment tests was positive for two
drugs, "1" would be entered in Column 3 on the Pre-Employment row. If
four of the company's one hundred random test results were reported
positive (three for one drug and one for two drugs), "4" would be
entered in Column 3 on the Random row.\]

**■ Section III, Columns 4 through 8. Positive** (for specific drugs) \~
These columns require entry of the by-drug data for which specimens were
reported positive by the MRO.

\[Example: The pre-employment positive test reported by the MRO was
positive for marijuana, "1" would be entered in Column 4 on the
Pre-Employment row. If three of the four positive results for random
testing were reported by the MRO to be positive for marijuana, "3" would
be entered in Column 4 on the Random row. If one of the four positive
results for random testing was reported positive for both PCP and
opiates, "1" would be entered in Column 6 on the Random row and "1"
would be entered in Column 7 of the Random row.\]

***[TIP]{.underline}** \~ Column 1 should equal the sum of Columns 2, 3,
9, 10, 11, and 12. Remember you have not counted specimen results that
were ultimately cancelled or were from blind specimens. So, Column 1 =
Column 2 + Column 3 + Column 9 + Column 10 + Column 11 + Column 12.
Certainly, double check your records to determine if your actual results
count is reflective of all negative, positive, and refusal counts.*

*An MRO may report that a specimen is positive for more than one drug.
When that happens, to use the company example above (i.e., one random
test was positive for both PCP and opiates), the positive results should
be recorded in the appropriate columns -- PCP and opiates in this case.
There is no expectation for Columns 4 through 8 numbers to add up to the
numbers in Column 3 when you report multiple positives.*

**Section III, Columns 9 through 12. Refusal Results** \~ The refusal
section is divided into four refusal groups -- they are: Adulterated;
Substituted; "Shy Bladder" \~ With No Medical Explanation; and Other
Refusals To Submit to Testing. The MRO reports two of these refusal
types -- adulterated and substituted specimen results -- because of
laboratory test findings.

When an individual does not provide enough urine at the collection site,
the MRO conducts or causes to have conducted a medical evaluation to
determine if there exists a medical reason for the person's inability to
provide the appropriate amount of urine. If there is no medical reason
to support the inability, the MRO reports the result to the employer as
a refusal to test: Refusals of this type are reported in the "Shy
Bladder" \~ With No Medical Explanation category.

Finally, additional reasons exist for a test to be considered a refusal.
Some examples are: the employee fails to report to the collection site
as directed by the employer; the employee leaves the collection site
without permission; the employee fails to empty his or her pockets at
the collection site; the employee refuses to have a required shy bladder
evaluation. Again, these are only four examples: there are more.

**■ Section III, Column 9. Adulterated** \~ This column requires the
count of the number of tests reported by the MRO as refusals because the
specimens were adulterated.

\[Example: If one of the fifty pre-employment tests was adulterated, "1"
would be entered in Column 9 of the Pre-Employment row.\]

**■ Section III, Column 10. Substituted** \~ This column requires the
count of the number of tests reported by the MRO as refusals because the
specimens were substituted.

\[Example: If one of the 100 random tests was substituted, "1" would be
entered in Column 10 of the Random row.\]

**■ Section III, Column 11. "Shy Bladder" \~ With No Medical
Explanation** \~ This column requires the count of the number of tests
reported by the MRO as being a refusal because there was no legitimate
medical reason for an insufficient amount of urine.

\[Example: If one of the 100 random tests was a refusal because of shy
bladder, "1" would be entered in Column 11 of the Random row.\]

**■ Section III, Column 12. Other Refusals To Submit To Testing** \~
This column requires the count of refusals other than those already
entered in Columns 9 through 11.

\[Example: If the company entered "100" as the number of random
specimens collected, however it had five employees who refused to be
tested without submitting specimens: two did not show up at the
collection site as directed; one refused to empty his pockets at the
collection site; and two left the collection site rather than submit to
a required directly observed collection. Because of these five refusal
events, "5" would be entered in Column 11 of the Random row.\]

***[TIP]{.underline}** \~ Even though some testing events result in a
refusal in which no urine was collected and sent to the laboratory, a
"refusal" is still a final test result. Therefore, your overall numbers
for test results (in Column 1) will equal the total number of negative
tests (Column 2); positives (Column 3); and refusals (Columns 9, 10, 11,
and 12). Do not worry that no urine was processed at the laboratory for
some refusals; all refusals are counted as a testing event for MIS
purposes and for establishing random rates.*

**Section III, Column 13. Cancelled Tests** \~ This column requires a
count of the number of tests in each testing category that the MRO
reported as cancelled. You must not count any cancelled tests in Column
1 or in any other column. For instance, you must not count a positive
result (in Column 3) if it had ultimately been cancelled for any reason
(e.g., specimen was initially reported positive, but the split failed to
reconfirm).

\[Example: If a pre-employment test was reported cancelled, "1" would be
entered in Column 13 on the Pre-Employment row. If three of the
company's random test results were reported cancelled, "3" would be
entered in Column 13 on the Random row.\]

**TOTAL Line. Columns 1 through 13** \~ This line requires you to add
the numbers in each column and provide the totals.

### [Section IV. Alcohol Testing Data]{.underline}

This section summarizes the alcohol testing conducted for all covered
employees (to include applicants). The table in this section requires
alcohol test data by test type and by result. The categories of test
types are: Pre-Employment; Random; Post-Accident; Reasonable Suspicion /
Reasonable Cause; Return-to-Duty, and Follow-Up.

The categories of results are: Number of Screening Test Results;
Screening Tests with Results Below 0.02; Screening Tests with Results
0.02 Or Greater; Number of Confirmation Test Results; Confirmation Tests
with Results 0.02 through 0.039; Confirmation Tests with Results 0.04 Or
Greater; Refusals due to "Shy Lung" with No Medical Explanation, and
Other Refusals to Submit to Testing; and Cancelled Results.

***[TIP]{.underline}** \~ Be sure to enter all pre-employment testing
data regardless of whether an applicant was hired or not. Of course, for
most employers pre-employment alcohol testing is optional, so you may
not have conducted this type of testing. You do not need to separate
"reasonable suspicion" and "reasonable cause" alcohol testing data on
the MIS form. \[Therefore, if you conducted only reasonable suspicion
alcohol testing (i.e., FMCSA, FAA, FTA, and RSPA), enter that data; if
you conducted both reasonable suspicion and reasonable cause alcohol
testing (i.e.., FRA), simply enter the data with no differentiation.\]
RSPA does not authorize "random" testing for alcohol. Finally, you may
leave blank any row or column in which there were no results, or you may
enter "0" (zero) instead. Please note that USCG-regulated employers do
not report alcohol test results on the MIS form: Do not fill-out Section
IV if you are a USCG-regulated employer.*

**Section IV, Column 1. Total Number of Screening Test Results** **\~**
This column requires a count of the total number of screening test
results in each testing category during the entire reporting year. Count
the number of screening tests as the number of screening test events
with final screening results of below 0.02, of 0.02 through 0.039, of
0.04 or greater, and all refusals. Do not count cancelled tests in this
total.

\[Example: A company that conducted twenty pre-employment tests would
enter "20" on the Pre-Employment row. If it conducted fifty random
tests, "50' would be entered. If that company did no post-accident,
reasonable suspicion, reasonable cause, return-to-duty, or follow-up
tests, those categories will be left blank or zeros entered.\]

**Section IV, Column 2. Screening Tests With Results Below 0.02** \~
This column requires a count of the number of tests in each testing
category that the BAT or STT reported as being below 0.02 on the
screening test.

\[Example: If seventeen of the company's twenty pre-employment screening
tests were reported as being below 0.02, "17" would be entered in Column
2 on the Pre-Employment row. If forty-four of the company's fifty random
screening test results were reported as being below 0.02, "44" would be
entered in Column 2 on the Random row. Because the company did no other
testing, those other categories would be left blank or zeros entered.\]

**Section IV, Column 3. Screening Tests With Results 0.02 Or Greater**
\~ This column requires a count of the number of screening tests in each
testing category that BAT or STT reported as being 0.02 or greater on
the screening test.

\[Example: If one of the twenty pre-employment tests was reported as
being 0.02 or greater, "1" would be entered in Column 3 on the
Pre-Employment row. If four of the company's fifty random test results
were reported as being 0.02 or greater, "4" would be entered in Column 3
on the Random row.\]

**Section IV, Column 4. Number of Confirmation Test Results** \~ This
column requires entry of the number of confirmation tests that were
conducted by a BAT as a result of the screening tests that were found to
be 0.02 or greater. In effect, all screening tests of 0.02 or greater
should have resulted in confirmation tests. Ideally the number of tests
in Column 3 and Column 4 should be the same. However, we know that this
required confirmation test sometimes does not occur. In any case, the
number of confirmation tests that were actually performed should be
entered in Column 4.

\[Example: If the one pre-employment screening test reported as 0.02 or
greater had a subsequent confirmation test performed by a BAT, "1" would
be entered in Column 4 on the Pre-Employment row. If three of the four
random screening tests that were found to be 0.02 or greater had a
subsequent confirmation test performed by a BAT, "3" would be entered in
Column 4 on the Random row.\]

**Section IV, Column 5. Confirmation Tests With Results 0.02 Through
0.039** \~ This column requires entry of the number of confirmation
tests that were conducted by a BAT that led to results that were 0.02
through 0.039.

\[Example: If the one pre-employment confirmation test yielded a result
of 0.042, Column 5 of the Pre-Employment row would be left blank or
zeros entered. If two of the random confirmation tests yielded results
of 0.03 and 0.032, "2" would be entered in Column 5 of the Random row.\]

**Section IV, Column 6. Confirmation Tests With Results 0.04 Or
Greater** \~ This column requires entry of the number of confirmation
tests that were conducted by a BAT that led to results that were 0.04 or
greater.

\[Example: Because the one pre-employment confirmation test yielded a
result of 0.042, "1" would be entered in Column 6 of the Pre-Employment
row. If one of the random confirmation tests yielded a result of 0.04,
"1" would be entered in Column 6 of the Random row.\]

***[TIP]{.underline}** \~ Column 1 should equal the sum of Columns 2, 3,
7, and 8. The number of screening tests results should reflect the
number of screening tests you have no matter the result (below 0.02 or
at or above 0.02, plus refusals to test), unless of course, the tests
were ultimately cancelled. So, Column 1 = Column 2 + Column 3 + Column
7 + Column 8. Certainly, double check your records to determine if your
actual screening results count is reflective of all these counts.*

*There is no need to record MIS confirmation tests results below 0.02:
That is why we have no column for it on the form. \[If the random test
that screened 0.02 went to a confirmation test, and that confirmation
test yielded a result below 0.02, there is no place for that confirmed
result to be entered.\] We assume that if a confirmation test was
completed but not listed in either Column 5 or Column 6, the result was
below 0.02. In addition, if the confirmation test ended up being
cancelled, it should not have been included in Columns 1, 3, or 4 in the
first place.*

**Section IV, Columns 7 and 8. Refusal Results** \~ The refusal section
is divided into two refusal groups -- they are: Shy Lung \~ With No
Medical Explanation; and Other Refusals To Submit to Testing. When an
individual does not provide enough breath at the test site, the company
requires the employee to have a medical evaluation to determine if there
exists a medical reason for the person's inability to provide the
appropriate amount of breath. If there is no medical reason to support
the inability as reported by the examining physician, the employer calls
the result a refusal to test: Refusals of this type are reported in the
"Shy Lung \~ With No Medical Explanation" category.

Finally, additional reasons exist for a test to be considered a refusal.
Some examples are: the employee fails to report to the test site as
directed by the employer; the employee leaves the test site without
permission; the employee fails to sign the certification at Step 2 of
the ATF; the employee refuses to have a required shy lung evaluation.
Again, these are only four examples; there are more.

**■ Section IV, Column 7. "Shy Lung" \~ With No Medical Explanation** \~
This column requires the count of the number of tests in which there is
no medical reason to support the employee's inability to provide an
adequate breath as reported by the examining physician; subsequently,
the employer called the result a refusal to test.

\[Example: If one of the 50 random tests was a refusal because of shy
lung, "1" would be entered in Column 7 of the Random row.\]

**■ Section IV, Column 8. Other Refusals To Submit To Testing** \~ This
column requires the count of refusals other than those already entered
in Columns 7.

\[Example: The company entered "50" as the number of random specimens
collected, however it had one employee who did not show up at the
testing site as directed. Because of this one refusal event, "1" would
be entered in Column 8 of the Random row.\]

***[TIP]{.underline}** \~ Even though some testing events result in a
refusal in which no breath (or saliva) was tested, there is an
expectation that your overall numbers for screening tests (in Column 1)
will equal the total number of screening tests with results below 0.02
(Column 2); screening tests with results 0.02 or greater (Column 3); and
refusals (Columns 7 and 8). Do not worry that no breath (or saliva) was
tested for some refusals; all refusals are counted as a screening test
event for MIS purposes and for establishing random rates.*

**Section IV, Column 9. Cancelled Tests** \~ This column requires a
count of the number of tests in each testing category that the BAT or
STT reported as cancelled. Do not count any cancelled tests in Column 1
or in any other column other than Column 9. For instance, you must not
count a 0.04 screening result or confirmation result in any column,
other than Column 9, if the test was ultimately cancelled for some
reason (e.g., a required air blank was not performed).

\[Example: If a pre-employment test was reported cancelled, "1" would be
entered in Column 9 on the Pre-Employment row. If three of the company's
random test results were reported cancelled, "3" would be entered in
Column 13 on the Random row.\]

**TOTAL Line. Columns 1 through 9** \~ This line requires you to add the
numbers in each column and provide the totals.