SUMMARY: This document presents interpretive guidance material for the 
Federal Motor Carrier Safety Regulations (FMCSRs) now contained in the 
FHWA's Motor Carrier Regulation Information System (MCREGIS). The FHWA 
has consolidated previously issued interpretations and regulatory 
guidance materials and developed concise interpretive guidance in 
question and answer form for each part of the FMCSRs. These questions 
and answers are generally applicable to drivers, commercial motor 
vehicles, and motor carrier operations on a national basis. All prior 
interpretations and regulatory guidance of the FMCSRs issued previously 
in the Federal Register, as well as FHWA memoranda and letters, may no 
longer be relied upon as authoritative insofar as they are inconsistent 
with the guidance published today. Many of the interpretations of the 
FMCSRs published on November 23, 1977, and the interpretations of the 
Inspection, Repair, and Maintenance regulations published on July 10, 
1980, have been revised. These revisions are reflected in the new 
questions and answers. This document also includes regulatory guidance 
issued since November 17, 1993, when the agency last published a 
collection of such guidance. Future regulatory guidance will be issued 
within the MCREGIS which will be kept current in the FHWA's Office of 
Motor Carrier Standards. The MCREGIS will be updated periodically and 
published in the Federal Register so that interested parties may have 
ready reference to official interpretations and guidance regarding the 
FMCSRs. This guidance will provide the motor carrier industry with a 
clearer understanding of the applicability of many of the requirements 
contained in the FMCSRs in particular situations.

EFFECTIVE DATE: May 4, 1997.

FOR FURTHER INFORMATION CONTACT: Mr. Neill L. Thomas or Mr. Nathan C. 
Root, Office of Motor Carrier Standards, (202) 366-1790, or Mr. Charles 
E. Medalen, Office of the Chief Counsel, (202) 366-1354, Federal 
Highway Administration, Department of Transportation, 400 Seventh 
Street, SW., Washington, DC 20590. Office hours are from 7:45 a.m. to 
4:15 p.m., e.t., Monday through Friday, except Federal legal holidays.

SUPPLEMENTARY INFORMATION: This document is an update of the notice of 
regulatory guidance for the FMCSRs issued by the FHWA November 17, 1993 
(58 FR 60734). This notice contains previously issued, revised, and new 
regulatory guidance pertaining to Title 49, Code of Federal Regulations 
(CFR), Parts 40, 325, 382, 383, 384, 386, 387, 390 to 393, 395 to 397, 
and 399 of the FMCSRs. In some instances, old regulatory guidance has 
been removed. The information published in this document supersedes all 
previously issued interpretations and regulatory guidance, to the 
extent they are inconsistent with the guidance published today, 
including that published on November 23, 1977, at 42 FR 60078, and on 
July 10, 1980, at 45 FR 46425. To the maximum extent possible, all 
valid prior opinions have been incorporated into this document. This 
notice is consistent with the Small Business Regulatory Enforcement 
Fairness Act of 1996 (Pub. L. 104-121, March 29, 1996).
    The FHWA issued a final rule on March 8, 1996, which codified most 
of the regulatory guidance for CDL waivers under Sec. 383.3 (61 FR 
9546). Guidance concerning CDL waivers had been issued under 
Sec. 383.7. From the 1993 Regulatory Guidance notice for Sec. 383.7, 
only questions 7(a), 8, 9, 10, 16, 17, 21, and 22 still remain. These 
questions and guidance are now listed as guidance for Sec. 383.3, where 
the CDL waivers have been codified.
    Guidance for question 3 under Sec. 383.5 has been changed to 
reflect a more expansive version of the same guidance in existence 
prior to the November 1993 Notice. Guidance for question 2 under 
Sec. 383.93, as it appeared in the 1993 notice, has been revised to 
clarify the existing guidance. Guidance for question 1 under 
Sec. 390.31 has been expanded to include guidance derived from a Final 
Order issued by the Department (58 FR 62467). Guidance for question 1 
of Sec. 391.1 has been changed to remove a reference to part 391 
subpart H. Guidance for question 6 under Sec. 391.11 has been moved to 
Sec. 392.9. Guidance for question 2 under Sec. 391.27 has been removed: 
violations of size and weight laws are not considered violations of 
motor vehicle traffic laws. Question 1 for Sec. 391.41 has been changed 
for clarity. Guidance for question 1 under Sec. 391.43 has been 
expanded for greater clarity. Guidance for Sec. 392.62 has been moved 
to Sec. 391.41. Guidance for question 1 of Sec. 393.51, question 1 of 
Sec. 393.65, question 1 of Sec. 393.75, question 5 of Sec. 393.100, and 
question 1 of Sec. 393.106 have been amended for clarity. Guidance for 
question 1 under Sec. 393.95 has been incorporated into the regulations 
(58 FR 34708) and is therefore removed from this document. Guidance for 
Sec. 395.1 has been reordered to consecutively follow the paragraphs 
within the section. Question 15 under Sec. 395.2 was expanded by 
guidance issued June 11, 1995. Question 20 under Sec. 395.2 has been 
revised to reflect an interpretation previously issued August 15, 1991, 
treating the same issue in a more explicit manner. Question 1 under 
Sec. 397.1 has been changed to more accurately explain who must comply 
with part 397. The 1994 Regulatory Guidance booklet, which reprinted 
the interpretations issued in the Federal Register in 1993, is 
available in the public docket on this rulemaking for reference
    The FHWA issued an advance notice of proposed rulemaking on 
November 5, 1996 (61 FR 57252) concerning the hours of service 
regulations (49 CFR part 395). On page 57258 of the notice, the FHWA 
erroneously indicated that an interpretation which allowed CMVs to be 
driven from motels to restaurants in the vicinity as ``off-duty time'' 
had recently been rescinded. The FHWA intended to rescind recent 
interpretations that describe conditions under which a CMV may be used 
as a ``personal conveyance'' (issued August 10, 1995), and address the 
entire issue of personal conveyance through notice and comment 
rulemaking. Question 8 under Sec. 395.2 has been expanded by guidance 
issued November 18, 1996, and placed more appropriately under 
Sec. 395.8 (see Sec. 395.8, question 27). All prior interpretations of 
personal conveyance are invalid.
    Since 1993, new interpretive guidance has been issued for, or 
existing guidance has been removed from, the following sections:

49 CFR Part 40 Secs. 40.3, 40.21, 40.23, 40.25, 40.29, 40.31, 40.33, 
40.35, 40.39, 40.69, 40.81, 40.93, Special Topics--Requirements for 
Random Testing, Special Topics--Procedures for Handling and Processing 
a Split Specimen
49 CFR Part 382 Secs. 382.103, 382.105, 382.107, 382.109, 382.113, 
382.115, 382.204, 382.205, 382.213, 382.301, 382.303, 382.305, 382.307, 
382.401, 382.403, 382.405, 382.413, 382.501, 382.507, 382.601, 382.603, 
382.605, Subpart B--Prohibitions, Special Topics--Responsibility for 
Payment for Testing, Special Topics-- Multiple Service Providers, Special Topics--Medical Examiners 
Acting as MRO, Special Topics--Biennial (Periodic) Testing Requirements
49 CFR Part 383 Secs. 383.3, 383.5, 383.7, 383.31, 383.71, 383.73, 
383.91, 383.93, Special Topics--International
49 CFR Part 384 Secs. 384.209, 384.211
49 CFR Part 387 Secs. 387.9, 387.15, 387.39
49 CFR Part 390 Secs. 390.3, 390.5, 390.15, Special Topics--Serious 
Pattern of Violations
49 CFR Part 391 Secs. 391.1, 391.11, 391.27, 391.41, 391.43, 391.49, 
391.51, 391.63
49 CFR Part 392 Secs. 392.5, 392.9, 392.62
49 CFR Part 393 Secs. 393.11, 393.42, 393.48, 393.51, 393.65, 393.75, 
393.89, 393.95, 393.100, 393.106, 393.201
49 CFR Part 395 Secs. 395.1, 395.2, 395.8, 395.13, 395.15
49 CFR Part 396 Secs. 396.11, 396.17, 396.23

    Additional guidance will continue to be published in future issues 
of the Federal Register. The FHWA will be modifying or removing 
numerous regulations as part of President Clinton's Regulatory Reform 
Initiative. Many of these changes will have an impact on the regulatory 
guidance in this document. These changes will be reflected in future 
issues of the Federal Register. Members of the motor carrier industry 
and other interested parties may access the guidance in this document 
through the FHWA's Electronic Bulletin Board System (FEBBS) using a 
microcomputer and modem. The FEBBS is a read-only facility. Access 
numbers for FEBBS are (202) 366-3764 for the Washington, DC area, or 
toll-free at (800) 337-3492. The system supports a variety of modem 
speeds up to 14,400 baud line speeds, and a variety of terminal types 
and protocols. Modems should be set to 8 data bits, full duplex, and no 
parity for optimal performance. Once a connection has been established, 
new users will have to go through a registration process. Instructions 
are given on the screen. FEBBS is mostly menu-drive and hot keys are 
indicated with ``< >'' enclosing the hot key. After logging on to FEBBS 
and arriving at the MAIN MENU, select  for Conference; then  for 
Motor Carrier; then either  again for MCREGIS Questions and Answers, 
or  for Information (more detailed help).
    For Technical Assistance to gain access to FEBBS, contact: FHWA 
Computer Help Desk, HMS-40, room 4401, 400 Seventh Street, SW, 
Washington, DC 20590 (202) 366-1120. Specific questions addressing any 
of the interpretive material published in this document may be directed 
to the contact persons listed above, the FHWA Regional Offices, or the 
FHWA Division Office in each State.
    For ease of reference, the following listing of acronyms used 
throughout this document is provided:

Appendix G--The Minimum Periodic Inspection Standards published as 
an appendix to the Federal Motor Carrier Safety Regulations
BAT--Breath Alcohol Technician
CDL--Commercial Driver's License
CDLIS--Commercial Driver's License Information System
CFR--Code of Federal Regulations
CMV--Commercial Motor Vehicle
CMVSA--Commercial Motor Vehicle Safety Act of 1986
COE--Cab-over-engine truck tractor
C/TPA--Consortium or Third-Party Administrator
CVSA--Commercial Vehicle Safety Alliance
DHHS-SAMHSA--Department of Health and Human Services, Substance 
Abuse Mental Health Services Administration
DOT--U.S. Department of Transportation
DVIR--Driver Vehicle Inspection Report
DWI--Driving While Intoxicated
EAP--Employee Assistance Program
EPA--U.S. Environmental Protection Agency
FHWA--Federal Highway Administration
FMCSRs--Federal Motor Carrier Safety Regulations
FMVSS--Federal Motor Vehicle Safety Standards (developed and issued 
by the National Highway Traffic Safety Administration)
FR--Federal Register
FRSI--Farm-Related Service Industries
GCWR--Gross Combination Weight Rating
GVW--Gross Vehicle Weight
GVWR--Gross Vehicle Weight Rating
HM--Hazardous Materials
HMRs--Hazardous Materials Regulations
HMTUSA--Hazardous Materials Transportation Uniform Safety Act of 
1990
ICC--Interstate Commerce Commission
Forms MCS-90 and MCS-90B--Endorsements for Motor Carrier Policies of 
Insurance for Public Liability Under Sections 29 and 30 of the Motor 
Carrier Act of 1980 issued by an insurer
MCSA--Motor Carrier Safety Act of 1984
MPH--Miles Per Hour
MRO--Medical Review Officer
NDR--National Driver Register
NHTSA--National Highway Traffic Safety Administration within DOT
RDMC--Regional Director of Motor Carriers
SAP--Substance Abuse Professional
SSN--Social Security Number
STAA--Surface Transportation Assistance Act of 1982
STT--Screening Test Technician
U.S.C.--United States Code

Table of Contents

Part 40--Procedures for Transportation Workplace Drug and Alcohol 
Testing Programs
Part 325--Compliance With Interstate Motor Carrier Noise Emission 
Standards
Part 382--Controlled Substances and Alcohol Use and Testing
Part 383--Commercial Driver's License Standards; Requirements and 
Penalties
Part 384--State Compliance With Commercial Driver's License Program
Part 386--Rules of Practice for Motor Carrier Safety and Hazardous 
Materials Proceedings
Part 387--Minimum Levels of Financial Responsibility for Motor 
Carriers
Part 390--Federal Motor Carrier Safety Regulations; General
Part 391--Qualifications of Drivers
Part 392--Driving of Motor Vehicles
Part 393--Parts and Accessories Necessary for Safe Operation
Part 395--Hours of Service of Drivers
Part 396--Inspection, Repair and Maintenance
Part 397--Transportation of Hazardous Materials; Driving and Parking 
Rules
Part 399--Employee Safety and Health Standards

Regulatory Guidance

Part 40--Procedures for Transportation Workplace Drug and Alcohol 
Testing Programs

Sections Interpreted

40.3  Definitions
40.21  The Drugs
40.23  Preparation for testing
40.25  Specimen collection procedures
40.29  Laboratory analysis procedures
40.31  Quality assurance and quality control
40.33  Reporting and review of results
40.35  Protection of employee records
40.39  Use Of DHHS-certified laboratories
40.69  Inability to provide an adequate amount of breath
40.81  Availability and disclosure of alcohol testing information 
about individual employees
40.93  The screening test technician
Special Topics--Requirements for random testing
Special Topics--Procedures for Handling and Processing a Split 
Specimen

Section 40.3  Definitions

    Question 1: May a Doctor of Chiropractic, holding a Certified 
Addiction Professional degree, serve as an MRO?
    Guidance: A Doctor of Chiropractic, holding a Certified Addiction 
Professional degree, is not considered to be a licensed medical doctor 
or doctor of osteopathy and, therefore, cannot serve as an MRO.
    Question 2: What are the qualifications and responsibilities of the 
MRO? Are MROs required to be certified?
    Guidance: Section 40.3 defines the qualifications for an MRO and 
Sec. 40.33 specifies the MRO's responsibilities. An MRO is defined as a 
licensed physician (medical doctor or doctor of osteopathy) responsible 
for receiving laboratory results generated by an employer's drug testing program who has 
knowledge of substance abuse disorders and has appropriate medical 
training to interpret and evaluate an individual's confirmed positive 
test result together with his or her medical history and any other 
relevant biomedical information. An MRO is responsible for reviewing 
and interpreting confirmed positive test results obtained through the 
employer's testing program. The DOT does not require any certification 
of MROs at the present time. However, there are several national 
professional organizations which provide MRO certification.

Section 40.21  The Drugs

    Question 1: Is testing for additional drugs authorized? Must a 
separate specimen be obtained?
    Guidance: Under part 40, an employer must test for the following 
drugs: marijuana, cocaine, amphetamines, opiates, and phencyclidine. An 
employer may not test for any other substances under DOT authority. 
Part 40 does not, however, prohibit an employer from testing for other 
controlled substances as long as that testing is done under the 
authority of the employer.
    Employers in the transportation industry who establish a drug 
testing program that tests beyond the five drugs currently required by 
part 40 must also make clear to their employees what testing is 
required by DOT authority and what testing is required by the company. 
Additionally, employers must ensure that DOT urine specimens are 
collected in accordance with the provisions outlined in part 40 and 
that a separate specimen collection process including a separate act of 
urination is used to obtain specimens for company testing programs.
    Question 2: Should labs conduct tests for five (5) drugs even if 
the drug testing custody and control form fails to indicate what tests 
are to be performed?
    Guidance: Part 40 indicates that DOT agency drug testing programs 
require that employers test for marijuana, cocaine, opiates, 
amphetamines, and phencyclidine (Sec. 40.21). All DOT specimens, 
therefore, must be tested for the above five categories of drugs even 
if the accompanying drug testing custody and control form fails to 
indicate this.
    While the DOT does not view this type of collection site error as a 
fatal flaw, it nevertheless jeopardizes the integrity of the entire 
collection process and could lead to a challenge and subsequent third 
party review. These errors should be addressed with the site supervisor 
in the hope of preventing future mistakes.

Section 40.23  Preparation for Testing

    Question 1: On the testing of a split specimen, is it necessary to 
maintain anonymity of a person, at the laboratory level, when both the 
primary laboratory and the laboratory testing the split may have fees 
and could directly bill the employee?
    Guidance: Section 40.23(a) addresses mandatory use of the Federal 
Drug Testing Custody and Control Form in DOT urine collection and 
testing. This paragraph states, in part, that ``* * * personal 
identifying information on the donor (other than the social security 
number or other employee ID number) may not be provided to the 
laboratory.'' If circumstances arise in which the MRO orders a test of 
the split specimen, at the request of the employee, no additional 
identifying information on the employee may be provided to the 
laboratory that will be testing the split specimen. As directed by 
Sec. 40.33(f), ``* * * The MRO shall direct, in writing, the laboratory 
to provide the split specimen to another DHHS-certified laboratory for 
analysis.'' This request would reference only items contained on the 
face of the Drug Testing Custody and Control Form (e.g., Specimen 
Identification No., SSN or Employee ID No., Collection Date, etc.); the 
MRO would not specify the employee's name. Should a personal check 
(bearing the employee's name) accompany the request (e.g., a letter 
from the MRO), the MRO should not make any particular reference linking 
the split request with the person signing the check. In actuality, the 
primary laboratory will most likely bill the employer for the cost of 
sending the split specimen to the split laboratory; the split 
laboratory will normally require a cashier's check, money order, or an 
account to be set up (generally by the employer) prior to initiating 
processing.
    Question 2: In a case where an employee is providing a urine 
specimen and a breath test is conducted at the same time, may a 
laboratory receive both the Federal Drug Testing Custody and Control 
Form (with the specimens for testing) and the employer's copy of the 
Breath Alcohol Testing Form (with the test results) from the collection 
site?
    Guidance: The DOT provided clarification in its Guidance on the 
Role of Consortia and Third-Party Administrators in DOT Drug and 
Alcohol Testing Programs published on July 25, 1995 in the Federal 
Register which stated in part ``* * * MROs and BATs must send final 
individual test results directly to the actual employer as soon as the 
results are available * * * results may be maintained afterwards by the 
C/TPA * * * while there is no objection to the MRO or BAT transmitting 
results simultaneously both to the employer and to the C/TPA, it is not 
appropriate for the MRO or BAT to send the results only to the C/TPA, 
which subsequently retransmits them to the employer.''
    A laboratory, regardless of what type of arrangement it has with 
the employer, is prohibited from receiving the employer's copy of the 
Breath Alcohol Testing Form together with the Federal Drug Testing 
Custody and Control Form(s) which accompany the urine specimen. The 
breath testing form contains individual identifying information. The 
DOT rule specifically states that this information may not be provided 
to a laboratory.
    However, a laboratory functioning as a C/TPA may receive the 
employer's copies of the Federal Drug Testing Custody and Control Form 
and the employer's copy of the Breath Alcohol Testing Form from the 
collection site under the following conditions:
    a. The employer's copy of the Federal Drug Testing Custody and 
Control Form (Copy 7) must not be included with the laboratory copies 
(Copies 1 and 2) which accompany the urine specimen.
    b. The employer's copies of the Federal Drug Testing Custody and 
Control Form and the Breath Alcohol Testing Forms must not be received 
by the accession/receiving (testing) section of the laboratory.
    These procedures should prevent that portion of the laboratory 
which conducts the drug analysis from having access to the identity 
(from the alcohol testing form) of the donor.
    The DOT rule requires the BAT immediately to transmit the results 
to the employer, regardless of what procedures have been established 
for providing to the employer or the C/TPA, the employer's copy of the 
breath testing form.
    In all instances, it is the employer (not the C/TPA) who designates 
in writing to the BAT or the BAT's company, who the employer's agent is 
and the procedures that the employer wants the BAT to use for 
transmission of data and forms.
    Question 3: Is a specific MRO name required in Step 1 on the 
Federal Drug Testing Custody and Control Form, or may a clinic, 
hospital, health care organization, or MRO company name appear in the 
MRO Name and Address area?
    Guidance: The DOT has determined that a specific physician's name 
and address is required in Step 1 of the Federal Drug Testing Custody and Control Form as opposed to only a 
generic clinic, health care organization, or company name. The name 
should be that of a responsible physician rather than an administrative 
staff member or other company official. However, a company name may 
appear as part of the address, provided it is followed by or includes 
the MRO's name. Collection sites send copies of the MRO's custody and 
control form to this address, and drug testing laboratories use it to 
submit laboratory results to the MRO. The use of the MRO name will 
preclude potential compromises of confidentiality. In many cases, where 
only the name of a clinic, hospital or company appears on the mailing 
address, the laboratory results are sent to the clinic or hospital and 
are either circulated through numerous departments or, in some cases, 
never reach the MRO.
    The physician named in Step 1 may be the MRO who will actually 
perform the verification review or the name of a physician within the 
practice (company), but not necessarily the one who will actually 
perform the verification (in those cases where there is more than one 
MRO working in that office or company).
    Question 4: Is the collector's signature required on the chain of 
custody section of drug testing custody and control form?
    Guidance: The collector's signature is required in both the 
``received by'' and the ``released by'' spaces in Step 6 of the drug 
testing custody and control form. Part 40 Appendix A specifies that the 
form shall provide both ``received by'' and ``released by'' entries of 
the collector's signature and printed names (see the instructions on 
the back of Appendix A, copy 7, Step 6. Combining these entries is not 
authorized by the rule.
    Question 5: May the drug testing custody and control form be used 
for non-DOT tests?
    Guidance: Employee drug testing conducted under local, State, or 
private authority must not be represented to the employee as being 
Federally mandated or required. The use of the custody and control form 
required under 49 CFR part 40 conveys that the testing is being 
conducted in accordance with applicable Federal regulations. A ``look-
alike'' form that deletes references to DOT, Part 40, and Federal 
requirements may be used for non-DOT testing.
    Question 6: Is collection of blood authorized? May blood specimens 
be supported by the drug testing custody and control form? May blood 
test results be used to take DOT-required administrative actions?
    Guidance: The collection of blood for alcohol or drug testing under 
DOT authority is not authorized. Therefore, while a company, under its 
own authority, may require a blood specimen to be collected and tested 
for drugs and/or alcohol under certain circumstances, it is not 
acceptable for the company-required blood specimen to be supported by 
the same custody and control form that accompanies a DOT-required urine 
specimen.
    If a urine specimen for a DOT reasonable suspicion test is rejected 
for testing at the laboratory, results from a blood specimen collected 
in accordance with a company policy could be used to take action 
against an employee depending upon the drug testing policy established 
by that company. Under no circumstances, however, may the results of 
the blood test be used to take administrative or disciplinary action 
against an employee using DOT authority, for the reasons cited above.
    Question 7: Is the collector required to sign or initial the 
shipping container label?
    Guidance: Sections 40.23(c) and 40.25(h) describe the requirements 
for packaging the specimen and custody and control form in preparation 
for shipment to the laboratory. Section 40.23(c) states that the 
shipping container must be sealed and initialed to prevent undetected 
tampering. Section 40.25(h) states that the collection site person 
shall sign and enter the date specimens were sealed in the shipping 
containers for shipment. The DOT has determined that initialing and 
dating the seal by the collection site person is sufficient to meet the 
intent of the regulation.
    Question 8: How and to whom are copies of drug testing custody and 
control forms distributed?
    Guidance: The historically acceptable procedures for handling the 
custody and control form have been as follows: Parts 1, 2, and 3 must 
accompany the urine specimen in a sealed shipping container to the 
laboratory; Part 3 (Split Specimen) must be retained by the laboratory 
in case the split specimen must be sent to a second laboratory; Part 4 
must be sent from the collection site directly to the physician (MRO); 
Part 5 is given to the donor at the collection site; Part 6 is retained 
by the collection site personnel; and Part 7 is provided to the 
employer representative. It is unacceptable for the MRO copy of the 
form to accompany the urine specimen to the laboratory. Clearly the 
intent of the regulation is for the urine specimen and Parts 1, 2, and 
3 of the Federal custody and control form to be sent directly from the 
collection site to the laboratory, and the MRO (Part 4) copy of the 
custody and control form to be sent directly to the physician. There is 
no need to maintain a chain of custody tracking the handling of the 
sealed shipping container. In fact, the August 19, 1994 Federal 
Register (59 FR 42996) expressly notes this fact in changes to 
Sec. 40.25 to clarify this point.
    Question 9: Should a specimen be rejected by a lab if the donor-
identifying information is erroneously provided?
    Guidance: The intent of the DOT procedures is to limit the amount 
of personal identifying information that is recorded on the specimen 
bottle and those copies of the drug testing custody and control form 
that accompany the specimen bottle to the laboratory. The rule only 
requires that a donor initial the specimen bottle label/seal and 
provide an SSN or employee identification number to be recorded on the 
laboratory copies of the drug testing custody and control form. The 
rule does not allow for additional personal information to be provided 
to the laboratory. In fact, the intent was to prevent the donor's 
identity from being routinely disclosed to the laboratory.
    It was never intended, however, that the inadvertent or erroneous 
disclosure of the donor's identity (i.e., name or signature) on the 
specimen bottle or laboratory copies of the drug testing custody and 
control form be a justification, in and of itself, for a laboratory to 
reject the specimen for testing or for an MRO to invalidate the test 
results. Furthermore, all accessioning procedures at laboratories 
certified by the DHHS-SAMHSA requires that specimens be identified by 
specimen identification number, donor identification number, and 
laboratory accession number only. Even though laboratory accessioning 
personnel may have access to a donor's name in these cases, the 
analytical personnel will not. Therefore, the donor's identity is still 
protected during the actual testing process.
    Question 10: Must the collector provide a real name on the 
collector certification section of drug testing custody and control 
form?
    Guidance: The intent of the DOT drug testing custody and control 
form is to provide complete documentation of the specimen collection 
process including the name of the collector and the location of the 
collection site. The collection site person who receives the urine 
specimen from the donor should be identified by name on the block 
specifying ``collector's name.'' Use of a ``code name,'' collector I.D. 
number, or other substitution for the collector's name is not acceptable. The 
collector's name should be the same as that appearing on the 
identification each collector is required to make available to the 
donor, if so requested.

Section 40.25  Specimen Collection Procedures

    Question 1: Under what circumstances must an employee be observed 
while submitting a urine sample? Under what circumstances is 
observation an optional choice of the employer?
    Guidance: A direct-observation collection is mandatory only when 
the collection site person observes behavior clearly indicating an 
attempt to tamper or when the specimen temperature is outside the 
normal range and an oral body temperature reading is refused or is 
inconsistent with the specimen temperature.
    The collection site person would contact a higher-level supervisor, 
or a designated employer representative, to relay the circumstances 
which require the observed collection. The supervisor or representative 
would review the circumstances for compliance with Part 40 
requirements, and finding such, would approve in advance the decision 
to do the observed collection. The collection site person--of the same 
gender as the employee--would immediately conduct the observed 
collection.
    The employer has the discretion to require the employee to provide 
a specimen under direct-observation collection procedures for the 
return-to-duty test and any subsequent follow-up tests. The employer 
also has the authority to require an employee to provide a specimen 
under direct-observation procedures when the specific gravity and 
creatinine content of the employee's previous sample are below the 
regulatory standards. In the latter case, the MRO would receive the 
test results from the laboratory (i.e., positive, negative, or in the 
case where no immunoassay result is reported) along with information 
that the specimen had a specific gravity of less than 1.003 and 
creatinine concentration less than 0.2g/L. The MRO would inform the 
employer of the laboratory findings. The employer would make the 
decision to do a direct-observation collection on the employee on the 
next DOT test that the employee is required to take.
    It would be the employer's responsibility to notify the employee of 
the decision to exercise the option to do the collection(s) under the 
direct-observation procedure. The employer would authorize the 
collection site person to do the observed collection(s), as applicable. 
Directly observed collections are always performed by a collector of 
the same gender as the employee.
    Question 2: In a ``shy bladder'' situation, if the physician 
conducting the medical examination is not the MRO, may that physician 
report his/her conclusions directly to the employer? Also, if a company 
has a corporate or contract physician, may that physician perform the 
examination?
    Guidance: The rule does not preclude the MRO from performing this 
medical evaluation if the MRO has the expertise and is willing to 
conduct this evaluation. The DOT's requirement that the MRO review the 
results of the medical evaluation is related to the fact that the MRO 
may have additional information on the circumstances surrounding the 
attempt to provide the urine specimen, other pertinent information 
regarding the collection process, problems or lack of problems during 
previous collections, etc.
    All reporting to the employer regarding the final determination on 
the results of a urine specimen is accomplished by the MRO. This 
includes the findings and conclusions of the medical examination.
    If a company has a physician on the staff or has a contract 
physician, this individual may perform the medical examination if he/
she has the required expertise. The company should ensure that the MRO 
is informed of this arrangement and makes the referral to that 
particular physician. However, the requirement still exists to submit 
the findings of the evaluation to the MRO, who then reports his/her 
conclusions to the employer. A company may also designate its staff 
physician or contract physician as the MRO if that individual meets the 
regulatory criteria.
    Question 3: In a ``shy bladder'' scenario, may an employer require 
an individual to provide a specimen within three hours, and if the 
individual doesn't provide a specimen, is the inability considered to 
be a refusal?
    Guidance: The individual must provide the specimen within three 
hours. The inability to provide does not automatically mean that the 
individual being tested will be deemed to have refused testing. The 
required medical evaluation would produce the information which the MRO 
will use to draw final conclusions. If the finding by the MRO is that 
there was no legitimate medical reason for the individual's inability 
to provide the sufficient quantity of urine, then this finding 
constitutes a refusal. A refusal to provide a specimen has the same 
sanctions under the DOT rule as a positive test.
    Once it has been determined that the employee has violated a DOT 
rule (e.g., verified positive test, refusal), the employee must be 
immediately removed from performing any safety-sensitive duties. The 
employee may not again perform safety-sensitive duties until he or she 
has met the conditions of the applicable operating administration 
(e.g., Federal Highway Administration) rule for return to duty. The DOT 
rule does not address employer policies on subsequent personnel 
actions.
    Question 4: In a ``shy bladder'' scenario, does DOT consider a 
company's ordering the donor back to work prior to completion of the 
time and fluid intake period an obstruction of the collection process? 
Or, is the donor's failure to complete the collection, after having 
been compelled by the employer to leave the collection site, considered 
a refusal to test if no medical reason is provided for donor's failure 
to provide the required amount of urine?
    Guidance: A company's ordering the employee to return to work prior 
to the expiration of the time period, with no provisions for personal 
observation or for ensuring the employee's return to the collection 
site, appears to be in clear violation of DOT rules. The employer is 
not authorized to discontinue a test or to conduct a subsequent 
collection at a later time in lieu of a current collection. The 
employer could order the employee back to work while waiting for the 
three-hour period to elapse, but the employer must ensure that the 
employee drinks the prescribed amount of liquids, is under observation 
during the entire period of time, and returns to the collection site 
prior to the expiration of the three hours.
    It should be noted that because the donor was not afforded the full 
time period during which to provide a specimen, the donor's inability 
to provide the required amount of urine does not constitute a refusal 
to test but is the result of employer hindrance with the collection 
process. The MRO should advise the employer of its violation of 49 CFR 
part 40 and propose corrective action accordingly (i.e., establish 
correct policy). In addition, the MRO may report the violation to the 
appropriate DOT operating administration or may request that the DOT 
Drug Enforcement and Program Compliance office report the matter. The 
company is required to maintain, in accordance with the appropriate 
governing regulation, a record of this ``test'' for review by a DOT 
operating administration in the event of an audit. Question 5: Is a current and valid picture/photo identification 
required before a urine collection takes place or may a physical 
description verification by telephone by an employer representative 
suffice?
    Guidance: The rule does not address if the photo identification is 
current nor does it prohibit telephonic verification of identity. The 
intent of the rule was that if the employee did not have proper 
identification, an employer's representative would be on site to 
identify that employee. There is no requirement that the representative 
sign any type of form, although procedures should be established to 
ensure the true identity of the representative.
    If telephonic identification is used, specific procedures should be 
in place to ensure that the employer representative is fully identified 
to the collection site person and that reasonable procedures exist to 
ensure that the employer's representative can truly identify the 
employee. If the employee's identification cannot be established to the 
satisfaction of the collection site person (or based on the collection 
site protocol for identification), the collection should not be 
completed. Additionally, any identification procedure allowed under 
specific DOT operating administration's rules is also permissible.
    Exception: If the donor is self-employed and has no photo 
identification, the collector should notify the collection site 
supervisor and record in the remarks section that positive 
identification is not available. The donor must be asked to provide two 
items of identification bearing his/her signature. Proceed with the 
collection. When the donor signs the certification statement, compare 
the donor's signature with signatures on the identification presented. 
If the signatures appear consistent, continue the collection process. 
If the signature does not match signatures on the identification 
presented, make an additional note in remarks section stating that 
``signature identification is unconfirmed'' and continue the collection 
process.
    When this (self-employed) donor does not have appropriate 
identification this should not be considered a refusal. The collector 
should remember that his/her primary function is to obtain a specimen 
that can be tested for drugs under DOT rules. The collector should 
provide sufficient information in the remarks section to help the MRO 
make a determination regarding the merit of the collection process or 
for the employer to determine if there are systemic problems or other 
shortfalls in its policy/program.
    Question 6: May a urine specimen collection site be constructed to 
have two or more collectors or must each collection ``station'' be 
physically separated by a barrier or wall to ensure modesty and privacy 
of the donor?
    Guidance: In specifying privacy and security of the collection 
site, the DOT was concerned that the act of urination by a donor would 
have maximum privacy under most circumstances and that the specimen 
sample would be under sufficient security to prevent any allegation of 
tampering. Additionally, the regulatory requirement exists that the 
collection site person have only one donor under his/her supervision at 
any one time. In other words, one collection site person may not 
process the paperwork or collect a specimen from more than one donor at 
a time. There are collection sites, particularly at health clinics, 
that may have ``stations'' or booths which are partially partitioned 
from each other or from the rest of the clinic. The collection site 
person usually gathers relevant information from the donor at the 
booth, completes the necessary paperwork, and escorts the donor to a 
toilet area where the donor can provide a specimen in privacy.
    The rule does not permit unauthorized personnel in any part of the 
designated collection site where urine specimens are collected or 
stored. In the multiple booth situation, another collection site person 
would not be considered an unauthorized person. However, when other 
donors are present in a waiting area or another donor is being 
processed by another collection site person, the integrity of the 
specimen must be ensured. During the collection process, the collection 
site person must ensure that the specimen is under his or her direct 
control from the time the specimen is provided by the donor to the time 
it is sealed in the mailer. Additionally, regardless of the physical 
configuration of the collection site, there is the expectation that the 
donor will have some semblance of aural and visual privacy. For 
example, a donor may tell the collector that he/she is suffering from a 
particular illness, is on medication, or that he/she has an indwelling 
catheter, and wonder if this will impact on the test results. The donor 
should be able to make these statements without embarrassment or 
concern that another individual (i.e., another collector or donor) may 
overhear or see what the donor is providing to the collector.
    Question 7: May donors be required to remove all clothing, wear a 
hospital gown, or empty pockets?
    Guidance: The DOT's procedures for transportation workplace drug 
testing programs contained in Sec. 40.25(f)(4) states: ``The collection 
site person shall ask the individual to remove any unnecessary outer 
garments such as a coat or jacket that might conceal items or 
substances that could be used to tamper with or adulterate the 
individual's urine specimen. The collection site person shall ensure 
that all personal belongings such as a purse or briefcase remain with 
the outer garments. The individual may retain his or her wallet.'' 
(Emphasis added.)
    While it is clear that the rule does allow for collectors to 
request that donors remove unnecessary outer garments in order to 
ensure the integrity of the collection, the rule does not authorize 
collectors to require or request that donors remove other garments as 
well, e.g. shirts, blouses, pants, or skirts, thereby ensuring a 
modicum of privacy and reducing potential embarrassment. Additionally, 
donors may not be required or requested to wear hospital or examination 
gowns when providing a specimen.
    There is an exception to the above. The DOT has determined that if 
a urine specimen is being collected as part of a DOT-required physical 
examination (i.e., Sec. 391.43 Medical examination; certificate of 
physical examination) in which an individual is required to disrobe and 
wear a hospital or examination gown, the collection may be completed 
with the donor so attired.
    It should also be noted that if a collection site person, during 
the course of a collection procedure, notices an unusual indicator that 
an individual may attempt to tamper with or adulterate a specimen as 
evidenced by a bulging or overstuffed pocket for example, the collector 
may request that the donor empty his or her pockets, display the items, 
and explain the need for them during the collection. This procedure may 
be done only when there is a suspicion that an individual may be about 
to tamper with or adulterate a specimen. Otherwise, requiring donors to 
empty their pockets as a common practice is also prohibited under the 
current rules.
    Question 8: Please clarify donor identifying information 
requirements on the drug testing custody and control form.
    Guidance: In accordance with Sec. 40.25(f)(20), the donor/employee 
is required to initial the specimen bottle seal/label. The employee/
donor's identification number or SSN is to be provided on the custody and control form and shall not be included on 
the specimen bottle seal/label. Other donor identification (i.e., name, 
signature) should not be provided on the copies of the custody and 
control form that accompany the specimen to the laboratory. However, 
disclosure of the donor's name/signature does not, in and of itself, 
require that the specimen be rejected for testing by the laboratory.
    Question 9: Is a consent form authorized?
    Guidance: Section 40.25(f)(22)(ii) states, ``When specified by DOT 
agency regulation or required by the collection site (other than an 
employer site) or by the laboratory, the employee may be required to 
sign a consent or release form authorizing the collection of the 
specimen, analysis of the specimen for designated controlled 
substances, and release of the results to the employer.'' The purpose 
of this statement is to allow collection sites or laboratories, of 
their own accord, or when required by a DOT agency regulation, to 
utilize consent or release of information forms for the collection, 
analysis, and release of specimen results to the employer. 
Sec. 40.25(f)(22)(ii) continues, ``The employee may not be required to 
waive liability with respect to negligence on the part of any person 
participating in the collection, handling, or analysis of the specimen 
or to indemnify any person for the negligence of others.'' The intent 
of this statement is to prevent anyone who participates in either the 
collection, handling, or analysis of the specimen from trying to 
require the employee to exempt them from liability arising from their 
actions. This pertains not only to collection site and laboratory 
personnel, but also to MROs, their staff, if applicable, and to the 
employer. Failure of an employee to sign the consent form does not 
equal a refusal to test and the test must proceed in all circumstances. 
The DOT also intends that this interpretation shall be followed for 
alcohol testing requirements.
    Question 10: Is the donor's presence required when the collector 
prepares a specimen for shipment?
    Guidance: The tamper-proof seal placed on the specimen bottle must 
be affixed in the presence of the donor, but the regulation is clear 
that the donor does not have to be present when the specimens are 
prepared for shipment to the laboratory. The collection site person is 
the only person required to sign or initial the seal on the shipment 
container. In fact, the rule allows the use of shipment containers that 
accommodate multiple specimen bottles. It would be impossible to have 
more than one donor witness the sealing of their specimen bottles in 
one shipment container when collectors are required by rule to deal 
with only one donor at a time.
    Question 11: In a post-accident situation requiring both a company 
test and a DOT test, which should be conducted first?
    Guidance: In a post-accident situation in which drug/alcohol 
testing is required under company authority or policy, and DOT-mandated 
tests are required, the DOT tests must be conducted first.
    Question 12: Please address the issue of low specific gravity/
creatinine.
    Guidance: Laboratory reports. The laboratory may report in the 
laboratory remarks section of the custody and control form that 
specific gravity is less than 1.003 and creatinine is less than 0.2 
grams per liter. Actual values of specific gravity and creatinine 
should not be reported.
    Medical Review Officer Interpretations MROs shall report the 
laboratory findings (positive, negative or not tested (canceled)) to 
the employer and that specific gravity and creatinine are below 1.003 
and 0.2 g/l, respectively.
    Employer Actions The employer shall not require the driver to 
submit to another specimen collection under FHWA authority. A dilute 
specimen does not constitute reasonable suspicion of controlled 
substance use. The employer may require the next specimen, required by 
DOT regulations, submitted by the driver to be collected under direct 
observation.
    Question 13: What should donors do if specimen collection 
procedures are not being followed?
    Guidance: Under DOT agency regulations, the employer is responsible 
for ensuring that specimens are collected in accordance with part 40. 
If the employees subject to DOT-mandated drug testing regulations 
believe that part 40 collection procedures are not being followed, they 
should so inform the employer. If the employer does not respond to the 
complaints and take appropriate corrective actions, the employees may 
seek resolution of their complaints through a DOT agency that has 
regulatory authority over the employer.
    Question 14: Is failure to check the temperature box on the drug 
testing custody and control form considered a fatal flaw?
    Guidance: In accordance with Sec. 40.29, the collector is to check 
the temperature of the specimen to ensure the integrity of the 
specimen. The fact that it was checked should be marked appropriately 
on the custody and control form. Inadvertently not marking the 
temperature-taken box, in and of itself, does not constitute a ``fatal 
flaw'' in the DOT chain of custody process.
    Question 15: What are the collection site requirements?
    Guidance: Section 40.25(a)-(b) outlines employer requirements for 
designating and maintaining the security of collection sites. To 
summarize the contents of this section, a collection site must at a 
minimum provide: (1) An enclosure where privacy for urination is 
possible; (2) A toilet for urination (unless a single use, disposable 
container is used with sufficient capacity to contain the entire void); 
(3) A source of water for washing hands; (4) A suitable writing surface 
for completing the required paperwork (custody and control form); and 
(5) Restricted access so that the site is secure during collection.
    Any facility, including a physician's office, that meets the 
minimum requirements may be used as a collection site for DOT-required 
drug tests. It is the employer's responsibility to not only designate 
and ensure that collection sites meet these minimum requirements, but 
also to ensure that collection site personnel at these locations are 
properly trained and/or qualified to collect urine specimens in 
accordance with the provisions outlined in 49 CFR part 40.
    Question 16: Are middle names required on the drug testing custody 
and control form?
    Guidance: Section 40.25(a) specifies that the custody and control 
form used to document DOT mandated drug testing shall provide space for 
collector, donor, and laboratory certifying scientist names and 
signatures. The regulation does not specify that a middle name or 
initial must be used. The intent of the regulation is to provide for 
the identification of the person(s) signing the certification 
statements. The use of supplemental instructions on the custody and 
control form (e.g. further defining name to include first, middle, 
last), does not impact on the security, identification, or integrity of 
the urine specimen and should not be used as a basis for invalidating 
the specimen results.

Section 40.29 Laboratory Analysis Procedures

    Question 1: May a laboratory provide ``one-stop shopping'' to an 
employer by including the services of a MRO or a list of MROs (which 
the laboratory does not employ) from which the employer or client could 
select a specific MRO?
    Guidance: Under current DOT interpretation of the rule, a 
laboratory would be prohibited from supplying a limited list of MROs from which 
the employer would select individuals that would provide MRO services. 
In this circumstance, there is a clear financial advantage to the MROs 
who appear on the laboratory list, since this makes them among the 
candidates for use by that laboratory's clients. This advantage could 
readily be viewed as providing these MROs an incentive to maintain a 
good relationship with the laboratory, so as to ensure that they remain 
on the list, which is in their financial interest. The existence of 
this incentive could, in turn, call into question the objectivity and 
independence of the MROs in the review of the test results and the 
reporting to relevant officials of any potential errors in test results 
or procedures. The regulatory prohibition is not limited to actual, 
demonstrated conflict of interest. It includes matters that ``may be 
construed as a potential conflict of interest''. The DOT position is 
that the above described laboratory arrangement presents the appearance 
of a conflict of interest.
    Question 2: May a laboratory continue to submit monthly summary 
reports to the employer/consortia or is the laboratory limited to 
quarterly reports only?
    Guidance: The DOT changed the requirement for a monthly statistical 
report to a quarterly report to provide cost savings to the industry 
without substantially decreasing the effectiveness of the report. 
Although the original regulatory language appears to require reporting 
only on a quarterly basis, the intent of this change was to require, as 
a minimum, a quarterly report, but not to limit those employers or 
laboratories who desired monthly reports. Monthly reports may be 
generated provided the reports do not contain personal identifying 
information or other data from which it is reasonably likely that 
information about individuals' tests can be readily inferred. If a 
laboratory provides monthly reports, there is no requirement to 
additionally provide a quarterly aggregate report. Likewise, the 
regulatory requirement to prevent individual identifying information 
remains for both monthly and quarterly reports. If a report is withheld 
for this reason, the laboratory will notify the employer.
    Question 3: Explain the requirements for quarterly lab summaries.
    Guidance: Section 40.29(g)(6) requires each laboratory to ``provide 
the employer an aggregate quarterly statistical summary of urinalysis 
testing of the employer's employees. Laboratories may provide the 
report to a consortium provided the laboratory provides employer-
specific data and the consortium forwards the employer-specific data to 
the respective employers within 14 days of receipt of the laboratory 
report.''
    The above reference also contains the following information: 
``Quarterly reports shall not contain personal identifying information 
or other data from which it is reasonably likely that information about 
individuals' tests can be readily inferred. If necessary, in order to 
prevent disclosure of such data, the laboratory shall not send a report 
until data are sufficiently aggregated to make such an inference 
unlikely. In any quarter in which a report is withheld for this reason, 
or because no testing was conducted, the laboratory shall so inform the 
consortium/employer in writing.''
    As referred to above, the DOT has held that during a quarter in 
which there was ``no activity'' the laboratory is still required to 
inform the employer, in writing, of the negative activity. This 
provision is necessary to assist Federal auditors during inspections of 
employers that are required by an Operating Administration to conduct a 
drug testing program. Unless the auditor has a complete quarter-by-
quarter history and record of drug testing results from a laboratory, 
there is nothing to preclude an employer, for example, from destroying 
a quarterly summary that does contain a confirmed positive result and 
claim that there simply was no activity during the month. This, of 
course, would allow the company to continue to use that individual in a 
safety-sensitive function with no evidence that there was a confirmed 
positive drug test result. In effect, the negative lab report serves as 
an important check and balance used by auditors in their compliance and 
enforcement efforts.
    Question 4: May labs transmit results to an MRO by faxing Part 2 of 
drug testing custody and control form?
    Guidance: Laboratory test results may be provided to the MRO via 
facsimile transmission of the custody and control form. However, the 
``true copy'' of the custody and control form must also be sent to the 
MRO. The purpose of permitting facsimile transmission of the custody 
and control form is to facilitate a quicker administrative review of 
test results by the MRO. The MRO may complete verification of a 
negative result based on the facsimile of the custody and control form; 
however, the verification of a positive result cannot be completed 
until the ``true copy'' of the custody and control form bearing the 
original signature of the laboratory's certifying scientist is received 
by the MRO.
    Question 5: May a lab certifying scientist use a ``signature 
stamp''?
    Guidance: In accordance with Sec. 40.29(g)(5), ``in the case of a 
positive report for drug use [the drug testing custody and control form 
(part 2)], shall be signed (after the required certification block) by 
the individual responsible for day-to-day management of the drug 
testing laboratory or the individual responsible for attesting to the 
validity of the test reports.* * *''
    In accordance with Sec. 40.29(g)(1), ``Before any test result is 
reported (the results of initial tests, confirmatory tests, or quality 
control data), it shall be reviewed and the test certified as an 
accurate report by the responsible individual.'' The DOT's opinion is 
that negative reports must be reviewed and the test certified as an 
accurate report by the laboratory's responsible individual. This 
certification must be accomplished by a signature for positive test 
results while a signature stamp with initials for negative test results 
on the custody and control form may be used.
    Question 6: Does the regulation require lab ``batch reporting'' of 
drug test results?
    Guidance: The laboratory may report results to the MRO as soon as 
the results have been reviewed by the appropriate laboratory personnel. 
There is no requirement for ``batch reporting,'' or reporting 
simultaneously all results for specimens received in a given shipment. 
Nor does part 40 require ``batch reporting'' of results by the MRO to 
the employer. Batch reporting, which causes the transmission of 
negative results before positive results have been verified, may create 
a problem by leading an employer to make premature assumptions about a 
particular test result. However, the rule provides no authority for an 
employer to take any adverse action against an employee whose test 
result is pending. The differences in reporting time of test results 
may be due to a variety of circumstances including laboratory 
processing time, MRO administrative review processes for negatives, or 
the verification process for positives.
    Question 7: Is a lab required to send results directly to the MRO?
    Guidance: Yes. Section 40.29(g) requires confidentiality and 
limited access to laboratory test results, and the laboratory must send 
only to the MRO the original or a certified true copy of the drug 
testing custody and control form (Part 2). Furthermore, 
Sec. 40.33(b)(3) states: ``The role of the MRO is to review and 
interpret confirmed positive test results obtained through the 
employer's testing program.'' Section 40.33(c)(2) states: ``The MRO shall contact 
the individual directly, on a confidential basis, to determine whether 
the employee wishes to discuss the test result. A staff person under 
the MRO's supervision may make the initial contact, and a medically 
licensed or certified staff person may gather information from the 
employee.''
    Given the above, it should be clear that the intent of the current 
regulations is that all laboratory test results be sent directly to the 
MRO. When the test result is positive, the MRO must make the 
verification determination; when the test result is negative, the MRO 
may delegate to a person under his/her direct supervision the 
administrative review of the negative results.
    Question 8: Does the regulation allow the MRO to disclose to the 
employer the drug(s) involved in a positive test?
    Guidance: Section 40.29(g)(3) requires MROs to report to employers 
whether the drug test was positive or negative. It also allows the MRO 
to report the drug(s) for which there was a positive test.

Section 40.31  Quality Assurance and Quality Control

    Question 1: Please explain the timing of blind performance test 
specimens.
    Guidance: Section 40.31(d) delineates employer and consortia blind 
performance test requirements. The intent of these requirements is to 
test the laboratory's ability to correctly identify positive and 
negative samples. These samples are to be unidentifiable as blind 
samples by the laboratory.
    The regulation does not specify the distribution or the timing of 
the submissions except to stipulate in Sec. 40.31(d)(2) that each 
``employer shall submit three blind performance test specimens for each 
100 employee specimens it submits, up to a maximum of 100 blind 
performance test specimens submitted per quarter.'' This is the basic 
requirement. The optimum program would be to evenly space the 
submission of blind samples throughout the period.

Section 40.33  Reporting and Review of Results

    Question 1: Does the MRO have to personally conduct the 
verification of a positive drug test result?
    Guidance: The DOT requirement that the MRO be a licensed physician 
with knowledge of substance abuse disorders (Sec. 40.33(b)(1)) 
indicates the importance that the DOT placed on this function. The 
regulatory requirement is that prior to making a final decision to 
verify a positive test result, the individual is given an opportunity 
to discuss the test result directly with the MRO. An appropriately 
medically trained staff person (e.g., a nurse with substance abuse 
training) may gather information from an employee about the employee's 
explanation for a positive result. In every case, however, the MRO must 
talk to the employee before making the decision to confirm a laboratory 
positive as a verified positive drug test result. No staff person may 
make this decision for the MRO.
    Question 2: Does the DOT drug testing rule permit the use of a 
second and different MRO to whom the results of the split specimen can 
be sent by the second laboratory?
    Guidance: There is no appropriate role for a second and different 
MRO to whom the results of the split specimen would be submitted. The 
DOT's interpretation is that this procedure is not permissible under 
the DOT rule.
    The laboratory results of the split specimen are for the presence 
of the drug or drug metabolite and the rule text does not authorize a 
``second'' verification process of the split results. Therefore, the 
use of a second MRO does not add to the overall verification process 
required by the rule. Additionally, if the split specimen fails to 
reconfirm or is not available for testing, it is the responsibility of 
the (original) MRO to cancel the test and provide notification of this 
cancellation to the appropriate parties. It would be inappropriate for 
the second MRO to cancel the test nor would the second MRO have the 
appropriate information to accomplish the cancellation notification.
    Question 3: If the MRO determines that a donor has a legitimate 
prescription for Marinol, would this be reported as a negative result? 
What if in the MRO's opinion, the use of the prescribed medication may 
compromise safety?
    Guidance: Section 40.33(a)(1) states in part, that `` * * * A 
positive test result does not automatically identify an employee/
applicant as having used drugs in violation of a DOT agency regulation. 
An individual with a detailed knowledge of possible alternate medical 
explanations is essential to the review of the results.'' The DOT's 
interpretation has been that if the MRO c