# Regulatory Guidance for the Federal Motor Carrier Safety Regulations

> Briefs, arguments, decisions, and more.

URL: https://www.frixlaw.com/law-library/documents/fr%3A97-8406

## Record

- **Collection:** Federal Register
- **Document type:** Rule
- **Published:** April 4, 1997
- **Citation:** 62 FR 16370

## Text

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--

[[Page 16371]]

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

[[Page 16372]]

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

[[Page 16373]]

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

[[Page 16374]]

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.

[[Page 16375]]

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

[[Page 16376]]

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

[[Page 16377]]

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

[[Page 16378]]

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 can determine that the donor
has a legitimate prescription, the positive result would be ``down
graded'' to a negative. This would apply to any legitimately prescribed
drug, including Marinol. If the MRO determines that the use of that
particular prescription/substance may compromise safety in the
performance of a transportation related safety sensitive function
(whether or not the substance is prescribed for the appropriate
condition), the MRO should discuss this with the donor's (prescribing)
physician. The donor's physician may decide to prescribe an alternate
substance that may not have adverse effects on the donor's performance
of his/her duties.
Section 40.33(i) states in part, that ``(1) The MRO may disclose
such [medical] information to the employer, a DOT agency * * * or a
physician responsible for determining the medical qualification of the
employee * * * if * * * (iii) * * * the information indicates that
continued performance by the employee * * * could pose a significant
safety risk. (2) Before obtaining medical information from the employee
as part of the verification process, the MRO shall inform the employee
that information may be disclosed to third parties as provided in this
paragraph * * * ''. If after talking to the prescribing physician, the
MRO still determines that a safety risk exists, he/she may inform the
employer, DOT, or the employer's physician of the existence of a
medical condition that could preclude the donor from performing a
safety sensitive function. However, the MRO must ensure that he/she
informed the employee prior to the verification process that this
(medical) information may be provided to a third party.
Question 4: Is there such a thing as an MRO management company or
does the law specify that a single certified MRO review each lab result
from tested employees and personally transmit the test results to the
specific employer? Does the law require that the owner of an MRO
management company be a physician? Do negative test results have to be
handled by a physician MRO, or may the results be handled by the MRO
management company administrators?
Guidance: While part 40 makes no mention of an ``MRO management
company'' the regulations do address the role of the C/TPA. The rules
do not permit the C/TPA to receive drug testing results directly from
either the laboratory or from the MRO. The laboratory results are
reported directly to the MRO, and the MRO results are reported directly
to the employer.
Through interpretation of Sec. 40.33(a), the DOT has permitted the
administrative review to be conducted by staff persons working under
the direct supervision of the MRO. While allowing this delegation of
MRO responsibility, the DOT never intended nor can it condone a
practice which allows for MROs to appoint outside ``agents'' to perform
this review. The

[[Page 16379]]

MRO should have a direct supervisory relationship with the reviewer and
not simply have access to the ``process'' of the administrative review.
Conversely, a C/TPA cannot contract for the MRO to review only positive
drug test results, leaving the review or processing of negatives to the
C/TPA.
Question 5: May a C/TPA act as an agent of the MRO for the purpose
of conducting administrative reviews of all negative urine drug test
results and receive drug testing results directly from the laboratory?
Guidance: No. The DOT never intended nor can it condone a practice
which allows MROs to appoint outside agents to conduct such reviews.
Additionally, Sec. 40.29(g) requires that all drug test results be
transmitted by the laboratory directly to the MRO. Transmission to the
MRO means to the MRO's place of business and not to a subsidiary or
contractor for the MRO. There is also the requirement that, regardless
of what forms/records a consortium or third party administrator
maintains for an employer, notification of all positive results will be
performed by the MRO and not through or by anyone else.
Question 6: What are the MRO's review requirements during the
verification process when the MRO copy of the custody and control form
is not available?
Guidance: The MRO may complete the verification process if the
MRO's copy of the custody and control form is not available for review.
The MRO needs to review a copy of the chain of custody which contains
the employee's signature. A copy may be obtained from the employee, the
collector, or the employer. These copies have the employee's signature.
The preamble to part 40 (Medical Officer Issues) published on
December 1, 1989 requires the MRO not to declare a verified positive
result until he or she receives the hard copy of the original chain of
custody form from the laboratory. This is because, prior to determining
that the test is a verified positive, the MRO verifies the identifying
information and the facial completeness of the chain of custody (i.e.,
determines that, on the face of the document, all the sign-offs are in
the right places).
Question 7: Does the MRO have to verify each drug when the
laboratory reports a multiple positive drug test results for the same
individual under the DOT drug and alcohol rule?
Guidance: Section 40.33(a) states ``Medical review officer shall
review confirmed positive results.'' The DOT drug rule requires
analysis of urine for five drugs. Multiple drug positive results for
the same specimen (donor) require the MRO to verify each reported drug
to determine if there is a medical explanation for each positive
result. Additionally, the DOT drug and alcohol management information
system requests information on multiple drug results (for each
individual). The intent is to capture this information.
However, in the preemployment process, it would appear that with
the employer's consent, the MRO may report a verified positive result
for one drug out of several laboratory positive results (for one
individual) without continuing to seek verification for the other drugs
reported by the laboratory. The MRO may need to use his/her
professional judgement to determine if verification of the other drugs
may be accomplished expeditiously. Regardless of the number of drugs
that are reported as verified for one individual, that individual
cannot perform safety-sensitive work until he/she provides a urine
specimen that is negative.
In the case where the MRO verifies and reports only one drug, the
other drugs should not be reported to the employer if they have not
been verified. The MRO may document these unverified positive results
in his/her records as unverified and unreported results.
Question 8: Is a company obligated to pay for the processing of a
split urine specimen when the primary specimen is positive? Does a
company have to pay for testing the split specimen if it was a pre-
employment test?
Guidance: The split sample procedure is a statutory requirement of
the Omnibus Transportation Employee Testing Act of 1991 for employers
in the aviation, highway, rail, and transit industries, as well as the
DOT rules. Section 40.3 states, in part: ``Employee. An individual
designated in a DOT agency regulation as subject to drug testing and/or
alcohol testing. As used in this part ``employee'' includes an
applicant for employment.'' And Sec. 40.33(f) states, in part: ``If the
employee requests an analysis of the split specimen within 72 hours of
having been informed of a verified positive test, the MRO shall direct,
in writing, the laboratory to provided the split specimen to another
DHHS-certified laboratory for analysis.'' In other words, if the
applicant or employee makes the request within this time period, the
split specimen must be tested. This is true of all types of tests,
including pre-employment.
The employer is responsible for ensuring that the test occurs,
including taking responsibility for paying for it. The employer may
arrange with the applicant or employee for reimbursement, but in no
case does the refusal by the applicant or employee to contribute to the
cost of the test excuse the employer from ensuring that the test takes
place. A previous agreement negotiated between the employee and
employer or a labor-management agreement that specifies payment
arrangements, could dictate the ultimate payment source.
The split specimen testing process, initiated by the MRO's written
request, should not be delayed while awaiting payment to come from the
applicant or employee. If there is a dispute, the fall-back position
would be for the employer to be billed (by either the primary
laboratory for sending the split specimen, or the receiving laboratory
for testing the split specimen) and then for the employer to settle the
matter after-the-fact with the applicant or employee.
Question 9: When may the MRO notify an employer of a positive drug
test result?
Guidance: The MRO may not notify the employer of a positive test
until he/she has verified the test as positive. Verification requires
that the MRO review the chain of custody documentation, contact the
employee, review any documentation of a legitimate medical explanation
for a positive test, and determine that the positive resulted from
unauthorized use of a controlled substance. The MRO is not required to
delay verification pending the outcome of the reanalysis or the split
specimen. Only upon verification shall the MRO notify the employer of
the positive result, and the employer shall then remove the employee
from the safety-sensitive duties/position. Once having received notice
of a verified positive result from the MRO, the employer shall not
delay removal of the employee from safety-sensitive duties pending the
outcome of the reanalysis or the split specimen.
Question 10: Must the MRO report to employers be in writing
Guidance: Part 40 does not require the MRO to provide written
notification to employers of verified drug test results. The FHWA,
however, does require MROs to forward a signed, written notification to
the employer within three business days of the completion of the MRO's
review for both positive and negative results. A legible photocopy of
the fourth copy of the Federal Drug Testing Custody and Control Form
required by part 40 appendix A may be used to make the signed, written
notification to the employer for all test results (positive, negative,
canceled, etc.), provided that the controlled

[[Page 16380]]

substance(s) verified as positive, and the MRO's signature, shall be
legibly noted in the remarks section of step 8 of the form completed by
the MRO.
Question 11: May an MRO use part 2 of drug testing custody and
control form to report negative results?
Guidance: No. The MRO should not provide the employer with a copy
of the custody and control form bearing the results from the
laboratory. Often, positive results reported by the laboratory are
determined by the MRO to be explained by authorized medical use of a
substance, and thus are verified and reported negative. Employers are
not permitted to have the laboratory information, only the MRO's
determination.
Question 12: Please explain an MRO's review of negative results.
Guidance: The duties of the MRO with respect to reviewing negative
urine drug test results are strictly administrative, but must include a
review of the drug testing custody and control form prior to releasing
the results to the employer. This is necessary to substantiate that the
reported negative result is correctly identified with the donor and to
ensure that the form is complete and sufficient on its face
(Sec. 40.33(a) (1-2)). While the DOT, through interpretation, has
permitted the administrative review to be conducted by a staff person
working under the direct supervision of the MRO, the requirement to
conduct the review in accordance with current regulations remains in
effect.
Question 13: Please explain MRO verification of opiate positives.
Guidance: The MRO verification process of any positive laboratory
report requires several specific actions. These include a review of the
drug testing custody and control form for completeness and accuracy,
notifying and providing the donor an opportunity to discuss the
results, reviewing the donor's medical history and medical records, and
investigating other biomedical factors that may account for the
positive result.
The above actions are especially important when the MRO is
confronted with an opiate positive, as the result may be caused by the
use of a legally prescribed medication or an ingested substance, such
as poppy seeds. Using the above steps as a guide, the MRO first ensures
that the drug testing custody and control form is complete and accurate
on its face. Next, the MRO notifies the donor of the positive test
result and offers the individual an opportunity to discuss the results.
If the donor expressly declines the opportunity to discuss the test
results, or fails to contact the MRO within five days after being
notified by a designated employer representative to do so, the MRO may
verify the laboratory test result as a positive. This includes results
that are positive for opiates.
If the donor accepts the opportunity to discuss the results with
the MRO, the MRO must review any medical records provided by the donor
to determine if the opiate positive resulted from a legally prescribed
medication. If the donor is unable to produce medical evidence and
admits to unauthorized use of an opiate, the MRO should verify the
result as a positive. However, if the donor is unable to produce
medical evidence, denies unauthorized use of an opiate, or denies using
another individual's medication, the MRO must determine that there is
clinical evidence--in addition to the urine test--of unauthorized use
of any opium, opiate, or opium derivative before verifying the test
result as positive. Examples of clinical evidence include recent needle
tracks or behavioral or psychological signs of acute opiate
intoxication or withdrawal. If a laboratory confirms the presence of 6-
acetylmorphine (6-AM) through a GC/MS test, no clinical evidence is
necessary, since 6-AM is a direct deacetylated metabolite of heroin,
detectable within minutes, and its presence proves the recent use of
heroin. If 6-AM is not found, clinical evidence will be required to
verify a positive opiate result whether or not the donor claims poppy
seed ingestion as a defense for the positive result.
The verification process for an opiate positive result can be a
very complex and very difficult task for the MRO and should be
undertaken with a great deal of caution.
Question 14: Please clarify the MRO/lab relationship.
Guidance: Section 40.29(n)(6) states: ``The laboratory shall not
enter into any relationship with an employer's MRO that may be
construed as a potential conflict of interest or derive any financial
benefit by having an employer use a specific MRO.'' Section 40.33(b)(2)
further states: ``The MRO shall not be an employee of the laboratory
conducting the drug test unless the laboratory establishes a clear
separation of functions to prevent any appearance of a conflict of
interest, including assuring that the MRO has no responsibility for,
and is not supervised by or the supervisor of, any persons who have
responsibility for the drug testing or quality control operations of
the laboratory.'' Therefore, the rule prohibits an employer-employee or
contract relationship between the laboratory and the MRO, and it is
obvious that there must be a clear separation of functions between the
MRO and the laboratory.
Question 15: In what situations may an MRO reopen a verification of
a drug test?
Guidance: Section 40.33 specifically allows the reopening of an
MRO's verification of a confirmed positive drug test in only two
situations. When a donor provides documentation that serious illness,
injury, or other circumstances unavoidably prevented the employee from
timely contacting the MRO, the MRO may conclude from the documentation
that there is a legitimate explanation for the employee's failure to
contact the MRO (see Sec. 40.33(c)(6)). The second situation is if
neither the employer nor the MRO is able to contact the employee and
the MRO declares the test result to be positive, and the employee
subsequently provides documentation that serious illness, injury, or
other circumstances unavoidably prevented the employee from contacting
the MRO in a timely manner, the MRO may conclude from the documentation
that there is a legitimate explanation for the employee's failure to
contact the MRO (see Sec. 40.33(g)).

Section 40.35 Protection of Employee Records

Question 1: Please clarify release of alcohol and drug test results
with or without written authorization.
Guidance: The rules governing release of employee test results
(Secs. 40.35 and 40.81) permit disclosure to persons other than the
employee, employer, or decision-maker in a lawsuit or grievance action,
only with the written authorization of the employee. The authorization
must be an informed consent, in that the employee fully understands the
intended use and disclosure of the test results. Each entity's request
for test results would require a separate authorization and must be
specific. Specific items including the purpose of the release, specific
test(s) to be released, the party(ies) to whom these specific results
will be released must be included.
Question 2: May employees be required to sign release forms for
third-party disclosures?
Guidance: The intent of (Secs. 40.29(g)(3), 40.35 and 40.37) is to
ensure confidentiality of employee drug test results. Employees cannot
be required to sign release or consent statements for third-party
disclosure as part of the drug testing process. Information concerning
the drug test may be released by the employer in

[[Page 16381]]

unemployment or workmen's compensation proceedings, or other situations
in which the employee is seeking a benefit or challenges an action
taken by the employer as a result of a drug test.
It should be noted, however, that employers are required to request
written authorization from CMV drivers to obtain past verified positive
drug test results, refusals to test, and alcohol concentrations of 0.04
or greater over the past 2 years of driving a CMV (Secs. 382.405(f) and
382.413(a)).

Section 40.39 Use of DHHS-Certified Laboratories

Question 1: May additional testing be conducted on a DOT specimen
reported by the laboratory as negative?
Guidance: Section 2.4(e)(3) of the Department of Health and Human
Service's Mandatory Guidelines for Federal Workplace Drug Testing
Programs states, ``Specimens that test negative on all initial
immunoassay tests shall be reported as negative. No further testing of
those negative specimens for drugs is permitted and the specimens shall
be either discarded or pooled for use in the laboratory's internal
quality control program.''
The DOT requires use of DHHS-certified laboratories to do all DOT-
required testing. Therefore, the above DHHS requirement is a DOT
requirement as well. When a DOT specimen is reported as negative by the
laboratory, no additional testing of the specimen is permissible.
Question 2: Why use DHHS-certified laboratories?
Guidance: The DOT requires that all drug testing mandated under the
provisions of its drug testing rules must be conducted in DHHS-
certified laboratories. The DOT decision to use DHHS-certified
laboratories for drug testing is mandated by statute (Omnibus
Transportation Employee Testing Act of 1991). The DHHS standards for
certification and the proficiency testing requirements comprise the
most stringent laboratory accreditation program available in analytical
forensic toxicology for urine drug testing. Additionally, the DHHS
certification program provides for standardization of laboratory
methodology and procedures, ensuring equal treatment of all specimens
analyzed. Finally, the use of DHHS-certified laboratories provides a
standard that has withstood the test of legal challenges in Federal
drug testing.

Section 40.69 Inability To Provide an Adequate Amount of Breath

Question 1: If an employee is unable to provide an amount of breath
sufficient to permit a valid breath test, but does not allege that such
inability is due to a medical condition, what actions must follow?
Guidance: The rules prohibit a covered employee from refusing to
submit to required alcohol tests. Post-accident, random, reasonable
suspicion, or follow-up tests must be taken when those tests are
required. Section 40.69 sets forth the procedures to be followed when
an employee is unable to provide an adequate amount of breath for any
reason. These procedures apply to the employee who claims a particular
medical condition is creating the inability to provide breath; they
also apply to the employee who claims to have no idea as to the cause
of the inability, or to the employee who says nothing at all.
It is imperative that the employee understands that during the
required follow-on medical evaluation, the physician will concentrate
solely on finding a medical condition to explain the inability.
Paragraphs (d)(2)(i) and (d)(2)(ii) of Sec. 40.69 dictate that the only
acceptable reason for an employee to be unable to provide an adequate
amount of breath for testing is a medical condition. If a medical
condition is not found, the employee will be deemed to have refused
testing.

Section 40.81 Availability and Disclosure of Alcohol Testing
Information About Individual Employees

Question 1: If there is one or more BAT working for a company, does
the BAT supervisor have the right to review (have access to) the Breath
Alcohol Testing Forms for purposes of supervisory control? Likewise,
may this form be passed along by the BAT or the employer to billing
personnel?
Guidance: The rule holds employers responsible for implementation
of the total program. This includes confidentiality of information and
maintenance of records (including BAT and MRO records). Individuals
such as supervisors of BATs and billing personnel with a ``need to
know'' are considered authorized company personnel and are permitted to
have access to breath alcohol testing documentation. Access to
information would be for a specific purpose and necessary for the
employer's successful implementation of the program. This would include
review of the forms for completion, obtaining specific billing data
from the forms, filing the forms, etc. Individuals with access to these
forms are under the same regulatory requirements for maintaining
confidentiality of these records as are employers and BATs. Breath
Alcohol Testing Forms should not be duplicated for purposes of
supervision or billing as this would create additional ``data bases''
or files with potential problems of disclosure of confidential
information. Access to these records by unauthorized personnel would be
difficult to control. This does not preclude use of input forms filled
out by the BAT or other personnel that would contain appropriate
billing data and which could be maintained as backup documentation.
When the employer uses a C/TPA to act as the agent of the employer,
then that C/TPA could have access to the Breath Alcohol Testing Form or
the authority to obtain a copy of the form. Likewise, the employer's
copy of the form may be submitted to the C/TPA by the employer or by
the BAT when the employer has directed the BAT in writing to do so. In
all cases of positive results at or above the .02 BAC level, the
employer must be notified immediately, and prior to notification of the
C/TPA. Positive results may not be sent from the BAT to the C/TPA and
then submitted to the employer.

Section 40.93 The Screening Test Technician

Question 1: May an STT become trained to proficiency on an
evidential breath tester (EBT) for the purposes of conducting screening
tests on that device?
Guidance: No. Section 40.93 only authorizes the STT to operate an
alcohol screening device (ASD); it does not authorize the STT to
operate an EBT. This was by design. Likewise, the STT training manual
does not address the use of an EBT by the STT. This is in contrast with
the training manual for the BAT which concentrates solely on the EBT;
in fact, an entire unit in the BAT training manual is devoted to ``EBT
Methodology.'' Additionally, the proficiency requirements for the ASD,
as contained in the STT manual, are different from the proficiency
requirements for the EBT, as contained in the BAT manual.
When an EBT is used to conduct a DOT alcohol test, the operator
must be a BAT. An STT is limited to conducting only the alcohol
screening test, and the only instrument the STT may use is an ASD.
Special Topics--Requirements for Random Testing
Question 1: Please explain the random testing rates for alcohol and
drugs.
Guidance: The DOT drug testing rules require employers initially to
conduct

[[Page 16382]]

random drug testing at a rate equal to 50 percent of their covered
employees. Thus, if an employer has 100 covered employees, the employer
must administer 50 random drug tests. The number of random tests is
determined by the covered employee population, while the number of
employees randomly tested varies depending on the random selection
process. It is possible that 50 random tests may be conducted on less
than 50 employees, some employees being tested two or more times due to
the random selection of donors. The highway industry may be allowed to
reduce the annual rate to 25 percent in calendar year 1998 based on the
highway industry's performance in calendar years 1995 and 1996. The
rate may be lowered to 25 percent based on two years of data reported
to FHWA indicating a positive rate of less than 1.0 percent use of
drugs by CMV drivers. The rate may increase again, however, to 50
percent based on one year of data reported to FHWA indicating a
positive rate equal to or greater than 1.0 percent use of drugs by CMV
drivers.
The alcohol testing rules require employers initially conduct
random testing at a rate equal to 25 percent of their covered
employees. Thus, if an employer has 100 covered employees, the employer
must administer 25 random drug tests. The number of random tests is
determined by the covered employee population, while the number of
employees randomly tested varies depending on the random selection
process. It is possible that 25 random tests may be conducted on less
than 25 employees, some employees being tested two or more times due to
the random selection of donors. The highway industry may be allowed to
reduce the annual rate to 10 percent in calendar year 1999 based on the
highway industry's performance in calendar years 1996 and 1997. The
rate may be lowered to 10 percent based on two years of data reported
to FHWA indicating a violation rate of less than 0.5 percent use of
alcohol by CMV drivers. The highway industry would be required to raise
the annual rate to 50 percent in calendar year 1998 or later years
based on the highway industry's performance in calendar year 1996 or
later years. The rate may increase to 50 percent based on one year of
data reported to FHWA indicating a violation rate of is equal to or
greater than 1.0 percent use of alcohol by CMV drivers.
Question 2: Is use of a consortium to conduct random testing
allowed?
Guidance: The FHWA requires individual owner-operators to be in a
random testing pool of two or more persons. This, in effect, requires
an individual owner-operator to be in a consortium for random testing
purposes. The DOT allows and even advocates the use of a consortium to
assist smaller companies in complying with the alcohol and drug testing
regulations. While it is true that in a combined employer pool, some
employers will have a higher percentage of their employees selected for
testing than others in a given 12-month period, over time this will
even out. Additionally, the DOT believes that the deterrent effect of
random drug testing remains as powerful in a combined employers pool as
it would be in a stand-alone single company pool. With this in mind,
the DOT has determined that combining employer pools within a
consortium meets the spirit and intent of the alcohol and drug testing
regulations and is, therefore, permissible.
Question 3: May an employer combine DOT and non-DOT random pools?
Guidance: No. While it would seem to be advantageous for an
employer to combine all employees into one random testing pool, this
move could dilute the number of DOT-covered employees who would
actually be tested. For example, in a pool that is comprised of 50 DOT-
covered employees and 50 non-DOT-covered employees, and assuming a
testing rate of 50 percent, it is possible that no DOT-covered
employees would be tested (100 employees, 50 tests, all 50 tests
conducted on non-DOT employees). The likelihood of this happening,
albeit remote, is possible under a truly random scheme. On the other
hand, keeping the above two classes of employees in separate pools
assures that at least 25 of the tests conducted by the company will be
conducted on DOT-covered employees. It is this assurance that
ultimately mandates that DOT-covered employees remain in separate
random pools.
Question 4: May an employer combine employees covered by different
operating administration rules into a single pool for random testing?
Guidance: The DOT has determined that it is, indeed, permissible
for an employer to combine covered employees from different operating
administrations (e.g. Research and Special Programs Administration,
Coast Guard, and FHWA), into a single selection pool for the purpose of
conducting random drug testing under DOT authority. When exercising
this option, however, the employer must ensure that the random testing
rate is at least equal to the highest rate required by each of the
operating administrations.
Question 5: Is it permissible to separate union and non-union
employees, both covered by DOT, into stand-alone pools?
Guidance: The DOT has determined that it is permissible for an
employer to separate union and non-union employees into separate pools
for the purpose of random drug testing. If using this approach, the
employer must ensure that employees from each pool are tested at equal
rates. For example, if pool ``A'' consists of 50 non-union employees
and pool ``B'' consists of 300 union employees, the employer must
ensure, if testing is done at a 50 percent rate, that 25 tests are
conducted annually on employees from pool ``A'' and that 150 tests are
conducted annually on employees from pool ``B.''
Special Topics--Procedures for Handling and Processing a Split Specimen
Question: Describe the proper handling and processing of a split
specimen.
Guidance: ``Where the employer has used the split sample method,
and the laboratory observes that the split sample is untestable,
inadequate, or unavailable for testing, the laboratory shall
nevertheless test the primary specimen. The laboratory does not inform
the MRO or the employer of the untestability, inadequacy, or
unavailability of the split specimen until and unless the primary
specimen is a verified positive test and the MRO has informed the
laboratory that the employee has requested a test of the split
specimen.'' (Sec. 40.29(b)(1)(ii))
``In situations where the employer uses the split sample collection
method, the laboratory shall log in the split specimen, with the split
specimen bottle seal remaining intact.'' (Sec. 40.29(b)(2))
``When directed in writing by the MRO to forward the split specimen
to another DHHS-certified laboratory for analysis, the second
laboratory shall analyze the split specimen by GC/MS to reconfirm the
presence of the drug(s) or drug metabolite(s) found in the primary
specimen.'' (Sec. 40.29(b)(3))
``If the employee requests an analysis of the split specimen within
72 hours of having been informed of a verified positive test, the MRO
shall direct, in writing, the laboratory to provide the split specimen
to another DHHS-certified laboratory for analysis. If the analysis of
the split specimen fails to reconfirm the presence of the drug(s) or
drug metabolite(s) found in the specimen, or if the split specimen is
unavailable, inadequate for testing or untestable, the MRO shall cancel
the test and report cancellation and the

[[Page 16383]]

reasons for it to the DOT, the employer, and the employee.''
(Sec. 40.33(f))
If the primary laboratory does not receive a split specimen with
the primary, or the split specimen is leaking, or the split specimen's
seal is broken, or has any other problem that would make it unavailable
for testing, the primary laboratory must still process the primary
specimen as if there were no problems with the split specimen. The
laboratory should not bring any split specimen deficiency to the
attention of the MRO at this time. (Sec. 40.29(b)(1)(ii))
The seal on the split specimen must remain intact--just as the
split specimen was sealed at the collection site. (Sec. 40.29(b)(2))
The MRO will direct the primary laboratory to forward the split
specimen to a second DHHS-certified laboratory. At the second DHHS-
certified laboratory, the split specimen shall only be used to
reconfirm the presence of the drug(s) or drug metabolite(s) found in
the primary specimen. (Sec. 40.29(b)(3))
Only a request from the employee can authorize the MRO to initiate
the forwarding of the split specimen to the second DHHS-certified
laboratory for analysis. (Sec. 40.33(f))

PART 325--COMPLIANCE WITH INTERSTATE MOTOR CARRIER NOISE EMISSION
STANDARDS

Sections Interpreted

325.1

Section 325.1 Scope Of The Rules In This Part

Question 1: What noise emission requirements are applicable to
auxiliary generators?
Guidance: Auxiliary generators which normally operate only when a
CMV is stopped or moving at 5 mph or less are ``auxiliary equipment''
of the kind contemplated by EPA and are, therefore, exempt from the
noise limits in Part 325. However, noise from generators that run while
the CMV is moving at higher speeds would be measured as part of total
vehicle noise.
Question 2: Do refrigeration units on tractor-trailer combinations
fall within the exemption listed in part 325, subpart A of the FMCSRs?
Guidance: No.

PART 382--CONTROLLED SUBSTANCES AND ALCOHOL USE AND TESTING

Sections Interpreted

382.103 Applicability
382.105 Testing Procedures
382.107 Definitions
382.109 Preemption of State and Local Laws
382.113 Requirement for Notice
382.115 Starting Date for Testing Programs
382.205 On-Duty Use
382.213 Controlled Substances Use
382.301 Pre-employment Testing
382.303 Post-accident Testing
382.305 Random Testing
382.307 Reasonable Suspicion Testing
382.401 Retention of Records
382.403 Reporting of Results in a Management Information System
382.405 Access to Facilities and Records
382.413 Release of Alcohol and Controlled Substances Test
Information by Previous Employers
382.501 Removal From Safety-Sensitive Functions
382.507 Penalties
382.601 Motor Carrier Obligation to Promulgate a Policy on the
Misuse of Alcohol and Use of Controlled Substances
382.603 Training for Supervisors
382.605 Referral, Evaluation, and Treatment

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

Section 382.103 Applicability

Question 1: Are intrastate drivers of CMVs, who are required to
obtain CDLs, required to be alcohol and drug tested by their employer?
Guidance: Yes. The definition of commerce in 382.107 is taken from
49 U.S.C. Sec. 31301 which encompasses interstate, intrastate and
foreign commerce.
Question 2: Are students who will be trained to be motor vehicle
operators subject to alcohol and drug testing? Are they required to
obtain a CDL in order to operate training vehicles provided by the
school?
Guidance: Yes. Section 382.107 includes the following definitions:
Employer means any person (including the United States, a State,
District of Columbia or a political subdivision of a State) who owns or
leases a CMV or assigns persons to operate such a vehicle. The term
employer includes an employer's agents, officers and representatives.
Driver means any person who operates a CMV.
Truck and bus driver training schools meet the definition of an
employer because they own or lease CMVs and assign students to operate
them at appropriate points in their training. Similarly, students who
actually operate CMVs to complete their course work qualify as drivers.
The CDL regulations provide that ``no person shall operate'' a CMV
before passing the written and driving tests required for that vehicle
(49 CFR 383.23(a)(1)). Virtually all of the vehicles used for training
purposes meet the definition of a CMV, and student drivers must
therefore obtain a CDL.
Question 3: Are part 382 alcohol and drug testing requirements
applicable to firefighters in a State which gives them the option of
obtaining a CDL or a non-commercial class A or B license restricted to
operating fire equipment only?
Guidance: No. The applicability of part 382 is coextensive with
part 383--the general CDL requirements. Only those persons required to
obtain a CDL under Federal law and who actually perform safety-
sensitive duties, are required to be tested for drugs and alcohol.
The FHWA, exercising its waiver authority, granted the States the
option of waiving firefighters from CDL requirements. A State which
gives firefighters the choice of obtaining either a CDL or a non-
commercial license has exercised the option not to require CDLs.
Therefore, because a CDL is not required, by extension part 382 is not
applicable.
A firefighter in the State would not be required under Federal law
to be tested for drugs and alcohol regardless of the type of license
which the employer required as a condition of employment or the driver
actually obtained. It is the Federal requirement to obtain a CDL,
nonexistent in the State, that entails drug and alcohol testing, not
the fact of actually holding a CDL.
Question 4: An employer or State government agency requires CDLs
for drivers of motor vehicles: (1) with a GVWR of 26,000 pounds or
less; (2) with a GCWR of 26,000 pounds or less inclusive of a towed
unit with a GVWR of 10,000 pounds or less; (3) designed to transport 15
or less passengers, including the driver; or (4) which transport HM,
but are not required to be placarded under 49 CFR part 172, subpart F.
Are such drivers required by part 382 to be tested for the use of
alcohol or controlled substances?
Guidance: No. Part 382 requires or authorizes drug and alcohol
testing only of those drivers required by part 383 to obtain a CDL.
Since the vehicles described above do not meet the definition of a CMV
in part 383, their drivers are not required by Federal regulations to
have a CDL.
Question 5: Are Alaskan drivers with a CDL who operate CMVs and
have been waived from certain CDL requirements subject to controlled
substances and alcohol testing?
Guidance: Yes. Alaskan drivers with a CDL who operate CMVs are
subject to controlled substances and alcohol

[[Page 16384]]

testing because they have licenses marked either ``commercial driver's
license'' or ``CDL''. The waived drivers are only exempted from the
knowledge and skills tests, and the photograph on license requirements.
Question 6: Do the FHWA's alcohol and controlled substances testing
regulations apply to employers and drivers in U.S. territories or
possessions such as Puerto Rico and Guam?
Guidance: No. The rule by definition applies only to employers and
drivers domiciled in the 50 states and the District of Columbia.
Question 7: Which drivers are to be included in a alcohol and
controlled substances testing program under the FHWA's rule?
Guidance: Any person who operates a CMV, as defined in
Sec. 382.107, in intrastate or interstate commerce and is subject to
the CDL requirement of 49 CFR part 383.
Question 8: Is a foreign resident driver operating between the U.S.
and a foreign country from a U.S. terminal for a U.S.-based employer
subject to the FHWA alcohol and controlled substances testing
regulations?
Guidance: Yes. A driver operating for a U.S.-based employer is
subject to part 382.
Question 9: What alcohol and drug testing provisions apply to
foreign drivers employed by foreign motor carriers?
Guidance: Foreign employers are subject to the alcohol and drug
testing requirements in part 382 (see Sec. 382.103). All provisions of
the rules will be applicable while drivers are operating in the U.S.
Foreign drivers may also be subject to State laws, such as probable
cause testing by law enforcement officers.

Section 382.105 Testing Procedures

Question 1: What does a BAT do when a test involves an independent,
self-employed owner-operator with a confirmed alcohol concentration of
0.02 or greater, to notify a company representative as required by
Sec. 40.65(i)?
Guidance: The independent, self-employed owner-operator will be
notified by the BAT immediately and the owner-operator's certification
in Step 4 notes that the self-employed owner-operator has been
notified. No further notification is necessary. The BAT will provide
copies 1 and 2 to the self-employed owner-operator directly.
Question 2: A driver does not have a photo identification card.
Must an employer representative identify the driver in the presence of
the BAT/urine specimen collector or may the employer representative
identify the driver via a telephone conversation?
Guidance: Those subject to part 382 are subject first, generally,
to part 383. Part 383 requires all States, with an exception in Alaska
for a very small group of individuals, to provide a CDL document to the
individual that includes, among other things: the full name, signature,
and mailing address of the person to whom such license is issued;
physical and other information to identify and describe the person
including date of birth (month, day, and year), sex, and height; and, a
color photograph of the person. Except in these rare Alaskan instances,
the FHWA fully expects most employer's to require the driver to present
the CDL document to the BAT or urine collector.
A driver subject to alcohol and drug testing should be able to
provide the CDL document. In those rare instances that the CDL or other
form of photo identification is not produced for verification, an
employer representative must be contacted and must provide
identification. The FHWA will allow employer representatives to
identify drivers in any way that the employer believes will positively
identify the driver.
Question 3: Will foreign drug testing laboratories need to be
certified by the National Institute on Drug Abuse (NIDA)? Will they
need to be certified by the Department of Health and Human Services
(DHHS)?
Guidance: The NIDA, an agency of the DHHS, no longer administers
the workplace drug testing laboratory certification program. This
program is now administered by the DHHS' Substance Abuse and Mental
Health Services Administration. All motor carriers are required to use
DHHS-certified laboratories for analysis of alcohol and controlled
substances tests as neither Mexico nor Canada has an equivalent
laboratory certification program.
Question 4: Particularly in light of the coverage of Canadian and
Mexican employees, how should MROs deal, in the verification process,
with claims of the use of foreign prescriptions or over-the-counter
medication?
Guidance: Possession or use of controlled substances are prohibited
when operating a CMV under the FHWA regulations regardless of the
source of the substance. A limited exception exists for a substance's
use in accordance with instructions provided by a licensed medical
practitioner who knows that the individual is a CMV driver who operates
CMVs in a safety-sensitive job and has provided instructions to the CMV
driver that the use of the substance will not affect the CMV driver's
ability to safely operate a CMV (see Secs. 382.213, 391.41(b)(12), and
392.4(c)). Individuals entering the United States must properly declare
controlled substances with the U.S. Customs Service. 21 CFR 1311.27.
The FHWA expects MROs to properly investigate the facts concerning
a CMV driver's claim that a positive controlled substance test result
was caused by a prescription written by a knowledgeable, licensed
medical practitioner or the use of an over-the-counter substance that
was obtained in a foreign country without a prescription. This
investigation should be documented in the MRO's files.
If the CMV driver lawfully obtained a substance in a foreign
country without a prescription which is a controlled substance in the
United States, the MRO must also investigate whether a knowledgeable,
licensed medical practitioner provided instructions to the CMV driver
that the use of the ``over-the-counter'' substance would not affect the
driver's ability to safely operate a CMV.
Potential violations of Sec. 392.4 must be investigated by the law
enforcement officer at the time possession or use is discovered to
determine whether the exception applies.

Sections 382.107 Definitions

Question 1: What is an owner-operator?
Guidance: The FHWA neither defines the term ``owner-operator'' nor
uses it in regulation. The FHWA regulates ``employers'' and
``drivers.'' An owner-operator may act as both an employer and a driver
at certain times, or as a driver for another employer at other times
depending on contractual arrangements and operational structure.

Section 382.109 Preemption Of State And Local Laws

Question 1: An employer is required by State or local law,
regulation, or order to bargain with unionized employees over
discretionary elements of the DOT alcohol and drug testing regulations
(e.g., selection of DHHS-approved laboratories or MROs). May the
employer defer the 1995 or 1996 implementation dates for testing
employees until the collective bargaining process has produced
agreement on these discretionary elements, or must the employer
implement testing as required by part 382?
Guidance: The FHWA provided large employers 45 weeks and small
employers 97 weeks collectively to bargain the discretionary elements
of

[[Page 16385]]

the part 382 testing program. An employer must implement alcohol and
controlled substances testing in accordance with the schedule in
Sec. 382.115. If observance of the collective bargaining process would
make it impossible for the employer to comply with these deadlines,
Sec. 382.109(a)(1) preempts the State or local bargaining requirement
to the extent needed to meet the implementation date.

Section 382.113 Requirement For Notice

Question 1: Must a notice be given before each test or will a
general notice given to drivers suffice?
Guidance: A driver must be notified before submitting to each test
that it is required by part 382. This notification can be provided to
the driver either verbally or in writing. In addition, the FHWA
believes that the use of the DOT Breath Alcohol Testing Form, OMB No.
2105-0529, and the Drug Testing Custody and Control Form, 49 CFR part
40, appendix A, will support the verbal or written notice that the test
is being conducted in accordance with Part 382.

Section 382.115 Starting Date For Testing Programs

Question 1: In a governmental entity structured into various
subunits such as departments, divisions, and offices, how is the number
of an employer's drivers determined for purposes of the implementation
date of controlled substances and alcohol testing?
Guidance: Part 382 testing applies to governmental entities,
including those of the Federal government, the States, and political
subdivisions of the States. An employer is defined as any person that
owns or leases CMVs, or assigns drivers to operate them. Therefore, any
governmental entity, or a subunit of it that controls CMVs and the day-
to-day operations of its drivers, may be considered the employer for
purposes of part 382. For example, a city government divided into
various departments, such as parks and public works, could consider the
departments as separate employers if the CMV operations are separately
controlled. The city also has the option of deeming the city as the
employer of all of the drivers of the various departments.

Section 382.205 On-duty Use

Question 1: What is meant by the terms ``use alcohol'' or ``alcohol
use?'' Is observation of use sufficient or is an alcohol test result
required?
Guidance: The term ``alcohol use'' is defined in Sec. 382.107. The
employer is prohibited in Sec. 382.205 from permitting a driver to
drive when the employer has actual knowledge of the driver's use of
alcohol, regardless of the level of alcohol in the driver's body. The
form of knowledge is not specified. It may be obtained through
observation or other method.

Section 382.213 Controlled Substances Use

Question 1: Must a physician specifically advise that substances in
a prescription will not adversely affect the driver's ability to safely
operate a CMV or may a pharmacist's advice or precautions printed on a
container suffice for the advice?
Guidance: A physician must specifically advise the driver that the
substances in a prescription will not adversely affect the driver's
ability to safely operate a CMV.

Section 382.301 Pre-Employment Testing

Question 1: What is meant by the phrase, ``an employer who uses,
but does not employ, a driver * * * ?'' Describe a situation to which
the phrase would apply.
Guidance: This exception was contained in the original drug testing
rules and was generally applied to ``trip-lease'' drivers involved in
interstate commerce. A trip-lease driver is generally a driver employed
by one motor carrier, but who is temporarily leased to another motor
carrier for one or more trips generally for a time period less than 30
days. The phrase would also apply to volunteer organizations that use
loaned drivers.
Question 2: Must school bus drivers be pre-employment tested after
they return to work after summer vacation in each year in which they do
not drive for 30 consecutive days?
Guidance: A school bus driver whom the employer expects to return
to duty the next school year does not have to be pre-employment tested
so long as the driver has remained in the random selection pool over
the summer. There is deemed to be no break in employment if the driver
is expected to return in the fall.
On the other hand, if the driver is taken out of all DOT random
pools for more than 30 days, the exception to pre-employment drug
testing in Sec. 382.301 would be unavailable and a drug test would have
to be administered after the summer vacation.
Question 3: Is a pre-employment controlled substances test required
if a driver returns to a previous employer after his/her employment had
been terminated?
Guidance: Yes. A controlled substances test must be administered
any time employment has been terminated for more than 30 days and the
exceptions under Sec. 382.301(c) were not met.
Question 4: Must all drivers who do not work for an extended period
of time (such as layoffs over the winter or summer months) be pre-
employment drug tested each season when they return to work?
Guidance: If the driver is considered to be an employee of the
company during the extended (layoff) period, a pre-employment test
would not be required so long as the driver has been included in the
company's random testing program during the layoff period. However, if
the driver was not considered to be an employee of the company at any
point during the layoff period, or was not covered by a program, or was
not covered for more than 30 days, then a pre-employment test would be
required.
Question 5: What must an employer do to avail itself of the
exceptions to pre-employment testing listed under Sec. 382.301(c)?
Guidance: An employer must meet all requirements in Sec. 382.301(c)
and (d), including maintaining all required documents. An employer must
produce the required documents at the time of the Compliance Review for
the exception to apply.
Question 6: May a CDL driving skills test examiner conduct a
driving skills test administered in accordance with 49 CFR part 383
before a person subject to part 382 is tested for alcohol and
controlled substances?
Guidance: Yes. A CDL driving skills test examiner, including a
third party CDL driving skills test examiner, may administer a driving
skills test to a person subject to part 382 without first testing him/
her for alcohol and controlled substances. The intent of the CDL
driving skills test is to assess a person's ability to operate a
commercial motor vehicle during an official government test of their
driving skills. However, this guidance does not allow an employer
(including a truck or bus driver training school) to use a person as a
current company, lease, or student driver prior to obtaining a verified
negative test result. An employer must obtain a verified negative
controlled substance test result prior to dispatching a driver on his/
her first trip.

Section382.303 Post-Accident Testing

Question 1: Why does the FHWA allow post-accident tests done by
Federal, State or local law enforcement agencies to substitute for a
Sec. 382.303 test even though the FHWA does not allow a Federal, State
or local law

[[Page 16386]]

enforcement agency test to substitute for a pre-employment, random,
reasonable suspicion, return-to-duty, or follow-up test? Will such
substitutions be allowed in the future?
Guidance: A highway accident is generally investigated by a
Federal, State, or local law enforcement agency that may determine that
probable cause exists to conduct alcohol or controlled substances
testing of a surviving driver. The FHWA believes that testing done by
such agencies will be done to document an investigation for a charge of
driving under the influence of a substance and should be allowed to
substitute for a FHWA-required test. The FHWA expects this provision to
be used rarely.
The FHWA is required by statute to provide certain protection for
drivers who are tested for alcohol and controlled substances. The FHWA
believes that law enforcement agencies investigating accidents will
provide similar protection based on the local court's prior action in
such types of testing.
The FHWA will not allow a similar approach for law enforcement
agencies to conduct testing for the other types of testing. A law
enforcement agency, however, may act as a consortium to provide any
testing in accordance with parts 40 and 382.
Question 2: May an employer allow a driver, subject to post-
accident controlled substances testing, to continue to drive pending
receipt of the results of the controlled substances test?
Guidance: Yes. A driver may continue to drive, so long as no other
restrictions are imposed by Sec. 382.307 or by law enforcement
officials.
Question 3: A commercial motor vehicle operator is involved in an
accident in which an individual is injured but does not die from the
injuries until a later date. The commercial motor vehicle driver does
not receive a citation under State or local law for a moving traffic
violation arising from the accident. How long after the accident is the
employer required to attempt to have the driver subjected to post-
accident testing?
Guidance: Each employer is required to test each surviving driver
for alcohol and controlled substances as soon as practicable following
an accident as required by Sec. 382.303. However, if an alcohol test is
not administered within 8 hours following the accident, or if a
controlled substance test is not administered within 32 hours following
the accident, the employer must cease attempts to administer that test.
In both cases the employer must prepare and maintain a record stating
the reason(s) the test(s) were not promptly administered.
If the fatality occurs following the accident and within the time
limits for the required tests, the employer shall attempt to conduct
the tests until the respective time limits are reached. The employer is
not required to conduct any tests for cases in which the fatality
occurs outside of the 8 and 32 hour time limits.
Question 4: What post-accident alcohol and drug testing
requirements are there for U.S. employer's drivers involved in an
accident occurring outside the U.S.?
Guidance: U.S. employers are responsible for ensuring that drivers
who have an accident (as defined in Sec. 390.5) in a foreign country
are post-accident alcohol and drug tested in conformance with the
requirements of 49 CFR parts 40 and 382. If the test(s) cannot be
administered within the required 8 or 32 hours, the employer shall
prepare and maintain a record stating the reasons the test(s) was not
administered (see Secs. 382.303 (b)(1) and (b)(4)).
Question 5: What post-accident alcohol and drug testing
requirements are there for foreign drivers involved in accidents
occurring outside the United States?
Guidance: Post-accident alcohol and drug testing is required for
CMV accidents occurring within the U.S. and on segments of interstate
movements into Canada between the U.S.-Canadian border and the first
physica

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A97-8406. Public record. Not legal advice.