[Federal Register Volume 64, Number 236 (Thursday, December 9, 1999)]
[Proposed Rules]
[Pages 69076-69136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-31510]
[[Page 69075]]
_______________________________________________________________________
Part II
Department of Transportation
_______________________________________________________________________
Office of the Secretary
_______________________________________________________________________
49 CFR Part 40
Procedures for Transportation Workplace Drug and Alcohol Testing
Programs; Proposed Rules
Federal Register / Vol. 64, No. 236 / Thursday, December 9, 1999 /
Proposed Rules
[[Page 69076]]
DEPARTMENT OF TRANSPORTATION
Office of the Secretary
49 CFR Part 40
[Docket OST-99-6578]
RIN 2105-AC49
Procedures for Transportation Workplace Drug and Alcohol Testing
Programs
AGENCY: Office of the Secretary, DOT.
ACTION: Notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: The Department of Transportation proposes to revise its drug
and alcohol testing procedures regulation. The purposes of the revision
are to make the organization and language of the regulation clearer, to
incorporate guidance and interpretations of the rule into its text, and
to update the rule to include new provisions responding to changes in
technology, the testing industry, and the Department's program.
DATES: Comments should be received by April 7, 2000. Late-filed
comments will be considered to the extent practicable.
ADDRESSES: Comments should be sent to Docket Clerk, Attn: Docket No.
OST-99-6578, Department of Transportation, 400 7th Street, SW., Room
PL401, Washington DC, 20590. For the convenience of persons wishing to
review the docket, it is requested that comments be sent in triplicate.
Persons wishing their comments to be acknowledged should enclose a
stamped, self-addressed postcard with their comments. The docket clerk
will date stamp the postcard and return it to the sender. Comments may
be reviewed at the above address from 9:00 a.m. through 5:30 p.m.
Monday through Friday. Commenters may also submit their comments
electronically. Instructions for electronic submission may be found at
the following web address: http://dms.dot.gov/submit/.. The public may
also review docketed comments electronically. The following web address
provides instructions and access to the DOT electronic docket: http://
dms.dot.gov/search/.
FOR FURTHER INFORMATION CONTACT: Mary Bernstein, Director, Office of
Drug and Alcohol Policy and Compliance (ODAPC), 400 7th Street, SW.,
Room 10403, Washington DC, 20590, 202-366-3784 (voice), 202-366-3897
(fax), or mary.bernstein@ost.dot.gov (e-mail); Robert C. Ashby, Deputy
Assistant General Counsel for Regulation and Enforcement, 400 7th
Street, SW., Room 10424, Washington DC, 20590, 202-366-9306 (voice),
202-366-9313 (fax), or bob.ashby@ost.dot.gov (e-mail); or Jim L. Swart,
Drug and Alcohol Policy Advisor, Office of Drug and Alcohol Policy and
Compliance (ODAPC), 400 7th Street, SW., Room 10403, Washington DC,
20590, 202-366-3784 (voice), 202-366-3897 (fax), or
jim.swart@ost.dot.gov (e-mail).
SUPPLEMENTARY INFORMATION:
Background
The Department of Transportation first published its drug testing
procedures regulation (49 CFR Part 40) on November 21, 1988 (53 FR
47002), as an interim final rule. The rule was based on the Department
of Health and Human Services (HHS) guidelines for Federal agency
employee drug testing, with some adaptations for the transportation
workplace drug testing program. The Department published a final rule
responding to comments on the interim rule a year later (54 FR 49854;
December 1, 1989).
The Department added alcohol testing procedures to Part 40 in a
February 15, 1994, final rule (59 FR 7340). This rule also modified
drug testing procedures pertaining to split samples. Since that time,
the Department has amended specific provisions of Part 40 on various
occasions (e.g., with respect to non-evidential alcohol screening
devices, ``shy bladder'' procedures).
In the 10 years since Part 40 was first published, the Department
has issued a large volume of guidance and over 100 written
interpretations, as well as a significant amount of informal advice.
Most of this material has not been incorporated into the regulatory
text. There have been changes in testing technology, the structure of
the drug and alcohol testing business, and the functioning of the
Department's drug and alcohol testing programs, making it desirable to
update some regulatory provisions. Because the rule was originally
based on that of another agency, there are some provisions that never
were a close fit for the Department's programs. Moreover, the rule's
organization and language do not meet the objectives of the Clinton
Administration's current ``Plain Language'' policies. Under section 610
of the Regulatory Flexibility Act, agencies are directed to review
existing rules from time to time with an eye to their effects on small
businesses and other small entities.
For all these reasons, the Department decided to review Part 40. As
a first step, we issued an advance notice of proposed rulemaking
(ANPRM) on April 29, 1996 (61 FR 18713), asking for suggestions for
change in the rule. We received 30 comments in response to this ANPRM.
Organization of Draft
Perhaps the first thing readers will notice about this proposal is
that Part 40 has been thoroughly restructured, with subparts organized
by subject matter area. Compared to the present rule, the text is
divided into many more sections, with fewer paragraphs each on average,
to make it easier to find regulatory provisions. The proposal uses a
question-answer format, with language specifically directing particular
parties to take particular actions (e.g., ``As an MRO, you must . .
.''). We have also tried to express the (admittedly sometimes
technical) requirements of the rule in plain language. The Department
seeks comment on the clarity, format, and style of the NPRM and
solicits suggestions for improving it.
Noteworthy Substantive Changes Proposed
The following section of the preamble lists the NPRM's most
noteworthy proposed substantive changes from the existing rule and
briefly states the reasons for them.
Interpretations/Exemptions
To avoid confusion and the possibility of overlapping or
contradictory guidance, Sec. 40.5 spells out specifically the sources
and dates of authoritative guidance of the proposed rule. Guidance
would come from the Office of the Secretary (OST), either ODAPC or
General Counsel's office. It could later be incorporated in written
guidance issued by the DOT agencies, though it would be identified as
ODAPC/General Counsel's office guidance. Since this proposal is
intended to lead to a revised regulation, the language states that only
post-issuance guidance or interpretations are valid, since earlier
material pertains to the old version of the rule. ODAPC intends to
follow a practice of putting new Part 40 interpretations and guidance
on the DOT Web site for users' convenience.
This is an OST rule. Therefore, anyone wanting an exemption from it
would use the procedures and standards of 49 CFR Part 5, OST's
rulemaking procedures. These procedures, rather than those of any of
the DOT agencies, would apply to such a request. The proposed section
spells out the long-standing procedures of Part 5 for granting an
exemption. These standards are intended to preclude ``rulemaking by
exemption,'' which is contrary to good rulemaking practice and the
Administrative Procedure Act.
[[Page 69077]]
Service Agent Assurance
Proposed Sec. 40.11 includes new provisions that call for both
regulated employers and their service agents to sign a contract
provision committing them to compliance with Part 40 provisions.
``Service agent'' is a new term, intended to encompass participants in
the testing process other than employers themselves (e.g., medical
review officers (MROs), substance abuse professionals (SAPs),
collectors, laboratories, third-party administrators). The Department
is using ``service agent'' as a working term for this collection of
participants who provide testing-regulated services to employers. The
Department invites suggestions for other terms for this group of
service providers.
NRC Procedures
In response to a comment from the Nuclear Regulatory Commission
(NRC), the proposed rule would permit an entity which has employees
covered by both DOT and NRC testing requirements to use either agency's
procedural requirements.
Prohibition of Additional Testing
This section places a number of long-standing DOT interpretations
into the regulatory text. It proposes to say that there must be a
firewall between DOT and non-DOT tests, which extends to the use of
Federal forms for non-DOT tests. Tests not expressly authorized by DOT
rules on ``DOT specimens'' are forbidden (e.g., tests for additional
drugs, DNA tests). Nor can anyone take into account an unauthorized
test (e.g., in a situation in which an employee with a positive test
obtains a test result from his own doctor that he attempts to use in a
grievance proceeding).
The rule text omits current language permitting testing of
additional drugs with DOT and HHS regulatory consent. HHS has never
authorized any additional drugs. If additional drugs are authorized,
the Department can amend the rule at that time.
Collector Training
While current Part 40 has specific training requirements for
screening test technicians (STTs) and breath alcohol technicians (BATs)
in the alcohol testing program, it does not have analogous requirements
for drug testing collectors. The Department is also aware that mistakes
in the collection process are generally regarded as being a common
cause of problems in the drug testing process. Consequently, the
Department proposes in Sec. 40.33 that collectors read and understand
DOT rules and guidance concerning collections, demonstrate proficiency
by completing three consecutive error-free trial collections, and
receive retraining as needed. The Department seeks comment on whether
self-instruction is adequate for this purpose or whether more formal
training should be required (e.g., a specified course with a
certification requirement, as is the case for STTs and BATs).
In this and several other contexts, we propose to require
individuals who are training or evaluating participants in the testing
process to be ``sufficiently knowledgeable'' about testing requirements
and procedures. We recognize that this term does not precisely define
the experience and information the individual must possess. Our aim in
using this language is to ensure that people involved in the training
process know what they need to know to judge fairly whether a
collector, BAT, etc. has grasped the essentials of the function. It is
not our intent, however, to require formal instruction or a standard
curriculum for trainers. Doing so could increase costs and make the
program unnecessarily rigid. We seek comment on whether a different
term or other requirements would be appropriate in this area.
Drug Testing Forms and Materials
The NPRM proposes (Secs. 40.47 and 40.49) that no one can use a DOT
drug testing form for a non-DOT test or vice-versa. However, because
obtaining a test result is the more important factor, use of a non-DOT
form for a DOT test is, in cases where a look-alike form is used, a
correctable error in the testing process. Collectors also must use a
testing kit conforming to DOT requirements (see Appendix A for
additional information on the kit). This proposal is based on our
experience and a thorough review of testing kits by DOT staff. The
Department also seeks comment on what, if any, additional security
measures would be appropriate for testing materials and supplies. The
proposal (Sec. 40.45(e)) also would continue existing policy that
foreign employers can use foreign-language versions of the forms (e.g.,
Spanish in Mexico, French in Canada). Should U.S. employers also be
permitted to use these or other foreign-language versions of the forms?
If this is allowed, additional questions may arise (e.g., should a
foreign-language form be used only when both collector and employee
understand the language?).
HHS is presently revising that form and has published it for public
comment in a Notice of Proposed Revision in the Federal Register
[November 15, 1999 (Volume 64, Number 219)]. We will not publish, in
this NPRM, copies of the HHS-proposed Federal Drug Testing Custody and
Control Form (CCF) or the CCF currently in use. (Nor will we publish
the Breath Alcohol Testing Form (BATF) currently in use.)
Electronic Records and Signatures
From time to time, interested parties have raised, and the
Department has sought comment about, the potential use of electronic
records and signatures in the DOT drug and alcohol testing program. The
regulatory text of this NPRM does not make any new proposals in this
area. However, the Department is willing to consider ideas that would,
to a greater degree than is currently the case, permit the use of
electronic records and signatures in the program.
We are also aware that other Federal agencies have taken steps to
encourage greater use of electronic records and signatures. For
example, the Food and Drug Administration (FDA) issued rules to this
effect (62 FR 13430; March 20, 1997). The FDA rules authorize
electronic signatures in many documents submitted to the agency, with a
number of safeguards designed to ensure the reliability and
trustworthiness of the signatures.
The Department again seeks comment on the potential applications,
advantages, risks, and safeguards for the use of electronic signatures
and the greater use of electronic records in the DOT drug and alcohol
testing program. For example, are there electronic ``stamping''
mechanisms we should permit for use with the CCF?
Collection Process
Section 40.61 incorporates a number of provisions that are new or
based on existing interpretations (e.g., collections are to begin
without delay, it is improper to attempt to collect urine from
unconscious employees, collectors can inspect boots for adulterants).
Sections 40.63-65 provide a step-by-step process for collectors for the
initial stages of the collection process. Collection steps concerning
completion of the CCF are written in this NPRM based upon the
collector's use of the current Federal form. When HHS approves use of a
new form, the Department will modify Part 40 collection steps (as well
as laboratory and MRO responsibilities for completion of the CCF)
accordingly.
The proposed rule would stipulate that in the event an employee,
after presenting an insufficient amount of urine, refuses to drink
fluids as directed by the collector, the collector is to stop
[[Page 69078]]
the collection proceedings. A failure to drink as directed would
constitute a refusal to test (Secs. 40.191(a)(5) and 40.193(b)(2)). The
Department seeks comment on this proposal. Should the collection be
curtailed at this point and the refusal to test be the final result?
Or, should the employee have up to three hours to present a complete
specimen, with the ``shy bladder'' procedures taking place if the
employee subsequently fails to provide the required amount of urine?
Directly Observed and Monitored Collections
In Secs. 40.67 and 40.69, the NPRM consolidates in one place the
requirements concerning directly observed and monitored collections,
respectively. The language states that an immediate collection under
direct observation would be called for in some situations involving
unsuitable specimens or when a previous test has been canceled because
of the unavailability of a split specimen. The Department seeks comment
on whether we should also require an immediate recollection under
direct observation if an employee's specimen is dilute. We also seek
comment on whether employers should be permitted the ability to reject
a negative test result when a specimen is reported negative but dilute
by the MRO. Currently, the rules permit an employer to have the
employee's next test to be collected under direct observation, but this
opportunity may not occur for months.
The proposal notes that a refusal to permit a directly observed or
monitored collection has the same effect as any other refusal to test.
The NPRM clearly distinguishes between the activities of an observer
(e.g., who actually watches the urination) and a monitor (who stands by
and listens but does not watch).
Laboratories
Some laboratory-related material (e.g., present Sec. 40.27,
concerning personnel) would be deleted, as unnecessarily duplicative of
the HHS guidelines. The NPRM would make laboratories subject to public
interest exclusions if they failed to comply with DOT rules, even if
their HHS certification remained intact (Sec. 40.81(c), (d)). The
Department asks for comment on whether, in the case of an amphetamine
positive, the laboratory should perform a d-and l-separation in all
cases.
For the first time, laboratories would be required to test for
nitrites, pH, creatinine and, in certain circumstances, specific
gravity (Sec. 40.91). This so-called ``adulteration panel'' would
increase the ability of the testing process to catch attempts to cheat.
We note that, under HHS guidance for the Federal agency personnel
testing program, these tests are discretionary. We seek comment on the
advantages, disadvantages, costs, and benefits of mandatory adulterant
testing. In addition, the NPRM contains largely new procedures for
dealing with unsuitable specimens and situations in which a split
specimen does not reconfirm the result of the primary specimen
(Secs. 40.151 and 40.177).
The rule text, like that of the present rule, is silent on the
issue of who selects a laboratory for testing. From the Department's
point of view, any HHS-certified laboratory will do. The selection of
the laboratory can be made by the employer, or it could be made as a
matter of collective bargaining where applicable. In any case, the
laboratory must be suitable to the employer.
To reduce paperwork and save time in the process, laboratories
would no longer have to routinely send original copies of certain
copies of the drug testing form to the MRO. The MRO would request
original copies if, for example, faxed copies were unclear.
The proposed rules (Secs. 40.83 and 40.155) would also clarify
under what circumstances a laboratory may reject a specimen for testing
and one circumstance that they must reject a specimen for testing. The
Department seeks comment on the length of time laboratories should
maintain rejected specimens. In addition, the rules delineate the
laboratory reporting requirements as well as the role of the MRO in
ruling out collector error as being the causative factor. MRO reporting
requirements are highlighted. DOT seeks comments on the viability of
having the employee return for a second collection if collector error
results in a laboratory's rejecting a specimen for testing.
In its implementation of the existing rule, the Department has
identified a number of situations that potentially present conflicts of
interest or their appearance. In a number of cases, the Department has
provided guidance to employers and service agents that these practices
are inappropriate. Examples of such practices are: the laboratory
employs the MRO; the laboratory has a contract or retainer with the
MRO; the laboratory designates which MRO the employer is to use, gives
the employer a slate of MROs from which to choose, or refers the
employer to or recommends certain MROs; the laboratory gives the
employer a discount or other incentive to use a particular MRO; the
laboratory has its place of business co-located with that of the MRO;
the laboratory derives a financial or other benefit from having an
employer use a particular MRO; and the laboratory permits an MRO, or an
MRO's organization, to have a significant financial interest in the
laboratory. It should be noted that problems of this kind arise when a
laboratory has a relationship with an MRO who reviews the laboratory's
DOT test results.
The Department seeks comment on whether the text of the final rule
should, in order to provide clear notice to affected parties, provide a
specific list of prohibited practices. If so, should the items above be
part of such a list? Should items be added or deleted? We are also
interested in your comments on what limitations, if any, should be
placed on laboratories and MROs serving as third-party administrators
or collection sites, and what conflict of interest issues these
relationships may raise.
The NPRM would require each laboratory to sign a certification that
there exists no conflict of interest or the appearance of conflict of
interest between the laboratory and any MRO to whom they transmit DOT
test results. In the absence of regulatory specification of the nature
of such conflicts, is this proposed requirement meaningful or
enforceable? For enforcement purposes, would it be useful for a
laboratory to maintain a list of the MROs to whom this certification
applies?
Laboratory Reports
49 CFR Part 40, published December 1, 1989, contained the same
requirements for the laboratory summary report (monthly at that time)
as the requirements contained in the HHS Mandatory Guidelines for
Federal Workplace Drug Testing Programs (i.e., the number of specimens
received, screened positive, and the number that subsequently confirmed
positive, by type of drug).
An amendment to Part 40, published August 19, 1994, changed the
original requirement for monthly reports to quarterly, clarified
authority for laboratories to provide these reports to consortia, and
changed the type of information that should be included by deleting the
requirement for screening results. One of the Department's concerns
underlying this change was to avoid the potential for identifying
individuals who may have been positive, but whose results were
subsequently ``downgraded'' based on medical use. This issue is
important in that if laboratories report confirmed laboratory positive
results by type of test (e.g., pre-employment, reasonable suspicion),
the potential exists to
[[Page 69079]]
identify individuals, even if there are more than five tests results
listed on the report.
The following chart compares current DOT and HHS laboratory report
requirements:
------------------------------------------------------------------------
DOT HHS
------------------------------------------------------------------------
Initial Testing: Initial Testing:
1. Number of samples received for 1. Number of samples
testing. received.
2. Number of samples
reported out.
3. Number screened positive
for:
A. marijuana metabolites.
B. cocaine metabolite.
C. opiate metabolites.
D. phencyclidine.
E. amphetamines.
Confirmatory Testing: Confirmatory Testing:
1. Number received for
confirmation.
2. Number confirmed positive for: 2. Number confirmed positive
for:
A. marijuana metabolites....... A. marijuana metabolites.
B. cocaine metabolite.......... B. cocaine metabolite.
C. opiate metabolites.......... C. opiate metabolites.
D. phencyclidine............... D. phencyclidine.
E. amphetamines................ E. amphetamines.
F. methamphetamines.
3. Number for which test was not
performed.
------------------------------------------------------------------------
DOT and HHS agree that the laboratory summary reports required by
each agency should be the same. This would minimize additional
paperwork that laboratories would be subjected to in providing two
different reports. Additionally, deleting the HHS requirement to report
screened results would lower the laboratory workload and shorten the
report.
Currently, there is no requirement for laboratories to report to
employers the number of tests received by the laboratory by type of
test (pre-employment, random, etc.). However, it appears that many
employers want this information, thinking that it could be used as a
check on their own statistical data. Large employers and service agents
generally maintain appropriate statistical data for their programs and
the Department is interested in hearing from the industry if this type
of additional information from the laboratories is truly helpful.
The Department would also like to know if information identifying
the number of specimens that must be canceled and/or are adulterated
would be useful to employers, service agents, or in the overall
enforcement process. Please note that the requirements would be for
submission of the report on a monthly basis under HHS regulations and
semi-annually under the proposed DOT rules, with more frequent
reporting as required by the Federal agency with regulatory authority
over the employer.
The Department also seeks comment on record retention requirements
for laboratories (see Sec. 40.109). Are the proposed record retention
periods appropriate? Should any of the periods be lengthened or
shortened?
Blind Specimens
Current rules require employers to send ``blind'' urine specimens
to laboratories for drug testing. These samples are unannounced and are
made to look like normal samples. Whether they are negative or positive
(and for which drugs) is known in advance only by the senders. These
specimens are used to test the accuracy of the laboratory testing
system. Together with other quality control procedures, blind specimens
are an important means of keeping the testing program legitimate in the
eyes of the courts, congress, and employee groups.
Currently, all employers must send these samples to the respective
laboratories they use. The NPRM, in the interest of reducing burdens on
regulated parties, would reduce blind specimen requirements from
current levels (Sec. 40.103). Parties with fewer than 2000 DOT covered
employees would no longer have to provide blind specimens
(Sec. 40.103(a)). For other parties, blind specimens would only have to
be provided at a one percent rate, up to a cap of fifty blind specimens
per calendar quarter. This change is intended to be helpful to small
businesses. In addition, since consortiums that send in large numbers
of specimens collected from a variety of employers will continue to
have to submit blind specimens, we do not expect that this change will
adversely affect the accuracy of the laboratory testing process.
The Department seeks comment on whether the blind specimen
requirement should be eliminated entirely or modified in a different
way from the NPRM proposal. The proposed language provides examples of
how the blind specimen requirements would work. Section 40.105 would
specify what happens if there is a laboratory error on any specimen, to
include a blind specimen. In addition, we ask whether testing blind
specimens for adulterants is warranted.
MRO Training and Responsibilities
MROs would have to take a training course every two years or
certify that they have reviewed and understand Part 40 and applicable
DOT agency regulations and guidance. The NPRM also sets out a list of
MRO responsibilities, including acting as an independent ``gatekeeper''
for the accuracy and integrity of the testing process and correcting
and reporting problems when they are found (Sec. 40.123). It is
particularly important that MROs not be involved in relationships with
laboratories that could create a conflict of interest or the appearance
of such a conflict. There are proposed conflict of interest
requirements for MROs parallel to those for laboratories (Sec. 40.125).
The Department wishes to emphasize its view that the MRO is a very
important player in the testing process, who more than any other person
is responsible for maintaining the integrity of that process. It is the
MRO's responsibility to advocate for and defend the accuracy of the
process. This part of the MRO's role makes a conflict
[[Page 69080]]
of interest especially sensitive. These issues are not necessarily
limited to MRO/laboratory relationships. Given the MRO's role as an
evaluator of the testing process, does the MRO's ownership or
administration of a collection site create the appearance or reality of
a conflict of interest?
The rule, at various points, sets time frames for certain actions
by MROs (e.g., 14 days for verifying a ``non-contact positive'' in
Sec. 40.133(a)(2)). Should such time frames be expressed in ``business
days'' (i.e., excluding weekends and holidays) rather than calendar
days?
It is common for MROs to conduct their functions across state
lines. An MRO located in one state may perform functions concerning
drug tests and employees located in many other states. Recently, we
have learned of some concerns that some state medical licensing
agencies may believe that out-of-state MROs who are not licensed to
practice in the state may not be authorized to perform MRO functions
with respect to employees located in the state. The Department is
interested in learning whether this is a significant issue, and if so
whether the issue poses a serious obstacle to the performance of MRO
functions in a national safety program. If there is such a problem,
should the Department take regulatory action to address it? If so, what
action would be appropriate?
MRO Reviews of Test Results
The Department believes that it is important to draw a clear
distinction between the roles of the MRO, on one hand, and the MRO's
staff, on the other. MROs are responsible for supervising their staffs
(see for instance Sec. 40.127(a)). When MRO staff review test result
documents, MROs would personally have to oversee their work, including
direct re-review of a portion of the documents they have reviewed.
Staff members can handle administrative contacts with employees and
remind them to have medical information ready for their MRO interviews,
but actually gathering medical information and drawing conclusions from
the information would be the personal responsibility of the MRO (see
for instance Sec. 40.131(b)).
The ways a MRO makes use of a designated employer representative
(DER) to contact a difficult-to-find employee are also spelled out in
greater detail than in the present rule. In response to a number of
requests, the proposal would define a reasonable time for a DER to
contact an employee as two attempts over a 24-hour period. The rule
(Sec. 40.133(a)(2)) would also authorize MROs to verify a test positive
if neither the MRO nor the DER had been able to contact the employee
within 14 days of the MRO's receipt of the confirmed positive test
result. The Department seeks comment on whether this time period is
appropriate, or a longer or shorter period should be used.
The MRO provisions of the NPRM contain proposed language consistent
with the Department's discussion of the ``stand-down'' issue (see
``Employer Actions'' below). The MRO provisions in the proposed
regulatory text would prohibit MROs from telling or, in the
alternative, permit MROs to tell, the employer for whom the MRO is
working that the MRO has received a laboratory confirmed positive test
result, pending the completion of the MRO verification process
(Sec. 40.129(d)). The rule text will contain both options.
MRO Verification Process
Section 40.135 lists explicitly what MROs would have to tell
employees at the beginning of the verification interview, including
warnings about the effect of the refusal to provide information for a
medical evaluation (see Sec. 40.135(c)) and that the MRO may provide
medical information to employers or others under some circumstances.
Sections 40.137 and 40.139 distinguish between the burdens of proof
applicable to opiates and to all other drug types. The MRO bears the
burden of showing unauthorized use of opiates, while the employee bears
the burden of showing that there was a legitimate medical explanation
for the presence of other drugs. The MRO would have to offer the
employee the chance to provide a legitimate medical explanation. The
Department seeks comment on whether an exception to this rule should be
made in the case of PCP, for which there are no known legitimate
medical applications.
In making a verification of the unauthorized use of opiates, the
MRO may consider such factors as needle tracks, behavioral or
psychological signs of acute addiction, clinical history of
unauthorized use (including admissions by employees), or use of foreign
medication without substantiation that the medication was obtained and
used legally. It should be emphasized that the MRO is intended to
exercise good professional judgment on a case-by-case basis; the rule
does not mandate a finding of positive or negative on the basis of any
particular piece of evidence (aside from a laboratory finding of the
presence of 6-AM).
In the case of opiate verifications, the Department seeks comment
on whether it would be appropriate to shift the burden of proof in
cases of very high opiate levels. That is, if the quantity of opiates
in a specimen is very high (i.e., at or above 15,000 ng/mL), making an
innocent-ingestion explanation (e.g., poppy seed bagels) very unlikely,
then the employee would have the burden of proving that there was a
legitimate medical explanation (e.g., a prescription medication) for
the laboratory positive. In such a situation, the verification process
for high levels of opiates would work like the verification process for
other drugs. The proposed rule text incorporates this approach. In
reaching this decision, the Department reviewed a number of scientific
studies of food products containing poppy seeds. While most studies
found concentrations of 5,000 ng/mL or below, in only one study (C. M.
Selavka. ``Poppy seed ingestion as a contributing factor to opiate-
positive urinalysis results: the Pacific perspective.'' Journal of
Forensic Sciences, 1991;36(3):685-696.), did a product show
concentration above 5000, this one at 11,571 ng/mL. Is our level of
15,000 ng/mL (which is approximately thirty percent above any known
concentration attributable to poppy seed ingestion) too high or too
low?
MROs are cautioned against considering evidence from unauthorized
sources (e.g., non-DOT urine tests, blood tests, hair tests, DNA tests)
and evidence outside the test documentation (e.g., an employee's
assertion that the documents do not accurately reflect what happened at
the collection site). MROs are also cautioned against considering
``innocent ingestion'' defenses (e.g., ``Someone slipped the drug into
my drink at the party;'' ``I ate a hemp product;'' ``I was hanging out
with people who were smoking funny-looking cigarettes'') that, even if
true, do not constitute a legitimate medical explanation for the
presence of a drug in an employee's specimen (Sec. 40.143). This is
also true of statements by an employee that he or she has used
marijuana for medical purposes in a state that has a so-called
``medical marijuana'' law. Use of marijuana on the basis of a doctor's
prescription or recommendation does not constitute a legitimate medical
explanation that is sufficient to permit an MRO to verify a test as
negative. Use of a hemp product is not a legitimate medical
explanation, either.
In the context of pre-employment testing, the NPRM states that a
person with a permanent or long-term disability preventing him or her
from providing a sufficient specimen may be regarded as testing
negative. In such a case, the individual must undergo a medical
examination to determine if the individual is free of signs or symptoms
[[Page 69081]]
of illegal drug use. The Department seeks comment on whether a similar
provision should be created to apply to other types of testing. For
example, if an individual has this type of permanent or long-term
disability, should the individual undergo a medical examination to
determine if he or she is free of signs or symptoms of drug abuse in
lieu of a futile attempt to complete a random drug test in the usual
way? This would avoid the necessity of going through the ``shy
bladder'' procedure repeatedly, while providing a surrogate for the
drug test that could accomplish the safety goal of testing.
One of the most common misunderstandings of the current rule is
that an employee who makes a timely request for the test of a split
specimen (where such testing is mandated by statute) may be denied such
a test if he or she does not pay for it up front from his or her own
funds. To avoid this problem in the future, Sec. 40.145 specifies that
an MRO must explicitly inform the employee that, if he or she has a
verified positive test and asks for a test of the split specimen in a
timely manner, the test will be performed, regardless of whether the
employee complies with a request from a laboratory, employer, or other
party to pay for it in advance. While the rule is intentionally silent
on who ultimately pays for a test, the employer is responsible for
ensuring the test occurs. (See also Secs. 40.171 and 40.173.)
The text also proposes that MROs can conduct the verification
process and report results if the MRO has received legible copies of
the MRO and laboratory copies of the CCF. The text also delineates an
MRO's responsibility in pre-employment testing situations when the
employee has a disability preventing the submission of a urine
specimen.
Adulterated, Substituted, and Dilute Tests
This NPRM proposes to mandate testing for adulterated and
substituted specimens (``validity testing''), which will likely
increase the number of situations in which laboratories determine that
a specimen has been adulterated or substituted. This proposal is based
on the concern that adulteration and substitution are real and possibly
increasing threats to the integrity of the Department's drug testing
program, with the potential for increased safety risks if drug users
succeed in frustrating the testing process.
The proposed rule (Sec. 40.93) sets forth standards and a process
for determining when a specimen is adulterated, substituted, or dilute.
For substituted and adulterated specimens, the proposed rule,
consistent with HHS guidance, requires laboratories to test two
different aliquots of the primary specimen. In many cases, the
laboratory must use different procedures, at least one of which is
quantitative, for each of the aliquots. Only then does the laboratory
determine that the specimen is substituted or adulterated. The
requirement to test two different aliquots is designed to ensure that
the laboratory makes such a determination only on the basis of a
reproducible result. This is an important safeguard for the accuracy of
the process.
DOT policy provides that an individual who has been found to have
adulterated or substituted a specimen is viewed as having refused to
test. Such a refusal is a violation of DOT agency regulations, with
consequences similar to those of a positive test. That is, an employee
who refuses to test is prohibited from performing safety-sensitive
functions unless and until he or she completes the return-to-duty
process. Under some DOT agency regulations (e.g., the FRA), the
consequences of a refusal to test can be more stringent than those of a
positive test. There are also some employer policies that treat
refusals more strictly than positive tests.
The increased prominence of testing for adulteration and
substitution of specimens, combined with the seriousness of
consequences for refusing to test, has resulted in increased interest
in safeguards for employees. In particular, some unions and other
parties have suggested that the Department should apply split specimen
testing procedures to specimens that have been found to be adulterated
or substituted.
This suggestion grows out of a requirement in the Federal Motor
Carrier Safety Administration (FMCSA) [prior to January 1, 2000, the
Federal Highway Administration], the Federal Transit Administration
(FTA), the Federal Railroad Administration (FRA), and the Federal
Aviation Administration (FAA) testing rules that employees who test
positive for drugs are entitled to ask for a test of a second, or
``split,'' specimen at a second laboratory to confirm the presence of
the drug. This requirement is mandated by provisions of the Omnibus
Transportation Employee Testing Act of 1991. In the Research and
Special Programs Administration (RSPA) and United States Coast Guard
(USCG) programs, which are not covered by the Omnibus Act, split
specimens are optional with employers.
The Department is seeking comment on three options concerning this
issue. The first option is to do nothing beyond the procedure set forth
in the regulatory text, in which there would be two separate tests of
the primary specimen before a finding of substitution or adulteration
is made. The Department is confident that this option is legally
defensible. It also is less costly and less prone to the possibility of
administrative error than a system involving testing of the split
specimen.
Split specimen testing, even in the context of positive drug test
results, is not constitutionally mandated. The Department's drug
testing rules, prior to the 1994 amendments implementing the Omnibus
Act, left split specimen testing to the discretion of employers. The
Department's drug testing requirements and procedures were upheld as
constitutional by the courts before those amendments were made. It is
not reasonable to assert that the Department is constitutionally
required to expand the application of a procedure which is not
constitutionally required to be used in the first place.
Nor is split specimen testing required by the statutes and
regulations governing the Department drug testing programs. The split
specimen provision of the FMCSA, FTA, FRA, and FAA rules results from a
requirement of the Omnibus Transportation Employee Testing Act of 1991
(49 U.S.C. Sec. 5331(d)(5)). This section provides that:
. . . each specimen be subdivided, secured, and labeled in the
presence of the tested individual and that a part of the specimen be
retained in a secure manner to prevent the possibility of tampering,
so that if the individual's confirmation test results are positive
the individual has an opportunity to have the retained part tested
by a 2d confirmation test done independently at another certified
laboratory if the individual requests the 2d confirmation test not
later than 3 days after being advised of the results of the first
confirmation test. [emphasis added]
This provision is implemented in the Department's current drug
testing procedural regulations:
. . . the MRO shall notify each employee who has a confirmed
positive test that the employee has 72 hours in which to request a
test of the split specimen, if the test is verified as positive. . .
. If the [second laboratory's] analysis fails to reconfirm the
presence of the drug(s) or drug metabolite(s) found in the primary
specimen, . . . the MRO shall cancel the test. . . . [49 CFR
Sec. 40.33(f); emphasis added]
In the first instance, both the statutory and regulatory language
create a right to a test of the split specimen only in situations where
there is a confirmed
[[Page 69082]]
positive test. A confirmed positive test occurs only when the
laboratory confirmation test detects sufficient quantities of the
specified drug(s) or drug metabolite(s). In a case where the laboratory
has found an adulterant in the specimen or has determined it to be
substituted, the laboratory does not report a confirmed positive test
to the MRO. The condition precedent to the right to a second
confirmation test has not occurred, since there has never been a
confirmed positive test for a drug reported to the MRO in the first
place.
The current regulation, in spelling out the procedure for
requesting a test of a split specimen, provides that a request must be
made within 72 hours of a verified positive test. (The MRO verifies a
confirmed laboratory test as positive if the MRO cannot determine that
there is a legitimate medical explanation for a laboratory confirmed
positive test result.) In the absence of a confirmed positive test,
there can never be a verified positive test, which is the trigger for
the employee's opportunity to request a test of the split specimen.
The current regulation further provides that if the test of the
split specimen fails ``to reconfirm the presence of the drug(s) or drug
metabolite(s) found in the primary specimen,'' the test must be
canceled. In a case involving a finding of adulteration or
substitution, there has never been a reported finding that drug(s) or
drug metabolite(s) are present in the employee's specimen. One cannot
``reconfirm'' a finding that has never been made. The regulation
requires cancellation of a test only if the presence of drug(s) or drug
metabolite(s) is not reconfirmed in the split specimen.
In addition to the use of split specimen testing in adulteration or
substitution cases not being legally required, the first option is
supported by three policy considerations. First, the Department is very
concerned that present adulterants and other interfering substances may
degrade over time. That is, when an adulterant is present in the
primary specimen but degrades chemically to the point where it cannot
be detected or changes to another chemical state in the split specimen
(e.g., HHS has recently identified one adulterant that appears to
degrade in a matter of hours), our making split specimen testing
available for adulterants could help drug users ``beat the test.'' In
addition, manufacturers of commercial products intended to defeat drug
testing--who engage in a well-publicized ``arms race'' to find new
means of defeating drug tests--may well be able to develop, in the
future, adulterants that degrade even faster.
Second, the Department's experience is that the overwhelming
majority of test cancellations related to split specimens result from
collection or logistical problems (e.g., collector fails to collect the
split specimen, a split specimen is lost or leaks in transit). The
Department has been reluctant to expand the application of split
specimen testing to areas where it is not required by statute, which
could have the result of canceling otherwise valid tests and allowing
drug users to continue to perform safety-sensitive functions.
Third, the Department has viewed an adulterated or substituted
specimen as more closely analogous to a refusal to test than to a
positive test. Employee A flatly tells the collector that he will not
provide a specimen, or simply does not show up for the test. Employee B
shows up, provides a specimen, signs the statement on the custody and
control form certifying that he or she has not tampered with the
specimen, but nevertheless puts a substance into the specimen that
prevents the laboratory from testing it. The actions of Employee A and
Employee B are equivalent. Having a second opportunity to defeat the
testing process is no more appropriate for Employee B than for Employee
A.
The second and third options would both add a further element to
the language in the proposed regulatory text. The Department seeks
comment on all three options, as well as any other suggestions
commenters may have on this subject.
The second option would be to treat an adulterated or substituted
test result the same as a verified positive and allow the employee to
request a split specimen test by a second laboratory. For example,
suppose a laboratory makes an adulteration or substitution finding.
Within 72 hours of being informed of the finding, the employee would
have the opportunity to request a test of the split specimen by the
second laboratory to see if the adulteration or substitution finding
could be reconfirmed. If it were not reconfirmed, the test would be
canceled, just as in the case where a split specimen fails to reconfirm
the presence of a drug or metabolite found in a positive primary
specimen. This option would ensure that employees who face similar or
more severe employment consequences compared to employees with positive
tests for drugs have an equal ability to challenge a laboratory's
primary specimen determination. The argument in favor of this approach
is basically one of fairness.
This additional safeguard for the fairness of the process could
provide reassurance to the vast majority of employees who fully and
honestly cooperate in drug testing programs. It could also discourage
frivolous challenges to drug test results by employees who know they
have submitted adulterated samples.
In addition, more research needs to be done in the area of
adulterants degrading over time. There are technical questions that
need to be resolved about the protocols and standards to be applied in
split specimen reconfirmation in adulteration and substitution
situations. The Department is working with HHS to ensure that this
information is available in time for the final rule. Meanwhile, we
invite comment on the technical and scientific issues concerning
adulteration and substitution testing and reconfirmation.
The Department seeks comment on whether, if a provision for split
specimen testing for adulterated and substituted specimens is included
in the final rule, it should be required or optional. That is, should
we require employers to make split specimen testing available in these
circumstances, or should employers (or employers and unions, where
collective bargaining agreements apply to drug testing issues) have the
choice of whether to make split specimen testing available?
In addition, we seek comment on whether Part 40 should also be
amended to require employer submissions of adulterated and substituted
specimens as part of the external quality control (``blind specimen'')
program. If so, how should selection of adulterants be made? How many
adulterated specimens should be included within the minimum number of
blind specimens submitted? To what extent have such specimens been
included in existing blind testing programs? What practical issues
could arise with regard to administration of such a program?
A third option occupies a middle ground between the first two
options. When a laboratory finds that a primary specimen has been
adulterated or substituted, it would immediately test a third aliquot
of the same specimen to see if the same result was obtained (two
aliquots would already have been tested before the original finding of
adulteration or substitution had been made). If the retest did not
confirm the original finding, the test would be canceled. The
Department seeks comment on what the standards should be for this
additional test. For example, should we set a standard that to be
regarded as confirming the presence of an adulterant, the additional
test result should be within +/-20 percent of the
[[Page 69083]]
original result (while still satisfying the initial reporting
criteria)?
This approach would add a safeguard for employees, by adding
another level of assurance that the laboratory was relying on a
reproducible result. Reproducibility is a key component of the validity
of any scientific process, and this approach would ensure that no one
would suffer adverse consequences on the basis of a result that could
not be reproduced.
Since the retest would occur immediately, degradation of most
adulterants would not be a major problem. In addition, because it would
take place in the same laboratory and would not involve the split
specimen, collection or transmission errors affecting the split
specimen would not result in the cancellation of an otherwise valid
adulteration or substitution result.
Finally, the proposed rule text includes material adapted from the
DOT and HHS guidance concerning other types of ``problem tests''
(Secs. 40.147 through 40.153). As current DOT guidance states, a retest
under direct observation is required in situations of some
``unsuitable'' specimens. The Department seeks comment on whether a
retest under direct observation should also be required in cases of
dilute specimens. The Department also seeks comment on a frequently-
asked question about dilute specimens: should an employer have the
discretion to disregard a dilute result? For example, if an employer in
a pre-employment test situation receives a test result that is negative
and dilute, should the employer be able to require that the applicant
take another test and get a negative result from an undiluted specimen
before beginning to work in a safety-sensitive position?
Employer Actions
Section 40.159 addresses the so-called ``stand-down'' issue. Some
employers have expressed a preference for standing-down employees--
taking them temporarily out of service based on a report from the MRO
that the employee has a confirmed positive test, pending completion of
the verification process. Some employers who have an in-house MRO
appear particularly attracted to this approach. The proponents of this
approach assert that it enhances safety and that it can include
safeguards for employee privacy.
In the program for regulated industries, the Department's current
rules and interpretations have prohibited stand-down. The reason for
this approach is that such policies may result in the stigmatization of
employees as drug users in cases when positive laboratory results are
downgraded as a result of the MRO verification process. The
Department's rules have always striven to provide a balance between
safety objectives and the protection of legitimate employee privacy
interests. In addition, the Department is not aware of any evidence
that, in the millions of tests conducted in compliance with the
Department's rules since the program began in 1988, the existing
prohibition on stand-downs has ever had adverse safety consequences.
However, the Department's internal drug testing program for DOT
employees, which applies to air traffic controllers and other safety-
sensitive employees, has used a stand-down procedure for many years.
Consequently, the Department's overall approach to this issue has been
inconsistent.
Given this situation, the Department has decided to seek comment on
both approaches. The proposed regulatory text includes language, in the
alternative, relating to both. Alternative 1 is the present approach,
which prohibits stand-down. Alternative 2 would permit stand-down, with
requirements for maintaining confidentiality of information concerning
the confirmed positive test result of the employee. We seek comment on
which alternative is preferable for the final rule. If the final rule
permits employers to implement stand-down policies, the Department
seeks comment on several associated issues.
For example, should the rule specify that an employee who is stood
down may continue to perform non-safety sensitive duties? What should
be the pay status of an individual being stood-down? What additional
privacy provisions, if any, are needed to limit dissemination of
information about the employee's stand-down status based upon the
existence of a laboratory positive test? Difficulties in maintaining
confidentiality may be particularly acute in smaller companies (e.g., a
trucking company with 10 or fewer drivers). Are there any special
provisions we should include for small employers? Finally, how would a
stand-down policy apply to owner-operators? It seems implausible that
owner-operators would stand themselves down after being informed of
laboratory positive tests by MROs.
We also point out that, in addition to the proposed alternative
language in Secs. 40.129 and 40.159, there may be a need for conforming
changes to other sections of the regulation in the event we choose
Alternative 2. We seek comment on what, if any, such additional changes
to the rule would be needed.
Finally, the proposed regulation would make other employer
responsibilities clear. When an employer receives a report from the MRO
that there is a substituted or adulterated specimen, the employer must
remove the affected employee immediately from safety-sensitive
functions. When the MRO informs the employer of an unsuitable specimen,
the employer must direct the employee involved to immediately submit a
new specimen under direct observation. Likewise, when the employer
receives a report from the BAT that there is a result 0.02 or above,
the employer must remove the affected employee immediately from safety-
sensitive functions.
Split Specimens
Section 40.173 again underlines that, where split specimen testing
is required by DOT regulations, employers must make sure that a test of
the split occurs every time that an employee makes a timely request.
Payment or agreement by the employee to pay the cost of the test is not
a prerequisite for conducting a test of the split specimen, though the
employer may seek to recover the cost of the test. Laboratories
conducting tests of split specimens must refer a specimen to a third
laboratory for additional testing when necessary (Sec. 40.177(d)). The
Department also seeks comment on whether (as proposed at
Sec. 40.183(d)(4)) there should be a retest under direct observation
when a split specimen is unavailable for testing.
Split specimen tests are statutorily mandated only in FMCSA, FTA,
FRA, and FAA. They are currently optional with employers in RSPA and
USCG. The Department is interested in determining if continuing use of
single specimen collections by RSPA and USCG causes confusion for
collectors, employers, laboratories, and MROs in light of the fact that
FMCSA, FTA, FRA, and FAA are required by the Omnibus Act to use split
specimen collection methodology. Will there be fewer errors in the
collection process if all DOT urine specimens are collected using split
specimen procedures? Will employers covered under multiple rules (e.g.,
RSPA and FMCSA) be less likely to order the wrong collection if all of
DOT's OAs require split specimen procedures (e.g., a situation in which
a pipeline repair person also drives a truck)? Is it sound policy to
keep the current bifurcated specimen collection system that requires
split specimen collection within some transportation
[[Page 69084]]
industries and permits single specimen collections for others?
``Problem'' Drug Tests
The NPRM would spell out the circumstances in which an employee's
actions are considered to be a refusal to test (Sec. 40.191). The NPRM
also includes a list of testing problems that must or may result in
cancellation of a test, including instructions on how to correct
problems that would otherwise result in cancellation (Sec. 40.201).
This portion of the proposed rule also notes the effect of a canceled
test (Sec. 40.205) and introduces the concept of a mistake in the
process which must be documented when discovered but which does not
result in cancellation of the test (Sec. 40.207). We also request
information on whether there are other common mistakes that we should
mention in this section.
In connection with the ``shy bladder'' provisions, the rule
provides that a physician ``acceptable'' to the employer shall evaluate
the employee (the same provision applies to inability to provide
sufficient breath for an alcohol test). We understand that, in some
cases, employers apparently do not check to determine the suitability
of a physician to perform this evaluation. Should the language simply
require the employer to ``select'' the physician? Should the rule
establish criteria for this selection (e.g., expertise in urology)?
The proposed rule also would incorporate 1998 DOT guidance
concerning individuals whose tests are canceled on a pre-employment
test because of a serious, long-term disability. These individuals
could perform safety-sensitive functions after ``passing'' a
physician's evaluation for signs or symptoms of drug abuse, which could
include a blood test. Because pre-employment alcohol tests are no
longer mandatory, is it necessary to include a similar provision in
``insufficient breath'' situations? The Department seeks comment on
this question.
Alcohol Test Administration
Alcohol testing requirements are not proposed to be changed as much
as the older drug testing requirements. Some of the changes proposed
include mandatory retraining for BATs and STTs who make a mistake
resulting in the cancellation of a test (Sec. 40.213(a)(3), new
requirements for test site security (Sec. 40.223(a)), authorization for
foreign-language testing forms (e.g., in Spanish for use in Mexico),
more specific instructions on the steps for beginning alcohol tests
(Sec. 40.241) and clarifications concerning the timing of confirmation
tests (Sec. 40.251). There are updated sections on ``fatal flaws'' and
``correctable flaws,'' and how to correct the latter (Sec. 40.271).
Section 40.233 requires quality assurance plans for evidential
breath testing devices. Are these plans necessary or useful? Should the
requirement be retained, changed, or eliminated? Can it be improved or
modified? The Department also seeks comment on how well the current
alcohol testing form is working for collection and other concerned
personnel. Are there improvements we should make? We also seek comment
on whether the provisions of the rule concerning the use of saliva
devices (Sec. 40.245) adequately describe how these devices work, or
whether we should modify this language.
Substance Abuse Professionals
The Department issued an Advance Notice of Proposed Rulemaking
(ANPRM) in the Federal Register [June 3, 1999 (Volume 64, Number 106)]
concerning the inclusion of additional groups of certified drug and
alcohol addiction counselors in the definition of a SAP. The NPRM
incorporates material from this ANPRM and the comments we received. An
overwhelming number of respondents supported the Department's desire to
streamline the process for reviewing certification groups' application
materials and for evaluating the quality of those groups' certification
testing processes. While some commenters favored maintaining the
current review process and one favored individual certification for
every SAP, the vast majority favored the Department's proposal to
require National Commission for Certifying Agencies (NCCA)
accreditation for certification agencies wishing to have their
certified counselors included in the SAP definition. Because two
counselor organizations--the National Association of Alcoholism and
Drug Abuse Counselors Certification Commission (NAADAC) and the
International Certification Reciprocity Consortium / Alcohol & Other
Drug Abuse (ICRC)--have been through the current rigorous DOT
evaluation process, the Department believes that NAADAC and ICRC will
not need NCCA accreditation to have their certified counselors remain
in the SAP definition.
The NPRM would add training requirements for SAPs (Sec. 40.281(c)).
The NPRM also clarifies the role of the employer, employee, and SAP in
the return-to-duty process (Secs. 40.283 through 40.291), including a
strengthened prohibition on waivers of liability. The NPRM would also
incorporate into the rule text a number of existing interpretations
concerning the SAP's role (e.g., a SAP assessment must be face-to-face,
an employer or employee cannot ``shop around'' for a favorable SAP
evaluation, no one may modify or change a SAP's assessment of an
employee (Secs. 40.295 and 40.297); the SAP is to make a recommendation
for a return to work agreement). The rule would also specify that
recommendations for follow-up tests and post-return-to-duty follow-up
treatment would be included in the SAP's recommendation, and that the
employer must follow these recommendations (Secs. 40.307 and 40.309).
Finally, the NPRM lists the items that must be included in SAP reports
on employee evaluations (Sec. 40.311).
Some SAPs have asked to receive reports of the quantity of drugs in
an employee's system, to help them determine what sort of treatment
might be appropriate. They do not receive quantitations in the normal
course of business. Should SAPs be able to obtain this information from
laboratories, much as MROs now can?
The NPRM, like the current rule, requires at least six follow-up
tests over the period of one year following an individual's return to
safety-sensitive duties after a rule violation (e.g., positive drug
test). From rehabilitation and safety viewpoints, is this minimum
requirement adequate? For example, would it be better if there were a
minimum requirement of twelve follow-up tests during the year? The
Department seeks comment on this matter.
Finally, because of the Department's growing concern that no
adverse consequences exist for most applicants for DOT safety-sensitive
positions who test positive on or refuse to take a pre-employment drug
test, we propose to prohibit those individuals from performance of any
and all DOT safety-sensitive duties until and unless the person
completes the SAP evaluation, referral, and treatment process. DOT
agency regulations would be modified accordingly.
Confidentiality and Release of Information
The basic confidentiality provision of the existing part 40 would
continue in effect: Information about an employee's drug or alcohol
tests can be released to third parties only with the written consent of
the employee. The NPRM specifies that this consent must be specific to
the information in question, not a ``blanket'' release
(Sec. 40.321(b)). However, a service agent (e.g., an MRO)
[[Page 69085]]
can transfer their records to a successor without obtaining such
consent, as long as no disclosure to outside parties occurs
(Sec. 40.325(a)). MROs can, with employee consent, contact a
prescribing physician to determine if an alternative medication not
having side effects that adversely affect safety can be substituted
(Sec. 40.327(c)).
The NPRM specifies that MROs would be required to report drug test
information directly, and only, to actual employers. They could not
report results via an intermediary, such as a consortium or third-party
administrator. Use of intermediaries has the potential to delay the
transmission of results and increase the likelihood of administrative
error. There is one exception to this requirement: DOT agencies could
have a regulatory provision authorizing the provision of results
through an intermediary. At the present time, only the Coast Guard has
such a provision. No other DOT agency authorizes this practice.
The proposed approach is based on the Department's 1995 guidance on
the role of consortia and third-party administrators. As that guidance
suggests, reporting through an intermediary might be appropriate in
certain specific situations (e.g., when use of a third party is the
only practicable way to direct an owner-operator to cease performing
safety-sensitive functions or to report a violation to a DOT agency for
purposes of taking licence or certification action following a
violation). The Department is reluctant to extend these provisions any
wider. What are the advantages versus the disadvantages of the current
system?
To resolve a dilemma that some MROs have faced, Sec. 40.329 would
authorize MROs who work for more than one DOT employer to inform
Employer B that an employee has had a positive test or a refusal to
test in his capacity as an employee of Employer A. This proposed
exception to the employee consent rule has a number of protections to
ensure that it is not abused or used too broadly. Should this provision
be broadened (e.g., so that the MRO could provide the information to an
employer whom the MRO does not serve)? If so, how should a broadened
provision be drafted in order to avoid an open-ended license to share
information (e.g., within an organization with many MROs and/or a large
data base)? One purpose of part 40 is to maintain an appropriate
balance between safety and privacy considerations, and we seek comment
on how best to strike this balance in this situation.
The existing rule requires laboratories to provide certain
information to employees about, among other things, their HHS
certifications. Despite this requirement, laboratories have sometimes
refused to provide the information. Section 40.331 specifies the scope
of this requirement in greater detail and emphasizes the laboratories'
obligation to comply. It should be noted that refusal by a laboratory
to provide required information could subject the laboratory to public
interest exclusion proceedings under subpart R.
The NPRM currently authorizes the provision of information about a
post-accident drug or alcohol test to the National Transportation
Safety Board (NTSB), in connection with an NTSB investigation of an
accident to which the post-accident test pertained. The Department
seeks comment on whether this provision should be broadened to apply to
other types of tests (e.g., pre-employment, random, follow-up) in the
individual employee's past. Should the provision apply to the
employee's urine specimens collected for the post-accident test (on
which NTSB might want to conduct additional testing)? The issue
involves how best to balance the potential relevance of the additional
information to NTSB's investigation of the accident with the additional
effects of broader dissemination of the information on the individual's
privacy. If we do broaden the availability of such information to the
NTSB, should the rule place conditions limiting further disclosure
(e.g., in the text of NTSB reports)?
Finally, in some situations a service agent may be aware that an
individual is continuing to perform safety-sensitive functions despite
having violated a DOT agency regulation. For example, a third-party
administrator may learn that a truck driver is continuing to drive a
commercial motor vehicle after having tested positive for drug use.
There is no present requirement for the service agent to report such a
situation to the DOT agency involved. In the interest of safety, should
there be such a requirement?
Service Agent Roles and Responsibilities
Subpart Q of the rule is based in part on existing DOT guidance
concerning the roles and responsibilities of service agents, such as
third-party administrators and consortia. There is also new material,
such as an explicit statement that service agents cannot impose
requirements not authorized by DOT rulemaking, a reference to the
subpart R public interest exclusion process and its consequences, and
expanded provisions on the relationship between service agents and
MROs.
The Department is concerned about any potential for conflicts of
interest with all service agents and welcomes comments in this area.
The Department has a long-standing prohibition against the laboratory
and the MRO having an affiliation or financial arrangement with one
another that may be construed as a conflict of interest. Should this
prohibition be strengthened? If so, how? We are also interested in your
comments on what limitations, if any, should be placed upon
laboratories and MROs serving as third-party administrators. How can we
ensure that there exists no conflict of interest in a laboratory-based
third-party administrator's selection of an MRO? Or, in an MRO-based
third-party administrator's selection of a laboratory?
Public Interest Exclusions (PIEs)
The Department of Transportation requires hundreds of thousands of
transportation employers to conduct drug and alcohol tests on millions
of employees performing safety-sensitive functions. As part of this
program, the Department requires the employers to comply with the
specific and detailed testing procedures in part 40. These procedures
ensure the accuracy, integrity, and privacy of the testing process, and
they contain significant safeguards for employers and employees alike.
Employers who do not comply with these procedures are subject to
sanctions, such as civil penalties or withdrawal of Federal funding.
Most DOT-regulated employers today do not use their own personnel
to provide drug and alcohol testing services. Rather, they rely on a
series of ``service agents'' (e.g., collectors, BATs, laboratories,
MROs, substance abuse professionals, testing consortia, third-party
administrators), with whom they contract to provide these services.
When service agents fail or refuse to carry out part 40 requirements,
employers who engage their services in good faith are placed at risk of
being found in noncompliance and subjected to DOT sanctions. The
employers--especially the many small businesses involved--do not have
the expertise or resources to determine whether the service agents are
providing services in a way that meets part 40 requirements.
Relying on employer penalties alone to ensure service agent
compliance does not adequately address the problem. For example,
imposing a $1000 civil penalty on a small trucking company that has
used a service agent that is not performing its functions properly does
little to correct the service agent's
[[Page 69086]]
malfeasance. The service agent can go right on performing badly for the
many other DOT employers with which it contracts. Attempting to address
the problem through employer-by-employer sanctions is also a very
inefficient use of the Department's resources. If a DOT agency must
conduct separate civil penalty actions against 30 different employers
to address the effects of a single service agent's malfeasance, its use
of resources is much less efficient than if there is one DOT action
focused on the service agent itself. Nor are educational efforts likely
to be sufficient: existing DOT agency and private training efforts,
while useful, have not prevented some recurring problems about which we
know.
Noncompliance by service agents with part 40 requirements can have
serious consequences that go beyond the possibility of DOT sanctions on
employers. For example, if an MRO is unqualified, does not conduct
verification interviews, or disregards DOT rules and guidance for
making verification decisions, individuals who apparently have tested
positive for drugs can have their test results invalidated and be put
back to work in safety-sensitive positions, endangering transportation
safety, or individuals can be unfairly identified as drug users. If a
collector or BAT does not conduct the collection process as part 40
provides, then valid tests can be overturned, tests will have to be
repeated, and hiring actions may be delayed (in the case of pre-
employment tests), creating potential safety and cost problems. If a
laboratory or MRO breaches confidentiality requirements, employees'
privacy rights can be compromised, upsetting the program's carefully
constructed balance between the government's interest in safety and the
employee's interest in privacy.
To address these concerns, the Department is proposing a new
subpart that would create a ``public interest exclusion'' mechanism. A
public interest exclusion (PIE) would be a directive from the
Department to its regulated employers to not use a service agent that
fails or refuses to provide its services as part 40 requires. While a
PIE obviously has adverse business consequences for the service agent
involved, its imposition is not for the purpose of punishment. Its
purpose is to serve the public interest by making it easier for
employers to comply with our rules and to protect them from
noncompliance with DOT regulations. We also believe it is important to
protect employees from the consequences of services that do not meet
DOT requirements. The proposed process would work as follows:
When a DOT agency, ODAPC, or the Inspector General's
office becomes aware of a problem with service agent performance,
through an inspection or complaint, the office in question would first
decide whether to pursue the matter through this process. This would be
a ``prosecutorial discretion'' decision by the office, made in view of
the seriousness of the problem and would, of course, be subject to the
availability of DOT resources. We contemplate the use of this process
only in cases having considerable significance, not for minor mistakes.
In addition, in most cases, DOT offices would resort to this process
only after having unsuccessfully tried other means of resolving the
problem.
Because the primary purpose of the process is compliance,
the initiating office would first send a correction notice to the
service agent, spelling out the problem and asking the service agent to
fix it.
If the service agent corrected its problem(s) within 60
days, no further proceedings would be necessary.
If the problem(s) was not corrected, the initiating office
would notify the service agent in writing that the Department was
proposing to issue a PIE.
To ensure that the service agent had administrative due
process, it would have the opportunity to contest the issuance of a
proposed PIE. This would include the opportunity to submit information
and arguments in writing and to meet with the ODAPC Director in
situations where there were material facts in dispute. (To ensure
separation of functions, the ODAPC Director, as the decisionmaker,
would not participate in the decision to initiate the proceeding, and
there would be a firewall between the Director and other ODAPC, DOT
agency, or IG staff concerning the case.)
The Director would notify the service agent of the
decision and the reasons for it in writing and issue a Federal Register
notice to inform employers when a PIE was issued.
The PIE would stay in effect for a period of from one to
five years, depending on the seriousness of the problem. However, it
could be lifted earlier if the service agent was able to show that the
problem(s) resulting in the order had been corrected.
This process is analogous to the procedure for imposing suspension
and debarment in nonprocurement situations (see 49 CFR part 29). It
should be noted that this proposed provision is not a sweeping new
assertion of regulatory authority over entities who were previously
untouched by DOT regulations. Provisions of both part 40 and DOT agency
drug and alcohol testing regulations already govern in detail the
activities conducted by laboratories, MROs, collectors, substance abuse
professionals, and other service agents. The proposed provision adds no
new substantive requirements. Rather, it uses the Department's existing
regulatory authority over transportation employers to direct the
employers, in the public interest and in the interest of their own
compliance with our regulations, not to use service agents whose
conduct violates part 40. The General Counsel of the Department of
Transportation has determined that the Department has sufficient legal
authority to implement these proposed requirements.
The Department also seeks comment on three alternative methods to
achieve the objective of this provision. We believe that all these
alternative approaches could use due process procedures like those
outlined above:
(1) The process would work as described above, but instead of
issuing a PIE, the Department would issue an advisory notice to
employers telling them that the service agent was not providing
services as required by part 40, placing employers using the agent at
peril of enforcement action.
(2) As a condition of participation, all service agents would be
required to self-certify that they provide all services as required by
Part 40. Instead of issuing a PIE, the Department would decertify
service agents that failed to carry out requirements properly.
(3) A contract provision in all agreements between service agents
and regulated employers (see Sec. 40.11(d)) would bind service agents
to providing services in compliance with Part 40. Noncompliance would
breach this provision, leading to termination of the contract.
The Department seeks comment on all the alternatives, combinations
of them, or other means to accomplish the purpose of the proposed
Subpart R, as well as on the general concept of a mechanism to protect
employers and employees from noncomplying service agents.
Table of Sources
As noted earlier in the preamble, this proposed rule would
significantly change the organization of Part 40. To help readers
follow the origin of the proposed provisions, we have created a table
that lists a provision of the current Part 40 or other sources of each
provision. The following are examples of some of the most common types
of source notations:
[[Page 69087]]
``Sec. 40.33(b)''--The material in the proposed rule
originated in Sec. 40.33(b) of the existing rule. This does not mean
that the proposed section is the same as the existing section, but
simply that the proposed section addresses the same subject matter as
the existing provision. Often, the language of the proposing and
exiting provisions will be different.
``Interp.''--The material in the proposed rule text comes
from an interpretation issued by the Department under the present Part
40.
``9/98 guidance''--The material in the proposed rule text
comes from a guidance memorandum issued by the Department in September
1998.
``Modal regulation''--The material in the proposed rule
text comes from a DOT agency regulation (e.g., the FRA drug testing
rule).
``New''--The material in the proposed rule would add
material not found in the present Part 40 or in written interpretations
or guidance.
``HHS''--The material in the proposed rule would
incorporate material from the Department of Health and Human Services
drug testing guidelines or HHS guidance interpreting those guidelines.
``Comment''--The material in the proposed rule responds to
a comment on the ANPRM.
``Alcohol (or Drug) parallel''--The proposed rule text
concerning drug testing procedures would be parallel to language on a
similar provision in the alcohol testing procedures, or vice-versa.
Using the table, readers should be able to readily identify the
source of a given provision and where the proposed rule differs from
the present Part 40. This should help commenters determine whether they
support proposed changes, support existing language, or whether they
wish to recommend alternatives to the proposals. In a version of the
NPRM on the Department's web site, we have placed these source notes in
brackets after each section, for greater convenience to the reader
(Federal Register format does not permit this placement in the
published version of the document). The table follows:
------------------------------------------------------------------------
Section of NPRM Source
------------------------------------------------------------------------
40.1............................... 40.1
40.3............................... 40.3, HHS, except ``alcohol test,''
``designated employer
representative,'' ``dilute
specimen,'' ``notice,'' ``service
agents,'' and ``substituted
specimen,'' which are new.
40.5............................... New
40.7............................... 49 CFR part 5, interp.
40.11.............................. New
40.13(a)........................... New
(b).......................... Comment
40.15 (a), (b), (d), (e), (f)...... Interp.
(c).......................... 40.21(c)
40.17(a)........................... Guidance
(b), (c)..................... New
40.19.............................. Interp.
40.21.............................. New
40.31 (a), (b)..................... New
(c).......................... 40.23(d)(3), interp.
(d).......................... 40.23(d)(3)
40.33 (a)(1)....................... New
(a)(2)(i).................... 40.23(d)(2)
(a)(2)(iii).................. 40.23(d)(1)
(a)(3)-(5)................... New
(b).......................... New
40.35.............................. New
40.37.............................. New
40.41 (a), (b)..................... New
(c).......................... 40.25(a)(1)
(d)(1), (3).................. 40.25(a)(2)
(d)(2)....................... New
(e).......................... 40.25(a)(2), HHS
(f), (g)..................... 40.25(a)(1)
40.43(a)........................... 40.25(b)
(b)(1)-(6)................... 40.25(b)(1)-(2)
(b)(7)-(8)................... New
(c).......................... 40.25(b)(2)
(d)(1)....................... 40.25(d)
(d)(2)....................... 40.25(g)
(d)(3)....................... 40.25(d)
(d)(4)....................... 40.25(f)(25)(ii)
(d)(5)....................... 40.25(f)(25)(i)
(e).......................... 40.25(d)
(e)(1)-(4)................... New
40.45(a)........................... 40.23(a)(1)(i)
(b)(1)....................... 40.23(a)(1)(ii)
(b)(2)-(5)................... Comments
(c).......................... 40.23(a)(1)(ii)
(d).......................... 40.23(a)(1)(iii)
(e).......................... New
40.47(a)........................... Interp.
(b).......................... Interp., new
40.49.............................. New
40.51.............................. Interp., new
[[Page 69088]]
40.61(a)........................... 40.25(f)(3), new
(b).......................... Interp.
(b)(1)....................... New
(b)(2)....................... 40.25(j)
(b)(3)....................... Interp.
(c).......................... 40.25(f)(2), HHS
(d).......................... 40.25(f)(2), new
(e).......................... Alcohol parallel
(f)(1)-(2)................... 40.25(f)(4)
(f)(3)....................... Interp., HHS
(f)(4)-(6)................... New
(g).......................... 40.25(f)(22)(ii)
40.63 (a).......................... Alcohol parallel
(b).......................... 40.25(f)(5)-(6), (11)
(c).......................... 40.25(f)(7), HHS, interp.
(d).......................... 40.25(f)(10), new
(e).......................... 40.25(f)(8), new
40.65.............................. Checklist format new
(a).......................... New, interp.
(b) (1)-(5).................. 40.25(e)(2)
(b)(6)....................... Interp.
(b)(7)....................... Interp., new
(c).......................... New, interp.
40.67(a)(1)........................ HHS
(a)(2)....................... New
(b)(1)....................... 40.25(e)(2)(iv)
(b)(2)....................... 9/98 guidance
(c)(1)....................... New
(c)(2)....................... 40.25(e)(2)(iii); new
(c)(3)....................... 40.25(e)(2)(i)
(c)(4)....................... 40.25(e)(2)(iii)
(d).......................... HHS
(e).......................... New
(f).......................... 40.25(f)(16), interp., HHS
(g).......................... New
(h).......................... Interp.
(i).......................... Interp., HHS
(j).......................... HHS
(k).......................... Interp.
40.69(a)........................... 40.25(f)(9)
(b)-(c)...................... New
(d)-(h)...................... 40.25(f)(9), Interp.
(i).......................... HHS
(j).......................... Interp.
40.71(a)........................... 40.25(f)(10)(iii)
(b).......................... New
(c).......................... 40.25(f)(19), HHS
(d).......................... 40.25(f)(10)(iii), 40.25(f)(17)
(e).......................... 40.25(f)(20)
(f).......................... New
40.73 (a)-(b)...................... 40.25(f)(19)(ii)(B)(1), new
(c).......................... New
(d).......................... 40.25(f)(19), HHS
(e).......................... 40.25(f)(10)(iii), 40.25(f)(17)
(f).......................... 40.25(f)(20)
40.75(a)(1)........................ 40.25(f)(22)(i), HHS
(a)(2)....................... 40.25(f)(23), HHS
(a)(3)-(4)................... HHS
(a)(5)....................... New
(a)(6)-(7)................... HHS
(a)(8)-(10).................. New
(a)(11)...................... HHS
(b).......................... 40.25(c), (h), (k)
(c).......................... New
40.81(a)........................... 40.39(a)
(b).......................... 40.39(b)
(c)-(d)...................... New
40.83(a)-(c)....................... 40.25(k), 40.29(a)(2)
(d).......................... HHS, new
(e).......................... Interp.
(f).......................... Interp., new
(g).......................... New
40.85.............................. 40.21(a)
40.87(a)........................... 40.29(e)(1), new
[[Page 69089]]
(b).......................... 40.29(f)
40.89(a)........................... 40.29(e)(1) and (f)(1)
(b)-(c)...................... 40.29(g)(2)
40.91 (a)-(b)...................... New, HHS
(c).......................... 9/98 guidance
(d).......................... HHS
40.93.............................. New, HHS
40.95(a)........................... 40.29(g)(1)
(b)-(e)...................... HHS, new
40.97(a)........................... 40.29(g)(4), new
(b)(1)....................... HHS, new
(b)(2)....................... 40.29(g)(4), new
(c).......................... 40.29(g)(4)
(d)-(e)...................... New
40.99(a)(1)........................ 40.29(b)(2), HHS
(a)(2)....................... 40.29(h), HHS
(b).......................... 40.29(h)
(c)-(e)...................... New
40.101(a).......................... 40.29(n)(6), new
(b).......................... New
40.103(a).......................... 40.31(d)(1)-(2), new
(b).......................... 40.31(d)(5), new
(c).......................... 40.31(d)(3)
(c)(1)....................... HHS
(c)(2)....................... New
(d).......................... HHS, new
40.105(a).......................... 40.31(d)(7)-(8), new
(b).......................... 40.31(d)(8)
(c).......................... 40.31(d)(7), new
(d).......................... 40.31(d)(8), new
40.107............................. 40.29(1)
40.109(a)-(b)...................... New
(c).......................... 40.29(g)(6), 40.29(m)
(d).......................... 40.29(m), new
(e).......................... HHS, new
40.111............................. 40.29(g)(6), HHS, new
40.113............................. New
40.121(a).......................... 40.33(b)(1)
(b).......................... 40.33(a)
(c)-(f)...................... New
40.123............................. New
40.125............................. 40.33(b)(2), new
40.127(a).......................... 40.33(a)(2), new
(b).......................... Interp., new
(c)-(d)...................... New
(e).......................... 9/98 guidance, new
40.129(a)(1)....................... 40.33(a), interp.
(a)(2)....................... New
(a)(3)....................... 40.33(c)(1)-(2)
(a)(4)....................... 40.33(a)(2)
(a)(5)....................... New
(b).......................... Interp., new
(c).......................... 9/98 guidance
(d).......................... Interp., new
40.131(a)-(c)...................... 40.33(c)(2), new
(d).......................... 40.33(c)(3)-(4), new
40.133(a).......................... 40.33(c)(3), (c)(5)
(b).......................... New
(c).......................... 40.33(c)(6)
40.135 (a)-(c)..................... New
(d).......................... 40.33(i)(2)
40.137(a)-(b)...................... 40.33(a), (b)(3), (c)
(c)-(d)...................... Interp.
40.139(a).......................... 40.33(d)
(b).......................... New
(c).......................... 40.33(d), new
(c)(1)-(4)................... Interp., new, MRO training
materials
40.141............................. New
(a).......................... 40.33(a), (b)(3), new
(b).......................... 40.33(b)(3), new
(c).......................... 40.33(e)
40.143(a).......................... 40.33(b)(3), interp.
(b).......................... New
(c).......................... Interp.
[[Page 69090]]
(d).......................... Interp., MRO training materials
(e).......................... Interp.
(f).......................... Guidance
40.145(a).......................... New
(b).......................... 40.33(e)-(f)
(c).......................... New
(d).......................... New, interp.
(e).......................... 40.33(e)-(f)
(f).......................... Interp.
40.147(a)-(b)...................... 9/98 guidance, new
(c).......................... Interp., new
40.149(a)-(b)...................... 9/98 guidance, new
(c).......................... Interp., new
40.151(a).......................... 9/98 guidance
(b)-(c)...................... Interp., new
40.153(a).......................... 9/98 guidance, new
(b).......................... Interp., new
40.155............................. New
40.157 (a)-(b)..................... Alcohol parallel--40.65(i)
(c).......................... FMCSA regulation--49 CFR
382.407(a)(1)
(d).......................... New
40.159(a).......................... 40.33(a)(1),interp., new
(b).......................... New
(c)-(f)...................... 9/98 guidance, new
(g).......................... New
40.161(a).......................... Interp.
(b).......................... New
40.163............................. New
40.171(a).......................... 40.33(f)
(b).......................... 40.33(g)
(c).......................... Interp.
(d).......................... 40.25(f)(10)(E)
40.173............................. Interp.
40.175(a).......................... 40.129(b)(2), new
(b).......................... New
(c).......................... 40.29(c)
(c)(1)-(2)................... 40.29(b)(2), new
(d).......................... 40.25(f)(10)(F)
(e).......................... 40.33(f)
(f).......................... Interp.
(g).......................... New
40.177(a).......................... HHS
(b).......................... 40.29 (b)(3)
(c)-(d)...................... HHS
(e).......................... Interp.
40.179............................. New
40.181............................. HHS
40.183............................. 9/98 guidance, new
40.185............................. New
40.187............................. New
40.191(a)(1)....................... Interp., comment
(a)(2)....................... Modal regulations
(a)(3)....................... Interp.
(a)(4)....................... 40.25(f)(10)(iv)(2),
40.69(d)(2)(ii)
(a)(5)-(6)................... Interp.
(a)(7)....................... 40.67(a)
(b).......................... 9/98 guidance
(c).......................... Modal regulations
(d).......................... 40.67(a), interp.
(e).......................... Comment
40.193 (a)-(f), (h)-(i)............ 40.25(f)(10)(iv)
(g).......................... Guidance, new
40.195............................. Guidance, new
40.197............................. DOT and HHS guidance, interp.
40.199............................. Guidance, new
40.201............................. DOT and HHS guidance, interp., new
40.203(a).......................... 40.67(b), new
(b).......................... New, interp.
40.205............................. Interp.
40.207............................. Interp., new
40.211(a)-(c)...................... 40.51, 40.93
(d).......................... 40.51(b), new
40.213(a)(1)....................... 40.51(a)(1)
(a)(1)(i).................... 40.51(a)(2)
[[Page 69091]]
(a)(1)(ii)................... 40.51(a)(3)
(a)(1)(iii).................. Interp.
(a)(1)(iv)................... Drug parallel
(a)(2)....................... 40.93(c)
(a)(3)....................... New
(b)(1)....................... 40.51(a)(1)
(b)(1)(i).................... 40.51(a)(2)
(b)(1)(ii)................... 40.51(a)(3)
(b)(1)(iii).................. New
(b)(1)(iv)................... Drug parallel
(b)(3)....................... New
(c).......................... Interp.
(d).......................... 40.51(c)
(e)-(g)...................... New
40.215............................. New
40.217............................. New
40.221(a)-(b)...................... New
(c)-(d)...................... 40.57(a)
(e).......................... 40.57(e)
(f).......................... 40.57(b)
40.223(a).......................... 40.57, new
(b).......................... 40.55(c)
(c).......................... 40.57(c)
(d).......................... 40.57(e), 40.99(b)
(d)(1)....................... New
(d)(2)....................... Interp.
(d)(3)....................... 40.57(e), 40.99(b)
40.225(a).......................... 40.59(a)
(b)(1)....................... Drug parallel-40.23(a)(1)(i) and
CCF
(b)(2)....................... 40.59(a)
(b)(3)-(6)................... Comment
(c).......................... New
40.227(a).......................... Interp.
(b).......................... New
40.229............................. 40.53, 40.91
40.231(a).......................... 40.53(a), 40.91
(b).......................... 40.53(b)
40.233(a).......................... 40.55(a)
(a)(1)....................... 40.55(a)(1)-(3)
(a)(2)....................... 40.55(a)(4)
(b).......................... 40.55(b), (b)(1), new
(c).......................... 40.55(a)(1)
(d).......................... 40.55(b)(2)
(e).......................... 40.55(b)(4)
(f).......................... 40.55(b)(3)
40.235(a).......................... 40.95 (a), (a)(1)
(b).......................... 40.95(b), (c)
(c).......................... New
(d).......................... 40.55(a)(2)
40.241(a).......................... New
(b)(1)....................... New, Drug parallel--40.25(f)(3)
(b)(2), (b)(2)(i)............ New
(b)(2)(ii)................... Drug parallel--40.25(j)
(b)(3)....................... Drug parallel--40.25(f)(2)
(b)(4)....................... Drug parallel--40.25((f)(2), new
(b)(5)....................... 40.61(b), 40.101(d)(1)
(b)(6)-(7)................... 40.63(a), 40.101(b)
40.243(a).......................... Drug parallel--40.25(f)(7), HHS,
interp.
(b).......................... 40.63(b)
(c).......................... 40.63(c)
(d).......................... 40.63(d)(2)(i), (d)(3), (d)(4)
(e).......................... New
(f).......................... 40.63(d)(3)
(g).......................... 40.63(d)(2)(i)
40.245(a).......................... 40.101(d)(2)
(b).......................... 40.101(d)(3)
(c).......................... New
(d).......................... 40.101(d)(5)
(e).......................... 40.101(d)(6)
(f).......................... 40.101(d)(7)
(g).......................... 40.101(d)(8)
(h).......................... 40.101(d)(9)
(i).......................... 40.101(d)(10)
40.247(a).......................... 40.101(e)
[[Page 69092]]
(b)(1)....................... 40.63(e)(1), 40.101(e)
(b)(2)....................... 40.62(e)(i)(3)
(b)(3)....................... 40.63(e)(2)
(c)(1)....................... 40.63(f)
(c)(2)....................... 40.63(g), 40.101(e)
(c)(3)(i)-(iv)............... 40.63(h)(1)
(c)(3)(v)-(vii).............. 40.63(h)(2)
(c)(3)(viii)................. New
(c)(3)(ix)................... 40.63(h)(3)
(d).......................... 40.63(e)(4)
40.251(a)-(b)...................... 40.65(b), new
(c).......................... 40.63(a), 40.101(b)
(d).......................... 40.65(b), new
40.253(a).......................... 40.65(d)
(b).......................... 40.63(b), 40.65(c)(2)
(c).......................... 40.65(e)
(d).......................... 40.63(b), 40.65(c)(2)
(e)-(f)...................... 40.65(g)(1)-(2)
(g).......................... 40.65(g)(1)
40.255(a)(1)....................... 40.65(h)(1)
(a)(2)....................... 40.65(h)(1)-(2)
(a)(3)....................... 40.65(h)(3)
(a)(4)....................... 40.65(i)(1)
(a)(4)(i).................... 40.65(i)(1)-(2)
(a)(4)(ii)................... 40.65(i)(4)
(b)(1)....................... 40.65(i)(3)
(b)(2)....................... 40.65(i)(4)
40.257............................. New, drug parallel
40.261(a)(1)....................... Interp., comment
(a)(2)....................... Modal regulations
(a)(3)....................... 40.63(e)(3)
(a)(4)....................... 40.69(d)(2)(ii), drug parallel-
40.25(f)(10)(iv)(2)
(a)(5)....................... Interp.
(a)(6)....................... 40.67(a), interp.
(b).......................... Modal regulations
(c).......................... 40.67(a), interp.
40.263............................. 40.105
40.265............................. 40.69, 40.105
40.267(a)(1)....................... 40.107(a)(1)
(a)(2)....................... 40.107(a)(2)
(a)(3)....................... 40.107(a)(3)
(b).......................... 40.79(a)(7), 40.107(b)
(c)(1)....................... 40.79(a)(2)
(c)(2)-(3)................... 40.79(a)(3)
(c)(4)....................... 40.79(a)(6)
(c)(5)....................... 40.79(a)(1)
40.269(a).......................... 40.79(a)(4)
(b).......................... 40.79(a)(5), 40.107(b)
(c).......................... 40.107(a)(4)
(d).......................... New
40.271(a).......................... 40.67(b), new
(b).......................... New, interp.
40.273............................. Interp.
40.275............................. New, interp.
40.277............................. Interp.
40.281............................. Interp., new, 40.3
40.283............................. Modal regulations, new
40.285............................. Modal regulations, new
40.287(a).......................... Modal regulations, interp.
(b).......................... Modal regulations, new
(c)-(e)...................... Interp.
40.289............................. Modal regulations, SAP guidelines
40.291............................. Interp.
40.293............................. Interp., SAP guidelines, modal
regulations
40.295............................. Interp.
40.297............................. Interp., SAP guidelines
40.299(a).......................... SAP guidelines
(b).......................... SAP guidelines, modal regulations
(c).......................... Modal regulations, examples new
(d).......................... New
40.301............................. Interp., SAP guidelines, modal
regulations
40.303............................. New
40.305............................. Interp., SAP guidelines
40.307............................. Modal regulations, interp., SAP
guidelines
[[Page 69093]]
40.309............................. Modal regulations, interp., SAP
guidelines
40.311 all except.................. Interp., SAP guidelines
(e)(10), (f)................. New
40.313............................. New
40.321............................. 40.3(i), 40.35, 40.81(b), (g), (i)
(a).......................... New
(b).......................... Interp.
40.323............................. 40.35, 40.81(H)
40.325............................. New
40.327 (a)......................... 40.33(i)(1)--(2), new
(b).......................... 40.33(i)(1)(ii)--(iii)
(c).......................... New
40.329............................. New
40.331(a).......................... 40.37, 40.81(c)
(b)--(c)..................... Interp.
40.333 (a)......................... 40.81(g), (i)
(b)(1)....................... 40.81(d)
(b)(2)....................... 40.81(e), new
(c)(1)....................... 40.81(d)
(c)(2)....................... 40.81(e), new
(d).......................... 40.81(f)
(e).......................... New
40.335............................. 40.81, 382.401
40.341--40.353..................... Consortium/third party
administrator guidance
40.361--40.385..................... New
------------------------------------------------------------------------
Regulatory Analyses and Notices
This rule is a significant rule for purposes of Executive Order
12866. It is significant because of its policy importance and its
impact upon sizeable industries. It is not, however, an economically
significant regulation. It is a reworking of existing requirements,
imposing few new mandates, and should not have significant incremental
costs. Because of its multimodal impact and policy interest to
regulated parties and service agents, it is a significant rule for
purposes of the DOT Regulatory Policies and Procedures. Throughout this
regulation, we have attempted to balance the costs of new requirements
with the cost savings accrued through the elimination of some current
requirements.
There are two features of the proposed regulation that would add
new requirements that may have some economic impacts. The first is the
requirement that laboratories test for dilute, substituted, and
adulterated specimens. Existing regulations were devised before the
widespread use of ``designer'' adulterants that some employees are
putting into their urine to mask the results of positive drug tests.
The DOT has worked with HHS and laboratory scientists to develop a set
of appropriate forensic testing protocols for identifying these masking
agents.
The revision expands existing regulations and guidance concerning
these difficult testing situations by making mandatory laboratories'
use of additional protocols for discovering adulteration, as well as
for detecting situations in which an employee has substituted something
other than normal human urine for the required urine specimen. As the
result of work by HHS and the laboratories, these protocols are already
in place and are being used by most laboratories, so we expect the
incremental costs of this requirement to be modest. The Department
believes that public safety is well-served by these steps to identify
and hold accountable employees in safety-sensitive positions who
attempt to cheat the testing process.
Second, the Department is proposing additional training
requirements for some service agents. Errors in the testing process
resulting from lack of training can lead to increased employer program
costs and increased paperwork required to document the errors and
repeat the testing process. The NPRM would upgrade requirements for
urine collectors and other personnel. This additional training
requirement can be met without formalized instruction to minimize the
cost impact.
Also, MROs and SAPs would either attend a training session every
two years to keep current on developments in the field or would be
permitted to self-certify they have re-reviewed and understand the
regulations in lieu of training. These training courses already exist
and are widely attended. Again, we anticipate that overall net costs of
these new training requirements and options would be quite modest
because the requirement may be met without formalized instruction.
At the same time, the Department anticipates cost savings from some
provisions of the regulation, such as the reductions in blind specimen
requirements and mitigation of some reporting requirements. The
additional training requirements discussed in the previous paragraphs
will help to reduce costs from errors in the system. For example, every
time a better-trained collector conducts a collection properly instead
of making a mistake, the costs of developing memorandums for
correction, preparing laboratory litigation packages, arbitration or
court proceedings, and reversing personnel actions are avoided.
The Department has made some preliminary estimates of the cost
increases and decreases that could be expected if the proposed rule's
provisions are made final. It is important to understand that this is a
big program, touching some 8.34 million employees working for about
673,413 employers. Around 30,000 individuals and organizations work as
service agents.
In terms of new costs, the Department estimates an annual cost of
about $902,000 for adulterant testing plus about $25,322 for training
documentation. We believe there will not be any measurable additional
costs for actual SAP and MRO training, because most SAPs and MROs
already undergo such training as part of professional continuing
education requirements. The option also exists for MROs and SAPs to
self-administer training through study of DOT rules and guidance. In
addition, we estimate that there will be one-time costs for a variety
[[Page 69094]]
of administrative requirements in the first year of implementation of
approximately $1.93 million.
On the other hand, we anticipate saving at least $5.4 million
annually from the proposed reduction in blind specimen testing (the
savings will probably be somewhat greater, because fewer organizations
will be required to submit blind specimens). By changing the current
quarterly laboratory report requirement to require a semiannual report,
we anticipate saving another $1.69 million annually. By permitting
positive test results to be faxed rather than sent by overnight
express, we project an annual $3.1 million saving. These annual savings
are greater than the additional annual costs we anticipate for the
proposed rule.
This NPRM does not have sufficient Federalism impacts to warrant a
Federalism assessment under Executive Order 13132. With respect to the
Regulatory Flexibility Act, the Department certifies that, if adopted,
this rule would not have a significant economic impact on a substantial
number of small entities, so a Regulatory Flexibility analysis has not
been prepared. While this rule affects a large number of small
entities, we do not expect the rule to have a significant economic
impact on anyone.
This rulemaking involves a ``610 Review'' under the Small Business
Regulatory Enforcement Fairness Act. We have reviewed the existing
program to identify areas in which the rule can be improved with the
effect of assisting small businesses to comply in a rational and cost-
effective manner. In addition to the general clarification of the
program this rule provides, we have identified some specific areas
(e.g., blind specimen requirements, the addition of the public interest
exclusion provision) that should be particularly helpful to small
regulated employers. We seek comment on any changes that commenters
might suggest to further assist small businesses who are affected by
this rule.
Part 40 is one portion of a ``ONE-DOT'' drug and alcohol testing
program that also involves regulations from six DOT agencies. The costs
and impacts of Part 40 are intertwined with the costs and impacts of
the DOT agency regulations. In connection with the 610 review, we are
seeking comments on the effects of the entire program, including all
its regulatory components, on small entities and on ways of improving
the program from this point of view.
This proposed rule also contains information collection
requirements. As required by the Paperwork Reduction Act of 1995 (the
PRA, 44 U.S.C. 3507(d)), the Department has submitted these
requirements to the Office of Information and Regulatory Affairs of the
Office of Management and Budget for review, as required under the
Paperwork Reduction Act.
As noted elsewhere in this preamble, this proposed rule would amend
49 CFR Part 40 to clarify and update the Department's alcohol and drug
testing procedures. In the course of so doing, the proposal would
increase some information collection requirements and decrease others,
resulting in what we estimate to be a modest net reduction in
information collection burdens, compared to the present regulation. The
information collections involve such subjects as drug and alcohol
specimen collection, quality control, and the reporting and retention
of drug and alcohol testing information.
The regulated parties to whom these requirements apply are
transportation employers and participants in the drug and alcohol
testing industry, the numbers of which are summarized above. As
summarized above, the Department anticipates that there will be new
costs of $2.86 million and new savings of about $10.9 million, most of
which represent costs involved with information collection. In terms of
burden hours, we anticipate new collections amounting to 65,000 hours
and savings on collections amounting to 168,888 hours, resulting in a
net reduction of 103,888 hours compared to the present regulation.
The Department is soliciting comments to (1) evaluate whether the
proposed collections are necessary for the functioning of the drug and
alcohol testing program, including whether the information will have
practical utility; (2) evaluate the accuracy of the Department's
estimate of the burden; (3) enhance the quality, utility, and clarity
of the information to be collected; and (4) minimize the burden of
information collection for regulated parties, including through the use
of appropriate automated, electronic, mechanical, or other
technological information collection techniques or other forms of
information technology (for example, permitting electronic submission
of reports).
Individuals and organizations may submit comments on the
information collection elements of this NPRM by April 7, 2000 and
should direct them to the DOT docket specified at the beginning of the
NPRM. According to OMB's regulations implementing the PRA (5 CFR
1320.8(b)(2)(vi)), an agency may not conduct or sponsor, and a person
need not respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control number for this
information will be published in the Federal Register after it is
approved by OMB.
There are a number of other Executive Orders that can affect
rulemakings. These include Executive Orders 13084 (Consultation and
Coordination with Indian Tribal Governments), 12988 (Civil Justice
Reform), 12875 (Enhancing the Intergovernmental Partnership), 12630
(Governmental Actions and Interference with Constitutionally Protected
Property Rights), 12898 (Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations), 13045
(Protection of Children from Environmental Health Risks and Safety
Risks), and 12889 (Implementation of North American Free Trade
Agreement). We have considered these Executive Orders in the context of
this NPRM, and we believe that the proposed rule does not directly
affect the matters that the Executive Orders cover.
We have prepared this rulemaking in accordance with the
Presidential Directive on Plain Language.
List of Subjects in 49 CFR Part 40
Administrative practice and procedure, Alcohol abuse, Alcohol
testing, Drug testing, Laboratories, Reporting and recordkeeping
requirements, Safety, Transportation.
Issued this 29th day of November, 1999, at Washington, DC.
Rodney E. Slater,
Secretary of Transportation.
For the reasons set forth in the preamble, the Department of
Transportation proposes to revise part 40 of Title 49, Code of Federal
Regulations, to read as follows:
PART 40--PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL
TESTING PROGRAMS
Subpart A--Administrative Provisions
Sec.
40.1 Whom does this regulation cover?
40.3 What do the terms used in this regulation mean?
40.5 Who issues authoritative interpretations of this regulation?
40.7 How are exemptions granted from this regulation?
Subpart B--Participant Responsibilities
40.11 What are the basic responsibilities of employers under this
regulation?
40.13 If an employer has employees subject to testing under both
DOT and the Nuclear Regulatory Commission (NRC) regulations, what
procedures does it follow?
[[Page 69095]]
40.15 If an employer conducts non-DOT testing, under its own
authority, as well as DOT testing, what Federal restrictions apply
for the two tests?
40.17 Can an employer use a service agent to meet DOT drug and
alcohol testing requirements?
40.19 May service agents impose requirements on employers that DOT
agency regulations do not specifically authorize?
40.21 Do service agents have to comply with DOT drug and alcohol
testing requirements?
Subpart C--Urine Collection Personnel
40.31 Who collects urine specimens for DOT drug testing?
40.33 What requirements must a collector meet?
40.35 What requirements must organizations employing collectors
meet?
40.37 Where is other information on the role of collectors found in
this regulation?
Subpart D--Collection Sites, Forms, Equipment and Supplies Used in DOT
Urine Collections
40.41 Where does a urine collection for a DOT drug test take place?
40.43 What steps must collection sites take to protect the security
and integrity of urine collections?
40.45 What form is used to document a DOT urine collection?
40.47 May employers use the CCF for non-DOT collections or non-
Federal forms for DOT collections?
40.49 What materials are used to collect urine drug specimens?
40.51 What materials are used to send urine specimens to the
laboratory?
Subpart E--Drug Test Collections
40.61 What are the preliminary steps in the collection process?
40.63 What steps does the collector take in the collection process
before the employee provides a urine specimen?
40.65 What does the collector check for when the employee presents
a specimen?
40.67 When and how is a directly observed collection conducted?
40.69 When and how is a monitored collection conducted?
40.71 How does the collector process a single specimen collection?
40.73 How does the collector process a split specimen collection?
40.75 How is the collection process completed?
Subpart F--Drug Testing Laboratories
40.81 What laboratories may be used for DOT drug testing?
40.83 How do laboratories process incoming specimens?
40.85 What drugs do laboratories test for?
40.87 What methods do laboratories use for screening and
confirmation tests?
40.89 What are the cutoff concentrations for screening and
confirmation tests?
40.91 What additional testing must be done by laboratories on
primary specimens?
40.93 What methods and criteria do laboratories use for validity
testing?
40.95 What do laboratories need to report to MROs regarding primary
specimen results?
40.97 Through what methods and to whom must a laboratory transmit
results?
40.99 How long does the laboratory retain specimens after testing?
40.101 What relationship may a laboratory have with an MRO?
40.103 What blind specimens must be sent to a laboratory?
40.105 What happens if there is a laboratory error on any test?
40.107 Who may inspect laboratories?
40.109 What documentation must the laboratory keep, and for how
long?
40.111 When and how must a laboratory disclose statistical
summaries and other information it maintains?
40.113 Where is other information concerning laboratories found in
this regulation?
Subpart G--Medical Review Officers (MROs)
40.121 Who is qualified to act as an MRO?
40.123 What are the MRO's responsibilities in the DOT drug testing
program?
40.125 What relationship may an MRO have with a laboratory?
40.127 What are the MRO's functions in reviewing negative test
results?
40.129 What are the MRO's functions in reviewing laboratory
confirmed positive drug test results?
40.131 How is the employee notified of the verification process
after a confirmed positive test result?
40.133 Under what circumstances may the MRO verify a test as
positive without interviewing the employee?
40.135 What does the MRO tell the employee at the beginning of the
verification interview?
40.137 On what basis does the MRO verify test results involving
marijuana, cocaine, amphetamines, and PCP?
40.139 On what basis does the MRO verify test results involving
opiates?
40.141 How does the MRO obtain information for the verification
decision?
40.143 What are MROs prohibited from doing as part of the
verification process?
40.145 How does the MRO notify employees of their right to a test
of the split specimen or to a retest of a single specimen?
40.147 What happens when a negative or positive test result is also
dilute?
40.149 What happens when a test is not performed because of a fatal
or uncorrected flaw?
40.151 What happens when a drug test specimen is unsuitable for
testing?
40.153 What happens when a drug test specimen is substituted or
adulterated?
40.155 What happens when a drug test specimen is rejected for
testing?
40.157 How does the MRO report test results to the employer?
40.159 When MROs send reports of positive, dilute, unsuitable,
substituted, or adulterated test results to employers, what is an
employer to do?
40.161 May the employer or MRO change a verified drug test result?
40.163 Where is other information concerning the role of MROs found
in this regulation?
Subpart H--Split Specimen Tests and Retests
40.171 How does an employee request a test of a split specimen?
40.173 Who is responsible for paying for the test of a split
specimen?
40.175 What steps does the first laboratory take with a split
specimen?
40.177 What does the second laboratory do with the split specimen?
40.179 Through what methods and to whom must a laboratory transmit
split specimen results?
40.181 What information do laboratories need to report to MROs
regarding split specimen results?
40.183 What does the MRO do with the split specimen laboratory
results?
40.185 Are employees' requests for reanalysis of the specimen from
a single specimen collection handled the same way as requests for
the test of the split specimen?
40.187 Where is other information concerning split specimens found
in this regulation?
Subpart I--Problems in Drug Tests
40.191 What is a refusal to take a DOT drug test, and what are the
consequences?
40.193 What happens when an employee is unable to provide a
sufficient amount of urine for a drug test?
40.195 What happens when an individual is unable to provide a
sufficient amount of urine for a pre-employment drug test because of
a permanent or long-term disability?
40.197 What problems will always result in a drug test being
canceled?
40.199 What problems will always result in a drug test being
canceled and may result in a requirement for another collection?
40.201 What problems will result in the drug test being canceled
unless they are corrected?
40.203 How are drug test problems corrected?
40.205 What is the effect of a canceled drug test?
40.207 What is the effect of procedural problems that are not
sufficient to cancel a drug test?
Subpart J--Alcohol Testing Personnel
40.211 Who conducts DOT alcohol tests?
40.213 What requirements must STTs and BATs meet?
40.215 What requirements must organizations employing STTs and/or
BATs meet?
40.217 Where is other information on the role of STTs and BATs
found in this regulation?
Subpart K--Testing Sites, Forms, Equipment and Supplies Used In Alcohol
Testing
40.221 Where does an alcohol test take place?
[[Page 69096]]
40.223 What steps must be taken to protect the security of alcohol
testing sites?
40.225 What form is used for an alcohol test?
40.227 May employers use the BATF for non-DOT tests, and vice-
versa?
40.229 What devices are used to conduct alcohol screening tests?
40.231 What devices are used to conduct alcohol confirmation tests?
40.233 What are the requirements for proper use and care of EBTs?
40.235 What are the requirements for proper use and care of ASDs?
Subpart L--Alcohol Screening Tests
40.241 What are the first steps in any alcohol screening test?
40.243 What is the procedure for an alcohol screening test using an
EBT or non-evidential breath ASD?
40.245 What is the procedure for an alcohol screening test using a
saliva ASD?
40.247 What happens next after the alcohol screening test result?
Subpart M--Alcohol Confirmation Tests
40.251 What are the first steps in an alcohol confirmation test?
40.253 What are the procedures for conducting an alcohol
confirmation test?
40.255 What happens next after the alcohol confirmation test
result?
40.257 When BATs report test results of 0.02 or greater to
employers, what is an employer to do?
Subpart N--Problems in Alcohol Testing
40.261 What is a refusal to take an alcohol test, and what are its
consequences?
40.263 What happens when an employee is unable to provide an
adequate amount of saliva for an alcohol screening test?
40.265 What happens when an employee is unable to provide a
sufficient amount of breath for an alcohol test?
40.267 What problems always cause an alcohol test to be canceled?
40.269 What problems cause an alcohol test to be canceled unless
they are corrected?
40.271 How are alcohol testing problems corrected?
40.273 What is the effect of a canceled alcohol test?
40.275 What is the effect of procedural problems that are not
sufficient to cancel an alcohol test?
40.277 Are alcohol tests other than saliva or breath for screening
and breath for confirmation permitted under these regulations?
Subpart O--Return-to-Duty Process and Role of Substance Abuse
Professionals (SAPs)
40.281 Who is qualified to act as a SAP?
40.283 When is a SAP evaluation required?
40.285 What information is an employer required to provide
concerning SAP services to an employee who has a DOT drug and
alcohol regulation violation?
40.287 Are employers required to provide SAP and treatment services
to employees?
40.289 What is the role of the SAP in the evaluation, referral, and
treatment process of an employee who has violated the DOT drug and
alcohol regulations?
40.291 Can employees who are referred for SAP evaluations be
required to waive liability with regard to negligence or malpractice
on the part of the SAP?
40.293 What is the SAP's function in conducting the initial
evaluation of an employee?
40.295 Can employees or employers seek a second SAP evaluation if
they disagree with the first SAP's recommendations?
40.297 Does anyone (e.g., employer, managed-care ``gatekeeper,'' or
any service agent or service agent network) have the authority to
change a SAP's initial assessment recommending assistance?
40.299 What is the SAP's role and what are the limits on a SAP's
discretion in referring employees for treatment and education?
40.301 What is the SAP's function in the follow-up evaluation of an
employee?
40.303 What happens if the SAP believes the employee needs
additional treatment, aftercare, or support group services even
after the employee returns to safety-sensitive duties?
40.305 Must an employer return an employee to safety-sensitive
functions following a SAP determination that the employee
demonstrated successful compliance with the SAP's recommendation?
40.307 What is the SAP's function in prescribing the employee's
follow-up tests?
40.309 What are the employer's responsibilities with respect to the
SAP's directions for follow-up tests?
40.311 Are there any special instructions regarding SAP reports to
employers and SAP records?
40.313 Where is other information on SAP functions found in this
regulation?
Subpart P--Confidentiality and Release of Information
40.321 What is the general confidentiality rule for drug and
alcohol test information?
40.323 Can program participants release drug or alcohol test
information in connection with legal proceedings?
40.325 May service agents transfer drug or alcohol test information
to one another?
40.327 When may the MRO release medical information gathered in the
verification process?
40.329 May an MRO provide information about a positive drug test
result to another employer?
40.331 What information must laboratories and other service agents
release to employees?
40.333 To what additional parties must employers and service agents
release information?
40.335 What records must employers keep?
Subpart Q--Roles and Responsibilities of Service Agents
40.341 Can an employer use a service agent to meet DOT drug and
alcohol testing requirements?
40.343 May service agents impose requirements on employers that DOT
agency regulations do not authorize?
40.345 If, as a service agent, you fail to comply with DOT
regulations, can employers use your services?
40.347 What functions can service agents perform with respect to
selection for testing?
40.349 What requirements must a service agent implement concerning
the use and confidentiality of information?
40.351 What principles govern the interaction between MROs and
other service agents?
40.353 What other limitations apply to the activities of service
agents?
Subpart R--Public Interest Exclusions
40.361 What is the purpose of a public interest exclusion?
40.363 In what circumstances does the Department issue a public
interest exclusion concerning a service agent?
40.365 Who issues public interest exclusions on behalf of the
Department?
40.367 Who initiates the public interest exclusion process?
40.369 Does a service agent have the opportunity to correct a
problem before becoming subject to a public interest exclusion?
40.371 How does the process leading to a public interest exclusion
begin?
40.373 How does a service agent contest the issuance of a public
interest exclusion?
40.375 How does the Department make decisions in public interest
exclusion matters?
40.377 How does the Department notify service agents and employers
about decisions on public interest exclusions?
40.379 To whom does a public interest exclusion apply?
40.381 What is the effect of a public interest exclusion?
40.383 How long does a public interest exclusion stay in effect?
40.385 What is the role of the Inspector General's office?
Appendix A to Part 40--DOT Standards for Urine Collection Kits
Appendix B to Part 40--DOT Drug Testing Semi-annual Laboratory
Report
Appendix C to Part 40--CCF Copies Needed for the MRO Review
Appendix D to Part 40--DOT Drug Testing MRO Report Summary
Appendix E to Part 40--Report Format For Split Specimen Failure To
Reconfirm
Appendix F to Part 40--SAP Equivalency Requirements for
Certification Organizations
Authority: 49 U.S.C. 102, 301, 322, 5331, 20140, 31306, and
45101 et seq.
[[Page 69097]]
Subpart A--Administrative Provisions
Sec. 40.1 Whom does this regulation cover?
(a) This part tells all parties required to conduct drug and
alcohol tests by Department of Transportation (DOT) agency regulations
how to conduct these tests and what procedures to use.
(b) This part covers transportation employers, safety-sensitive
transportation employees (including self-employed individuals and
volunteers), and everyone who provides drug or alcohol testing services
to them, including, but not limited to, consortia, third-party
administrators, medical review officers (MROs), substance abuse
professionals (SAPs), urine collectors, breath alcohol technicians
(BATs), screening test technicians (STTs), and laboratories.
Sec. 40.3 What do the terms used in this regulation mean?
When the terms listed in this section occur in this part, they have
the following meanings:
Adulterated specimen. A urine specimen into which the employee has
introduced a foreign substance.
Affiliate. Persons are affiliates of one another if, directly or
indirectly, one controls or has the power to control the other, or a
third party controls or has the power to control both. Indicia of
control include, but are not limited to: interlocking management or
ownership, identity of shared interest among family members, shared
facilities or equipment, common use of employees, or a business entity
organization following the issuance of a public interest exclusion
which has the same or similar management, ownership, or principal
employees as the service agent concerning whom a public interest
exclusion is in effect.
Air blank. A reading by an evidential breath testing device of
ambient air containing no alcohol. (In evidential breath testing
devices using gas chromatography technology, a reading of the device's
internal standard.)
Alcohol. The intoxicating agent in beverage alcohol, ethyl alcohol
or other low molecular weight alcohols, including methyl or isopropyl
alcohol.
Alcohol concentration. The alcohol in a volume of breath expressed
in terms of grams of alcohol per 210 liters of breath as indicated by a
breath test under this part.
Alcohol screening device (ASD). A breath or saliva device, other
than an EBT, that is approved by the National Highway Traffic Safety
Administration (NHTSA) and placed on a conforming products list (CPL)
for such devices. An ASD can be used only for screening tests for
alcohol, and may not be used for confirmation tests.
Alcohol use. The drinking or swallowing of any beverage, liquid
mixture or preparation (including any medication), containing alcohol.
Blind specimen or blind performance test specimen. A urine specimen
submitted to a laboratory for quality control testing purposes, with a
fictitious identifier, so that the laboratory cannot distinguish it
from employee specimens, and which is spiked with known quantities of
specific drugs or which is blank, containing no drugs.
Breath Alcohol Technician (BAT). A trained and certified individual
who instructs and assists individuals in the alcohol testing process
and operates an evidential breath testing device.
Canceled test. In drug testing, a drug test that has been declared
invalid by an MRO. A canceled test is neither a positive nor a negative
test. For purposes of this part, a specimen that has been rejected for
testing by a laboratory is treated the same as a canceled test. In
alcohol testing, a test that is deemed to have a problem identified
which cannot be or has not been corrected.
Chain of custody. The procedure used to document the handling of
the urine specimen from the time the employee gives the specimen to the
collector until the specimen is destroyed. This procedure uses the
Federal Drug Testing Custody and Control Form (CCF).
Collection container. An authorized container into which the
employee urinates to provide the specimen for a drug test.
Collection site. A place selected by the employer where employees
present themselves for the purpose of providing a urine specimen for a
drug test and/or a breath or saliva specimen for an alcohol test.
Collector. A trained individual who instructs and assists employees
at a collection site, who receives and makes an initial inspection of
the urine specimen provided by those employees, and who initiates and
completes the CCF.
Confirmation (or confirmatory) test. In drug testing: the test
conducted by gas chromatography/mass spectrometry (GC/MS) to confirm
the presence of drug(s) or drug metabolite(s) detected by the screening
test at concentrations at or above cutoff concentrations established by
the Department of Health and Human Services. In alcohol testing: a
second test using an evidential breath testing device, following a
screening test with a result of 0.02 or greater, that provides
quantitative data of the alcohol concentration.
Confirmed drug test. A confirmation test result received by an MRO
from a laboratory.
Designated employer representative (DER). An employer or
individual(s) identified by the employer as able to receive
communications and test results directly from medical review officers,
BATs, screening test technicians, collectors, and substance abuse
professionals, and who is authorized to take immediate actions to
remove employees from safety-sensitive duties and to make required
decisions in the testing and evaluation processes. Service agents
cannot serve as DERs, except where a DOT agency has issued regulations
permitting them to do so.
Dilute specimen. A urine specimen whose creatinine and specific
gravity values are diminished by the employee through the introduction
of fluid (usually water) into the specimen either directly or through
excessive consumption of fluids.
DOT. Department of Transportation or any designee of the Secretary,
Department of Transportation.
DOT agency. Any agency of the Department of Transportation
administering regulations related to drug or alcohol testing, including
but not limited to the United States Coast Guard (for drug testing
purposes only), the Federal Aviation Administration, the Federal
Railroad Administration, the Federal Motor Carrier Safety
Administration, the Federal Transit Administration, the Research and
Special Programs Administration, and the Office of the Secretary. This
term includes a designee of the DOT agency.
Drugs. The drugs for which tests are required under this part and
DOT agency regulations are marijuana, cocaine, amphetamines,
Phencyclidine (PCP), and opiates.
Employee. An individual who is designated in a DOT agency
regulation as subject to drug testing and/or alcohol testing. The term
includes individuals currently occupying safety-sensitive positions
designated in DOT agency regulations and applicants for employment
subject to pre-employment testing.
Employer. An entity employing one or more employees (including an
individual who is self-employed) that is subject to DOT agency
regulations requiring compliance with this part. The term includes an
employer's officers, representatives, and management personnel. The
term, as used in this document, references the entity responsible for
overall implementation of DOT drug and alcohol program
[[Page 69098]]
requirements, as well as those individuals employed by the entity who
take personnel actions resulting from violations of this part and any
applicable DOT agency regulations. Service agents are not regarded as
employers, except where a DOT agency has issued regulations so
designating them.
Evidential Breath Testing Device (EBT). A device approved by the
National Highway Traffic Safety Administration (NHTSA) for the
evidential testing of breath, placed on NHTSA's Conforming Products
List (CPL) for ``Evidential Breath Measurement Devices'' and identified
on the CPL as conforming with the model specifications available from
NHTSA, Office of Traffic Injury Control Programs.
HHS. The Department of Health and Human Services or any designee of
the Secretary, Department of Health and Human Services.
Laboratory. Any laboratory which meets the minimum standards to
engage in urine drug testing, as set forth in Subpart C of the HHS
Mandatory Guidelines for Federal Workplace Drug Testing Programs. To
participate in the DOT drug testing program, laboratories must be
certified by HHS under the National Laboratory Certification Program
or, in the case of foreign laboratories, be approved for participation
by DOT. (The HHS Mandatory Guidelines for Federal Workplace Drug
Testing Programs is available at www.health.org/workpl.htm. and at
Division of Workplace Programs, 5600 Fishers Lane, Rockwall II, Suite
815, Rockville, MD 20856.)
Medical Review Officer (MRO). A licensed physician (doctor of
medicine or osteopathy) responsible for receiving laboratory results
generated by an employer's drug testing program who has knowledge of
substance abuse disorders and has appropriate training to interpret and
evaluate an individual's confirmed positive or ``unsuitable'' drug test
results together with his or her medical history and any other relevant
biomedical information. The MRO is also required to have a working
knowledge of this part and the DOT agency regulations applicable to the
employer(s) for which he or she evaluates drug test results.
Notice. In the context of a public interest exclusion proceeding, a
written communication served in person or sent by certified mail,
return receipt requested, or its equivalent, to the last known address
of a service agent, its identified counsel, or agent for the service of
process, or any partner, officer, director, owner, or joint venturer of
the service agent. Notice, if undeliverable, shall be considered to
have been received by the addressee five days after being properly sent
to the last address known by the Department.
Primary specimen. In drug testing: the urine specimen that is
opened and tested by a first laboratory to determine whether the
employee has drug(s) or drug metabolite(s) in his or her system. The
primary specimen is distinguished from the split specimen, defined in
this section.
Screening test (or initial test). In drug testing: an immunoassay
screen to eliminate ``negative'' urine specimens from further analysis.
In alcohol testing: an analytic procedure to determine whether an
employee may have a prohibited concentration of alcohol in a breath or
saliva specimen.
Screening Test Technician (STT). A trained individual who instructs
and assists individuals in the alcohol testing process and operates an
alcohol screening device.
Secretary. The Secretary of Transportation or the Secretary's
designee.
Service agents. All parties who provide services to employers in
connection with DOT drug and alcohol testing requirements. This
includes, but is not limited to, collection site personnel, BATs and
STTs, laboratories, MROs, substance abuse professionals, consortia, and
third-party administrators.
Shipping container. A container that is used for transporting and
protecting one or more urine specimen bottle(s) and associated
documents from the collection site to the laboratory.
Specimen bottle. The bottle that, after being sealed and labeled
according to the procedures in this part, is used to hold the urine
specimen during transportation to the laboratory.
Split specimen. A part of the urine specimen that is sent to the
first laboratory and retained unopened, and which will be transported
to a second laboratory in the event that the employee requests it be
tested following a verified positive test of the primary specimen.
Substance Abuse Professional (SAP). A licensed physician (doctor of
medicine or osteopathy); or a licensed or certified psychologist,
social worker, or employee assistance professional; or an addiction
counselor (certified by the National Association of Alcoholism and Drug
Abuse Counselors Certification Commission or by the International
Certification Reciprocity Consortium / Alcohol & Other Drug Abuse). All
must have knowledge of and clinical experience in the diagnosis and
treatment of alcohol and controlled substances-related disorders. The
SAP is also required to have a working knowledge of this part and the
DOT agency regulation applicable to the employer(s) for which he or she
evaluates employees who have engaged in a DOT drug and alcohol
regulation violation.
Substituted specimen. A specimen, not consistent with human urine,
that has been submitted by the employee in place of his or her own
urine.
Verified drug test. A certified laboratory drug test result that
has undergone review and final determination by the MRO.
Sec. 40.5 Who issues authoritative interpretations of this regulation?
The Department of Transportation (DOT) Office of Drug and Alcohol
Policy and Compliance (ODAPC) and the DOT Office of General Counsel
(OGC) provide written interpretations of the provisions of this part.
Such interpretations are the only official and authoritative
interpretations of DOT concerning the provisions of this part. DOT
agencies may incorporate ODAPC/OGC interpretations in written guidance
they transmit to parties they regulate. Only Part 40 interpretations
issued after [effective date of the final regulation] shall be
considered valid and binding.
Sec. 40.7 How are exemptions granted from this regulation?
(a) If you want an exemption from any provision of this part, you
must request it in writing from the Office of the Secretary of
Transportation, under the provisions and standards of 49 CFR part 5.
The address to send requests for an exemption is the following:
Department of Transportation, Assistant General Counsel for Regulation
and Enforcement, 400 7th Street, SW., Room 10424, Washington, DC 20590.
(b) Under the standards of 49 CFR part 5, we will grant the request
only if the request documents special or exceptional circumstances, not
likely to be generally applicable, and not contemplated in connection
with the rulemaking that established this part, that make your
compliance with a specific provision of this part impracticable.
(c) As the party granted the exemption, you must agree to take
steps we specify to comply with the intent of the provision from which
an exemption is granted.
(d) We will issue written responses to all exemption requests.
(e) When the Office of the Secretary grants or denies an exemption
request, the decision is implemented as to
[[Page 69099]]
regulated employers through the DOT agency regulations that incorporate
this part.
Subpart B--Participant Responsibilities
Sec. 40.11 What are the basic responsibilities of employers under this
regulation?
(a) As an employer, you are responsible for making sure that
everything required by this part occurs.
(b) You must conduct DOT tests of your employees in accordance with
this part. This responsibility includes ensuring that all service
agents you use comply with all requirements in this part.
(c) You are responsible for all actions of your officials,
representatives, and agents in carrying out the requirements of the DOT
agency regulations.
(d) You must include in each contract or agreement you enter into,
renew, or modify with a service agent, the following statement:
Compliance With 49 CFR Part 40
[Name of service agent] agrees to provide all services
concerning drug and/or alcohol tests required by Department of
Transportation regulations in full compliance with the provisions of
49 CFR Part 40. Compliance with Part 40 is a mandatory term of this
agreement. If the Department of Transportation determines that [name
of service agent] is in noncompliance with Part 40 with respect to
DOT regulated drug and alcohol programs, this agreement will be
terminated for cause by the employer unless the noncompliance is
corrected.
(e) If there is not a written agreement, you must ensure that the
statement in paragraph (d) of this section is stipulated to in writing
and signed by the service agent.
(f) The statement in paragraph (d) of this section shall be signed
by the service agent.
Sec. 40.13 If an employer has employees subject to testing under both
DOT and the Nuclear Regulatory Commission (NRC) regulations, what
procedures does it follow?
(a) As an employer who has employees subject to both DOT agency
drug and alcohol testing regulations and the NRC's drug and alcohol
testing regulations, you may use either procedures in this part or
procedures in NRC regulations to conduct DOT-required tests of those
employees. For example, suppose you are a nuclear power plant that
employs technicians subject to NRC testing. Some of these technicians
are also truck drivers who are subject to testing under FMCSA
regulations. You can follow either this part or NRC procedural
regulations to test these double-covered employees, and DOT will regard
you as complying with its testing procedure requirements.
(b) As an employer who has employees subject to both DOT agency
drug and alcohol testing regulations and the NRC's drug and alcohol
testing regulations, you are required to collect and maintain all drug
and alcohol testing information, in accordance with either DOT or NRC
regulations, and make arrangements for that information to be available
for inspection or submission to representatives of either agency upon
request.
Sec. 40.15 If an employer conducts non-DOT testing, under its own
authority, as well as DOT testing, what Federal restrictions apply for
the two tests?
(a) Non-DOT tests must be completely separate from DOT tests in all
respects.
(b) The DOT tests must take priority and must be conducted and
completed before a concurrent non-DOT test is begun.
(c) No tests may be performed on DOT urine or breath specimens
other than those specifically authorized by this part or DOT agency
regulations. For example, you may not test a DOT urine specimen for
additional drugs, and a laboratory may not make a DOT urine specimen
available for a DNA test or other types of specimen identity testing.
(d) The single exception to paragraph (c) of this section is when a
DOT drug test collection is conducted as part of a physical examination
required by DOT agency regulations. It is permissible to conduct
required medical tests related to this physical examination on any
urine remaining in the collection container after the drug test urine
specimen has been sealed into the specimen bottles.
(e) No one may change or disregard the results of DOT tests based
on the results of non-DOT tests. For example, an employer may not
disregard a verified positive DOT drug test result because the employee
presents a negative test result from a blood or urine specimen
collected by the employee's physician or a DNA test result purporting
to question the identity of the DOT specimen.
(f) Employers are prohibited from using the Federal Drug Testing
Custody and Control Form (CCF) and the DOT Breath Alcohol Testing Form
(BATF) in your non-DOT drug and alcohol testing programs. This
prohibition includes the use of the DOT forms with references to DOT
programs and agencies crossed out.
Sec. 40.17 Can an employer use a service agent to meet DOT drug and
alcohol testing requirements?
(a) As an employer, you are held fully responsible for compliance
with this part and DOT agency drug and alcohol testing regulations.
However, you may use a service agent to perform the tasks needed to
comply with this part and DOT agency drug and alcohol testing
regulations.
(b) As an employer, you must ensure that the service agent you use
performs these tasks in accordance with DOT agency regulations.
(c) If a service agent fails to comply with DOT agency regulations,
a DOT agency can subject you and/or the service agent to sanctions for
the noncompliance of a service agent who works for you.
Sec. 40.19 May service agents impose requirements on employers that
DOT agency regulations do not specifically authorize?
No. As a service agent, you must not impose conditions or
requirements on employers that DOT regulations do not authorize. For
example, as a consortium or third-party administrator serving employers
in the pipeline or motor carrier industry, you may not require
employers to have provisions in their DOT plans that RSPA or FMCSA
regulations do not require.
Sec. 40.21 Do service agents have to comply with DOT drug and alcohol
testing requirements?
(a) As a service agent, you must comply with this part and the DOT
agency drug and alcohol testing regulations that apply to the
transportation employer for whom you are providing services.
(b) If you do not comply, DOT may make you ineligible to
participate in DOT drug and alcohol testing. DOT will use the
procedures in Subpart R of this part to make decisions in eligibility
cases.
Subpart C--Urine Collection Personnel
Sec. 40.31 Who collects urine specimens for DOT drug testing?
(a) Collectors meeting the requirements of this subpart are the
only persons authorized to collect urine specimens for DOT drug
testing.
(b) A collector must be trained to proficiency in correctly
carrying out the urine collection requirements of this part.
(c) As the direct supervisor of a particular employee, you may not
act as the collector when that employee is tested, unless no other
collector is available and you are permitted to do so under DOT agency
regulations.
(d) You may not act as the collector for a particular employee if
you work for a HHS-certified laboratory (e.g., as a technician or
accessioner) and could
[[Page 69100]]
link the employee with a urine specimen, drug testing result, or
laboratory report.
Sec. 40.33 What requirements must a collector meet?
(a) To be a collector, you must do the following:
(1) Read the drug testing procedures in this part and the current
``DOT Urine Specimen Collection Procedures Guidelines'' and attest in
writing to your understanding of them. (The ``DOT Urine Specimen
Collection Procedures Guidelines'' is available at ODAPC, Department of
Transportation, 400 7th Street, SW., Room 10403, Washington DC, 20590.)
(2) Be trained to proficiency on collection procedures in this part
by another person(s) sufficiently knowledgeable in the applicable
collection procedures of this part to be able to evaluate the
collector's performance.
(i) The person providing the instruction must provide written
documentation that you have demonstrated proficiency in collections
under this part by your completing five consecutive error-free trial
collections.
(A) The five trial collections must include both uneventful and
problematic examples.
(B) In addition to two uneventful collection scenarios, one must
address insufficient quantity of urine, one the temperature out of
range, and one in which the employee refuses to sign the CCF.
(ii) The person providing the instruction will monitor, evaluate,
and attest whether or not the trial collections are ``error-free.''
(iii) The person providing the instruction must emphasize that you
are responsible for maintaining the integrity of the collection
process, ensuring the privacy of employees being tested, and avoiding
conduct or statements that could be viewed as offensive or
inappropriate.
(3) Meet the requirements of paragraph (b)(2) of this section by
[date six months from the effective date of the final regulation], if
you were a collector prior to [effective date of the final regulation].
Meet the requirements of paragraph (b)(2) of this section prior to your
first collection, if you become a collector after [effective date of
the final regulation].
(4) Receive additional training, as needed, to ensure proficiency
as the technology you use changes.
(5) Be retrained to proficiency if you make a mistake in the
collection process that has caused a test to be canceled.
(i) This retraining must be provided and your proficiency
documented in writing by a person sufficiently knowledgeable in the
applicable collection procedures of this part.
(ii) The instruction need only be in the general area of your
deficiency that caused the test to be canceled.
(iii) As part of the retraining, you will have to demonstrate your
proficiency in the collection procedures of this part by completing
three consecutive error-free trial collections before you conduct
another DOT collection of a safety-sensitive employee.
(iv) The person providing the instruction will monitor, evaluate,
and attest whether or not the trial collections are ``error-free.''
(b) As a collector, you must be retrained in the elements of
paragraph (a) of this section by [date one year from the effective date
of the final regulation], or two years from the date you became a
collector, whichever is later, and once every two years, thereafter.
(c) As a collector, you must maintain all documentation of
training/retraining as long as you serve as a collector.
Sec. 40.35 What requirements must organizations employing collectors
meet?
This section becomes effective [date six months from the effective
date of the final regulation].
(a) As an organization employing the collector (e.g., a
transportation employer, third-party administrator, occupational health
clinic), you must maintain in your files the following information:
(1) A signed statement by the collector that he or she has read and
understood the drug testing procedures in this part and the current
``DOT Urine Specimen Collection Procedures Guidelines'; and (2) A
signed statement by an official of the organization that the collector
has received training/retraining and has demonstrated proficiency as
required by this part.
(b) You must retain these signed statements as long as the person
performs collector functions for the organization and for 2 years after
the person ceases to perform these functions for the organization.
(c) You must provide to collectors the name and telephone number of
a designated employer representative (DER) to contact about any
problems or issues that may arise during the collection process.
Sec. 40.37 Where is other information on the role of collectors found
in this regulation?
You can find other information on the role and functions of
collectors in the following sections of this part:
Sec. 40.1--coverage.
Sec. 40.3--definition.
Sec. 40.43--steps to prepare and secure collection site.
Secs. 40.45-40.47--use of CCF.
Secs. 40.61-40.63--preliminary steps in collections.
Sec. 40.65--role in checking specimens.
Sec. 40.67--role in directly observed collections.
Sec. 40.69--role in monitored collections.
Sec. 40.71--role in single specimen collections.
Sec. 40.73--role in split specimen collections.
Sec. 40.75--chain of custody completion and finishing the collection
process.
Sec. 40.191--action in case of refusals to take test.
Sec. 40.193--action in ``shy bladder'' situations.
Sec. 40.197-40.199--collector errors in tests, effects, and means of
correction.
Subpart D--Collection Sites, Forms, Equipment and Supplies Used in
DOT Urine Collections
Sec. 40.41 Where does a urine collection for a DOT drug test take
place?
(a) A urine collection for a DOT drug test must take place in a
collection site meeting the requirements of this section.
(b) If you are operating a collection site, you must make sure that
it meets the security requirements of Sec. 40.43.
(c) If you are operating a collection site, you must have all
needed personnel, materials, equipment, facilities and supervision to
provide for the collection, temporary storage, and shipping of urine
specimens to a laboratory, and a suitable clean surface for writing.
(d) Your collection site must include a closed room within which
urination can occur.
(1) The room must provide visual and aural privacy to the employee
and a toilet for completion of urination (unless a single-use
collection container with sufficient capacity to contain the complete
void is used).
(2) Whenever available, the closed room must be a single-toilet
room with a full-length privacy door.
(3) No one but the employee may be present in the room during the
collection, except for the observer in the event of a directly observed
collection.
(e) If you are operating a collection site, you must have a source
of water for washing hands, that, if practicable, should be external to
the closed room where urination occurs. If a water source is not
available, you may meet this requirement by providing moist towelettes
outside the closed room.
(f) If a collection site fully meeting all the visual and aural
privacy requirements and security requirements of paragraph (d) of this
section is not readily available, the collection may take place at a
site that partially meets these requirements.
[[Page 69101]]
(1) Such a site is one that provides substantial visual privacy but
not aural privacy (e.g., a toilet stall with a partial-length door in a
multi-stall restroom) and meets all other requirements of this section.
(2) If you use a multi-stall restroom, you must secure all water
sources and place bluing agent in all toilets or secure the toilets to
prevent access.
(3) Such a site may be used only for monitored collections (see
Sec. 40.69). In this case, the site must afford aural privacy to the
employee to the greatest extent practicable.
(g) A collection site can be in a medical facility, a mobile
facility (e.g., a van), a dedicated collection facility, or any other
location meeting the requirements of this section.
Sec. 40.43 What steps must collection sites take to protect the
security and integrity of urine collections?
(a) Collectors and collection sites must take the steps listed in
this section to prevent unauthorized access which could compromise the
integrity of collections.
(b) As a collector, you must do the following before each
collection:
(1) Secure any water sources or otherwise make them unavailable to
employees (e.g., turn off water inlet, tape handles to prevent opening
faucets);
(2) Make sure that the water in the toilet is blue;
(3) Make sure that no soap, disinfectants, cleaning agents, or
other possible adulterants are present;
(4) Inspect the site to make sure that no foreign or unauthorized
substances are present;
(5) Tape or otherwise secure shut any movable toilet tank top, or
put bluing in the tank;
(6) Make sure that undetected access (e.g., through a door not in
your view) is not possible;
(7) Secure areas and items (e.g., ledges, trash receptacles, paper
towel holders, under-sink areas) that appear suitable for concealing
contaminants; and
(8) Recheck items in paragraphs (b) (1) through (7) of this section
following each collection to ensure the site's continued integrity.
(c) If the collection site uses a facility normally used for other
purposes, like a public rest room or hospital examining room, you must,
as a collector, also make sure before the collection that:
(1) Access to collection materials and specimens is effectively
restricted; and
(2) The facility is secured against access during the procedure to
ensure privacy to the employee and prevent distraction of the
collection site person and limited-access signs are posted.
(d) As a collector, you must take the following additional steps to
ensure security during the collection process:
(1) To avoid distraction that could compromise security, make sure
you have only one employee under your supervision at any time.
(2) To the greatest extent you can, keep an employee's collection
container within view of both you and the employee before and after the
employee has urinated.
(3) Make sure you are the only person in addition to the employee
who handles specimens before they are secured in the shipping
container.
(4) In the time between when the employee gives you the specimen
and the time you seal the specimen, remain within the collection site.
(5) Maintain personal control over each specimen and CCF throughout
the collection process.
(e) If you are operating a collection site, you must prevent
unauthorized personnel from entering any part of the site.
(1) The only people you are to treat as authorized persons are
employees being tested, collectors and other collection site workers,
DERs, employee representatives authorized by the employer (e.g.,
employer policy; labor-management agreement), and representatives of
DOT.
(2) You must make sure that all authorized persons are under the
supervision of a collector at all times when permitted into the site.
(3) You may remove any person who obstructs, interferes with, or
causes a delay in the collection process.
(4) You must make sure that no one except the employee, collector,
and monitor or direct observer enters the room in which urination
occurs.
(f) If you are operating a collection site, you must minimize the
number of persons handling specimens.
Sec. 40.45 What form is used to document a DOT urine collection?
(a) The Federal Drug Testing Custody and Control Form (CCF) must be
used to document every urine collection required by the DOT drug
testing program. The CCF must be a seven-part carbonless manifold form.
(The CCF is available at U.S. Government Printing Office,
Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250-
7954.)
(b) As a participant in the DOT drug testing program, you may not
modify or revise the CCF except as follows:
(1) You may include other information needed for billing or other
purposes necessary to the collection process.
(2) The CCF must include the employer's name, address and telephone
number, which may be preprinted, typed, or handwritten. In addition, a
consortium's or third-party administrator's name, address, and
telephone number may be included.
(3) Instead of printing the entire pages of the CCF in the colors
specified by HHS, you may use white pages with clearly discernible
borders in the specified color for each page.
(4) As an employer, you may add, in the ``Remarks'' section of the
CCF, the name of the DOT agency under whose authority the test
occurred.
(5) As a collector, you may use a CCF with your name, address, and
telephone number preprinted but under no circumstances are any
signatures to be added before the collection event.
(c) Under no circumstances may the CCF transmit personal
identifying information about an employee (other than a social security
number or other employee identification number) to a laboratory.
(d) As the collector, you must make sure that medical information
about the employee (e.g., medications the employee has taken) appears
only on the copy of the CCF given to the employee.
(e) As an employer outside the United States, you may use a
foreign-language (equivalent) version of the CCF approved by ODAPC
(e.g., in French for use in Canada or Spanish for use in Mexico).
Sec. 40.47 May employers use the CCF for non-DOT collections or non-
Federal forms for DOT collections?
(a) No. As an employer, you are prohibited from using the CCF for
non-DOT urine collections. You are also prohibited from using non-
Federal forms for DOT urine collections. Doing either subjects you to
enforcement action under DOT agency regulations.
(b) In the rare case where the collector, either by mistake, or as
the only means to conduct a test under difficult circumstances (e.g.,
post-accident test with insufficient time to obtain the CCF), uses a
non-Federal form for a DOT collection, the use of a non-Federal forms
does not, in and of itself, present a reason for the laboratory to
reject the specimen for testing or for an MRO to cancel the result.
However, if the laboratory discovers use of the incorrect form, they
must obtain a signed statement from the collector stating the reason
why the CCF was not used for the DOT collection. The MRO must
accomplish this if use of the wrong
[[Page 69102]]
form was not discovered by the laboratory.
Sec. 40.49 What materials are used to collect urine drug specimens?
For each DOT drug test, you must use a collection kit meeting the
requirements of Appendix A of this part.
Sec. 40.51 What materials are used to send urine specimens to the
laboratory?
(a) A shipping container (e.g., standard courier cardboard box,
small cardboard box) must be used that adequately protects the specimen
bottles from shipment damage in the transport of specimens from
collection site to the laboratory.
(b) A shipping container box is not necessary if a laboratory
courier hand-delivers the specimens from the collection site to the
laboratory.
Subpart E--Drug Test Collections
Sec. 40.61 What are the preliminary steps in the collection process?
As the collector, you must take the following steps before actually
beginning a collection:
(a) If an employee does not show up at the collection site at the
scheduled time, contact the DER to determine the appropriate interval
within which the employer has determined the employee is authorized to
arrive. If the employee's arrival is delayed beyond that time, you must
notify the DER that the employee is a ``no show.''
(b) Make sure that, when the employee enters the collection site,
you begin the testing process without delay. For example, you must not
wait because the employee says he or she is not ready or is unable to
urinate or because an authorized employer or employee representative is
delayed in arriving.
(1) If the employee is also going to take a DOT alcohol test, you
must make sure that the alcohol test is completed before the urine
collection process begins.
(2) If the employee needs medical attention (e.g., an injured
employee in an emergency medical facility who is required to have a
post-accident test), do not delay this treatment to collect a specimen.
(3) You may not collect (e.g., by means of catheterization) urine
from an unconscious employee for purposes drug test under this part.
(c) Require the employee to provide positive identification. You
must see a photo ID issued by the employer or a Federal, state, or
local government agency for this purpose. You may not accept faxes or
photocopies of identification. Positive identification by an employer
representative (not a co-worker or another employee being tested) is
also acceptable. If the employee cannot produce positive
identification, you must contact a DER to verify the identity of the
employee.
(d) If the employee asks, provide identification to the employee.
Your identification must include your name and your employer's name,
address, and telephone number but does not have to include your
picture, address, or telephone number.
(e) Explain the basic collection procedure to the employee,
including showing the employee the instructions on the back of the CCF.
(f) Direct the employee to remove outer clothing (e.g., coveralls,
jacket, coat, hat) and to leave these garments and any briefcase,
purse, or other personal belongings with you.
(1) If the employee asks for a receipt for any belongings left with
you, you must provide one.
(2) You must allow the employee to keep his or her wallet.
(3) You must not ask the employee to remove other clothing (e.g.,
shirts, pants, dresses, underwear), to remove all clothing, or to
change into a hospital or examination gown (unless the urine collection
is being accomplished simultaneously with a DOT agency-authorized
medical examination).
(4) You must direct the employee to empty his or her pockets and
display the items in them to ensure that no items are present which
could be used to adulterate the specimen. If nothing is there that can
be used to adulterate a specimen, the employee can place the items back
into the pockets. The employee must allow you to make this observation.
(5) You must require an employee who is wearing boots (e.g., work
boots or cowboy boots) to remove the boots and allow you to look into
the boots to ensure that no items are present which could be used to
adulterate the specimen. If nothing is there that can be used to
adulterate a specimen, the employee can put the boots back on. The
employee must allow you to make this observation.
(6) If, in your duties under paragraphs (f)(4) and (5) of this
section, you find a material or materials that could be used to alter a
specimen, you must:
(i) If the material appears to be brought to the collection site
with the intent to alter the specimen, conduct a directly observed
collection using direct observation procedures (see Sec. 40.67); or
(ii) If the material appears to be inadvertently brought to the
collection site, secure and maintain it until the collection process is
completed and conduct a normal (i.e., unobserved) collection.
(g) You must not require the employee to sign a consent, release,
or waiver of liability, or indemnification agreement with respect to
any part of the collection or testing process.
Sec. 40.63 What steps does the collector take in the collection
process before the employee provides a urine specimen?
As the collector, you must take the following steps before the
employee provides the urine specimen:
(a) Complete Step 1 of the CCF.
(b) Instruct the employee to wash and dry his or her hands at this
time. You must tell the employee not to wash his or her hands again
until after delivering the specimen to the collector. You must not give
the employee any further access to water or other materials that could
be used to adulterate or dilute a specimen.
(c) Select, or allow the employee to select, an individually
wrapped or sealed collection container from collection kit materials.
Either you or the employee, with both of you present, must unwrap or
break the seal of the collection container. You must not unwrap or
break the seal at this time on any specimen bottle. You must not allow
the employee to take anything from the collection kit into the room
used for urination except the collection container.
(d) Direct the employee to go into the room used for urination,
provide a specimen of at least 45 mL (split specimen collections) or 30
mL (single specimen collections), not flush the toilet, and return to
you with the specimen as soon as the employee has completed the void.
Except in the case of an observed or a monitored collection (see
Secs. 40.67 and 40.69), neither you nor anyone else may go into the
room with the employee.
(e) You must pay careful attention to the employee during the
entire collection process to note any conduct that clearly indicates an
attempt to substitute or adulterate a specimen (e.g., substitute urine
in plain view or an attempt to bring into the collection site an
adulterant or urine substitute.). If you detect such conduct, you must
direct that a collection take place immediately under direct
observation (see Sec. 40.67) and note the conduct and the fact that the
collection was observed in the ``Remarks'' section of the CCF. You must
also, as soon as possible, inform the DER and collection site
supervisor that the collection took place under direct observation and
the reason for doing so.
[[Page 69103]]
Sec. 40.65 What does the collector check for when the employee
presents a specimen?
As a collector, you must check the following when the employee
gives the collection container to you:
(a) Sufficiency of specimen. You must check to make sure that the
specimen contains a sufficient amount of urine (45 mL for a split
specimen collection; 30 mL for a single specimen collection).
(1) If it does not, you must follow ``shy bladder'' procedures (see
Sec. 40.193).
(2) When you follow ``shy bladder'' procedures, you must discard
the original specimen, unless another problem (i.e., temperature out of
range, apparent adulteration) also exists.
(3) You are never permitted to combine urine collected from
separate voids to create a specimen.
(b) Temperature. You must check the temperature of the specimen no
later than four minutes after the employee has given you the specimen.
(1) The acceptable temperature range is 32-38 deg.C/90-100 deg.F.
(2) You must determine the temperature of the specimen by reading
the temperature strip attached to the collection container.
(3) If the specimen temperature is within the acceptable range, you
must mark the ``Yes'' box on the CCF.
(4) If the specimen temperature is outside the acceptable range,
you must mark the ``No'' box on the CCF.
(5) If the specimen temperature is outside the acceptable range,
you must immediately conduct a new collection using the direct
observation procedures (see Sec. 40.67).
(6) In a case where a specimen is collected under direct
observation because of the temperature being out of range, you must
process both the original specimen and the specimen collected using
direct observation and send them to the laboratory. This is true even
in a case in which the original specimen has insufficient volume but
the temperature is out of range.
(7) In a case where the employee refuses to provide another
specimen (see Sec. 40.191(a)(3)) or does not provide the requisite
amount of urine (see Sec. 40.193(b)(4)) under direct observation, you
must notify the DER. As soon as you have notified the DER, you may
discard the previous specimen.
(c) Signs of adulteration or substitution. You must inspect the
specimen for unusual color, presence of foreign objects or material, or
other signs of adulteration (e.g., if you notice any unusual odor).
(1) If it is apparent from this inspection that the employee has
adulterated or substituted the specimen (e.g., blue dye in the
specimen, excessive foaming when shaken, smell of bleach), you must
immediately conduct a new collection using direct observation
procedures (see Sec. 40.67).
(2) In a case where a specimen is collected under direct
observation because of showing signs of adulteration or substitution,
you must process both the original specimen and the specimen collected
using direct observation and send them to the laboratory. This is true
even in a case in which the original specimen has insufficient volume
but it shows signs of adulteration or substitution.
(3) In a case where the employee refuses to provide another
specimen (see Sec. 40.191(a)(3)) or does not provide the requisite
amount of urine (see Sec. 40.193(b)(4)) under direct observation, you
must notify the DER. As soon as you have notified the DER, you may
discard the previous specimen.
Sec. 40.67 When and how is a directly observed collection conducted?
(a) As an employer you must direct an immediate collection under
direct observation with no advance notice to the employee, if:
(1) The laboratory reported a specimen as unsuitable for testing,
and the MRO reported to you that there was not an adequate medical
explanation for the unsuitability; or
(2) The MRO reported to you that the original positive test result
had to be canceled because the test of the split specimen was not
performed.
(b) As an employer you may direct a collection under direct
observation of an employee if:
(1) The drug test is a return-to-duty test or a follow-up test; or
(2) The MRO reports that the employee's immediately prior drug test
result was dilute.
(c) As a collector, you must conduct a collection under direct
observation under the following circumstances if:
(1) You are directed by the DER to do so (see paragraphs (a) and
(b) of this section); or
(2) You observed materials brought to the collection site or
employee conduct clearly indicating an attempt to adulterate or
substitute a specimen (see Secs. 40.61(f)(6)(i) and 40.63(e)); or
(3) The temperature on the original specimen was out of range (see
Sec. 40.65(b)(5)); or
(4) The original specimen appeared to have been adulterated or
substituted (see Sec. 40.65(c)(1)).
(d) As the collector, you must complete a new CCF for the directly
observed collection. You must enter the reason (e.g., suspected
adulteration, prior specimen dilute) for conducting the directly
observed collection in the ``Remarks'' section of the CCF.
(e) In a case where two specimens (or sets of specimens, where the
split specimen method of collection is used) are being sent to the
laboratory because of suspected adulteration or substitution at the
collection site, enter in the ``Remarks'' section of the CCF for each
specimen a notation to this effect (e.g., collection 1 of 2, or 2 of
2.).
(f) As the collector, you must make sure that the observer is the
same gender as the employee. You must never permit an opposite gender
person to act as the observer. The observer can be a different person
from the collector and need not be a qualified collector.
(g) As the collector, if someone else is to observe the collection,
you must verbally instruct that person to follow procedures at
paragraphs (h) and (i) of this section. If you, the collector, are the
observer, you too must follow these procedures.
(h) As the observer, you must watch the employee urinate into the
collection container. Specifically, you are to watch the urine go from
the employee's body into the collection container.
(i) As the observer but not the collector, you must not take the
collection container from the employee, but you must observe the
specimen as the employee takes it to the collector.
(j) As the collector, when someone else has acted as the observer
(e.g., in order to ensure a same gender observer), you must include the
observer's name in the remarks section of the CCF.
(k) As the employee, if you decline to allow a directly observed
collection required or permitted under this section to occur, this is a
refusal to test.
Sec. 40.69 When and how is a monitored collection conducted?
(a) As a collector, you are permitted to conduct a monitored
collection only if these conditions are met:
(1) A collection site fully meeting all the visual and aural
privacy requirements and security requirements of Sec. 40.41(d) is not
readily available; and
(2) The available collection site does offer substantial visual
privacy but not aural privacy (e.g., a toilet stall with a partial-
length door in a multi-stall restroom) and meets the other requirements
of Sec. 40.41.
(b) No one is permitted to conduct a monitored collection under any
other circumstances.
(c) As the collector, you must enter the reasons for conducting the
monitored collection in the ``Remarks'' section of the CCF.
(d)(1) As the collector, you must secure the room being used for
the
[[Page 69104]]
monitored collection so that no one except the employee and the monitor
can enter it until after the collection has been completed.
(2) You must also put bluing agent into the toilet's water before
the collection takes place and direct the employee not to flush the
toilet until after giving the specimen to the collector.
(e) As the collector, you must make sure that the monitor is the
same gender as the employee. You may permit an opposite gender person
to act as the monitor only if that person is a medical professional
(e.g., nurse, doctor, physician's assistant). The monitor can be a
different person from the collector and need not be a qualified
collector.
(f) As the collector, if someone else is to monitor the collection,
you must verbally instruct that person to follow procedures at
paragraph (g) of this section. If you, the collector, are the monitor,
you too must follow these procedures.
(g) As the monitor, you must not watch the employee urinate into
the collection container. However, you must stand near the enclosure in
which the collection is taking place and listen for any sounds that
could indicate an attempt to substitute or adulterate a specimen (e.g.,
opening of a plastic package or tube, an object dropping to the floor).
If you hear such sounds or make other observations indicating an
attempt to substitute a specimen, there must be an additional
collection under direct observation (see Secs. 40.63(e) and 40.67(c)).
(h) As the monitor, you must ensure that the employee takes the
collection container directly to the collector as soon has the employee
has exited the enclosure.
(i) As the collector, when someone else has acted as the monitor
(e.g., in order to ensure a same gender monitor), you must include the
name of the monitor in the remarks section of the CCF.
(j) As the employee, if you decline to permit a collection required
or permitted to be monitored under this section to be monitored, this
is a refusal to test.
Sec. 40.71 How does the collector process a single specimen
collection?
As the collector, you must take the following steps, in order,
after the employee brings the urine specimen to you:
(a) You, not the employee, must--in the employee's presence--pour
at least 30mL of urine from the collection container into the specimen
bottle.
(b) You, not the employee, must place and secure (i.e., tighten or
snap) the lid/cap on the bottle.
(c) You, not the employee, must write the date on the tamper-
evident bottle seal.
(d) You, not the employee, must seal the bottle by placing the
tamper-evident bottle seal over the bottle cap/lid and down the sides
of the bottle.
(e) You must then make sure that the employee initials the tamper-
evident bottle seal for the purpose of certifying that the bottle
contains the specimen he or she provided.
(f) You must dispose of the extra tamper-evident bottle seal if it
was included in the collection kit or on the CCF.
Sec. 40.73 How does the collector process a split specimen collection?
As the collector, you must take the following steps, in order,
after the employee brings the urine specimen to you:
(a) You, not the employee, must--in the presence of the employee--
first pour 30 mL of urine from the collection container into one
specimen bottle, to be used for the primary specimen.
(b) You, not the employee, must--in the presence of the employee--
then pour at least 15 mL of urine from the collection container into
the second specimen bottle to be used for the split specimen.
(c) You, not the employee, must place and secure (i.e., tighten or
snap) the lids/caps on the bottles.
(d) You, not the employee, must write the date on the tamper-
evident bottle seals.
(e) You, not the employee, must seal the bottles by placing the
tamper-evident bottle seals over the bottle caps/lids and down the
sides of the bottles.
(f) You must then make sure that the employee initials the tamper-
evident bottle seals for the purpose of certifying that the bottles
contain the specimens he or she provided.
Sec. 40.75 How is the collection process completed?
(a) As the collector, you must do the following things to complete
the collection process:
(1) Direct the employee to read and sign the certification
statement on Copy 4 of the CCF and provide date of birth, printed name,
and day and evening contact telephone numbers. If the employee refuses
to sign the CCF, you must note this in the ``Remarks'' section of the
CCF.
(2) Complete the collector certification section of the CCF (Step
5) by printing the name, address, and telephone number of the
collection site (Note: You may pre-print this information); checking
the box indicating whether this was a split specimen collection;
printing your name; recording the time and date of the collection; and
signing the certification statement.
(3) Sign the first line of the chain of custody block of the CCF
(Step 6), indicating that you received the specimen from the employee,
and print your name and the date.
(4) Complete the second line of the chain of custody by printing
and signing your name in the ``Specimen Released By'' block and
completing the ``Specimen Received By'' block by printing the specific
name of the courier or shipping service and the date. You must also
complete the ``Purpose of Change'' block to indicate the reason for
transfer (e.g., ``shipment to lab'').
(5) Ensure that all copies of the CCF are legible and complete.
(6) Remove Copy 5 of the CCF, give it to the employee.
(7) Place the specimen bottle(s) and Copies 1 and 2 (plus Copy 3 in
the case of a split specimen collection) of the CCF in the appropriate
pouches of the plastic bag.
(8) Using the tamper-evident seal for the plastic bag, secure both
pouches of the plastic bag, initial the seal and enter the collection
date.
(9) Advise the employee that he or she may leave the collection
site.
(10) To prepare the sealed plastic bag containing the specimens and
CCFs for shipment you must:
(i) Place the sealed plastic bag in a shipping container (e.g.,
standard courier box) designed to minimize the possibility of damage
during shipment. (More than one sealed plastic bag can be placed into a
single shipping container if you are doing multiple collections.)
(ii) Seal the container as appropriate.
(iii) If a laboratory courier hand-delivers the specimens from the
collection site to the laboratory, prepare the sealed plastic bag for
shipment as directed by the courier process.
(11) Send Copy 4 of the CCF to the MRO and Copy 7 to the DER. Keep
Copy 6 for the period of time specified by applicable DOT agency
regulations.
(b) Each time a specimen is handled or transferred, the date and
purpose of the action, as well as the individual taking the action,
must be documented on the CCF. The following are exceptions to this
general rule:
(1) The activity of couriers, express carriers, postal service
personnel, and other persons who are involved only with the
transportation of the specimen
[[Page 69105]]
to a laboratory is not required to be documented on the CCF.
(2) When a specimen already in the sealed plastic bag is put into
or taken out of secure storage before transportation personnel pick it
up, documentation on the CCF is not required.
(c) As a collector or collection site, you must make sure that each
specimen you collect is shipped to a laboratory as expeditiously as
possible, the same day preferably. You must also make sure that all
copies of the CCF are sent to the persons designated on the bottom of
the CCF as soon as the specimen is sent to the laboratory.
Subpart F--Drug Testing Laboratories
Sec. 40.81 What laboratories may be used for DOT drug testing?
(a) As a drug testing laboratory located in the U.S., you are
permitted to participate in DOT drug testing only if you are certified
by HHS under the National Laboratory Certification Program (NLCP).
(b) As a drug testing laboratory located outside of the U.S. which
is not certified by HHS under the NLCP, you are permitted to
participate in DOT drug testing only if:
(1) The DOT, based on a written recommendation from HHS, has
certified your laboratory as meeting HHS laboratory certification
standards or deemed your laboratory fully equivalent to a laboratory
meeting HHS laboratory certification standards; or
(2) The DOT, based on a written recommendation from HHS, has
recognized a foreign certifying organization as having equivalent
laboratory certification standards and procedures to those of HHS, and
the foreign certifying organization has certified your laboratory under
those equivalent standards and procedures.
(c) As a laboratory participating in the DOT drug testing program,
you must comply with the requirements of this part. You must also
comply with all applicable requirements of HHS in testing DOT
specimens, whether or not the HHS requirements are explicitly stated in
this part.
(d) If DOT determines that you are in noncompliance with this part,
you will be ineligible to participate in the DOT drug testing program,
and employers covered by DOT agency regulations will be prohibited from
using your services for DOT drug testing. You will be ineligible to
participate under these circumstances even if you continue to meet the
requirements of paragraph (a) or (b) of this section.
Sec. 40.83 How do laboratories process incoming specimens?
As the laboratory, you must do the following when you receive a DOT
specimen:
(a) Use the chain of custody on the CCF and an internal chain of
custody document(s) to maintain control and accountability of the
specimen from the time you receive it until you ultimately dispose of
it. The provisions of Sec. 40.75(b) apply to your use of chain of
custody documentation.
(b) Inspect each specimen and CCF for the following ``fatal flaws''
and take the appropriate reporting actions outlined in
Sec. 40.95(d)(4):
(1) The specimen ID numbers on the specimen bottle and the CCF do
not match;
(2) There is no specimen ID number on the specimen bottle;
(3) The specimen bottle seal is broken or shows evidence of
tampering (unless a split specimen can be redesignated, see paragraph
(f) of this section); and
(4) There is insufficient amount of urine in the primary or single
specimen bottle for analysis and any necessary reanalysis for quality
control (unless the specimens can be redesignated, see paragraph (f) of
this section) and, in the case of a single specimen, reconfirmation of
results.
(c) Inspect each specimen and CCF for the following ``correctable
flaws'' and take the appropriate actions as noted in Sec. 40.203(b):
(1) The collector's signature is omitted on the certification
statement on the CCF.
(2) The chain of custody block on the CCF is incomplete.
(3) The employee's social security number or ID number is omitted
from the CCF, unless the employee's refusal to provide the information
is noted in the ``Remarks'' section.
(d) Inspect each specimen for integrity and consistency (e.g.,
foreign material or color differences between the primary and the split
specimens).
(1) If, as a result of your receipt-inspection protocol, you note
that the primary specimen contains a visible foreign material and you
are unable to test the specimen, take appropriate reporting actions
outlined in Sec. 40.95(d)(3) and (4)(viii).
(2) If, as a result of your receipt-inspection protocol, you note
that the primary specimen shows a marked color difference (e.g., light
vs. dark, blue vs. yellow) from the split specimen, do not test the
specimen but take appropriate reporting actions outlined in
Sec. 40.95(d)(3) and (4)(viii).
(e) If the CCF is marked indicating that a split specimen
collection was collected and if the split specimen does not accompany
the primary, has leaked, or is otherwise unavailable for testing,
follow appropriate procedures outlined in Sec. 40.175(b) regarding the
unavailability of the split specimen for testing.
(f)(1) The primary specimen and the split specimen can be
redesignated (i.e., Bottle B is redesignated as Bottle A, and vice
versa) if:
(i) The primary specimen appears to have leaked out of its sealed
bottle and the laboratory believes a sufficient amount urine exists in
the split specimen to conduct all appropriate primary laboratory
testing; or
(ii) The primary specimen is labeled as Bottle B, and the split
specimen as Bottle A; or
(iii) The laboratory opens the split specimen instead of the
primary specimen, the primary specimen remains sealed, and the
laboratory believes a sufficient amount of urine exists in the split
specimen to conduct all appropriate primary laboratory testing; or
(iv) The primary specimen seal is broken but the split specimen
remains sealed and the laboratory believes a sufficient amount of urine
exists in the split specimen to conduct all appropriate primary
laboratory testing. You must also follow appropriate procedures
outlined in Sec. 40.175(b) regarding the unavailability of the split
specimen for testing.
(2) In situations outlined in paragraph (f)(1) of this section, the
laboratory shall mark through the ``A'' and write ``B,'' then initial
and date the change. A corresponding change shall be made to the other
bottle by marking through the ``B'' and writing ``A,'' and initialing
and dating the change. A notation shall be made on the original CCF
(Copy 1) and on the split specimen copy (Copy 3).
(g) Comply with all applicable provisions of the HHS Guidelines
concerning accessioning and processing of urine drug specimens.
Sec. 40.85 What drugs do laboratories test for?
As a laboratory, you must test for the following five drugs or
classes of drugs in a DOT drug test. You must not test ``DOT
specimens'' for any other drugs.
(a) Marijuana metabolites.
(b) Cocaine metabolites.
(c) Amphetamines.
(d) Opiate metabolites.
(e) Phencyclidine (PCP).
Sec. 40.87 What methods do laboratories use for screening and
confirmation tests?
As a laboratory, you must use the following methods for a DOT drug
test.
[[Page 69106]]
You may not use any other testing methods.
(a) For the screening test, you must use an immunoassay test that
meets Food and Drug Administration requirements for commercial
distribution, and has had its application in the laboratory approved by
HHS inspection criteria or validation.
(b) For the confirmation test, you must use gas chromatography/mass
spectrometry (GC/MS) and perform a quantitative analysis.
Sec. 40.89 What are the cutoff concentrations for screening and
confirmation tests?
(a) As a laboratory, you must use the cutoff concentrations
displayed in the following chart for screening and confirmation tests.
All cutoff concentrations are expressed in nanograms per milliliter
(ng/mL). The chart follows:
----------------------------------------------------------------------------------------------------------------
Type of drug Screening test Confirmation test
----------------------------------------------------------------------------------------------------------------
(1) Marijuana metabolites............ 50 .........................................................
(i) Delta-9-Tretrahydrocannabinol- .............. 15
9-carbolic acid (THC)...........
(2) Cocaine metabolites.............. 300 .........................................................
(i) Benzoylecgonine.............. .............. 150
(3) Phencyclidine (PCP).............. 25 25
(4) Amphetamines..................... 1000 .........................................................
(i) Amphetamine.................. .............. 500
(ii) Methamphetamine............. .............. 500
(Specimen must also contain amphetamine at a
concentration greater than or equal to 200 ng/mL.)
(5) Opiate metabolites............... 2000 .........................................................
(i) Codeine...................... .............. 2000
(ii) Morphine.................... .............. 2000
(Test for 6-acetylmorphine (6-AM) in the specimen)
(iii) 6-acetylmorphine (6-AM).... .............. 10
(Conduct this test only when specimen contains morphine
at a concentration greater than or equal to 2000 ng/mL.)
----------------------------------------------------------------------------------------------------------------
(b) On a screening test, you must report a result below the cutoff
concentration as negative. If the result is at or above the cutoff
concentration, you must conduct a confirmation test.
(c) On a confirmation test, you must report a result below the
cutoff concentration as negative and a result at or above the cutoff
concentration as confirmed positive.
Sec. 40.91 What additional testing must be done by laboratories on
primary specimens?
(a) As a laboratory, you must subject each primary specimen to
specimen validity testing. Specimen validity testing is the evaluation
to determine if the specimen is consistent with normal human urine.
Specifically, you will determine if certain adulterants or foreign
substances were added to the urine, if the urine was diluted, or if the
specimen was substituted.
(1) Each primary specimen must be tested for creatinine, pH, and
nitrite concentration. You must also determine the specific gravity of
the primary specimen if you find that the creatinine level is <20 mg/="" dl.="" (2)="" each="" primary="" specimen="" may="" also="" be="" tested="" for,="" but="" not="" limited="" to,="" pyridine,="" glutaraldehyde,="" bleach,="" and="" soap.="" (3)="" when="" you="" suspect="" the="" presence="" of="" an="" interfering="" substance/="" adulterant="" (e.g.,="" glutaraldehyde,="" surfactant,="" bleach)="" that="" could="" make="" a="" specimen="" unsuitable="" for="" testing,="" you="" may,="" using="" scientifically="" suitable="" validity="" tests,="" conduct="" tests="" to="" identify="" the="" interfering="" substance/="" adulterant.="" if="" you="" are="" unable="" to="" identify="" it,="" you="" may="" send="" the="" specimen="" to="" another="" hhs="" certified="" laboratory="" that="" has="" the="" capability="" of="" doing="" so.="" such="" specimen="" transfers="" must="" be="" documented="" with="" appropriate="" chains="" of="" custody.="" (b)="" specimen="" validity="" must="" be="" conducted="" on="" the="" split="" specimen="" if="" the="" split="" specimen="" fails="" to="" reconfirm="" the="" presence="" of="" the="" drug/analyte="" that="" was="" determined="" to="" be="" present="" in="" the="" primary="" specimen.="" (c)="" you="" must="" not="" use="" the="" split="" specimen="" to="" verify="" the="" primary="" specimen="" results="" for="" a="" substituted="" or="" adulterated="" result.="" (d)="" you="" must="" make="" every="" effort="" to="" conserve="" the="" specimen="" volume="" for="" possible="" future="" testing.="" sec.="" 40.93="" what="" methods="" and="" criteria="" do="" laboratories="" use="" for="" validity="" testing?="" (a)="" specimen="" validity="" can="" be="" determined="" by="" establishing="" parameters="" that="" are="" consistent="" with="" normal="" human="" urine="" and/or="" by="" testing="" for="" the="" presence="" of="" an="" abnormal="" or="" foreign="" substance="" in="" the="" urine.="" (b)="" for="" dilute="" specimens,="" at="" a="" minimum,="" creatinine="" and="" specific="" gravity="" must="" be="" measured="" by="" quantitative="" procedures="" at="" a="" cutoff="" of="" 20="" mg/dl="" and="" 1.003,="" respectively.="" (1)="" as="" a="" laboratory="" you="" must="" consider="" the="" primary="" specimen="" to="" be="" dilute="" if="" the="" creatinine="" is=""><20 mg/dl="" and="" the="" specific="" gravity="" is=""><1.003, unless="" the="" criteria="" for="" a="" substituted="" specimen="" are="" met.="" (2)="" [reserved]="" (c)="" for="" substituted="" specimens,="" at="" a="" minimum,="" creatinine="" must="" be="" measured="" by="" at="" least="" one="" quantitative="" procedure="" on="" two="" different="" aliquots="" both="" utilizing="" the="" specified="" cutoff="" of="" 5="" mg/dl.="" at="" a="" minimum,="" specific="" gravity="" must="" be="" performed="" on="" one="" of="" these="" aliquots="" utilizing="" the="" specified="" cutoffs="" of="" 1.001="" or="" 1.020.="" (1)="" as="" a="" laboratory="" you="" must="" consider="" the="" primary="" specimen="" to="" be="" substituted="" (i.e.,="" the="" specimen="" does="" not="" exhibit="" the="" clinical="" signs="" or="" characteristics="" associated="" with="" normal="" human="" urine)="" if="" the="" creatinine="" concentration="" is="">5 mg/dL and the specific gravity is
1.001 or 1.020.
(2) [Reserved]
(d) For adulterated specimens, concerning pH and nitrites, at a
minimum, two procedures must be performed for pH and nitrites. One
procedure must be quantitative and utilize the specified cutoff. The
second procedure may be qualitative, must be at least as sensitive as
the quantitative procedure, and must be performed on a separate
aliquot.
(1) As a laboratory you must consider the primary specimen to be
adulterated if the nitrite concentration is 500 g/
mL.; or if the pH is 3 or 11; or if an exogenous
substance (i.e., a substance which is not a normal constituent of
urine) or an endogenous substance at a higher concentration than normal
physiological concentration is present in the specimen.
(2) [Reserved]
[[Page 69107]]
(e) For adulterant analytes without a specified cutoff (e.g.,
glutaraldehyde, bleach, soap), at least one procedure must be performed
on two separate aliquots.
(f) All specimen validity testing methods must be characterized by
demonstrating precision and accuracy. Where cutoffs are specified, the
limit of quantitation (LOQ) and linearity must be determined. The limit
of detection (LOD) must be experimentally determined for qualitative
methods.
(g) All specimen validity tests must be performed using methods
that are validated by the laboratory. All methods used to characterize
and validate these tests must be documented in the laboratory's SOP.
Sec. 40.95 What do laboratories need to report to MROs regarding
primary specimen results?
As a laboratory, the following applies to your reports of
individual primary specimen drug test results:
(a) Before reporting a result, you must ensure that it has been
reviewed and certified as accurate by the certifying scientist.
(b) You will report drug test results as either Negative, Positive
(for a specific drug), or Test Not Performed.
(c) Additionally, you must include an appropriate comment on the
``Remarks'' line in Step 7 on the CCF when the specimen is dilute,
adulterated, substituted, or not tested for drugs (e.g., presence of a
fatal flaw or uncorrected flaw). If the additional comments cannot be
fully described on the ``Remarks'' line, you may attach a separate
sheet describing the problem, and reference the attachment on the
``Remarks'' line.
(d) When a specimen is reported as Negative, Positive, or Test Not
Performed:
(1) Negative. Check the ``Negative'' box in Step 7 on the CCF when
a negative drug test result is obtained on the initial test or on the
confirmatory test. If the specimen is also dilute, include the
statement, ``Dilute Specimen'' on the ``Remarks'' line.
(2) Positive. Check the ``Positive'' and the specific drug(s)/drug
metabolite(s) boxes in Step 7 on the CCF when a positive drug test
result is obtained on an initial test and a confirmatory test. If the
specimen is also dilute, include the statement, ``Dilute Specimen'' on
the ``Remarks'' line.
(3) Test Not Performed. Check the ``Test Not Performed'' box in
Step 7 on the CCF if the specimen is not tested because of a fatal flaw
(e.g., broken seal; specimen ID numbers do not match); not tested
because of an uncorrected flaw (e.g., a collector's signature was
omitted and a signed statement is not received to correct the error);
rejected for testing (e.g., significant color difference between the
primary and split specimens); unsuitable for testing or contains an
unidentified interfering substance and a valid drug test result cannot
be obtained; adulterated; or substituted.
(e) If the ``Test Not Performed'' box in Step 7 on the CCF is
checked, include one of the following statements (as appropriate) on
the ``Remarks'' line:
(1) ``Fatal Flaw'' (with the flaw stated).
(2) ``Uncorrected Flaw'' (with the flaw stated).
(3) ``Specimen Unsuitable: Cannot obtain valid drug test result''.
(4) ``Specimen Adulterated: Nitrite is too high''.
(5) ``Specimen Adulterated: pH is too high (or too low)''.
(6) ``Specimen Adulterated: Presence of (specify) detected''.
(7) ``Specimen Substituted: Not consistent with normal human
urine''.
(8) ``Specimen Rejected for Testing'' (with reason stated).
(f) You may not routinely report the quantitative results for
validity tests (e.g., nitrite concentration, creatinine concentration,
actual specific gravity, or actual pH) to the MRO, but may do so upon
MRO request on a case-by-case basis.
Sec. 40.97 Through what methods and to whom must a laboratory transmit
results?
(a) As a laboratory, you must transmit laboratory results directly,
and only, to the MRO at his or her place of business (not to the MRO
through a consortium or third-party administrator). You must not
transmit results to or through the DER or another service agent (e.g.,
consortia, third-party administrators).
(b) In transmitting these laboratory results:
(1) You must fax, courier, or mail a copy of the original and
fully-completed (as outlined in Sec. 40.95) Copy 2 of the CCF, which
has been signed by the individual responsible for day-to-day management
of your laboratory or the individual responsible for attesting to the
validity of test results.
(2) In addition, you may elect to forward a results report that
includes only the test result, remarks line items, the specimen number
as it appears on the CCF, and the laboratory specimen identification
number (accession number), and the cutoff concentrations for screening
and confirmation tests. This report can be transmitted through any
means that ensures accuracy and confidentiality (e.g., courier, mail,
fax, computer link), but never verbally by telephone.
(c) In transmitting these laboratory results to the MRO, you, the
MRO, and the employer must ensure the security of the transmission and
limit access to any transmission, storage, or retrieval system.
(d) In the case of a negative test, you must transmit the
laboratory result so that it reaches the MRO within 72 hours from the
time of the result.
(e) In the case of a positive test, a test not performed, or a
negative test that is dilute, you must transmit the laboratory result
so that it reaches the MRO within 24 hours from the time of the result.
Sec. 40.99 How long does the laboratory retain specimens after
testing?
(a) As a laboratory, you must keep positive urine specimens in
long-term frozen storage (-20 deg.C or less) for at least one year.
(1) Where there is a split specimen, you must keep it as well as
the positive primary specimen for the one-year period.
(2) You must keep these specimens in their original specimen
bottles.
(b) As a laboratory, you must keep a positive specimen indefinitely
if you know that there is a pending legal proceeding (e.g.,
unemployment or workers' compensation proceeding, unjust discharge or
personal injury lawsuit) for which the specimen may be evidence. You
must also keep a positive specimen beyond the one-year period if the
employee (through the MRO), employer or a DOT agency asks you.
Otherwise, you may discard the specimen at the end of the one-year
period.
(c) When you determine that a specimen is unsuitable, adulterated,
or substituted, you must keep it the same way you keep a positive
specimen.
(d) Once you have reported a negative result, a rejected for
testing result, a fatal flaw result, or an uncorrected flaw result on
the primary specimen to the MRO, you may discard the primary specimen
as well as the split specimen.
(e) As a laboratory testing the split specimen, you must keep a
split specimen that does not reconfirm the primary specimen in the same
way as you keep a positive specimen.
Sec. 40.101 What relationship may a laboratory have with an MRO?
(a) As a laboratory, you may not enter into any relationship with
an employer's MRO that creates a conflict of interest or the appearance
of a conflict of interest with the MRO's responsibilities for that
employer. You may not derive any financial benefit by having an
employer use a specific MRO.
(b) As a laboratory, you must maintain a statement, signed by the
responsible
[[Page 69108]]
person for laboratory management, for review by a DOT agency. The
statement will certify that the laboratory has no apparent financial or
potentially conflicting relationship with any MRO. The statement will
remain in effect until its conditions change, at which time you must
amend the statement to reflect current status.
Sec. 40.103 What blind specimens must be sent to a laboratory?
(a) As an employer, consortium, or third-party administrator with
2000 or more DOT-covered employees, you must send blind specimens to
laboratories you use. If you have fewer than 2000 DOT-covered
employees, you are not required to provide blind specimens.
(b) To each laboratory to which you send at least 100 specimens in
a year, you must transmit a number of blind specimens equivalent to one
percent of the specimens you send to that laboratory, up to a maximum
of 50 blind specimens in each quarter (i.e., January-March, April-June,
July-September, October-December). As a consortium or third-party
administrator, you must apply this percentage to the total number of
DOT-covered employees for whom you provide services. Your blind
specimen submissions must be evenly spread throughout the year. The
following examples illustrate how this requirement works:
(1) Example 1. You send 1500 specimens to Lab X in Year 1. In this
case, you would send 15 blind specimens to Lab X in Year 1. To meet the
even distribution requirement, you would send 4 in each of three
quarters and 3 in the other.
(2) Example 2. You send 1000 specimens to Lab X and 500 specimens
to Lab Y in Year 1. In this case, you would send 10 blind specimens to
Lab X and 5 to Lab Y in Year 1. The even distribution requirement would
apply in a similar way to that described in Example 1.
(3) Example 3. Same as Example 2, except that you also send 10
specimens to Lab Z. In this case, while you would send blind specimens
to Labs X and Y as in Example 2, you would not have to send any blind
specimens to Lab Z, because you sent fewer than 100 specimens to Lab Z.
(4) Example 4. You are a consortium sending 1000 specimens to Lab X
in Year 1. These 1000 specimens represent 150 small employers who have
an average of 15 covered employees each. In this case you--not the
individual employers--send 10 blind specimens to Lab X in Year 1, again
ensuring even distribution. The individual employers you represent are
not required to provide any blind specimens on their own.
(5) Example 5. You are a large third-party administrator that sends
40,000 specimens to Lab Y in Year 1. One percent of that figure is 400.
However, the 50 blind specimen per quarter ``cap'' means that you need
send only 50 blind specimens per quarter, rather than the 100 per
quarter you would have to send to meet the one percent rate. Your
annual total would be 200, rather than 400, blind specimens.
(c) Approximately 80 percent of the specimens you submit must be
blank (i.e., containing no drugs). The rest must be positive for one or
more of the five drugs involved in DOT tests.
(1) The blind specimens that you submit must be certified by
immunoassay and GC/MS and have stability data that verifies the
materials' performance over time.
(2) You may not obtain blind specimens from the laboratory to which
they are being sent, or knowingly, from any affiliate of that
laboratory.
(d) You must make sure that each blind specimen is
indistinguishable to the laboratory from a normal specimen.
(1) You must submit blind specimens to the laboratory through the
same channels (e.g., via a regular collection site) that employees'
specimens are sent to the laboratory.
(2) You must make sure that the collector uses a CCF, placing
fictional initials on the specimen bottle label/seal, indicating on
Copy 4 that the specimen is a blind specimen, and discarding Copy 5.
(3) If you normally send split specimens to the laboratory, the
blind specimens you send must be split specimens.
Sec. 40.105 What happens if there is a laboratory error on any test?
(a) If a laboratory error (either a false positive or false
negative) occurs, the MRO or other party discovering the error must
promptly notify ODAPC.
(b) When an error is brought to its attention, ODAPC will notify
HHS. HHS will take any appropriate action under its Guidelines.
(c) If the error is determined to be the result of an
administrative problem (e.g., specimen mix-up, clerical mistake), the
laboratory, at the direction of ODAPC and in consultation with HHS,
must take corrective action. If there is reason to believe that the
error could have been systematic, ODAPC may also require review and
reanalysis of previous specimens.
(d) If the error is determined to be technical or methodological in
origin, the laboratory, at the direction of ODAPC and in consultation
with HHS, must submit all quality control and subject data from the
batch of specimens that included the error.
(1) The laboratory, at the direction of ODAPC and in consultation
with HHS, may be required to retest all specimens for the drug(s)/drug
metabolite(s) involved in the error from the time the error is resolved
back to the time of the last satisfactory performance test cycle.
(2) The individual responsible for day-to-day management of the
laboratory's drug testing program must document this retesting through
a signed statement.
(3) ODAPC may require an unannounced on-site review of the
laboratory.
Sec. 40.107 Who may inspect laboratories?
As a laboratory, you must permit an inspection, with or without
prior notice, by ODAPC or a DOT agency.
Sec. 40.109 What documentation must the laboratory keep, and for how
long?
(a) As a laboratory, you must keep for at least one year all
records pertaining to each DOT urine specimen for which you obtain a
negative test result or did not test because of a fatal flaw or an
uncorrected flaw.
(b) As a laboratory, you must keep for at least five years all
records pertaining to each DOT urine specimen for which you obtain a
positive test result, determine that the specimen is unsuitable, or
determine that the specimen is substituted or adulterated.
(c) As a laboratory, you must keep for two years employer-specific
data required in Sec. 40.111.
(d) As a laboratory, you must keep for two years personnel files on
individuals with access to specimens; quality assurance and quality
control records; procedure manuals; performance records on performance
testing; and results of certification inspections. You must maintain
these longer if asked to do so in writing by a DOT agency.
(e) As a laboratory, you must keep documents for any specimen known
to be under legal challenge for an indefinite period.
Sec. 40.111 When and how must a laboratory disclose statistical
summaries and other information it maintains?
(a) As a laboratory, you must transmit an aggregate statistical
summary of the data listed in Appendix B of this part to the employer
on a semi-annual basis.
(1) The summary must not reveal the identity of any employee.
(2) In order to avoid sending data from which it is reasonably
likely that information about a employee's test
[[Page 69109]]
result can be readily inferred, you must not send a summary if the
employer has fewer than five aggregate tests results.
(3) When the condition in paragraph (a)(2) of this section exists,
you must send the employer a report indicating that insufficient
testing was conducted to warrant a summary.
(4) The summary must be sent by January 15 of each year for the
last 6 months (i.e., July 1 through December 31) of the prior year.
(5) The summary must be sent by June 15 of each year for the last 6
months (i.e., January 1 through June 30) of the current year.
(b) You must also provide the summary when the employer needs it in
response to an inspection, audit, or review by a DOT agency.
(c) You must also release information to appropriate parties as
provided in Secs. 40.331 and 40.333.
Sec. 40.113 Where is other information concerning laboratories found
in this regulation?
You can find more information concerning laboratories in several
sections of this part:
Sec. 40.3--definition.
Sec. 40.15--prohibition on making specimens available for other
purposes.
Sec. 40.31--conflicts of interest concerning collectors.
Sec. 40.47--laboratory rejections of test for improper form.
Sec. 40.125--conflicts of interest concerning MROs.
Sec. 40.175--role of first laboratory in split specimen tests.
Sec. 40.177--role of second laboratory in split specimen tests.
Sec. 40.179--40.181--transmission of split specimen test results to
MRO.
Sec. 40.199--40.203--role in correcting errors.
Sec. 40.331--provision of records to interested parties.
Sec. 40.333--limits on release of information.
Sec. 40.351--role with respect to other service agents.
Subpart G--Medical Review Officers (MROs)
Sec. 40.121 Who is qualified to act as an MRO?
You are qualified to act as an MRO in the DOT drug testing program
only if you meet each of the following criteria:
(a) You are a licensed physician (Doctor of Medicine or
Osteopathy).
(b) You have knowledge of and clinical experience in controlled
substances abuse disorders, including detailed knowledge of alternative
medical explanations for laboratory confirmed positive drug tests.
(c) You have working knowledge of laboratory results relating to
adulterated and substituted specimens as well as the possible medical
causes of specimens being unsuitable for testing.
(d) You have a working knowledge of this part, the DOT MRO
Guidelines, and the DOT agency regulation applicable to the employers
for which you evaluate drug test results.
(e) You participate in and document training (e.g., a course) at
least once every two years that relates directly to the MRO
responsibilities of the DOT program, or self-certify that you have re-
reviewed and understand this part and the applicable DOT guidelines.
You must retain these records for two years.
(f) If you were an MRO prior to the date these regulations are
published, you must meet the requirements of paragraph (e) of this
section by [date six months from the effective date of the final
regulation]. If you become an MRO after [effective date of the final
regulation], you must meet the requirements of paragraph (e) of this
section prior to acting as an MRO.
Sec. 40.123 What are the MRO's responsibilities in the DOT drug
testing program?
As an MRO, you have the following basic responsibilities:
(a) You must act as an independent and impartial ``gatekeeper'' for
the accuracy and integrity of the drug testing process.
(b) You must provide a quality assurance review of the drug testing
process for the specimens under your purview. This includes, but is not
limited to:
(1) Ensuring the review of the CCF on all specimen collections for
the purposes of determining whether there is a problem that may cause a
test to be canceled (see Secs. 40.197 and 40.201);
(2) Providing feedback to collection sites and laboratories
regarding performance issues where necessary; and
(3) Reporting to the ODAPC or a relevant DOT agency any program
issue for which you need assistance in resolving.
(c) You must determine whether there is a legitimate medical
explanation for confirmed positive drug tests results from the
laboratory.
(d) You must act to investigate and correct problems where
possible, or notify appropriate parties (e.g., HHS/DWP, DOT/ODAPC,
employers, service agents) where assistance is needed, (e.g., canceled
or problematic tests, incorrect results, problems with blind
specimens).
(e) You must ensure the timely flow of test results and other
information to employers.
(f) You must protect the confidentiality of the testing process.
(g) You must perform all your functions in compliance with this
part and other DOT agency regulations.
Sec. 40.125 What relationship may an MRO have with a laboratory?
(a) As an MRO, you may not enter into any relationship with an
employer's laboratory that creates a conflict of interest or the
appearance of a conflict of interest with your responsibilities for
that employer. You may not derive any financial benefit by having an
employer use a specific laboratory.
(b) As an MRO, you must maintain a statement for review by a DOT
agency. The statement will certify that you do not have any financial
or potentially conflicting relationship with any laboratory. The
statement will remain in effect until its conditions change, at which
time you must amend the statement to reflect current status.
Sec. 40.127 What are the MRO's functions in reviewing negative test
results?
As the MRO, you must do the following with respect to negative drug
test results you receive from a laboratory, prior to verifying the
result and releasing the result to the DER:
(a) Review Copy 4 of the CCF to determine if there are any errors
in the chain of custody or elsewhere that may require you to cancel the
test (see Secs. 40.197, 40.199, and 40.201).
(1) Staff under your direct, personal supervision may conduct this
administrative review for you (including the steps set forth in
paragraphs (b) through (e) of this section), but only you can cancel a
test.
(2) On specimen results that are reviewed by your staff, you are
responsible for assuring the quality of their work.
(i) You are required to personally review at least 10 percent of
the CCFs reviewed by your staff on a quarterly basis, and take
corrective action as necessary to ensure compliance with this part.
(ii) You must attest to the quality assurance review by initialing
the CCFs which you reviewed.
(iii) You must mark these CCFs to make them easily identifiable for
review by DOT agencies.
(b) You may report a negative test result when you are in
possession of a copy of Copy 2 or the original Copy 2 of the CCF, or
you are in possession of the laboratory results report that conveys the
negative laboratory test result. In addition, you must have a copy of
Copy 4 or the original Copy 4 of the CCF, or any copy of the CCF
containing the employee's signature.
[[Page 69110]]
(c) If the copy of the documentation provided to you by the
laboratory appears unclear or erroneous, you must request that the
laboratory send you an original or certified true copy.
(d) On Copy 4 of the CCF, place a check mark in the ``Negative''
box in Step 8 and sign, initial, or stamp and date the verification
statement.
(e) Report the result directly to the DER in a confidential manner.
Sec. 40.129 What are the MRO's functions in reviewing laboratory
confirmed positive drug test results?
(a) As the MRO, you must do the following with respect to confirmed
positive drug tests you receive from a laboratory, prior to verifying
the result and releasing the result to the DER:
(1) Review the CCF to determine if there are any errors in the
chain of custody or elsewhere that may require you to cancel the test
(see Secs. 40.197. 40.199, and 40.201). Staff under your direct,
personal supervision may conduct this administrative review for you,
but only you may cancel a test.
(2) If the copy of the documentation provided to you by the
laboratory appears unclear or possibly erroneous, you must request that
the laboratory send you an original or certified true copy.
(3) Except in the circumstances spelled out in Sec. 40.133, conduct
a verification interview. This interview must include direct contact in
person or by telephone between you and the employee.
(4) Verify the test result as either positive or negative, or
cancel the test, consistent with the requirements of Secs. 40.135
through 40.139.
(5) Report verified positive drug test results directly to the DER
in a confidential manner, consistent with the requirements of
Sec. 40.157.
(b) You may only report a positive test result when you are in
possession of a copy of Copy 2 or the original Copy 2 of the CCF. In
addition, you must have a copy of Copy 4 or the original Copy 4 of the
CCF, or any copy of the CCF containing the employee's signature.
(c) Place a check mark in the ``Positive'' box in Step 8 on Copy 4
of the CCF, indicate the drug(s)/drug metabolite(s) detected on the
``Remarks'' line, sign and date the verification statement, and report
the result directly to the DER.
Alternative 1 for Paragraph (d)
(d) As the MRO, you must never inform the employer that you have
received an employee's laboratory confirmed positive test result. You
are prohibited from reporting any information to the DER or other
persons until you verify the test result. For example, as an MRO
employed directly by a company, you must not tell anyone on the
company's staff or management that you have received an employee's
laboratory confirmed positive test result, and you must structure the
way in which this information is received and stored to make sure that
other personnel of the company do not have access to it.
Alternative 2 for Paragraph (d)
(d)(1) As the MRO, except as provided in paragraph (d)(2) of this
section, you must never inform the employer that you have received an
employee's laboratory confirmed positive test result. You are
prohibited from reporting any information to the DER or other persons
until you verify the test result. For example, as an MRO employed
directly by a company, you must not tell anyone on the company's staff
or management that you have received an employee's laboratory confirmed
positive test result, and you must structure the way in which this
information is received and stored to make sure that other personnel of
the company do not have access to it.
(2) If an employer has a stand-down policy that meets the
requirements of Sec. 40.159(a), you may report to the DER that you have
received an employee's laboratory confirmed positive laboratory test
result.
Sec. 40.131 How is the employee notified of the verification process
after a confirmed positive test result?
(a) When, as the MRO, you receive a confirmed positive test result
from the laboratory, along with the appropriate collection
documentation (see Appendix C of this part), you must contact the
employee directly, on a confidential basis, and determine whether the
employee wants to discuss the test result. In making this contact, you
must explain to the employee that, if he or she declines to discuss the
result, you will verify the test as positive.
(b) As the MRO, staff under your personal supervision may conduct
this initial contact for you.
(1) This staff contact must be limited to explaining the
consequences of the employee's declining to speak with you and
scheduling the discussion between you and the employee.
(2) A staff person must not gather any medical information or
information concerning possible explanations for the confirmed positive
test result.
(3) A staff person may advise an employee to have medical
information ready to present at the interview with the MRO.
(4) Since you are required to speak personally with the employee,
your staff must not inquire if the employee wishes to speak with you.
(c) As the MRO, if you cannot reach the employee directly after
making reasonable efforts (at a minimum, two attempts) to reach the
employee at the day and/or evening telephone numbers listed on the CCF
over a period of at least 24 hours, you must:
(1) Document the efforts you made to contact the employee,
including dates and times.
(2) Contact the DER, instructing the DER to contact the employee.
(i) You must simply direct the DER to inform the employee to
contact you.
(ii) You must not inform the DER that the employee has a confirmed
positive test result.
(iii) You must document the dates and times of your attempts to
contact the DER, and you must document the name of the DER you
contacted and the date and time of the contact.
(d) As the DER, you must attempt to contact the employee
immediately, using procedures that protect, as much as possible, the
confidentiality of the MRO's request that the employee contact the MRO.
If you contact the employee, you must document the date and time of the
contact, and inform the MRO.
(1) As the DER, you must not inform anyone else working for the
employer that you are seeking to contact the employee on behalf of the
MRO.
(2) If, as the DER, you have made all reasonable efforts to contact
the employee but failed to do so, you may place the employee on
temporary medically unqualified status or medical leave.
(i) Reasonable efforts include, as a minimum, two attempts to reach
the employee at the day and/or evening telephone numbers listed on the
CCF over a period of 24 hours. As the DER, you must document the dates
and times of these efforts.
(ii) If, as the DER, you are unable to contact the employee within
this 24-hour period, you must leave a message for the employee by any
practicable means (e.g., voice mail, E-mail, letter) to contact the MRO
and inform the MRO of the date and time of this attempted contact.
Sec. 40.133 Under what circumstances may the MRO verify a test as
positive without interviewing the employee?
(a) As the MRO, you normally may verify a confirmed positive test
result only after interviewing the employee as provided in Secs. 40.135
through 40.143. However, there are three circumstances
[[Page 69111]]
in which you may verify a confirmed positive test result (regardless of
which drugs are involved) without such an interview:
(1) You may verify a test result as positive if the employee
expressly declines the opportunity to discuss the test with you.
Complete documentation of this occurrence must be made, including
notation of informing, or attempting to inform, the employee of the
consequences of not exercising the option to speak with the MRO.
(2) You may verify a test result as positive if neither you nor the
DER, after making all reasonable efforts, has been able to contact the
employee within 14 days of the date on which the MRO receives the
confirmed positive test result from the laboratory.
(3) You may verify a test result as positive if you or the DER has
successfully made and documented a contact with the employee and
instructed the employee to contact the MRO (see Sec. 40.131(c) and
(d)), and more than 72 hours have passed since the time DER contacted
the employee.
(b) As the MRO, when you verify a test result as positive under
this section, you must document the date, time and reason.
(c) As the MRO, if you verify a test result as positive under this
section, you must allow the employee to present information to you
documenting that serious illness, injury, or other circumstances
unavoidably precluded contact with the MRO and/or DER in the times
provided.
(1) On the basis of such information, you may reopen the
verification, allowing the employee to present information concerning a
legitimate medical explanation for the confirmed positive test result.
(2) If you conclude that there is a legitimate medical explanation
for the positive test result, you must change the verified result to
negative, and report the change directly to the DER.
Sec. 40.135 What does the MRO tell the employee at the beginning of
the verification interview?
As the MRO, you must provide the following information to the
employee at the beginning of the verification interview:
(a) You must tell the employee that the laboratory has determined
that the employee's test result was positive. You must also tell the
employee of the drugs for which his or her specimen tested positive.
(b) You must explain the verification interview process to the
employee, and that you will decide whether to verify the test result as
positive based on information the employee provides in the interview.
(c) You must explain that, if further medical evaluation is needed
for the verification process, the employee must comply with your
request for this evaluation and that failure to do so is equivalent of
expressly declining to discuss the drug test result.
(d) You must tell the employee that you are authorized to provide
to the employer, DOT, or another Federal safety agency any positive
test result or medical information he or she provides during the
interview under the circumstances stated in Sec. 40.327. This may
include providing information to employers concerning medication or
medical conditions that could adversely affect the employee's safety-
sensitive duties.
Sec. 40.137 On what basis does the MRO verify test results involving
marijuana, cocaine, amphetamines, and PCP?
(a) As the MRO, you must verify a confirmed positive test result
for marijuana, cocaine, amphetamines, and/or PCP unless the employee
presents a legitimate medical explanation for the presence of the
drug(s)/drug metabolite(s) in his or her system.
(b) You must offer the employee an opportunity to present a
legitimate medical explanation in all cases.
(c) The employee has the burden of presenting evidence that a
legitimate medical explanation exists. If you determine that there is
such an explanation, you must verify the test result as negative.
Otherwise, you must verify the test result as positive.
(d) In determining whether a legitimate medical explanation exists,
you may consider the employee's use of a medication from a foreign
country where it can be substantiated that the medication was legally
obtained and used.
Sec. 40.139 On what basis does the MRO verify test results involving
opiates?
As the MRO, you must proceed as follows when you receive laboratory
confirmed positive opiate results:
(a) If the laboratory detects the presence of 6-acetylmorphine (6-
AM) in the specimen, you must verify the test result positive.
(b) In the absence of the 6-AM, if the laboratory detects the
presence of either morphine or codeine at 15,000 ng/mL or above, you
must verify the test result positive unless the employee presents a
legitimate medical explanation for the presence of the drug metabolite
in his or her system, as in the case of other drugs (see Sec. 40.137).
Consumption of food products (e.g., poppy seeds) must not be considered
a legitimate medical explanation for the employee having morphine or
codeine at these levels.
(c) For all other opiate positive results, you must verify a
confirmed positive test result for opiates only if you determine that
there is clinical evidence, in addition to the urine test, of
unauthorized use of any opium, opiate, or opium derivative (i.e.,
morphine or codeine).
(1) As an MRO, it is your responsibility to use your best
professional and ethical judgement and discretion to determine whether
there is clinical evidence of unauthorized use of opiates. Examples of
information that you may consider in making this judgement include, but
are not limited to, the following:
(i) Recent needle tracks;
(ii) Behavioral and psychological signs of acute opiate
intoxication or withdrawal;
(iii) Clinical history of unauthorized use, such as an admission by
the employee that an opiate drug was ingested without legal
authorization; or
(iv) Use of a medication from a foreign country where it cannot be
substantiated that the medication was legally obtained and legally
used.
(2) In order to establish the clinical evidence referenced in
paragraphs (c)(1)(i) and (ii) of this section, personal observation of
the employee is essential.
(i) Therefore, you, as the MRO, must conduct, or cause to be
conducted, a face-to-face interview with the employee.
(ii) No face-to-face interview is needed in establishing the
clinical evidence referenced in paragraphs (c)(1)(iii) and (iv) of this
section.
(3) To be the basis of a verified positive result for opiates, the
clinical evidence you find must concern a drug metabolite that the
laboratory found in the specimen. (For example, if the test confirmed
the presence of codeine, and the employee admits to unauthorized use of
hydrocodone, you do not have grounds for verifying the test positive.
The admission must be for the substance that was found).
(4) As the MRO, you have the burden of establishing that there is
clinical evidence of unauthorized use of opiates referenced in this
paragraph (c). If you cannot make this determination (e.g., there is
not sufficient clinical evidence and the employee does not state that
he or she used opiates), you must verify the test as negative. The
employee does not need to show you that a legitimate medical
explanation exists if no clinical evidence is established.
[[Page 69112]]
Sec. 40.141 How does the MRO obtain information for the verification
decision?
As an MRO, you must do the following as you make the determinations
needed for verification decision.
(a) You must conduct a medical interview. You may review the
employee's medical history and any other relevant biomedical factors.
You may direct the employee to undergo further medical evaluation by
you or another physician.
(b) When the employee asserts that the presence of a drug(s)/drug
metabolite(s) in his or her system results from taking prescription
medication, you must review all medical records the employee provides.
You may contact the employee's physician or other relevant medical
personnel for further information.
(c) Before completing the verification process, and at your sole
discretion, you may direct the laboratory to conduct a reanalysis of
the primary specimen. (You may do so regardless of whether a single
specimen or split specimen collection is involved.) You may choose the
laboratory that tested the primary specimen or another HHS-certified
laboratory for this reanalysis. The purpose of this reanalysis is to
gather further information concerning any questions you have about the
technical or scientific validity of the laboratory's test.
Sec. 40.143 What are MROs prohibited from doing as part of the
verification process?
As an MRO, you are prohibited from doing the following as part of
the verification process:
(a) You must not consider any evidence from tests of urine samples
or other body fluids or tissues (e.g., blood or hair samples) that are
not obtained or tested in accordance with this part. For example, if an
employee tells you he went to his own physician, provided a urine
specimen, sent it to a laboratory, and received a negative test result
or a DNA test result questioning the identity of his DOT specimen, you
are required to ignore this test result.
(b) In reviewing the CCF, you must not consider evidence
inessential to the documents in determining whether the test is valid.
For example, you must review only what is on the face of the CCF for
this purpose, not assertions by the employee that the CCF does not
accurately reflect what happened at the collection site.
(c) It is not your function to determine whether the employer
should have directed that a test occur. For example, if an employee
tells you that the employer misidentified him as the subject of a
random test, or directed him to take a reasonable suspicion or post-
accident test without proper grounds under a DOT agency regulation, you
must inform the employee that you cannot play a role in deciding these
issues.
(d) It is not your function to consider explanations of confirmed
positive test results that would not, even if true, constitute a
legitimate medical explanation. For example, an employee may tell you
that someone slipped amphetamines into her drink at a party, that she
unknowingly ingested a marijuana brownie, or that she traveled in a
closed car with several people smoking crack. MROs are unlikely to be
able to verify the facts of such passive or unknowing ingestion
stories. Even if true, such stories do not present a legitimate medical
explanation. Consequently, you must not declare a test as negative
based on an explanation of this kind.
(e) You must not verify a test negative based on information that a
physician recommended that the employee use a drug listed in Schedule I
of the Controlled Substances Act (e.g., under a state law that purports
to authorize such recommendations, such as the ``medical marijuana''
laws that some states have adopted).
(f) You must never accept an assertion of consumption or other use
of a hemp or other marijuana-related product as a basis for verifying a
marijuana test negative. Consuming or using such a product is not a
legitimate medical explanation.
Sec. 40.145 How does the MRO notify employees of their right to a test
of the split specimen or to a retest of a single specimen?
(a) You must notify the employee of procedures for requesting a
retest of the specimen (single specimen collections) or a test of the
split specimen (split specimen collections). The purpose of these tests
is to determine whether drug(s)/drug metabolite(s) are present in the
specimen tested.
(b) You must inform the employee that he or she has 72 hours to
make a timely request for the additional test.
(c) You must tell the employee how to contact you in order to make
a timely request. You must provide telephone numbers or other
information that will allow the employee to make this request. As the
MRO, you must have the ability to receive the employee's calls at all
times during the 72 hour period (e.g., by use of an answering machine
with a time stamp feature when there is no one in your office to answer
the phone).
(d) You must tell the employee that if he or she requests the
additional test in a timely manner, the employer must ensure that the
test takes place, and that the employee is not required to pay for the
test from his or her own funds before the test takes place. You must
also tell the employee that the employer may seek reimbursement for the
cost of the test (see Sec. 40.173).
(e) You must tell the employee that, when the test resulted from a
split specimen collection, a retest of the primary specimen is not
authorized.
(f) You must tell the employee that additional tests of the
specimen (e.g., DNA tests) are not authorized.
Sec. 40.147 What happens when a negative or positive test result is
also dilute?
(a) As the MRO, when the laboratory reports that the specimen was
dilute, you must report directly to the DER that, in addition to the
specimen being negative or positive, the specimen was dilute and that
the next time the employee is selected for a drug test the employer may
require the specimen to be collected under direct observation.
(b) You must note that the specimen is dilute on the ``Remarks''
line in Step 8 on Copy 4 of the CCF.
(c) You may only report a dilute test result when you are in
possession of a copy of Copy 2 or the original Copy 2 of the CCF. In
addition, you must have a copy of Copy 4 or the original Copy 4 of the
CCF, or any copy of the CCF containing the employee's signature.
Sec. 40.149 What happens when a test is not performed because of a
fatal or uncorrected flaw?
(a) As the MRO, when the laboratory reports that a specimen test
must be canceled because of a fatal or uncorrected flaw, you must place
check marks in the ``Test Not Performed'' and ``Test Canceled'' boxes
in Step 8 Copy 4 of the CCF and enter, ``Fatal Flaw, ________'' (with
the flaw stated) or ``Uncorrected Flaw, ________'' (with the flaw
stated), as appropriate, on the ``Remarks'' line.
(b) Report directly to the DER that the test is canceled, the
reason for cancellation, and that no further action is required unless
a negative test result is required (e.g., pre-employment, return-to-
duty, follow-up).
(c) You may only report a fatal or uncorrected flaw test result
when you are in possession of a copy of Copy 2 or the original Copy 2
of the CCF. In addition, you must have a copy of Copy 4 or the original
Copy 4 of the CCF, or any copy of the CCF containing the employee's
signature.
[[Page 69113]]
Sec. 40.151 What happens when a drug test specimen is unsuitable for
testing?
(a) As the MRO, when the laboratory reports that the test result is
``Test Not Performed--Specimen Unsuitable: Cannot obtain valid drug
test result,'' you must do the following:
(1) Discuss the laboratory results with the certifying scientist to
obtain more specific information.
(2) Contact the employee and inform the employee that the specimen
was not suitable for testing or contained an unexplained interferant.
(3) After explaining the limits of disclosure (see Sec. 40.327),
you should inquire as to medications the employee may have taken that
may interfere with some immunoassay tests.
(4) If the employee gives an explanation that is acceptable, you
must:
(i) Place check marks in the ``Test Not Performed'' and ``Test
Canceled'' boxes in Step 8 on Copy 4 of the CCF and enter ``Specimen
Unsuitable: Cannot obtain valid drug test result'' on the ``Remarks''
line.
(ii) Report directly to the DER that the test is canceled, the
reason for cancellation, and that no further action is required unless
a negative test result is required (e.g., pre-employment, return-to-
duty, follow-up).
(5) If the employee is unable to provide an explanation and/or a
valid prescription for a medication that interfered with the
immunoassay test but denies having adulterated the specimen, you must:
(i) Place check marks in the ``Test Not Performed'' and ``Test
Canceled'' boxes in Step 8 on Copy 4 of the CCF and enter ``Specimen
Unsuitable: Cannot obtain valid drug test result'' on the ``Remarks''
line.
(ii) Report directly to the DER that the test is canceled, the
reason for cancellation, and that a second collection must take place
immediately under direct observation.
(b) You may only report an unsuitable for testing test result when
you are in possession of a copy of Copy 2 or the original Copy 2 of the
CCF. In addition, you must have a copy of Copy 4 or the original Copy 4
of the CCF, or any copy of the CCF containing the employee's signature.
(c) If the employee admits to having adulterated the specimen, you
must follow procedures outlined in Sec. 40.153.
Sec. 40.153 What happens when a drug test specimen is adulterated or
substituted?
(a) As the MRO, when the laboratory reports that the test result is
``Test Not Performed--Specimen Adulterated/Substituted,'' you must do
the following:
(1) Check the ``Test Not Performed'' box in Step 8 on Copy 4 of the
CCF and enter ``Adulterated,'' or ``Substituted,'' and ``Refusal to
test'' on the ``Remarks'' line.
(2) Report directly to the DER that the specimen was adulterated or
substituted, either of which constitutes a refusal to test.
(3) Also, inform the DER that the employee has no right to have the
split specimen tested (or to have a retest of a single specimen). You
must not authorize a test of a split specimen or a retest of the
primary specimen following an adulterated or substituted test result.
The laboratory has already tested two aliquots of the primary specimen
to confirm the accuracy of their result.
(b) You may only report an adulterated or substituted testing test
result when you are in possession of a copy of Copy 2 or the original
Copy 2 of the CCF. In addition, you must have a copy of Copy 4 or the
original Copy 4 of the CCF, or any copy of the CCF containing the
employee's signature.
Sec. 40.155 What happens when a drug test specimen is rejected for
testing?
(a) As the MRO, when the laboratory reports that the test result is
``Test Not Performed--Specimen Rejected for Testing,'' you must do the
following:
(1) Rule out collector error as the reason the specimen was
rejected for testing. You may consult with the laboratory and must
consult with the collection site in making this determination.
(2) If the rejection is a result of collector error, you must:
(i) Place check marks in the ``Test Not Performed'' and ``Test
Canceled'' boxes in Step 8 on Copy 4 of the CCF and enter ``Specimen
Rejected for Testing: Collection Error____________'' (with reason
stated) on the ``Remarks'' line.
(ii) Report directly to the DER that the test is canceled, the
reason for the cancellation, and that a second collection must take
place immediately. This collection is not to be conducted under direct
observation.
(3) If you determine that the rejection is not a result of
collector error, you must:
(i) Place check marks in the ``Test Not Performed'' and ``Test
Canceled'' boxes in Step 8 on Copy 4 of the CCF and enter ``Specimen
Rejected for Testing: ____________'' (with reason stated) on the
``Remarks'' line.
(ii) Report directly to the DER that the test is canceled, the
reason for cancellation, and that a second collection must take place
immediately under direct observation.
(b) You may only report a specimen rejected for testing test result
when you are in possession of a copy of Copy 2 or the original Copy 2
of the CCF. In addition, you must have a copy of Copy 4 or the original
Copy 4 of the CCF, or any copy of the CCF containing the employee's
signature.
Sec. 40.157 How does the MRO report test results to the employer?
As the MRO, you must report all drug test results (e.g., positive,
negative, test not performed, canceled) directly to the DER in a
confidential manner.
(a) You must make the reports and other communications concerning
test results directly to the DER.
(b) You must as expeditiously as possible, the same day preferably,
report directly to the DER verified positive test results, results
requiring an immediate collection under direct observation, and
adulterated or substituted specimen results.
(1) Direct telephone contact with the DER is the preferred method
of immediate reporting.
(2) You are responsible for identifying yourself to the DER, and
the DER must have a means to confirm your identification.
(3) Your report shall contain all of the information in paragraph
(c) of this section.
(c) In all cases, verified test results must be provided directly
to the DER in writing. The report must include the following
information:
(1) A statement that the test was conducted in accordance with this
part;
(2) The full name, as indicated on the CCF, of the employee tested;
(3) The type of test as indicated on the CCF (e.g., random, post-
accident);
(4) The date and location of the collection;
(5) The identities of the persons or entities performing the
collection, analyzing the specimen, and serving as the MRO for the
test;
(6) The result of the test (e.g., positive, negative, test not
performed, and canceled) and the date the result was verified; and (7)
For verified positive tests, the substance for which the test was
positive.
(d) Within three days of your verification of the result, you must
provide the DER the signed, written report of the verified test result.
(1) For any result (positive, negative, test not performed, or
canceled), you may use Copy 4 of the CCF or a legible photocopy of it.
If you provide a written report to the employer using any means other
than Copy 4, you must retain a signed (for positive, test not
performed, or canceled tests) or stamped (for a negative test) Copy 4
in your records.
[[Page 69114]]
(2) For a negative test, if you do not use Copy 4 of the CCF or a
legible photocopy of it, you may use such means as a letter listing
negative results for a group of specimens, each identified by its
specimen ID number, or an individual letter providing each test result.
(3) You must not use Copy 1 or Copy 2 to report negative drug test
results. Your signature must be on the report; you may sign or rubber-
stamp the report of the result (or a staff member can rubber-stamp it
for you with your written authorization). You may not use electronic
signatures for this purpose.
(4) For a positive test, you must make sure that your signature and
the substance(s) for which the test was positive are legibly noted in
Step 8 of the CCF. You must sign the report; rubber stamps are not
acceptable. You may not use electronic signatures for this purpose.
(5) For a test not performed or for a canceled test, you must make
sure that your signature and the required explanation(s) for the result
are legibly noted in Step 8 of the CCF. You must sign the report;
rubber stamps are not acceptable. You may not use electronic signatures
for this purpose.
Sec. 40.159 When MROs send reports of positive, dilute, unsuitable,
substituted, or adulterated test results to employers, what is an
employer to do?
Alternative 1 for Paragraph (a)
(a) As an employer, you must never take any personnel or
disciplinary action, permanent or temporary, related to a DOT drug test
(including removing the employee from safety-sensitive functions)
before receiving a verified positive test result from the MRO.
Specifically, you are prohibited from standing-down an employee on the
basis of information or belief that the employee has a laboratory
confirmed positive drug test result. You may, however, temporarily
medically disqualify an employee in the circumstances spelled out in
Sec. 40.131(d)(2).
Alternative 2 for Paragraph (a)
(a) As an employer, you must never take any permanent personnel or
disciplinary action, related to a DOT drug test, before receiving a
verified positive drug test result from the MRO.
(1) However, you may stand-down an employee (i.e., temporarily
remove the employee from the performance of safety-sensitive functions)
after your DER is informed by the MRO that the individual has a
laboratory confirmed positive drug test result, pending the completion
of the MRO's verification process.
(2) If you choose to stand-down an employee, you must ensure that
information about the laboratory confirmed positive test result or the
reason for the employee's temporary removal from performance of safety-
sensitive functions is not made available by the MRO or DER to any
other employees of your organization or other persons.
(3) If the MRO reports to you that the test has been verified
negative or has been canceled, you must immediately return the employee
to the performance of safety-sensitive duties, without any adverse
consequences to the employee and with no notation of the stand-down or
the laboratory confirmed positive test result retained in any records
pertaining to the employee. You may also temporarily medically
disqualify an employee in the circumstances referenced in
Sec. 40.131(d)(2).
(b) As an employer who receives a verified positive test result
from the MRO, you must immediately remove the employee involved from
performing safety sensitive functions. You must take this action upon
receiving the initial report from the MRO. Do not wait to receive the
written report or the result of a split specimen test.
(c) As an employer who receives a test result from the MRO
indicating that the employee's specimen was adulterated or substituted,
you must consider this a refusal to test and immediately remove the
employee involved from performing safety sensitive functions. You must
take this action on receiving the initial report from the MRO. Do not
wait to receive the written report.
(d) As an employer who receives a test result from the MRO
indicating that the employee's specimen was dilute, the next time the
employee is selected for a drug testing, you may require the specimen
to be collected under direct observation.
(e) As an employer who receives a test result from the MRO
indicating that the employee's specimen was unsuitable for testing or
rejected for testing and that a second collection must take place under
direct observation--
(1) You must immediately direct the employee to provide a new
specimen under direct observation.
(2) You must not attach consequences to the finding of
unsuitability other than collecting a new specimen under direct
observation.
(3) You must not give any advance notice of this test requirement
to the employee and can only notify the employee immediately before the
collection.
(4) You must instruct the collector to note on the CCF the same
reason (e.g. random test, post-accident test) as for the original
collection.
(f) As an employer who receives a canceled test result when a
negative result is required (e.g., pre-employment, return-to-duty, or
follow-up test), you must direct the employee to provide another
specimen.
(g) As an employer, you may also be required to take additional
actions required by DOT agency regulations (e.g., FAA requires some
positive drug tests to be reported to the Federal Air Surgeon).
Sec. 40.161 May the employer or MRO change a verified drug test
result?
(a) As the employer, you must not change a test result that you
have received from the MRO.
(b) As the MRO, you may change a verified drug test result only in
the following situations:
(1) When you have reopened a verification that was done without an
interview with an employee, as in Sec. 40.133(c).
(2) If you receive information, not available to you at the time of
the original verification, demonstrating that the laboratory made an
error in identifying (e.g., a paperwork mistake) or testing (e.g., a
false positive or negative) the employee's primary or split specimen.
For example, suppose the laboratory originally reported a positive test
result for Employee X and a negative result for Employee Y. You
verified the test results as reported to you. Then the laboratory
notifies you that it mixed up the two test results, and X was really
negative and Y was really positive. You would change X's test result
from positive to negative and contact Y to conduct a verification
interview.
(3) If you receive, within 60 days of the original verification
decision, information that could not reasonably have been provided to
you at the time of the decision demonstrating that there is a
legitimate medical explanation for the presence of drug(s)/ drug
metabolite(s) in the employee's specimen. For example, if the
employee's physician provides you a valid prescription that he or she
failed to find at the time of the original verification, you may change
the test result from positive to negative if you conclude that the
prescription provides a legitimate medical explanation for the drug(s)/
drug metabolite(s) in the employee's specimen. If you receive the
information after the 60 day period, you must consult with ODAPC prior
to changing the result.
[[Page 69115]]
(4) When you have made an administrative error and reported an
incorrect result.
(c) As the MRO, in any case where you change a result, you must
notify the DER of the changed result as provided in Sec. 40.157.
Sec. 40.163 Where is other information concerning the role of MROs
found in this regulation?
You can find more information concerning the role of MROs in
several sections of this part:
Sec. 40.3--definition.
Sec. 40.67--role in direct observation and other atypical test
situations.
Sec. 40.83--corrective actions in atypical test situations.
Sec. 40.95--receipt of laboratory reports.
Sec. 40.99--authorization of longer laboratory retention of
specimens.
Sec. 40.101--relationship with laboratories; avoidance of conflicts
of interest.
Sec. 40.107--notification of laboratory errors.
Sec. 40.171--request for test of split specimen.
Sec. 40.183--action concerning split specimen test results.
Sec. 40.191--role in ``shy bladder'' situations.
Sec. 40.193--role in canceling tests.
Secs. 40.199-40.203--documenting errors in tests.
Sec. 40.325--transfer of records.
Sec. 40.327--confidentiality and release of information.
Sec. 40.329--providing information to other employers.
Sec. 40.351--relationships with service agents.
Subpart H--Split Specimen Tests And Retests
Sec. 40.171 How does an employee request a test of a split specimen?
(a) As an employee, when the MRO has notified you that you have a
verified positive test, you have 72 hours from the time of notification
to request a test of the split specimen. The request may be verbal or
in writing. If you make this request to the MRO within 72 hours, you
trigger the requirements of this section for a test of the split
specimen.
(b)(1) If, as an employee, you have not requested a test of the
split specimen within 72 hours, you may present to the MRO information
documenting that serious injury, illness, lack of actual notice of the
verified positive test, inability to contact the MRO (e.g., there was
no one in the MRO's office and the answering machine was not working),
or other circumstances unavoidably prevented you from making a timely
request.
(2) As the MRO, when you conclude from the employee's information
that there was a legitimate reason for the employee's failure to
contact you within 72 hours, you must direct that the test of the split
take place, just as you would when there is a timely request.
(c) As an employer, you may authorize the MRO to act on a request
for the test of a split specimen that an employee makes later than 72
hours from the time of notification.
(d) When the employee makes a valid request for a test of the split
specimen under paragraphs (a) through (c) of this section, as the MRO,
you must immediately provide written notice to the laboratory that
tested the primary specimen, directing the laboratory to forward the
split specimen to a second HHS-certified laboratory and identifying the
drug(s)/drug metabolite(s) to be tested for. You must also document the
date and time of the employee's request.
Sec. 40.173 Who is responsible for paying for the test of a split
specimen?
(a) As the employer, you are responsible for making sure that the
MRO, first laboratory, and second laboratory perform the functions
noted in Secs. 40.175 and 40.177 in a timely manner, once the employee
has made a timely request for a test of the split specimen.
(b) As the employer, you must not condition your compliance with
these requirements on the employee's direct payment to the MRO or
laboratory or the employee's agreement to reimburse you for the costs
of testing. For example, if you ask the employee to pay for some or all
of the cost of testing the split specimen, and the employee is
unwilling or unable to do so, you must make sure that the test takes
place in a timely manner, even though this means that you pay for it.
(c) As the employer, you may seek payment or reimbursement of all
or part of the cost of the split specimen by the employee. This
regulation takes no position on who ultimately pays the cost of the
test, so long as the employer ensures that the testing is conducted as
required.
Sec. 40.175 What steps does the first laboratory take with a split
specimen?
(a) As the laboratory at which the primary and split specimen first
arrive, you must check to see whether the split specimen as well as the
primary specimen is available for testing.
(b) If the split specimen is unavailable or appears insufficient,
you must still test the primary specimen. You must then do the
following:
(1) Report the results for the primary specimen without providing
the MRO information regarding the unavailable split specimen.
(2) Upon receiving a letter from the MRO instructing you to forward
the split specimen to another laboratory for testing, report to the MRO
that the split specimen is unavailable for testing, and provide as much
information as you can as to the cause of the unavailability.
(c) If the split specimen is available and appears sufficient, you
must keep it in secure, short-term refrigerated storage (with
temperatures not to exceed 6 deg.C) until you have completed the test
of the primary specimen.
(1) If the test of the primary specimen is negative, you may
discard the primary and split specimens.
(2) If the test of the primary specimen is a confirmed positive, or
is adulterated or substituted, you must retain the primary and split
specimens for one year unless you are requested to keep it longer.
(d) As the laboratory that tested the primary specimen, you are not
authorized to open the split specimen under any circumstances.
(e) When you receive written notice from the MRO that the employee
has made a valid request (i.e., for a verified positive test result,
not an adulterated or substituted test result) for a test of the split
specimen, you must forward the following things to a second laboratory.
(1) The split specimen in its original specimen bottle, with the
seal intact.
(2) A copy of the MRO's written request, which identifies the
drug(s)/drug metabolite(s) to be tested for.
(3) The split specimen copy of the CCF with appropriate chain of
custody entries.
(4) Your external chain of custody for specimen transfer.
(f) You must not send to the second laboratory any information
about the identity of the employee. Inadvertent disclosure does not
cause a fatal flaw.
(g) This subpart does not prescribe who gets to decide which
laboratory is used to test the split specimen. That decision is left to
the parties involved.
Sec. 40.177 What does the second laboratory do with the split
specimen?
(a) As the laboratory testing the split specimen, you must test the
split specimen for the drug(s)/drug metabolite(s) detected in the
primary specimen.
(b) You must conduct this test, using GC/MS, at the level of
detection without regard to the cutoff concentrations of Sec. 40.89.
(c) If the test fails to reconfirm the presence of the drug(s)/drug
metabolite(s) that was reported positive in the primary specimen, you
must conduct validity tests in an attempt to determine the reason for
being unable to reconfirm the presence of the drug(s)/drug
metabolite(s). You should conduct the same validity tests as you would
conduct on a primary specimen set forth in Sec. 40.91.
[[Page 69116]]
(d) If unable to conduct the validity tests, you must send the
split specimen and Copy 3 of the CCF using chain of custody procedures
to a third laboratory that has the capability to conduct the validity
tests. If the validity tests conducted by the third laboratory do not
determine the reason for being unable to reconfirm the presence of the
drug(s)/drug metabolite(s) in the split specimen, the third laboratory
must test the split specimen for the drug(s)/drug metabolite(s) found
in the primary specimen by the first laboratory.
(e) You must not conduct tests of the split specimen for any
purposes (e.g. for adulterants found in the primacy specimen) other
than reconfirming the presence of the drug(s)/drug metabolite(s)
detected in the primary specimen or conducting the validity tests in
paragraphs (c) and (d) this section.
Sec. 40.179 Through what methods and to whom must a laboratory
transmit split specimen results?
(a) As the laboratory testing the split specimen, you must transmit
laboratory results directly, and only, to the MRO at his or her place
of business (not to the MRO through a consortium or third-party
administrator). You must not transmit results to or through the DER or
another service agent (e.g., consortia, third-party administrators).
(b) You must fax, courier, or mail a copy of the original and
fully-completed Copy 3 of the CCF, which has been signed by the
individual responsible for day-to-day management of your laboratory or
the individual responsible for attesting to the validity of split
specimen test results.
(c) You must transmit the laboratory result so that it reaches the
MRO within 24 hours from the time of the split specimen test result.
Sec. 40.181 What information do laboratories need to report to MROs
regarding split specimen results?
(a) As the laboratory responsible for testing the split specimen,
you must report split specimen test results as either Reconfirmed
[notating the specific drug in the appropriate drug(s)/drug
metabolite(s) box(es)], Failed to Reconfirm, or Test Not Performed in
Step 7 on Copy 3 of the CCF.
(b) Additionally, you must include an appropriate comment on the
``Remarks'' line if you find that the specimen is adulterated or
substituted, or if the drug test was not performed.
(c) You must check the ``Failed to Reconfirm'' box in Step 7 on
Copy 3 of the CCF if the drug(s)/drug metabolite(s) is not detected,
the specimen is adulterated, or the specimen is substituted.
(d) If you check the ``Failed to Reconfirm'' box, one of the
following statements must be included (as appropriate) on the
``Remarks'' line:
(1) ``Drug/Drug Metabolite Not Detected''.
(2) ``Specimen Adulterated: Nitrite is too high''.
(3) ``Specimen Adulterated: pH is too high (or too low)''.
(4) ``Specimen Adulterated: Presence of __________ (specify)
Detected''.
(5) ``Specimen Substituted: Not consistent with normal human
urine''.
(e) You must check the ``Test Not Performed'' box in Step 7 on Copy
3 of the CCF if the specimen is not tested or if the testing could not
be completed successfully.
(f) If you check the ``Test Not Performed'' box one of the
following statements must be included (as appropriate) on the
``Remarks'' line:
(1) ``Fatal Flaw, __________ (with the flaw stated)''.
(2) ``Uncorrected flaw, __________ (with the flaw stated)''.
(3) ``Specimen Unsuitable: Cannot obtain valid confirmatory test
result''.
(4) ``Specimen Unsuitable: Insufficient specimen volume to complete
testing''.
Sec. 40.183 What does the MRO do with the split specimen laboratory
results?
As an MRO, you must take the following actions when a laboratory
reports:
(a) Reconfirmed. (1) Check the ``Reconfirmed'' box in Step 8 on
Copy 3 of the CCF.
(2) Indicate the specific drug/drug metabolite detected on the
``Remarks'' line.
(3) Report the reconfirmation directly to the DER and the employee.
(b) Failed to Reconfirm: Drug/Drug Metabolite Not Detected. (1)
Check the ``Failed to reconfirm: Both tests canceled'' box in Step 8 on
Copy 3 of the CCF.
(2) Report directly to the DER and the employee that both tests
must be canceled.
(3) Using a format that includes the items in Appendix E, inform
ODAPC of the failure to reconfirm.
(c) Failed to Reconfirm: Specimen Adulterated/Substituted. (1)
Check the ``Failed to Reconfirm'' box.
(2) Line through the accompanying phrase, ``Both tests canceled.''
(3) Enter (as appropriate) ``Adulterated'' or ``Substituted,'' and
``Refusal to test'' on the ``Remarks'' line in Step 8 on Copy 3 of the
CCF.
(4) Report directly to the DER and the employee that the specimen
was adulterated or substituted, either of which constitutes a refusal
to test. Therefore, ``refusal to test'' becomes the final, single
result for both tests.
(d) Test Not Performed. (1) Check the ``Test not performed: Both
tests canceled'' box in Step 8 on Copy 3 of the CCF.
(2) Provide the reason for the test not being performed on the
``Remarks'' line.
(3) Report directly to the DER and the employee that both tests
must be canceled and the reason for cancellation.
(4) Order an immediate collection of another specimen from the
employee under direct observation and inform the DER that no advance
notice should be given to the employee of this collection requirement,
until immediately before the collection.
(5) Using a format that includes the items in Appendix E of this
part, inform ODAPC of the failure to reconfirm.
Sec. 40.185 Are employees' requests for reanalysis of the specimen
from a single specimen collection handled the same way as requests for
the test of the split specimen?
(a) Yes. When an employee makes a request for a reanalysis of the
specimen from a single specimen collection, all the provisions of this
subpart apply just as they do in the case of the request for a test of
a split specimen.
(b) Such reanalysis may be conducted in the same laboratory that
originally tested the specimen, or may be conducted in another HHS
laboratory.
Sec. 40.187 Where is other information concerning split specimens
found in this regulation?
You can find more information concerning split specimens in several
sections of this part:
Sec. 40.3--definition.
Secs. 40.63-40.65--quantity of split specimen.
Sec. 40.67--directly observed test when split specimen is
unavailable.
Secs. 40.73-40.75--collection process for split specimens.
Sec. 40.83--laboratory accessioning of split specimens.
Sec. 40.95--laboratory reports of unavailability.
Sec. 40.99--laboratory retention of split specimens.
Sec. 40.103--blind split specimens.
Sec. 40.145--MRO notice to employees on tests of split specimen.
Sec. 40.153--use for other purposes prohibited.
Sec. 40.157--employer actions.
Secs. 40.193-40.205--MRO actions on insufficient or unavailable
split specimens.
Sec. 40.329--MRO provision of information to other employers.
[[Page 69117]]
Subpart I--Problems in Drug Tests
Sec. 40.191 What is a refusal to take a DOT drug test, and what are
the consequences?
(a) As an employee, you have refused to take a drug test if you:
(1) Fail to show up for any test within a reasonable time after
being directed to do so by the employer. This includes the failure of
an employee (including an owner-operator) to appear for a test when
called by a third-party administrator or consortium. (see
Sec. 40.61(a));
(2) Fail to provide a urine specimen for any drug test required by
this part or DOT agency regulations;
(3) In the case of a directly observed or monitored collection in a
drug test, fail to permit the observation or monitoring of your
provision of a specimen (see Secs. 40.67(k) and 40.69(i));
(4) Fail to provide a sufficient amount of urine when directed,
unless the physician has determined, through a required medical
evaluation, that there was an adequate medical explanation for the
failure (see Sec. 40.193(d)(2));
(5) Fail to drink fluids as directed by the collector following a
failure to provide a sufficient amount of urine (see
Sec. 40.193(b)(2));
(6) Fail to undergo an additional medical examination, as directed
by the MRO as part of the verification process, or as directed by the
physician conducting the evaluation as part of the ``shy bladder''
procedures of this part; or
(7) Fail to cooperate (e.g., leave the test site before the
collection process is completed, refuse to empty pockets or boots) with
any part of the testing process.
(b) As an employee, you are also considered to have refused to take
a drug test if your specimen is found to have been adulterated or
substituted.
(c) As an employee, if you refuse to take a drug test, you incur
the consequences specified under DOT agency regulations for a violation
of those DOT agency regulations.
(d) As a collector or an MRO, or as the physician evaluating a
``shy bladder'' condition, when an employee refuses to participate in
the part of the testing process in which you are involved, you must
terminate the portion of the testing process in which you are involved,
document the refusal on the CCF (or in a separate document which you
cause to be attached to the form), and notify the DER.
(e) As an employee, when you refuse to take a non-DOT test or to
sign a non-DOT testing or consent form, you have not refused to take a
DOT test. There are no consequences under DOT agency regulations for
such a refusal.
Sec. 40.193 What happens when an employee is unable to provide a
sufficient amount of urine for a drug test?
(a) If an employee is unable to provide a sufficient amount of
urine to permit a valid drug test (i.e., 30 mL of urine for a single
specimen collection or 45 mL of urine for a split specimen collection),
the following steps must be taken.
(b) As the collector, you must do the following:
(1) Discard the insufficient specimen, except where the
insufficient specimen was out of temperature range or showed evidence
of adulteration or tampering (see Sec. 40.65(b) and (c)).
(2) Direct the employee to drink up to 40 ounces of fluid,
distributed reasonably through a period of up to three hours, or until
the individual has provided a new sufficient amount of urine, whichever
occurs first.
(3) If the employee refuses to drink fluids as directed or to
provide a new urine specimen, you must discontinue the collection, note
the fact in the ``Remarks'' section of the CCF, and immediately notify
the DER. This is a refusal to test.
(4) If the employee has not provided a sufficient specimen within
three hours of the first unsuccessful attempt to provide the specimen,
you must discontinue the collection, note the fact in the ``Remarks''
section of the CCF, and immediately notify the DER.
(c) As the DER when the collector informs you that the employee has
not provided a sufficient amount of urine (see paragraph (b)(4) of this
section), you must direct the employee to obtain, within five working
days, an evaluation from a licensed physician who is acceptable to the
employer concerning the employee's medical ability to provide a
sufficient amount of urine. This physician may, but need not, be the
MRO. DOT agency regulations may specify a different time period within
which this evaluation must take place.
(d) As the examining physician, you must make one of the following
determinations, in your reasonable medical judgment:
(1) A medical condition has, or with a high degree of probability
could have, precluded the employee from providing a sufficient amount
of urine. In this case, the test is canceled.
(2) There is not an adequate basis for determining that a medical
condition has, or with a high degree of probability could have,
precluded the employee from providing a sufficient amount of urine.
This is a refusal to test.
(e) For purposes of this paragraph, a medical condition includes an
ascertainable physiological condition (e.g., a urinary system
dysfunction) or a documented pre-existing psychological disorder, but
does not include unsupported assertions of ``situational anxiety'' or
dehydration.
(f) As the examining physician, after making your determination,
you must provide a written statement of your conclusions to the MRO.
You must not include in this statement detailed information on the
employee's medical condition.
(g) If, as the examining physician in the case of a pre-employment
test, you determine that the employee's medical condition is a serious
and permanent or long-term disability that is highly likely to prevent
the employee from providing a sufficient volume of urine for a very
long or indefinite period of time, you must set forth your
determination and the reasons for it in your written statement to the
MRO. Upon receiving such a report, the MRO must follow the requirements
of Sec. 40.195.
(h) As the MRO, you must report the examining physician's
determination directly to the DER in writing as soon as you receive it.
(i) As the employer, when you receive a report from the MRO
indicating that a test is canceled as provided in paragraph (d)(1) of
this section, you take no further action with respect to the employee.
The employee remains in the random testing pool.
Sec. 40.195 What happens when an individual is unable to provide a
sufficient amount of urine for a pre-employment drug test because of a
permanent or long-term disability?
(a) When it is determined, through the required medical evaluation
outlined in Sec. 40.193(d) that an individual has a medical condition
that precluded him or her from providing the requisite amount of urine
during a pre-employment test event and that the condition is documented
as being permanent or long-term, as an MRO:
(1) You must determine if there is clinical evidence that would
indicate the individual is an illicit drug user. You will accomplish
this by personally conducting a medical examination and through
consultation with the employee's physician and/or the physician who
conducted the Sec. 40.193(d) medical evaluation.
(2) If unable to personally conduct the medical examination, you
must ensure that one is conducted by a licensed physician. This
physician must be suitable to the employer.
(b) For purposes of this section, DOT will offer no objection if
the MRO or examining physician believes a blood test to be one of the
medically-appropriate procedures in determining clinical evidence of
drug use.
[[Page 69118]]
(c) If the medical examination reveals no clinical evidence of drug
use, as the MRO, you will report the result to the employer as a
negative test with written notations regarding results of both the
Sec. 40.193(d) evaluation and the medical examination--one determining
that a permanent or long-term medical condition exists making requisite
urination impossible, the other determining that no signs and symptoms
of drug use exist.
(d) If the medical examination reveals clinical evidence of drug
use, as the MRO, you will report the result to the employer as a
canceled test with written notations regarding results of both the
Sec. 40.193(d) evaluation and the medical examination--one determining
that a permanent or long-term medical condition exists making requisite
urination impossible, the other determining that signs and symptoms of
drug use exist.
(e) For purposes of this section, permanent or long-term medical
conditions are those physiologic, anatomic, or psychological
abnormalities documented as being present prior to the attempted
collection, and considered not amenable to correction or cure for an
extended period of time, if ever.
(1) Examples would include destruction (any cause) of the
glomerular filtration system leading to renal failure; unrepaired
traumatic disruption of the urinary tract; a severe psychiatric
disorder focused on genito-urinary matters.
(2) Acute or temporary medical conditions, such as cystitis,
urethritis or prostatitis, though they might interfere with collection
for a limited period of time, cannot receive the same exceptional
consideration as the permanent or long-term conditions discussed in
paragraph (e)(1) of this section.
Sec. 40.197 What problems will always result in a drug test being
canceled?
As the MRO, you must cancel a drug test if any of the following
problems occur. These are ``fatal flaws.'' You must inform the DER that
the test was canceled and must be treated as if the test never
occurred. These problems are:
(a) The specimen ID numbers on the specimen bottle and the CCF do
not match;
(b) There is no specimen ID number on the specimen bottle;
(c) The specimen bottle seal is broken or shows evidence of
tampering (unless a split specimen can be redesignated, see
Sec. 40.83(f)); or
(d) Because of leakage or other causes, there is insufficient
amount of urine in the primary or single specimen bottle for analysis
and any necessary reanalysis for quality control and, in the case of a
single specimen, reconfirmation of results.
Sec. 40.199 What problems will always result in a drug test being
canceled and may result in a requirement for another collection?
As the MRO, you must cancel a drug test if any of the following
problems occur. You must inform the DER that the test was canceled and
must be treated as if the test never occurred. You must also direct the
DER to ensure that an additional collection occurs, when required by
the appropriate procedures specified in paragraphs (a) through (d) of
this section.
(a) The laboratory reports result test as ``Test Not Performed:
Specimen Unsuitable.'' You must follow appropriate procedures outlined
at Sec. 40.151.
(b) The laboratory reports the result as ``Test Not Performed:
Specimen Rejected for Testing.'' You must follow appropriate procedures
outlined at Sec. 40.155.
(c) The laboratory's test of the primary specimen is positive and
the split specimen is reported by the laboratory as either ``Failure to
Reconfirm: Drug/Drug Metabolite Not Detected'' or ``Test Not
Performed.'' You must follow appropriate procedures outlined at
Sec. 40.183(b) and (d).
(d) The examining physician has determined that there is an
acceptable medical explanation of the employee's failure to provide a
sufficient amount of urine (see Sec. 40.193(d)(1)).
Sec. 40.201 What problems will result in the drug test being canceled
unless they are corrected?
As an MRO, you must cancel a drug test if any of the following
problems occur, unless they are corrected. These are ``correctable
flaws.'' If the problems are not corrected, you must inform the DER
that the test was canceled and must be treated as if the test never
occurred.
(a) The collector's signature is omitted on the certification
statement on the CCF (see Sec. 40.75(a)(2)).
(b) The chain of custody block on the CCF is incomplete. (To be
complete, the block must include, as a minimum, two signed entries by
the collector, both dated, and a shipping/storage entry (see
Sec. 40.75(a)(3)and (4)).
(c) The employee's signature is omitted from the certification
statement, unless the employee's refusal to sign is noted in the
``Remarks'' section of the CCF (see Sec. 40.75(a)(1)).
(d) The employee's social security number or ID number is omitted
from the CCF, or is incorrect, unless the employee's refusal to provide
the information is noted in the ``Remarks'' section of the CCF.
(e) The certifying scientist's signature is omitted on the
laboratory copy of the CCF for a positive test result.
(f) The collector uses a non-DOT form for the test, provided that
the testing process is conducted in a HHS-certified laboratory in
accordance with DOT screening and confirmation test criteria (see
Secs. 40.45 and 40.47).
Sec. 40.203 How are drug test problems corrected?
(a) As a collector, you have the responsibility of trying to
successfully complete a collection procedure for each employee.
(1) If, during or shortly after the collection process, you become
aware of any event that prevents the completion of a valid test or
collection (e.g., a procedural or paperwork error), you must try to
correct the problem promptly, if doing so is practicable. You may
conduct another collection as part of this effort.
(2) If another collection is necessary, you must begin the new
collection procedure as soon as possible, using a new CCF and a new
collection kit.
(b) If, as a collector, laboratory, MRO, employer, or other person
implementing these drug testing regulations, you become aware of a
problem that may be corrected (see Sec. 40.201), but which has not
already been corrected under paragraph (a) of this section, you must
take all practicable action to correct the problem so that the test is
not canceled.
(1) If the problem resulted from the omission of required
information, you must, as the person responsible for providing that
information, supply, in writing, the missing information and a
statement that it is true and accurate. For example, suppose you are a
collector, and you forgot to make a notation in the ``Remarks'' section
of the CCF that the employee refused to sign the certification. You
would, when the problem is called to your attention, supply a written
statement that the employee refused to sign the certification, and you
would certify, in writing, that your statement is true and accurate.
(2) If the problem is the use of a non-DOT form, you must, as the
person responsible for the use of the incorrect form, certify in
writing that the incorrect form contains all the information needed for
a valid DOT test and does not contain information prohibited in DOT
tests. You must also provide a written statement that the incorrect
form was used inadvertently or out of
[[Page 69119]]
necessity, as the only means of conducting a test, in circumstances
beyond your control and the steps you have taken to prevent future use
of non-DOT forms for DOT tests. For this flaw to have been corrected,
the test of the specimen must have occurred at a HHS-certified
laboratory where it was tested using the testing protocol in this part.
(3) The written documentation of a correction must be maintained
with the CCF.
Sec. 40.205 What is the effect of a canceled drug test?
(a) A canceled drug test is neither positive nor negative.
(1) As an employer, you must not attach to a canceled test the
consequences of a positive test (e.g., removal from a safety-sensitive
position).
(2) As an employer, you must not use a canceled test for the
purposes of a negative test (e.g., in the case of a pre-employment, a
return-to-duty, or a follow-up test, to authorize the employee to
perform safety-sensitive functions).
(b) A canceled test does not count toward compliance with DOT
requirements, such as a minimum random testing rate.
Sec. 40.207 What is the effect of procedural problems that are not
sufficient to cancel a drug test?
(a) As a collector, laboratory, MRO, employer or other person
administering the drug testing process, you must document any errors in
the testing process of which you become aware, even if they are not
considered problems that will cause a test to be canceled as listed in
this subpart. Decisions about the ultimate impact of these errors will
be determined by other administrative or legal proceedings, subject to
the limitation of paragraph (b) of this section.
(b) No person concerned with the testing process may declare a test
canceled based on an error that does not have a significant adverse
effect on the right of the employee to have a fair and accurate test.
For example, it is inconsistent with these regulations to cancel a test
based on a minor administrative mistake (e.g., the omission of the
employee's middle initial) or an error that does not affect employee
protections under this part (e.g., the collector's failure to add
bluing agent to the toilet bowl, which adversely affects only the
ability of the collector to detect tampering with the specimen by the
employee).
(c) As an employer, these errors, even though not sufficient to
cancel a drug test result, may subject you to enforcement action under
DOT agency regulations.
Subpart J--Alcohol Testing Personnel
Sec. 40.211 Who conducts DOT alcohol tests?
(a) Screening test technicians (STTs) and breath alcohol
technicians (BATs) meeting their respective requirements of this
subpart are the only people authorized to conduct DOT alcohol tests.
(b) An STT or a BAT must be trained to proficiency in correctly
carrying out the alcohol testing requirements of this part.
(c) An STT can only conduct alcohol screening tests, but a BAT can
conduct alcohol screening and confirmation tests.
(d) As the direct supervisor of a particular employee, you may not
act as the STT or BAT when that employee is tested, unless no other STT
or BAT is available and you are permitted to do so under DOT agency
regulations.
Sec. 40.213 What requirements must STTs and BATs meet?
(a) To be an STT, you must do the following:
(1) Be trained to proficiency on the alcohol testing procedures of
this part and in the operation of the particular alcohol screening
device(s) (ASD) you are using by an instructor(s) sufficiently
knowledgeable in the DOT Model Course and in the use of the ASD(s) that
you will be using to be able to evaluate STT performance. (The DOT
Model Course is available at U.S. Government Printing Office,
Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250-
7954.)
(i) The training must be provided using the DOT Model Course for
STTs or a course of instruction equivalent to it, as determined by
ODAPC. On request, ODAPC will review STT instruction courses for
equivalency.
(ii) The course of instruction must provide written documentation
by the instructor that you have demonstrated proficiency on the
specific ASD(s) you will use.
(iii) The demonstration of proficiency must be done in front of the
instructor, in order that he or she can accurately determine if you are
qualified to be an STT.
(iv) The instruction must emphasize that you are responsible for
maintaining the integrity of the testing process, ensuring the privacy
of employees being tested, and avoiding conduct or statements that
could be viewed as offensive or inappropriate.
(2) Be able to discern changes, contrasts, or readings correctly if
you are using an ASD that indicates readings by changes or contrasts,
or other readings in color.
(3) Be retrained to proficiency if you have made a mistake in the
testing process that has caused a test to be canceled.
(i) This retraining must be provided and your proficiency
documented in writing by a person sufficiently knowledgeable in the
applicable alcohol testing procedures of this part to be able to
evaluate STT performance.
(ii) The instruction need only be in the general area of your
deficiency that caused the test to be canceled.
(iii) As part of the retraining, you will have to demonstrate your
proficiency in alcohol testing under this part by completing three
consecutive error-free trial tests before you conduct another DOT
alcohol test.
(iv) The person providing the instruction will monitor, evaluate,
and attest whether or not the trial tests are ``error-free.''
(b) To be a BAT, you must do the following:
(1) Be trained to proficiency on the alcohol testing procedures of
this part and in the operation of the particular evidential breath
testing device(s) (EBTs) you are using, by an instructor(s)
sufficiently knowledgeable in the DOT Model Course and in the use of
the EBT(s) that you will be using to be able to evaluate BAT
performance.
(i) The training must be provided using the DOT Model Course for
BATs or a course of instruction equivalent to it, as determined by
ODAPC. On request, ODAPC will review BAT instruction course for
equivalency.
(ii) The course of instruction must provide written documentation
by the instructor that you have demonstrated proficiency on the
specific EBT(s) you will use.
(iii) The demonstration of proficiency must be done in front of the
instructor, in order that he or she can accurately determine if you are
qualified to be a BAT.
(iv) The instruction must emphasize that you are responsible for
maintaining the integrity of the testing process, ensuring the privacy
of employees being tested, and avoiding conduct or statements that
could be viewed as offensive or inappropriate.
(2) Be retrained to proficiency if you have made a mistake in the
testing process that has caused a test to be canceled.
(i) This retraining must be provided and your proficiency
documented in writing by a person sufficiently
[[Page 69120]]
knowledgeable in the applicable alcohol testing procedures of this part
to be able to evaluate BAT performance.
(ii) The instruction need only be in the general area of your
deficiency that caused the test to be canceled.
(iii) As part of the retraining, you will have to demonstrate your
proficiency in alcohol testing under this part by completing three
consecutive error-free trial tests before you conduct another DOT
alcohol test.
(iv) The person providing the instruction will monitor, evaluate,
and attest whether or not the trial test collections are ``error-
free.''
(c) Anyone meeting the requirements of Sec. 40.213 to be a BAT may
act as an STT, provided that the individual has demonstrated
proficiency in the operation of the ASD that he or she is using.
(d) Law enforcement officers who have been certified by state or
local governments to conduct breath alcohol testing are deemed to be
qualified as BATs. In order for a test conducted by such an officer to
be accepted under DOT alcohol testing requirements, the officer must
have been certified by a state or local government to use the EBT or
ASD that was used for the test.
(e) As an STT or BAT, you must receive additional training, as
needed, to ensure proficiency on new or additional devices or changes
in technology that you will use.
(f) As an STT or BAT, you must read the alcohol testing procedures
in this part and the current DOT Model Course, as applicable, and
attest in writing to your understanding of them. You will have to
demonstrate your proficiency in alcohol testing of this part by
completing three consecutive error-free trial tests in front of a
person sufficiently knowledgeable in the applicable alcohol testing
procedures of this part to be able to evaluate STT or BAT performance.
That person will monitor, evaluate, and attest whether or not the trial
tests are ``error-free.'' You must complete the requirements of this
paragraph by [date one year from the effective date of the final
regulation], or two years from the date you became an STT or BAT,
whichever is later, and once every two years, thereafter.
(g) As an STT or BAT, you must maintain all documentation of
training/retraining as long as you serve as an STT and/or BAT.
Sec. 40.215 What requirements must organizations employing STTs and/or
BATs meet?
This section becomes effective [date one year from the effective
date of the final regulation].
(a) As an organization employing the STT and/or BAT (e.g., a
transportation employer, third-party administrator, occupational health
clinic), you must maintain in your files documentation, signed by the
person providing the training or retraining, that the STT and/or BAT
has demonstrated proficiency as required by this subpart.
(b) You must retain this documentation as long as the person
performs STT and/or BAT functions for the organization and for two
years after the person ceases to perform these functions for the
organization.
(c) You must provide to the STTs and BATs the name and telephone
number of the appropriate DER to contact about any problems or issues
that may arise during the testing process.
Sec. 40.217 Where is other information on the role of STTs and BATs
found in this regulation?
You can find other information on the role and functions of STTs
and BATs in the following sections of this part:
Sec. 40.1--application of rule to STTs and BATs.
Sec. 40.3--definitions.
Sec. 40.223--responsibility for supervising employees being tested.
Secs. 40.225-40.227--use of the alcohol testing form.
Secs. 40.241-40.243--screening test procedures.
Sec. 40.243--use of ASDs.
Sec. Sec. 40.251-40.255--confirmation test procedures.
Sec. 40.261--refusals to test.
Secs. 40.263-40.265--insufficient saliva or breath.
Sec. 40.267--problems requiring cancellation of tests.
Secs. 40.267-40.271--correcting problems in tests.
Subpart K--Testing Sites, Forms, Equipment and Supplies Used in
Alcohol Testing
Sec. 40.221 Where does an alcohol test take place?
(a) A DOT alcohol test is required to take place at an alcohol
testing site meeting the requirements of this section.
(b) If you are operating an alcohol testing site, you must make
sure that it meets the security requirements of Sec. 40.223.
(c) If you are operating an alcohol testing site, you must make
sure that it provides visual and aural privacy to the employee being
tested, sufficient to prevent unauthorized persons from seeing or
hearing test results.
(d) If you are operating an alcohol testing site, you must make
sure that it has all needed personnel, materials, equipment,
facilities, and supervision to provide for the collection and analysis
of breath and/or saliva samples, and a suitable clean surface for
writing.
(e) If an alcohol testing site fully meeting all the visual and
aural privacy requirements of paragraph (c) of this section is not
readily available, this regulation allows a reasonable suspicion or
post-accident test to be conducted at a site that partially meets these
requirements. In this case, the site must afford visual and aural
privacy to the employee to the greatest extent practicable.
(f) An alcohol testing site can be in a medical facility, a mobile
facility (e.g., a van), a dedicated collection facility, or any other
location meeting the requirements of this section.
Sec. 40.223 What steps must be taken to protect the security of
alcohol testing sites?
(a) If you are operating an alcohol testing site, you must prevent
unauthorized personnel from entering the testing location.
(1) The only people you are to treat as authorized persons are
employees being tested, BATs, STTs, and other alcohol site workers,
DERs, employee representatives authorized by the employer (e.g., on the
basis of employer policy or labor-management agreement), and DOT agency
representatives.
(2) You must make sure that all persons are under the supervision
of a BAT or STT at all times when permitted into the site.
(3) You may remove any person who obstructs, interferes with, or
causes unnecessary delay in the testing process.
(b) If you are operating an alcohol testing site, you must make
sure that when an EBT is not being used for testing, you store it in a
secure place.
(c) If you are operating an alcohol testing site, you must make
sure that no one other than BATs or other employees of the site have
access to the site when an EBT is unsecured.
(d) As a BAT or STT, to avoid distraction that could compromise
security, you may have only one employee under your direct supervision
at any time.
(1) When an EBT screening test on an employee indicates a result at
the 0.02 concentration or higher, and the same EBT will be used for the
confirmation test, you are not allowed to use the EBT for a screening
test on another employee before completing the confirmation test on the
first employee.
(2) As a BAT who will conduct both the screening and the
confirmation test, you are to complete the entire screening and
confirmation process on one employee before starting the screening
process on another employee.
[[Page 69121]]
(3) You are not allowed to leave the alcohol testing site while the
testing process for a given employee is in progress.
Sec. 40.225 What form is used for an alcohol test?
(a) The DOT Breath Alcohol Testing Form (BATF must be used for
every DOT alcohol test. The BATF must be a three-part carbonless
manifold form. (The BATF is available at U.S. Government Printing
Office, Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA
15250-7954.)
(b) As an employer in the DOT alcohol testing program, you may not
modify or revise the BATF except as follows:
(1) You may include other information needed for billing or other
purposes necessary to the collection process.
(2) You may use a BATF directly generated by an EBT which omits the
space for affixing a separate printed result to the BATF, provided the
EBT prints the result directly on the BATF.
(3) You may use a BATF that has the employer's name, address, and
telephone number preprinted.
(4) Instead of printing the entire pages of the BATF in the colors
specified by DOT, you may use white pages with clearly discernible
borders in the specified color for each page.
(5) As a BAT or STT, you may add, in the ``Remarks'' section of the
BATF, the name of the DOT agency under whose authority the test
occurred.
(6) As a BAT or STT, you may use a BATF that has your name,
address, and telephone number preprinted, but under no circumstances
can your signature be preprinted.
(c) As an employer outside the United States, you may use an
equivalent foreign-language version of the BATF approved by ODAPC
(e.g., in French for use in Canada or Spanish for use in Mexico).
Sec. 40.227 May employers use the BATF for non-DOT tests, and vice-
versa?
(a) No. As an employer, you are prohibited from using the BATF for
non-DOT alcohol tests. You are also prohibited from using non-DOT forms
for DOT alcohol tests. Doing either subjects you to enforcement action
under DOT agency regulations.
(b) If the STT or BAT, either by mistake, or as the only means to
conduct a test under difficult circumstances (e.g., post-accident test
with insufficient time to obtain the BATF), uses a non-DOT form for a
DOT test, the use of a non-DOT form does not, in and of itself, require
the employer or service agent to cancel the test. However, in order for
the test to be considered valid, a signed statement must be obtained
from the STT or BAT stating the reason why the BATF was not used for
the DOT test.
Sec. 40.229 What devices are used to conduct alcohol screening tests?
EBTs and ASDs on the National Highway Traffic Safety
Administration's (NHTSA) conforming products lists (CPL) for evidential
and non-evidential devices are the only devices you are allowed to use
to conduct alcohol screening tests under this part.
Sec. 40.231 What devices are used to conduct alcohol confirmation
tests?
(a) EBTs on the NHTSA CPL for evidential devices that meet the
requirements of paragraph (b) of this section are the only devices you
may use to conduct alcohol confirmation tests under this part.
(b) To conduct a confirmation test, you must use an EBT that has
the following capabilities:
(1) Provides a printed triplicate result (or three consecutive
identical copies of a result) of each breath test;
(2) Assigns a unique, sequential number to each completed test,
which the BAT and employee can read before each test and which is
printed on each copy of the result;
(3) Prints, on each copy of the result, the manufacturer's name for
the device, its serial number, and the time of the test;
(4) Distinguishes alcohol from acetone at the 0.02 alcohol
concentration level;
(5) Tests an air blank; and
(6) Performs an external calibration check.
Sec. 40.233 What are the requirements for proper use and care of EBTs?
(a) As an EBT manufacturer, you must submit, for NHTSA approval, a
quality assurance plan (QAP) for your EBT before NHTSA places the EBT
on the CPL.
(1) Your QAP must specify the methods used to perform external
calibration checks on the EBT, the tolerances within which the EBT is
regarded as being in proper calibration, and the intervals at which
these checks must be performed. In designating these intervals, your
QAP must take into account factors like frequency of use, environmental
conditions (e.g., temperature, humidity, altitude) and type of
operation (e.g., stationary or mobile).
(2) Your QAP must also specify the inspection, maintenance, and
calibration requirements and intervals for the EBT.
(b) As the manufacturer, you must include, with each EBT,
instructions for its use and care consistent with the QAP. As an
employer, you must follow these instructions, including performance of
external calibration checks at the intervals the instructions specify.
(c) As an employer conducting external calibration checks, you must
use calibration devices listed on NHTSA's CPL for ``Calibrating Units
for Breath Alcohol Tests.''
(d) If an EBT fails an external check of calibration, as an
employer you must take the EBT out of service. You may not use the EBT
again for DOT alcohol testing until it is repaired and passes an
external calibration check.
(e) As an employer, you must maintain records of the external
calibration checks of EBTs as provided in Sec. 40.335(a)(v).
(f) As an employer, you must ensure that inspection, maintenance,
and calibration of the EBT are performed by its manufacturer or a
maintenance representative certified either by the manufacturer or by a
state health agency or other appropriate state agency.
Sec. 40.235 What are the requirements for proper use and care of ASDs?
(a) As an ASD manufacturer, you must submit, for NHTSA approval, a
QAP for your ASD before NHTSA places the ASD on the CPL. Your QAP must
specify the methods used for quality control checks, temperatures at
which the ASD must be stored and used, the shelf life of the device,
and environmental conditions (e.g., altitude, humidity) that may affect
the ASD's performance.
(b) As a manufacturer, you must include, with each ASD, provided to
an employer, instructions for its use and care consistent with the QAP.
The instructions must include directions on the proper use of the ASD,
the time within which the device must be read, and the manner in which
the reading is made.
(c) As the employer, you must follow the QAP instructions.
(d) As an employer, you are not permitted to use an ASD that does
not pass the specified quality control checks or that has passed its
expiration date.
Subpart L--Alcohol Screening Tests
Sec. 40.241 What are the first steps in any alcohol screening test?
(a) This section lists the procedures used to begin any alcohol
screening test, no matter whether an ASD or EBT is being used.
(b) As the BAT you will take the following steps:
[[Page 69122]]
(1) If an employee does not show up at the testing site at the
scheduled time, contact the DER to determine the appropriate interval
within which the DER has determined the employee is authorized to
arrive. If the employee's arrival is delayed beyond that time, you must
notify the DER that the employee is a ``no show.''
(2) Make sure that, when the employee enters the alcohol testing
site, you begin the alcohol testing process without delay. For example,
you must not wait because the employee says he or she is not ready or
because an authorized employer or employee representative is delayed in
arriving.
(i) If the employee is also going to provide a urine specimen, you
must complete the alcohol test before the urine collection process
begins.
(ii) If the employee needs medical attention (e.g., an injured
employee in an emergency medical facility who is required to have a
post-accident test), do not delay this treatment to conduct a test.
(3) Require the employee to provide positive identification. You
must see a photo ID issued by the employer or a Federal, state, or
local government agency for this purpose. You may not accept faxes or
photocopies of identification. Positive identification by an employer
representative (not a co-worker or another employee being tested) is
also acceptable. If the employee cannot produce positive
identification, you must contact a DER to verify the identity of the
employee.
(4) If the employee asks, provide identification to the employee.
Your identification must include your name, your employer's name,
address, and telephone number but does not have to include your
picture, address, or telephone number.
(5) Explain the testing procedure to the employee, including
showing the employee the instructions on the back of the BATF.
(6) Complete Step 1 of the BATF.
(7) Direct the employee to complete Step 2 on the BATF and sign the
certification.
(i) If the employee refuses to sign this certification, you must
document this refusal in the remarks section and immediately notify the
DER.
(ii) The employer must treat the event described in paragraph
(b)(7)(i) of this section as a refusal to test on the part of the
employee.
Sec. 40.243 What is the procedure for an alcohol screening test using
an EBT or non-evidential breath ASD?
As the BAT or STT, you must take the following steps:
(a) Select, or allow the employee to select, an individually
wrapped or sealed mouthpiece from the testing materials.
(b) Open the individually wrapped or sealed mouthpiece in view of
the employee and insert it into the device in accordance with the
manufacturer's instructions.
(c) Instruct the employee to blow steadily, and forcefully, into
the mouthpiece for at least six seconds or until the device indicates
that an adequate amount of breath has been obtained.
(d) Show the employee the displayed test result.
(e) If the device is one that prints the test number, testing
device name and serial number, time and result directly onto the BATF,
you must check to ensure that the information has been printed
correctly onto the BATF.
(f) If the device is one that prints the test number, testing
device name and serial number, time and result, but on a separate
printout rather than directly onto the BATF, you must affix the
printout of the information to the designated space on the back of the
BATF with tamper-evident tape.
(g) If the device is one that does not print the test number,
testing device name and serial number, time, and result, or it is a
device not being used with a printer, you must record this information
in Step 3 of the BATF.
Sec. 40.245 What is the procedure for an alcohol screening test using
a saliva ASD?
As the STT, you must take the following steps:
(a) Check the expiration date on the device and show it to the
employee. You may not use the device after its expiration date.
(b) Open an individually wrapped or sealed package containing the
device in the presence of the employee.
(c) Offer the employee the opportunity to use the device. If the
employee uses it, you must instruct the employee to insert it into his
or her mouth and use it in a manner described by the device's
manufacturer.
(d) If the employee chooses not to use the device, or in all cases
in which a new test is necessary because the device did not activate
(see paragraph (g) of this section), you must insert the device into
the employee's mouth and gather saliva in the manner described by the
device's manufacturer. You must wear single-use examination or similar
gloves while doing so and change them following each test.
(e) When the device is removed from the employee's mouth, you must
follow the manufacturer's instructions regarding necessary next steps
in ensuring that the device has activated.
(f)(1) If you were unable to successfully (e.g., the device breaks,
you drop the device on the floor) follow the procedures of paragraphs
(c) through (e) of this section, you must discard the device and
conduct a new test using a new device.
(2) The new device you use must be one that has been under your
control or that of the employer before the test.
(3) You must note in the ``Remarks'' section of the BATF the reason
for the new test. (Note: You may continue using the same BATF with
which you began the test.)
(4) You must offer the employee the choice of using the device or
having you use it unless the employee, in the opinion of the STT or
BAT, was responsible (e.g., the employee dropped the device) for the
new test needing to be conducted.
(5) If you are unable to successfully follow the procedures of
paragraphs (c) through (e) of this section on the new test, you must
end the collection and put an explanation in the ``Remarks'' section of
the BATF.
(6) You must then direct the employee to take a new test, using an
EBT for the screening test.
(g) If you are able to successfully follow the procedures of
paragraphs (c) through (e) of this section, but the device does not
activate, you must discard the device and conduct a new test, in the
same manner as provided in paragraph (f) of this section. In this case,
you must place the device into the employee's mouth to collect saliva
for the new test.
(h) You must read the result displayed on the device no sooner than
the device's manufacturer instructs. In all cases the result displayed
must be read within 15 minutes of the test. You must then show the
device and its reading to the employee and enter the result on the
BATF.
(i) You must never re-use devices, swabs, gloves or other materials
used in saliva testing.
Sec. 40.247 What happens next after the alcohol screening test result?
After the ASD or EBT has displayed or printed a result on an
alcohol screening test, you must, as the STT or BAT, take the following
additional steps:
(a) In the case of a screening test using an ASD, you must write in
the ``Remarks'' section of the BATF whether you used a saliva device or
a non-evidential breath device.
(b) If the test result is an alcohol concentration of less than
0.02, you must do the following:
[[Page 69123]]
(1) Sign and date Step 3 of the BATF;
(2) Instruct the employee to sign and date Step 4 of the BATF. If
the employee does not do so, you must note this in the ``Remarks''
section of the BATF. You must not treat the employee's failure to sign
Step 4 as a refusal to test; and
(3) Transmit the result directly to the DER in a confidential
manner, as provided in Sec. 40.255.
(c) If the test result is an alcohol concentration of 0.02 or
higher, you must do the following:
(1) Direct the employee to take a confirmation test and conduct the
test using procedures beginning at Sec. 40.251; or
(2) If you are not the BAT who will conduct the confirmation test,
direct the employee to take a confirmation test, sign and date Step 3
of the BATF, and give the employee Copy 2 of the BATF; and
(3) If the confirmation test will be performed at a different site
from the screening test, you must take the following additional steps:
(i) Advise the employee not to eat, drink, put anything (e.g.,
cigarette, chewing gum) into his or her mouth, or belch;
(ii) Tell the employee the reason for the waiting period (i.e., to
prevent an accumulation of mouth alcohol from leading to an
artificially high reading);
(iii) Explain that following your instructions concerning the
waiting period is to the employee's benefit;
(iv) Explain that the confirmation test will be conducted at the
end of the waiting period, even if the instructions have not been
followed;
(v) Note in the remarks section of the BATF that the waiting period
instructions were provided;
(vi) Advise the employee not to drive, operate heavy equipment, or
perform safety-sensitive functions, and show the employee the warning
to this effect in Step 4 of the BATF;
(vii) Instruct the employee to sign and date Step 4 of the BATF. If
the employee does not do so, you must note this in the ``Remarks''
section of the BATF. You must not treat the employee's failure to sign
Step 4 as a refusal to test;
(viii) Instruct the employee to carry a copy of the BATF to the BAT
who will perform the confirmation test; and
(ix) Make sure that you or another BAT, STT, or employer
representative observe the employee as he or she is transported to the
confirmation testing site.
(d) If the screening test is invalid, you must tell the employee
the test is canceled and note the problem in the ``Remarks'' section of
the BATF. If practicable, conduct a re-test (see Sec. 40. 271).
Subpart M--Alcohol Confirmation Tests
Sec. 40.251 What are the first steps in an alcohol confirmation test?
As the BAT for an alcohol confirmation test, you must follow these
steps to begin the confirmation test process:
(a) You must carry out a requirement for a waiting period before
the confirmation test, by taking the following steps:
(1) You must ensure that the waiting period lasts at least 15
minutes, but not more than 30 minutes, starting with the completion of
the screening test.
(i) If the confirmation test is taking place at a different
location from the screening test (see Sec. 40.247(c)(3)) the time of
transit between sites counts toward the waiting period if the STT or
BAT who conducted the screening test provided the waiting period
instructions.
(ii) If you cannot verify, through review of the BATF, that waiting
period instructions were provided, then you must carry out the waiting
period requirement.
(2) Concerning the waiting period, you must tell the employee:
(i) Not to eat, drink, put anything (e.g., cigarette, chewing gum)
into his or her mouth, or belch;
(ii) The reason for the waiting period (i.e., to prevent an
accumulation of mouth alcohol from leading to an artificially high
reading);
(iii) That following the instructions concerning the waiting period
is to the employee's benefit; and
(iv) That the confirmation test will be conducted at the end of the
waiting period, even if the instructions have not been followed.
(3) If you become aware that the employee has not followed the
instructions, you must note this in the ``Remarks'' section of the
BATF.
(b) If you did not conduct the screening test for the employee, you
must require positive identification of the employee, explain the
confirmation procedures, and use a new BATF. You must note in the
``Remarks'' section of the BATF that a different BAT or STT conducted
the screening test.
(c) Complete Step 1 of the BATF.
(1) Direct the employee to complete Step 2 on the BATF and sign the
certification.
(2) If the employee refuses to sign this certification, you must
document this refusal in the remarks section and immediately notify the
DER. This is considered a refusal to test.
(d) Even if more than 30 minutes have passed since the screening
test result was obtained, you must begin the confirmation test
procedures in Sec. 40.253, not another screening test.
(1) You must note in the ``Remarks'' section of the BATF the time
that elapsed between the two events and the reason why the confirmation
test could not begin within 30 minutes of the screening test.
(2) Beginning the confirmation test procedures after the 30 minutes
have elapsed does not invalidate the screening or confirmation tests,
but may constitute a regulation violation subject to DOT agency
sanction.
Sec. 40.253 What are the procedures for conducting an alcohol
confirmation test?
As the BAT for an alcohol confirmation test, you must follow these
steps in order to complete the confirmation test process:
(a) In the presence of the employee, you must conduct an air blank
on the EBT you are using before beginning the confirmation test and
show the reading to the employee.
(1) If the reading is 0.00, the test may proceed. If the reading is
greater than 0.00, you must conduct another air blank.
(2) If the reading on the second air blank is 0.00, the test may
proceed. If the reading is greater than 0.00, you must take the EBT out
of service.
(3) If you take an EBT out of service for this reason, no one may
use it for testing until the EBT is found to be within tolerance limits
on an external check of calibration.
(4) You must proceed with the test of the employee using another
EBT, if one is available.
(b) You must open a new individually wrapped or sealed mouthpiece
in view of the employee and insert it into the device in accordance
with the manufacturer's instructions.
(c) You must make sure that you and the employee read the
sequential test number displayed on the EBT.
(d) You must instruct the employee to blow steadily and forcefully
into the mouthpiece for at least six seconds or until the device
indicates that an adequate amount of breath has been obtained.
(e) You must show the employee the result displayed on the EBT.
(f) You must show the employee the result and sequential test
number that the EBT prints out either directly onto the BATF or onto a
separate printout.
(g) If the EBT provides a separate printout of the result, you must
attach the printout to the designated space on the back of the BATF,
using tamper-evident tape.
[[Page 69124]]
Sec. 40.255 What happens next after the alcohol confirmation test
result?
(a) After the EBT has printed the result of an alcohol confirmation
test, you must, as the BAT, take the following additional steps:
(1) Sign and date Step 3 of the BATF.
(2) Direct the employee to sign and date Step 4 of the BATF. If the
employee does not do so, you must note this in the ``Remarks'' section
of the BATF. You must not treat the employee's failure to sign Step 4
as a refusal to test.
(3) If the test is invalid, tell the employee the test is canceled
and note the problem in the ``Remarks'' section of the BATF. If
practicable, conduct a re-test. (see Sec. 40.271).
(4) Transmit the result directly to the DER in a confidential and
immediate manner.
(i) You may transmit the results in writing (using Copy 1 of the
BATF), in person, by telephone, or by electronic means. In any case,
you must immediately notify the DER of any result of 0.02 or greater by
any means (e.g., telephone or secure facsimile machine) that ensures
the result is immediately received by the DER.
(ii) If you do not make the initial transmission in writing, you
must follow up the initial transmission with Copy 1 of the BATF.
(b) As an employer, you must take the following steps with respect
to the receipt and storage of alcohol test result information:
(1) If you receive any test results that are not in writing (e.g.,
by telephone or electronic means), you must establish a mechanism to
establish the identity of the BAT sending you the results.
(2) You must store all test result information in a way that
protects confidentiality (as outlined in subpart P of this part).
Sec. 40.257 When BATs report test results of 0.02 or greater to
employers, what is an employer to do?
(a) As an employer who receives a test result of 0.04 or greater
from the BAT, you must immediately remove the employee involved from
performing safety sensitive functions. You must take this action upon
receiving the initial notification from the BAT. Do not wait to receive
a written report.
(b) As an employer who receives a test result of 0.02 through 0.039
from the BAT, you must immediately remove the employee involved from
performing safety sensitive functions under the conditions stipulated
by the appropriate DOT agency regulation. You must take this action
upon receiving the initial notification from the BAT. Do not wait to
receive a written report.
Subpart N--Problems in Alcohol Testing
Sec. 40.261 What is a refusal to take an alcohol test, and what are
its consequences?
(a) As an employee, you are considered to have refused to take an
alcohol test if you:
(1) Fail to show up for any test within a reasonable time after
being directed to do so by the employer. This includes the failure of
an employee (including an owner-operator) to appear for a test when
called by a third-party administrator or consortium. (see
Sec. 40.241(b)(1));
(2) Fail to provide a saliva or breath specimen, as applicable, for
any test required by this part or DOT agency regulations;
(3) Refuse to sign the certification in Step 2 of the BATF (see
Sec. 40.241(b)(7));
(4) Fail to provide a sufficient breath specimen, unless the
physician has determined, through a required medical evaluation, that
there is an adequate medical explanation for the failure (see
Sec. 40.265(c));
(5) Fail to undergo an additional medical examination, as directed
by the physician conducting the evaluation as part of the insufficient
breath procedures outlined at Sec. 40.265(c); or
(6) Fail to cooperate with any part of the testing process.
(b) As an employee, if you refuse to take an alcohol test, you
incur the same consequences specified under DOT agency regulations for
a violation of those DOT agency regulations.
(c) As a BAT or an STT, when an employee refuses to take an alcohol
test, you must terminate the portion of the testing process in which
you are involved, document the refusal on the BATF, and immediately
notify the DER by any means (e.g., telephone or secure facsimile
machine) that ensures the refusal notification is immediately received
by the DER.
Sec. 40.263 What happens when an employee is unable to provide an
adequate amount of saliva for an alcohol screening test?
(a) As the STT, you must take the following steps if an employee is
unable to provide sufficient saliva to complete a test on a saliva
screening device (e.g., the employee does not provide sufficient saliva
to activate the device).
(1) You must conduct a new screening test using a new screening
device.
(2) If the employee refuses to complete the new test, you must
discontinue testing, note the fact in the ``Remarks'' section of the
BATF, and immediately notify the DER.
(3) If the employee has not provided a sufficient amount of saliva
to complete the new test, you must note the fact in the ``Remarks''
section of the BATF and immediately notify the DER.
(b) As the DER, when the STT informs you that the employee has not
provided a sufficient amount of saliva (see paragraph (a)(3) of this
section), you must immediately arrange to administer an alcohol test to
the employee using an EBT or other breath testing device.
Sec. 40.265 What happens when an employee is unable to provide a
sufficient amount of breath for an alcohol test?
(a) If an employee does not provide a sufficient amount of breath
to permit a valid breath test, you must take the steps listed in this
section.
(b) As the BAT or STT, you must instruct the employee to attempt
again to provide a sufficient amount of breath.
(1) If the employee refuses to make the attempt, you must
discontinue the test, note the fact in the ``Remarks'' section of the
BATF, and immediately notify the DER.
(2) If the employee again attempts and fails to provide a
sufficient amount of breath, you must note the fact in the ``Remarks''
section of the BATF and immediately notify the DER.
(3) If you are using an EBT that has the capability of operating
manually, you may attempt to conduct the test in manual mode.
(4) If you are qualified to use a saliva ASD and you are in the
screening test stage, you may change to a saliva ASD only to complete
the screening test.
(c) As the employer, when the BAT or STT informs you that the
employee has not provided a sufficient amount of breath (see paragraph
(b)(2) of this section), you must direct the employee to obtain, within
five working days, an evaluation from a licensed physician who is
acceptable to you concerning the employee's medical ability to provide
a sufficient amount of breath.
(1) You are required to provide the physician who will conduct the
evaluation with the following information and instruction:
(i) That the employee was required to take a DOT breath alcohol
test, but was unable to provide a sufficient amount of breath to
complete the test;
(ii) The consequences of the appropriate DOT agency regulation for
refusing to take the required alcohol test;
(iii) That the physician must provide you with a written statement
of his or her conclusions; and
(iv) That the physician, in his or her reasonable medical judgment,
must base those conclusions on one of the following determinations:
(A) A medical condition has, or with a high degree of probability
could have,
[[Page 69125]]
precluded the employee from providing a sufficient amount of breath.
The physician must not include in the written statement detailed
information on the employee's medical condition. In this case, the test
is canceled.
(B) There is not an adequate basis for determining that a medical
condition has, or with a high degree of probability could have
precluded the employee from providing a sufficient amount of breath.
This constitutes a refusal to test.
(C) For purposes of paragraphs (c)(1)(iv)(A) and (B) of this
section, a medical condition includes an ascertainable physiological
condition (e.g., a respiratory system dysfunction) or a documented pre-
existing psychological disorder, but does not include unsupported
assertions of ``situational anxiety'' or hyperventilation.
(2) Upon receipt of the report from the examining physician, you
must immediately inform the employee and take appropriate action based
upon your DOT agency regulations.
Sec. 40.267 What problems always cause an alcohol test to be canceled?
As an employer, a BAT, or an STT, you must always cancel an alcohol
test if any of the following problems occur. These are ``fatal flaws''
that always cause an alcohol test to be canceled and cannot be
corrected:
(a) In the case of a screening test conducted on a saliva ASD:
(1) The STT reads the result either sooner than or later than the
time allotted by the manufacturer (see Sec. 40.245(h));
(2) The device does not activate (see Sec. 40.245(e), (f), and(g));
or
(3) The device is used for a test after the expiration date printed
on its package (see Sec. 40.245(a)).
(b) In the case of a screening or confirmation test conducted on an
EBT, the sequential test number or alcohol concentration displayed on
the EBT is not the same as the sequential test number or alcohol
concentration on the printed result (see Sec. 40.253(c)).
(c) In the case of a confirmation test:
(1) The BAT conducts the confirmation test before the end of the
minimum 15-minute waiting period (see Sec. 40.251(a)(1));
(2) The BAT does not conduct an air blank before the confirmation
test (see Sec. 40.253(a));
(3) There is not a 0.00 result on the air blank conducted before
the confirmation test (see Sec. 40.253(a)(1) and(2));
(4) The EBT does not print the result (see Sec. 40.253(f)); or
(5) The next external calibration check of the EBT produces a
result that differs by more than the tolerance stated in the QAP from
the known value of the test standard. In this case, every result of
0.02 or above obtained on the EBT since the last valid external
calibration check is canceled (see Sec. 40.233(a)(1) and (d)).
Sec. 40.269 What problems cause an alcohol test to be canceled unless
they are corrected?
You must treat an alcohol test as canceled if any of the following
problems occur, unless they are corrected. These are ``correctable
flaws.''
(a) The BAT or STT does not sign the BATF (see Secs. 40.247(c)(2)
and 40.255(a)(1)).
(b) The BAT or STT fails to note in the remarks section of the BATF
that the employee has failed or refused to sign the BATF after the
result is obtained (see Secs. 40.247(b)(2) and 40.255(a)(2)).
(c) In the case of a screening test using an ASD, the BAT or STT
fails to note in the remarks section of the BATF, whether the test was
conducted using a saliva or non-evidential breath ASD (see
Sec. 40.247(a)).
(d) The BAT or STT uses a non-DOT form for the test (see
Sec. 40.225(a)).
Sec. 40.271 How are alcohol testing problems corrected?
(a) As a BAT or STT, you are responsible for completing
successfully an alcohol test for each employee.
(1) If, during or shortly after the testing process, you become
aware of any event that will cause the test to be canceled (see
Sec. 40.267), you must try to correct the problem promptly, if
practicable. You may repeat the testing process as part of this effort.
(2) If repeating the testing process is necessary, you must begin a
new test as soon as possible. You must use a new BATF, a new sequential
test number, and, if needed, a new ASD and/or a new EBT.
(b) If, as an STT, BAT, employer or other service agent
administering the testing process, you become aware of a ``correctable
flaw'' (see Sec. 40.269) that has not already been corrected, you must
take all practicable action to correct the problem so that the test is
not canceled.
(1) If the problem resulted from the omission of required
information, you must, as the person responsible for providing that
information, supply, in writing, the missing information and a signed
statement that it is true and accurate. For example, suppose you are a
BAT and you forgot to make a notation in the ``Remarks'' section of the
BATF that the employee refused to sign the certification. You would,
when the problem is called to your attention, supply a written
statement that the employee refused to sign the certification, and you
would certify, in writing, that your statement is true and accurate.
(2) If the problem is the use of a non-DOT form, you must, as the
person responsible for the use of the incorrect form, certify in
writing that the incorrect form contains all the information needed for
a valid DOT. You must also provide a written statement that the
incorrect form was used either by mistake, or as the only means to
conduct a test under difficult circumstances (e.g., post-accident test
with insufficient time to obtain the BATF), and the steps you have
taken to prevent future use of non-DOT forms for DOT tests.
Sec. 40.273 What is the effect of a canceled alcohol test?
(a) A canceled alcohol test is neither positive nor negative.
(1) As an employer, you must not attach to a canceled test the
consequences of a test result that is 0.02 or greater (e.g., removal
from a safety-sensitive position).
(2) As an employer, you must not use a canceled test for the
purposes of a test result that is below 0.02 (e.g., in the case of a
pre-employment, return-to-duty, or follow-up test to authorize the
employee to perform safety-sensitive functions).
(b) A canceled test does not count toward compliance with DOT
requirements, such as a minimum random testing rate.
Sec. 40.275 What is the effect of procedural problems that are not
sufficient to cancel an alcohol test?
(a) As an STT, BAT, employer or other service agent administering
the testing process, you must document any errors in the testing
process of which you become aware, even if they are not ``fatal flaws''
or ``correctable flaws'' listed in this subpart. Decisions about the
ultimate impact of these errors will be determined by administrative or
legal proceedings, subject to the limitation of paragraph (b) of this
section.
(b) No person concerned with the testing process may declare a test
canceled based on a mistake in the process that does not have a
significant adverse effect on the right of the employee to a fair and
accurate test. For example, it is inconsistent with these regulations
to cancel a test based on a minor administrative mistake (e.g., the
omission of the employee's middle initial,) or an error that does not
affect employee protections under this part.
(c) As an employer, these errors, even though not sufficient to
cancel an
[[Page 69126]]
alcohol test result, may subject you to enforcement action under DOT
agency regulations.
Sec. 40.277 Are alcohol tests other than saliva or breath for
screening and breath for confirmation permitted under these
regulations?
No. Other types of alcohol tests (i.e., blood and urine) are not
authorized for testing done under this part. Only saliva or breath for
screening tests and breath for confirmation tests are permitted.
Subpart O--Return-to-duty Process And Role of Substance Abuse
Professionals (SAPs)
Sec. 40.281 Who is qualified to act as a SAP?
You are qualified to act as a SAP in DOT drug and alcohol testing
programs if you meet each of the following criteria:
(a) You have knowledge of and clinical experience in the diagnosis
and treatment of alcohol and controlled substances-related disorders,
and:
(1) You are a licensed physician; or
(2) You are a licensed or certified social worker; or
(3) You are a licensed or certified psychologist; or
(4) You are a licensed or certified employee assistance
professional; or
(5) You are a drug and alcohol counselor certified by the National
Association of Alcoholism and Drug Abuse Counselors Certification
Commission or by the International Certification Reciprocity
Consortium/Alcohol and Other Drug Abuse.
(b) You have a working knowledge of this part, the current
``Substance Abuse Professional Procedures Guidelines'' and the DOT
agency regulations applicable to the employers for which you evaluate
employees. In addition, you are cognizant of the SAP function as it
relates to employer interests in safety-sensitive duties. (The
``Substance Abuse Professional Procedures Guidelines'' is available at
ODAPC, Department of Transportation, 400 7th Street, SW., Room 10403,
Washington DC, 20590.)
(c) You participate in and document training (e.g., a course) at
least once every two years that relates directly to the SAP
responsibilities of the DOT program, or self-certify that you have re-
reviewed and understand this part and applicable DOT agency
regulations. You must maintain these records for two years.
(d) If you were a SAP prior to [effective date of the final
regulation], you must meet the requirements of paragraph (c) of this
section by [date six months from the effective date of the final
regulation]. If you become a SAP after [effecitve date of the final
regulation], you must meet the requirements of paragraph (c) of this
section prior to acting as a SAP.
(e) If you represent a certification organization that wants DOT to
authorize its certified drug and alcohol counselors to be included in
paragraph (a)(5) of this section, you may submit a written petition to
DOT requesting a review of your petition for inclusion.
(1) You must obtain the National Commission for Certifying Agencies
(NCCA) accreditation as a prerequisite for having the DOT review your
petition.
(2) You must meet the minimum requirements at Appendix F of this
part as a prerequisite for having the DOT review your petition.
(3) If you are a certification organization with a petition already
submitted for DOT review, you must obtain NCCA accreditation before the
review can continue.
(4) If you were a certification organization listed in paragraph
(a)(5) of this section prior to [effective date of the final
regulation], you are not required by DOT to have NCCA accreditation.
Sec. 40.283 When is a SAP evaluation required?
(a) When an employee has violated DOT drug and alcohol regulations,
the employee cannot again perform any DOT safety-sensitive duties until
and unless he or she completes the SAP evaluation, referral, and
treatment process set forth in this subpart and in applicable DOT
agency regulations. (In some cases, DOT agency regulations may prohibit
your return to work in safety-sensitive functions.) The first step in
this process is to be evaluated by a SAP.
(b) For purposes of this subpart, a verified positive DOT drug test
result, a DOT alcohol test with a result indicating an alcohol
concentration of 0.04 or greater, a refusal to test, or any violation
of the prohibition on the use of alcohol or drugs under a DOT agency
regulation constitutes a DOT drug and alcohol regulation violation.
Sec. 40.285 What information is an employer required to provide
concerning SAP services to an employee who has a DOT drug and alcohol
regulation violation?
As an employer, you must provide to each employee who engages in a
DOT drug and alcohol regulation violation, a listing of SAPs readily
available to the employee, with names, addresses, and telephone
numbers. You cannot charge the employee any fee for compiling or
providing this list.
Sec. 40.287 Are employers required to provide SAP and treatment
services to employees?
(a) As an employer, you are not required to provide a SAP
evaluation or any subsequent recommended education or treatment for an
employee who has violated a DOT drug and alcohol regulation.
(b) However, if you offer that employee an opportunity to return to
a DOT safety-sensitive duty following a violation, then before the
employee again performs that duty, you must first ensure that the
employee receives an evaluation by a SAP suitable to you and that the
employee successfully complies with the SAP's evaluation
recommendations.
(c) As an employer, you must ensure that the selected SAP is
qualified to do the job, and is aware of the SAP role and function as
it relates to your interests in safety sensitive duties.
(d) You must, as an employer, use as a SAP only someone who is
knowledgeable about this part, the DOT SAP guidelines, and the
appropriate DOT agency regulation under which you conduct your drug and
alcohol program.
(e) SAP and treatment payment matters are left for employers and
employees to decide and may be governed by existing management-labor
agreements and insurance coverage.
Sec. 40.289 What is the role of the SAP in the evaluation, referral,
and treatment process of an employee who has violated the DOT drug and
alcohol regulations?
As a SAP, you are charged with:
(a) Making a face-to-face clinical assessment and evaluation to
determine what assistance, if any, is needed by the employee to resolve
problems associated with alcohol and/or drug use.
(b) Referring the employee to an appropriate education and/or
treatment program(s) if assistance is needed.
(c) Conducting a face-to-face follow-up evaluation to determine if
the employee has actively participated in the education and/or
treatment program and has demonstrated successful compliance with the
initial assessment and evaluation recommendations (if assistance was
needed).
(d) Providing the DER with a follow-up drug and/or alcohol testing
plan for the employee.
Sec. 40.291 Can employees who are referred for SAP evaluations be
required to waive liability with regard to negligence or malpractice on
the part of the SAP?
(a) As a SAP, you must not ask or require an employee or employer
to waive liability with regard to negligence and/or malpractice related
to the SAP
[[Page 69127]]
evaluation, referral, treatment, and follow-up evaluation processes,
nor indemnify any person or group for the negligence of others in the
SAP process.
(b) As a service agent or service agent representative, you must
not ask or require an employee or employer to sign any form, statement,
or authorization with regard to waiving SAP liability.
Sec. 40.293 What is the SAP's function in conducting the initial
evaluation of an employee?
As a SAP, when an employee comes to you following a DOT drug and
alcohol regulation violation, you must accomplish the following:
(a) Provide a comprehensive face-to-face assessment and clinical
evaluation to determine if the employee needs assistance resolving
problems associated with alcohol and/or drug use.
(b) If you find the employee is in need of assistance as a result
of your evaluation, recommend a course of education and/or treatment
with which the employee must demonstrate successful compliance prior to
returning to DOT safety-sensitive duty.
(1) Appropriate education modalities may include, but are not
limited to, self-help groups (e.g., Alcoholics Anonymous) and community
lectures, where attendance can be independently verified, and bona fide
drug and alcohol education courses.
(2) Appropriate treatment modalities may include, but are not
limited to, in-patient hospitalization, partial in-patient treatment,
out-patient counseling programs, and aftercare.
(3) You must provide a written report directly to the DER
highlighting your specific recommendations for assistance (see
Sec. 40.311(c)).
(c) If you find the employee needs no assistance as a result of
your evaluation, you must follow the instructions for follow-up testing
at Sec. 40.307(b), and provide a written report (see Sec. 40.311(d))
directly to the DER. You have no additional responsibilities with
regard to Secs. 40.301, 40.303, and 40.311(c) and (e).
Sec. 40.295 Can employees or employers seek a second SAP evaluation if
they disagree with the first SAP's recommendations?
(a) As an employee with a DOT drug and alcohol regulation
violation, when you have been evaluated by a SAP suitable to the
employer, you cannot seek a second SAP's evaluation in order to obtain
another recommendation.
(b) As an employer, you cannot seek a second SAP's evaluation if
the employee has already been evaluated by a SAP suitable to you.
Sec. 40.297 Does anyone have the authority to change a SAP's initial
assessment recommending assistance?
No one (e.g., an employer, employee, a managed-care coordinator, or
any service agent or service agent network) has the authority to
change, append, or modify the SAP's evaluation recommendation for
assistance. This is most important in cases where a third party wishes
to lessen or downgrade a SAP's recommendation by changing the SAP's
evaluation or seeking another SAP's evaluation. In situations where the
third party wishes a more stringent recommendation, the same basic
principle applies.
Sec. 40.299 What is the SAP's role and what are the limits on a SAP's
discretion in referring employees for treatment and education?
(a) As a SAP, upon your determination of the best recommendation
for assistance, you will serve as a referral source to assist the
employee's entry into a treatment and/or education program.
(b) To prevent the appearance of a conflict of interest, you must
not refer an employee requiring assistance to your private practice or
to a person or organization from which you receive remuneration or to a
person or organization in which you have a financial interest. You are
precluded from making referrals to entities with which you are
financially associated.
(c) There are four exceptions to the prohibitions contained in
paragraph (b) of this section. You may refer an employee to any of the
following providers of assistance, regardless of your relationship with
them:
(1) A public agency (e.g., treatment facility) operated by a state,
county, or municipality;
(2) The employer or a person or organization under contract to the
employer to provide alcohol or drug treatment services (e.g., the
employer's contracted treatment provider);
(3) The sole source of therapeutically appropriate treatment under
the employee's health insurance program (e.g., the single substance
abuse in-patient treatment program made available by the employee's
insurance coverage plan); or
(4) The sole source of therapeutically appropriate treatment
reasonably available to the employee (e.g., the only appropriate
treatment facility reasonably located within the general commuting
area).
(d) As a SAP, you must maintain a signed statement that you will
not make treatment referrals covered under this DOT program to yourself
or to persons and entities with which you are financially associated.
The statement will remain in effect and be maintained until its
conditions change, at which time you will so notify the employer of the
change. This signed statement will be made available for review by
employers.
Sec. 40.301 What is the SAP's function in the follow-up evaluation of
an employee?
(a) As a SAP, when you have prescribed assistance under
Sec. 40.293, you must re-evaluate the employee to determine if the
employee has successfully carried out your education and/or treatment
recommendations.
(1) This is your way to gauge for the employer the employee's
ability to demonstrate successful compliance with the education and/or
treatment plan.
(2) Your evaluation may serve as one of the reasons the employer
decides to return the employee to safety-sensitive duty.
(b) As the SAP making the follow-up evaluation determination, you
must:
(1) Confer with the appropriate education or treatment program
professionals where the employee was referred;
(2) Conduct a face-to-face clinical interview with the employee to
determine if the employee demonstrates successful compliance with your
initial evaluation recommendations; and
(3) Provide a written report directly to the DER highlighting your
clinical determination whether the employee has demonstrated successful
compliance with your initial evaluation recommendation (see
Sec. 40.311(e)).
(c) You may determine that an employee has successfully
demonstrated compliance even though the individual has not completed
the full regimen of treatment you recommended or needs additional
treatment or continuing care. For example, if the employee has
successfully completed the 30-day in-patient program you prescribed,
you may make a ``successful completion'' determination even though you
conclude that the employee has not completed the out-patient counseling
you recommended or should continue in an aftercare program.
(d) As a SAP, if you believe, as a result of the follow-up
evaluation, the employee has not demonstrated successful compliance
with your initial recommendation, you must postpone the follow-up
evaluation pending the employee's further compliance with the education
and/or treatment plan.
[[Page 69128]]
Sec. 40.303 What happens if the SAP believes the employee needs
additional treatment, aftercare, or support group services even after
the employee returns to safety-sensitive duties?
(a) As a SAP who believes that on-going services are needed to
assist an employee to maintain sobriety or abstinence from drug use
upon returning to safety-sensitive duties, you must clearly state what
services are needed as part of the follow-up evaluation report sent
directly to the DER (see Sec. 40.311(e)(10)).
(b) As an employer receiving this determination from the SAP, you
must, as part of a return-to-work agreement with the employee, require
the employee to continue to participate in recommended on-going
services after returning to safety-sensitive duties.
(c) As an employer, you must monitor and document the employee's
participation in on-going services after returning to safety-sensitive
duties.
Sec. 40.305 Must an employer return an employee to safety-sensitive
functions following a SAP determination that the employee demonstrated
successful compliance with the SAP's recommendation?
(a) As an employer, you are not obligated under DOT regulations to
return the employee to safety-sensitive duties.
(b) The employee's demonstrating successful compliance with
prescribed education and/or treatment as determined by the SAP and
subsequently testing negative on the return-to-duty drug and/or alcohol
test are not guarantees of continued employment or of return to work in
a safety-sensitive position. They are merely preconditions the employee
must meet in order to be considered for reinstatement into safety-
sensitive duties.
(c) As a SAP, you are not to make a ``fitness for duty''
determination as part of this re-evaluation unless required to do so
under an applicable DOT agency regulation. It is the employer, rather
than you, who must decide whether to put the employee back to work in a
safety-sensitive position.
Sec. 40.307 What is the SAP's function in prescribing the employee's
follow-up tests?
(a) As the SAP, when you have made a ``successful compliance''
determination regarding the employee during the follow-up evaluation,
you must then determine what manner of follow-up testing (as specified
in paragraph (c) of this section) is needed when the employee returns
to safety-sensitive duties, and present a plan for follow-up testing
directly to the DER (see Sec. 40.311(e)(9)).
(b) Under specific DOT agency regulations, you must determine what
manner of follow-up testing (as specified in paragraph (c) of this
section) is needed following an initial evaluation when you have
concluded that the employee needs no assistance and present a plan for
follow-up testing directly to the DER (see Sec. 40.311(d)(6)).
(c) You are the sole determiner of the number and frequency of
follow-up tests and whether these tests will be for drugs, alcohol, or
both, unless otherwise directed by the appropriate DOT agency
regulation. For example, if the employee had a positive drug test, but
your evaluation or the treatment program professionals determined that
the employee had an alcohol problem as well, you could require that the
employee have follow-up tests for both drugs and alcohol.
(d) However, you must, at a minimum, direct that the employee be
subject to six unannounced follow-up tests in the first 12 months
following the employee's return to safety-sensitive duties.
(1) You may require a greater number of tests during the first 12-
month period (e.g., you may require one test a month during the 12-
month period; you may require two tests per month during the first 6-
month period and one test per month during the final 6-month period).
(2) You may also require follow-up tests during the 48 months
following this first 12-month period.
(3) You are not to establish the actual dates for the follow-up
tests you prescribe. The decision on specific dates to test is up to
the employer.
(e) You may modify the determinations you have made concerning
follow-up tests. For example, even if you recommended follow-up testing
beyond the first 12-months, you can terminate the testing requirement
at any time after the first year of testing.
Sec. 40.309 What are the employer's responsibilities with respect to
the SAP's directions for follow-up tests?
(a) As the employer, you must carry out the SAP's follow-up testing
requirements. You may not allow the employee to continue to perform
safety-sensitive functions unless follow-up testing is conducted as
directed by the SAP.
(b) You should schedule follow-up tests on dates of your own
choosing, but you must ensure that the tests are unannounced with no
discernable pattern as to their timing, and that the employee is given
no advance notice.
(c) You cannot substitute any other tests (e.g., those carried out
under the random testing program) conducted on the employee for this
follow-up testing requirement.
(d) You cannot count a follow-up test that has been canceled as a
completed test. A canceled follow-up test must be recollected.
Sec. 40.311 Are there any special instructions regarding SAP reports
to employers and SAP records?
(a) As the SAP conducting the required evaluations, you must send
your written reports in writing directly to the DER and not to a third
party or entity for forwarding to the DER.
(b) As an employer, you must ensure that you receive SAP written
reports directly from SAPs performing the evaluation and that no third
party or entity forwarded those reports to you or changed the SAP's
report in any way.
(c) The SAP's written report, following an initial evaluation that
determines that assistance is needed to address the employee's drug
and/or alcohol problems, must be on the SAP's letterhead, signed by the
SAP, and must contain the following delineated items:
(1) Employee's name and SSN;
(2) Employer's name and address;
(3) Reason for the assessment;
(4) Date of the assessment;
(5) SAP's education and/or treatment recommendation; and
(6) SAP's telephone number.
(d) The SAP's written report, following an initial evaluation that
determines that no assistance is needed to address the employee's drug
and/or alcohol problems, must be on the SAP's letterhead, signed by the
SAP, and must contain the following delineated items:
(1) Employee's name and SSN;
(2) Employer's name and address;
(3) Reason for the assessment;
(4) Date of the assessment;
(5) SAP's reasons for determining that no assistance is needed;
(6) Follow-up testing plan (if required or authorized by the
appropriate DOT agency regulation); and
(7) SAP's telephone number.
(e) The SAP's written report concerning the follow-up evaluation
that determines the employee has demonstrated successful compliance,
must be on the SAP's letterhead, signed by the SAP, and must contain
the following delineated items:
(1) Employee's name and SSN;
(2) Employer's name and address;
(3) Reason for the initial assessment;
(4) Date of the initial assessment and synopsis of the treatment
plan;
(5) Name of practice(s) or service(s) providing the recommended
education and/or treatment;
[[Page 69129]]
(6) Inclusive dates of employee's program participation;
(7) Clinical characterization of employee's program participation;
(8) SAP's clinical determination as to whether the employee has
demonstrated successful compliance;
(9) Follow-up testing plan;
(10) Employee's continuing care needs with specific treatment,
aftercare, and/or support group services recommendations; and
(11) SAP's telephone number.
(f) As a SAP, you must provide these written reports directly to
the employee if the employee has no current employer and to the gaining
DOT regulated employer in the event the employee obtains another
transportation industry safety-sensitive position.
(g) As a SAP, you are to maintain copies of your reports to
employers for 5 years, and your employee clinical records in accordance
with Federal, state, and local laws regarding record maintenance,
confidentiality, and release of information.
(h) As an employer, you must maintain your reports from SAPs for 5
years.
Sec. 40.313 Where is other information on SAP functions found in this
regulation?
You can find other information on the role and functions of SAPs in
the following sections of this part:
Sec. 40.1--application to SAPs of regulation coverage.
Sec. 40.3--definition.
Sec. 40.347--service agent assistance with SAP-required follow-up
testing.
Sec. 40.353--transmission of SAP reports.
Subpart P--Confidentiality and Release of Information
Sec. 40.321 What is the general confidentiality rule for drug and
alcohol test information?
Except as otherwise provided in this subpart, as a service agent or
employer participating in the DOT drug or alcohol testing process, you
are prohibited from releasing individual test results or medical
information about an employee to third parties without the employee's
specific written consent.
(a) A ``third party'' is any person or organization to whom other
subparts of this regulation do not explicitly authorize or require the
transmission of information in the course of the drug or alcohol
testing process.
(b) ``Specific written consent'' means a statement signed by the
employee that he or she agrees to the release of a particular piece of
information to a particular, explicitly identified, person or
organization at a particular time. ``Blanket releases,'' in which an
employee agrees to a release of a category of information (e.g., all
test results) or to release information to a category of parties (e.g.,
other employers who are members of a consortium, companies to which the
employee may apply for employment) are not permitted under this part.
Sec. 40.323 Can program participants release drug or alcohol test
information in connection with legal proceedings?
(a) As an employer, you may release information pertaining to an
employee's drug or alcohol test without the employee's consent in
certain legal proceedings.
(1) These proceedings include a lawsuit (e.g., a wrongful discharge
action), grievance (e.g., an arbitration concerning disciplinary action
taken by the employer), or administrative proceeding (e.g., an
unemployment compensation hearing) brought by, or on behalf of, an
employee and resulting from a positive DOT drug or alcohol test.
(2) In such a proceeding, you may release the information to the
decisionmaker in the proceeding (e.g., the court in a lawsuit, the
arbitrator in a grievance). You may release the information only with a
binding stipulation that the party to whom it is released will not
release it to additional parties.
(b) If you are a service agent, you may release information
pertaining to an employee's drug or alcohol test without the employee's
consent to the employer who directed that the test occur so that the
employer can introduce it in such a proceeding or directly to the
decision maker in the proceeding.
Sec. 40.325 May service agents transfer drug or alcohol test
information to one another?
(a) As a service agent authorized to maintain drug and/or alcohol
test results and you are no longer providing services with respect to
an employer, you may transfer that employer's records to your successor
without obtaining each employee's consent. For example, if Employer X
is replacing Dr. A with Dr. B as its MRO, Dr. A may transfer drug
testing records of Employer X's employees to Dr. B without getting the
employees' consent.
(b) The service agent must use the provisions of Sec. 40.335 in
determining which records to transfer and the time period that must be
covered.
(c) Records that are not transferred must be maintained for the
employer in accordance with the provisions of section Sec. 40.335.
Sec. 40.327 When may the MRO release medical information gathered in
the verification process?
(a) As the MRO, you must warn an employee who has a confirmed
positive test that you may provide medical information the employee
gives you in the verification process to other persons specified in
this section, without the employee's consent.
(1) You must give this warning to the employee before obtaining any
medical information as part of the verification process.
(2) For purposes of this section, medical information includes
information on medications or other substances the employee reports
using or medical conditions the employee reports having.
(3) The only other persons to whom you may provide such information
are the employer, a physician responsible for determining the medical
qualifications of the employee under an applicable DOT agency safety
regulation, a DOT agency, the National Transportation Safety Board in
the course of an accident investigation, or another employer who would
receive a positive test result under Sec. 40.329.
(b) As the MRO, you may provide medical information to third
parties without the employee's consent only if you determine, in your
reasonable medical judgment, that:
(1) The information is likely to result in the employee being
determined to be medically unqualified under an applicable DOT agency
regulation; or
(2) The information indicates that continued performance by the
employee of his or her safety-sensitive function is likely to pose a
significant safety risk.
(c) As the MRO, before informing any third party about any
medication the employee is using pursuant to a prescription legally
valid under the Controlled Substances Act, you should, if the employee
consents, contact the prescribing physician to determine if the
medication can be changed to one that does not make the employee
medically unqualified or does not pose a significant safety risk.
Sec. 40.329 May an MRO provide information about a positive drug test
result to another employer?
(a) Except as otherwise provided in this section, as an MRO you
must provide the results of a verified drug positive test result only
to the employer who required that particular test to be conducted.
(b) If you have personal knowledge that an employee whose drug test
result you have verified positive is also employed or is seeking
employment in
[[Page 69130]]
a safety-sensitive position for another employer subject to a DOT
agency's drug testing regulations, you must notify the other employer
of the positive drug test result if you meet all of the following
conditions:
(1) You also personally are the current MRO, perform DOT-required
physical examinations, function as the Aviation Medical Examiner, or
function as the Medical Examiner conducting medical qualification
physicals in the transportation industry for the other employer;
(2) Your knowledge that the employee works for the other employer
was obtained in one of these capacities or through your review of the
result of a drug test mandated by a DOT agency regulation;
(3) You have affirmed that the employee is currently employed by
the other employer in a safety-sensitive position subject to drug
testing under a DOT agency regulation; and
(4) You have informed the employee at the beginning of the
verification process that a verified positive test result may be shared
with other employers for whom the employee is performing, or is seeking
employment to perform, safety-sensitive functions subject to drug
testing under a DOT agency regulation.
(c) The only party to whom you are authorized to convey this
information is the other employer itself. You must not convey the
information to or through a service agent who performs drug testing
services for the other employer.
(d) In notifying the other employer, you must follow the same
procedures as you follow in notifying any employer of a drug test
result. In doing so, you must notify the other employer to immediately
remove the employee from performing safety-sensitive functions. You
must also inform the other employer if the employee requests a test of
a split specimen, cautioning the other employer not to take irrevocable
personnel action until the result of the test of the split specimen is
known. You must also provide to the other employer the results of the
test of the split specimen.
Example to Sec. 40.329: Employer 1 sends in Employee X for a
random drug test. You verify the result positive. You also act as
the MRO for Employer 2, which is subject to DOT drug testing
regulations. In that capacity, you have learned that Employee X also
performs DOT safety sensitive functions for Employer 2. You must
inform Employer 2 about the positive test result. You do not need to
obtain the employee's consent to do so. Employer 2 has the same
obligation as Employer 1 after receiving this information. That is,
both employers must remove Employee X from the performance of
safety-sensitive functions.
Sec. 40.331 What information must laboratories and other service
agents release to employees?
(a) As a service agent you must provide, within 10 business days of
receiving a written request from an employee, copies of any records
pertaining to the employee's use of alcohol and/or drugs, including
records of the employee's DOT-mandated drug and/or alcohol tests. You
may charge no more than the cost of preparation and reproduction for
copies of these records.
(b) As a laboratory, you must also provide, within 10 business days
of receiving a written request from an employee, and made through the
MRO, the records relating to the results of any relevant HHS
certification, review, or revocation-of-certification (i.e., Federal
Register Notice listing current laboratories). You may charge no more
than the cost of preparation and reproduction for copies of these
records.
(c) As a laboratory, you must also provide, within 10 business days
of receiving a written request from an employee, and made through the
MRO, the records relating to the results of the employee's drug test
(i.e., laboratory report and data package). You may charge no more than
the cost of preparation and reproduction for copies of these records.
Sec. 40.333 To what additional parties must employers and service
agents release information?
As an employer or service agent you must release information under
the following circumstances:
(a) If you receive a specific, written consent from an employee
authorizing the release of information about that employee's drug or
alcohol tests to an identified person, you must provide the information
to the identified person. For example, as an employer, when you receive
a written request from someone who worked for you to provide
information to a subsequent employer, you must do so. In providing the
information, you must comply with the terms of the employee's consent.
(b) Upon request and as required by DOT agency regulations,
employers must provide to DOT agencies the following:
(1) Access to your facilities used for this part and DOT agency
drug and alcohol program functions.
(2) All written, printed, and computer-based drug and alcohol
program records and reports (including copies of name-specific records
or reports), files, materials, data, documents/documentation,
agreements, contracts, policies, and statements that are required by
this part and DOT agency regulations.
(c) Upon request and as required by DOT agency regulations, service
agents must provide to DOT agencies the following:
(1) Access to your facilities used for this part and DOT agency
drug and alcohol program functions.
(2) All written, printed, and computer-based drug and alcohol
program records and reports (including copies of name-specific records
or reports), files, materials, data, documents/documentation,
agreements, contracts, policies, and statements that are required by
this part and DOT agency regulations.
(d) When requested by the National Transportation Safety Board as
part of an accident investigation, you must provide information
concerning post-accident tests administered after the accident.
(e) As a laboratory you must not release or provide a specimen or
an aliquot of a specimen to a requesting party, without first obtaining
written consent from a DOT agency. You are permitted to release a
specimen or an aliquot of a specimen if you are presented with a court
order to do so from a court with proper and legal jurisdiction.
Sec. 40.335 What records must employers keep?
(a) As an employer, you must keep the following records for the
following periods of time:
(1) You must keep the following records for five years:
(i) Records of employee alcohol test results indicating an alcohol
concentration of 0.02 or greater;
(ii) Records of employee verified positive drug test results;
(iii) Documentation of refusals to take required alcohol and/or
drug tests;
(iv) SAP reports;
(v) Calibration documentation for EBTs;
(vi) Records related to the administration of the alcohol and drug
testing programs; and
(vii) All follow-up tests and schedules for follow-up tests.
(2) You must keep records related to the alcohol and drug testing
process, records of the inspection and maintenance (but not
calibration) of EBTs, for two years.
(3) You must keep records of negative and canceled drug test
results and alcohol test results with a concentration of less than 0.02
for one year.
(4) You must keep records related to the education and training of
applicable
[[Page 69131]]
service agents, supervisors, and employees as long as the individual
performs the functions which require the training and for two years
after he or she ceases to perform those functions.
(5) You must keep signed statements of any agreements with service
agents as long as the organization or individual performs functions
under the DOT drug and alcohol testing program and for two years after
it ceases doing so.
(b) You do not have to keep records related to a program
requirement that does not apply to you (e.g., a maritime employer who
does not have a DOT-mandated alcohol testing program need not maintain
alcohol testing records).
(c) You must maintain the records in a secure location with
controlled access.
(d) A service agent may maintain these records for you. However,
you must ensure that you can produce these records, at your principal
place of business, in the time required by the DOT agency. For example,
as a motor carrier, when an FMCSA inspector requests your records, you
must make sure that you can provide them within two working days.
Subpart Q--Roles And Responsibilities of Service Agents
Sec. 40.341 Can an employer use a service agent to meet DOT drug and
alcohol testing requirements?
(a) Yes. As an employer, you may use a service agent to perform the
tasks needed to comply with DOT agency drug and alcohol testing
regulations.
(b) As an employer, you are responsible for ensuring that the
service agent you use performs these tasks in accordance with DOT
agency regulations.
(c) If a consortium, third-party administrator, or other service
agent fails to comply with DOT agency regulations, you as the employer
are responsible for the noncompliance. A DOT agency can subject you to
sanctions for the noncompliance of a consortium, third-party
administrator, or any other service agent who works for you.
Sec. 40.343 May service agents impose requirements on employers that
DOT agency regulations do not authorize?
As a service agent, you must not impose conditions or requirements
on employers that DOT regulations do not authorize. For example, as a
consortium or third-party administrator serving employers in the
pipeline industry, you may not require employers to have provisions in
their plans that RSPA regulations do not require.
Sec. 40.345 If, as a service agent, you fail to comply with DOT
regulations, can employers use your services?
(a) As a service agent, employers are not permitted to use your
services if, in providing these services, you fail to comply with DOT
drug and alcohol testing requirements.
(b) If you do not comply, you are subject to proceedings under
Subpart R of this part that can result in a directive to employers not
to use your services.
Sec. 40.347 What functions can service agents perform with respect to
selection for testing?
As a service agent, you may perform the following functions for
employers concerning random selection and other selections for testing.
(a) You may operate random testing programs for employers and may
assist (e.g., contracting with labs or collectors, conducting
collections) employers with other types of testing (e.g., pre-
employment, post-accident, reasonable suspicion, return-to-duty, and
follow-up).
(b) You may combine employees from more than one employer or one
transportation industry in a random pool if permitted by individual DOT
agency regulations.
(1) If you combine employees from more than one transportation
industry, you must ensure that the random testing rate is at least
equal to the highest rate required by each DOT agency.
(2) Employees not covered by DOT agency regulations may not be part
of the same random pool with DOT covered employees.
(c) You may assist employers in ensuring that follow-up testing is
conducted in accordance with the schedule established by the SAP or
MRO. However, you may not randomly select employees from a ``follow-up
pool'' for follow-up testing.
Sec. 40.349 What requirements must a service agent implement
concerning the use and confidentiality of information?
As a service agent, the following requirements apply to you with
respect to the use and confidentiality of information.
(a) You may receive confidential information about employees (e.g.,
individual test results) from an employer without the employees'
written consent. You must follow the same confidentiality regulations
as the employer with respect to the use and release of this
information.
(b) You may receive and maintain all records concerning DOT drug
and alcohol testing programs, including individual test results, both
positive and negative, as well as SAP follow-up summary reports to
employers.
(c) Where DOT agency regulations require employers to keep certain
information in their own files (e.g., for purposes of review during
inspections), employers must do so, but you may also maintain copies of
these records at the employer's direction.
(d) You may maintain information needed for operating a drug/
alcohol program (e.g., names of employees in random pools, random
selection lists, copies of notices to employers of selected employees)
on behalf of an employer.
(e) If you are either conducting or arranging for drug testing, the
employer's copy of the CCF may pass through you to provide notice so
that you know the employee's specimen has been collected. You must
ensure that the document is forwarded immediately to the actual
employer.
(f) You must follow all confidentiality and records retention
requirements applicable to employers.
(g) You may not provide individual test results or other
confidential information to another employer without a specific,
written consent from the employee. For example, suppose you are a
consortium that has employers X and Y as members. Employee Jones works
for X, and has a drug or alcohol test result maintained for X by you.
Jones wants to change jobs and work for Y. You may not inform Y of the
result of a test conducted for X without obtaining specific, written
consent from Jones. Likewise, you may not provide this information to
Z, who is not a consortium member, without this consent.
(h) You may not use blanket consent forms authorizing the release
of employee testing information.
(i) You must establish adequate confidentiality and security
measures to ensure that confidential employee records are not available
to unauthorized persons. This includes protecting the physical security
of records, access controls, and computer security measures to
safeguard confidential data in electronic data bases.
(j) You must permit DOT agency access to all facilities, files,
records, and documents used in complying with DOT agency drug and
alcohol testing regulations.
Sec. 40.351 What principles govern the interaction between MROs and
other service agents?
As a service agent, the following principles govern your
interaction with MROs:
[[Page 69132]]
(a) As a service agent you may provide MRO services to employers,
directly or through contract, if you ensure that the provisions of
Secs. 40.101(a) and 40.125(a) are met.
(b) If you employ or contract for an MRO, the MRO must perform
duties independently and confidentially. When you have a relationship
with an MRO, you must structure the relationship in writing (e.g.,
through a contract) to ensure that this independence and
confidentiality are not compromised. Specific means (including both
physical and operational measures, as appropriate) to separate MRO
functions and other service agent functions are essential.
(c) Only your staff who are actually under the day-to-day
supervision and control of an MRO with respect to MRO functions may
perform these functions. This does not mean that those staff may not
perform other functions at other times. However, the designation of
your staff to perform MRO functions under MRO supervision must be
limited and not used as a subterfuge to circumvent confidentiality and
other requirements of this part and DOT agency regulations. You must
ensure that MRO staff operate under controls sufficient to ensure that
the independence and confidentiality of the MRO process are not
compromised.
(d) You may not act as an intermediary in the transmission of
individual drug test results from the laboratory to the MRO. That is,
the laboratory may not send results to you, with you in turn sending
them to the MRO. For example, a practice in which results are
transmitted from a laboratory to your computer system, and then
assigned to an available MRO, is not permitted.
(e) You may not act as an intermediary in the transmission of
negative and verified positive test results from the MRO to the actual
employer. That is, the MRO may not send these results to you, with you
in turn sending them to the actual employer. However, you may maintain
individual test results after they are sent to the DER, and the MRO may
transmit such results to you simultaneously with sending them to the
DER.
(f) In exception to paragraph (e) of this section, you may receive
positive results directly from the MRO, if you are authorized by a DOT
agency's regulation to do so.
(g) Like other MROs, an MRO whom your service agent employs or
contracts with must personally conduct verification interviews with
employees who have tested positive and must personally make the
decision concerning whether to verify a test as positive or negative.
Your staff cannot perform these functions.
Sec. 40.353 What other limitations apply to the activities of service
agents?
As a service agent, you are subject to the following limitations on
your activities in the DOT drug and alcohol testing program.
(a) You may not act as an intermediary in the transmission of
individual positive alcohol test results from the BAT to the actual
employer. That is, the BAT may not send such results to you, with you
in turn sending them to the actual employer. However, you may maintain
individual test results after they are sent to the DER, and the BAT may
transmit such results to you simultaneously with sending them to the
DER.
(b) You may not act as an intermediary in the transmission of
individual SAP reports to the actual employer. That is, the SAP may not
send such reports to you, with you in turn sending them to the actual
employer. However, you may maintain individual SAP summary reports and
follow-up testing plans after they are sent to the DER, and the SAP may
transmit such reports to you simultaneously with sending them to the
DER.
(c) You cannot make decisions to test an employee based upon
reasonable suspicion, post-accident, return-to-duty, and follow-up
determination criteria. These are non-delegable duties of the actual
employer. You may, however, provide advice and information to employers
regarding these testing issues and schedule required testing.
(d) You cannot make a determination that an employee has refused a
drug or alcohol test. This is a non-delegable duty of the actual
employer. You may, however, provide advice and information to employers
regarding refusal-to-test issues.
(e) In exception to paragraph (d) of this section, you may make a
determination that an employee has refused a drug or alcohol test, if:
(1) You are authorized by a DOT agency's regulation to do so; and
(2) You schedule a required test for an owner-operator and
subsequently find out that he or she failed to show for the test.
(f) It is not your responsibility, but the actual employer's, to
make sure that an employee who has tested positive for alcohol or
drugs, or otherwise violated the DOT agency regulations, is removed
from performance of safety-sensitive duties.
(g) While you must follow the DOT agency regulations, the actual
employer remains obligated to DOT for compliance, and your failure to
implement any aspect of the program as required in this part and
applicable DOT agency regulations make the employer as well as you
subject to enforcement action by the Department.
(h) You may not act as ``program manager'' in FAA and RSPA
programs, which call for the employer itself to designate an individual
within the company to manage the drug and alcohol testing program for
the employer.
(i) You must continue to transmit laboratory statistical summaries
to each actual employer.
(j) The limitations on SAP referrals (see Sec. 40.299(b)) for
education and/or treatment apply where SAPs are part of your
organization or its services.
(k) Even if your organization is operated by or affiliated with a
laboratory, you must ensure that laboratories receive only the
appropriate CCFs. (This is because, under this part, it is not
appropriate for laboratories to receive an individual's CCF and the
BATF packaged or attached (e.g., stapled) together, since this is
inconsistent with the privacy and confidentiality of personally-
identified test records.) You can comply with this requirement by, for
example, establishing separate addresses for the receipt of CCFs and
BATFs, respectively, or establishing procedures to separate alcohol and
drug forms that arrive together.
Subpart R--Public Interest Exclusions
Sec. 40.361 What is the purpose of a public interest exclusion?
(a) The purpose of a public interest exclusion (PIE) is to protect
employers from noncompliance with DOT drug and alcohol regulations
resulting from the use of a service agent who fails or refuses to
provide drug and alcohol testing-related services to DOT-regulated
employers consistent with the requirements of this part. A PIE is also
intended to protect employees from the consequences of services that do
not meet DOT requirements. A PIE is a serious action used only in the
public interest and not for the purposes of punishment.
(b) Nothing in this subpart precludes a DOT agency from taking
other action authorized by its regulations with respect to service
agents or employers that violate its regulations.
Sec. 40.363 In what circumstances does the Department issue a public
interest exclusion concerning a service agent?
(a) The Department may issue a PIE concerning a service agent if
the
[[Page 69133]]
Department determines that the service agent has failed or refused to
provide drug or alcohol testing services to one or more DOT-regulated
employers consistent with the requirements of this part.
(b) The Department also may issue a PIE concerning a service agent
who has failed to cooperate with DOT agency representatives concerning
inspections, complaint investigations, interviews, compliance and
enforcement reviews, or requests for documents and other information.
Sec. 40.365 Who issues public interest exclusions on behalf of the
Department?
The person responsible for issuing PIEs is the ODAPC Director, or
her or his designee.
Sec. 40.367 Who initiates the public interest exclusion process?
(a) If a DOT agency official, an ODAPC official (other than the
Director), or an official of the Office of Inspector General learns
that a service agent may be failing or refusing to provide drug and
alcohol testing-related services to DOT-regulated employers consistent
with the requirements of this part, this official (the ``initiating
official'') may investigate the matter.
(b) Initiating officials have broad discretion in deciding whether
to take action on the basis of information concerning the conduct of a
service agent. In exercising their discretion, initiating officials may
take into account such factors as the seriousness of the alleged
conduct of the service agent and the availability of agency resources
to pursue the matter.
Sec. 40.369 Does a service agent have the opportunity to correct a
problem before becoming subject to a public interest exclusion?
(a) If the initiating official determines that there is a
reasonable basis for believing that the service agent is failing or
refusing to provide drug and alcohol testing-related services to DOT-
regulated employers consistent with the requirements of this part, the
official issues a written correction notice to the service agent. This
notice tells the service agent what changes it must make to ensure that
its services to DOT-regulated employers are provided consistent with
the requirements of this part.
(b) If the service agent makes and documents the changes set forth
in the correction notice to the satisfaction of the initiating official
within 60 days of the date the notice is received, the Department will
not begin the process leading to a PIE. In this case, the Department
sends a notice to the service agent that the matter is concluded.
(c) If the initiating official learns, in a matter concluded
through a notice under paragraph (b) of this section, that the service
agent has failed to implement satisfactory corrections, the initiating
official may begin the process set forth in Sec. 40.371. The initiating
official does not issue a second correction notice in this case.
Sec. 40.371 How does the process leading to a public interest
exclusion begin?
(a) If a service agent who receives a correction notice does not
make and document the corrections set forth in the notice in a manner
satisfactory to the initiating official within 60 days of receiving the
notice, the initiating official sends a written notice to the service
agent.
(b) The notice will include the following information:
(1) That the Department is considering issuing a PIE concerning the
service agent;
(2) The reasons for believing that the service agent is not
providing drug and/or alcohol testing services to DOT-regulated
employers consistent with the requirements of this part;
(3) The consequences of the PIE that the Department is considering
issuing and a proposed interval between the issuance of an exclusion
and the first date on which the service agent may apply to end it; and
(4) That the service agent will have the opportunity to contest the
issuance of a PIE, as provided in Sec. 40.373.
Sec. 40.373 How does a service agent contest the issuance of a public
interest exclusion?
(a) If, as a service agent, you receive a notice that the
Department is considering issuing a PIE concerning you, you have the
right to contest the issuance of the exclusion.
(b) Within 30 days of receiving the notice, you may submit a
written response containing information and arguments contesting the
issuance of a PIE. You submit this material to the Director. If you do
not submit a written response contesting the issuance of the PIE within
this time, the matter will proceed as an uncontested case.
(c) Within this same 30-day period, you may also request, in
writing, an opportunity to meet with the Director or her or his
designee, stating what material facts, if any, you believe are in
dispute. If you do not submit such a written notice within this time,
the matter will proceed as a case in which there are no material facts
in dispute. The Director will grant your request for a meeting if she
or he determines that there are any material facts in dispute. The
meeting may be in person or a teleconference, at the option of the
service agent.
(d) This opportunity to meet with the Director is informal. During
the meeting, you may appear with a representative, submit documentary
evidence, present witnesses, and confront any witnesses the initiating
official presents.
(e) A transcribed record of the meeting will be made available to
the service agent, at cost, upon the service agent's request.
Sec. 40.375 How does the Department make decisions in public interest
exclusion matters?
(a) The initiating official acts as the proponent of issuing a PIE.
The Director acts as a neutral decisionmaker.
(b) The initiating official bears the burden of proof, which is to
demonstrate by a preponderance of the evidence that the service agent
has failed or refused to perform drug and/or alcohol testing services
as required by this part.
(c) In an uncontested case or a case in which there are no material
facts in dispute, the Director makes her or his decision on the basis
of all the information in the administrative record, including any
submission by the service agent.
(d) In a case in which there are material facts in dispute, the
Director makes written findings of fact. The Director makes her or his
decision on the basis of the facts as found, together with any
information and argument submitted by the service agent, and any other
information in the administrative record (including any meeting between
the Director and the service agent).
(e) The initiating official and the service agent, with the
concurrence of the Director or her or his designee, may settle a PIE
matter at any time before the issuance of the Director's decision.
(f) For purposes of judicial review under the Administrative
Procedure Act, the Director's decision is a final administrative action
of the Department.
Sec. 40.377 How does the Department notify service agents and
employers about decisions on public interest exclusions?
(a) The Director provides a notice to the service agent concerning
her or his decision on whether to issue a PIE. The notice includes the
following elements:
(1) A reference to the notice that initiated the process (see
Sec. 40.371);
(2) A statement of the reasons for the decision; and
(3) When the Director issues a PIE, a statement of the first date
on which the service agent may apply to end the exclusion.
[[Page 69134]]
(b) When the Director issues a PIE, she or he also issues a Federal
Register notice, the text of which is posted on the Department's Web
site. This notice includes the name of the service agent and other
persons to which the exclusion applies (see Sec. 40.379), the reason
for the PIE, and the first date on which the service agent may apply to
end the exclusion. This issuance constitutes notice to DOT-regulated
employers that they may not use the service agent's drug or alcohol
testing-related services. ODAPC also publishes a list in the Federal
Register on a quarterly basis of those service agents who are currently
the subject of PIEs.
(c) The Director notifies the DOT agencies of her or his decision.
Sec. 40.379 To whom does a public interest exclusion apply?
(a) A PIE applies to all the divisions and organizational elements
of, and types of services provided by, the service agent, unless the
Director limits the scope of the exclusion to one or more of those
divisions, organizational elements, or types of services.
(b) A PIE may apply to any affiliate of the service agent, if the
affiliate is specifically notified and given the opportunity to respond
as provided by this subpart.
(c) A PIE applies to individuals who are officers, employees,
directors, shareholders, partners, or other individuals associated with
the service agent in the following circumstances:
(1) Conduct forming any part of the basis of PIE occurred in
connection with the individual's performance of duties by or on behalf
of the service agent; or
(2) The individual knew, had reason to know of, approved, or
acquiesced in such conduct. The individual's acceptance of benefits
derived from such conduct is evidence of such knowledge, acquiescence,
or approval.
Sec. 40.381 What is the effect of a public interest exclusion?
(a) As an employer, you must not use a service agent that is
covered by a PIE that the Director has issued under this subpart. If
you do so, you are in violation of the Department's regulations.
(b) As an employer, you must stop using the services of a service
agent concerning whom the Director has issued a PIE no later than 90
days after the Department has published the decision in the Federal
Register and posted it on its Web site.
(c) This prohibition on using a service agent concerning whom the
Director has issued a PIE applies to employers in all industries
subject to DOT drug and alcohol testing regulations. For example, if
the initiating office is the FAA, and the conduct forming the basis of
the PIE pertains to the aviation industry, as an employer in another
regulated industry (e.g., trucking, railroads, transit), you are also
prohibited from using the service agent involved.
(d) The issuance of a PIE does not affect the validity of drug or
alcohol tests conducted using the service agent involved before the
issuance of the Director's decision or up to 90 days following its
publication in the Federal Register and posting on the Department's Web
site. For example, if the Department published a decision issuing a PIE
concerning a service agent on September 1, all tests conducted using
the service agent's services before September 1, and through November
30, would be valid for all purposes under DOT drug and alcohol testing
regulations, assuming they met all other regulatory requirements.
(e) If you are a service agent concerning whom the Director has
issued a PIE, you must, on the request of any employer covered by DOT
drug and alcohol testing regulations, immediately transfer all records
pertaining to that employer and its employees to the employer or to any
service agent the employer designates.
Sec. 40.383 How long does a public interest exclusion stay in effect?
(a) A PIE remains in effect until the Director ends it.
(b) In each decision issuing a PIE, the Director designates the
first date on which a service agent may apply to end its exclusion.
This date shall be at least nine months but no more than five years
from the date on which the Department publishes the exclusion in the
Federal Register and posts it on its Web site.
(c) As a service agent concerning whom the Department has issued a
PIE, you may apply to the Director at any time after this date, in
writing, to end the exclusion. You must include documentation that
supports a determination that the reasons for the issuance for the
exclusion have been eliminated and all drug or alcohol testing-related
services provided to DOT-regulated employers will be consistent with
the requirements of this part.
(d) If the Director determines that the reasons for the issuance
for the exclusion have been eliminated and all drug or alcohol testing-
related services provided to DOT-regulated employers will be consistent
with the requirements of this part, the Director issues a notice ending
the exclusion.
(e) The Department will publish a notice ending an exclusion in the
Federal Register and post it on the Department's Web site.
Sec. 40.385 What is the role of the Inspector General's office?
(a) An official of the DOT Office of Inspector General may act as
the initiating official in a PIE proceeding.
(b) Any person may bring concerns about waste, fraud, or abuse on
the part of a service agent to the attention of Office of Inspector
General.
(c) In appropriate cases, the Office of Inspector General may
pursue criminal or civil remedies against a service agent.
(d) The Office of Inspector General may provide factual information
to other DOT officials for use in a PIE proceeding.
Appendix A to Part 40--DOT Standards for Urine Collection Kits
The Collection Kit Contents
1. Single-Use Plastic Collection Container
a. Must be large enough to easily catch and hold at least 55 mL
urine voided from the body.
b. Must have a graduated volume markings clearly noting levels
of 45 mL and above.
c. Must have a temperature strip providing graduated temperature
readings 90 deg.-100 deg. F or 32 deg.-38 deg. C, that is affixed or
can be affixed at a proper level on the collection container.
d. Must be individually wrapped in a sealed plastic sack or
shrink wrapping; or must have a peelable, sealed lid or other
tamper-evident system.
2. Plastic Specimen Bottles
a. Each bottle must be large enough to hold at least 35 mL; or
alternatively, they may be two distinct sizes of specimen bottles
provided that the bottle designed to hold the primary specimen holds
at least 35 mL of urine and the bottle designed to hold the split
specimen holds at least 20 mL.
b. Must have screw-on or snap-on caps that prevent seepage of
the urine from the bottles.
c. Must have markings clearly indicating the appropriate levels
(30 mL for the primary specimen and 15 mL for the split) of urine
that must be poured into the bottles.
d. Must be designed so that the required tamper-evident bottle
seals made available on the CCF fit with no damage to the seal when
the employee initials it nor with chance that seal overlap would
conceal printed information.
e. Must be wrapped (with caps) together in a sealed plastic sack
or shrink wrapping; or must be wrapped (with cap) individually in
sealed plastic sacks or shrink wrapping; or must have peelable,
sealed lid or other easily-visible tamper-evident system.
f. Must be leach-resistant.
3. Leak-resistant Plastic Bag
Must have two sealable compartments or pouches; one large enough
to hold two specimen bottles and the other large enough to hold the
CCF paperwork.
[[Page 69135]]
4. Plastic Bag Seal
a. Must be tamper-evident.
b. Must have pre-printed space for the collector's initials and
the date of the collection.
5. Shipping Container
a. Must be a box (e.g., standard courier cardboard box, small
cardboard box) designed to adequately protect the specimen bottles
from shipment damage in their transport of specimens from collection
site to the laboratory.
b. May be made available separately at collection sites rather
than being part of an actual kit sent to collection sites.
c. A shipping container is not necessary if a laboratory courier
hand-delivers the specimens from the collection site to the
laboratory.
Appendix B to Part 40--DOT Drug Testing Semi-annual Laboratory
Report
The following items are required on each report:
Reporting Period: (inclusive dates)
Laboratory Identification:
Employer Identification:
C/TPA Identification: (where applicable)
1. Number of specimen results reported: (total number) By test
type:
(a) Pre-employment testing: (number)
(b) Post-accident testing: (number)
(c) Random testing: (number)
(d) Reasonable suspicion/cause testing: (number)
(e) Return-to-duty testing: (number)
(f) Follow-up testing: (number)
(g) Type not noted on CCF: (number)
2. Number of specimens reported as Negative: (total number)
3. Number of specimens reported as Test Not Performed: (total
number) By reason:
(a) Fatal Flaw/Uncorrected Flaw: (number)
(b) Specimen Unsuitable: (number)
(c) Specimen Rejected for Testing: (number)
(d) Specimen Adulterated: (number)
(e) Specimen Substituted: (number)
4. Number of specimens reported as Positive: (total number) By
drug:
(a) Marijuana Metabolite: (number)
(b) Cocaine Metabolite: (number)
(c) Opiates:
(1) Codeine: (number)
(2) Morphine: (number)
(3) 6-AM (number)
(d) Phencyclidine: (number)
(e) Amphetamines: (number)
Appendix C to Part 40--CCF Copies Needed for the MRO Review
I. Negative Laboratory Results
a. To initiate and complete the MRO's administrative review and
report the test result to the employer, the MRO needs:
1. The original or a legible facsimile of the original MRO copy
of the CCF, or if not available, a legible copy of any copy of the
CCF signed by the employee; and
2. A legible facsimile of the original laboratory copy of the
CCF, or the original laboratory copy of the CCF, or the
electronically-transmitted laboratory report.
b. Laboratories sending an electronically-transmitted report
must also follow-up by sending a legible facsimile of the original
laboratory copy or the original laboratory copy of the CCF. Upon
receiving this laboratory copy of the CCF, MROs must match it with
the MRO copy.
II. All Other Laboratory Results
a. To initiate the MRO review, the MRO needs:
1. The original or a legible facsimile of the original MRO copy
of the CCF; or if not available, a legible copy of any copy of the
CCF signed by the employee; and
2. A legible facsimile of the original laboratory copy of the
CCF, the original laboratory copy of the CCF, or the electronically-
transmitted laboratory report.
b. To complete the MRO review and report the result to the
employer, the MRO needs:
1. The original or a legible facsimile of the original MRO copy
of the CCF; or if not available, a legible copy of any copy of the
CCF signed by the employee; and
2. A legible facsimile of the original laboratory copy or the
original laboratory copy of the CCF.
III. Employee Inability to Provide Requisite Amount of Urine at the
Collection Site
To report the result (i.e., refusal to test or canceled test) to
the employer, the MRO needs:
1. The original or a legible facsimile of the original MRO copy
of the CCF; and
2. The examining physician's report documenting whether the
employee had a legitimate medical (i.e., physiological or
psychological) reason for the inability to provide a complete urine
specimen.
IV. Employee Refusals to Test at the Collection Site
To advise the employer, the MRO needs the original or a legible
facsimile of the original MRO copy of the CCF that documents the on-
site refusal (e.g., employee leaves collection site prior to
providing specimen) to test.
Appendix D to Part 40--DOT Drug Testing MRO Reporting Summary
A. Bottle A Lab Report:
----------------------------------------------------------------------------------------------------------------
MRO Reporting Action
----------------------------------------------------------------------------------------------------------------
1. Negative........................................................... The MRO reports the negative result
to the employer.
2. Negative Dilute.................................................... The MRO reports the negative result
to the employer and informs the
employer that the next time the
employee is selected for a drug
test the employer may require the
specimen to be collected under
direct observation.
3. Positive........................................................... a. If the MRO verifies the test as
positive, the MRO reports the
positive result to the employer.
b. If the MRO ``downgrades'' the
test, the MRO reports the negative
result to the employer.
4. Positive Dilute.................................................... a. If the MRO verifies the test as
positive, the MRO reports the
positive result to the employer and
informs the employer that the next
time the employee is selected for a
drug test the employer may require
the specimen to be collected under
direct observation.
b. If the MRO ``downgrades'' the
test, the MRO reports the negative
result to the employer and informs
the employer that the next time the
employee is selected for a drug
test the employer may require the
specimen to be collected under
direct observation.
5. Test Not Performed--Fatal Flaw or Uncorrected Flaw................. The MRO reports the result to the
employer as canceled and the reason
for cancellation. Certain tests--
pre-employment, return-to-duty, and
follow-up tests--requiring a
negative result, must be
recollected.
6. Test Not Performed--Specimen Unsuitable............................ a. If the employee provides an
acceptable explanation and/or a
prescription, the MRO reports to
the employer that the test is
canceled and the reason for
cancellation. Certain tests--pre-
employment, return-to-duty, and
follow-up tests--requiring a
negative result, must be
recollected.
b. If the employee is unable to
provide an acceptable explanation
and/or a prescription, but denies
having adulterated the specimen,
the MRO reports to the employer
that the test is canceled and the
reason for cancellation. The MRO
shall also inform the employer that
an immediate collection under
direct observation of another
specimen is required of the
employee and that no advanced
notice is to be given the
employee.\1\
[[Page 69136]]
7. Test Not Performed--Specimen Rejected for Testing.................. a. If the MRO determines that the
specimen is rejected for testing
due to collector error, the MRO
reports the result to the employer
as canceled and the reason for
cancellation. The MRO shall also
inform the employer that an
immediate collection of another
specimen is required of the
employee and that no advanced
notice is to be given the employee.
This collection is not to be
collected under direct observation.
b. If the MRO determines that
collector error is not the cause of
the specimen being rejected for
testing, the MRO reports to the
employer that the test is canceled
and the reason for cancellation.
The MRO shall also inform the
employer that an immediate
collection under direct observation
of another specimen is required of
the employee and that no advanced
notice is to be given the employee.
8. Test Not Performed--Specimen Adulterated/Substituted............... The MRO reports to the employer that
the test was either adulterated or
substituted and is, therefore, a
``refusal to test.'' \2\
B. Bottle B Lab Report:
1. Reconfirmed........................................................ The MRO reports the reconfirmation
to the employer and to the
employee.
2. Failure to Reconfirm--Drug/Drug Metabolite Not Detected............ The MRO reports to the employer and
to the employee that both tests
must be canceled. The MRO also
reports the failure to reconfirm to
the ODAPC.
3. Failure to Reconfirm--Specimen Adulterated/Substituted............. The MRO reports to the employer and
to the employee that the specimen
was adulterated or substituted and
that this constitutes a ``refusal
to test.'' The ``refusal to test''
becomes the final, single result
for both tests.
4. Test Not Performed................................................. The MRO reports to the employer and
the employee that both tests must
be canceled and the reason for
cancellation. The MRO shall also
inform the employer that an
immediate collection under direct
observation of another specimen is
required of the employee and that
no advanced notice is to be given
the employee.
----------------------------------------------------------------------------------------------------------------
\1\ For a ``test not performed specimen unsuitable'' lab result, if the employee admits to adulterating or
substituting a specimen, the result will be a ``refusal to test.''
\2\ The employee cannot have the ``split'' specimen tested following an adulterated or substituted test result.
Appendix E to Part 40--Report Format for Split Specimen Failure to
Reconfirm
Fax or mail to: Department of Transportation, Office of Drug and
Alcohol Policy and Compliance 400 7th Street, SW., Washington, DC
20590, (fax) 202 366-3897.
1. MRO name, address, phone number, and fax number.
2. Collector name, address, and phone number.
3. Date of collection.
4. Specimen I.D. number.
5. Laboratory accession number.
6. Primary specimen laboratory name, address, and phone number.
7. Date specimen received.
8. Split specimen laboratory name, address, and phone number.
9. Date split specimen received.
10. Drug present in primary specimen.
11. Reason for failure to reconfirm as reported by the
laboratory (e.g., drug not present, specimen unsuitable for testing,
split not collected, insufficient volume).
12. Action taken by MRO.
Appendix F to Part 40--SAP Equivalency Requirements for
Certification Organizations
1. Experience: Minimum requirements are for three years' full-
time supervised experience or 6,000 hours of supervised experience
as an alcoholism and/or drug abuse counselor. The supervision must
be provided by a licensed or certified practitioner. Supervised
experience is important if the individual is to be considered a
professional in the field of alcohol and drug abuse evaluation and
counseling.
2. Education: There exists a requirement of 270 contact hours of
education and training in alcoholism and/or drug abuse or related
training. These hours can take the form of formal education, in-
service training, and professional development courses. Part of any
professional counselor's development is participation in formal and
non-formal education opportunities within the field.
3. Continuing Education: The certified counselor must receive at
least 40--60 hours of continuing education units (CEU) during each
two year period. These CEUs are important to the counselor's keeping
abreast of changes and improvements in the field.
4. Testing: A passing score on a national test is a requirement.
The test must accurately measure the application of the knowledge,
skills, and abilities possessed by the counselor. The test
establishes a national standard that must be met to practice.
5. Testing Validity: The certification examination must be
reviewed by an independent authority for validity (examination
reliability and relationship to the knowledge, skills, and abilities
required by the counseling field). The reliability of the exam is
paramount if counselor attributes are to be accurately measured. The
examination passing score point must be placed at an appropriate
minimal level score as gauged by statistically reliable methodology.
6. Measurable Knowledge Base: The certification process must be
based upon measurable knowledge possessed by the applicant and
verified through collateral data and testing. That level of
knowledge must be of sufficient quantity to ensure a high quality of
SAP evaluation and referral services.
7. Measurable Skills Base: The certification process must be
based upon measurable skills possessed by the applicant and verified
through collateral data and testing. That level of skills must be of
sufficient quality to ensure a high quality of SAP evaluation and
referral services.
8. Quality Assurance Plan: The certification agency must ensure
that a means exists to determine that applicant records are verified
as being true by the certification staff. This is an important check
to ensure that true information is being accepted by the certifying
agency.
9. Code of Ethics: Certified counselors must be pledged to
adhering to an ethical standard for practice. It must be understood
that code violations could result in de-certification. These
standards are vital in maintaining the integrity of practitioners.
High ethical standards are required to ensure quality of client care
and confidentiality of client information as well as to guard
against inappropriate referral practices.
10. Re-certification Program: Certification is not just a one
time event. It is a continuing privilege with continuing
requirements. Among these are continuing education, continuing state
certification, and concomitant adherence to the code of ethics. Re-
certification serves as a protector of client interests by removing
poor performers from the certified practice.
11. Fifty State Coverage: Certification must be available to
qualified counselors in all 50 states and, therefore, the test must
be available to qualified applicants in all 50 states. Because many
companies are multi-state operators, consistency in SAP evaluation
quality and opportunities is paramount. The test need not be given
in all 50 states but should be accessible to candidates from all
states.
12. National Commission for Certifying Agencies (NCCA)
Accreditation: Having NCCA accreditation is a means of demonstrating
to the Department of Transportation that your certification has been
reviewed by a panel of impartial experts that have determined that
your examination(s) has met stringent and appropriate testing
standards.
[FR Doc. 99-31510 Filed 12-8-99; 8:45 am]
BILLING CODE 4910-62-U
