WAIS Document Retrieval[Federal Register: December 9, 1999 (Volume 64, Number 236)]
[Proposed Rules]
[Page 69075-69136]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09de99-22]
[[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
[[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 state
|
|
|
