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:
    <bullet> 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.
    <bullet> 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.
    <bullet> If the service agent corrected its problem(s) within 60 
days, no further proceedings would be necessary.
    <bullet> 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.
    <bullet> 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.)
    <bullet> 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.
    <bullet> 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]]

    <bullet> ``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.
    <bullet> ``Interp.''--The material in the proposed rule text comes 
from an interpretation issued by the Department under the present Part 
40.
    <bullet> ``9/98 guidance''--The material in the proposed rule text 
comes from a guidance memorandum issued by the Department in September 
1998.
    <bullet> ``Modal regulation''--The material in the proposed rule 
text comes from a DOT agency regulation (e.g., the FRA drug testing 
rule).
    <bullet> ``New''--The material in the proposed rule would add 
material not found in the present Part 40 or in written interpretations 
or guidance.
    <bullet> ``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.
    <bullet> ``Comment''--The material in the proposed rule responds to 
a comment on the ANPRM.
    <bullet> ``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 <ls-thn-eq>5 mg/dL and the specific gravity is 
<ls-thn-eq>1.001 or <ls-thn-eq>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 <ls-thn-eq>500 <greek-m>g/
mL.; or if the pH is <ls-thn-eq>3 or <ls-thn-eq>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