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 provi