[Federal Register Volume 60, Number 142 (Tuesday, July 25, 1995)]
[Proposed Rules]
[Pages 38200-38203]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-18041]
[[Page 38199]]
_______________________________________________________________________
Part V
Department of Transportation
_______________________________________________________________________
Office of the Secretary
_______________________________________________________________________
49 CFR Part 40
Workplace Drug and Alcohol Testing Programs; Proposed Rule and Notice
Federal Register / Vol. 60, No. 142 / Tuesday, July 25, 1995 /
Proposed Rules
[[Page 38200]]
DEPARTMENT OF TRANSPORTATION
Office of the Secretary
49 CFR Part 40
[Docket OST 95-321; Notice 95-8]
RIN 2105-AC22
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 modify current
procedures governing situations in which employees are unable to
provide sufficient specimens for urine drug testing. The proposed
changes would allow additional time to collect a sufficient sample. In
addition, the Department proposes to clarify requirements concerning
relationships between laboratories and medical review officers; provide
procedures for situations in which employees do not have contact with
medical review officers following a laboratory-confirmed positive test;
and make explicit that MROs are to report split specimen test results
to employers, regardless of who pays for the test.
DATES: Comments should be received by September 25, 1995. Late-filed
comments will be considered to the extent practicable.
ADDRESSES: Comments should be sent to Docket Clerk, Att: Docket No.
OST-95-321, 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 comment. The docket clerk
will date stamp the postcard and return it to the sender. Comments may
be reviewed at the above address from 9 a.m. through 5:30 p.m. Monday
through Friday.
FOR FURTHER INFORMATION CONTACT: Albert Alvarez, Director, Office of
Drug Enforcement and Program Compliance, 400 7th Street, SW., Room
10317, 202-366-3784; or Robert C. Ashby, Deputy Assistant General
Counsel for Regulation and Enforcement, 400 7th Street, SW., Room
10424, 202-366-9306.
SUPPLEMENTARY INFORMATION:
``Shy Bladder''
In the February 15, 1994, revision of 49 CFR Part 40 (59 FR 7340),
the Department established new ``shy bladder'' procedures, for
situations in which employees cannot provide a sufficient urine sample.
These procedures were established in conjunction with a reduction in
the required sample volume from 60 to 45 milliliters (mL) (for split
samples) or 30 mL (single specimen collections). For employees who are
unable to provide this reduced sample volume, the rule
(Sec. 40.25(f)(10)(iv)) directs the collection site person to
``instruct the individual to drink not more than 24 ounces of fluid
and, after a period of up to two hours, again attempt to provide a
complete sample.'' If the individual cannot do so, the medical review
officer (MRO) is directed to ``refer the individual for a medical
evaluation to develop pertinent information concerning whether the
individual's inability to provide a specimen is genuine or constitutes
a refusal to test.'' (This referral is not mandated in the case of pre-
employment testing where the employer does not want to hire the
individual.)
There were several reasons for this action. First, the Department
of Transportation and the Department of Health and Human Services had
both received information indicating that forcing large quantities of
fluids over a longer period of time could result in water intoxication
(i.e., a condition resulting from rapid, copious water intake, that may
result in dilution of the plasma and an influx of water into the
brain), which if severe can result in harm to employees' health (e.g.,
lethargy, confusion, or seizures). Second, ingesting large quantities
of fluids can help to dilute specimens, giving drug-using employees a
mechanism for trying to ``beat the test.'' Third, the Department's Drug
Enforcement and Program Compliance Office consulted with the medical
community, learning that most adults, in most circumstances, could
produce 45 mL of urine following the ingestion of 24 ounces of fluid
over a two-hour period. Fourth, allowing up to eight hours for testing
had resulted in employees remaining off the job for long periods of
time, with consequent costs to employers, including some employees who
appeared to intentionally and unnecessarily delay the provision of a
specimen.
Since the adoption of this provision, employers, employees and MROs
have expressed various concerns to the Department. Since, absent an
adequate medical explanation, a ``shy bladder'' constitutes a refusal
to test, and a refusal to test is equivalent to a positive test,
program participants (especially in the railroad industry, where a
refusal to test can carry a nine-month suspension) have become
concerned about the operation of this provision. The principal concern
expressed has been that two hours is too short a time to allow
employees to generate sufficient urine, particularly if employees have
become somewhat dehydrated on the job (e.g., railroad unions have said
that their members are sometimes on the job for several hours without
relief, with little fluid intake). Another concern is that the
regulation does not provide sufficient guidance on the factors on which
physicians should rely in determining whether the employee's inability
to provide a sufficient specimen is medically ``genuine.''
The Department is willing to consider changing the ``shy bladder''
provision of the rule in response to these concerns. We will propose
several changes for purposes of soliciting comment on them. These
changes are intended to balance the considerations favoring the present
rule (e.g., lower probability of water intoxication, less likelihood of
producing a dilute specimen, fewer hours off the job) and those
favoring a longer period of time (e.g., greater probability of
producing a complete specimen). The amendment would provide up to four
hours for an employee to drink up to 40 ounces of fluid before making
the second attempt to provide a complete specimen. The employee would
be directed to drink 8 ounces of fluid each 30 minutes during this
period until the 40 ounce maximum is reached. Obviously, this process
would be cut short if the employee provided a sufficient specimen.
Refusal to drink the fluids or make another attempt to provide a new
specimen would be treated as a refusal to test.
The quantity of water consumed under these provisions would be
unlikely to result in water intoxication. A medical journal article
addressing this issue that has recently come to our attention (``Acute
Water Intoxication as a Complication of Urine Drug Testing in the
Workplace,'' David Klonoff and Andrew Jurow, Journal of the American
Medical Association, January 2, 1991, pp. 84-85) related that, in every
reported case of water intoxication the authors found in their
literature search, the patient consumed at least 1.35 liters of water.
(In a particular case cited at length in the article, the patient, in
the course of a drug test, consumed 3 liters of water in a 3-hour
period.) They also noted that it was common medical practice to
administer up to 1 liter of water over a period of 1 hour to distend
the bladder for ultrasound examination. Forty fluid ounces is
approximately equivalent to 1.2 liters, less than the
[[Page 38201]]
1.35 liters or more that the authors found in water intoxication cases
reported in the medical literature. While greater than the 1 liter the
authors found to be common medical practice, the fluids provided under
these procedures would be administered in stages over a two-hour
period, rather than in one hour. While avoiding water intoxication,
this approach would provide 16 more ounces of fluids and 2 more hours
than the current rules, allowing a greater probability of the
individual being able to provide a sufficient specimen.
The Department seeks comment from the medical community, employers,
employees, and other interested persons concerning the appropriateness
of the proposed 4 hour/40 ounce rule. In particular, we are seeking
comments, with rationales and information attached, about whether a
longer or shorter time period or greater or lesser water intake would
be desirable. In addition, we seek comment on whether an unsuccessful
attempt to provide a sufficient specimen should be required in every
instance before the four-hour clock begins to run. (This is the
Department's interpretation of its current rule.) That is, if an
individual comes to the collection site and reports that he or she
cannot provide a sample immediately, should the collection site person
have the discretion to skip the first collection attempt and proceed
immediately to the shy bladder procedure?
To further clarify the rule, we would incorporate language from the
parallel provision of the alcohol testing procedures concerning the
task of the physician who evaluates the employee. Section 40.69(d)
provides as follows:
(d) If the employee attempts and fails to provide an adequate
amount of breath, the employer shall proceed as follows `
(1) [Reserved]
(2) The employer shall direct the employee to obtain, as soon as
practical after the attempted provision of breath, an evaluation
from a licensed physician who is acceptable to the employer
concerning the employee's medical ability to provide an adequate
amount of breath.
(i) If the physician determines, in his or her reasonable
medical judgment, that a medical condition has, or with a high
degree of probability, could have, precluded the employee from
providing an adequate amount of breath, the employee's failure to
provide an adequate amount of breath shall not be deemed a refusal
to take a test. The physician shall provide to the employer a
written statement of the basis for his or her conclusion.
(ii) If the licensed physician, in his or her reasonable medical
judgment, is unable to make the determination set forth in paragraph
(d)(2)(i), the employee's failure to provide an adequate amount of
breath shall be regarded as a refusal to take a test. The licensed
physician shall provide a written statement of the basis for his or
her conclusion to the employer.
The NPRM proposes similar language for ``shy bladder'' situations. By a
``medical condition,'' we mean an ascertainable physiological condition
(e.g., a urinary system dysfunction), as distinct from assertions of
``situational anxiety'' or unsupported claims of dehydration.
The Department is not proposing to allow urine from different voids
to be combined. That is, if an individual voids and provides 25 mL of
urine, that specimen must be discarded. It could not be added to a
subsequent 20 mL void to create a combined 45 mL specimen. Testing a
specimen consisting of urine from two different voids at two separate
times adds too much uncertainty to the testing process. Nor is the
Department proposing to allow individuals who have failed to provide a
sufficient specimen to provide a subsequent urine sample when they
visit the physician for the assessment of whether a medical condition
exists that prevents them providing a complete sample. Such a provision
would allow employees time to take steps to avoid a positive test by
drinking enough fluids to dilute the specimen or otherwise to ``beat
the test.'' In addition, producing a specimen at the doctor's office a
short time after failing to provide it at the testing site might well
be viewed as evidence that there is, in fact, no medical condition
preventing the individual from providing a sufficient sample.
Body Temperature
Currently, Sec. 40.25(e)(i) refers to measurements of oral body
temperature that are made as part of the process of determining whether
the temperature of a urine specimen is consistent with the temperature
of the employee. The reference to ``oral'' may unnecessarily restrict
the means used to test body temperature, since other ways of taking
body temperature (e.g., tympanic temperature) exist. We propose to
delete the word ``oral,'' with the result that taking the individual's
temperature by any medically-accepted means (including oral) would be
permitted.
MRO/Laboratory Relationships
In its August 19, 1994, amendments to Part 40 (59 FR 42996), the
Department added Sec. 40.29(n)(6). Based on a Department of Health and
Human Services regulatory provision, it provides that
The laboratory shall not enter into any relationship with an
employer's MRO that may be construed as a potential conflict of
interest or derive any financial benefit by having an employer use a
specific MRO.
This language is the definitive, and most recent, statement by the
Department of the rules governing relationships between MROs and
laboratories. As such, it was intended to supersede the older language
of Sec. 40.33(b)(2), which provided that
The MRO shall not be an employee of the laboratory conducting
the drug test unless the laboratory establishes a clear separation
of functions to prevent any appearance of a conflict of interest,
including assuring that the MRO has no responsibility for, and is
not supervised by or the supervisor of, any persons who have
responsibility for the drug testing or quality control operations of
the laboratory.
In the August 19, 1994, amendments to part 40, the Department
inadvertently failed to remove the latter provision. While the two
provisions have a common purpose--ensuring that there is not even the
appearance of a conflict of interest between the laboratory and the
MRO--it has been pointed out to the Department that, considered
together, they may cause confusion as to the Department's intent. To
avoid the possibility of any such confusion, this NPRM would remove
Sec. 40.33(b)(2).
The Department is also seeking comment on a related issue,
concerning the application of this conflict of interest provision. In
response to an inquiry from a laboratory, the Department determined
that a ``closed panel'' type of operation--in which a laboratory that
packaged drug testing services to clients provided a list of MROs to
the clients from which the clients had to choose--was inconsistent with
this provision. The rationale of this determination was that since
there is a financial advantage to MROs to be on such a list (i.e., it
directs business to them), there could be an incentive for the MROs to
be less than ideally independent in their reviews of test results from
the laboratory establishing the list. This, in turn, can create at
least the appearance of a conflict of interest. (Though the issue did
not arise in the context of this determination, we note that the
conflict of interest provision works both ways, and would apply to
arrangements in which MROs select laboratories as well as to
arrangements in which laboratories select MROs.)
The laboratory in question and other participants have responded
that arrangements of this kind are common and accepted in the industry
and provide for a higher level of quality control in the drug testing
process, since
[[Page 38202]]
laboratories have a market incentive to provide only the best-qualified
MROs to their clients. Other parties have suggested that MRO/laboratory
arrangements that are not arms-length, however configured, will
compromise the independence of the parties in the process to an
unacceptable degree. The Department wishes to maintain this
independence, but also wishes to avoid interfering unreasonably with
rational arrangements that may serve employers well. The Department
seeks comment on whether there are some specific provisions that should
be included in the regulation, or in guidance, that strike an
appropriate balance.
Unresolved Confirmed Positive Tests
Section 40.33 establishes procedures for MROs and employers to
follow when it is difficult for the MRO to contact an employee
following a report from the laboratory of a confirmed positive drug
test. If, after making all reasonable efforts to contact the employee,
the MRO cannot do so, the MRO asks a designated management official to
contact the employee. If the designated management official cannot do
so, then the employer may place the employee on medical leave or
similar status. The confirmed positive does not become a verified
positive--the only result having consequences under the rule--in this
situation. There can be a ``non-contact positive'' only if the employee
declines an opportunity to discuss the test with the MRO or the
employer has contacted the employee and the employee fails to contact
the MRO within five days. In the latter circumstances, the MRO can
reopen the verified positive test if there is a showing that illness,
injury, or other circumstances beyond the control of the employee
prevented a timely contact.
The Department has become aware of a situation these procedures do
not cover. If neither the MRO nor employer ever succeeds in contacting
the employee (e.g., the applicant never gets back in touch with the
employer in a pre-employment test case, an employee quits or never
shows up again following a random test), a confirmed laboratory
positive test is left in limbo, with no way to verify it either as a
positive or negative test. This creates problems for MROs, who have the
unresolved tests on their books indefinitely.
This situation can also create problems for subsequent employers
and the Department's program. For example, under the Federal Highway
Administration's drug testing requirements (49 CFR part 382), the new
employer is required to seek information on previous drug test results
from other employers. In the unresolved test situation described above,
however, a previous employer will not have a drug test result that it
can report, because only a verified positive or negative test can be
reported. The employee, in this case, may be able to obtain employment
with another employer because the ``limbo'' positive was never
reported.
To avoid this difficulty, the Department is proposing to add
language to Sec. 40.33. In any situation where neither the MRO nor the
employer has been able to contact the employee within 30 days from the
date the MRO receives the confirmed positive test result from the
laboratory, the MRO will be instructed to verify the laboratory result
positive and report it to the employer as such. The same provisions
allowing the employee to reopen the verification will apply as in the
case where the employer did contact the employee and the employee
failed to contact the MRO within 5 days. The Department seeks comment
on this approach and on the appropriate amount of time before a ``non-
contact positive'' can be declared. We also seek comment on what, if
any, documentation of the efforts to contact the employee should be
maintained by the MRO and/or designated employer representative.
The Department also seeks comment on how this provision should
apply in the case of opiate positives. Once an MRO has a confirmed
positive laboratory test result for other drugs, the MRO verifies the
test as positive unless he or she determines that there is a legitimate
medical explanation for the presence of the drug. By contrast, the MRO
cannot verify a confirmed opiate positive unless the MRO finds
independent clinical evidence supporting the positive result. In the
Department's experience, a high percentage of confirmed laboratory
positives for opiates are verified negative. Given this background,
should there be different procedures for ``non-contact positives''
involving laboratory results that are positive only for opiates? If so,
how should the procedures differ?
We also seek comment on whether a similar provision should be
extended to situations in which an employee has contacted the MRO and,
in the course of the verification interview, asserted that there is
documentation of a legitimate medical explanation for the presence of a
drug or metabolite. If the individual, or the individual's physician,
does not produce this documentation after 30 days or some other
reasonable time period, should the rule explicitly authorize the MRO to
verify the test positive at that time?
Reporting of Split Sample Results
Section 40.33 goes into some detail concerning the procedures the
MRO must follow concerning reporting the split specimen test results to
the employer and employee. The section is quite specific on the
consequences of a test of the split specimen that does not reconfirm
the positive result of the primary sample. However, the section does
not explicitly specify what the MRO does in the case of a split
specimen test that does reconfirm the positive result of the test of
the primary specimen. The Department has encountered situations in
which employees who have paid for the test of the split specimen have
objected to the MRO reporting the positive result to the employer. To
clarify that the Department intends that the result of the test of a
split specimen be reported to both the employer and the employee--
regardless of who pays for the test--we propose to add language to this
effect. -
Electronic Signatures
Various inquiries from drug and alcohol testing industry sources
have raised the question of the place that technological developments,
such as electronic signatures, should play in the Department's
programs. In an electronic signature system, an individul using a pen-
like stylus signs an electronic pad connected to a computer system. The
signature is recorded electronically by the computer system and
incorporated into a data base, without any technical need for a paper
signature or printout.
The use of this technology raises a number of issues in the context
of the Department's testing programs. Part 40 currently calls for
signatures on a multiple-copy paper form, and does not, absent future
modification, provide for the use of electronic signatures. Copies of
the form are distributed to various parties (e.g., the employer,
employee, laboratory, MRO). It is unclear how a ``paperless'' system
would provide equivalent service. While one could presumably use an
electronic signature device in something short of a literally paperless
system, combining electronic signatures with a system using paper forms
creates its own set of questions. For example, would there be both a
paper and an electronic signature? Would an electronic signature
somehow be transferred to the paper form? What efficiencies are gained
if one has both an electronic and paper signature?
There are also important issues concerning the security and
identification of electronic signatures. What kinds of technical
requirements (e.g., electronic encryption for
[[Page 38203]]
signatures, computer security software) and operational safeguards
(e.g., access restrictions) should surround their use? Should such
controls be part of DOT regulations? Are there industry consensus
standards that have been or could be developed to address these issues,
to which DOT rules could refer? What are the electronic equivalents of
the physical security measures and controls the Department requires for
paper records?
While the Department is not, at this time, making specific
proposals in this area, we are interested in receiving thoughts and
information from interested parties on how the Department can best
respond to technological changes of this kind that can affect its
program. We invite comment on these matters.
Regulatory Analyses and Notices
This is not a significant rule under Executive Order 12866 or under
the Department's Regulatory Policies and Procedures. It does not impose
costs on regulated parties. It merely clarifies provisions of the
regulations and addresses certain administrative problems that have
arisen in the drug testing program. There are not sufficient Federalism
implications to warrant the preparation of a Federalism Assessment. The
Department certifies that this rule will not have a significant
economic impact on a substantial number of small entities. -
List of Subjects in 49 CFR Part 40
Drug testing, Alcohol testing, Laboratories, Reporting and
recordkeeping -requirements, Safety, Transportation.
Issued this 11th Day of July, 1995, at Washington, D.C.
Federico Pena,
Secretary of Transportation.
For the reasons set forth in the preamble, 49 CFR Part 40 is
proposed to be amended as follows:
PART 40--[AMENDED]
1. The authority citation for Part 40 would be revised to read as
follows:
Authority: 49 U.S.C. 102, 301, 322, 5331, 20140, 31306, 45101-
45106.
2. Section 40.25 is proposed to be amended by removing the word
``oral'' from paragraph (e)(2)(i)(A) and by removing the words ``Oral
body'' from paragraph (e)(2)(i)(B) and adding ``Body'' in their place.
3. Section 40.25(f)(10)(iv) is proposed to be revised to read as
follows:
Sec. 40.25 Specimen collection procedures.
* * * * *
(f) * * *
(10) * * *
(iv)(A)(1) In either collection methodology, upon receiving the
specimen from the individual, the collection site person shall
determine if it has at least 30 milliliters of urine for a single
specimen collection or 45 milliliters of urine for a split specimen
collection.
(2) If the individual has not provided the required quantity of
urine, the specimen shall be discarded. The collection site person
shall direct the individual to drink 8 ounces of fluid immediately. The
individual shall be directed to drink an additional 8 ounces of fluid
each 30 minutes thereafter up to a total of 40 ounces or until the
individual has provided a new urine specimen, whichever occurs first.
If the employee refuses to drink fluids as directed or to provide a new
urine specimen, the collection site person shall terminate the
collection and notify the employer that the employee has refused to
submit to testing.
(3) If the individual has not, within four hours from the time the
original insufficient urine specimen was presented to the collection
site person, provided a sufficient specimen, the collection site person
shall discontinue the collection and notify the employer.
(B) The employer shall direct any employee who does not provide a
sufficient urine specimen (see paragraph (f)(10)(iv)(A)(3) of this
section) to obtain, as soon as practical after the attempted provision
of urine, an evaluation from a licensed physician who is acceptable to
the employer concerning the employee's medical ability to provide an
adequate amount of urine.
(1) If the physician determines, in his or her reasonable medical
judgment, that a medical condition has, or with a high degree of
probability, could have, precluded the employee from providing an
adequate amount of urine, the employee's failure to provide an adequate
amount of urine shall not be deemed a refusal to take a test. The
physician shall provide to the employer a written statement of the
basis for his or her conclusion.
(2) If the physician, in his or her reasonable medical judgment, is
unable to make the determination set forth in paragraph
(f)(10)(iv)(B)(1) of this section, the employee's failure to provide an
adequate amount of urine shall be regarded as a refusal to take a test.
The physician shall provide a written statement of the basis for his or
her conclusion to the employer.
* * * * *
4. Section 40.33 is proposed to be amended by removing and
reserving paragraph (b)(2), by revising paragraphs (c)(5) and (c)(6),
by designating the existing text of paragraph (f) as paragraph (f)(1),
and by adding paragraph (f)(2) to read as follows:
Sec. 40.33 Reporting and review of results.
* * * * *
(c) * * *
(5) The MRO may verify a test as positive without having
communicated directly with the employee about the test in four
circumstances:
(i) The employee expressly declines the opportunity to discuss the
test;
(ii) Neither the MRO nor the designated employer representative,
after making all reasonable efforts, has been able to contact the
employee within 30 days of the date on which the MRO receives the
confirmed positive test result from the laboratory;
(iii) The designated employer representative has successfully made
and documented a contact with the employee and instructed the employee
to contact the MRO (see paragraphs (c) (3) and (4) of this section),
and more than five days have passed since the date the employee was
successfully contacted by the designated employer representative; or
(iv) Other circumstances provided for in DOT agency drug testing
regulations.
(6) If a test is verified positive under the circumstances
specified in paragraph (c)(5) (ii) or (iii) of this section, the
employee may present to the MRO information documenting that serious
illness, injury, or other circumstances unavoidably prevented the
employee from being contacted by the MRO or designated employer
representative (paragraph (c)(5)(iii) of this section) or from
contacting the MRO (paragraph (c)(5)(iii) of this section) within the
times provided. The MRO, on the basis of such information, may reopen
the verification, allowing the employee to present information
concerning a legitimate explanation for the confirmed positive test. If
the MRO concludes that there is a legitimate explanation, the MRO
declares the test to be negative.
* * * * *
(f)(1) * * *
(2) If the analysis of the split specimen is reconfirmed by the
second laboratory for the presence of the drug(s) or drug
metabolite(s), the MRO shall notify the employer and employee of the
results of the test.
* * * * *
[FR Doc. 95-18041 Filed 7-24-95; 8:45 am]
BILLING CODE 4910-62-U