[Federal Register Volume 61, Number 140 (Friday, July 19, 1996)]
[Rules and Regulations]
[Pages 37693-37700]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18015]


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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

49 CFR Part 40

[Docket OST-95-321]
RIN 2105-AC22


Procedures for Transportation Workplace Drug and Alcohol Testing 
Programs; Insufficient Specimens and Other Issues

AGENCY: Office of the Secretary, DOT.


[[Page 37694]]


ACTION: Final rule.

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SUMMARY: The Department of Transportation is modifying its procedures 
governing situations in which employees are unable to provide 
sufficient specimens for urine drug testing. The changes will allow 
additional time to collect a sufficient sample. In addition, the 
Department is clarifying requirements concerning relationships between 
laboratories and medical review officers; providing procedures for 
situations in which employees do not have contact with medical review 
officers following a laboratory-confirmed positive test; and making 
explicit that MROs are to report split specimen test results to 
employers, regardless of who pays for the test.

DATES: This rule is effective August 19, 1996.

FOR FURTHER INFORMATION CONTACT: Mary Bernstein, Director, Office of 
Drug Enforcement and Program Compliance, 400 7th Street, SW., Room 
10317, 202-366-3784; or Robert Ashby, Deputy Assistant General Counsel 
for Regulation and Enforcement, 400 7th Street, SW., Room 10424. 202-
366-9306.

SUPPLEMENTARY INFORMATION:

``Shy Bladder''

Background

    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 
sample collections) 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 
(DHHS) 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 results in 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.''
    In response to these concerns, the Department proposed changing the 
procedures to 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 (60 FR 38201; July 25, 1995). The employee would be 
directed to drink 8 ounces of fluid each 30 minutes during this period 
until the 40 ounce maximum is reached.
    We also proposed to incorporate language from the parallel 
provision of the alcohol testing procedures concerning the task of the 
physician who evaluates the employee, in order to make the alcohol and 
drug portions of Part 40 more consistent.
    Comments: The Department received substantial comment on this 
issue, from employers, employee organizations, and medical and testing 
service providers. Thirty-five comments, mostly from employers and 
testing service organizations, opposed the proposal to lengthen the 
time period for collections. Several commenters mentioned that actual 
shy bladder situations were very rare, meaning that there would be few 
benefits gained from increasing the time period. On the other hand, a 
number of commenters, particularly in the transit industry, expressed 
the concern that the proposed increase to four hours would increase 
costs for employers. Already, commenters said, some employees stretch 
out the time spent at the collection site to the maximum two hours, in 
order to avoid returning to work. If we increased the time, time 
permitted for this gold-bricking would increase, raising lost-time 
costs for employers. Some collection sites were concerned about having 
to remain open longer after hours to accommodate longer shy bladder 
situations, increasing their overtime and other operating costs. Two 
medical service providers mentioned that an individual with a normally-
functioning urinary system should be able to provide a sufficient 
sample under the existing rule.
    Seventeen commenters, mostly employee organizations but also 
including some testing service organizations and employers, supported 
the proposed extension to four hours. They said this would avoid 
situations, which had happened, of people being unable to provide a 
sufficient sample in two hours. A longer time frame would also reduce 
costs by eliminating unnecessary medical referrals, they said. Two 
testing service industry commenters suggested that three hours would be 
a reasonable middle ground, while two unions supported eight hours or 
no time limit at all.
    Twenty-one comments, mostly from unions but including some from 
other sources, supported the NPRM's proposal of having the employee 
drink 40 ounces of fluid. This would better allow employees to deal 
with the effects of on-the-job dehydration, they said. One commenter 
favored upping the fluids to 48 ounces. Twenty-five commenters, mostly 
employers and testing service organizations, suggested smaller amounts 
(e.g., 24 or 32 ounces). Some of

[[Page 37695]]

these commenters said that increasing the amounts was objectionable 
because doing so went along with the extended time period, which they 
opposed. One commenter thought that increasing the water amount could 
lead to increased numbers of dilute specimens, while two commenters 
thought 32 ounces provided a better margin of safety with respect to 
water intoxication. Two comments suggested that the 8 ounces every 30 
minutes schedule was too restrictive and difficult to supervise. One 
commenter favored allowing an additional 8 ounces (or 30 minutes) when 
an employee claimed dehydration.
    Nine commenters favored, and 11 opposed, retaining the existing 
requirement that employee make a first, unsuccessful attempt at 
providing a complete sample before the shy bladder procedure and its 
time period began. Opponents of this requirement, in other words, would 
start the clock without a first collection attempt, when the employee 
asserted at the beginning of the collection process that he or she 
could not provide a sufficient sample. Two comments suggested allowing 
a first, insufficient, specimen to be combined with a second specimen 
to form a sufficient specimen as part of the same collection.
    There were a number of comments on the subject of the medical 
evaluations that follow a collection that does not result in a 
sufficient specimen. The NPRM had suggested that only a medical 
explanation pertaining to a physiological reason for the inability to 
provide would be adequate, as distinct from an assertion of 
``situational anxiety'' or other psychological causes. Three comments 
on this point approved and three disagreed with the NPRM's suggestion. 
One of the comments that favored limiting the basis for a medical 
explanations to physiological causes did note, however, that there were 
situations in which a psychological explanation might be sufficient 
(e.g., a documented pre-existing condition, diagnosed before the 
collection in question, that is represented in Diagnostic and 
Statistical Manual IV).
    One union objected to the provision of the NPRM that limits 
examining physicians to those acceptable to the employer, and two 
commenters supported having the employer, rather than the MRO, 
directing the employee to have a post-collection medical evaluation. 
Two commenters suggested that the employer should receive, from the 
examining physician, only a conclusory statement about whether there 
was an adequate medical explanation, rather than a complete diagnostic 
work-up. This would help protect the confidentiality of medical 
information. Three commenters said the medical evaluation should be 
done promptly after the collection, and two suggested that refusal to 
attend or cooperate with the evaluation should be regarded as a refusal 
to test.
    There were a number of comments on miscellaneous shy bladder-
related subjects. Two commenters supported making the language of the 
provision parallel to that in the alcohol testing procedures. Two 
commenters supported, and one opposed, specifying that refusing to 
drink water, or other non-cooperation, constitutes a refusal to be 
tested. One comment suggested specifying that only water, and not other 
drinks, could be consumed. Others suggested using blood tests when 
enough urine could not be produced and allowing collectors to proceed 
to other collections while an employee was waiting and drinking before 
a second attempt.
    DOT Response: The basic purpose of the NPRM proposal was fairness 
to employees. That is, if an employee is unable to produce a sufficient 
quantity of urine within the two-hour period presently provided, giving 
the employee a longer time to provide a specimen might allow the 
employee to produce sufficient urine to avoid the necessity for a 
medical evaluation and the possibility of a refusal finding. The most 
significant objection to the proposal in the comments centered on the 
perception by some employers that employees already spent the maximum 
time possible at collection sites, apparently with the aim of being 
paid for not working. If we said that employees could take four hours 
to provide a sufficient sample, we could look forward to employees 
taking twice as long off the job, while employers' costs mounted. In 
addition, having to keep a collection site open for a longer time 
(e.g., for an employee who came to the site at 4:30 p.m. and forced the 
site to stay open until 8:30) would increase collection costs.
    On the surface, these concerns are plausible. The comments to this 
effect were impressionistic, however, and were not accompanied by data. 
There is substantial uncertainty, therefore, about how factually based 
these concerns are. Recently, the Substance Abuse Program 
Administrators' Association (SAPAA) shared with us information from a 
survey they conducted concerning the time it took to complete a DOT 
collection. The survey results concerned about 18,800 tests conducted 
over a two-week period at nearly 500 collection sites affiliated with 
SAPAA. The mean time reported for a DOT urine collection, from the time 
the employee started filling out the paperwork (not the time the 
employee first walked into the collection site) until the time the 
collection was completed and the employee was told he or she could 
leave the site, was about 12.4 minutes.
    About 1.7% of the collections took 90 minutes or more to complete, 
and slightly less than a third of these took two hours or more. About 
1.2% of the total number of tests were ``shy bladder'' situations, in 
which a collection could not be completed because of insufficient 
volume.
    The results of this survey have some limitations. They are not 
based on a statistically representative sample of collection sites or a 
scientifically rigorous survey design, and some responses contain 
ambiguities. They represent a two-week ``snapshot'' of the experience 
of the particular collection sites that responded to SAPAA's request. 
However, the data are suggestive with respect to the ``stretch-out'' 
issue raised by commenters.
    That is, it does not appear that many tests were stretched out to 
near or over the two-hour time frame of the existing rule. Indeed, the 
average running time of tests was far short of the two-hour time frame 
of the current regulation. Suppose that the time period for shy bladder 
situations were three or four hours instead of two. Is it reasonable to 
infer that tests that average 12.4 minutes in length (or even if they 
averaged twice that duration) would suddenly jump to close to the new 
maximum? If less than two percent of tests now exceed 90 minutes in a 
two-hour time period, is it reasonable to infer that a much greater 
percentage of tests would approach a three or four-hour time period? 
The likelihood of such dramatic changes appears low. Consequently, 
while there may be a number of individual instances of employees 
seeking to prolong their time at collection sites in preference to 
returning to the job, the available information suggests that this is 
not a pervasive problem that would lead to prohibitive cost increases 
if we provided additional time for collections.
    Also, given that lengthy collections and shy bladder situations 
appear to arise in a very small percentage of cases, it appears that 
cost increases based on keeping collection sites open longer than usual 
would probably be low. Some SAPAA survey responses, as well as 
anecdotal information that DOT staff have received, suggests that some 
collection sites may follow a practice of simply sending an employee 
home when the normal closing time approaches, even if the employee has

[[Page 37696]]

not completed the collection process. This practice is contrary to the 
rules. Once begun, a collection process must be completed. We also 
recommend that collection sites begin to process employees as soon as 
they arrive at the collection site. Some collection sites apparently 
permit employees to wait a significant period of time before beginning 
the collection process. Such waiting appears to create inefficiencies 
and unnecessary costs in the system.
    Given that we do not have any data, beyond anecdotal expressions of 
concern, showing that stretched-out collections are a pervasive 
problem, and that we have some data that suggest the contrary 
conclusion, the Department believes the fairness rationale for 
extending the collection time period is more persuasive, at this time, 
than the cost rationale for not doing so. Consequently, the final rule 
will extend the time period in ``shy bladder'' situations. In order to 
minimize any potential adverse effects, the time period will be three 
hours, rather than four as proposed in the NPRM. Given the medical 
service provider comments about the speed of urine production, this 
additional time should provide a comfortable margin of safety to 
employees who may need additional time to generate a sufficient 
specimen.
    With respect to the amount of fluids to be consumed, the Department 
will retain the 40 ounce level proposed in the NPRM. This amount could 
as easily be consumed within a three-hour period as within a four-hour 
period. As discussed in the preamble to the NPRM, the 40 ounce level is 
appropriate, in light of evidence in the medical literature concerning 
water intoxication. Compared to smaller amounts, it offers an enhanced 
chance of assisting employees in providing a sufficient specimen. It is 
sufficiently limited that the probability of it resulting in dilute 
specimens is low. The Department will not mandate the proposed schedule 
for drinking fluids (i.e., 8 ounces each half hour until the 40-ounce 
level is reached), out of concern that it would make the collection 
process unnecessarily complicated to administer. The rule will require 
simply that the fluids be administered at reasonable intervals 
throughout the three-hour period. While we anticipate that collection 
sites will provide water in the vast majority of instances, the 
Department does not think it necessary to prohibit the administration 
of other appropriate fluids.
    If an employee refuses to drink the water needed to produce a 
sufficient specimen, it seems clear that the employee is failing to 
cooperate with the testing process in a way that can frustrate its 
completion. The same can be said of an employee who is directed to 
report for a medical evaluation and either declines to do so or does 
not comply with the directions of the physician in the course of the 
examination. In both cases, the Department believes it is appropriate 
to treat the employee's behavior as a refusal to be tested, which has 
the same consequences as a positive test. The final rule so provides.
    The issue of what constitutes an adequate medical explanation for a 
failure to provide a sufficient specimen is one that ultimately must be 
decided by the examining physician on a case-by-case basis. The final 
rule clarifies the determination the physician must make by providing, 
first, that a finding of a physiological cause (e.g., urinary system 
dysfunction) for the insufficient specimen is a ground for making a 
determination of an adequate medical explanation.
    The rule also provides that there are some narrow and limited 
circumstances in which a psychological explanation will suffice. This 
is true only in a case where there is documentation of a diagnosed pre-
existing psychological disorder (i.e., one designated in DSM IV) that 
can account for the failure to provide a complete specimen. By a pre-
existing disorder, the Department means one the symptoms of which were 
documented before the shy bladder incident took place. This is to avoid 
basing determinations solely on information developed after the fact of 
the collection in question. Assertions of ``situational anxiety'' or of 
dehydration are essentially unverifiable, and the final rule directs 
physicians not to determine that there is an adequate medical 
explanation based on such assertions.
    The Department does not believe there is any compelling reason to 
require the MRO, as distinct from the employer, to refer an individual 
for a medical evaluation under this portion of the rules. The employer 
may delegate this function to the MRO, and in many cases it might be 
efficient to do so. In other cases, however, the MRO may not be 
conveniently located to the employer and/or employee, and would not 
know appropriate physicians in their vicinity. However, the evaluating 
physician, if someone other than the MRO, would provide the results of 
the evaluation to the MRO, rather than directly to the employer. The 
MRO would then provide his or her conclusion to the employer, as under 
the current rule.
    Allowing urine from different voids to be combined increases the 
possibility of error or contamination in the collection process, and 
is, in any event, inconsistent with the DHHS guidelines. The Department 
also declines to change the requirement that employees attempt to 
provide a specimen at the beginning of the collection process. Forty-
five ml. is not a tremendous amount of urine. Many employees who do not 
subjectively feel ready to do so may well be able to provide such an 
amount. In any case, the failure of the first attempt to provide a 
sufficient specimen is a clear, easily understandable point to start 
the clock for the three hour time period for the shy bladder procedure. 
A new collection kit would be used for the second or any subsequent 
attempts at collecting a complete specimen.
    The rule contemplates the following sequence of events. For 
example, the employee arrives at the collection site at 1:45 p.m. The 
employee and collection site person begin the testing process by 
filling out the initial portions of the chain of custody and control 
form. The collection site person directs the employee to go to the 
bathroom and provide a specimen (whether or not the employee claims to 
be ``ready'' to do so). The employee returns the collection container 
to the collection site person.
    It is now 2 p.m. If the employee asserts that he or she has tried 
and failed to produce a specimen or the specimen is short of the 
required amount of urine, the employee will have until 5 p.m. (i.e., 
three hours from the time the employee returned the initial collection 
container to the collection site person) to drink up to 40 ounces of 
fluid and make another attempt to provide a sufficient specimen. The 
Department emphasizes that collection site personnel should not attempt 
to hurry the process unreasonably. There have been instances in which, 
by asking an employee to ``try again'' too soon, a collection site 
person has created a situation in which the employee produces two or 
three ``short'' specimens instead of one complete specimen. Collection 
site personnel should take care to avoid this problem.
    The Department believes that commenters made good suggestions 
concerning limiting information provided to employers, allowing 
collectors to work on other tests while an employee was waiting and 
drinking, and requiring medical examinations to take place promptly 
after the collection. The final rule incorporates these comments. On 
the other hand, the Department believes it is necessary to retain the 
requirement that the examining physician be acceptable to the employer. 
Employers have the responsibility for the safety of their

[[Page 37697]]

operations and for compliance with the Department's rules. Employees 
may have an incentive to shop for a friendly evaluation. The Department 
has consistently declined to permit the use of blood tests in the 
context of alcohol testing, and we believe, for much the same set of 
reasons, that it is inadvisable in the context of drug testing. Under 
the Omnibus Employee Testing Act of 1991 and Part 40, only urine drug 
testing is permitted.

Body Temperature

    Currently, Sec. 40.25(e)(1)(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. Because 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, the NPRM 
proposed to delete the word ``oral,'' with the result that taking the 
individual's temperature by any medically-accepted means (including 
oral) would be permitted.
    Eleven comments supported the proposal and none opposed it. Four 
comments suggested that the use of rectal thermometers should be 
precluded or limited, because of the intrusiveness and unpleasantness 
of that method. We agree with these comments, and the final rule adopts 
the proposal with that modification.

MRO/Laboratory Relationships

    The NPRM contained a discussion of MRO/laboratory relationship 
issues, including a proposal to delete Sec. 40.33(b)(2), which could 
cause confusion in relation to the more recent and definitive language 
of Sec. 40.29 (n)(6), which prohibits laboratory/MRO conflicts of 
interest. The NPRM also asked questions about how the Department could 
best frame regulatory provisions on this general subject.
    The four commenters who mentioned the proposal to delete 
Sec. 40.33(b)(2) all agreed with it. The Department is adopting this 
proposal. Eleven commenters favored either existing provisions 
requiring laboratories and MROs to be independent of one another or of 
adding more stringent requirements on this subject. Some of these 
commenters mentioned other relationships that concerned them, such as 
those between MROs and consortia/third-party administrators, 
collectors, or employers. On the other hand, six other commenters 
favored liberalizing MRO/laboratory relationship rules, permitting 
laboratories to refer MROs to clients, for example.
    The marketplace for drug testing services has changed considerably 
since the Department issued its original rules, with mergers producing 
ever-larger laboratories and a strong trend towards integration of 
services manifesting itself. While these changes are understandable in 
economic terms, the Department is concerned lest checks and balances 
fundamental to the fairness and integrity of the Department's rules be 
compromised. In a forthcoming proposal to revise and update Part 40, 
the Department anticipates taking a comprehensive look at the 
relationships among MROs, laboratories, employers, consortiums and 
third-party administrators, collection sites, and other parties in the 
testing service business to determine how best to preserve needed 
checks and balances. The Department is not taking further final action 
at this time, however.

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.
    As noted in the NPRM, 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 proposed 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 would 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 would apply as in the case where 
the employer did contact the employee and the employee failed to 
contact the MRO within 5 days.
    Twenty-eight commenters, all of whom were employers or testing 
industry companies, favored the proposal, one mentioning that they 
currently have 115 unresolved tests on record that they could close out 
under such a provision. Only one commenter, a union, opposed it as too 
harsh on workers. Of the supporters, nine favored the proposed 30-day 
time period while the remaining 19 favored shorter periods, mostly 
ranging from five to 15 days. The Department will adopt the proposal, 
while reducing the time period to 14 days. This reduction is made in 
the interest of safety, as well as to enable employers and others to 
have reasonably expeditious closure in the process. A month seems like 
an unnecessarily long time to hold such a case open: an employee who is 
out of touch and unavailable for that amount of time likely does not 
want to be contacted. On the other hand, the five-day period proposed 
by some commenters (parallel to the time an employee is given to 
contact the MRO after being told to do so) may be too short, since 
employees might often have legitimate reasons for being out of contact 
for that length of time. In any case, the employee will have the 
opportunity to re-open the matter for good cause, as the NPRM provided.

[[Page 37698]]

    Seven commenters supported, and three opposed, treating confirmed 
opiate positives the same as confirmed positives for other drugs for 
this purpose. While the MRO verification procedure is different for 
opiates, the employee has an obligation in all cases to participate in 
the verification process. Employees who, without adequate 
justification, are unavailable to participate in the verification 
process should be treated the same, regardless of the drug for which 
they tested positive. For this reason, the Department will not 
differentiate among drugs in this provision.
    Some commenters made procedural suggestions concerning this 
provision. For example, two commenters discussed sending certified mail 
letters to employees to officially start the clock with respect to the 
time period. While doing so may be a reasonable step for employers to 
take, the Department will not require it, lest we introduce more 
procedural complexity, and opportunity for administrative error, into 
the system.

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--the NPRM proposed to add language 
to this effect.
    Ten commenters, all employers and testing service companies, 
supported the proposal, while two unions opposed it, saying that the 
employee should be able to keep the report from the employer in this 
circumstance. The Department does not agree with these latter two 
comments. All drug testing results pertain to the safety of the 
transportation services provided by employers. The employer is 
responsible for compliance with these regulations. In the Department's 
view, the employer, in order to perform its functions under DOT safety 
rules, must have access to all results of the drug testing process. The 
Department's rules do not specify who ultimately pays for testing 
services, including tests of split specimens, but the identity of the 
person making payment is irrelevant to how the results are treated 
under the rules. Both the employer and the employee have a need to know 
the outcome of all tests that are part of the system, and the final 
rule adopts the NPRM proposal.
    Program participants continue to raise a number of other questions 
about carrying out the split sample requirements of Part 40. In the 
Part 40 revision project, the Department will consider clarifying 
changes to the regulatory text itself. Meanwhile, the Department would 
like to take this opportunity to repeat guidance it has provided on 
certain split sample-related issues.
    First, when an employee makes a timely request to the MRO for a 
test of the split specimen, the MRO is required to pass on the request 
to the laboratory possessing the specimen, which is required to send 
the specimen to a second DHHS-certified laboratory, which is required 
to test the split specimen. The employer is responsible for making sure 
that all actions required under the regulations occur. Consequently, 
while the Department's rules do not specify who ultimately must pay the 
cost of testing the split specimen, the employer is responsible for 
ensuring payment in the first instance. For this reason, if the 
employee chooses not to pay ``up front'' for the test of the split 
specimen, the employer must ensure, nevertheless, that the test takes 
place. An employer, MRO, or laboratory cannot require, as a 
prerequisite to conducting the test of a split specimen, that the 
employee first produce payment. Subsequently, the employer could seek 
reimbursement from the employee.
    Second, the rule is silent with respect to who chooses the second 
laboratory at which the split specimen is tested. The rule does not 
give employees a right to choose a particular laboratory (though such a 
laboratory could be designated in a labor-management agreement). All 
the rule requires is that the second laboratory be certified by DHHS; 
whether it is chosen by the employer, employee, MRO, or first 
laboratory does not matter from the point of view of Part 40.
    Third, a technical problem that sometimes occurs in testing of 
split samples is that samples may occasionally fail to reconfirm 
because of differences in specific methodologies or equipment among 
laboratories. Each laboratory has one or more methods for clearly 
identifying drug metabolites in a specimen and dealing with impurities 
in the specimen that may delay or interfere with clearly identifying 
the metabolites (so-called ``derivitization'' methods). The chemical 
composition of urine samples differs from one specimen to another, 
however, and may change with the age of the specimen. The 
derivitization method used by a given laboratory may, on infrequent 
occasions, not work well enough on a particular specimen to identify a 
drug metabolite clearly enough to meet quality control guidelines that 
tell the laboratory when they may call a test positive.
    If Laboratory A has identified the primary specimen as positive, 
but Laboratory B, because of the problem described above, believes that 
the drug or metabolite is present in the split specimen but cannot call 
it positive, is it appropriate for Laboratory B to send it to 
Laboratory C for further analysis?
    DOT and DHHS representatives, at a November 1995 conference with 
laboratory representatives, said that, in such a situation, after 
consultation with the MRO, referral to Laboratory C was appropriate. 
Reconfirmation by Laboratory C would be recognized under Part 40. To 
avoid the necessity for such a procedure, the Department strongly 
recommends that participants take care to ensure that the laboratory 
that tests the split specimen be one that uses the same methods as the 
laboratory that determined that the primary specimen was positive.

Electronic Signatures

    The NPRM asked for comments on the issue of the use of electronic 
signatures in the drug and alcohol testing process (e.g., to sign 
alcohol testing forms). In the NPRM, the Department noted that, in an 
electronic signature system, an individual (e.g., the employee taking 
an alcohol test) using a pen-like stylus signs an electronic pad 
connected to a computer system (e.g., attaching the electronic 
signature to an electronic version of the alcohol testing form). 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 NPRM noted a number of issues that this kind of application may 
raise in the context of the Department's testing programs. For example, 
Part 40 currently calls for signatures on a multiple-copy paper form, 
and does not 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

[[Page 37699]]

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?
    The NPRM also mentioned issues concerning the security and 
identification of electronic signatures. What kinds of technical 
requirements (e.g., electronic encryption for 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?
    Six commenters to the NPRM favored the use of these technologies, 
and four others thought the idea was worth exploring. Several 
commenters in both categories mentioned a number of issues, such as 
security, legal sufficiency of electronic signatures, confidentiality 
safeguards, etc., that should be worked out. It is fair to say that the 
comments did not thoroughly address the questions and concerns the 
Department has on this issue.
    The Department believes that electronic signature technology has 
promise, and that, together with industry, we should continue to 
explore and discuss its use in the DOT alcohol and drug testing 
program. Meanwhile, we emphasize that pen-and-ink signatures on hard 
copy forms are mandatory in the program. The use of electronic 
signatures by any participant in the program (e.g., the collector, 
donor, BAT, STT, MRO, certifying scientist) is not currently 
authorized. Any testing services company that uses electronic 
signatures is acting contrary to the express requirements of DOT 
regulations, and employers who use the services of a testing services 
company that uses electronic signatures are out of compliance with 
these rules.

Regulatory Analyses and Notices

    This is not a significant rule under Executive Order 12866 or under 
the Department's Regulatory Policies and Procedures. 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. The basis of this certification is that the changes to the 
shy bladder procedure, as noted above, are unlikely to significantly 
increase program costs for regulated entities, and the other changes to 
the rule are minor or technical and should not have any measurable cost 
impacts.

List of Subjects in 49 CFR Part 40

    Alcohol testing, Drug testing, Laboratories, Reporting and 
recordkeeping requirements, Safety, Transportation.

    Issued this 9th day of July, 1996, at Washington, DC.
Federico Pena,
Secretary of Transportation.

    For the reasons set forth in the preamble, 49 CFR Part 40 is 
amended as follows:

PART 40--[AMENDED]

    1. The authority citation for Part 40 is revised to read as 
follows:

    Authority: 49 U.S.C. 102, 301, 322, 5331, 20140, 31306, 45101-
45106.

    2. Section 40.25 is amended by removing the word ``oral'' from 
paragraph (e)(2)(i)(A) and paragraph (e)(2)(i)(B), and adding after the 
word ``temperature,'' in paragraph (e)(2)(1)(A), the following words: 
``(taken by a means other than use of a rectal thermometer)''.
    3. Section 40.25(f)(10)(iv) is 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 the specimen 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 up to 40 ounces of fluid, 
distributed reasonably through a period of up to three hours, 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 employee has not provided a sufficient specimen within 
three hours of the first unsuccessful attempt to provide the 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 possible after the attempted provision 
of urine, an evaluation from a licensed physician who is acceptable to 
the employer concerning the employee's 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. For 
purposes of this paragraph, a medical condition includes an 
ascertainable physiological condition (e.g., a urinary system 
dysfunction) or a documented pre-existing psychological disorder, but 
does not include unsupported assertions of ``situational anxiety'' or 
dehydration. The physician shall provide to the MRO a brief written 
statement setting forth his or her conclusion and the basis for it, 
which shall not include detailed information on the medical condition 
of the employee. Upon receipt of this statement, the MRO shall report 
his or her conclusions to the employer in writing.
    (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 to the MRO a brief written statement 
setting forth his or her conclusion and the basis for it, which shall 
not include detailed information on the medical condition of the 
employee. Upon receipt of this statement, the MRO shall report his or 
her conclusions to the employer in writing.
* * * * *
    4. Section 40.33 is 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 
(f)(2) to read as follows:


Sec. 40.33  Reporting and review of results.

* * * * *
    (c) * * *

[[Page 37700]]

    (5) The MRO may verify a test as positive without having 
communicated directly with the employee about the test in three 
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 14 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 (c)(4) of this section), 
and more than five days have passed since the date the employee was 
successfully contacted by the designated employer representative.
    (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)(ii) 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 
metabolites(s), the MRO shall notify the employer and employee of the 
results of the test.
* * * * *
[FR Doc. 96-18015 Filed 7-18-96; 8:45 am]
BILLING CODE 4910-62-P