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

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

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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

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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

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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.

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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]

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