Procedures for Transportation Workplace Drug and Alcohol Testing Programs and Proposed Model Specifications for Screening Devices To Measure Alcohol in Bodily Fluids; Final Rule, Proposed Rule, Notice DEPARTMENT OF TRANSPORTATION

SUMMARY: Under the Omnibus Transportation Employee Testing Act of 1991,

the Department of Transportation is required to implement alcohol

testing programs in various transportation industries. This rule

establishes uniform testing procedures that would be used by all

Department of Transportation operating administrations conducting

alcohol testing programs under the Act or conducting alcohol testing

programs modeled on those required by the Act. This rule also

implements changes required by the statute in the Department's drug

testing procedures.

DATES: Effective Dates: This rule is effective March 17, 1994, except

Sec. 40.25(f)(10)(i)(B), which is effective August 15, 1994. Compliance

Date: Compliance with Sec. 40.25(f)(10)(i)(B) is authorized beginning

March 17, 1994.

FOR FURTHER INFORMATION CONTACT: Donna Smith, Acting Director,

Department of Transportation Office of Drug Enforcement and Program

Compliance, 400 7th Street, SW., Washington DC, 20590, room 9404, 202-

366-3784; or Robert C. Ashby, Deputy Assistant General Counsel for

Regulation and Enforcement, 400 7th Street, SW., room 10424. 202-366-

9306.

SUPPLEMENTARY INFORMATION:

Background

The Omnibus Transportation Employee Testing Act of 1991, enacted

October 28, 1991, directed significant changes in the Department of

Transportation's substance abuse-related programs for most

transportation industries that the Department regulates. These changes

are discussed in detail in the Common Preamble published in today's

Federal Register. With respect to drug testing procedures, the Act

added a requirement for using the ``split sample'' approach to testing,

which Congress believed would provide an additional safeguard for

employees. The Act also imposes a variety of requirements for alcohol

testing procedures, which this regulation also implements. The Coast

Guard is not amending its existing alcohol testing regulations (33 CFR

part 95 and 46 CFR part 4), and will continue to use separate

procedures for that testing.

The Department's drug testing procedures, 49 CFR part 40, have

governed drug testing under all six operating administration drug

testing rules since 1988. Likewise, this rule governs alcohol testing

procedures for the five modes affected (the Coast Guard is not covered

by the alcohol testing procedures of this part). Under the rule, the

existing drug testing procedures become a separate subpart of the

regulation, and we are adding new subpart containing the alcohol

testing procedures.

Having all the Department's uniform drug and alcohol testing

procedures in a single regulation will simplify compliance for covered

parties and avoid confusion by permitting all parties to look to one

source for information on these issues. This should be particularly

helpful to those employers who have employees covered by more than one

DOT operating administration. However, employers regulated solely by

the Coast Guard should continue to refer to 33 CFR part 95 and 46 CFR

part 4 for alcohol testing requirements and procedures.

The Department published the Notice of Proposed Rulemaking (NPRM)

for this rule on December 15, 1992, at the same time as the operating

administrations (OAs) published their proposed alcohol and, in some

cases, drug testing rules. We received over 250 comments to the part 40

docket. In addition, the OAs' dockets received some comments on the

testing procedure issues raised by the part 40 NPRM. The Department

considered all these comments.

Comments and Responses

Split Sample Procedures for Drug Testing

This discussion concerns how we will carry out a statutory

requirement to use the ``split sample'' method for collecting and

analyzing urine samples for purposes of the Department's drug testing

program. The Act requires split samples to be used for testing under

the Federal Highway Administration (FHWA), Federal Aviation

Administration (FAA), Federal Transit Administration (FTA), and Federal

Railroad Administration (FRA) rules.

Mandatory Use of Split Sample Method

The NPRM proposed to implement the statutory requirement for split

samples in drug testing by making mandatory the optional split sample

procedure in the existing part 40. The procedure would remain optional

under the Research and Special Programs Administration (RSPA) and Coast

Guard drug testing rules, which are not affected by the Act. Several

commenters wanted the split sample procedure to remain optional in all

modes. Because the statute requires the use of split samples in the

four OAs mentioned above, the Department cannot adopt this comment. In

order to give employers time to prepare to use the split sample

collection method, the rule does not require affected employers to

begin using this method until 6 months from the date of this rule's

publication. Employers, who under the existing rule have the option of

using this approach, may begin using the split sample method at any

time.

Sample Volume

The NPRM proposed that the total amount of urine collected be 45 ml

(30 ml for the primary specimen and 15 ml for the split specimen). The

existing rule calls for a 60 ml collection; the Department believed

that this was a greater quantity than is needed. Eighteen comments

supported the NPRM proposal; two commenters opposed the proposal, one

of whom supported collecting 60 ml each for the primary and split

specimens. Based on information about laboratory testing needs gained

over the course of four years of implementing a drug testing program,

the Department is persuaded that 45 ml (30 ml for the primary specimen

and 15 ml for the split specimen) is sufficient. This reduction from

the current 60 ml minimum should also reduce ``shy bladder'' situations

in which a test is canceled for lack of sufficient specimen volume.

Time Period for Requesting Test of Split Specimen

Another subject of interest to commenters was the time frame in

which employees could request a test of a split specimen. The NPRM

proposed a 72-hour period, following the employee's being informed of a

verified positive test, during which he or she could request a test of

the split specimen. Twenty commenters favored this approach, saying

that this period was sufficient to allow an employee to make a choice

about whether to request the test of the split specimen. Some of these

commenters also asserted that allowing the much longer times permitted

under some OA regulations (e.g., 60 days) could lead to tests of

deteriorated samples and unreasonably postpone employer disciplinary

actions. Seven commenters suggested a longer time frame (e.g., a week,

20 days, 30 days, or 60 days). One of these comments asserted that

employees needed a longer time to become aware of their rights, study

their options, and seek representation. Three commenters favored a

uniform time frame applicable to all OA rules, while one favored

allowing each OA to set its own time frame. One commenter asked whether

medical review officers (MROs) were required to inform employees of the

time period available to request a test of a split specimen.

The Department will adopt, on a uniform basis, the 72-hour time

period. The Act requires the Department's procedures to provide for a

test of the split specimen ``if the individual requests the independent

test within 3 days of being advised of the results of the confirmation

test.'' To comply with the statute, the Department is not required to

provide a time period longer than 72 hours.

Moreover, the Department has not seen a persuasive rationale for

permitting a longer time period. Nothing prevents an employee who is

told of a verified positive test from deciding in a very short time to

seek a test of the split specimen. For example, some employees testing

positive admit that they used drugs. Such employees may well not

believe that testing the split specimen is necessary. If the employee

concedes that the test was accurate, but contends that the MRO should

have verified the test negative based on information concerning

legitimate use of a drug, the employee is likely to seek redress other

than a test of the split specimen. If, on the other hand, the employee

is adamant that he or she never used a prohibited substance, or

believes that the laboratory erred, the employee may well seek a test

of the split specimen. None of these decisions on the employee's part

need take more than 72 hours. Decisions concerning legal options,

representation etc. can be made in the time frames appropriate to the

processes involved: the decision on whether to seek a test of a split

specimen need not wait on a decision about whether or how to make use

of a grievance procedure, for example.

By saying that the 72-hour time period for requesting a test of the

split specimen is a uniform requirement, we mean that any time an

employee makes a request for a split specimen test within 72 hours of

being informed of a verified positive test, the split specimen must be

tested. Except in the limited circumstances discussed below, employers

or MROs are not required by part 40 to provide for a test of a split

specimen if the employee makes the request more than 72 hours after

being informed of a verified positive test. There is no information in

the rulemaking record to support the need of employees in any

particular industry for a longer time period. Nothing in this provision

prohibits an employer from voluntarily (e.g., as part of a labor-

management agreement) honoring a request for a test of a split specimen

made after 72 hours.

The suggestion that MROs inform employees of this time period is a

good one. To make the 72-hour period for making a choice on testing a

split specimen meaningful, it is necessary to ensure that the employee

knows about the timeframe. For this reason, we have added to the final

rule a requirement that the MRO notify each employee about this choice.

We have inserted parallel language concerning requests for the

reanalysis of the primary specimen in situations (i.e., under the Coast

Guard and RSPA drug rules) where the split sample collection method is

not used.

Under the final rule, when the MRO tells the employee that he or

she has a confirmed positive test, the MRO must also tell the employee

that he or she will have 72 hours following notice of a verified

positive test in which to request a test of the split specimen. This

notification is required in all cases of confirmed positive laboratory

results, except in those situations in which an employee has

effectively waived the opportunity to talk to the MRO. The 72-hour

clock does not start to run until the time when the employee is

notified, whether by the MRO or the employer, that the test result is a

verified positive.

The employee is not required to wait until after a verified

positive test in order to request an analysis of the split specimen. An

employee could, if he or she chose, ask the MRO at the time of the

notification of a confirmed positive test to initiate the test of the

split specimen. The MRO would satisfy this request. The verification

process would continue, and the MRO would notify the employer of the

verified result in the usual way. The verification and notification

processes would not be on hold pending the result of the analysis of

the split specimen. Such a delay in removing from performance of a

safety-sensitive function an individual with a verified positive test

could not be justified on safety grounds. Once a test is verified as

positive, the employee must be removed from safety-sensitive functions.

The employee may not again perform safety-sensitive duties until he or

she has met the conditions of the applicable operating administration

rule for return to duty, pending the result of the test of the split

specimen.

In any situation in which the MRO does not personally notify the

employee of a verified positive test, we advise the MRO, upon receipt

of a request from an employee to test the split specimen, to contact

the employer or other party for verification of the time the employee

was notified of the verified positive test. This should help to avoid

potential questions about whether the employee has made a timely

request.

In addition, to ensure that employees are not unfairly deprived of

the opportunity to request a test of the split specimen, the Department

is adding a provision to allow an employee who fails to request this

test within 72 hours to present information to the MRO that the failure

to make a timely request was caused by circumstances beyond the

employee's control. This provision is similar to one in the existing

rule concerning an employee's opportunity to convince the MRO that

there was a good reason for the employee's failure to contact the MRO

for verification purposes (see Sec. 40.33(c)(6)). If the employee

persuades the MRO, the MRO would initiate a test of split specimen,

even though the employee's request had been made after the 72-hour

period ended.

Number of Collection Containers

With respect to the collection itself, the NPRM proposed that the

employee provide the specimen into a collection container, which would,

in most cases, be subdivided and poured into two separate specimen

bottles. One commenter favored the proposed approach; six others said

that a two-container, rather than three-container approach, made more

sense. That is, in all situations--not just unusual situations, as the

NPRM proposed--the employee should urinate into a specimen bottle,

which would become one specimen. The collection site person would then

pour an amount of the urine from that bottle into a second bottle,

which would become the other specimen. Commenters said this approach

would save time and money.

The Department believes that these comments have merit, and the

final rule permits either approach. The employer could use a collection

container with the specimen subdivided and poured into two specimen

bottles. Alternatively, the employer could use a specimen bottle

capable of holding at least 60 ml, into which the employer would

urinate. The specimen would then be subdivided, with 30 ml being poured

into a second specimen bottle, which becomes the primary specimen for

testing purposes. The original specimen bottle, into which the employee

had urinated, would become the split specimen.

This latter point may seem counter-intuitive, but there is a reason

for it. We want to make sure that there is a 30 ml primary specimen.

Pouring 30 ml of the void into the second specimen bottle ensures that

this will be the case. If the instructions were to pour 15 ml of the

void into the second bottle, to be used for the split specimen, the

primary specimen might wind up with less than 30 ml of urine if the

collection site person overpoured. Laboratories have informed the

Department that they intend to provide only 60 ml bottles to collection

sites, because of the economies of mass producing a single size

container and to avoid confusion by collection site personnel. For this

reason, the final rule's procedure should not result in extra costs.

Storage of Split Specimens

Three commenters recommended that employers be authorized to store

split specimens at the collection site rather than send them to the

laboratory, in order to reduce shipping costs. The Department is not

adopting this suggestion. Generally, laboratories have better, more

secure storage facilities than many collection sites. The chances of

loss, deterioration, tampering, etc. of a specimen are likely to

increase in non-laboratory locations. A uniform procedure for storage

and re-shipment of split specimens is likely to reduce opportunities

for error in the system. The rule also addresses the issue of how long

the split specimen should remain in storage. As noted above, the

employee must notify the MRO within 72 hours of being informed of a

verified positive test to trigger a requirement for a test of the split

specimen. Consequently, it is not necessary for the laboratory to

retain the split specimen for a prolonged period. In the Department's

view, it is sufficient to require the split specimen to be stored 60

days from the date it arrives at the laboratory, if a request for

testing it has not been received. (The primary specimen would remain in

storage for one year, as under the existing rule.)

Choice of Alcohol Testing Methods and Devices

NPRM Proposal

The NPRM for alcohol testing procedures proposed that both the

initial and confirmation tests would be done on an evidential breath

testing device (EBT). An EBT is a breath testing device that is on the

National Highway Traffic Safety Administration's (NHTSA) Conforming

Products List (CPL), a list of breath testing devices that NHTSA has

approved for use by law enforcement agencies in drunk driving cases. In

addition, the EBTs would have to print out results and assign a

sequential number to tests, to ensure that test results were preserved

in a way that minimized the chances for human error or collusion (e.g.,

the disregarding of an initial positive test by an employer who did not

want to lose an employee's services).

The NPRM also proposed training requirements for breath alcohol

technicians (BATs), who would administer the tests, and maintenance and

calibration requirements for EBTs. In requiring EBTs for all testing,

DOT proposed that other testing methods--blood, saliva, urine, non-

evidential breath, performance testing--could not be used for either

screening or confirmation tests. In summary, the Department made this

proposal because EBTs are a well-established, reliable, and accurate

testing method; EBTs are minimally intrusive; EBTs can provide an on-

the-spot result that allows employers to take action that prevents

potential safety risks; and EBTs can produce a printed record of the

test result that will prevent disputes about the accuracy and integrity

of the testing process.

Comments

Overview

This proposal generated more comments than any other feature of the

NPRM. Approximately 190 of the comments to part 40 addressed some

aspect of testing methodology. These comments came from a variety of

sources, including employers in all the industries covered by the

proposed regulations, unions, laboratories, manufacturers of testing

equipment and products, and consortia and third-party testing service

providers. The most consistent theme among comments on this subject was

a desire for greater flexibility in the choice of testing methodology

than the NPRM proposed.

Support for NPRM Proposal

Twenty-six comments, representing employers in several industries,

unions, third-party testing services, manufacturers of breath testing

equipment, state police agencies, and the National Transportation

Safety Board, supported the NPRM proposal. They cited as reasons for

their support the non-invasiveness of breath testing, its long

acceptance by courts and employees, its provision of a quantitative

readout, simplicity compared to blood or urine testing, and the

relatively low operating costs involved. Some of these commenters

qualified their support of the NPRM proposal by saying that breath

testing, while a good method, should be one of an array of options

available to employers, or required only for certain types of testing

(e.g., pre-employment and random) where the employer has control over

the time and place of testing.

Concerns About Cost of NPRM Proposal

Eighty commenters, representing principally employers in all the

regulated industries, third-party testing service providers, and

manufacturers of other testing devices that compete with EBTs, said

using EBTs for both screening and confirmation tests was too expensive.

They quoted capital costs per EBT between $2-10 thousand (some EBT

manufacturers who commented agreed with the lower end of this range).

This cost would be multiplied, they believe, by a need to obtain EBTs

for all the locations in which employers operate. For example, a

trucking association cited a motor carrier that would have to buy an

EBT for each of its 600 locations, at an estimated cost of $1.2

million. In addition, there would be BAT training, maintenance, and

calibration costs. Commenters who talked in cost per test terms cited

estimates of between $20-100 per test, which they said was much higher

than for competing methods. Railroad industry employers (who now use

breath testing for alcohol) said that, to reduce capital costs, EBTs

should not be required to have the sequential numbering and printout

capabilities proposed in the NPRM (which they said would add $1500 to

the cost of an EBT).

Concerns About Difficulty in Implementing NPRM Proposal

Some commenters feared that there would be insufficient numbers of

EBTs, BATs, and testing sites available to implement the proposal.

There would be a rapid expansion of the need for EBTs (one commenter

estimated a 3000-4000 percent increase in the market) that

manufacturers may be unable to fulfill, as well as a rapid training

need for thousands of BATs that would take substantial time to meet.

Seventeen commenters (including a number of third-party service

providers and employers) said that the cost of obtaining EBTs and

training BATs, the unfamiliarity of many third-party testing sites with

breath testing, and liability concerns would deter many potential

third-party service providers from participating. This would

particularly be a problem in small towns and rural areas, where the low

volume of testing would make the needed investment too costly.

Concern About Confrontations

Twenty-eight commenters (principally third-party service providers

and employers) expressed concern about the possibility of

confrontations between BATs and employees. These confrontations would

occur, commenters said, because the BAT--not an employer representative

with supervisory authority over the employee--would be the messenger of

bad news about a test result. Several commenters cited the image of a

90-pound female BAT having to deal with an angry (and perhaps

intoxicated) 300-pound truck driver who had just been told he had

failed an alcohol test.

Other Comments About NPRM Proposal

Commenters expressed other concerns about the EBT-EBT approach.

Some found the process too time-consuming. Others pointed out that the

collection site is commonly recognized as the weak point of the drug

testing process, and that conducting the alcohol testing process there

increased the chance of error. Other comments said that there were too

many opportunities for human and mechanical error in the breath testing

process, which, together with what they regarded as the unreliability

of EBTs at low alcohol concentrations, created numerous opportunities

for litigation. Some commenters also said that, if all screening and

confirmation testing were done on EBTs, the two tests should be run on

different machines.

Legal Issues

Several commenters raised legal challenges to the proposal. Nine

commenters (primarily manufacturers of competing devices and unions)

said that the statute requires split samples (i.e., the subdivision and

retention of a portion of a sample for an additional test at a

laboratory as a safeguard for the accuracy of the process) in all

cases. Generally, EBTs do not retain breath samples. Therefore, these

comments said, methods that permitted split samples (e.g., blood,

urine, saliva) must be used. Thirty-one comments said that the statute

contemplated the use of different methods for the screening and

confirmation test, respectively. Eleven comments said that, since the

results of EBT tests would be used to refer persons for rehabilitation

or treatment, they would be considered medical devices subject to

Department of Health and Human Services (DHHS) regulation. Since DHHS

had not approved EBTs as medical devices, their use could be blocked.

Desire for More Flexibility

Seventy-five commenters (representing a wide variety of equipment

manufacturers, employers, and third-party service providers) favored

allowing employers to choose the best testing method for them. In

addition to the virtue of flexibility, this approach would permit each

employer to choose the most cost-effective method of compliance in its

own circumstances.

Most of these commenters appeared to favor testing methods that

would use two different testing methods (e.g., non-evidential breath or

saliva screening test, blood test for confirmation). Ten commenters

disagreed on this point, saying that non-evidential screening tests

should never be permitted. Their primary concern was about the accuracy

of these testing methods. Several commenters who favored using non-

evidential screening tests conceded that it would probably be necessary

to suspend an employee's performance of safety sensitive functions

pending a confirmation test of a positive non-evidential screening

test. Most commenters who addressed confirmation procedures in a two-

method system said that confirmation tests (of whatever body fluid)

should be done on GC (gas chromatography, the same highly accurate

method used for confirmation tests under the drug testing program).

Specific Comments on Other Testing Methods

Non-Evidential Breath Testing Devices

(e.g., tubes filled with materials that turn a certain color when

alcohol-laden breath is blown into them or small, hand-held electronic

devices that register the presence or absence of alcohol concentration

in breath)

Twenty-nine commenters, including a variety of employers and

manufacturers of the devices, supported using non-evidential breath

testing devices. Most commenters cited cost (estimated at between $90-

550 for various models of non-evidential breath testing machines, and

about $2-4 each for disposable devices) and convenience as reasons. A

few opponents of non-evidential breath testing devices said their

accuracy was questionable, both with respect to false positives and

false negatives.

Saliva Testing

(i.e., a device which registers a particular alcohol concentration when

a swab with saliva from the employee's mouth is inserted into it)

Forty-five commenters favored the use of saliva testing. These

commenters included a variety of employers, third-party service

providers, equipment manufacturers, and others. Commenters claimed

several advantages for use of screening saliva tests: modest cost

(estimated at between $5-20 per test); simplicity of use, little need

for training; existing ``approvals'' from NHTSA and Food and Drug

Administration (FDA) for some devices (though in contexts other than a

workplace testing program); non-invasive nature of the devices;

sufficient accuracy for screening tests. Two commenters also said that,

while it was most typical to use blood testing for confirmation after a

saliva screen, saliva specimens could also be used for confirmation, as

laboratories could run a gas chromatography analysis on saliva.

A few commenters expressed concerns about saliva testing devices. A

union provided data that it said showed that saliva devices had a mixed

record for accuracy. Other commenters said saliva remained an unproven

method, that saliva devices were not ethanol-specific, and that saliva

alcohol and blood alcohol results may differ. Proponents of saliva

testing devices conceded that chain of custody forms would be needed

and that there was no method of automatically generating permanent

records of test results that positively identified a particular

employee with a particular result. They said that keeping paper records

was adequate for this purpose, however.

Blood Testing

Forty-eight commenters (again representing a variety of employers,

plus third-party providers, laboratories and others) favored allowing

the use of blood testing as a confirmation test method. The advantages

cited for this method included well-established scientific and legal

acceptance for accuracy, the availability almost anywhere of

technicians trained in drawing blood, and utility for post-accident

testing on employees who are unconscious. Some of these commenters said

that, while blood testing is admittedly more invasive than other

methods, employees accept it because of its reputation for accuracy.

Also, they said, the low expected positive rates on screening tests

will mean that few blood confirmation tests would have to be performed.

Commenters estimated costs to be in the $20-60 range per test.

Seven commenters opposed the use of blood testing, primarily on the

ground that it is too invasive. In addition, a few commenters said that

DHHS or DOT would have to develop laboratory certification standards

for blood testing. Some comments said that employees might have to be

required to ``stand down'' during the interval between the blood

collection and the return of the test result from the laboratory.

Urine Testing

Eight commenters favored allowing the use of urine testing,

including some employers who now use this approach to their

satisfaction and laboratories that do urine testing. One advantage

cited for this approach is that alcohol could simply be added to the

list of substances for which urine samples taken for drug testing are

tested, at a low incremental cost. Commenters said that DOT or DHHS

should develop laboratory certification procedures and cutoff levels.

Some commenters also noted that detailed collection procedures would

have to be developed, since urine testing for alcohol is more

complicated than urine testing for drugs (e.g., two voids, twenty

minutes apart, are recommended to measure alcohol concentration in

urine).

Performance Testing

Five commenters, most of whom were manufacturers of the devices,

supported the use of performance tests for the screening or screening

test. (A performance test does not measure alcohol concentration; it

measures deviations from a personal norm of reaction time, motor

coordination, etc.) One commenter opposed performance testing devices

as inappropriate for this program.

Responses to Comments on Testing Methods

Legal Issues

The Act provides, with respect to confirmation testing, that all

tests * * * shall be confirmed by a scientifically recognized method of

testing capable of providing quantitative data regarding alcohol * * *

Some comments asserted that this provision requires that a different

testing method be used for the screen and confirmation tests,

respectively. The statute says no such thing, stating only that the

confirmation test must use a ``scientifically recognized'' method that

can provide ``quantitative data'' regarding alcohol. As long as the

method of confirmation meets these criteria, the statutory requirement

is satisfied. Breath testing is scientifically and legally recognized

as a method for accurately testing alcohol concentration, and devices

meeting the Department's requirements provide quantitative data. (Blood

testing, of course, also meets the statutory criteria.)

The ability of a method of confirmation testing to pass these

statutory tests is not dependent on the choice of a method of screening

testing. Testing of breath for confirmation, as provided in this rule,

is equally valid under the statute whether evidential breath testing,

non-evidential breath testing, or saliva is used for the screening

test. Testing of blood for confirmation is equally valid under the

statute whether blood, breath, saliva or urine is used for the

screening test. All that matters is that the confirmation testing

method meet the statutory criteria in its own right.

With respect to split samples, the Act requires the Department's

regulations to provide that each specimen sample be subdivided * * *

and that a portion thereof be retained in a secure manner to prevent

the possibility of tampering, so that in the event the individual's

confirmation tests results are positive the individual has an

opportunity to have the retained portion assayed by a confirmation test

done independently at a second certified laboratory if the individual

requests the independent test within 3 days after being advised of the

result of the confirmation test * * *

Some commenters asserted that this language should be read to require

that split samples be used in all alcohol testing, with the implication

that a method that did not permit the use of split samples could not be

used. Since most EBTs--including those proposed by the Department in

the NPRM--do not retain a sample that could theoretically be subdivided

and preserved for testing of a split specimen, some of these commenters

asserted not only that blood or other liquid-based testing methods were

required, but that breath testing was prohibited.

This interpretation is flatly contrary to the statute, which

specifically contemplates the use of breath testing (see, e.g., sec.

3(a) of the Act, adding section 614(d)(6) to the Federal Aviation Act).

Breath testing is a well-recognized form of alcohol testing, and there

is no evidence that Congress had any intention of prohibiting its use,

either indirectly by requiring split samples or otherwise. The

legislative history makes clear that the Senate sponsors of the

legislation intended that breath testing be used and that split samples

were not mandated for breath testing. In the floor debate, during a

colloquy between Senators Danforth and Hollings, Senator Hollings

stated

[t]here are also requirements for split samples, primarily

included in the legislation to allow urine samples to be retested.

DOT would have the authority to determine that blood samples should

be similarly handled. This specific requirement is not relevant in

the case of breath testing for alcohol, but DOT is directed by this

legislation to provide necessary safeguards in this area to ensure

the validity of test results.

137 Cong. Rec S 14764, 14770.

There is also internal evidence in the wording of the statutory

provision that supports the reasonable interpretation that the split

sample requirement is intended to apply to liquid body fluids like

urine and blood, but not to breath. The statute uses the word

``samples'' in ways that refer primarily to samples of liquid body

fluids. For example, section 614(d)((1) of the amended Federal Aviation

Act refers to the need for ``privacy in the collection of specimen

samples.'' Privacy is very important with respect to collection of

urine samples for drug testing. Because elimination functions are not

involved, privacy is not as important in breath collections. In

paragraph (d)(6) of the same section, the statute refers to detecting

and quantifying ``alcohol in breath and body fluid samples, including

urine and blood.'' In this language, the phrase ``including urine and

blood'' is best understood as modifying ``body fluid samples,'' as

opposed to ``breath.'' Given the way that the term ``sample'' is used

in these portions of the statute, the use in paragraph (d)(5) of

``sample'' should also be used to refer to liquid body fluid samples

(i.e., urine and blood). When this paragraph speaks of the ``specimen

sample be[ing] subdivided,'' then, it is imposing a split sample

requirement on blood and urine, not on breath.

Some commenters argued that the language mentioned above from

paragraph (d)(6), requiring the Department to ``ensure appropriate

safeguards for testing to detect and quantify alcohol in breath and

body fluid samples, including urine and blood * * *,'' creates a right

for employees to have a screening test confirmed by blood testing. This

language, on its face, does not create such a requirement, since it

does not specify any particular sort of test for either screening or

confirmation purposes. There is ambiguous legislative history on the

point, with the Senate report on the Act saying both that ``an employee

testing positive for alcohol using a specimen other than blood shall be

entitled, at that employees [sic] option, to a blood test'' and that

``the Committee has not specified the type of test to be used in either

the screening or confirmation test.'' Given that the statute does not

explicitly require blood testing for confirmation, and that the portion

of the statute that mandates confirmation testing requires only a

``scientifically recognized'' confirmation test that can produce

``quantitative data'' (criteria that breath testing clearly meets), the

Department does not believe it would be reasonable to view this

ambiguous legislative history as a mandate for the availability of

blood confirmation testing in all cases.

The Department does not believe that regulations of the Food and

Drug Administration (FDA) would interfere with the implementation of

breath testing under this rule. FDA does regulate the safety, labeling,

etc. of medical devices. It is our understanding that FDA may be

considering initiatives to regulate EBTs used as medical devices in

medical settings. FDA does not, however, regulate or certify the

precision or accuracy of EBTs that are currently used for law

enforcement purposes or that would be used under the DOT alcohol

testing program. (These would not be viewed as medical devices used in

medical settings.) We believe that current FDA rules are, and future

FDA rules would be, consistent with NHTSA certification of EBTs.

Flexibility and Cost

Many commenters made flexibility in testing methods a high

priority. The Department agrees that flexibility is desirable. However,

the Department also believes that any testing system should meet a

series of criteria, each of which is necessary to execute the statute

faithfully and to ensure that the safety and accuracy goals of the

program are met. The Department cannot emphasize too strongly the

importance of ensuring accuracy and reliability of testing devices and

methods, at both the screening and confirmation test stages. This is

needed, among other reasons, to protect employees from even temporarily

being identified as misusers of alcohol. In the context of drug testing

litigation, the courts, in upholding the Department's program, relied

to a substantial extent on the reliability and accuracy safeguards in

that program.

Within these constraints, our objective is to provide maximum

flexibility and minimum cost. The Department's criteria for carrying

out its objectives in this area are the following:

As required by the statute, the method used for

confirmation should be scientifically recognized and able to produce a

quantitative result. The method should meet NHTSA Conforming Products

List (CPL) standards at 0.02 and higher alcohol concentrations.

The confirmation method should be alcohol-specific (i.e.,

does not produce a reading for acetone).

The confirmation method should generally provide

documentation of quality control/calibration and be admissible as

forensic evidence in administrative proceedings.

The testing method used for confirmation should provide a

result at the time and place of the test, so that an employee whose

continued performance of a safety sensitive function may present a

safety risk can be removed from performing that function.

The testing method used for the screening test should

minimize the occurrence of false positives and false negatives and

should meet stringent standards for precision and accuracy (e.g., +/-

.005 at 0.02 alcohol concentration).

The testing method used for screening tests should provide

a result at the time and place of the test and be specific for

measuring alcohol concentration.

The testing methods used for confirmation tests should

provide a printed, permanent record of the test number and test result,

in order to avoid uncertainty about whether this employee took this

test with this result. The testing methods used for screening tests

should provide either this kind of record or be used in conjunction

with procedures that provide a record of the test result linked to the

individual tested through some form of permanent documentation. The

purpose of this criterion is to prevent collusion and cheating.

The testing methods used for screening and confirmation

tests should, as a policy matter, be as non-invasive as possible.

At the present time, only evidential breath testing methods meet

all these criteria for screening and confirmation tests. Applying these

criteria strictly would result in a final rule that, like the NPRM,

permitted only evidential breath testing for both tests. The points

made by commenters favoring the NPRM approach further support using

evidential breath testing for both tests.

The Department, to achieve a reasonable balance between the legal

and policy goals on which the criteria are based and commenters' desire

for greater flexibility, is modifying the approach proposed in the

NPRM. First, the final rule will permit EBTs that are on the NHTSA CPL,

but that do not meet the additional requirements for confirmation EBTs

(e.g., sequential numbering and print-out capability), to be used for

any screening test. While these EBTs may be used for screening tests at

this time, because NHTSA has determined them to meet appropriate

accuracy and precision standards, non-evidential breath screening

devices (e.g., ``breath tubes'') may not be used at this time.

Second, in an NPRM published in today's Federal Register, the

Department will propose to permit blood testing to be used in limited

circumstances. In the case of a reasonable suspicion test or a post-

accident test, where an EBT meeting the requirements of part 40 is not

readily available, the employer could use blood testing for the

confirmation test. Blood alcohol testing would also be available as an

option in ``shy lung'' situations. This NPRM also proposes blood

testing procedures to be used in these circumstances. The rationale for

allowing this limited use of blood testing is discussed in the preamble

to the NPRM.

Third, the Department is also publishing in today's Federal

Register a notice proposing to adopt criteria and procedures that would

permit additional alcohol screening devices to be used for screening

tests in the program. This proposal would be intended to result in the

adoption of model specifications for a conforming products list for

alcohol screening devices. Under this proposal, manufacturers of

devices could submit their products to DOT for evaluation and, if their

devices met the model specifications, the Department would authorize

their use as screening devices in DOT-mandated alcohol testing. This

approach will permit greater flexibility in the use of screening

devices that are not now appropriate for use, including those supported

by their manufacturers and others in comments to the part 40 docket, if

they are able to meet DOT model specifications.

With respect to costs, commenters had three basic concerns, First,

commenters believed that EBTs meeting all the NPRM's requirements would

be too expensive. Some commenters believed that adding features such as

a sequential numbering and printout capability would add considerably

to the cost of the devices. The Department's information, included in

our regulatory evaluations, and based on data obtained from

manufacturers, suggests that the list price per unit of an EBT meeting

all the NPRM criteria for use in confirmation tests is about $2000.

(There are some indications that prices may be lower for purchases in

quantity.) There are other EBTs on the CPL, available under the final

rule to be used for screening tests, that list for about $1000, again

with the possibility of lower prices for purchases in quantity.

Because the Department is proposing to permit blood testing in

post-accident and reasonable suspicion situations where a breath

testing unit is not readily available, the numbers of EBTs that any

employer would have to obtain may be reduced significantly from earlier

estimates, lowering many commenters' estimated capital costs of the

program. This is because employers would not have to provide an EBT at

all its work sites against the contingency of a reasonable suspicion or

post-accident test happening there, as a number of employers' estimates

assumed. Commenters identified having to pre-position EBTs at all work

sites, even the small and remote ones, as a major cost of compliance

with the NPRM (even though the NPRM would not have imposed this

requirement). In addition making blood testing available means that the

time workers would be held out of service pending a test would be

reduced significantly, resulting in further savings. We refer

commenters to today's NPRM on blood alcohol testing for further

information.

Second, commenters expressed concern about the costs of training

personnel and maintaining and calibrating the instruments. While

training can be expensive, we believe that these costs are difficult to

avoid if the accuracy and integrity of the testing program are to be

protected. As other devices are approved under the Department's

forthcoming procedures, employers will have the opportunity to

determine if use of other methods will reduce their overall costs.

Third, some commenters (especially from the railroad industry) who

already use EBTs expressed concern about the costs of the additional

features that the NPRM would have required (e.g., sequential numbering

capacity, print-out capability). The final rule responds to these

concerns by allowing EBTs without these features to be used for

screening purposes. A railroad could use its existing EBTs (assuming

they are on the NHTSA CPL) for screening tests, while obtaining only as

many of the machines with the additional features as it needed for

confirmation testing. This would reduce the additional costs that these

employers would have to incur.

When the Department issues a broad mandate for employee testing,

the overall effect is likely to be the creation of additional

opportunities for professionals, manufacturers, and other businesses to

serve the markets created by the DOT requirements. These opportunities

can fairly be expected to lead to an influx of participants into the

market. There is ample evidence that this has been the case in the

Department's drug testing program, and it is reasonable to expect that

similar economic opportunities will draw businesses and professionals

into the alcohol testing market. The Department believes that this

factor is likely to outweigh, by a substantial margin, any deterrent

effects on participation in the program related to equipment or

training costs, the newness of the procedures, liability, or the

willingness of businesses and professionals to participate.

Comments that potential participants would be deterred for these

reasons were, for the most part, speculative. Given the market's

response to the drug testing rules since 1988, it is fairer to assume

that the market's response to the even larger-scale alcohol testing

program will not be timid. With respect to the issue of sufficient EBTs

being available, the Department has contacted EBT manufacturers, and we

do not anticipate any serious shortage of devices as the program begins

operation. If, at any time, the Department learns that there are

inadequate supplies, the Department could postpone or otherwise modify

its rules.

While the image of a large, angry, intoxicated employee confronting

a 90-pound female BAT over a positive result is a graphic one, the

speculation and spotty anecdotal evidence provided by commenters to

back up their concern on this matter is not sufficient to cause the

Department to retreat from its position that immediate results are

needed. (This concern goes to any testing method that provides an

immediate result, not just to breath testing. It might appear even more

strongly in a situation in which an individual is told, as the result

of a non-evidential screen, that he is to ``stand down'' and not work

for three days while a laboratory test result is obtained.)

The point of getting an immediate result is safety: if an employee,

of whatever size, has a higher alcohol concentration than the

Department's rules permit, the individual should not be performing a

safety-sensitive function. In the interest of safety, we need to stop

the individual's performance of that function now, not two or three

days later when a laboratory test result becomes available. We also

want to prevent the unnecessary cost of holding an employee out of

service for two or three days pending laboratory results following a

non-evidential screen. BATs are not given the responsibility of taking

a driver's keys away. The DOT alcohol testing form includes a

statement, to be signed by the employee, that persons who test positive

should not drive or perform other safety-sensitive functions. Employers

have a responsibility, as part of their alcohol education for

employees, to emphasize that employees must cease performing safety

sensitive functions if they test positive.

The Department does not believe that it is necessary to use two

separate EBTs in order to have a valid, defensible result. EBTs on the

NHTSA CPL are designed for accuracy, and the internal and external

calibration checks built into the Department's procedures are

sufficient insurance against error. (Where employers choose to use an

EBT without the additional features for screening tests, of course, the

employer will necessarily use a different machine for the confirmation

test.) The Department is convinced that EBTs meeting its requirements

are sufficiently accurate and reliable, at the alcohol concentrations

that will be tested for, and that excessive invalidations of tests or

successful lawsuits or grievances will not occur. Similarly, the

likelihood of extensive errors by testing personnel should be

diminished by the BAT training requirements.

Manufacturers of alternative testing devices, and some other

commenters as well, advocated various other methods of testing,

particularly for screening tests. As noted above, the Department

intends to take action that could result in decisions to authorize use

of other screening devices and to authorize the use of blood testing in

some circumstances. The Department has decided not to permit the use of

these alternative methods until they can meet the criteria we believe

are necessary for accurate testing meeting the requirements of the

statute. The following paragraphs summarize the Department's reasons

for not permitting the use, at this time, of other testing methods:

Blood Testing

This is the most invasive form of testing.

Employees may fear needles or fear infection from

improper medical procedures.

Additional collection procedures, chain of custody

procedures, and equipment requirements would be needed, making

regulatory requirements more complex.

Laboratory certification standards and testing

protocols would need to be established. As noted in the accompanying

NPRM, this poses potentially significant problems even in the

limited context in which the Department is proposing to permit the

use of blood testing.

Results would not be available for at least 24 hours,

and could take 3-4 days to arrive. Confirmed results would,

therefore, not be available at the time the employee was affected by

alcohol, which would reduce the safety benefits of the program.

Urine Testing

Present laboratory certification standards and testing

protocols do not cover urine testing for alcohol. There would have

to be additional laboratory certification procedures and testing

protocols developed for urine testing.

Urine testing for alcohol (as distinct from drugs)

requires a complex collection process, involving two separate voids

with an interval between them. Addition of a preservative to prevent

the creation of alcohol by microbial fermentation is also

recommended. We would need to add new collection procedures to

accommodate these requirements, as well as new training requirements

for collection site personnel. These additional procedures would

make the collection process more complex and multiply the chances

for errors.

Urine testing is regarded as the least accurate method

currently available for determining the amount of alcohol in the

body.

A blood to urine ratio has not been definitively

established, making it difficult to equate a urine test result for

alcohol to a particular blood or breath alcohol level.

There are greater costs of employee ``downtime,'' for

transporting the employee to a collection site for testing and for

the longer collection procedure.

Testing of urine specimens would have to take place in

a laboratory. Results would not be available for at least 24 hours,

and could take 3-4 days to arrive. Confirmed results would,

therefore, not be available at the time the employee was affected by

alcohol, which would reduce the safety benefits of the program.

Saliva Testing

Especially at low alcohol levels, saliva devices are

likely to have a higher rate of false positives and negatives than

EBTs on the CPL.

Some saliva devices do not provide quantitative

results.

Because saliva screening testing devices are

disposable, and do not generate a record of the test, ascertaining

whether a particular employee took a particular test and had a

particular result, or that the test took place at all, would be

difficult. (The use of a log book, which helps to address this

concern where EBTs without sequential numbering or printout

capabilities are used, would be difficult in the case of disposable

devices. The log book would accompany the EBT wherever it went,

which would not be possible with disposable devices.)

There are different saliva-based technologies, each

requiring the establishment of criteria for accuracy, reliability,

etc. Until NHTSA criteria are established for these technologies, it

is premature to permit their use in the DOT program.

If laboratory confirmation methods (e.g., blood) are

used in combination with saliva screens, confirmation results would

not be available for at least 24 hours, and could take 3-4 days to

arrive. Confirmed results would, therefore, not be available at the

time the employee was affected by alcohol, which would reduce the

safety benefits of the program. If breath testing confirmation is

used, cost savings claimed for the use of disposable devices over

the use of breath testing for both screening and confirmation

testing would be reduced substantially.

The Department would have to establish additional

procedures, training requirements, quality control requirements,

etc. for saliva testing, adding further complexity to the program.

Non-evidential Breath Testing

Non-evidential breath devices (i.e., disposable devices

and others not on the CPL) have a higher rate of false positives and

negatives than evidential EBTs.

Non-evidential breath screening testing devices do not

generate a record of the test, so that ascertaining whether a

particular employee took a particular test and had a particular

result, or that the test took place at all, would be difficult. (The

use of a log book, which helps to address this concern where EBTs

without sequential numbering or printout capabilities are used,

would be difficult in the case of disposable devices. The log book

would accompany the EBT wherever it went, which would not be

possible with disposable devices.)

If laboratory confirmation methods (e.g., blood) are

used in combination with non-evidential breath screens, confirmation

results would not be available for at least 24 hours, and could take

3-4 days to arrive. Confirmed results would, therefore, not be

available at the time the employee was affected by alcohol, which

would reduce the safety benefits of the program. If breath testing

confirmation is used, cost savings claimed for the use of non-

evidential devices over the use of evidential breath testing for

both screening and confirmation testing would be reduced

substantially.

Non-evidential EBTs on the market appear to vary

greatly in type of technology used, quality, and accuracy. Until

NHTSA criteria are established for these devices, it is premature to

permit their use in the DOT program.

The Department would have to establish additional

procedures, training requirements, quality control requirements,

etc. for non-evidential breath testing, adding further complexity to

the program.

Performance Testing

The statute requires testing for alcohol concentration,

not diminished performance. A test for performance appears not to

meet this statutory requirement.

Performance tests are very unspecific, which could

result in positives caused by a wide variety of things other than

alcohol use (e.g., illness, prescription or over-the-counter

medication, fatigue, emotional distress). This would lead to many

unnecessary confirmation tests and could result in employees being

taken off the job while awaiting confirmation test results, adding

extra costs for employers and employees.

The accuracy of many performance testing devices is

unproven.

Many performance testing devices do not generate a

record of the test. Ascertaining whether a particular employee took

a particular test and had a particular result, or that the test took

place at all, could be difficult.

Most performance testing devices require the

establishment of individual baseline data for each employee, which

can be a time-consuming and costly procedure.

In many systems, performance evaluation must relate to

critical job skills, measures of which have not been established for

many occupations.

Performance testing devices or systems on the market

appear to vary greatly in quality and accuracy. Until NHTSA criteria

are established for these devices, it is premature to permit their

use in the DOT program.

The Department would have to establish additional

procedures, training requirements, quality control requirements,

etc. for performance testing, adding further complexity to the

program.

This discussion is in the context of an extensive, multi-modal

testing program, including pre-employment and random testing as well as

reasonable suspicion and post-accident testing. Greater protections are

needed in such a program, particularly in the absence of procedural

protections present in some existing programs that may use non-

evidential testing in some circumstances. For example, the Coast Guard

post-accident alcohol testing program can involve administrative

proceedings in which the employee has the opportunity to challenge test

results before a license is revoked or an investigative inquiry at

which further evidence could be introduced.

Breath Alcohol Technicians

The NPRM proposed that breath alcohol technicians (BATs) be trained

to proficiency in using EBTs and in DOT alcohol testing procedures,

using a NHTSA- or state-approved course. The competence of the BAT

would have to be documented. Additional (i.e., refresher) training

would be required, as needed, to maintain proficiency. An employee's

supervisor could not act as the BAT for that employee unless allowed by

a DOT rule and no other qualified BAT were available.

Commenters spoke to several provisions of this section. Six

commenters favored, and 15 opposed, requiring BATs to be tested to

ensure that they are alcohol free (an issue about which the Department

had asked a question in the NPRM preamble). A number of the opponents

said that this issue should be decided by the BATs' employers. The

Department is not adopting this idea, which we believe to be

unnecessary to the program.

Forty-nine comments addressed the training and qualification of

BATs. All these commenters favored training, though two mentioned that

training might be very costly or difficult, especially for smaller

companies. Sixteen comments said that it was not necessary for the

regulation to specify that BATs be trained in the pharmacology and

physiology of alcohol, about which the NPRM preamble had asked a

question. Three commenters took the opposite position. The Department

agrees that this training is not needed for BATs, whose training should

be focused on the proper operation of testing devices.

Seventeen commenters supported the NPRM approach (including the

concept of ``training to proficiency''), while two thought the NPRM too

vague. Eleven favored specific numbers of hours of training, ranging

from 4 to 40, with most of the comments suggesting something between 4

and 8 hours. Two expressed support of recurrent training, one asking

for a more specific requirement than the NPRM proposed. The Department

believes it is most relevant to ensure the BATs' proficiency. Our goal

is to ensure that BATs are able to use the testing devices that they

will operate. The Department believes that the best way to make sure

that BAT training results in proficient operators is to require that

BAT training include a course that is equivalent to the DOT Model

Course. Courses followed by state law enforcement agencies and other

organizations appear to vary substantially from one another, and may be

focused on breath testing in other contexts (e.g., enforcement of DUI

laws). NHTSA will review training courses and issue determinations

concerning whether they are equivalent to the NHTSA Model Course.

Who should be a BAT? Twenty-two of 23 commenters supported

permitting a trained law enforcement officer to act as a BAT. The

Department agrees that it is appropriate to authorize trained law

enforcement officers to act as BATs (e.g., off-duty officers under

contract to an employer), as long as they have been certified by a

state or local law enforcement agency. The officers would have to

follow DOT testing requirements, including this part, and to be

certified to operate the EBT used in the DOT-mandated test. The

officers could perform any type of DOT test. Except for the FHWA rule,

the OA rules do not permit the substitution of law enforcement tests

for tests conducted under DOT procedures.

There was less consensus on the issue of supervisors as BATs.

Sixteen commenters favored allowing properly trained supervisors to act

as BATs, pointing out that, particularly in reasonable suspicion or

post-accident testing, or at remote sites, supervisors may be the most

readily available, or perhaps the only available, trained BATs. Eleven

other commenters disagreed, most saying that an employee's supervisor

should never be the employee's BAT. These commenters appeared concerned

about the appearance or reality of a conflict of interest between the

supervisor's managerial role and his objectivity as a BAT. The

Department believes that, when possible, someone other than an

employer's supervisor must act as a BAT for the employee's test.

However, a supervisory BAT is better than no BAT at all. To enable a

test to go forward when no other BAT is available in a timely manner,

the Department will permit a BAT-trained supervisor to conduct the

test. However, if a DOT operating administration regulation prohibits

the use of a supervisor in this role (e.g., in reasonable suspicion

testing), the supervisor may not act as the BAT even in this

circumstance.

EBT Technology

The NPRM required EBTs used for screening and confirmation testing

to be on the NHTSA CPL, have the capacity to print out triplicate (or

three consecutive identical) results, assign a sequential number to

each test, distinguish alcohol from acetone at the 0.02 alcohol

concentration level, and have the capability for performing both air

blanks and external calibration checks. Commenters addressed a number

of points concerning EBT technology.

Some commenters pointed to what they viewed as shortcomings of the

CPL itself, particularly that it did not require EBTs to be accurate at

the 0.02 level. This was true of the CPL at the time the NPRMs were

issued; however, NHTSA has since modified the model specifications for

the CPL to require accuracy and precision at the 0.02 level. Other

commenters said that since inclusion on the CPL is based on testing of

a prototype, rather than testing of each device, the CPL was an

inadequate assurance of accuracy. The final rule does not rely on the

CPL alone to ensure accuracy, however. The rule requires there to be a

quality assurance plan (QAP) for the instrument as well as air blanks

and external calibration checks.

As noted above, a number of commenters criticized the requirement

for printing results and sequential numbering capability, saying that

these features were unnecessarily costly. Any device on the CPL should

be able to be used, one of these commenters said. The final rule

responds to these comments by allowing any device on the CPL to be used

for screening tests, with the additional features required only on

those machines used for confirmation testing. This should reduce the

number of the more expensive models employers will have to obtain.

Some commenters expressed concern about radio frequency

interference (RFI) affecting the results of some types of EBTs.The

concern is that, in airports and other locations where communications

or other electronic equipment is operating, alcohol concentration

readings could be distorted. DOT asked manufacturers about this issue,

who said that most models of EBTs are shielded to avoid this problem.

NHTSA tested three models of EBTs at Washington National Airport and

detected no RFI effects on their readings. In addition, NHTSA plans, as

part of its process for reviewing quality assurance plans (see

discussion below), to have manufacturers establish operational

guidelines to avoid RFI problems. The Department believes that it is

not necessary to modify the regulatory text to address the commenters'

concerns.

Commenters also expressed concern that some EBTs might not be able

to distinguish acetone from some alcohols. Commenters also questioned

the suitability of the CPL for instruments measuring alcohol

concentrations at the 0.02/0.04 levels, since the CPL, at the time of

the NPRM, did not address testing at these levels. As noted above,

NHTSA has revised the model specifications on which CPL listing of

devices is based. The revised specifications address both issues, and

EBTs on the CPL will distinguish acetone from alcohol and be accurate

at the 0.02/0.04 levels.

A few comments raised other technical issues about the use of EBTs.

One issue was the effect of altitude on external calibration standards.

Altitude affects gas aerosol standards; NHTSA will address this problem

by requiring gas aerosol standards on its CPL for calibration devices

to be criterion-referenced for various altitudes.

Another concern was based on the belief that EBTs that display

results to only two, rather than three, decimal places would round up.

That is, commenters were concerned that someone whose actual alcohol

concentration was .036 would be reported as a 0.04, subjecting the

individual to heavier sanctions. EBTs on the CPL provide three-digit

displays, so this problem does not arise for these devices.

Finally, some commenters expressed concern that defining alcohol

concentration in terms of grams of alcohol per 210 liters of breath was

not as accurate as desirable (or as accurate as a blood alcohol

reading), because this ratio could vary among individuals. The

Department's information is that any variation is very minor and

unlikely to affect the results of a breath test or its consequences

under these rules. In addition, EBTs are typically calibrated to

account for any variation by slightly undercounting alcohol

concentration.

Quality Assurance Plans

The NPRM proposed that EBT manufacturers would develop a quality

assurance plan (QAP) for each EBT model. The plan would cover such

matters as external calibration methods, tolerances and intervals and

inspection and maintenance requirements. The manufacturer would have to

obtain NHTSA approval of the QAP, and employers would have to comply

with it. This compliance includes making external calibration checks as

called for in the QAP and taking EBTs out of service if they ``flunk''

an external calibration check. In addition, the employer would have to

ensure that inspection, calibration and maintenance of EBTs is done by

the manufacturer, a representative certified by the manufacturer, or an

appropriate state agency.

On the basic concept of the QAP, five commenters supported the

NPRM's approach, while another eight said that NHTSA, rather than the

manufacturer, should establish the standards. Some of the latter

commenters appeared concerned that manufacturers may have incentives to

establish requirements for their devices that were not optimal. The

Department believes that NHTSA approval of the QAPs should be

sufficient to ensure that the manufacturer's standards are adequate and

that the manufacturers are better positioned than we are to establish

model-specific requirements for individual EBTs. For this reason, we

are retaining the proposed approach. QAPs would be required for all

EBTs on the NHTSA CPL that would be used in DOT-required alcohol

testing, whether or not a particular EBT met the additional

requirements of this part for use in confirmation testing.

Commenters suggested a wide variety of requirements concerning how

frequently an external calibration test must be performed. Some of the

ideas included performing such checks before and/or after every test,

after every positive test, before, during and after the testing shift,

every day, after every five tests, every thirty days, or before

disciplinary action is taken on the basis of a positive test. All these

comments respond to a basic point: if an EBT ``flunks'' an external

calibration check, positive tests conducted on that device since the

last previous successful external calibration check must be regarded as

invalid. This fact provides a strong incentive to employers and BATs to

conduct these checks frequently enough to avoid retroactive

invalidations of positive tests. In conjunction with the manufacturer's

instructions on the QAP, this incentive should be sufficient to induce

employers acting in good faith and testers to conduct these checks at

appropriate intervals. A generally applicable regulatory requirement

for external checks of calibration at a stated interval, on the other

hand, would provide less flexibility and might not fit a variety of

situations well.

A few commenters suggested specific types of calibration solutions

or obtaining such solutions from certified laboratories. Others

suggested that the Department establish particular standards for

external calibration devices, or allow use of only those external

calibration devices that are on the NHTSA CPL. Others suggested

particular tolerance standards (e.g., +/- .005). The Department does

agree that the employers should use external calibration devices that

are on the NHTSA CPL, and this requirement has been incorporated into

the final rule. The Department does not certify laboratories for

production of external calibration solutions, so we could not

reasonably require employers to obtain solutions from certified

laboratories. For the types of solution that work best with a

particular machine, or for the tolerance standard that is most

relevant, we believe that reliance on the QAP, based on the

manufacturer's knowledge of the behavior of its product, makes the most

sense.

On the subject of maintenance, most commenters supported the NPRM's

proposal for maintenance by manufacturers, or their representatives,

and careful documentation of this activity. These provisions have been

retained.

Testing Location

The NPRM called for a testing site that afforded visual and aural

privacy to the employee, though in unusual circumstances a test could

be conducted elsewhere. The site would have to be secured. A mobile

facility (e.g., a van) that met the requirements could be used. At the

site, the BAT was to supervise only one employee's use of an EBT at a

time, and the BAT could not leave the site when testing was in

progress. The Department, with some modifications, is adopting this

provision in the final rule. In our view, privacy in the context of

breath alcohol testing is primarily for the purpose limiting other

persons' access to information about the employee's test result. In

contrast to urine drug testing, where private elimination functions are

involved, privacy need not be as strict for breath alcohol testing. We

have also eliminated references to the site being ``secured,'' as such,

because this term could lead to confusion. Our concern is that

unauthorized persons not be in a position to see or overhear test

results. We are not requiring that testing take place behind locked

doors, in a totally enclosed space, or in a dedicated facility that is

not used for other purposes.

There were few comments on this provision. Two commenters noted

that privacy could be hard to achieve at a remote site. The NPRM

already made allowance for this problem, however, by saying that a

testing location did not have to provide full privacy in unusual

circumstances such as a post-accident or reasonable suspicion test in a

remote location. Other comments included a concern that privacy be

protected adequately, that too much privacy could sharpen the concern

about confrontations between BATs and employees, and that privacy

requirements should not exclude a witness (e.g., a union

representative) from the testing site. The provision establishes a

general performance standard for privacy of the physical site: It does

not address the issue of whether a witness may be present (that is a

matter for labor-management negotiation). It does not require a site

that is so isolated that a BAT could not find assistance if needed. One

commenter asked for a DOT-operated national inspection program for test

sites, analogous to the DHHS laboratory certification program. The

Department believes that such a system would not be practicable, given

the very high number of testing sites likely to be involved with the

program.

Testing Form and Log Book

The NPRM proposed to require the use of a standard form for DOT-

mandated testing, which employers could not modify. It would be a

triplicate form, with copies for the BAT, employer, and employee. The

colors of each copy of the form are intended to be consistent with the

colors of the Department's drug testing form. The Department has

decided to adopt this provision with minor modifications.

Seven commenters supported the NPRM provision as drafted. Thirteen

commenters favored having space on the form for recording a repeat of a

test, in order to reduce paperwork. The Department believes that adding

space for this purpose would result in a longer, more complicated form.

Moreover, it is likely to be only in a minority of cases that a test

will have to be repeated, meaning that the extra complexity of the form

would not serve a useful purpose in most cases. For this reason, the

Department is not adopting this comment.

Two commenters suggested that a combined drug/alcohol form be

developed. The Department responds that, because of the differences

between drug and alcohol testing, it would be difficult to develop a

combined form that would not be too cumbersome and would work in both

situations.

Two commenters asked that employers be able to modify the form. The

Department's experience with the drug testing program, where some

modification of the form has been permitted, is that the resulting

variety of forms leads to confusion, errors, and difficulty in

completing the form by collection site personnel. The Department

believes that an unvarying, standard form will minimize these problems.

Employers would have to use the form exactly as presented in Appendix A

to this regulation (though a form directly generated by an EBT could be

smaller and would not need a space to affix a separate printed result.)

One commenter suggested that DOT provide the forms to employers free of

charge. The Department does not believe that this is an appropriate use

of Federal funds.

Two commenters asked that the form specify that the test is being

conducted under the authority of DOT regulations. The Department's

experience under the drug testing program is that, for lack of such a

statement, some employees have been confused about whether a particular

test was being conducted under DOT authority or simply under the

employer's policy. The form being published with this rule includes

such a statement. The result of including such a statement is that

employers are not permitted to use the ``DOT form'' for a test not

conducted under DOT authority.

Two commenters questioned the option to have the EBT or printer

print results directly on the form, preferring to use a separate form.

The regulation's requirements for EBTs used in confirmation testing

provides this option, which is appropriate to provide flexibility. An

employer who is uncomfortable with one approach can use the other.

This section of the rule includes a new provision requiring the use

of a log book with EBTs, used for screening tests, that do not have the

sequential numbering and printing capabilities required for devices

used for confirmation tests. This section spells out the requirement

for the log book and what it must contain; the rationale for the log

book requirement is discussed below.

Preparation for Testing

The NPRM proposed that the BAT and the employee provide

identification to one another and that the BAT explain the testing

procedure to the employee. A commenter suggested that written

information be provided to the employee, so that the briefing could be

more detailed and the BAT had less verbal work to perform. The employer

may provide the information in this fashion, though the regulation will

not require it. Other comments were few and supportive. The NPRM

provisions have been retained. Some provisions of this NPRM section,

concerning filling out of forms and refused or incomplete tests, have

been moved to the next section.

Initial Breath Test Procedures

The NPRM proposed to require an air blank before and after the

screening test, which the machine had to pass in order to stay in

service. The NPRM also included proposed requirements concerning

completing the test paperwork.

Fifteen commenters addressed the issue of air blanks. Seven

commenters agreed with the NPRM that air blanks should be required

before and after each screening test. Two said that air blanks are not

technically relevant with some types of EBTs. Six commenters said that

an air blank should not be required after a test when the result was

less than 0.02, as this was a waste of time. Some of these commenters

favored pre-test air blanks, however. One commenter supported only pre-

test air blanks.

The Department has decided that it will not require air blanks

either before or after a screening test. First, most screening test

results will be below 0.02, making post-test air blanks of limited

value in those cases. Second, pre-test air blanks, at the screening

stage, are not crucial in preventing ``false positives'' for employees,

since no action against an employee may be taken without a confirmation

test. Third, the Department will require air blanks before confirmation

tests, which will build this protection into the testing process where

it matters most. Fourth, the Department is permitting all EBTs on the

NHTSA CPL to be used in screening tests, and some of these instruments

would not provide any durable record of an air blank, even if they were

able to perform air blanks. Finally, the absence of a requirement for

air blanks on the more frequent screening tests will result in some

cumulative savings of BAT and employee time and wear on the machines.

The NPRM called for a 15-20 minute waiting period before the

confirmation test; no such waiting period was proposed for before the

screening test. Seven commenters favored a waiting period before the

screening test, eight opposed it, and two favored employer discretion.

Because the confirmation testing procedures do provide for a waiting

period, and since action against an employee can be taken only on the

basis of a confirmation test, we believe that requiring an additional

waiting period before the screening test would be superfluous.

The NPRM provision addressed situations in which the printed and

displayed results did not match, proposing that such tests would be

invalid. The final rule modifies this provision, since it is irrelevant

concerning instruments that do not print out a result. The NPRM

provision remains in effect for EBTs that do print out.

The additional flexibility the Department has provided in screening

testing procedures, by permitting the use of EBTs that do not have

sequential numbering and result printing capabilities, makes it more

difficult to determine that a test of a particular employee, with a

particular result, has taken place, raising the possibility of cheating

by employers. To mitigate this potential problem, the final rule will

require a log book to be kept with each EBT used for screening that

does not have the sequential numbering and printout capabilities. (This

requirement does not apply to EBTs meeting the requirements for devices

used for confirmation testing. ) The BAT will fill out a log book entry

for each test in addition to completing the alcohol testing form. The

log book entries are intended to serve as a cross-check on the

performance and result of a test.

There were several comments both to this section and the next

section concerning whether the cutoff level for a test to which

consequences for the employee would attach should be 0.02, 0.04, or, as

the NPRM proposed, a bifurcated 0.02/0.04 standard, with different

consequences at each level. The rule takes the latter approach, for

reasons discussed in the common preamble to the OA rules.

The employee is told to sign the form after the test has been

taken. If the employee does not do so, it is not regarded as a refusal

to take the test. Obviously, it would be silly to regard as a refusal

to take the test a refusal to sign the form after the test had already

been successfully conducted. In this situation, the BAT is required to

not the failure to sign in the remarks section of the form.

Confirmation Breath Test Procedures

The NPRM instructed the BAT to tell the employee to avoid eating,

drinking, etc. during a 15-20 minute interval between the screening and

confirmation test, though the test would continue even if the employee

did not follow the directions. The BAT would also give the employee a

notice not to drive or perform other safety-sensitive functions if the

employee's alcohol concentration were 0.04 or greater. After performing

the same steps as with the screening test, the BAT would note the

alcohol concentration reading and transmit the results to the employer

in a confidential manner. The lower of the two readings--screening and

confirmation--would control the result.

There were 29 comments concerning the waiting period before the

confirmation test, fifteen of which supported the 15-minute minimum

time proposed in the NPRM. Four comments wanted a shorter interval

(e.g., two or five minutes) and four supported a longer interval (e.g.,

20 or 30 minutes). Two comments opposed any requirement concerning an

interval. Six comments either wanted no maximum waiting time or

preferred to rely on the employer's or EBT manufacturer's discretion.

The waiting period is important. It is intended to give the

employee the opportunity to ensure that any residual mouth alcohol does

not influence the result of the confirmation test. According to the

Department's information, fifteen minutes is the minimum period after

which one can be confident that any residual mouth alcohol has

disappeared. A shorter interval is not feasible for this reason. At the

same time, waiting a long period between tests can be costly in terms

of lost employee time and could influence the outcome of the

confirmation test. In order to guard against lengthy delays in the

performance of confirmation tests, which can allow alcohol

concentration levels to fall, the final rule retains the 20-minute

maximum. It should be pointed out that failing to observe the minimum

15-minute period is a ``fatal flaw'' (see Sec. 40.79 (a)),

automatically invalidating a test. This is because the Department

believes it is important to prevent artificially high readings due to

mouth alcohol residue. However, taking longer than 20 minutes between

tests is not a ``fatal flaw.'' The Department is aware that

circumstances may sometimes result in stretching the time between tests

for a few additional minutes.

Another issue addressed by commenters in a variety of ways was that

of whether the screening or confirmation test result prevails when one

is higher than the other. Eighteen commenters believed that the

confirmation test should prevail in all cases. Two commenters supported

using the higher of the two results, while three supported using the

lower of the two results. The Department believes that it is more

understandable, and less potentially confusing, for the confirmation

test result to determine the outcome of the test. The confirmation test

will always have to be performed using the most reliable methods. Also,

alcohol concentration can still be rising at the time of the screening

test. Although it is also possible for alcohol concentration to have

dropped since the screening test, the Department's requirement for the

confirmation test to be conducted a short time after the screening test

should minimize any problem. Finally, this approach is consistent with

that the Department takes in drug testing. Consequently, in situations

in which a confirmation test is needed, the final rule will attach

consequences only to the confirmation test result.

Nine commenters asked that the final rule, unlike the NPRM, provide

for medical review officer (MRO) review of the confirmation test

result, as the Department requires in drug testing. Among their reasons

were that there could be valid medical or food-related reasons for

alcohol concentrations, that there could be inadvertent alcohol

consumption, that someone should review results for procedural errors,

that an MRO should play the role assigned to the substance abuse

professional (SAP) by the proposed rules, or that the alcohol rules

should mirror the drug rules as much as possible.

In the drug testing context, an MRO determines whether there is a

legitimate medical explanation for an individual having in his or her

system a substance which is otherwise illegal. The alcohol rules are

different in this respect. They prohibit safety sensitive employees

from having alcohol concentrations above certain levels, regardless of

the source of the alcohol. An alcohol concentration of 0.04 resulting

from drinking beverage alcohol has the same consequences under the

rules as an alcohol concentration of 0.04 resulting from ingesting

medication. Both uses of alcohol are legal (as long as they do not

violate OA rules concerning on-duty use, pre-duty abstinence, etc.);

the resulting alcohol concentration is prohibited by DOT regulations

equally in both cases. In this context, there is nothing for an MRO to

decide. Inserting an MRO into the process without this key function

would add to the complexity and cost of the system without providing

any benefits. For these reasons, the Department will not require MRO

review of alcohol testing results.

The NPRM proposed that employers could use the same EBT for both

the screening and confirmation tests. Fifteen commenters objected to

this proposal. Some said that an entirely different methodology should

be used for the two tests. The legal issues section of the preamble

discusses this point. Others said that a different EBT should be used

for each test, some making the argument that using the same machine for

both tests constituted ``repetition,'' but not ``confirmation.'' This

semantic argument is not persuasive. The statute does not require

different machines to be used, as long as the machine used for the

second test meets statutory requirements. (Of course, where an employer

chooses to use a preliminary EBT for the screening device, it will

necessarily use two different machines.) Because of the reliability of

EBTs meeting the requirements of this rule, we believe it would be

unnecessarily expensive to require a second device to be used, which

could have the effect of roughly doubling the capital equipment costs

of the program.

Twelve of thirteen commenters opposed requiring a second

confirmation test after the first confirmation test had been positive,

a matter about which the NPRM preamble asked a question. The Department

does not see a basis for requiring a second confirmation test, and we

are not adding this requirement to the final rule.

A few commenters suggested getting rid of the requirement for the

BAT to notify someone testing positive that he or she should not drive.

The Department has decided to include a notice to this effect on the

alcohol testing form, making direct participation by the BAT

unnecessary.

Two commenters suggested that the rule be clarified to indicate

that an employer could have more than one representative to whom

results are transmitted. The Department has done so.

Two comments supported, and two opposed, the practice of back

extrapolation to obtain a result. The Department's NPRMs proposed that

the consequences of test results attach only to employees whose EBT

readings were in fact at the stated levels. The Department did not

propose to attach these consequences to inferences from EBT readings

about what an employee's alcohol concentration might have been at an

earlier point. For example, if an employee's EBT test result were .03,

the requirement that the individual not again perform safety-sensitive

functions until he or she was evaluated by a substance abuse

professional (SAP) and had passed a return-to-duty test, and the

requirement that the individual be subject to follow-up testing, would

not apply because the employer, SAP, or other party believed that the

individual's alcohol concentration had been 0.04 or greater prior to

the test. Given the wide individual variations in alcohol metabolism

among individuals, such inferences involve considerable uncertainty.

The Department is retaining the NPRM provision on this point. This

would not prevent an OA from making use of back extrapolation in

certain situations (e.g., FRA makes some use of back extrapolation in

its existing toxicological testing program, in a context involving the

use of samples of two different body fluids; inquiries into accident

causation or proceedings to revoke DOT-issued certificates or licenses

held by employees, where expert testimony can be produced with the

protection of the due process procedures of a hearing). These

situations are different from the use of back extrapolation by

employers in interpreting the results of tests conducted under part 40,

however.

There will be some cases in which the BAT who conducts the

screening test and the BAT who conducts the confirmation test are

different people. For example, BAT #1 conducts a screening test, using

an EBT not having sequential numbering or printout capabilities, in

location A. The confirmation test, using a device that has these

features, happens subsequently in location B, and is conducted by BAT

#2. In such a case, to minimize the possibility of lost forms or other

errors, the final rule provides that BAT #1 would complete the form for

the screening test and give the employee his or her copy of the form.

BAT #2 would then start a new form. The sections of the rule concerning

screening and confirmation testing procedures have been modified to

this effect.

Refused and Incomplete Tests

The final rule, in Sec. 40.67, picks up paragraphs from the NPRM

that do not fit conveniently in other sections. The first provides that

employee refusals to take certain actions (e.g., complete and sign Step

2 of the form, provide breath) constitute a refusal to be tested. Such

refusals, under the operating administration rules, have the same

consequences as a test result of 0.04 or greater. The NPRM provision on

which this paragraph is based was not the subject of comment. The

second paragraph provides that if a test cannot be completed, or an

event occurs that would invalidate the test, the BAT would, if

practicable, run a retest. All seventeen comments on the subject

favored this approach, and the Department is including it in the final

rule.

Inability to Provide Sufficient Breath

The NPRM proposed that if an employee were unable to provide enough

breath for an adequate sample, the BAT would ask the employee to try

again. If the same result occurred, then the employee would be referred

to a doctor for a medical evaluation. If the doctor determined that the

inability to provide breath was due, or probably due, to a medical

condition, the failure to provide the sample would be excused. If not,

it would be treated as a refusal.

Four comments supported the NPRM provision. Three others thought

that this situation was unlikely to arise, since only an employee who

was seriously disabled, unconscious, or dead would be unable to provide

the modest quantity of breath required to complete a test. We agree

that this situation should not occur frequently, but we believe it is

sensible to have a procedure in place to handle the occasional

occurrence.

Nine commenters suggested that, if the employee cannot provide

sufficient breath, the employee should be required to provide a sample

of a body fluid (e.g., blood, urine). Two comments urged employer

discretion in these cases. Ten commenters said that there should be a

medical evaluation in all cases where an employee cannot produce

sufficient breath, though these commenters disagreed with each other

about whether the employee should be held out of safety-sensitive

functions pending the result of the evaluation.

Under the final rule, the employer is required to direct the

employee to be medically evaluated in ``shy lung'' cases. The final

rule directs the employer to ensure that this evaluation occurs as soon

as possible. Employers, under their own authority, could choose to

``stand down'' an employee pending the result of a medical evaluation,

but the rule does not require this step.

In addition, the accompanying NPRM proposes that blood testing may

be used in post-accident and reasonable suspicion testing when an EBT

is not readily available. Since blood testing, and procedures for it,

may become part of the rule for these purposes, the Department is

responding to these comments by proposing blood testing as an option

(regardless of the type of testing involved) when an employee cannot

provide a sufficient breath sample. If the NPRM's proposal is made part

of a final rule, the employer would have discretion concerning which

alternative (blood alcohol testing or a medical evaluation) to select.

Persons interested in this issue are asked to comment to the NPRM

docket.

Invalid Tests

The original NPRM listed nine ``fatal flaws'' that would invalidate

breath tests. An invalid test is neither positive nor negative, and it

has no consequences for an employee. The NPRM being published today

proposes a similar list of fatal flaws for blood tests.

The NPRM proposed that failure to observe the 15-minute minimum

waiting period before the confirmation test would be a fatal flaw;

going over the 20-minute maximum would not. Comments generally agreed

with this approach, some noting that if exceeding a maximum waiting

time were to be a fatal flaw, the outer limit should be 30 or 60

minutes rather than 20. One commenter opposed making observance of the

minimum a fatal flaw. The Department is retaining the NPRM provision on

this point.

The Department is changing the provision concerning air blanks to

reflect the final rule's requirement of an air blank before only the

confirmation test. Likewise, the NPRM provision making the device's

failure to print out a result a fatal flaw has been changed to apply

only to confirmation tests. The provision on disagreement between the

printout and the machine display concerning sequential test numbers or

alcohol concentration has been modified for the same reason. If the

employee fails to sign Step 4 of the form, that is not a fatal flaw;

the BAT's failure to note the employee's failure to sign that portion

of the form would be a fatal flaw, however.

The NPRM proposed that if an EBT fails an external calibration

check, every test performed on the device since the last valid external

calibration test would be invalidated. Ten commenters opposed this

provision, pointing out that it would cause numerous problems for

employers if they had to invalidate tests after the fact, and perhaps

had to reverse personnel actions as well. Four commenters supported the

proposed requirement. The Department is well aware that after-the-fact

invalidations of tests can create serious problems for employers. The

Department does not see a workable alternative, however. If a valid

external calibration check was performed after test A, and an invalid

external calibration test was performed after test K, all we know for

certain is that the machine went out of kilter somewhere between tests

B and K. We cannot say for certain that test B or C was valid, or

assume that the error occurred only on test K. Since we cannot

determine that these tests were valid, we must, in fairness to the

employees involved, treat them as invalid. Tests with results of 0.02

and above would be deemed invalid in this situation. This is surely

incentive for employers to conduct frequent external calibration

checks, particularly after positive tests.

One commenter suggested additional fatal flaws, such as failure to

use a clean mouthpiece, inadequate grounds for reasonable suspicion,

etc. One commenter suggested that all flaws should be regarded as

fatal. The Department believes that only certain serious problems in

the process, that directly affect the integrity of the test or accuracy

of the result, should automatically invalidate the test. Other errors,

particularly in combination with one another, could form the basis for

a determination that a test is invalid (i.e., the listed fatal flaws

are not intended to be the only possible grounds for invalidation). The

Office of Drug Enforcement and Program Compliance is charged with

providing, on behalf of the Department, definitive guidance on issues

concerning the invalidation of tests.

Availability of Testing Information

The NPRM proposed provisions on alcohol test information

availability parallel to the existing provisions on the availability of

drug testing information, as the Department has interpreted them.

Employers could release information to a third party only with the

specific written consent of the employee, must keep confidential

information secure, but may make the information available in certain

litigation situations. Employers must make information available to DOT

or, under some circumstances, to the National Transportation Safety

Board (NTSB). Employers must also make information about an employee's

test available to that employee.

Seven commenters, most of whom were from the motor carrier

industry, asked that employers be authorized or required to make

testing information available to third parties without the employee's

consent. In this industry, the commenters said, there was a high

turnover rate. Employees move rapidly from employer to employer. In the

absence of authorization or requirement for a former employer to

provide testing information to a potential new employer, either the

hiring process would be slowed or important information about positive

tests in the employee's past would be unavailable to the new employer.

In response, the Department points out that an employer may,

without authorization from DOT, require an applicant, as a condition of

employment, to give written consent to the disclosure of this

information by a former employer. The Department is adding a sentence

to this provision of the rule telling employers that they must provide

the information when the employee consents to its transmission to a

third party. However, in order to maintain the confidentiality of

sensitive information, in which employees have a significant privacy

interest, the Department will not authorize the transmission of this

information among employers or potential employers without written

employee consent.

The Department emphasizes that the consent involved must be a

specific written consent for information to be sent from one named

party to another named party. Blanket consents (i.e., a consent for

testing information to be sent to all present or future employers or

members of a consortium) are not permitted. Each consent must pertain

to one specific employer providing the information about a particular

employee to another specific employer.

Two commenters suggested that an employee should not have to pay

for obtaining information in his or her own file concerning alcohol

tests. The Department believes that this is a matter better left to

employer-employee agreements. As the Department interprets this

provision, employers may impose reasonable charges to cover the cost of

retrieval, copying, and transmission of the records requested. The

employer is also expected only to provide copies within its possession

or control (including documents that may be maintained by a consortium

or third-party provider that conducted testing for the employer).

Records Concerning BATs and EBTs

The NPRM proposed that the employer maintain various records

concerning EBTs and BATs for five years. One commenter suggested that

consortia and third-party providers be authorized to keep the records

instead of the employer. The Department agrees that this is reasonable,

and the final rule requires the employer or its agent to maintain the

records. The employer retains ultimate responsibility for producing the

records, however. Two commenters suggested we reduce the record

retention period to two years, while one commenter said that the

recordkeeping requirements in the NPRM were not burdensome. Consistent

with the OA rules, the final part 40 rule establishes a 5-year

retention period for calibration records and a two-year retention

period for other records.

Other Issues

A number of commenters asked that we modify the definition of

alcohol to include alcohols other than ethanol (e.g., methanol,

isopropanol), in order to avoid loopholes in the program that would

allow an employee to claim that his or her alcohol concentration

reading was the result of ingesting a non-ethanol substance. The

Department agrees that the definition should be broadened to avoid any

potential problems with the use of non-ethanol alcohols, and the final

rule includes a modified definition to this effect. This revised

definition is consistent with that used by NHTSA in its model

specifications for evidential EBTs. We have also added a companion

definition of alcohol use, which emphasizes that any consumption of a

preparation including alcohol (e.g., beverages, medicines) counts as

alcohol use.

A few commenters asked that, for convenience, we centralize all the

definitions in part 40 in one section. We have done so, and all the

definitions are now in Sec. 40.3.

The NPRM preamble asked for suggestions on how to deal with

situations in which an arbitrator overturns an employer's personnel

action based on an alcohol test result. Employers had expressed concern

about perceived conflicts between the arbitrator's decisions and DOT

regulations, and several commenters echoed these concerns. The

Department is not convinced, however, that this problem is either

frequent enough or serious enough to warrant a mandate in the

regulatory text. Such a mandate, because it could not anticipate all

the nuances of the factual situations involved, might interfere with

reasonable resolutions of particular disputes.

However, it is clear that employers are obligated to comply with

DOT safety regulations, which have the force and effect of law. As a

matter of law, no decision by an employer, employee organization, or

individual or group appointed by those or other parties, can have the

effect of excusing noncompliance by an employer with a provision of a

DOT safety regulation. If a violation of DOT rules has occurred, then

the consequences prescribed by DOT rules must follow (e.g., the

employee must be removed from performing a safety-sensitive function).

In the NPRM preamble, the Department included a discussion of

handling of perceived conflicts between part 40 and operating

administration regulations, exemptions, and the obligations of

consortia and third-party providers (57 FR 59410; December 15, 1992).

This discussion applies to the implementation of the final part 40 as

well. The relevant language is reprinted below:

Although implementation of part 40 generally would be done

through an operating administration, part 40 is an Office of the

Secretary of Transportation (OST) regulation. As such, requests for

exemption would be processed under 49 CFR part 5, an existing

regulation covering requests for exemption from or amendment to all

OST rules, rather than through separate operating administration

exemption procedures. This would add an additional element of

consistency. This approach is consistent with the existing part 40

drug testing procedures, from which exemptions would also be granted

under part 40. (See 54 FR 49863; December 1, 1989).

The grant of an exemption under part 40 must be based on special

or exceptional circumstances. It is not appropriate to carve out a

generally applicable exception to a rule. Also, an exemption must be

based on circumstances not contemplated as part of the rulemaking.

The exemption process is not designed to revisit issues settled in

the rulemaking process.

Section 40.1 would also emphasize that other parties involved in

the testing process--such as consortia, contractors, and agents--

``stand in the shoes'' of the employer. They are, therefore, subject

to the same obligations and requirements as the employer. If an

employer is required to do something, so is the consortium that is

conducting testing for the employer. If the consortium fails to do

something correctly, the employer is in noncompliance.

Since, as noted above, part 40 is a regulation of the Office of the

Secretary of Transportation, the source of definitive interpretations

of the rule is the Office of the Secretary. Interpretations have been

and will continue to be made in close coordination among the OAs, the

Office of Drug Enforcement and Program Compliance (DEPC), and the

Office of General Counsel.

Regulatory Analyses and Notices

Because of substantial public interest and substantial impacts on a

wide range of private and public sector organizations, the Department

has determined that this rule--in conjunction with the operating

administration alcohol and drug testing rules--is significant under

Executive Order 12866. The rule has been reviewed under this Order. It

is also significant under the Department's regulatory policies and

procedures. The Department has prepared a regulatory evaluation for

part 40, which we have included in the docket. The costs of the

application of part 40 procedures to the programs of the various OAs

are estimated in each of the OAs' regulatory evaluations for their drug

and alcohol rules being published today.

This rule, in conjunction with the operating administration drug

and alcohol testing rules, is likely to have a significant economic

impact on a substantial number of small entities. These impacts are

assessed in the OAs' regulatory evaluations. The Federalism impacts of

this rule are either minimal or required by statute; for these reasons,

we have not prepared a Federalism assessment.

This rule also contains collection of information requirements. The

Department has submitted these requirements to the Office of Management

and Budget for review and approval under the Paperwork Reduction Act

(44 U.S.C. 350, et. seq.). Please see the Common Preamble on the status

of Paperwork Reduction Act approvals.

List of Subjects in 49 CFR Part 40

Drug testing, Reporting and recordkeeping requirements, Safety,

Transportation.

Issued This 25th day of January, 1994, at Washington, D.C.

Federico Pena,

Secretary of Transportation.

David R. Hinson,

Administrator, Federal Aviation Administration.

Rodney E. Slater,

Administrator, Federal Highway Administration.

Jolene M. Molitoris,

Administrator, Federal Railroad Administration.

Gordon J. Linton,

Administrator, Federal Transit Administration.

Ana Sol Gutierrez,

Acting Administrator, Research and Special Programs Administration.

Adm. J. William Kime,

Commandant, United States Coast Guard.

For the reasons set forth in the preamble, the Department of

Transportation amends Title 49, Code of Federal Regulations, part 40,

as follows:

PART 40--PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL

TESTING PROGRAMS

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

follows:

Authority: 49 U.S.C. 102,301,322; 49 U.S.C. app. 1301nt., app.

1434nt., app. 2717, app. 1618a.

2. Secs. 40.1 through 40.19 are designated as subpart A and revised

to read as follows:

Subpart A--General

40.1 Applicability.

40.3 Definitions.

40.5-40.19 [Reserved]

Subpart A--GENERAL

Sec. 40.1 Applicability.

This part applies, through regulations that reference it issued by

agencies of the Department of Transportation, to transportation

employers, including self-employed individuals, required to conduct

drug and/or alcohol testing programs by DOT agency regulations and to

such transportation employers' officers, employees, agents and

contractors (including, but not limited to, consortia). Employers are

responsible for the compliance of their officers, employees, agents,

consortia and/or contractors with the requirements of this part.

Sec. 40.3 Definitions.

The following definitions apply to this part:

Air blank. A reading by an EBT of ambient air containing no

alcohol. (In EBTs using gas chromatography technology, a reading of the

device's internal standard.)

Alcohol. The intoxicating agent in beverage alcohol, ethyl alcohol

or other low molecular weight alcohols including methyl or isopropyl

alcohol.

Alcohol concentration. The alcohol in a volume of breath expressed

in terms of grams of alcohol per 210 liters of breath as indicated by a

breath test under this part.

Alcohol use. The consumption of any beverage, mixture or

preparation, including any medication, containing alcohol.

Aliquot. A portion of a specimen used for testing.

Blind sample or blind performance test specimen. A urine specimen

submitted to a laboratory for quality control testing purposes, with a

fictitious identifier, so that the laboratory cannot distinguish it

from employee specimens, and which is spiked with known quantities of

specific drugs or which is blank, containing no drugs.

Breath Alcohol Technician (BAT). An individual who instructs and

assists individuals in the alcohol testing process and operates an EBT.

Canceled or invalid test. In drug testing, a drug test that has

been declared invalid by a Medical Review Officer. A canceled test is

neither a positive nor a negative test. For purposes of this part, a

sample that has been rejected for testing by a laboratory is treated

the same as a canceled test. In alcohol testing, a test that is deemed

to be invalid under Sec. 40.79. It is neither a positive nor a negative

test.

Chain of custody. Procedures to account for the integrity of each

urine or blood specimen by tracking its handling and storage from point

of specimen collection to final disposition of the specimen. With

respect to drug testing, these procedures shall require that an

appropriate drug testing custody form (see Sec. 40.23(a)) be used from

time of collection to receipt by the laboratory and that upon receipt

by the laboratory an appropriate laboratory chain of custody form(s)

account(s) for the sample or sample aliquots within the laboratory.

Collection container. A container into which the employee urinates

to provide the urine sample used for a drug test.

Collection site. A place designated by the employer where

individuals present themselves for the purpose of providing a specimen

of their urine to be analyzed for the presence of drugs.

Collection site person. A person who instructs and assists

individuals at a collection site and who receives and makes a screening

examination of the urine specimen provided by those individuals.

Confirmation (or confirmatory) test. In drug testing, a second

analytical procedure to identify the presence of a specific drug or

metabolite that is independent of the screening test and that uses a

different technique and chemical principle from that of the screening

test in order to ensure reliability and accuracy. (Gas chromatography/

mass spectrometry (GC/MS) is the only authorized confirmation method

for cocaine, marijuana, opiates, amphetamines, and phencyclidine.) In

alcohol testing, a second test, following a screening test with a

result of 0.02 or greater, that provides quantitative data of alcohol

concentration.

DHHS. The Department of Health and Human Services or any designee

of the Secretary, Department of Health and Human Services.

DOT agency. An agency of the United States Department of

Transportation administering regulations related to drug or alcohol

testing, including the United States Coast Guard (for drug testing

purposes only), the Federal Aviation Administration, the Federal

Railroad Administration, the Federal Highway Administration, the

Federal Transit Administration, the Research and Special Programs

Administration, and the Office of the Secretary.

Employee. An individual designated in a DOT agency regulation as

subject to drug testing and/or alcohol testing. As used in this part

``employee'' includes an applicant for employment. ``Employee'' and

``individual'' or ``individual to be tested'' have the same meaning for

purposes of this part.

Employer. An entity employing one or more employees that is subject

to DOT agency regulations requiring compliance with this part. As used

in this part, employer includes an industry consortium or joint

enterprise comprised of two or more employing entities.

EBT (or evidential breath testing device). An EBT approved by the

National Highway Traffic Safety Administration (NHTSA) for the

evidential testing of breath and placed on NHTSA's ``Conforming

Products List of Evidential Breath Measurement Devices'' (CPL).

Medical Review Officer (MRO). A licensed physician (medical doctor

or doctor of osteopathy) responsible for receiving laboratory results

generated by an employer's drug testing program who has knowledge of

substance abuse disorders and has appropriate medical training to

interpret and evaluate an individual's confirmed positive test result

together with his or her medical history and any other relevant

biomedical information.

Screening test (or initial test). In drug testing, an immunoassay

screen to eliminate ``negative'' urine specimens from further analysis.

In alcohol testing, an analytic procedure to determine whether an

employee may have a prohibited concentration of alcohol in a breath

specimen.

Secretary. The Secretary of Transportation or the Secretary's

designee.

Shipping container. A container capable of being secured with a

tamper-evident seal that is used for transfer of one or more urine

specimen bottle(s) and associated documentation from the collection

site to the laboratory.

Specimen bottle. The bottle that, after being labeled and sealed

according to the procedures in this part, is used to transmit a urine

sample to the laboratory.

Secs. 40.5--40.19 [Reserved]

2. Secs. 40.21 through 40.39 are designated subpart B.

Subpart B--Drug Testing

40.21 The drugs.

40.23 Preparation for testing.

40.25 Specimen collection procedures.

40.27 Laboratory personnel.

40.29 Laboratory analysis procedures.

40.31 Quality assurance and quality control.

40.33 Reporting and review of results.

40.35 Protection of employee records.

40.37 Individual access to test and laboratory certification

results.

40.39 Use of DHHS--certified laboratories.

Authority: 49 U.S.C. 102, 301, 322; 49 U.S.C. app. 1301nt., app.

1434nt., app. 2717, app. 1618a.

3. In Sec. 40.25, paragraph (f)(10) is revised to read as follows:

Sec. 40.25 Specimen collection procedures.

* * * * *

(f) * * *

(10) The collection site person shall instruct the employee to

provide at least 45 ml of urine under the split sample method of

collection or 30 ml of urine under the single sample method of

collection.

(i)(A) Employers with employees subject to drug testing only under

the drug testing rules of the Research and Special Programs

Administration and/or Coast Guard may use the ``split sample'' method

of collection or may collect a single sample for those employees.

(B) Employers with employees subject to drug testing under the drug

testing rules of the Federal Highway Administration, Federal Railroad

Administration, Federal Transit Administration, or Federal Aviation

Administration shall use the ``split sample'' method of collection for

those employees.

(ii) Employers using the split sample method of collection shall

follow the procedures in this paragraph (f)(10)(ii):

(A) The donor shall urinate into a collection container or a

specimen bottle capable of holding at least 60 ml.

(B) If a collection container is used, the collection site person,

in the presence of the donor, pours the urine into two specimen

bottles. Thirty (30) ml shall be poured into one bottle, to be used as

the primary specimen. At least 15 ml shall be poured into the other

bottle, to be used as the split specimen.

(C) If a single specimen bottle is used as a collection container,

the collection site person shall pour 30 ml of urine from the specimen

bottle into a second specimen bottle (to be used as the primary

specimen) and retain the remainder (at least 15 ml) in the collection

bottle (to be used as the split specimen).

(D) Both bottles shall be shipped in a single shipping container,

together with copies 1,2, and the split specimen copy of the chain of

custody form, to the laboratory.

(E) If the test result of the primary specimen is positive, the

employee may request that the MRO direct that the split specimen be

tested in a different DHHS-certified laboratory for presence of the

drug(s) for which a positive result was obtained in the test of the

primary specimen. The MRO shall honor such a request if it is made

within 72 hours of the employee having been notified of a verified

positive test result.

(F) When the MRO informs the laboratory in writing that the

employee has requested a test of the split specimen, the laboratory

shall forward, to a different DHHS-approved laboratory, the split

specimen bottle, with seal intact, a copy of the MRO request, and the

split specimen copy of the chain of custody form with appropriate chain

of custody entries.

(G) The result of the test of the split specimen is transmitted by

the second laboratory to the MRO.

(H) Action required by DOT agency regulations as the result of a

positive drug test (e.g., removal from performing a safety-sensitive

function) is not stayed pending the result of the test of the split

specimen.

(I) If the result of the test of the split specimen fails to

reconfirm the presence of the drug(s) or drug metabolite(s) found in

the primary specimen, the MRO shall cancel the test, and report the

cancellation and the reasons for it to the DOT, the employer, and the

employee.

(iii) Employers using the single sample collection method shall

follow the procedures in paragraph:

(A) The collector may choose to direct the employee to urinate

either directly into a specimen bottle or into a separate collection

container.

(B) If a separate collection container is used, the collection site

person shall pour at least 30 ml of the urine from the collection

container into the specimen bottle in the presence of the employee.

(iv) In either collection methodology, upon receiving the specimen

from the individual, the collection site person shall determine if it

has at least 30 milliliters of urine for the primary or single specimen

bottle and, where the split specimen collection method is used, an

additional 15 ml of urine for the split specimen bottle. If the

individual is unable to provide such a quantity of urine, the

collection site person shall instruct the individual to drink not more

than 24 ounces of fluids and, after a period of up to two hours, again

attempt to provide a complete sample using a fresh collection

container. The original insufficient specimen shall be discarded. If

the employee is still unable to provide an adequate specimen, the

insufficient specimen shall be discarded, testing discontinued, and the

employer so notified. The MRO shall 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. (In preemployment testing, if the employer does not

wish to hire the individual, the MRO is not required to make such a

referral.) Upon completion of the examination, the MRO shall report his

or her conclusions to the employer in writing.

* * * * *

4. In Sec. 40.29, paragraph (b)(2) is revised and paragraph (b)(3)

is added, as follows:

Sec. 40.29 Laboratory analysis procedures.

* * * * *

(b) * * * *

(2) In situations where the employer uses the split sample

collection method, the laboratory shall log in the split specimen, with

the split specimen bottle seal remaining intact. The laboratory shall

store this sample securely (see paragraph (c) of this section). If the

result of the test of the primary specimen is negative, the laboratory

may discard the split specimen. If the result of the test of the

primary specimen is positive, the laboratory shall retain the split

specimen in frozen storage for 60 days from the date on which the

laboratory acquires it (see paragraph (h) of this section). Following

the end of the 60-day period, if not informed by the MRO that the

employee has requested a test of the split specimen, the laboratory may

discard the split specimen.

(3) When directed in writing by the MRO to forward the split

specimen to another DHHS-certified laboratory for analysis, the second

laboratory shall analyze the split specimen by GC/MS to reconfirm the

presence of the drug(s) or drug metabolite(s) found in the primary

specimen. Such GC/MS confirmation shall be conducted without regard to

the cutoff levels of Sec. 40.29(f). The split specimen shall be

retained in long-term storage for one year by the laboratory conducting

the analysis of the split specimen (or longer if litigation concerning

the test is pending).

* * * * *

6. In Sec. 40.33 paragraphs (e), (f) and (g) are revised; paragraph

(h) is redesignated as paragraphs (i), and a new paragraph (h) is

added, as follows:

Sec. 40.33 Reporting and review of results.

* * * * *

(e) In a situation in which the employer has used the single sample

method of collection, the MRO shall notify each employee who has a

confirmed positive test that the employee has 72 hours in which to

request a reanalysis of the original specimen, if the test is verified

positive. If requested to do so by the employee within 72 hours of the

employee's having been informed of a verified positive test, the

Medical Review Officer shall direct, in writing, a reanalysis of the

original sample. The MRO may also direct, in writing, such a reanalysis

if the MRO questions the accuracy or validity of any test result. Only

the MRO may authorize such a reanalysis, and such a reanalysis may take

place only at laboratories certified by DHHS. If the reanalysis fails

to reconfirm the presence of the drug or drug metabolite, the MRO shall

cancel the test and report the cancellation and the reasons for it to

the DOT, the employer and the employee.

(f) In situations in which the employer uses the split sample

method of collection, the MRO shall notify each employee who has a

confirmed positive test that the employee has 72 hours in which to

request a test of the split specimen, if the test is verified as

positive. If the employee requests an analysis of the split specimen

within 72 hours of having been informed of a verified positive test,

the MRO shall direct, in writing, the laboratory to provide the split

specimen to another DHHS-certified laboratory for analysis. If the

analysis of the split specimen fails to reconfirm the presence of the

drug(s) or drug metabolite(s) found in the primary specimen, or if the

split specimen is unavailable, inadequate for testing or untestable,

the MRO shall cancel the test and report cancellation and the reasons

for it to the DOT, the employer, and the employee.

(g) If an employee has not contacted the MRO within 72 hours, as

provided in paragraphs (e) and (f) of this section, the employee may

present to the MRO information documenting that serious illness,

injury, inability to contact the MRO, lack of actual notice of the

verified positive test, or other circumstances unavoidably prevented

the employee from timely contacting the MRO. If the MRO concludes that

there is a legitimate explanation for the employee's failure to contact

the MRO within 72 hours, the MRO shall direct that the reanalysis of

the primary specimen or analysis of the split specimen, as applicable,

be performed.

(h) When the employer uses the split sample method of collection,

the employee is not authorized to request a reanalysis of the primary

specimen as provided in paragraph (e) of this section.

* * * * *

7. A new subpart C is added to part 40, to read as follows:

Subpart C--Alcohol Testing

40.51 The breath alcohol technician.

40.53 Devices to be used for breath alcohol tests.

40.55 Quality assurance plans for EBTs.

40.57 Locations for breath alcohol testing.

40.59 The breath alcohol testing form and log book.

40.61 Preparation for breath alcohol testing.

40.63 Procedures for screening tests.

40.65 Procedures for confirmation tests.

40.67 Refusals to test and uncompleted tests.

40.69 Inability to provide an adequate amount of breath.

40.71 [Reserved]

40.73 [Reserved]

40.75 [Reserved]

40.77 [Reserved]

40.79 Invalid Tests.

40.81 Availability and disclosure of alcohol testing information

about individual employees.

40.83 Maintenance and disclosure of records concerning EBTs and

BATs.

Appendix A--The Breath Alcohol Testing Form

Authority: 49 U.S.C. 102, 301, 322; 49 U.S.C. app. 1301nt., app.

1434nt., app. 2717, app. 1618a.

Sec. 40.51 The breath alcohol technician.

(a) The breath alcohol technician (BAT) shall be trained to

proficiency in the operation of the EBT he or she is using and in the

alcohol testing procedures of this part.

(1) Proficiency shall be demonstrated by successful completion of a

course of instruction which, at a minimum, provides training in the

principles of EBT methodology, operation, and calibration checks; the

fundamentals of breath analysis for alcohol content; and the procedures

required in this part for obtaining a breath sample, and interpreting

and recording EBT results.

(2) Only courses of instruction for operation of EBTs that are

equivalent to the Department of Transportation model course, as

determined by the National Highway Traffic Safety Administration

(NHTSA), may be used to train BATs to proficiency. On request, NHTSA

will review a BAT instruction course for equivalency.

(3) The course of instruction shall provide documentation that the

BAT has demonstrated competence in the operation of the specific EBT(s)

he/she will use.

(4) Any BAT who will perform an external calibration check of an

EBT shall be trained to proficiency in conducting the check on the

particular model of EBT, to include practical experience and

demonstrated competence in preparing the breath alcohol simulator or

alcohol standard, and in maintenance and calibration of the EBT.

(5) The BAT shall receive additional training, as needed, to ensure

proficiency, concerning new or additional devices or changes in

technology that he or she will use.

(6) The employer or its agent shall establish documentation of the

training and proficiency test of each BAT it uses to test employees,

and maintain the documentation as provided in Sec. 40.83.

(b) A BAT-qualified supervisor of an employee may conduct the

alcohol test for that employee only if another BAT is unavailable to

perform the test in a timely manner. A supervisor shall not serve as a

BAT for the employee in any circumstance prohibited by a DOT operating

administration regulation.

(c) Law enforcement officers who have been certified by state or

local governments to conduct breath alcohol testing are deemed to be

qualified as BATs. In order for a test conducted by such an officer to

be accepted under Department of Transportation alcohol testing

requirements, the officer must have been certified by a state or local

government to use the EBT that was used for the test.

Sec. 40.53 Devices to be used for breath alcohol tests.

(a) For screening tests, employers shall use only EBTs. When the

employer uses for a screening test an EBT that does not meet the

requirements of paragraphs (b) (1) through (3) of this section, the

employer shall use a log book in conjunction with the EBT (see

Sec. 40.59(c)).

(b) For confirmation tests, employers shall use EBTs that meet the

following requirements:

(1) EBTs shall have the capability of providing, independently or

by direct link to a separate printer, a printed result in triplicate

(or three consecutive identical copies) of each breath test and of the

operations specified in paragraphs (b) (2) and (3) of this section.

(2) EBTs shall be capable of assigning a unique and sequential

number to each completed test, with the number capable of being read by

the BAT and the employee before each test and being printed out on each

copy of the result.

(3) EBTs shall be capable of printing out, on each copy of the

result, the manufacturer's name for the device, the device's serial

number, and the time of the test.

(4) EBTs shall be able to distinguish alcohol from acetone at the

0.02 alcohol concentration level.

(5) EBTs shall be capable of the following operations:

(i) Testing an air blank prior to each collection of breath; and

(ii) Performing an external calibration check.

Sec. 40.55 Quality assurance plans for EBTs.

(a) In order to be used in either screening or confirmation alcohol

testing subject to this part, an EBT shall have a quality assurance

plan (QAP) developed by the manufacturer.

(1) The plan shall designate the method or methods to be used to

perform external calibration checks of the device, using only

calibration devices on the NHTSA ``Conforming Products List of

Calibrating Units for Breath Alcohol Tests.''

(2) The plan shall specify the minimum intervals for performing

external calibration checks of the device. Intervals shall be specified

for different frequencies of use, environmental conditions (e.g.,

temperature, altitude, humidity), and contexts of operation (e.g.,

stationary or mobile use).

(3) The plan shall specify the tolerances on an external

calibration check within which the EBT is regarded to be in proper

calibration.

(4) The plan shall specify inspection, maintenance, and calibration

requirements and intervals for the device.

(5) For a plan to be regarded as valid, the manufacturer shall have

submitted the plan to NHTSA for review and have received NHTSA approval

of the plan.

(b) The employer shall comply with the NHTSA-approved quality

assurance plan for each EBT it uses for alcohol screening or

confirmation testing subject to this part.

(1) The employer shall ensure that external calibration checks of

each EBT are performed as provided in the QAP.

(2) The employer shall take an EBT out of service if any external

calibration check results in a reading outside the tolerances for the

EBT set forth in the QAP. The EBT shall not again be used for alcohol

testing under this part until it has been serviced and has had an

external calibration check resulting in a reading within the tolerances

for the EBT.

(3) The employer shall ensure that inspection, maintenance, and

calibration of each EBT are performed by the manufacturer or a

maintenance representative certified by the device's manufacturer or a

state health agency or other appropriate state agency. The employer

shall also ensure that each BAT or other individual who performs an

external calibration check of an EBT used for alcohol testing subject

to this part has demonstrated proficiency in conducting such a check of

the model of EBT in question.

(4) The employer shall maintain records of the external calibration

checks of EBTs as provided in Sec. 40.83.

(c) When the employer is not using the EBT at an alcohol testing

site, the employer shall store the EBT in a secure space.

Sec. 40.57 Locations for breath alcohol testing.

(a) Each employer shall conduct alcohol testing in a location that

affords visual and aural privacy to the individual being tested,

sufficient to prevent unauthorized persons from seeing or hearing test

results. All necessary equipment, personnel, and materials for breath

testing shall be provided at the location where testing is conducted.

(b) An employer may use a mobile collection facility (e.g., a van

equipped for alcohol testing) that meets the requirements of paragraph

(a) of this section.

(c) No unauthorized persons shall be permitted access to the

testing location when the EBT remains unsecured or, in order to prevent

such persons from seeing or hearing a testing result, at any time when

testing is being conducted.

(d) In unusual circumstances (e.g., when it is essential to conduct

a test outdoors at the scene of an accident), a test may be conducted

at a location that does not fully meet the requirements of paragraph

(a) of this section. In such a case, the employer or BAT shall provide

visual and aural privacy to the employee to the greatest extent

practicable.

(e) The BAT shall supervise only one employee's use of the EBT at a

time. The BAT shall not leave the alcohol testing location while the

testing procedure for a given employee (see Secs. 40.61 through 40.65)

is in progress.

Sec. 40.59 The breath alcohol testing form and log book.

(a) Each employer shall use the breath alcohol testing form

prescribed under this part. The form is found in appendix A to this

subpart. Employers may not modify or revise this form, except that a

form directly generated by an EBT may omit the space for affixing a

separate printed result to the form.

(b) The form shall provide triplicate (or three consecutive

identical) copies. Copy 1 (white) shall be retained by the BAT. Copy 2

(green) shall be provided to the employee. Copy 3 (blue) shall be

transmitted to the employer. Except for a form generated by an EBT, the

form shall be 8\1/2\ by 11 inches in size.

(c) A log book shall be used in conjunction with any EBT used for

screening tests that does not meet the requirements of Sec. 40.53(b)

(1) through (3). There shall be a log book for each such device, that

is not used in conjunction with any other device and that is used to

record every test conducted on the device. The log book shall include

columns for the test number, date of the test, name of the BAT,

location of the test, quantified test result, and initials of the

employee taking each test.

Sec. 40.61 Preparation for breath alcohol testing.

(a) When the employee enters the alcohol testing location, the BAT

will require him or her to provide positive identification (e.g.,

through use of a photo I.D. card or identification by an employer

representative). On request by the employee, the BAT shall provide

positive identification to the employee.

(b) The BAT shall explain the testing procedure to the employee.

Sec. 40.63 Procedures for screening tests.

(a) The BAT shall complete Step 1 on the Breath Alcohol Testing

Form. The employee shall then complete Step 2 on the form, signing the

certification. Refusal by the employee to sign this certification shall

be regarded as a refusal to take the test.

(b) An individually-sealed mouthpiece shall be opened in view of

the employee and BAT and attached to the EBT in accordance with the

manufacturer's instructions.

(c) The BAT shall instruct the employee to blow forcefully into the

mouthpiece for at least 6 seconds or until the EBT indicates that an

adequate amount of breath has been obtained.

(d)(1) If the EBT does not meet the requirements of

Sec. 40.53(b)(1) through (3), the BAT and the employee shall take the

following steps:

(i) Show the employee the result displayed on the EBT. The BAT

shall record the displayed result, test number, testing device, serial

number of the testing device, time and quantified result in Step 3 of

the form.

(ii) Record the test number, date of the test, name of the BAT,

location, and quantified test result in the log book. The employee

shall initial the log book entry.

(2) If the EBT provides a printed result, but does not print the

results directly onto the form, the BAT shall show the employee the

result displayed on the EBT. The BAT shall then affix the test result

printout to the breath alcohol test form in the designated space, using

a method that will provide clear evidence of removal (e.g., tamper-

evident tape).

(3) If the EBT prints the test results directly onto the form, the

BAT shall show the employee the result displayed on the EBT.

(e)(1) In any case in which the result of the screening test is a

breath alcohol concentration of less than 0.02, the BAT shall date the

form and sign the certification in Step 3 of the form. The employee

shall sign the certification and fill in the date in Step 4 of the

form.

(2) If the employee does not sign the certification in Step 4 of

the form or does not initial the log book entry for a test, it shall

not be considered a refusal to be tested. In this event, the BAT shall

note the employee's failure to sign or initial in the ``Remarks''

section of the form.

(3) If a test result printed by the EBT (see paragraph (d)(2) or

(d)(3) of this section) does not match the displayed result, the BAT

shall note the disparity in the remarks section. Both the employee and

the BAT shall initial or sign the notation. In accordance with

Sec. 40.79, the test is invalid and the employer and employee shall be

so advised.

(4) No further testing is authorized. The BAT shall transmit the

result of less than 0.02 to the employer in a confidential manner, and

the employer shall receive and store the information so as to ensure

that confidentiality is maintained as required by Sec. 40.81.

(f) If the result of the screening test is an alcohol concentration

of 0.02 or greater, a confirmation test shall be performed as provided

in Sec. 40.65.

(g) If the confirmation test will be conducted by a different BAT,

the BAT who conducts the screening test shall complete and sign the

form and log book entry. The BAT will provide the employee with Copy 2

of the form.

Sec. 40.65 Procedures for confirmation tests.

(a) If a BAT other than the one who conducted the screening test is

conducting the confirmation test, the new BAT shall follow the

procedures of Sec. 40.61.

(b) The BAT shall instruct the employee not to eat, drink, put any

object or substance in his or her mouth, and, to the extent possible,

not belch during a waiting period before the confirmation test. This

time period begins with the completion of the screening test, and shall

not be less than 15 minutes. The confirmation test shall be conducted

within 20 minutes of the completion of the screening test. The BAT

shall explain to the employee the reason for this requirement (i.e., to

prevent any accumulation of mouth alcohol leading to an artificially

high reading) and the fact that it is for the employee's benefit. The

BAT shall also explain that the test will be conducted at the end of

the waiting period, even if the employee has disregarded the

instruction. If the BAT becomes aware that the employee has not

complied with this instruction, the BAT shall so note in the

``Remarks'' section of the form.

(c) (1) If a BAT other than the one who conducted the screening

test is conducting the confirmation test, the new BAT shall initiate a

new Breath Alcohol Testing form. The BAT shall complete Step 1 on the

form. The employee shall then complete Step 2 on the form, signing the

certification. Refusal by the employee to sign this certification shall

be regarded as a refusal to take the test. The BAT shall note in the

``Remarks'' section of the form that a different BAT conducted the

screening test.

(2) In all cases, the procedures of Sec. 40.63 (a), (b), and (c)

shall be followed. A new mouthpiece shall be used for the confirmation

test.

(d) Before the confirmation test is administered for each employee,

the BAT shall ensure that the EBT registers 0.00 on an air blank. If

the reading is greater than 0.00, the BAT shall conduct one more air

blank. If the reading is greater than 0.00, testing shall not proceed

using that instrument. However, testing may proceed on another

instrument.

(e) Any EBT taken out of service because of failure to perform an

air blank accurately shall not be used for testing until a check of

external calibration is conducted and the EBT is found to be within

tolerance limits.

(f) In the event that the screening and confirmation test results

are not identical, the confirmation test result is deemed to be the

final result upon which any action under operating administration rules

shall be based.

(g) (1) If the EBT provides a printed result, but does not print

the results directly onto the form, the BAT shall show the employee the

result displayed on the EBT. The BAT shall then affix the test result

printout to the breath alcohol test form in the designated space, using

a method that will provide clear evidence of removal (e.g., tamper-

evident tape).

(2) If the EBT prints the test results directly onto the form, the

BAT shall show the employee the result displayed on the EBT.

(h) (1) Following the completion of the test, the BAT shall date

the form and sign the certification in Step 3 of the form. The employee

shall sign the certification and fill in the date in Step 4 of the

form.

(2) If the employee does not sign the certification in Step 4 of

the form or does not initial the log book entry for a test, it shall

not be considered a refusal to be tested. In this event, the BAT shall

note the employee's failure to sign or initial in the ``Remarks''

section of the form.

(3) If a test result printed by the EBT (see paragraph (g)(1) or

(g)(2) of this section) does not match the displayed result, the BAT

shall note the disparity in the remarks section. Both the employee and

the BAT shall initial or sign the notation. In accordance with

Sec. 40.79, the test is invalid and the employer and employee shall be

so advised.

(4) The BAT shall conduct an air blank. If the reading is greater

than 0.00, the test is invalid.

(i) The BAT shall transmit all results to the employer in a

confidential manner.

(1) Each employer shall designate one or more employer

representatives for the purpose of receiving and handling alcohol

testing results in a confidential manner. All communications by BATs to

the employer concerning the alcohol testing results of employees shall

be to a designated employer representative.

(2) Such transmission may be in writing, in person or by telephone

or electronic means, but the BAT shall ensure immediate transmission to

the employer of results that require the employer to prevent the

employee from performing a safety-sensitive function.

(3) If the initial transmission is not in writing (e.g., by

telephone), the employer shall establish a mechanism to verify the

identity of the BAT providing the information.

(4) If the initial transmission is not in writing, the BAT shall

follow the initial transmission by providing to the employer the

employer's copy of the breath alcohol testing form. The employer shall

store the information so as to ensure that confidentiality is

maintained as required by Sec. 40.81.

Sec. 40.67 Refusals to test and uncompleted tests.

(a) Refusal by an employee to complete and sign the breath alcohol

testing form (Step 2), to provide breath, to provide an adequate amount

of breath, or otherwise to cooperate with the testing process in a way

that prevents the completion of the test, shall be noted by the BAT in

the remarks section of the form. The testing process shall be

terminated and the BAT shall immediately notify the employer.

(b) If a screening or confirmation test cannot be completed, or if

an event occurs that would invalidate the test, the BAT shall, if

practicable, begin a new screening or confirmation test, as applicable,

using a new breath alcohol testing form with a new sequential test

number (in the case of a screening test conducted on an EBT that meets

the requirements of Sec. 40.53(b) or in the case of a confirmation

test).

Sec. 40.69 Inability to provide an adequate amount of breath.

(a) This section sets forth procedures to be followed in any case

in which an employee is unable, or alleges that he or she is unable, to

provide an amount of breath sufficient to permit a valid breath test

because of a medical condition.

(b) The BAT shall again instruct the employee to attempt to provide

an adequate amount of breath. If the employee refuses to make the

attempt, the BAT shall immediately inform the employer.

(c) If the employee attempts and fails to provide an adequate

amount of breath, the BAT shall so note in the ``Remarks'' section of

the breath alcohol testing form and immediately inform the employer.

(d) If the employee attempts and fails to provide an adequate

amount of breath, the employer shall proceed as follows:

(1) [Reserved]

(2) The employer shall direct the employee to obtain, as soon as

practical after the attempted provision of breath, an evaluation from a

licensed physician who is acceptable to the employer concerning the

employee's medical ability to provide an adequate amount of breath.

(i) If the physician determines, in his or her reasonable medical

judgment, that a medical condition has, or with a high degree of

probability, could have, precluded the employee from providing an

adequate amount of breath, the employee's failure to provide an

adequate amount of breath shall not be deemed a refusal to take a test.

The physician shall provide to the employer a written statement of the

basis for his or her conclusion.

(ii) If the licensed physician, in his or her reasonable medical

judgment, is unable to make the determination set forth in paragraph

(d)(2)(i) of this section the employee's failure to provide an adequate

amount of breath shall be regarded as a refusal to take a test. The

licensed physician shall provide a written statement of the basis for

his or her conclusion to the employer.

Secs. 40.71-40.77 [Reserved]

Sec. 40.79 Invalid tests.

(a) A breath alcohol test shall be invalid under the following

circumstances:

(1) The next external calibration check of an EBT produces a result

that differs by more than the tolerance stated in the QAP from the

known value of the test standard. In this event, every test result of

0.02 or above obtained on the device since the last valid external

calibration check shall be invalid;

(2) The BAT does not observe the minimum 15-minute waiting period

prior to the confirmation test, as provided in Sec. 40.65(b);

(3) The BAT does not perform an air blank of the EBT before a

confirmation test, or an air blank does not result in a reading of 0.00

prior to or after the administration of the test, as provided in

Sec. 40.65;

(4) The BAT does not sign the form as required by Secs. 40.63 and

40.65;

(5) The BAT has failed to note on the remarks section of the form

that the employee has failed or refused to sign the form following the

recording or printing on or attachment to the form of the test result;

(6) An EBT fails to print a confirmation test result; or

(7) On a confirmation test and, where applicable, on a screening

test, the sequential test number or alcohol concentration displayed on

the EBT is not the same as the sequential test number or alcohol

concentration on the printed result.

(b) [Reserved]

Sec. 40.81 Availability and disclosure of alcohol testing information

about individual employees.

(a) Employers shall maintain records in a secure manner, so that

disclosure of information to unauthorized persons does not occur.

(b) Except as required by law or expressly authorized or required

in this section, no employer shall release covered employee information

that is contained in the records required to be maintained by this part

or by DOT agency alcohol misuse rules.

(c) An employee subject to testing is entitled, upon written

request, to obtain copies of any records pertaining to the employee's

use of alcohol, including any records pertaining to his or her alcohol

tests. The employer shall promptly provide the records requested by the

employee. Access to an employee's records shall not be contingent upon

payment for records other than those specifically requested.

(d) Each employer shall permit access to all facilities utilized in

complying with the requirements of this part and DOT agency alcohol

misuse rules to the Secretary of Transportation, any DOT agency with

regulatory authority over the employer, or a state agency with

regulatory authority over the employer (as authorized by DOT agency

regulations).

(e) When requested by the Secretary of Transportation, any DOT

agency with regulatory authority over the employer, or a state agency

with regulatory authority over the employer (as authorized by DOT

agency regulations), each employer shall make available copies of all

results for employer alcohol testing conducted under the requirements

of this part and any other information pertaining to the employer's

alcohol misuse prevention program. The information shall include name-

specific alcohol test results, records and reports.

(f) When requested by the National Transportation Safety Board as

part of an accident investigation, an employer shall disclose

information related to the employer's administration of any post-

accident alcohol tests administered following the accident under

investigation.

(g) An employer shall make records available to a subsequent

employer upon receipt of a written request from a covered employee.

Disclosure by the subsequent employer is permitted only as expressly

authorized by the terms of the employee's written request.

(h) An employer may disclose information required to be maintained

under this part pertaining to a covered employee to that employee or to

the decisionmaker in a lawsuit, grievance, or other proceeding

initiated by or on behalf of the individual, and arising from the

results of an alcohol test administered under the requirements of this

part, or from the employer's determination that the employee engaged in

conduct prohibited by a DOT agency alcohol misuse regulation

(including, but not limited to, a worker's compensation, unemployment

compensation, or other proceeding relating to a benefit sought by the

employee).

(i) An employer shall release information regarding a covered

employee's records as directed by the specific, written consent of the

employee authorizing release of the information to an identified

person. Release of such information is permitted only in accordance

with the terms of the employee's consent.

Sec. 40.83 Maintenance and disclosure of records concerning EBTs and

BATs.

(a) Each employer or its agent shall maintain the following records

for two years:

(1) Records of the inspection and maintenance of each EBT used in

employee testing;

(2) Documentation of the employer's compliance with the QAP for

each EBT it uses for alcohol testing under this part;

(3) Records of the training and proficiency testing of each BAT

used in employee testing;

(4) The log books required by Sec. 40.59(c).

(b) Each employer or its agent shall maintain for five years

records pertaining to the calibration of each EBT used in alcohol

testing under this part, including records of the results of external

calibration checks.

(c) Records required to be maintained by this section shall be

disclosed on the same basis as provided in Sec. 40.81.

Appendix A to Subpart C of Part 40--The Breath Alcohol Testing Form

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TR15FE94.015

TR15FE94.016

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[FR Doc. 94-2030 Filed 2-3-94; 1:00 pm]

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