[Federal Register Volume 59, Number 31 (Tuesday, February 15, 1994)]
[Unknown Section]
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From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-2030]
[[Page Unknown]]
[Federal Register: February 15, 1994]
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Part III
Department of Transportation
_______________________________________________________________________
Office of the Secretary
National Highway Traffic Safety Administration
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49 CFR Part 40
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
Office of the Secretary
49 CFR Part 40
[Docket 48513]
RIN 2105-AB95
Procedures for Transportation Workplace Drug and Alcohol Testing
Programs
AGENCY: Office of the Secretary, DOT.
ACTION: Final rule.
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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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[FR Doc. 94-2030 Filed 2-3-94; 1:00 pm]
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