[Federal Register Volume 59, Number 160 (Friday, August 19, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-20447]


[[Page Unknown]]

[Federal Register: August 19, 1994]


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Part VIII





Department of Transportation





_______________________________________________________________________



Office of the Secretary



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49 CFR Part 40




Procedures for Transportation Workplace Drug and Alcohol Testing 
Programs; Final Rule
DEPARTMENT OF TRANSPORTATION

Office of the Secretary

49 CFR Part 40

[Docket 49713; RIN 2105-AB95]

 
Procedures for Transportation Workplace Drug and Alcohol Testing 
Programs

AGENCY: Office of the Secretary, DOT.

ACTION: Final rule; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Department of Transportation is making a series of minor 
or technical amendments to its drug and alcohol testing procedures. The 
most significant of these include revising the initial test cutoff 
level for marijuana metabolites, changing split specimen collection 
procedures to be consistent with those of the Department of Health and 
Human Services, revising the temperature range for urine drug 
specimens, revising the drug testing custody and control form and 
modifying the alcohol testing form, clarifying laboratory reporting 
procedures to consortiums, deleting a requirement for a second ``air 
blank'' after alcohol confirmation tests, specifying procedures related 
to the display of the sequential number for alcohol tests, and 
clarifying chain of custody requirements. The changes have the purposes 
of updating the procedures to be consistent with Department of Health 
and Human Services guidelines and addressing implementation problems of 
which the Department has become aware.

DATES: This rule is effective September 19, 1994, with the following 
exceptions:
    (1) The amendments to Sec. 40.23(a) are effective February 16, 
1995, but compliance with these amendments is authorized on August 19, 
1994;
    (2) The amendments to Secs. 40.25(f)(10)(ii) (B) and (C) and 
40.29(b)(1) are effective August 15, 1994;
    (3) The amendments to Sec. 40.29 (e) and (f) are effective 
September 1, 1994; and
    (4) The amendments to Sec. 40.25 (c) and (h) are effective on 
August 19, 1994. Comments should be received by September 19, 1994, 
except that comments on the amendment to Sec. 40.23 should be received 
by October 18, 1994. Late-filed comments will be considered to the 
extent practicable.

FOR FURTHER INFORMATION CONTACT: Robert C. Ashby, Deputy Assistant 
General Counsel for Regulation and Enforcement, 400 7th Street, S.W., 
Room 10424. 202-366-9306. Information may also be obtained from the 
Office of Drug Enforcement and Program Compliance, 202-366-3784.

SUPPLEMENTARY INFORMATION: The Department is publishing this final rule 
to make several minor or technical amendments to its drug and alcohol 
testing procedures, 49 CFR Part 40. The changes to Part 40 are 
described below. The changes are intended, among other things, to 
conform Part 40 to a number of provisions in the recently revised 
Department of Health and Human Services (DHHS) guidelines (59 FR 29908; 
June 9, 1994) and to correct a misinterpretation of the Department's 
chain of custody requirements. The Department is seeking comments on 
these amendments and will publish a notice in the Federal Register 
responding to comments received including, if appropriate, any changes 
to the amendments based on the comments.

The Drug Testing Custody and Control Form

    As the result of a lengthy process of consultation among the 
Department of Transportation, the Department of Health and Human 
Services (DHHS), and other interested parties, the Department has made 
modifications to the drug testing custody and control form. This form 
will be used in Federal employee testing as well as testing under DOT 
rules. The form is reproduced in Appendix A. OMB has approved the form 
under the Paperwork Reduction Act.
    Under the current rule, program participants have had the 
discretion to modify the drug testing custody and control form, as long 
as the contents of the form met the requirements of the regulatory text 
describing the form in Sec. 40.23(a). In the Department's experience, 
this has led to a proliferation of different forms, with consequent 
confusion and increased probability of error. In the alcohol testing 
procedures, we required employers to use the Department's alcohol 
testing form without modification. Now that we have an improved drug 
testing custody and control form, we believe that it should be used 
universally in the program, without exception and without modification. 
For this reason, we are amending Sec. 40.23 to delete the regulatory 
text description of the form (which is no longer needed, since everyone 
would be using exactly the form printed in Appendix A) and to require 
participants in the program to use the Department's form without 
modification.
    We recognize that participants have stocks of existing forms. To 
provide participants a reasonable time to exhaust these stocks and 
begin to obtain new forms, this amendment will not be made effective 
until February 16, 1995. In addition, we are providing 60 days for 
interested persons to comment on this amendment (i.e., on the 
requirement to use the form without modification, not on the content or 
format of the form itself). Employers and other participants are 
authorized to use the new form immediately. We believe it would be very 
useful for those employers who must begin split sample testing on 
August 15, 1994, to begin using the new form as soon as possible, since 
we believe the new form is better suited to split sample testing than 
its predecessors.
    We emphasize that seven-part forms must be used in all cases for 
split samples. Older seven-part split sample forms may continue to be 
used during the six month transition period (six-part forms may never 
be used in split sample testing). After that, the new seven-part form 
must be used. RSPA and Coast Guard employers who choose to use single 
sample collection may continue to use old six-part forms during the six 
month transition period, and thereafter must use the new form, 
discarding copy three.

The Alcohol Testing Form and Log Book

    Currently, Copy 1 of the Alcohol Testing Form (the original) is 
designated as the breath alcohol technician's (BAT's) copy of the form, 
for which there is no record retention requirement stated. Copy 3 is 
designated the employer's copy, which the employer must retain. It 
makes more sense, in our view, for the original of the form to be 
retained by the employer, rather than a copy. Consequently, we are 
switching the form designations, so that Copy 1 will be the employer's 
copy and Copy 3 will be the BAT's copy. The statement to be signed by 
the employee in Step 4 of the form is reworded slightly to emphasize 
the employee's agreement that the test reflected on the form is the 
test that the employee took and that the result is recorded accurately.
    In Sec. 40.59(c), in the context of the discussion of the log book, 
the rule requires the notation of the ``quantified test result.'' The 
Department intends that this result be the numerical result displayed 
by the EBT. The term has the same meaning as the term ``result 
displayed on the EBT'' elsewhere in the rule (e.g., 
Sec. 40.63(d)(1)(i)), and we are changing the term for the sake of 
consistency.

Clarification of Reference to NHTSA CPL in Definition of ``EBT''

    The National Highway Traffic Safety Administration (NHTSA) 
Conforming Products List (CPL) for Evidential Breath Testing Devices 
(EBTs) includes both devices that meet September 1993 amendments to 
NHTSA's model specifications and devices that meet only the previous 
version of the model specifications. Only those devices on the CPL that 
meet the September 1993 model specifications may be used in the DOT 
alcohol testing program. Other devices on the CPL (those designated by 
an asterisk on the published CPL; see for instance 59 FR 18840 (April 
20, 1994)) are not authorized for use in DOT-mandated alcohol testing 
programs. We are adding a reference to the September 1993 model 
specifications in the definition of ``EBT'' in Sec. 40.3 to clarify 
this point.

Split Sample Collection Procedures

    The Department's procedures for collecting split samples for drug 
testing direct the collection site person to pour the urine from a 
collection container into one or two specimen bottles (depending on the 
collection method used). Some concern has been raised that this 
requirement would preclude the use of newer technologies that would 
subdivide a specimen into a primary and a split specimen without the 
necessity of a collection site person physically pouring the urine from 
one vessel into another. The Department does not intend its procedures 
to preclude the use of such methods or systems, as long as they result 
in primary and split samples that can be transmitted to laboratories 
and tested in ways that fully comply with Part 40 requirements. We have 
added language to this effect. The Department does not endorse drug 
testing products, and this change should not be construed as an 
endorsement of any particular product.
    In using whichever of the authorized methods of collecting split 
samples, the Department advises collectors that we believe the 
preferred practice is to have temperature strips attached to the 
collection container, which can reduce the time lag in checking the 
temperature and reduce the likelihood of errors or delays. The 
temperature should be read, of course, from the collection container 
itself, rather than from another bottle into which the split specimen 
may be poured.
    Section 40.25(f)(10)(ii)(C) of the Department's current regulation 
describes one of the alternative split specimen collection procedures. 
In this procedure, a single specimen bottle is used as the collection 
container. The collection site person pours 30 ml of the urine from 
this container into a second specimen bottle, which is then used as the 
primary specimen. The urine remaining in the collection container 
becomes the split specimen. When DHHS published its revised drug 
testing guidelines, however, DHHS provided that, in this situation, the 
collection site person would pour 15 ml of the urine into the second 
bottle, to be used as the split specimen, with 30 ml remaining in the 
collection container, to be used as the primary specimen. In other 
words, the DHHS procedure was the reverse of the one we issued in 
February. While there are advantages to the procedure in the current 
Part 40, we believe, on balance, that it is more important that the 
DHHS guidelines and Part 40 be consistent on this point. Consequently, 
we are changing our procedures to conform with those of DHHS.

Change in Temperature Range

    The revised DHHS guidelines modify the temperature range within 
which a specimen must fall in order to avoid creating a reason to 
believe that a urine specimen has been altered or substituted. The old 
range is 32.5-37.7C/90.5-99.8F. The new range is 32-38C/90-100F. Part 
40 references are being changed to conform with the DHHS revision.

Clarification of Chain of Custody Requirement

    Section 40.25 contains a number of references to use of chain of 
custody documentation in the handling and transportation of urine 
specimens. Recently, an arbitrator misinterpreted these provisions, 
determining that a chain of custody was invalid, and that the test must 
be canceled, because persons involved solely in the transportation of 
the intact shipping container did not make a chain of custody entry. 
This interpretation is contrary to Part 40 procedures, wholly 
unnecessary in order to preserve the integrity of the process, and, if 
followed, would result in a wholesale disruption of the DOT testing 
program. As DHHS recently pointed out in its revised drug testing 
guidelines, ``Since specimens are sealed in packages that would 
indicate any tampering during transit to the laboratory and couriers, 
express carriers, and postal service personnel do not have access to 
the chain of custody forms, there is no requirement that such personnel 
document chain of custody for the package during transit.''
    The Department interprets its existing regulatory provisions as not 
requiring couriers, postal employees, and other personnel involved in 
the transportation of urine specimens to make chain of custody form 
entries. Likewise, the Department interprets its existing rules as not 
requiring making entries on the chain of custody form when a sealed 
shipping container is put into or removed from temporary, secure 
storage. In present Sec. 40.25(c), for example, handling or 
transportation of a specimen from one ``place'' to another must be 
accomplished through chain of custody procedures. The Department 
interprets this as meaning that as long as there is an entry from an 
individual authorized to release the specimen from the collection site 
( ``Place'' #1) and another from an individual authorized to receive it 
on behalf of the laboratory (``Place'' #2), the persons who perform 
intervening, ministerial transportation services (e.g., couriers, truck 
drivers, airplane pilots, postal service employees, mail room 
employees) need not make such entries.
    Present paragraph 40.25(h) authorizes chain of custody 
documentation to be ``enclosed'' in the shipping container for shipment 
to the laboratory. This container is sealed with tamper-evident tape. 
As a program matter, the Department recommends enclosing chain of 
custody documentation in the shipping container, as opposed to 
attaching it to the exterior of the container, since this minimizes the 
likelihood of loss of or damage to the documents. Interpreting the rule 
to require persons performing intervening transportation services to 
make chain of custody entries would nullify this important provision of 
the rule. In order to make chain of custody entries, intervening 
transportation personnel would have to break the tamper-evident seal, 
dig out the documentation, make an entry, reinsert the documentation, 
and re-seal the container. Of course, a shipping container with a seal 
that had been broken and re-sealed a number of times would make it 
unlikely, if not impossible, for a valid test to be conducted of the 
specimen it contained. The Department could not interpret its 
regulations to create such an absurd result.
    Present Sec. 40.25 (k) directs the use of a chain of custody form 
``from the point of collection to the final disposition of the 
specimen.'' This provision directs that every individual ``in the 
chain'' be identified. Unlike authorized collection site and laboratory 
personnel, who actually handle the specimen, intervening transportation 
personnel are not, properly speaking, ``in the chain'' at all, a point 
which the Department has understood to be consistent with long-standing 
case law in a variety of contexts. Consequently, the Department never 
understood or intended this language to require that intervening 
transportation personnel make chain of custody entries.
    A related issue, raised in the same arbitration decision, concerns 
temporary secure storage. That is, a collection site person conducts 
the test, fills out the custody and control form, places the specimen 
and form in a sealed shipping container, and places the container in 
secure, temporary storage at the collection site, where a courier picks 
it up subsequently for transportation to the laboratory. Again, any 
tampering would be revealed by the tamper-evident seal. Here, too, 
requiring an entry in the chain of custody for putting the package into 
and removing it from the temporary secure storage is unnecessary and 
disruptive. Alternatives, such as not sealing the chain of custody 
documentation in the shipping container until immediately before 
pickup, or attaching the chain of custody documentation to the outside 
of the shipping container when it is ready for pickup, multiply the 
possibilities for error. We emphasize that the collector should, as a 
matter of good practice, document in its own records the times at which 
sealed shipping containers are put into and removed from temporary 
secure storage.
    Notwithstanding the Department's reasonable construction of its 
existing regulatory language, which has been communicated in the past 
to persons raising the question, at least one arbitrator did 
misinterpret these provisions. To prevent the possibility of any such 
mistakes in the future, the Department it taking this opportunity to 
clarify its regulations. To this end, we are adding language very 
similar to that of DHHS to Sec. 40.25 (c), (h), and (k), as well as an 
additional sentence that strongly emphasizes and underlines that chains 
of custody need not include entries from such personnel in order to be 
valid. In addition, the amendments to these paragraphs make clear that 
the absence of entries in the chain of custody relating to the putting 
the package into or retrieving it from temporary secure storage of the 
collection site does not invalidate the chain of custody.
    The Department is making this amendment effective immediately, 
because it is essential to protect DOT drug testing procedures from 
misinterpretations that, if followed, could invalidate virtually all 
chains of custody for DOT drug tests, even though they follow Part 40 
requirements. This necessity constitutes the good cause required by the 
Administrative Procedure Act to make a regulation effective without the 
normal 30-day effective date.

Untestable, Inadequate, or Unavailable Split Specimens

    In split sample testing, there could be situations in which the 
primary specimen reaches the laboratory unscathed, but the split 
specimen does not. Instead, the split specimen is untestable, 
inadequate, or unavailable. For example, the split specimen container 
may have leaked, leaving an inadequate amount of urine for testing. 
What is a laboratory to do? To answer this question, which the 
Department has been asked on a number of occasions, we are adding a 
paragraph to Sec. 40.29. The paragraph directs the laboratory to go 
ahead and test the primary specimen in the usual way. The laboratory 
then sends the result of the test of the primary specimen to the MRO in 
the usual way. If the test result from the laboratory was a confirmed 
positive, and the MRO verifies the result as positive, then the 
employee has 72 hours to request a test of the split specimen. If the 
employee does so, the MRO will pass the request on to the laboratory. 
It is only at this point, and not before, that the laboratory informs 
the MRO that the split specimen is untestable, inadequate, or 
unavailable. The MRO would then cancel the test. This approach is 
consistent with existing DOT guidance and the DHHS guidelines.
    The vast majority of tests of primary specimens have negative 
results. Of those that test positive, a portion are verified negative 
by MROs. Of those verified positive by MROs, not all will result in a 
timely request by the employee for a test of the split specimen. In 
view of these facts, it would be counterproductive for the laboratory 
to reject an otherwise testable primary specimen because the split 
specimen was unavailable, inadequate, or untestable. Nor would it be 
cost-effective for the laboratory to notify the MRO of the problem with 
the split specimen at an earlier stage of the process, which could 
result in the cancellation of tests that may otherwise stand up. There 
is no loss of protection to the employee, who will be in no worse 
position than if there was a testable split specimen. As a general 
matter, employers using split sample collection should not, as a matter 
of prudence, take irrevocable action (e.g., terminate, as opposed to 
suspend) against an employee until the result of the split specimen is 
available.
    Split specimens may become unavailable for testing at other stages 
of the process (e.g., the receiving laboratory mishandles or loses the 
split specimen in storage, the split specimen is lost in transit 
between the receiving laboratory and the second laboratory which would 
analyze the split). In all these cases, the same rule applies. The MRO 
is not notified of the unavailability, inadequacy, or untestability of 
the split specimen unless and until there is a verified positive test 
and the employee has made a timely request for a test of the split 
specimen.

Reduction of Marijuana Initial Test Level

    In its June 9, 1994, revision to its drug testing guidelines, DHHS 
reduced the initial test level for marijuana metabolites from 100 ng/ml 
to 50 ng/ml. This rule changes the initial test level for marijuana in 
Part 40 to conform with the revised DHHS guidelines. This change is 
consistent with the existing language of Sec. 40.29(e)(2), which states 
that the initial test levels for drugs are subject to change by DHHS. 
Since the new DHHS guidelines go into effect September 1, 1994, this 
provision will be effective on that date, so that DHHS and DOT testing 
level requirements remain consistent with one another.

Methamphetamine Levels

    The Department is also adding to the chart in this section showing 
confirmation test levels a new footnote 3, stating that, to be 
confirmed positive, a specimen containing methamphetamine must also 
contain amphetamine at a concentration equal to or greater than 200 ng/
ml. This footnote is also added to be consistent with the revised DHHS 
guidelines.

Reports to Employers and Consortia

    Section 40.29(g)(6), concerning monthly statistical summary reports 
from laboratories to employers, has been the subject of some confusion 
since it does not specify the role of consortia in the reporting chain. 
Laboratories had expressed concern that they were not authorized, by 
the present language of the paragraph, to provide these reports to a 
consortium instead of to individual employers. The Department is 
revising this paragraph to clarify this matter. Suppose a laboratory 
tests specimens originating with employers 1-100, all of whom are part 
of Consortium X. The laboratory may send its report summary only to 
Consortium X, rather than sending 100 single reports to each of the 
employers. However, the data provided to Consortium X must include 
employer-specific information for each of the employers and, within 14 
days of receiving the laboratory report, Consortium X is responsible 
for sending the employer-specific data to each of the 100 employers. 
When, as provided in the last sentence of Sec. 40.29(g)(6), employer-
specific data is withheld because no testing pertinent to the employer 
was held, or because release of the data would permit inferences about 
individual employees' identity, the written reports concerning the 
withholding of the data may also be provided to the employer via the 
consortium, through the mechanism described above.

MRO Conflicts of Interest

    In its revised guidelines, DHHS has added a new provision 
prohibiting relationships between laboratories and medical review 
officers (MROs) that could have the reality or create the appearance of 
a conflict of interest. DHHS added this provision in the belief, with 
which DOT concurs, that any such relationship that could be construed 
as a conflict of interest may be sufficient to undermine the integrity 
of the program. For this reason and to remain consistent with DHHS 
guidelines on this important issue, the Department is adding the DHHS 
language to Sec. 40.29(n).

Removal of Requirement for Second Air Blank

    The alcohol testing procedures in Subpart C, as originally issued, 
contained a requirement that the breath alcohol technician conduct an 
``air blank'' (i.e., an internal check of calibration) both before and 
after every confirmation test. Failure to do so, or a result for an air 
blank that exceeded 0.00, is a ``fatal flaw'' that automatically 
invalidates a test. We have decided, on further reflection, that the 
air blank after the confirmation test is unnecessary. The main point of 
an air blank is to ensure that each employee has a testing device that 
is a ``clean slate,'' unaffected by any alcohol from previous tests or 
other sources. The pre-test air blank accomplishes this objective 
fully; the post-test air blank is not necessary for this purpose. 
Moreover, on some breath testing devices, particularly where a test has 
shown a high alcohol concentration, it may take several minutes for all 
alcohol to clear from the device. Under the existing rule, if the 
breath alcohol technician were to do a post-test air blank under these 
circumstances too soon, it could result in a reading above 0.00, 
invalidating an otherwise valid test. Because it is unnecessary, and to 
avoid problems of this kind, we are deleting the provision requiring a 
post-test air blank and the provision making the failure to conduct 
such a test a ``fatal flaw.''

Display of Sequential Test Numbers

    Section 40.53(b)(2) requires that EBTs used for confirmation tests 
be capable of assigning a unique sequential number to each test, which 
can be read by the BAT and the employee before the test and printed out 
on each copy of the test result. Section 40.79(a)(7) makes it a ``fatal 
flaw'' if the sequential number displayed on the EBT before the test is 
not the same as the sequential number printed on the test result. 
However, the existing regulation leaves a gap between these two points, 
since the procedures for conducting alcohol tests (Secs. 40.63 and 
40.65) do not specify the handling of sequential numbers in the testing 
process.
    The Department is adding language to fill this gap. Section 
40.65(e) is being revised to require the BAT to ensure that the BAT and 
the employee read the displayed sequential number before the 
confirmation test, and Sec. 40.65(h)(3) is revised to direct the BAT to 
enter in the ``Remarks'' section of the form any disparity between that 
number and the sequential test number on the printed result. Such a 
disparity, per Sec. 40.79, is a fatal flaw. We have made parallel 
changes to Sec. 40.63 (d)(1) and (e)(2), which apply to situations in 
which a screening test is conducted with an EBT that has the features 
specified in Sec. 40.53(b) for EBTs that can be used for confirmation 
tests.

Record Retention Requirement for BAT Training

    The alcohol testing requirements of Part 40 currently call on 
employers or their agents to keep records of breath alcohol technician 
(BAT) training and proficiency for two years. The Department is 
concerned that, for BATs who work as such for longer than two years, 
this record retention requirement may not be sufficient. The Department 
requests comment on whether this record retention requirement should be 
extended (e.g., to require retention of records of the training of a 
BAT for as long as that BAT works for the employer). Such an extension 
would not apply, presumably, to BATs who were no longer working for the 
employer.

Regulatory Analyses and Notices

    This is not a significant rule under Executive Order 12866 or under 
the Department's Regulatory Policies and Procedures. It does not impose 
costs on regulated parties and may, to a limited extent, reduce 
regulatory burdens (e.g., the provisions concerning reporting and post-
test air blanks). Consequently, a regulatory evaluation has not been 
prepared.
    The Department finds, for purposes of the Administrative Procedure 
Act, that issuance of a notice of proposed rulemaking on these subjects 
is unnecessary, impracticable, or contrary to the public interest. This 
is because the amendments are conforming changes to actions of the 
Department of Health and Human Services or joint DOT/DHHS actions (the 
change in the marijuana initial test level, the new Federal drug 
testing custody and control form), important clarifications the rapid 
issuance of which is in the public interest (the clarifications to the 
split sample collection procedures, the chain of custody requirements, 
and the laboratory reporting procedures regarding consortia), or a 
correction of what we have come to regard as a mistake in procedures 
that have not been implemented (removal of the post-test air blank 
requirement).
    The particular effective dates are established for the following 
reasons. The 180-day effective date for the requirement to use the new 
drug testing custody and control form is established in order to give 
participants time to exhaust stocks of existing forms and also to give 
interested persons a 60-day opportunity to comment on this matter. The 
August 15 effective date for amendments pertaining to split sample 
testing procedures was established in view of the August 15 starting 
date for mandatory split sample testing in the aviation, motor carrier, 
and railroad industries. The September 1 effective date for the 
amendments to the initial test level for marijuana is established to be 
consistent with the September 1 effective date of the revised DHHS 
guidelines, with which the Department's requirements in this matter 
should be consistent. The immediate effective date for the amendments 
to the chain of custody is established because of the necessity of 
immediately correcting an error that could create potentially serious 
damage to the program.

List of Subjects in 49 CFR Part 40

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

    Issued this 10th day of August 1994, at Washington, DC.
Federico Pena,
Secretary of Transportation.
    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 49 CFR Part 40 continues to read as 
follows:

    Authority: 49 U.S.C. 102,301,322; 49 U.S.C. app. 1301nt., app. 
1434nt., app. 2717, app. 1618a.


Sec. 40.3  [Amended]

    2. In Sec. 40.3, the definition of the term ``EBT'' is amended by 
changing the period at the end of the definition to a comma and by 
adding the following: ``and identified on the CPL as conforming with 
the model specifications available from the National Highway Traffic 
Safety Administration, Office of Alcohol and State Programs.''
    3. Section 40.23(a) is revised to read as follows:


Sec. 40.23  Preparation for testing.

* * * * *
    (a) Use of the drug testing custody and control form prescribed 
under this Part. This form is found in Appendix A to this part. 
Employers and other participants in the DOT drug testing program may 
not modify or revise this form, except that the drug testing custody 
and control form may include such additional information as may be 
required for billing or other legitimate purposes necessary to the 
collection, provided that personal identifying information on the donor 
(other than the social security number or other employee ID number) may 
not be provided to the laboratory. Donor medical information may appear 
only on the copy provided to the donor.
* * * * *
    4. Sec. 40.25(c) is revised to read as follows:


Sec. 40.25  Specimen collection procedures.

* * * * *
    (c) Chain of Custody. The chain of custody block of the drug 
testing custody and control form shall be properly executed by 
authorized collection site personnel upon receipt of specimens. 
Handling and transportation of urine specimens from one authorized 
individual or place to another shall always be accomplished through 
chain of custody procedures. Since specimens and documentation are 
sealed in shipping containers that would indicate any tampering during 
transit to the laboratory and couriers, express carriers, and postal 
service personnel do not have access to the chain of custody forms, 
there is no requirement that such personnel document chain of custody 
for the shipping container during transit. Nor is there a requirement 
that there be a chain of custody entry when a specimen which is sealed 
in such a shipping container is put into or taken out of secure storage 
at the collection site prior to pickup by such personnel. This means 
that the chain of custody is not broken, and a test shall not be 
canceled, because couriers, express carriers, postal service personnel, 
or similar persons involved solely with the transportation of a 
specimen to a laboratory, have not documented their participation in 
the chain of custody documentation or because the chain of custody does 
not contain entries related to putting the specimen into or removing it 
from secure temporary storage at the collection site. Every effort 
shall be made to minimize the number of persons handling specimens.
    5. In Sec. 40.25(e)(2)(i), the words ``32 deg.-38 deg. C/90 deg.-
100 deg. F'' are substituted for the words ``32.5 deg.-37.7 deg. C/
90.5 deg.-99.8 deg. F''.
    6. Sec. 40.25(f)(10)(ii)(B) and (C) are revised to read as follows:


Sec. 40.25  Specimen collection procedures.

* * * * *
    (f) * * *
    (10) * * *
    (ii) * * *
    (B)(1) 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 specimen 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.
    (2) If a single specimen bottle is used as a collection container, 
the collection site person, in the presence of the donor, shall pour 15 
ml of urine from the specimen bottle into a second specimen bottle (to 
be used as the split specimen) and retain the remainder (at least 30 
ml) in the collection bottle (to be used as the primary specimen).
    (C) Nothing in this section precludes the use of a collection 
method or system that does not involve the physical pouring of urine 
from one container or bottle to another by the collection site person, 
provided that the method or system results in the subdivision of the 
specimen into a primary (30 ml) and a split (at least 15 ml) specimen 
that can be transmitted to the laboratory and tested in accordance with 
the requirements of this Subpart.
* * * * *
    7. In Sec. 40.25(f)(13), the words ``32 deg.-38 deg. C/90 deg.-
100 deg. F'' are substituted for the words ``32.5 deg.-37.7 deg. C/
90.5 deg.-99.8 deg. F''.
    8. Sec. 40.25(h) is revised to read as follows:


Sec. 40.25  Specimen collection procedures.

* * * * *
    (h) Transportation to Laboratory. Collection site personnel shall 
arrange to ship the collected specimen to the drug testing laboratory. 
The specimens shall be placed in shipping containers designed to 
minimize the possibility of damage during shipment (e.g., specimen 
boxes and/or padded mailers); and those containers shall be securely 
sealed to eliminate the possibility of undetected tampering with the 
specimen and/or the form. On the tape sealing the shipping container, 
the collection site person shall sign and enter the date specimens were 
sealed in the shipping container for shipment. The collection site 
person shall ensure that the chain of custody documentation is enclosed 
in each container sealed for shipment to the drug testing laboratory. 
Since specimens and documentation are sealed in shipping containers 
that would indicate any tampering during transit to the laboratory and 
couriers, express carriers, and postal service personnel do not have 
access to the chain of custody forms, there is no requirement that such 
personnel document chain of custody for the shipping container during 
transit. Nor is there a requirement that there be a chain of custody 
entry when a specimen which is sealed in such a shipping container is 
put into or taken out of secure storage at the collection site prior to 
pickup by such personnel. This means that the chain of custody is not 
broken, and a test shall not be canceled, because couriers, express 
carriers, postal service personnel, or similar persons involved solely 
with the transportation of a specimen to a laboratory, have not 
documented their participation in the chain of custody documentation or 
because the chain of custody does not contain entries related to 
putting the specimen into or removing it from secure temporary storage 
at the collection site.
* * * * *
    9. Sec. 40.25(k) is revised to read as follows:


Sec. 40.25  Specimen collection procedures.

* * * * *
    (k) Use of chain of custody form. A chain of custody form (and a 
laboratory internal chain of custody document, where applicable), shall 
be used for maintaining control and accountability of each specimen 
from the point of collection to final disposition of the specimen. The 
date and purpose shall be documented on the form each time a specimen 
is handled or transferred and every individual in the chain of custody 
shall be identified. Since specimens and documentation are sealed in 
shipping containers that would indicate any tampering during transit to 
the laboratory and couriers, express carriers, and postal service 
personnel do not have access to the chain of custody forms, there is no 
requirement that such personnel document chain of custody for the 
shipping container during transit. Nor is there a requirement that 
there be a chain of custody entry when a specimen which is sealed in 
such a shipping container is put into or taken out of secure storage at 
the collection site prior to pickup by such personnel. This means that 
the chain of custody is not broken, and a test shall not be canceled, 
because couriers, express carriers, postal service personnel, or 
similar persons involved solely with the transportation of a specimen 
to a laboratory, have not documented their participation in the chain 
of custody documentation or because the chain of custody does not 
contain entries related to putting the specimen into or removing it 
from secure temporary storage at the collection site. Every effort 
shall be made to minimize the number of persons handling specimens.
    10. The existing text of Sec. 40.29(b)(1) is redesignated as 
Sec. 40.29(b)(1)(i), and a new Sec. 40.29(b)(1)(ii) is added, to read 
as follows:


Sec. 40.29  Laboratory analysis procedures.

* * * * *
    (b) * * *
    (1) * * *
    (ii) Where the employer has used the split sample method, and the 
laboratory observes that the split specimen is untestable, inadequate, 
or unavailable for testing, the laboratory shall nevertheless test the 
primary specimen. The laboratory does not inform the MRO or the 
employer of the untestability, inadequacy, or unavailability of the 
split specimen until and unless the primary specimen is a verified 
positive test and the MRO has informed the laboratory that the employee 
has requested a test of the split specimen.
* * * * *
    11. In Sec. 40.29(e), the chart is revised to read as follows:
    (e) * * *

------------------------------------------------------------------------
                                                           Initial test 
                                                           cutoff levels
                                                              (ng/ml)   
------------------------------------------------------------------------
Marijuana metabolites...................................              50
Cocaine metabolites.....................................             300
Opiate metabolites......................................            *300
Phencyclidine...........................................              25
Amphetamines............................................           1,000
------------------------------------------------------------------------
*-25 ng/ml if immunoassay specific for free morphine.                   

    12. In Sec. 40.29(f), the chart is revised to read as follows:
    (f) * * * 

------------------------------------------------------------------------
                                                           Confirmatory 
                                                            test cutoff 
                                                          levels (ng/ml)
------------------------------------------------------------------------
Marijuana metabolite\1\.................................              15
Cocaine metabolite\2\...................................             150
Opiates                                                                 
  Morphine..............................................             300
  Codeine...............................................             300
Phencyclidine...........................................              25
Amphetamines:                                                           
  Amphetamine...........................................             500
  Methamphetamine \3\...................................            500 
------------------------------------------------------------------------
\1\Delta-9-tetrahydrocannabinol-9-carboxylic acid.                      
\2\Benzoylecgonine.                                                     
\3\Specimen must also contain amphetamine at a concentration greater    
  than or equal to 200 ng/ml.                                           


    13. Sec. 40.29(g)(6) is revised to read as follows:


Sec. 40.29  Laboratory analysis procedures.

* * * * *
    (g) * * *
* * * * *
    (6) The laboratory shall provide the employer an aggregate 
quarterly statistical summary of urinalysis testing of the employer's 
employees. Laboratories may provide the report to a consortium provided 
that the laboratory provides employer-specific data and the consortium 
forwards the employer-specific data to the respective employers within 
14 days of receipt of the laboratory report. The laboratory shall 
provide the report to the employer or consortium not more than 14 
calendar days after the end of the quarter covered by the summary. 
Laboratory confirmation data only shall be included from test results 
reported within that quarter. The summary shall contain only the 
following information:
    (i) Number of specimens received for testing;
    (ii) Number of specimens confirmed positive for--
    (A) Marijuana metabolite
    (B) Cocaine metabolite
    (C) Opiates;
    (D) Phencyclidine;
    (E) Amphetamines;
    (iii) Number of specimens for which a test was not performed.
    Quarterly reports shall not contain personal identifying 
information or other data from which it is reasonably likely that 
information about individuals' tests can be readily inferred. If 
necessary, in order to prevent disclosure of such data, the laboratory 
shall not send such a report until data are sufficiently aggregated to 
make such an inference unlikely. In any quarter in which a report is 
withheld for this reason, or because no testing was conducted, the 
laboratory shall so inform the consortium/employer in writing.
    14. A new paragraph (n)(6) is added to Sec. 40.29(n), to read as 
follows:


Sec. 40.29  Laboratory analysis procedures.

* * * * *
    (n) * * *
* * * * *
    (6) The laboratory shall not enter into any relationship with an 
employer's MRO that may be construed as a potential conflict of 
interest or derive any financial benefit by having an employer use a 
specific MRO.
    15. Sec. 40.59(b) is revised to read as follows:


Sec. 40.59  The breath alcohol testing form and log book.

* * * * *
    (b) The form shall provide triplicate (or three consecutive 
identical) copies. Copy 1 (white) shall be transmitted to the employer. 
Copy 2 (green) shall be provided to the employee. Copy 3 (blue) shall 
be retained by the BAT. Except for a form generated by an EBT, the form 
shall be 8\1/2\ by 11 inches in size.
* * * * *
    16. In Sec. 40.59(c), the words ``result displayed on the EBT'' are 
substituted for the words ``quantified test result''.
    17. In Sec. 40.63, paragraphs (d)(1), (2), and (3) are redesignated 
as paragraphs (d)(2), (3), and (4), respectively, and a new paragraph 
(d)(1) is added to read as follows:


Sec. 40.63  Procedures for screening tests.

* * * * *
    (d)(1) If the EBT does meet the requirements of Sec. 40.53(b)(1) 
through (3), the BAT shall ensure, before the screening test is 
administered for each employee, that he or she and the employee read 
the sequential test number displayed by the EBT.
* * * * *
    18. In Sec. 40.63, paragraphs (e)(2), (3), and (4) are respectively 
redesignated as paragraphs (e)(3), (4), and (2).
    19. Redesignated Sec. 40.63(e)(3) is revised to read as follows:


Sec. 40.63  Procedures for screening tests.

* * * * *
    (e) * * *
    (3) If a test result printed by the EBT (see paragraph (d)(3) or 
(d)(4) of this section) does not match the displayed result, or if a 
sequential test number printed by the EBT does not match the sequential 
test number displayed by the EBT prior to the screening test (see 
paragraph (d)(1) of this section), the BAT shall note the disparity in 
the ``Remarks'' section. Both the employee and the BAT shall initial 
and sign the notation. In accordance with Sec. 40.79, the test is 
invalid and the employee shall be so advised.
* * * * *
    20. Sec. 40.65 (d) and (e) are revised to read as follows:


Sec. 40.65  Procedures for confirmation tests.

* * * * *
    (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, which shall be taken out of service. However, 
testing may proceed on another instrument. 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 completed and the 
EBT is found to be within tolerance limits.
    (e) Before the confirmation test is administered for each employee, 
the BAT shall ensure that he or she and the employee read the 
sequential test number displayed by the EBT.
* * * * *
    21. Sec. 40.65(h) (2) and (3) are revised to read as follows:


Sec. 40.65  Procedures for confirmation tests.

* * * * *
    (h) * * *
* * * * *
    (2) If the employee does not sign the certification in Step 4 of 
the form, it shall not be considered a refusal to be tested. In this 
event, the BAT shall note the employee's failure to sign in the 
``Remarks'' section.
    (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, or if a 
sequential test number printed by the EBT does not match the sequential 
test number displayed by the EBT prior to the confirmation test (see 
paragraph (e) of this section), the BAT shall note the disparity in the 
``Remarks'' section. Both the employee and the BAT shall initial and 
sign the notation. In accordance with Sec. 40.79, the test is invalid 
and the employee shall be so advised.
* * * * *


Sec. 40.65  [Amended]

    22. Sec. 40.65(h)(4) is removed.
    23. In Sec. 40.65(i)(2), the comma after the words ``in writing'' 
is removed and the words ``(the employer copy (Copy 1) of the breath 
alcohol testing form),'' are added at that place.


Sec. 40.79  [Amended]

    24. In Sec. 40.79(a)(3), following the words ``0.00 prior to,'' the 
words ``or after'' are removed.
    25. Appendix A to part 40 is revised to read as follows:

Appendix A to Part 40--Federal Drug Testing Custody and Control 
Form

BILLING CODE 4910-62-P

TR19AU94.035


TR19AU94.036


TR19AU94.037


TR19AU94.038


TR19AU94.039


TR19AU94.040


TR19AU94.041


TR19AU94.042


TR19AU94.043


TR19AU94.044


BILLING CODE 4910-62-C
    26. Appendix A to Subpart C of Part 40 is redesignated as Appendix 
B to Part 40 and revised to read as follows:

Appendix B to Part 40--The Breath Alcohol Testing Form

BILLING CODE 4910-62-P

TR19AU94.045


TR19AU94.046


TR19AU94.047


TR19AU94.048


TR19AU94.049


TR19AU94.050


[FR Doc. 94-20447 Filed 8-16-94; 3:09 pm]
BILLING CODE 4910-62-C