[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]
_______________________________________________________________________
Part VIII
Department of Transportation
_______________________________________________________________________
Office of the Secretary
_______________________________________________________________________
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.
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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