[Federal Register: May 28, 2003 (Volume 68, Number 102)]
[Rules and Regulations]
[Page 31624-31627]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28my03-12]
[[Page 31624]]
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DEPARTMENT OF TRANSPORTATION
Office of the Secretary
49 CFR Part 40
[Docket OST-2003-15245]
RIN 2105-AD26
Procedures for Transportation Workplace Drug and Alcohol Testing
Programs
AGENCY: Office of the Secretary, DOT.
ACTION: Interim final rule.
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SUMMARY: The Department of Transportation (DOT) is amending a provision
of its drug and alcohol testing procedures to change the instructions
to medical review officers (MROs) with respect to reporting specimens
as dilute or substituted. The change is based on the Department's
experience since the adoption of its current rule and new scientific
information on the subject.
DATES: This rule is effective May 28, 2003. Comments on the interim
final rule should be submitted by August 26, 2003. Late-filed comments
will be considered to the extent practicable.
ADDRESSES: Anyone wishing to file a comment should refer to the OST
docket number (OST-2003-15245). You may submit your comments and
related material by only one of the following methods: You may mail
your comments to the Docket Management System, U.S. Department of
Transportation, room PL-401, 400 7th Street, SW., Washington, DC 20590-
0001; or you may submit your comments electronically through the Web
site for the Docket Management System at http://dms.dot.gov. For
instructions on how to submit comments electronically, visit the Docket
Management System Web site and click on the ``Help'' menu.
The Docket Management Facility maintains the public docket for this
rulemaking. Comments will become part of this docket and will be
available for inspection or copying at room PL-401 on the plaza level
of the Nassif Building at the same address during regular business
hours. You may also obtain access to this docket on the Internet at
http://dms.dot.gov.
Anyone is able to search the electronic form of all comments
received into the docket for this rulemaking by the name of the person
submitting the comment (or signing it, in the case of a comment
submitted on behalf of a business, association, or other organization).
You may review DOT's complete Privacy Act statement in the Federal
Register published April 11, 2000 (65 FR 19477-78), or you may visit
http://dms.dot.gov.
FOR FURTHER INFORMATION CONTACT: Robert C. Ashby, Deputy Assistant
General Counsel for Regulation and Enforcement, 400 7th Street, SW.,
Room 10424, Washington, DC, 20590, 202-366-9310 (voice), 202-366-9313
(fax), or bob.ashby@ost.dot.gov (e-mail) or Ken Edgell, Acting
Director, Office of Drug and Alcohol Policy and Compliance (ODAPC), 400
7th Street, SW., Room 10403, Washington, DC 20590, 202-366-3784
(voice), 202-366-3897 (fax), or kenneth.edgell@ost.dot.gov (e-mail).
SUPPLEMENTARY INFORMATION: In its current drug and alcohol testing
procedures (49 CFR part 40), the Department sets forth criteria for
determining when a specimen should be considered substituted (see Sec.
40.93(b)). This provision states that:
As a laboratory, you must consider the primary specimen to be
substituted if the creatinine concentration is less than or equal to
5 mg/dL and the specific gravity is less than or equal to 1.001 or
greater than or equal to 1.020.
These criteria, which are taken directly from Department of Health
and Human Services (HHS) program documents, are important because, if
an employee's specimen meets them, the employee will be regarded as
having refused the drug test, typically with consequences equivalent to
those for a positive test.
Substitution testing and criteria were controversial subjects
during the rulemaking that created the current part 40. In the preamble
to the final rule, the Department extensively discussed these issues
(see 65 FR 79478-79481; December 19, 2000). The Department concluded,
based on studies by HHS and the Department of Transportation, that the
creatinine criterion of less than or equal to 5 mg/dL was appropriate.
We concluded that it was very unlikely that employees could produce
urine meeting that standard through physiological means.
Nevertheless, the current rule provides procedures through which a
medical review officer (MRO) verifies tests that a laboratory reports
as substituted, including a means through which an employee can
demonstrate that there is a legitimate medical explanation for the
laboratory result (Sec. 40.145). If the MRO, after evaluating the
employee and receiving the recommendation of a referral physician and
the results of a demonstration that the individual can produce a low-
creatinine specimen by natural means, ultimately finds that there is a
legitimate medical explanation, the MRO will cancel the test result.
More recently, however, information has evolved suggesting that the
Department's treatment of substitution matters should be reconsidered.
The Department has become aware of a small number of cases in which
individuals appear to have had legitimate medical explanations for
producing specimens with a creatinine level of less than or equal to 5
mg/dL. These explanations have involved showings by a few individuals
that they can produce low-creatinine specimens in demonstrations for a
referral physician. Also, there is an increasing consensus among
scientific and medical experts in relevant fields that the 5 mg/dL
standard may not be appropriate. That is, there is probably a very
small, but not insignificant, number of individuals who may, under
normal circumstances, produce urine with creatinine concentrations
below that level.
This information was discussed at a conference sponsored by the
Federal Aviation Administration in Tampa, Florida, on February 4-6,
2003. The conference brought together toxicologists, nephrologists and
other physicians, MROs, technical experts in various fields, and DOT
and HHS officials. Attendees at the conference generally agreed that it
would be appropriate to lower the creatinine criterion. The purpose of
doing so would be to largely eliminate the possibility that individuals
who could naturally produce urine creatinine concentrations below that
current standard would be identified as having substituted a specimen.
As directed by the Senate Appropriations subcommittee with jurisdiction
over the FAA, which expressed concern about the possibility of some
employees inadvertently failing to meet current validity standards, the
Department will shortly submit to that subcommittee a final report
incorporating the material discussed at the conference. When the
Department submits this report, we will also post it in the docket for
this rulemaking.
The Department is continuing to work with HHS, laboratories, and
other interested persons on issues related to substitution. This
process may take considerable time. Meanwhile, the Department believes
that it is sensible to take an interim step to minimize the possibility
of individuals who can naturally produce urine with creatinine
concentrations of less than or equal to 5 mg/dL being identified as
having substituted their specimens.
[[Page 31625]]
Consequently, in this interim final rule, we are taking the following
steps.
1. We are directing laboratories to report to MROs, on Copy 1 of
the Custody and Control Form (CCF) (also in the optional laboratory
report), the creatinine and specific gravity quantifications for all
DOT specimens that meet the regulatory substitution criteria. In these
situations, laboratories will be required to include a notation on Copy
1 saying, for example, ``Creatinine, 4.5 mg/dL; Specific Gravity,
1.001.'' Note, however, that we are not changing existing substitution
criteria (see Sec. 40.93).
2. In making this report, laboratories would report quantitative
values for creatinine only when the creatinine concentration in a
specimen was above a laboratory's minimum detection limit. Anything
below this limit would be reported as ``creatinine not detected.'' If
MROs inquire what a particular laboratory's limit of detection is for a
particular specimen, the laboratory should provide this information. It
is our understanding that all HHS-certified laboratories have a limit
of detection for creatinine of 1 mg/dL or less
3. When an MRO gets a report from the laboratory that the
creatinine level in a specimen is less than 2 mg/dL or is ``creatinine
not detected,'' the MRO will report the specimen to the employer as
``substituted.'' When the MRO gets a report from the laboratory that
the creatinine level in a specimen is greater than or equal to 2 mg/dL
but less than or equal to 5 mg/dL, the MRO will report the specimen to
the employer as ``dilute,'' just as if the creatinine concentration
were greater than or equal to 5 but less than 20 mg/dL (and also
negative or positive, as provided in Sec. 40.155).
4. When the MRO gets a report from the laboratory that the
creatinine level in a specimen is 2 mg/dL or above but less than or
equal to 5 mg/dL, the MRO--in addition to reporting the specimen to the
employer as dilute--must take an additional step. This step is to
direct the employer to require the employee to undergo an immediate
recollection under direct observation. The employer must then ensure
that this recollection takes place.
The rationale for changing the reporting procedure for specimens in
the 2-5 mg/dL creatinine concentration range is to provide the maximum
margin of safety to ensure that people who may naturally produce low
creatinine levels--most cases that have been brought to the
Department's attention have been in the 4.1-4.9 mg/dL range--will not
be reported to employers as having substituted their specimens. The
Department is aware that this procedural change may for a time slightly
increase the risk of individuals attempting to substitute their
specimens to evade detection of drug use. We believe that this risk is
outweighed by the benefit of avoiding unfairly identifying persons as
having substituted specimens. Because specimens in the specified range
may create greater concern than less dilute specimens that a
substitution may have been attempted, we believe that heightened
scrutiny of these specimens is warranted. We believe that the
requirement for recollection under direct observation is justified as a
safeguard against tampering with specimens.
[Here, and in other places in the rule, where we express a
quantitative value as a whole number (e.g., 2 or 5), we mean exactly
that number (e.g., 2.0 or 5.0).]
This series of steps will not cause laboratories to change existing
criteria or procedures, limiting burdens on them to the ministerial
step of adding a brief notation of existing data on an existing form.
Based on laboratories' experience, laboratories are likely to have to
follow these procedures in only about 2000 out of the several million
DOT specimens tested each year.
The Department wishes to provide guidance to program participants
concerning some questions we anticipate may arise in the implementation
of these amendments to part 40 and related provisions. First, there may
be some substituted specimens in process on the date this amendment
becomes effective. If a laboratory has tested a specimen, found that it
meets the substitution criteria of Sec. 40.93, but has not yet
reported the substituted result to the MRO on the effective date of
this amendment, the laboratory should report it as substituted with the
quantitative creatinine and specific gravity values, as this amendment
provides.
If an MRO has received a substituted result before the effective
date of the amendment and has not yet reported the result to the
employer on the effective date of the amendment, the MRO should request
the quantitations from the laboratory before reporting the result to
the employer. The MRO would then report the result to the employer as
substituted or dilute, as this amendment provides.
If the employer received a substituted result from the MRO before
the effective date of this amendment, the employer would continue to
treat the result as substituted, as provided in part 40 prior to these
amendments. The employer in this case is not required to go back to the
MRO or laboratory and obtain the quantitations for creatinine and
specific gravity.
There could be situations in which a laboratory finds enough drug
or metabolite in a specimen to report it as positive and at the same
time determines that the specimen is substituted or, more likely,
adulterated. Suppose, in such a situation, testing of the split does
not confirm the substitution or adulteration finding. Program
participants would still treat the test as a positive test for the
drug.
Also, in order to reconfirm a substitution finding, it is not
necessary for the laboratory testing the split to come to precisely the
same quantitative result as the primary laboratory. Suppose the primary
laboratory's quantitation for creatinine is 1.2 mg/dL. The second
laboratory's quantitation is 1.8 mg/dL. Both results are less than 2
mg/dL. In this situation, we regard the initial result as having been
reconfirmed. On the other hand, suppose the quantitation of creatinine
by the first laboratory for the primary specimen is 1.9 mg/dL, and the
quantitation of creatinine by the second laboratory for the split
specimen is 2.3 mg/dL. In this case, the MRO would report the result of
the split specimen as ``dilute'' (see numbered paragraph 3 above) with
instructions to the employer to conduct an immediate recollection under
direct observation.
We emphasize that, in the case where creatinine is reported as
``creatinine not detected'' (see amended Sec. 40.97(e)(2)), the proper
action for the MRO is to report the specimen to the employer as
substituted. While the procedures of Sec. 40.145 apply to such a case,
Sec. 40.151(i) tells MROs not to accept as a legitimate medical
explanation for a substituted specimen an assertion that an employee
can produce urine with no detectable creatinine.
Regulatory Analyses and Notices
This rule is not a significant rule under Executive Order 12866 or
the Department of Transportation's Regulatory Policies and Procedures.
Costs to laboratories and MROs will be minimal, since the rule merely
makes a minor change in the way existing results are reported in a very
small percentage of cases. There will be no significant burdens or
economic effects on any of the participants in the drug testing
process. Consequently, the Department certifies, under the Regulatory
Flexibility Act, that this rule will not have a significant economic
impact on a substantial number of small entities.
[[Page 31626]]
Under the criteria of section 553 of the Administrative Procedure
Act, the Department has determined that prior notice and public comment
on this rule are impractical, unnecessary, or contrary to the public
interest. This is because, given the information now available to the
Department, we have concluded that it is necessary to make an interim
change immediately to avoid the possibility that individuals will be
incorrectly reported as having substituted a specimen. For the same
reason, the Department finds good cause to make this rule effective
immediately.
List of Subjects in 49 CFR Part 40
Administrative practice and procedures, Alcohol abuse, Alcohol
testing, Drug abuse, Drug testing, Laboratories, Reporting and
recordkeeping requirements, Safety, Transportation.
Issued this 16th day of May, 2003, at Washington, DC.
Norman Y. Mineta,
Secretary of Transportation.
0
For the reasons set forth in the preamble, the Department of
Transportation amends 49 CFR Part 40 as follows:
PART 40--[AMENDED]
0
1. The authority citation for Part 40 continues to read as follows:
Authority: 49 U.S.C. 102, 301, 322, 5331, 20140, 31306, and
45101 et seq.
0
2. Amend Sec. 40.67 by revising paragraph (a) to read as follows:
Sec. 40.67 When and how is a directly observed collection conducted?
(a) As an employer, you must direct an immediate collection under
direct observation with no advance notice to the employee, if:
(1) The laboratory reported to the MRO that a specimen is invalid,
and the MRO reported to you that there was not an adequate medical
explanation for the result;
(2) The MRO reported to you that the original positive,
adulterated, or substituted result had to be cancelled because the test
of the split specimen could not be performed; or
(3) The laboratory reported to the MRO that the specimen was
substituted with a creatinine concentration greater than or equal to 2
mg/dL and less than or equal to 5 mg/dL and the MRO reported the
specimen to you as negative and dilute (see Sec. Sec. 40.145(a)(1) and
40.197).
* * * * *
0
3. Amend Sec. 40.97 by revising paragraph (a) (7) and paragraph (e) to
read as follows:
Sec. 40.97 What do laboratories report and how do they report it?
* * * * *
(a) * * *
(7) Substituted, with quantitative values for creatinine and
specific gravity, and remarks; or
* * * * *
(e)(1) You must provide quantitative values for confirmed positive
drug and adulterated test results to the MRO when the MRO requests you
to do so in writing. The MRO's request may be either a general request
covering all such results you send to the MRO or a specific case-by-
case request.
(2) You must also provide to the MRO quantitative values for
creatinine and specific gravity for all substituted test results when
the result is above your detection limit. If the result is not above
your detection limit, you must report ``creatinine not detected'' to
the MRO. You must make these reports for in all cases of substituted
tests, without a request from the MRO.
* * * * *
0
4. Amend Sec. 40.131(a) by adding, in the first sentence, after the
word ``substituted'' and before the comma, the words ``with a
creatinine concentration of less than 2 mg/dL.''
0
5. Amend Sec. 40.145 by revising paragraphs (a) and (e)(2) to read as
follows:
Sec. 40.145 On what basis does the MRO verify test results involving
adulteration or substitution?
(a) As an MRO, when you receive a laboratory report that a specimen
is adulterated or substituted, you must treat that report in the same
way you treat the laboratory's report of a confirmed positive test for
a drug or drug metabolite, unless the creatinine concentration for a
substituted specimen was reported by the laboratory to be equal to or
more than 2 mg/dL.
(1) If the laboratory has reported the creatinine concentration for
a substituted specimen as equal to or more than 2 mg/dL, you must
report the specimen to the DER as being dilute, as provided in Sec.
40.155 of this part. Notwithstanding any other provision of this part,
you must also instruct the DER that a second collection under direct
observation must take place immediately.
(2) If the laboratory has reported the creatinine concentration for
a substituted specimen as less than 2 mg/dL or ``creatinine not
detected,'' you must follow the procedures set forth in paragraphs (b)
through (h) of this section.
* * * * *
(e) * * *
(2) To meet this burden in the case of a substituted specimen, the
employee must demonstrate that he or she did produce or could have
produced urine, through physiological means, meeting criteria for
creatinine of less than 2 mg/dL and for specific gravity of less than
or equal to 1.001 or greater than or equal to 1.020.
* * * * *
0
6. Amend Sec. 40.155 (a) by adding, after the words ``reports that a
specimen is dilute,'' the words ``or reports that a specimen is
substituted with a creatinine quantitation of greater than or equal to
2 mg/dL.``
0
7. Amend Sec. 40.187(a) by adding a new paragraph (a)(3), to read as
follows:
Sec. 40.187 What does the MRO do with split specimen laboratory
results?
(a) * * *
(3) In the case of a reconfirmed substituted result, in which the
creatinine concentration for the primary specimen was less than 2 mg/dL
and the creatinine concentration of the split specimen is between 2 and
5 mg/DL, inclusive, report the result to the employer as ``dilute'' and
instruct the employer to conduct an immediate recollection under direct
observation.
* * * * *
0
8. Revise Sec. 40.191 (a)(6) to read as follows:
Sec. 40.191 What is a refusal to take a DOT drug test, and what are
the consequences?
(a) * * *
(6) Fail or decline to take an additional drug test the employer or
collector has directed you to take (see, for instance, Sec.
40.197(b));
* * * * *
0
9. Revise Sec. 40.197 to read as follows:
Sec. 40.197 What happens when an employer receives a report of a
dilute specimen?
(a) As the employer, if the MRO informs you that a positive drug
test was dilute, you simply treat the test as a verified positive test.
You must not direct the employee to take another test based on the fact
that the specimen was dilute.
(b) As an employer, if the MRO informs you that a negative test was
dilute, take the following action:
(1) If the MRO directs you to conduct a recollection under direct
observation (i.e., because the creatinine concentration of the specimen
was equal to or greater than 2mg/dL, but less than or equal to 5 mg/dL
(see
[[Page 31627]]
Sec. 40.145(a)(1)), you must do so immediately.
(2) Otherwise (i.e., if the creatinine concentration of the dilute
specimen is greater than 5 mg/dL), you may, but are not required to,
direct the employee to take another test immediately.
(i) Such recollections must not be collected under direct
observation, unless there is another basis for use of direct
observation (see Sec. 40.67 (b) and (c)).
(ii) You must treat all employees the same for this purpose. For
example, you must not retest some employees and not others. You may,
however, establish different policies for different types of tests
(e.g., conduct retests in pre-employment situations, but not in random
test situations). You must inform your employees in advance of your
decisions on these matters.
(c) The following provisions apply to all tests you direct an
employee to take under paragraph (b) of this section:
(1) You must ensure that the employee is given the minimum possible
advance notice that he or she must go to the collection site;
(2) You must treat the result of the test you directed the employee
to take under paragraph (b) of this section--and not a prior test--as
the test result of record, on which you rely for purposes of this part;
(3) If the result of the test you directed the employee to take
under paragraph (b) of this section is also negative and dilute, you
are not permitted to make the employee take an additional test because
the result was dilute. Provided, however, that if the MRO directs you
to conduct a recollection under direct observation under paragraph
(b)(1) of this section, you must immediately do so.
(4) If the employee declines to take a test you directed him or her
to take under paragraph (b) of this section, the employee has refused
the test for purposes of this part and DOT agency regulations.
[FR Doc. 03-13242 Filed 5-27-03; 8:45 am]
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