[Federal Register Volume 68, Number 102 (Wednesday, May 28, 2003)]
[Rules and Regulations]
[Pages 31624-31627]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-13242]



[[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 [email protected] (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 [email protected] (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]
BILLING CODE 4910-62-U