[Federal Register Volume 69, Number 216 (Tuesday, November 9, 2004)]
[Rules and Regulations]
[Pages 64865-64868]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-25025]


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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

49 CFR Part 40

[Docket OST-2003-15245]
RIN 2105-AD47


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 is amending certain 
provisions of its drug and alcohol testing procedures to change 
instructions to laboratories and medical review officers with respect 
to adulterated, substituted, and diluted specimen results. This change 
is intended to avoid inconsistency with new requirements established by 
the U.S. Department of Health and Human Services that went into effect 
on November 1, 2004.

DATES: This rule is effective November 9, 2004. Comments to the interim 
final rule should be submitted by December 9, 2004. Late-filed comments 
will be considered to the extent practicable.

ADDRESSES: To ensure that you do not duplicate your docket submissions, 
please submit them by only one of the following means:
    (1) By mail to the Docket Management System (SVC-124), U.S. 
Department of Transportation, Room PL-401, 400 Seventh Street, SW., 
Washington, DC 20590-0001;
    (2) By delivery to room PL-401 on the Plaza Level of the Nassif 
Building, 400 Seventh Street, SW., Washington, DC, between 9 a.m. and 5 
p.m., Monday through Friday, except Federal holidays. The telephone 
number is (202) 366-9329;
    (3) By fax to the Docket Management Facility at (202) 493-2251; or,
    (4) By electronic means through the Web site for the Docket 
Management System at: http://dms.dot.gov.
    The Docket Management Facility maintains the public docket for this 
rulemaking. Comments to the docket will be available for inspection or 
copying at room PL-401 on the Plaza level of the Nassif Building, 400 
Seventh Street, SW., Washington, DC, between 9 a.m. and 5 p.m., Monday 
through Friday, except Federal holidays. The public may also review 
docketed comments electronically at: http://dms.dot.gov.
    Anyone wishing to file a comment should refer to the OST docket 
number (OST-2003-15245).

FOR FURTHER INFORMATION CONTACT: Jim L. Swart, Deputy Director (S-1), 
Office of Drug and Alcohol Policy and Compliance, 400 Seventh Street, 
SW., Washington, DC 20590; telephone number (202) 366-3784 (voice), 
(202) 366-3897 (fax) , or <a href="/cdn-cgi/l/email-protection#c6acafabe8b5b1a7b4b286a9b5b2e8a2a9b2e8a1a9b0"><span class="__cf_email__" data-cfemail="0c666561227f7b6d7e784c637f7822686378226b637a">[email protected]</span></a> (e-mail).

SUPPLEMENTARY INFORMATION:

Purpose

    Recently, the U.S. Department of Health and Human Services (HHS) 
revised their Mandatory Guidelines (69 FR 19644) with an effective date 
of November 1, 2004. Among the many revisions contained in the HHS 
Mandatory Guidelines are the requirements that laboratories modify 
substituted specimen and diluted specimen testing and reporting 
criteria. HHS revised laboratory requirements for adulterated specimen 
testing. HHS also requires each Federal agency to conduct specimen 
validity testing (SVT) to determine if urine specimens collected under 
HHS Federal Workplace Drug Testing Programs have been adulterated or 
substituted.

[[Page 64866]]

    While the Department of Transportation (DOT) intends to fully 
address all aspects of the HHS changes to their Mandatory Guidelines in 
a notice of proposed rulemaking (NPRM) to be published in the near 
future, we believe that it is appropriate to make a few modifications 
to part 40 to avoid a number of inconsistent requirements that the 
application of both part 40 and HHS Mandatory Guidelines may have 
created for laboratories and medical review officers (MROs) since 
November 1, 2004. Consequently, in this document, we are taking the 
following steps:
    1. We have removed from part 40 the requirement that MROs deal with 
substituted results in a two-tiered fashion (i.e., medical review for 
some and recollection under direct observation for others). MROs will 
provide medical review and verification for all laboratory-reported 
substituted specimen results. This change is necessary because, under 
the HHS Mandatory Guidelines, there will be no specimens with 
creatinine levels greater than or equal to 2 mg/dL that will be 
considered substituted.
    2. We have also removed all part 40 references to substituted 
specimens having creatinine levels greater than or equal to 2 mg/dL. 
These simply will no longer exist under HHS Mandatory Guidelines.
    3. We have made laboratory testing criteria for specific gravity 
and creatinine concentration of substituted specimens and diluted 
specimens consistent with the HHS Mandatory Guidelines. A urine 
specimen will be considered dilute when the creatinine concentration is 
greater than or equal to 2 mg/dL but less than 20 mg/dL and the 
specific gravity is greater than 1.0010 but less than 1.0030. 
Previously, urine specimens had been considered dilute when the 
creatinine concentration was above 5 mg/dL but less than 20 mg/dL and 
the specific gravity was greater than 1.001 but less than 1.003.
    4. We have revised Sec.  40.91 to make our authorized SVT 
consistent with the HHS Mandatory Guidelines. We have adopted HHS 
instructions that direct laboratories to perform validity tests for 
oxidizing adulterants and additional validity tests when certain 
conditions (e.g., abnormal physical characteristics) are observed.
    5. We have made laboratory results reporting requirements parallel 
to those in the HHS Mandatory Guidelines (with the exception of 
negative-dilute specimen results, explained in the section below).

Background

    The DOT issued an interim final rule (IFR) on May 28, 2003 (68 FR 
31624) in order to respond to scientific and medical information 
suggesting that we modify testing criteria for some specimens that were 
considered to be substituted and ultimately were treated as refusals to 
test. That 2003 IFR did not change the substitution criteria 
established by the HHS that we had used for our substitution criteria. 
However, the 2003 IFR required laboratories to report the numerical 
values of substituted specimens to MROs.
    MROs were subsequently directed by the 2003 IFR to treat a 
substituted result as negative-dilute if the creatinine concentration 
was greater than or equal to 2 mg/dL. But, unlike part 40 procedures 
with other negative-dilute specimen results, MROs were instructed to 
direct employers to have the employee return to the collection site for 
a directly observed collection with no prior notice given to the 
employee. The result of the observed collection would be the result of 
record for the entire testing event. The HHS Mandatory Guidelines' 
approach to substituted test results allows DOT to simplify our 
guidance to MROs on how to deal with them.
    The 2003 IFR solicited comments, and we received them from a dozen 
commenters. We will address these comments in the preamble to the 
forthcoming NPRM. In addition, some comments to the 2003 IFR mirrored 
comments that HHS received to the portion of the Mandatory Guidelines 
for which they requested comments. We will also take the HHS docket 
comments and their response to them into consideration in our upcoming 
NPRM.
    While we have changed a number of items in part 40 to bring 
consistency between part 40 and the HHS Mandatory Guidelines (see 
previous section) regarding SVT, there are several important items on 
which the DOT and HHS rules will differ.
    1. The DOT will maintain its current position that SVT is 
authorized but not required. In our 2000 regulation (65 FR 79462), we 
made SVT mandatory but retracted the requirement in technical 
amendments published in 2001 (66 FR 41944). We will not make SVT 
mandatory as a feature of this IFR, but may propose, in a forthcoming 
NPRM that we are considering, that such testing be made mandatory. 
Therefore, Sec.  40.89 remains unchanged by this IFR. However, 
laboratories conducting SVT of DOT specimens must do so in accordance 
with the testing requirements established in the HHS Mandatory 
Guidelines.
    In proposing mandatory SVT in the NPRM, we would consider HHS' 
entire Mandatory Guidelines and any subsequent HHS handbook materials. 
We would also update our cost figures for SVT (that were originally 
calculated four years ago) in the context of such a proposal. 
Ultimately, this should enable DOT-regulated employers not currently 
conducting SVT the time needed to arrange with their laboratories and 
Consortia/Third Party Administrators to do so.
    2. In this IFR, we will require MROs to treat laboratory reported 
negative-dilute results with creatinine levels greater than or equal to 
2 mg/dL but equal to or less than 5 mg/dL as negative-dilutes that 
require immediate recollections under direct observation. Therefore, 
MRO procedures at Sec.  40.155 reflect this requirement and employers 
will continue to follow their obligations for negative-dilute results 
at Sec.  40.197(b) and (c).
    3. To assist MROs with their negative-dilute results 
responsibilities, we will require laboratories to provide creatinine 
and specific gravity numerical values for all specimens they report to 
the MRO as being negative-dilute.

Regulatory Analyses and Notices

    The statutory authority for this rule derives from the Omnibus 
Transportation Employee Testing Act of 1991 (49 U.S.C. 102, 301, 322, 
5331, 20140, 31306, and 54101 et seq.) and the Department of 
Transportation Act (49 U.S.C. 322).
    This rule is not significant for purposes of Executive Order 12866 
or the DOT's regulatory policies and procedures. It represents minor 
modifications to our procedures which are intended to further align our 
laboratory and MRO procedures with those requirements that are being 
directed by HHS. Their economic effects will be negligible. 
Consequently, the Department certifies, under the Regulatory 
Flexibility Act, this rule will not have a significant economic impact 
on a substantial number of small entities.
    Under the criteria of section 553 of the Administrative Procedure 
Act (APA), an agency may, for good cause, determine that prior notice 
and public comment are impractical, unnecessary, or contrary to the 
public interest. The Department believes good cause exists for this 
interim change to be made without prior notice and public comment. It 
is imperative that some significant laboratory and MRO

[[Page 64867]]

requirements of the Department's regulation and that of HHS be 
harmonized.

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 4th Day of November, 2004, at Washington DC.
Norman Y. Mineta,
Secretary of Transportation.

0
For reasons discussed in the preamble, the Department of Transportation 
amends part 40 of Title 49 Code of Federal Regulations, subtitle A, as 
follows:

PART 40--PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL 
TESTING PROGRAMS

0
1. The authority citation for 49 CFR Part 40 is revised to read as 
follows:

    Authority: 49 U.S.C. 102, 301, 322, 5331, 20140, 31306, and 
54101 et seq.; 49 U.S.C. 322.


0
2. Section 40.67 is amended by revising paragraph (a)(3) to read as 
follows:


Sec.  40.67  When and how is a directly observed collection conducted?

    (a) * * *
    (3) The laboratory reported to the MRO that the specimen was 
negative-dilute with a creatinine concentration greater than or equal 
to 2 mg/dL but less than or equal to 5 mg/dL, and the MRO reported the 
specimen to you as negative-dilute and that a second collection must 
take place under direct observation (see Sec.  40.197(b)(1)).
* * * * *

0
3. Section 40.91 is amended by revising paragraphs (a), (b), (c), (d), 
and (e) and by removing paragraph (f) as follows:


Sec.  40.91  What validity tests must laboratories conduct on primary 
specimens?

* * * * *
    (a) You must determine the creatinine concentration on each primary 
specimen. You must also determine its specific gravity if you find the 
creatinine concentration to be less than 20 mg/dL.
    (b) You must determine the pH of each primary specimen.
    (c) You must perform one or more validity tests for oxidizing 
adulterants on each primary specimen.
    (d) You must perform additional validity tests on the primary 
specimen when the following conditions are observed:
    (1) Abnormal physical characteristics;
    (2) Reactions or responses characteristic of an adulterant obtained 
during initial or confirmatory drug tests (e.g., non-recovery of 
internal standards, unusual response); or
    (3) Possible unidentified interfering substance or adulterant.
    (e) If you determine that the specimen is invalid and HHS 
guidelines direct you to contact the MRO, you must contact the MRO and 
together decide if testing the primary specimen by another HHS 
certified laboratory would be useful in being able to report a positive 
or adulterated test result.

0
4. Section 40.93 is revised to read as follows:


Sec.  40.93  What criteria do laboratories use to establish that a 
specimen is dilute or substituted?

    (a) As a laboratory, you must consider the primary specimen to be 
dilute when:
    (1) The creatinine concentration is greater than or equal to 2 mg/
dL but less than 20 mg/dL, and
    (2) The specific gravity is greater than 1.0010 but less than 
1.0030 on a single aliquot.
    (b) As a laboratory, you must consider the primary specimen to be 
substituted when the creatinine concentration is less than 2 mg/dL and 
the specific gravity is less than or equal to 1.0010 or greater than or 
equal to 1.0200 on both the initial and confirmatory creatinine tests 
and on both the initial and confirmatory specific gravity tests on two 
separate aliquots.

0
5. Section 40.97 is amended by revising (a)(2), (6) and (7) and (e)(1) 
and (2), and adding paragraph (e)(3), to read as follows:


Sec.  40.97  What do laboratories report and how do they report it?

    (a) * * *
    (2) Negative-dilute, with numerical values for creatinine and 
specific gravity;
* * * * *
    (6) Adulterated, with numerical values (when applicable), with 
remark(s);
    (7) Substituted, with numerical values for creatinine and specific 
gravity; or
* * * * *
    (e)(1) You must provide quantitative values for confirmed positive 
drug 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 provide the numerical values that support the 
adulterated (when applicable) or substituted result, without a request 
from the MRO.
    (3) You must also provide to the MRO numerical values for 
creatinine and specific gravity for the negative-dilute test result, 
without a request from the MRO.
* * * * *


Sec.  40.131  [Amended]

0
6. Section 40.131(a) is amended by removing, after the word 
``substituted'' and before the comma, the words ``with creatinine 
concentration of less than 2 mg/dL''.

0
7. Section 40.145 is amended 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 for a 
drug or drug metabolite.
* * * * *
    (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 the creatinine 
concentration criterion of less than 2 mg/dL and the specific gravity 
criteria of less than or equal to 1.0010 or greater than or equal to 
1.0200 (see Sec.  40.93(b)).
* * * * *

0
8. Section 40.155 is amended by revising paragraphs (a) and (c) to read 
as follows:


Sec.  40.155  What does the MRO do when a negative or positive test 
result is also dilute?

    (a) When the laboratory reports that a specimen is dilute, you 
must, as the MRO, report to the DER that the specimen, in addition to 
being negative or positive, is dilute.
* * * * *
    (c) When you report a dilute specimen to the DER, you must explain 
to the DER the employer's obligations and choices under Sec.  40.197, 
to include the requirement for an immediate recollection under direct 
observation if the creatinine concentration of a negative-dilute 
specimen was greater than or equal to 2mg/dL but less than or equal to 
5mg/dL.

[[Page 64868]]

Sec.  40.197  [Amended]

0
9. Section 40.197 (b)(1) is amended by replacing the words ``(see Sec.  
40.145(a)(1))'' with the words ``(see Sec.  40.155(c))''.

[FR Doc. 04-25025 Filed 11-8-04; 8:45 am]
BILLING CODE 4910-62-P


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