**DEPARTMENT OF TRANSPORTATION**

**Office of the Secretary**

**49 CFR Part 4■**

**\[Docket OST-2003-15245\]**

**RIN 2105-AD47**

**Procedures for Transportation Workplace Drug and Alcohol Testing
Programs**

**AGENCY**: Office of the Secretary, DOT.

**ACTION:** Interim final rule.

## 

**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](http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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](http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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 <jim.swart@ost.dot.gov> (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.

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 §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, §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 §40.155 reflect this requirement and employers will
continue to follow their obligations for negative-dilute results at
§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 requirements of the
Department\'s regulation and that of HHS be harmonized.

**List of Subjects in 49 CFR Part 4■**

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.*

■ 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

■ 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.

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

**§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 §40.197(b)(1)).

\* \* \* \* \*

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

**§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.

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

**§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.

■ 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:

**§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.

\* \* \* \* \*

**§40.131 \[Amended\]**

■ 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".

■ 7. Section 40.145 is amended by revising paragraphs (a) and (e)(2) to
read as follows:

**§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 §40.93(b)).

\* \* \* \* \*

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

**§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 §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.

**§40.197 \[Amended\]**

■ 9. Section 40.197 (b)(1) is amended by replacing the words "(see
§40.145(a)(1))" with the words "(see §40.155(c))".

\[FR Doc. 04-25025 Filed 11-8-04; 8:45 am\]

BILLING CODE 4910-62-P

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