[Federal Register Volume 70, Number 15 (Tuesday, January 25, 2005)]
[Notices]
[Pages 3542-3543]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-1309]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Mandatory Guidelines for Federal Workplace Drug Testing Programs

AGENCY: Substance Abuse and Mental Health Services Administration, HHS.

ACTION: Mandatory Guidelines: Response to Public Comments.

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SUMMARY: In the Federal Register notice of April 13, 2004 (69 FR 
19644), the Department of Health and Human Services (``HHS'' or 
``Department'') published final changes to the Mandatory Guidelines for 
Federal Workplace Drug Testing Programs. These changes established 
specimen validity testing standards and reporting procedures for 
Federal agency urine specimens collected under the Mandatory Guidelines 
for Federal Workplace Drug Testing Programs. These changes to the 
Mandatory Guidelines were subject to further comment only on the 
creatinine criterion that is part of the requirement to report a urine 
specimen as substituted because the Department based this criterion on 
information received after the comment period on the proposed changes 
published on August 21,2001 closed. After reviewing the comments 
received regarding this issue, the Department has concluded that the 2 
mg/dL creatinine criterion established in the April 13, 2004, Federal 
Register notice (69 FR 19644) for a substituted specimen is the 
appropriate cutoff concentration to use for reporting a urine specimen 
as substituted.

EFFECTIVE DATE: November 1, 2004.

FOR FURTHER INFORMATION CONTACT: Walter F. Vogl, Ph.D., Division of 
Workplace Programs, SAMHSA, Room 2-1035, 1 Choke Cherry Road, 
Rockville, Maryland 20857, telephone (240) 276-2600, fax (240) 276-
2610, or e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The Mandatory Guidelines for Federal Workplace Drug Testing 
Programs(Mandatory Guidelines) establish the scientific and technical 
guidelines for Federal workplace drug testing programs and standards 
for certification of laboratories engaged in urine drug testing for 
Federal agencies, under authority of section 503 of Pub. L. 100-71, 5 
U.S.C. 7301 note, and E. 0. No. 12564. The Mandatory Guidelines were 
first published in the Federal Register on April 11, 1988 (53 FR 
11979), revised on June 9, 1994 (59 FR 29908), revised on November 13, 
1998 (63 FR 63483), and revised on April 13, 2004 (69 FR 19644).
    The April 13, 2004, Federal Register notice finalized the changes 
to the Mandatory Guidelines that were proposed in the Federal Register 
notice published on August 21, 2001 (66 FR 43876); established an 
effective date of November 1, 2004; but allowed further public comment 
on one issue. That is, comments were requested on the 2 mg/dL 
creatinine concentration criterion that was established as part of the 
requirement to report a urine specimen as substituted. This was left 
open for comment because the 2 mg/dL concentration level was based on 
information received after the comment period closed on the Federal 
Register notice published on August 21, 2001. The additional 
information that was provided indicated that it was possible for an 
individual to provide a normal urine specimen with a creatinine 
concentration less than the 5 mg/dL cutoff concentration criterion 
proposed in the August 21 notice.

II. Discussion of Public Comments

    As stated in the April 13, 2004, Federal Register notice, the 
Department was only accepting comments on the creatinine criterion. The 
Department did receive several comments on other sections of the 
Mandatory Guidelines including the effective date, but these sections 
and the effective date were not open to comment.
    Several commenters recommended that the Department take one or more 
of the following actions with regard to the creatinine criterion:
    Comment: Immediately collect another specimen from the donor when 
the creatinine concentration is between 2 mg/dL and 5 mg/dL because 
this policy will continue to detect ``truly substituted'' specimens.
    Response: The suggestion that a urine specimen with a creatinine 
concentration between 2 mg/dL and 5 mg/dL is ``truly substituted'' 
implies that the cutoff concentration should be raised to 5 mg/dL to 
ensure that all substituted specimens are correctly identified as 
substituted specimens. The Department disagrees with this suggestion. 
At the Department of Transportation Federal Aviation Administration's 
conference held February 4-6, 2003, to study substitution and 
adulteration issues, the experts attending the conference were 
convinced based on evidence presented that it was possible for some 
individuals to produce a valid urine specimen with a creatinine 
concentration of less than 5 mg/dL, the level specified in the Federal 
Register notice of August 21, 2001. After consideration of data on 
creatinine levels, they concluded that the level should be set at 2 mg/
dL. Lowering the concentration level will prevent the likelihood of 
individuals being falsely accused of substituting their specimen. The 
Department also notes that there is a second criterion for determining 
whether a specimen has been substituted--specific gravity--which has 
not been changed.
    Comment: Immediately collect another specimen from the donor when 
the creatinine concentration is between 2 mg/dL and 5 mg/dL because 
approximately one half of the second specimens collected from donors in 
this creatinine range are tested and reported drug positive.
    Response: The commenter who submitted this comment did not provide 
actual data to justify the claim that approximately one-half of the 
second specimens collected are tested and reported drug positive. The 
commenter based the observation on specimens between 2 mg/dL and 5 mg/
dL that one Medical Review Officer ordered to have a second specimen 
collected. There was no indication of the number of specimens that were 
recollected, the reason for testing (i.e., random, post-accident, pre-
employment), or whether they were Federal agency, DOT regulated, or 
private-sector specimens. The commenter did say that all of the 
recollections that were drug positive were from males and none from 
females. The Department believes this anecdotal information is not 
sufficient justification to require immediately collecting a second 
specimen from a Federal employee or applicant for a Federal agency 
testing designated position using a direct observed collection. The 
Department also believes that a urine specimen that tests negative for 
drugs, is dilute, and exhibits no other evidence of

[[Page 3543]]

possible tampering is a valid urine specimen and should not lead a 
Medical Review Officer to direct a Federal agency to immediately 
collect another specimen because the creatinine concentration is 
between 2 mg/dL and 5 mg/dL.
    Comment: The creatinine cutoff of less than 2 mg/dL is too low 
especially when using reagent strips to measure the creatinine 
concentration.
    Response: The Department agrees that reagent strips could not be 
used to obtain an accurate creatinine concentration at 2 mg/dL. 
However, since the Department does not permit certified laboratories to 
use reagent strips to determine creatinine concentration, this comment 
is not relevant to the creatinine analyses conducted by certified 
laboratories. The accepted methods to determine creatinine 
concentration are Jaffe or modified Jaffe colorimetric procedures using 
autoanalyzers and these methods can accurately analyze and record 
creatinine concentrations to one decimal place (using mg/dL units) at 
and below the 2 mg/dL cutoff concentration.
    Comment: Donors whose specimens are reported substituted should be 
directed to provide another specimen using a direct observed collection 
procedure to prove his or her innocence because the donor naturally 
produces ``ultra-dilute'' urine.
    Response: The Department disagrees with this comment for the 
following reasons: (1) The revised Mandatory Guidelines give a Federal 
employee the opportunity to provide medical records to the Medical 
Review Officer that support a legitimate explanation for a substituted 
result, and (2) the Federal employee is allowed to request a retest of 
a single specimen or the test of a split specimen to verify the result 
reported by the laboratory. The Department believes these two 
provisions are sufficient to protect the Federal employee's rights 
without the need to collect a second specimen using a direct observed 
collection procedure.
    Comment: The variation of the measurement of creatinine 
concentration within and between laboratories is too large to permit 
determining an accurate measurement of the creatinine concentration.
    Response: The Department disagrees with the comment because the 
results from the performance testing (PT) program clearly demonstrate 
the ability of the certified laboratories to accurately measure the 
creatinine concentration around the 2 mg/dL cutoff concentration. With 
regard to specimen validity tests, certified laboratories are required 
to ensure that their tests satisfy the strict quality control 
requirements specified in the Mandatory Guidelines and must implement 
quality assurance procedures to monitor assay performance. These 
requirements are essentially the same requirements that have been used 
and applied to the drug tests since the beginning of the Federal 
Workplace Drug Testing Program. In addition, the Department monitors 
the variation of the specimen validity test results through the 
laboratory inspection and PT programs. The Department believes that 
monitoring the performance of each laboratory's results on the PT 
samples that challenge each laboratory's specimen validity tests is 
sufficient and appropriate to ensure that each laboratory's specimen 
validity test results on Federal employee specimens are forensically 
and scientifically supportable; therefore, the Department is not 
changing the creatinine cutoff concentration.
    Comment: Lower the creatinine criterion because certain donors can 
naturally produce urine specimens with creatinine concentrations that 
are less than 2 mg/dL.
    Response: The Department agrees that under extreme circumstances 
there may be a few individuals that could theoretically provide a valid 
urine specimen having a creatinine concentration slightly below 2 mg/
dL. However, the Department believes that the policy giving a Federal 
employee the right to submit medical information to the Medical Review 
Officer to support a creatinine concentration that is less than 2 mg/dL 
is a safeguard that will prevent a Federal employee from being falsely 
accused of providing a substituted specimen.

    Dated: December 8, 2004.
Charles G. Curie,
Administrator, SAMHSA.

    Dated: January 14, 2005.
Tommy G. Thompson,
Secretary.
[FR Doc. 05-1309 Filed 1-24-05; 8:45 am]
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