[Federal Register Volume 72, Number 175 (Tuesday, September 11, 2007)]
[Notices]
[Pages 51887-51891]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-4428]


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DEPARTMENT OF TRANSPORTATION

Office of the Secretary


Informational Notice Regarding Certain Substituted Specimens

AGENCY: Office of the Secretary, U.S. Department of Transportation.
SUMMARY: The Office of Drug and Alcohol Policy and Compliance (ODAPC) 
is taking action to rectify what may be a mischaracterization of some 
test results as being substituted specimens. In appropriate cases, 
ODAPC will reconsider the employee's original refusal result, when 
reported from September 1998 through May 2003, and based upon a 
``substitution'' finding in a given numerical range.

FOR FURTHER INFORMATION CONTACT: Mark Snider, U.S. Department of 
Transportation, Office of the Secretary, Office of Drug and Alcohol 
Policy and Compliance, 1200 New Jersey Avenue, SE., Washington, DC 
20590; or Telephone (202) 366-3784; or E-mail [email protected].

SUPPLEMENTARY INFORMATION: In September 1998, Department of Health and 
Human Services (HHS) issued guidance (Program Document 035; September 
28, 1998), for laboratories to determine when to report a urine 
specimen to the Medical Review Officer (MRO) as substituted. Under this 
guidance, a substituted specimen must have had a creatinine level of 5 
mg/dL or less and a specific gravity less than or equal to 1.001 or 
greater than or equal to 1.020.
    On the same date--September 28, 1998--ODAPC issued a memorandum to 
MROs as a companion piece to HHS's PD 035. In its memorandum, ODAPC 
instructed MROs to consider laboratory reported substituted results as 
refusals to test. There were no provisions for MRO review of 
substituted laboratory results.
    The Department of Transportation amended part 40 (65 FR 79462), 
effective January 18, 2001, to put into practice, among other things, 
procedures for MRO review of substituted specimens. The amendment held 
that employees could show MROs that they had medical reasons for 
producing the result and present evidence that they could naturally 
produce specimens meeting the HHS criteria for substituted specimens. 
MROs could cancel a ``substituted'' result in these circumstances.
    In May 2003, in response to scientific information that suggested 
that some people could naturally produce urine with creatinine in the 2 
to 5 mg/dL range, the Department of Transportation issued an interim 
final rule (68 FR 31624; May 28, 2003) directing MROs not to treat 
these results as substituted, but as negative-dilute. Unlike part 40 
procedures with other negative-dilute results however, MROs were 
instructed to direct the employer to have the employee return to the 
collection site for a directly observed collection with no prior 
notice. The result of the observed collection would be the result of 
the record for the entire testing event.
    HHS revised its Mandatory Guidelines with an effective date of 
November 1, 2004 (69 FR 19659; April 13, 2004). Among the revisions 
contained in the HHS Guidelines was the requirement that laboratories 
modify substituted specimen criteria. Under the revised HHS Guidelines, 
there were, and are, no specimens with creatinine levels greater than 
or equal to 2 mg/dL being reported by laboratories as substituted.
    Substituted results with creatinine in the 2 to 5 mg/dL range 
occurring between September 1998 and May 2003 were, according to the 
valid regulations in effect at that time, properly interpreted as 
refusals to test. However, in the interest of fairness the Department 
of Transportation is providing to individuals with such results the 
opportunity to have their drug test result reconsidered. If an 
employee's substituted drug test result is reconsidered, employers will 
be instructed not to report the substituted result to other DOT 
regulated employers requesting the employee's drug and alcohol testing 
history as required in 49 CFR part 40.25.
    The Department of Transportation is issuing this notice to set 
forth the procedures for such reconsideration. According to the notice, 
we intend to grant reconsideration only to those employees who present 
credible medical documentation that demonstrates their ability to 
naturally produce urine specimens with creatinine concentrations equal 
to or greater than 2, but less than or equal to 5 mg/dL and a specific 
gravity less than or equal to 1.001 or greater than or equal to 1.020.

[[Page 51888]]

    Employers who discover that an employee was reported to have a 
refusal to test as the result of a laboratory finding of creatinine 
concentration equal to or greater than 2, but less than or equal to 5 
mg/dL, prior to May 28, 2003, should inform the employee that he or she 
may submit documentation to ODAPC for reconsideration. To be viewed by 
ODAPC as credible medical documentation, the employee would have to 
submit information from a licensed physician or a MRO which documents 
that the employee can physiologically produce urine meeting the 
creatinine and specific gravity criteria. ODAPC will also accept an MRO 
verified drug result from the employee which resulted from a Department 
of Transportation required drug testing event that demonstrates the 
employee's ability to produce a creatinine level equal to or greater 
than 2, but less than or equal to 5 mg/dL. This verified result must 
have been reported by the MRO to the employer after May 28, 2003.
    The notice also provides the address that employees should send 
their documentation. ODAPC will carefully review every submission and 
will respond in writing to each employee who seeks to have his or her 
original refusal to test result reviewed.

    Issued this 5th day of September 2007, at Washington, DC.
Jim L. Swart,
Acting Director, Office of Drug and Alcohol Policy and Compliance.

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[FR Doc. 07-4428 Filed 9-10-07; 8:45 am]
BILLING CODE 4910-9X-C