substituted urine sample

[Federal Register: September 11, 2007 (Volume 72, Number 175)]
[Notices]
[Page 51887-51891]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11se07-123]

-----------------------------------------------------------------------

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 mark.snider@dot.gov.

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.

[[Page 51889]]

[GRAPHIC] [TIFF OMITTED] TN11SE07.007


[[Page 51890]]


[GRAPHIC] [TIFF OMITTED] TN11SE07.008


[[Page 51891]]


[GRAPHIC] [TIFF OMITTED] TN11SE07.009

[FR Doc. 07-4428 Filed 9-10-07; 8:45 am]

BILLING CODE 4910-9X-C