07-4428. 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 [phone]; or E-mail [e-mail].

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.

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.