August 4, 2003

US Department of Transportation
Dockets Management Facility
Room PL-401
400 Seventh Street, SW
Washington, DC 20590
Docket OST-2003-15245


This is to submit comments on behalf of the Drug and Alcohol Testing Industry Association (DATIA) regarding the Department of Transportation’s (DOT) interim final rule concerning reporting specimens as dilute or substituted. While we are in favor of the rule’s intent, there are some areas that need to be clarified for effective implementation.

DATIA is an 1,100-member national trade association representing the full spectrum of drug and alcohol testing service agents including laboratories, collection sites, C/TPAs, BATs, MROs, SAPs, employers, and testing device manufacturers. DATIA’s mission includes working closely with key policy makers in Federal Agencies and in Congress to ensure that the interests of the industry are heard and taken into account when changes in drug and alcohol testing rules are proposed. DATIA works to ensure that these changes foster rather than hinder the industry’s growth. DATIA further works to educate the industry on current standards of service and regulatory policies and procedures.

The initial problem that DATIA sees with the rule as written is that MROs are required to report specimens with a creatinine level less than 5mg/dL, but greater than or equal to 2mg/dL, as either negative or positive dilute. The way that laboratories report specimens with a creatinine less than 5mg/dL, however, was not changed in the regulatory text. Specimens with a creatinine less than 5mg/dL are still only reported as “substituted”, without positive or negative, as required by §40.97. To meet the DOT’s intent, §40.97 will need to be changed to instruct laboratories to report substituted specimens as also positive or negative.

The second scenario that DATIA would like to address is whether or not MRO assistants can review reports of negative specimens greater than or equal to 2mg/dL but less than 5mg/dL. Since these test results are no longer considered a “substituted” result, but more an “ultradilute”, and MRO assistants are able to review negative dilute results, DATIA feels that MRO assistants should be able to review these results. This needs to be addressed §40.127 and §40.129

Finally, DATIA would like to ask why specific gravity has been removed from the equation. In §40.93 the criteria for a substituted specimen is a specimen with a creatinine of less than 5mg/dL AND a specific gravity of less than or equal to 1.001 or greater than 1.020. In the DOT’s Interim Final Rule, however, the only criteria discussed is the creatinine. Specific gravity is still a valid measure to determine the validity of a specimen and we would hope that the DOT would include this measure in their final rule.

DATIA appreciates the opportunity to provide these comments to the DOT. Should you have any questions or need further elaboration on any of our comments, I can be reached at 800-355-1257 or lshelton@datia.org.

Sincerely,

Laura Shelton
Executive Director


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