The Department of Transportation (DOT) issued an interim final rule on November 9, 2004 that amends drug and alcohol testing procedures for laboratories and medical review officers (MRO), making DOT requirements for specimen validity testing (SVT) consistent with the Department of Health and Human Services’ (HHS) new guidelines on SVT that became effective November 1, 2004.
This rule is effective November 9, 2004, but comments may be filed by December 9, 2004. Below, is a summary of the changes.
CHANGES
MROs will now provide medical review and verification for all laboratory-reported substitute specimen results, rather than providing medical review for some and direct-observation recollection for others. Under the new HHS guidelines, there will be no specimens with creatinine levels ≥ 2 mg/dL that will be considered substituted. In the same vein, all references in Part 40 to substituted specimens having creatinine levels ≥ 2 mg/dL will be removed.
DOT lab testing criteria will also change to mirror the HHS guidelines. A urine specimen will now be considered dilute when the creatinine concentration is ≥ 2 mg/dL, but ≤ 20 mg/dL, and the specific gravity is > 1.0010, but < 1.0030. (Previous urine specimens were considered dilute when the creatinine concentration is ≥ 5 mg/dL, but ≤ 20 mg/dL, and the specific gravity was > 1.001, but < 1.003).
Section 40.91 is changed to direct labs to perform validity tests for oxidizing adulterants and additional validity tests when certain conditions (e.g., abnormal physical characteristics) are observed.
The new rule also changes lab-reporting requirements, making them parallel to the new HHS reporting requirements except for the results of negative-dilute specimen results.
WHERE HHS and DOT DIFFER
DOT maintains that SVT is authorized, but not required. Section 40.89 does not change, but labs that conduct SVT are authorized to continue doing so and must follow the new HHS testing requirements.
MRO procedures in section 40.155 will require MROs to treat lab-reported negative-dilute results with the creatinine concentration ≥ 2 mg/dL, but ≤ 5 mg/dL as negative-dilutes that require immediate recollections under direct observation. Employers’ obligations under sections 40.197(b) and (c) do not change.
To help MROs with the new responsibilities, labs are now required to report numerical values for creatinine concentration and specific gravity on negative-dilute specimens reported to MROs.
LOOKING TOWARD THE FUTURE
DATIA will provide comments on behalf of the industry by the December 9, 2004, deadline. We also encourage members to submit comments individually.
Today’s Interim Final Rule also suggests that DOT will have a Notice of Proposed Rulemaking in the near future making SVT mandatory. DATIA will keep members informed of developments in this area, and continue to provide comments and voice concerns to DOT as these regulations proceed.
