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Summer 2008 Issue 37 |
| U.S. Department of Transportation | Federal Transit Administration | Office of Safety and Security |
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Introduction -
The Federal Transit Administration (FTA) published its revised rule on prohibited drug use and the prevention of alcohol misuse (49 CFR Part 655) on August 1, 2001. The FTA published the revised Implementation Guidelines for Drug and Alcohol Regulations in Mass Transit to provide a comprehensive overview of the regulations. Since the Guidelines were published, there have been numerous amendments, interpretations, and clarifications to the Drug and Alcohol testing procedures and program requirements. This publication is being provided to update the Guidelines and inform your transit system of these changes. This update is the thirty-seventh in a series. |
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Final Rule Makes Validity Testing Mandatory
On June 25, 2008, the Department of Transportation (DOT) published a final rule that amends 49 CFR Part 40 to make specimen validity testing mandatory. The rule that was published in the Federal Register, Volume 73, pages 35961–35975, will become effective on August 25, 2008. The rule change provides direction to collectors, laboratories, medical review officers, and employers regarding adulterated, substituted, diluted, and invalid urine specimen drug test results.
The final rule (§40.89(b)) makes specimen validity testing mandatory for all DOT tests, including those conducted for employers covered by the Federal Transit Administration (FTA). Certified laboratories are required to follow the testing protocols for adulterated and invalid urine specimens that are established by the Department of Health and Human Services (HHS). The identity of adulterants tested for and the cutoff levels for adulterated or invalid test results are not included in the final rule as the DOT will follow the criteria established in the HHS Mandatory Guidelines.
In an effort to make it more difficult to adulterate or substitute specimens, the final rule requires that specimens be collected under direct observation any time there is a specific reason to believe that any employee may be attempting to thwart the rule or has sufficient reason to evade the testing process. The conduct of observed collections for return-to-duty and follow-up drug testing will no longer be optional, but will be a required component of these testing circumstances (§40.67). The manner in which the observed collections will be performed is also described (see article on Page 2).
The long list of potential test results reported by the laboratories and Medical Review Officers (MROs) was clarified and simplified. Additionally, the final rule expanded the definition of a test refusal to include an employee admission of adulteration or substitution during the MRO review process of an invalid test result.
In addition, the MRO review process following an invalid test result for test categories requiring negative test results (i.e., pre-employment) was modified to allow MROs to accept medical evaluations ruling out signs and symptoms of drug use when employees/applicants have medical reasons for providing invalid results (§40.160). This procedure is consistent with the medical review process allowed for pre-employment testing circumstances when an individual has insufficient volume due to a long term or permanent disability.
The final rule also requires laboratories to provide the DOT with semi-annual reports providing statistical summaries of their DOT testing results and provides a clarification of their blind specimen quality control measures to include adulterated and substituted specimens.
For additional information regarding the rule change and its implication for employees, employers, and service agents, please refer to the articles provided on the following pages.
Specimen Validity Testing Definitions
Adulterated - A specimen is considered adulterated if it contains a substance that is not a normal constituent or contains an endogenous substance at a concentration that is not a normal physiological concentration.
Diluted - Diluted specimens have creatinine and specific gravity values that are lower than expected for human urine. The HHS has determined that specimens with creatinine levels greater than or equal to 2.0 mg/dL but less than 20.0 mg/dL and have a specific gravity greater than 1.0010 but less than 1.0030 are dilute. Individuals with creatinine levels greater than or equal to 2.0 mg/dL but less than 5.0 mg/dL are required to be retested under direct observation.
Substituted - Substituted specimens have creatinine and specific gravity values that are so diminished or so divergent that they are not consistent with normal human urine. The HHS has determined that specimens with creatinine levels of less than 2.0 mg/dL are substituted.
Invalid - An invalid specimen is one that contains an unidentified adulterant, contains an unidentified interfering substance, has an abnormal physical characteristic, or has an endogenous substance at an abnormal concentration that prevents the laboratory from completing testing or obtaining a valid drug test result.