FTA Drug and Alcohol Regulation Updates
Issue 17, page 4

Part 40 Amendments

49 CFR Part 40, Procedures for Transportation Workplace Drug Testing Programs

Revised:
December 19, 2000
Federal Register Vol. 65,
Pages 79462 - 79579.
Primary Topic: Procedures for Transportation Workplace Drug and Alcohol Testing Program Revised Final Rule (49 CFR Part 40)

• The DOT Office of Drug and Alcohol Policy and Compliance (ODAPC) is responsible for coordinating drug and alcohol testing program matters within the Department and providing information concerning the implementation of Part 40. The ODAPC is the only office within the DOT that can make official and authoritative interpretations concerning this rule. [40.203]
• Specimen validity testing is the evaluation of the specimen to determine if it is consistent with normal human urine. Laboratories are authorized to conduct validity testing following the requirements that are specified. These requirements will become mandatory August 1, 2001 or following the Department of Health and Human Services’ (HHS) publication of its mandatory requirements for validity testing, whichever is later. [40.205 – 40.207]
• Validity tests include tests for creatinine concentration, specific gravity, pH, and substances that may be used to adulterate a specimen. The regulation does not list the adulterants, but rather includes by reference the substances identified in current HHS requirements or specimen validity guidance. Criteria are established for determining when a specimen is dilute and adulterated. [40.207 - 40.211]
• Primary and split specimens that are reported as positive, adulterated, substituted, or invalid must be retained for a minimum of one year. The laboratory must retain the specimens longer if requested to do so by an MRO, employee, employer or a DOT agency. [40.213]
• Tests that result in findings of adulteration and substitution require review by a qualified MRO. The employee will also be offered the opportunity to have the split specimen tested. The MRO must follow the same procedures for verification of a confirmed positive drug test including providing an explanation of the laboratory finding, addressing technical questions raised by the employee, and offering the employee the opportunity to present a legitimate medical explanation for the laboratory result. The employee has the burden of proof and must demonstrate that the adulterant entered the specimen through physiological means. The same burden of proof and demonstration requirement must be met for substituted specimens as well. [40.215]
• Diversified Toxicology Consultants Inc. 901-757-2956
• The MRO has full discretion in the use of his/her professional judgment to determine a legitimate medical explanation for an adulterated or substitutional specimen. If a reasonable explanation may exist, the MRO must direct the employee to have a medical evaluation by a “referral physician” that has expertise in the medical issues raised. The employee must also demonstrate in a controlled environment how the results were possible. The final determination of whether there is a legitimate medical explanation is that of the MRO. [40.215]
• The DOT may institute a Public Interest Exclusion (PIE) that excludes service agents from participating in the DOT’s drug and alcohol testing program if they have serious noncompliance violations. PIE’s will be used to remedy situations if a service agent has failed or refused to provide drug or alcohol testing services consistent with the requirements of Part 40 or a DOT agency (i.e., FTA) drug and alcohol regulation. The DOT may also issue a PIE if a service agent has failed to cooperate with DOT agency representatives concerning inspections, complaint investigations, compliance and enforcement reviews, or requests for documentation. [Subpart F]