The U.S. Department of Transportation (DOT) has issued a final rule amending 49 CFR Part 40, effective Dec 5, 2024
The DOT’s May 2023 49 CFR Part 40 rule authorized oral fluid drug testing but encountered unforeseen circumstances related to compliance issues regarding mock collection monitors, consistency with privacy requirements, and collection volume documentation. This final rule addresses those issues that were identified in a Notice of Proposed Rulemaking (NPRM) issued June 21, 2024
- Temporary Qualification Requirements for Oral Fluid Collectors. Individuals who are not yet qualified oral fluid collectors can now monitor and evaluate mock oral fluid collections if they meet certain knowledge, skills, and abilities as specified in § 40.35(c)(2)(ii) or (iii). For a one-year period, the usual requirement of having at least one year of experience conducting collector training is waived, and individuals who have successfully completed an oral fluid “train the trainer” course are eligible to monitor and evaluate mock collections. This temporary provision will expire one year after the Department of Health and Human Services (HHS) publishes a Federal Register notice announcing the first certified oral fluid drug testing laboratory.
- Privacy During Oral Fluid Collections. The rule specifies that only the collector, the employee being tested, or a DOT agency representative may witness the oral fluid testing process.
- Documentation of Sufficient Oral Fluid Volume.: The rue clarifies that collectors document the collection of a sufficient oral fluid specimen by checking the “Volume Indicator(s) Observed” box in Step 2 of the Federal Custody and Control Form (CCF) after the employee provides a sufficient specimen.
PRACTICAL IMPLICATIONS
- Oral Fluid collector qualification training can begin, including the mock collections. Be aware that the specific oral fluid device used for the mock collections may not be the device utilized by any given certified laboratory. Consequently, mock collections may have to be conducted again using the DOT-compliant collection system specified by the laboratory in its NLCP certification process.
- DOT Oral Fluid Testing cannot be implemented until Two Laboratories Are Certified. As of now, no laboratories have been certified by HHS for oral fluid drug testing. In addition to laboratory certification, there must be at least one oral fluid collection device that meets DOT requirements as specified in Appendix B of 49 CFR Part 40. The collection device must be approved by HHS for use by the specific HHS-certified laboratory that will test the specimen.
- DOT-regulated Employer Policies and Procedures. Employers must update their policies and procedures to provide for oral fluid drug testing when it is fully authorized for implementation. The best guess for oral fluid laboratory HHS certification is the first quarter of 2025. Please note that every DOT-regulated employer must be able to conduct oral fluid testing, specifically in circumstances where a direct observation urine collection is required and the applicant/employee identifies as transgender/non-binary.
