The United States Department of Transportation (DOT), the Federal Aviation Administration (FAA) the Federal Railroad Administration (FRA), the Federal Motor Carrier Safety Administration (FMCSA), and the Federal Transit Administration (FTA) have jointly published a final rule to expand their regulated drug testing procedures to include oral fluid laboratory based testing, effective June 1, 2023. Please note that point of collection/rapid/instant testing continues to not be permitted. The addition of laboratory based oral fluid testing is a significant testing methodology change, as the DOT previously allowed only urine drug testing for safety-sensitive positions. This final rule stems from a Health and Human Services (HHS) final rule – in effect since Jan. 1, 2020 – allowing federal agencies to use oral fluid testing in their drug-testing program
Policy Behind the New Rule
As stated in the Summary to the Final Rule, the reasoning for this policy change is as follows:
“[t]his additional methodology for drug testing will give employers a choice that will help combat employee cheating on urine drug tests and provide a less intrusive means of achieving the safety goals of the program.” DOT also cited the following as additional reasons for adopting the final ruling: 1) all oral fluid collections are directly observed; 2) the collection process is donor-friendly, especially in situations where an observed collection is necessary; 3) oral fluid collections are much less intrusive than urine collections; 4) generally, oral fluid can be less expensive than urine testing; 5) oral fluid offers many unquantifiable benefits, such as: “shy bladder” elimination, alleviation of psychological/physical burdens associated with urine collections, opening job opportunities to those with disabilities, and thwarting drug test cheating attempts; 6) having both oral fluid and urine as options allows employers to efficiently deal with situations where an individual is unable to provide a sufficient specimen of either type; 7) oral fluid eliminates the need for same gender collectors; 8) oral fluid is a less time-consuming alternative when an individual cannot produce a sufficient urine specimen; and, 9) oral fluid can detect recent use of some drugs, including cannabis and cocaine.
Timing, Laboratories, Testing Devices, and Collectors
As noted above, this final rule will come into effect on June 1, 2023. However, conducting oral fluids laboratory based testing is practically not possible at this point in time. It may be a number of months or longer before such testing can be conducted by DOT covered employers. In order for an employer to implement oral fluid testing under the Final Rule, , HHS will need to certify at least two laboratories for oral fluid testing, which has not yet been done. In essence, the Final Rule clears a historical regulatory hurdle permitting such testing methodology to be used, but testing is not possible until the testing laboratories are certified by HHS.
With respect to oral fluid laboratory-based devices, the Final Rule states that employers will only be able to use a device that collects a single specimen that is subdivided in the presence of the donor. This means there may be some differences between SAMHSA approved devices and devices approved under this Rule. HHS must approve a certified laboratory to use a particular oral fluid collection device in order for it to be used for DOT testing purposes.
In order to act as a DOT oral fluid collector, an individual must meet the following conditions:
- be knowledgeable about current DOT oral fluid collection guidelines and applicable DOT
regulations; 2 have received qualification training that provides instruction on DOT testing procedures, device operation proficiency training for specific devices that will be used, correct
collection and CCF completion/transmission, problem collection situations, fatal/correctable flaws and how to correct problems, and the collector’s responsibility in terms of: collection integrity, employee privacy, specimen security, and the avoidance of offensive or inappropriate statements/conduct; 3) demonstrate collection proficiency following qualification training by completing five consecutive error-free mock collections for each device that will be used. Once an individual has completed all of the above requirements, they can begin performing DOT oral fluid collections. Refresher training must occur at least every five years and must meet all the same requirements as the initial DOT oral fluid collector training. These collections cannot be performed by the donor employee themselves, relatives, close friends, or the donor’s immediate supervisor (subject to limited exception).
More information on collection site requirements, the collection process, cutoff levels, can be found in the entire rule, here: https://www.govinfo.gov/content/pkg/FR-2023-05-02/pdf/2023-08041.pdf