The U.S. Department of Transportation (DOT) has published regulations overhauling and expanding its regulated employee testing program to include oral fluids drug tests.  The new regulations, which update 49 C.F.R. Part 40 (Part 40), will be effective June 1, 2023, although employers will not be able to include oral fluids testing in their regulated drug and alcohol testing program until regulators at the Department of Health and Human Services (HHS) certify at least two laboratories to process oral fluids samples before they actually begin to use oral fluids tests.  Once the oral fluids testing program is implemented, however, the use of such tests will be mandatory in some cases.

The change was necessitated by the federal government’s December 2019 embrace of oral fluids testing for federal workers, and the Omnibus Transportation Employee Testing Act’s requirement that DOT harmonize its testing requirements with those adopted by the HHS for federal workers.  Nevertheless, the DOT engaged in a detailed rulemaking process and considered feedback from the relevant stakeholders who each play a part in the federal transportation drug and alcohol testing process.

Now final, the regulations impact the drug and alcohol testing programs covering an estimated 8 million transportation workers, including each of the DOT’s sub agencies with mandatory drug testing requirements, including the Federal Aviation Administration (FAA), the Federal Motor Carrier Safety Administration (FMCSA), the Federal Railroad Administration (FRA), the Federal Transit Administration (FTA), and the Pipeline and Hazardous Materials Safety Administration (PMHSA).  The procedural changes will also impact Coast Guard drug and alcohol programs, which also follow DOT testing protocols.  The new regulations are published in the Federal Register at 88 FR 27596 and can be accessed from the DOT’s Office of Drug and Alcohol Policy & Compliance (ODAPC).

An employer typically will have the right to determine which type of sample it will collect for drug testing purposes.  This change to the regulations should provide welcome flexibility for both employers and employees.  For example, if an employee cannot produce a sufficient urine specimen and a recollection is needed, an oral fluids test can be administered more expeditiously than a second urine collection, which may take up to three hours to complete under existing regulation.  Obtaining an alternative specimen may also obviate the need for an employee who fails to produce a specimen in a timely manner to obtain a medical evaluation or be deemed to have refused the test.  Third-party administrators and collector representatives are urging employers to work with their drug testing vendors to ensure that their preferred approaches are communicated to their account managers.

Testing Mechanics

Oral fluids samples, like urine samples, will be collected and packaged for testing in a manner that will ensure a sufficient sample to conduct initial and confirmatory testing, as well as confirmatory re-tests for those workers who test positive and elect that procedure.  Oral fluids tests will be collected with the assistance of a trained collector, and the regulations include detailed procedures to ensure that the individual has not engaged in conduct to “beat” the test result, such as scanning the donor’s oral cavity before the test begins.  Conduct designed to thwart the collection of an oral fluids specimen has been added to Part 40’s list of conduct that is considered a “refusal to test.” 

Oral fluids tests will be considered “observed collections” for DOT purposes.  This means that whenever an observed collection is required, it will no longer be necessary for a same-gender observer to be present to ensure that the donor has not concealed a device that might be used to tamper with or substitute a urine sample, although in the case of urine collections, that process is still mandatory.  Once oral fluids testing laboratories are approved, the regulations provide oral fluids tests will be the only means of conducting observed specimen collections from transgender workers. 

A related change to Part 40 emphasizes that employers must ensure that their Designated Employer Representatives (DER) are available at all times—“24-7” according to the DOT—to answer questions from collectors.  The updated regulations remind employers that it is up to the employer, not the collector, to decide whether an individual (other than an individual who leaves the testing site prior to starting the pre-hire test process) has engaged in conduct that qualifies as a refusal to test.  That decision will, at times, affect whether the collector administers a second specimen collection or simply documents the refusal to test.

Collectors will need to be trained on administering oral fluids tests, the new federal Custody and Control form, and employer protocols for determining which tests to administer.  Part 40 has been expanded to include a detailed collection protocol for oral fluids testing, and the federal Custody and Control form has been amended to allow the collector to identify the specimen collected.  

Notably, the regulations will also continue the practice of allowing Substance Abuse Professionals (SAPs) who evaluate transportation workers who have violated the drug and alcohol testing regulations to conduct remote, rather than in-person face-to-face evaluations.  That change was originally permitted to address pandemic concerns about in-person meetings, but the DOT’s pandemic guidance ceases on May 11, 2023.  Evaluations must be face-to-face, so on-camera audio/visual technology provided through a secure interface is needed if the SAP and worker are not in the same room.  However, the ability to conduct remote evaluations will extend only as far as the SAP’s own licensing permits.  For example, an SAP will not be able to conduct evaluations of individuals in states where they do not have authority to practice. Medical review officer assistants will gain the ability to confirm prescriptions with pharmacies.

Agency-Specific Regulatory Updates

Although the primary purpose of the new regulations is to set out the details on how DOT oral fluids testing will be implemented, and therefore primarily impact the drug and alcohol testing procedures codified at Part 40, each of the DOT’s sub-agencies has adopted changes to its own drug and alcohol testing program to harmonize or conform to the new Part 40 as applicable.

As part of its agency-specific update to its drug and alcohol rules (49 CFR Part 382), the FMCSA also has updated its regulations to recognize that regulated employers no longer regularly gather drug and alcohol testing history information from candidate drivers’ prior FMCSA employers.  Instead, regulated employers now check the Drug and Alcohol Clearinghouse operated by the FMCSA for the required information.  The Clearinghouse is a secure online database that gives employers, the FMCSA, state driver licensing agencies and law enforcement personnel real-time information about commercial driver’s license (CDL) and commercial learner’s permit (CLP) holders’ drug and alcohol program violations, including driver return-to-work compliance progress.

Only FMCSA drug and alcohol violations are captured in the Clearinghouse database.  For that reason, the new regulations make it clear that if the CDL driver to be employed has within the last three years been subject to non-FMCSA DOT drug and alcohol requirements, the new employer must continue to seek information regarding that driver’s prior drug and alcohol violations directly from those prior employers.  For example, a bus operator who has worked for a regional transportation authority may be primarily subject to FTA drug and alcohol regulations.  The Clearinghouse holds no information on FTA drug and alcohol regulatory violations, necessitating the direct outreach to prior employers as a condition of performing FMCSA regulated safety-sensitive functions.

Next Steps

Regardless of transportation modality, regulated employers should ensure their DERs are aware of the DOT drug and alcohol program changes, and begin to review their policies and procedures to ensure compliance.  Taking steps to determine the protocol the employer will use once oral fluids testing is added to the testing panel will avoid confusion and policy updates will prepare employees for changes going forward.