Last Updated: 05/28/2023

DOT Rules and Regulations / Part 40: Drug and Alcohol Regulations / Part 40 Final Rule - DOT Summary of Changes

On May 02, 2023, the Department of Transportation (DOT) published a final rule in the Federal Register (88 FR 27596). This final rule, among other items, amends the DOT’s regulated industry drug testing program to include oral fluid testing.

When is the final rule effective?

The final rule is effective June 1, 2023.

Can anyone implement DOT-regulated oral fluid testing on the effective date?

  • Not yet!
  • DOT oral fluid testing cannot be implemented until the Department of Health and Human Services (HHS) certifies at least two laboratories (one to serve as a primary laboratory, and a second to serve as a split specimen laboratory).
  • Check here for the listing of HHS certified laboratories

What does this mean for employees?

  • You could be subject to either an oral fluid collection or a urine collection for any DOT-regulated test [i.e., pre-employment, random, reasonable suspicion/ cause, post-accident (other than FRA [1]), return-to-duty, or follow-up].
    • If there is a reason a second collection is needed during the testing event, (e.g., initial temperature out-of-range urine specimen, or insufficient quantity for either an oral fluid or a urine specimen), the employer may choose to change to the other type of collection to finish the testing event.
  • The choice of whether to conduct an oral fluid or a urine test is up to the employer.
  • Substance Abuse Professional (SAP) evaluations may be conducted remotely (additional detail under the SAP section below).

What does this mean for Consortium/Third Party Administrators (C/TPAs)?

  • If you are administering a program for an employer (to include C/TPAs administering a program for FMCSA-regulated owner operators) in accordance with the employer’s decision about the testing methodologies to be used, you need to make sure there are agreements in place for both oral fluid and urine collections and laboratory testing. 
    • While the employer may opt for only one methodology, oral fluid testing must be available for directly observed collections for transgender and nonbinary individuals.
  • Ideally, ensure there are standing orders from the employer and that the collectors know what specimen they need to collect for regular collections and for direct observation, shy bladder, and dry mouth collections.

What does this mean for employers?[2]

  • You, not the employee, choose the collection methodology for the test reason (e.g., randoms will start with urine; follow-ups will use oral fluid).
  • You, not the employee, choose the collection methodology for the subsequent collection following a shy bladder, dry mouth, or other test that requires a directly observed collection.
  • ​​​​Ensure you have business relationships with the oral fluid collectors and labs, whether directly or through your service agents.
  • It is a best business practice to have a standing order in place with each of your collection sites, so they know what kind of collection you want performed (i.e., urine or oral fluid) and when.
  • Designated Employer Representatives have always been required to be available to the collectors 24-7, but that is even more important now.
    • Ensure your phone number is correct on the CCF so the collector can reach you.
    • You need to be available to the collector to discuss if there are problem collections.
    • You should always be available to discuss standing orders on what type of test you want administered if problem collection scenarios arise (e.g., if an employee does not provide a sufficient urine specimen, do you want the collector to switch to an oral fluid collection?).
  • It is the employer’s duty to determine whether a refusal has occurred at the collection site. Employers have never been able to delegate this duty. So, a collector can tell you something appears to be a refusal, but the final determination is yours.
    • Remember, if an employee does not appear for a pre-employment drug test or leaves the collection site before receiving a cup (for a urine collection) or unwrapping the device (for an oral fluid collection) it is not a refusal.

What does this mean for collectors?

  • Ensure you know the employer’s preferences and standing orders for regular and problem collections.
  • Ensure that the collector’s phone number provided on the Federal Drug Testing Custody Control Form (CCF) in Step 1.G. connects directly to the collector and/or the collector’s supervisor, and not a general call center.
  • Employee ID on the CCF can be the individual’s actual Social Security Number, a unique identifier issued by the employer, a State-issued identification card number, a State-issued driver’s license number (including a CDL number) or any other State-issued or federally-issued identification number (must be CDL number and State for drivers regulated by FMCSA).
  • Since either a urine or an oral fluid collection may be required, ensure that either you or a coworker is qualified to collect either specimen type. If no one is qualified to conduct the alternate collection, contact the employer so the employer can make arrangements to have the employee tested at another collection site.

What should oral fluid collectors know?

  • You must obtain training to proficiency in the operation of the particular oral fluid collection device you will be using; if you will be using more than one device, then you need to prove initial proficiency on each device.
  • Ensure that you complete the correct line on Step 2 of the CCF – ORAL FLUID.
  • You must:
    • check the expiration date on the device or on the package containing the device and show it to the employee,
    • not use the device after its expiration date (this would be a “fatal flaw” and you will need to complete error correction training),
    • check “Each Device Within Expiration Date?” in Step 2 of the CCF after ensuring the device is within its expiration date, and
    • enter the Split Specimen Device Expiration Date in Step 4 of the CCF.

What does this mean for laboratories?

  • For an oral fluid collection, if you receive an expired device, you must reject the specimen for testing.
  • For an oral fluid collection, if the collector failed to enter the expiration date or was entered incorrectly in Step 4 of the CCF, the laboratory must reject the specimen unless the laboratory is able to determine the expiration date by inspecting Bottles A and B.  The laboratory will note the correct date and proceed with the testing process.
  • Labs must bi-annually provide DOT data that is categorized by DOT operating administration (FRA, FTA, FAA, PHMSA, FMCSA), test reason (pre-employment, random, return-to-duty, follow-up, post-accident, reasonable suspicion/cause) and specimen type (urine, oral fluid).

What does this mean for Medical Review Officers (MRO)?

  • MROs are not required to undergo recertification training, but it is strongly suggested that MROs seek supplemental information about oral fluid testing by the time HHS certifies at least two laboratories to conduct oral fluid testing.
  • MRO staff (not just an MRO) may contact a pharmacy to verify a prescription that an employee has cited as a potential legitimate medical explanation for a laboratory-confirmed positive test.
  • MROs are permitted to un-cancel a test that had been previously cancelled by the MRO due to un-corrected flaws (e.g. the MRO did not receive a copy of the CCF, but later receives a copy of the CCF).
  • In the rare circumstance when an employee is not able to provide a sufficient oral fluid specimen after an insufficient urine specimen or vice a versa (shy bladder/shy lung), the employee would only be required to have a referral physician evaluation for the second specimen type attempted.
  • Remember, it is the employer’s duty to determine whether a refusal has occurred at the collection site.  Employers have never been able to delegate this duty.

What does this mean for SAPs?

  • SAPs may conduct evaluations either in-person or remotely, with criteria for remote evaluations as follows:
    • Technology used must permit real-time two-way audio and visual interaction between the SAP and the employee.
    • Quality of the technology must be sufficient to allow the SAP to gather all the visual and audible information the SAP would normally observe in a face-to-face in-person interaction.
    • Technology must incorporate sufficiently robust security to protect the confidentiality of the conversation.
  • If you are an otherwise qualified SAP, you must abide by the geographic limitations applicable to your credential when performing remote evaluations.  You must not conduct an evaluation that exceeds your geographic limitations.

What are some of the other changes to Part 40?

  • For directly observed collections, if the same gender collector cannot be found:
    • If the employer has a standing order to allow oral fluid testing in such situations, the collector will follow that order.
    • If there is no standing order from the employer, the collector must contact the DER and either conduct an oral fluid test if the collection site is able to do so or send the employee to a collection site acceptable to the employer for the oral fluid test.
  • For direct observation collections involving transgender or nonbinary individuals, an oral fluid collection must be conducted.
  • Beginning with Subpart C of Part 40, new sections have been added and numerous sections have been redesignated (i.e., renumbered and reordered), including the Appendices, to provide a more easily followed flow for users of the regulatory provisions specific to oral fluid drug testing (see the Table provided in the “Background” section of the final rule).   

Where can I find a copy of the final rule?

You can view the final rule on ODAPC’s web site.

NOTE:   This document informally summarizes some of the important effects of the rule, but it is not a substitute for the rule and should not be relied upon to determine legal compliance with the rule.  ODAPC encourages affected entities, including employers and service agents, to review the final rule.

[1] Post-accident toxicological testing conducted under Federal Railroad Administration (FRA) authority is not subject to the OTETA mandate and therefore does not follow Part 40 procedures.  See 49 U.S.C. § 20140(f), § 40.1(c), § 219.205(a), and § 219.701(a)-(b).

[2] In the case of FMCSA-regulated owner operators, the C/TPA has many of the employer’s responsibilities.  See 49 CFR part 382 for additional details.


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