On May 2, 2023, the Department of Transportation (DOT) published a final rule in the Federal Register (88 FR 27596).

This final rule, among other provisions, 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 the primary laboratory, and a second to serve as the split specimen laboratory.

Check here for the list of HHS-certified laboratories: https://www.transportation.gov/odapc/labs

What does this mean for employees?

You may 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 a second collection is needed during the testing event (e.g., an initial out-of-range urine specimen or insufficient quantity for either specimen type), the employer may switch to the other collection method to complete the test.

The choice between an oral fluid or urine test is at the employer’s discretion.

Substance Abuse Professional (SAP) evaluations may be conducted remotely (see SAP section below for details).

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

If you administer a program for an employer (including FMCSA-regulated owner-operators), in accordance with the employer’s decision regarding testing methodologies, ensure agreements are in place for both oral fluid and urine collections and laboratory testing.

Although employers may choose only one methodology, oral fluid testing must be available for directly observed collections involving transgender and nonbinary individuals.

Ideally, obtain standing orders from employers and ensure collectors are aware of what specimen to collect for regular, directly observed, shy bladder, or dry mouth collections.

What does this mean for employers? [2]

• You, not the employee, select the collection method based on the test reason (e.g., use urine for randoms; oral fluid for follow-ups).
• You also choose the collection method for any subsequent test after a shy bladder, dry mouth, or other issue requiring a directly observed collection.
• Ensure you have business relationships with oral fluid collectors and labs—either directly or through service agents.
• It is best practice to have standing orders with each collection site, indicating whether urine or oral fluid is to be collected and when.
• Designated Employer Representatives (DERs) must be available 24/7 to communicate with collectors—this is now more critical than ever.
• Verify your phone number is accurate on the Custody and Control Form (CCF) to ensure collector access.
• Be available to resolve collection issues and to discuss standing orders when problem scenarios arise (e.g., insufficient specimen—should the collector switch methods?).
• You are responsible for determining whether a refusal occurred at the collection site. Collectors may inform you of a potential refusal, but you make the final call.

Note: If an employee fails to appear for a pre-employment test or leaves the site before receiving the cup or device, it is not considered a refusal.

What does this mean for collectors?

• Know the employer’s preferences and standing orders for both regular and problem collections.
• Ensure the phone number listed on the CCF in Step 1.G. connects directly to you or your supervisor—not a general call center.
• The Employee ID on the CCF may be a Social Security Number, employer-issued ID, state-issued ID, driver’s license (including CDL), or any other state/federal ID (CDL and state required for FMCSA drivers).
• If a urine or oral fluid collection is required, ensure you or a colleague is qualified to perform either. If not, contact the employer to arrange alternate testing.

What should oral fluid collectors know?

• Obtain training demonstrating proficiency with each oral fluid collection device you will use.
• Complete the ORAL FLUID line on Step 2 of the CCF correctly.

You must:

• Check and show the expiration date on the device/package to the employee.
• Not use expired devices (this is a “fatal flaw” requiring error correction training).
• Check “Each Device Within Expiration Date?” in Step 2 of the CCF after confirming validity.
• Enter the split specimen device expiration date in Step 4 of the CCF.

What does this mean for laboratories?

• If an expired device is submitted, reject the oral fluid specimen.
• If the collector fails to enter the expiration date correctly in Step 4 of the CCF, reject the specimen unless you can determine the expiration date from Bottles A and B; in that case, note the date and proceed.
• Labs must provide DOT testing data biannually, categorized by operating administration (FRA, FTA, FAA, PHMSA, FMCSA), test reason (pre-employment, random, return-to-duty, etc.), and specimen type (urine, oral fluid).

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

• Recertification training is not required, but MROs are strongly encouraged to seek information on oral fluid testing by the time two labs are HHS-certified.
• MRO staff (not just MROs) may contact pharmacies to verify employee prescriptions as part of the review process.
• MROs are allowed to reinstate (un-cancel) tests previously canceled due to uncorrected flaws if the missing information (e.g., the CCF) is later provided.
• In rare cases where a second insufficient specimen follows an initial insufficient specimen (e.g., shy bladder then shy lung), only one referral evaluation is required for the second method.
• Employers are always responsible for determining if a refusal occurred—this duty cannot be delegated.

What does this mean for SAPs?

SAPs may perform evaluations either in person or remotely, following these criteria:

• The technology used must allow real-time two-way audio and visual communication.
• The quality must be sufficient for the SAP to gather information equivalent to an in-person meeting.
• The system must ensure secure, confidential communication.
• SAPs must abide by geographic limits of their credentials when conducting remote evaluations—they must not evaluate individuals beyond those limits.

What are some of the other changes to Part 40?

For directly observed collections where a same-gender collector is unavailable:

• If the employer has a standing order permitting oral fluid testing, the collector will follow it.
• If no standing order exists, the collector must contact the DER and either proceed with an oral fluid collection if feasible or send the employee to an appropriate collection site.

For observed collections involving transgender or nonbinary individuals, oral fluid testing is mandatory.

Starting with Subpart C of Part 40, several new sections have been added, and many others (including Appendices) have been redesignated and renumbered to better support oral fluid testing users. See the “Background” section of the final rule for the updated structure.

Where can I find a copy of the final rule?

You can view the final rule on ODAPC’s website.

NOTE: This document provides an informal summary of key rule changes. It is not a substitute for the rule itself and should not be relied on for legal compliance. Affected entities—including employers and service agents—should consult the final rule.

[1] Post-accident toxicological testing conducted under Federal Railroad Administration (FRA) authority is not subject to OTETA and 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] For FMCSA-regulated owner-operators, the C/TPA assumes many employer responsibilities. See 49 CFR Part 382 for more details.

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