DOT Part 40 Drug and Alcohol Testing Rule 2026: Directly Observed Collections When Oral Fluid Is Unavailable

The U.S. Department of Transportation has revised the foundational rule that governs every DOT-regulated drug and alcohol testing program. The final rule, published in the Federal Register on May 11, 2026, changes how collection sites handle situations where an oral fluid test is the required collection method but oral fluid testing is not yet available at the site. In those cases, the collector is required to conduct a directly observed urine collection when oral fluid testing is the required method under Part 40 but cannot be performed at the collection site, as defined in the rule. The rule also updates terminology in 49 CFR Part 40 consistent with Executive Order 14168. Every DOT-regulated employer — across FMCSA, FAA, FRA, FTA, PHMSA, and the U.S. Coast Guard — operates under Part 40. That means DERs, MROs, SAPs, and collection sites operating under Part 40 should understand what changed and how it may affect their procedures.

What the rule says

The Department of Transportation's official summary of the rule, published in the Federal Register, states that "[t]he U.S. Department of Transportation revises its drug and alcohol testing procedures to require a directly observed urine collection in situations where oral fluid tests are currently required but cannot be conducted because oral fluid testing is not yet available."¹ The same notice indicates that the rule "updates terminology in these procedures consistent with Executive Order (E.O.) 14168, Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government."¹

The full text of the rule appears at Federal Register notice 2026-09290. Operators should consult the official text for the precise procedural language before updating internal SOPs. The full rule is the authoritative source; this article summarizes the change at a level useful for compliance planning. The rule is effective June 10, 2026. Operators should align SOP updates and training timelines with this date.

Two practical points sit underneath the language. First, the rule does not eliminate oral fluid testing as a collection method. Oral fluid remains a permitted method under Part 40, and it remains required in the situations DOT has previously specified. The rule addresses what the collector does when the required method cannot actually be performed at the collection site because the site does not yet have oral fluid testing available. Second, the rule names a specific fallback — directly observed urine collection — rather than allowing the collector to default to a standard urine collection. Direct observation is a higher-control procedure under Part 40, and the rule specifies when it applies as the required fallback. Second, the rule names a specific fallback — directly observed urine collection — in those defined scenarios rather than allowing the collector to default to a standard urine collection.

The terminology updates in the second part of the rule align Part 40 language with the executive order. Operators reviewing their own SOPs should plan to align internal terminology with the updated regulatory language in customer-facing forms, training materials, and DER scripts so that documentation remains consistent with Part 40.

Who this affects

49 CFR Part 40 is the procedural backbone of every DOT-regulated drug and alcohol testing program. The modal rules — FMCSA's 49 CFR Part 382 for CMV drivers, FAA's 14 CFR Part 120 for aviation, FRA's 49 CFR Part 219 for rail, FTA's 49 CFR Part 655 for transit, PHMSA's 49 CFR Part 199 for pipeline, and the U.S. Coast Guard's 46 CFR rules for credentialed mariners — all incorporate Part 40 by reference for the testing procedures themselves. A change to Part 40 therefore reaches every regulated employer in every mode at the same time.

That includes the people inside those programs:

• Designated Employer Representatives (DERs) who decide what to do when a collector calls about an unavailable testing method.
• Collection sites and collectors who must execute the new procedure in real time during a collection event.
• Medical Review Officers (MROs) who review results and need to recognize directly observed urine collection records correctly.
• Substance Abuse Professionals (SAPs) who handle return-to-duty processes that include directly observed collections.
• CDL and CMV drivers, flight crew members, and other regulated employees who need to know what to expect if a collection event escalates.

Insurance partners and brokers underwriting fleets with active D&A programs also have an interest, because procedural compliance on Part 40 is a frequent inspection and audit finding. Carriers that update SOPs early may reduce compliance risk and operational disruption when collection issues arise.

What to do and by when

1. Read the full Federal Register notice. The summary above is not a substitute for the text. The procedural specifics — including the precise circumstances that trigger the directly observed fallback and the recordkeeping requirements for those collections — sit in the rule itself. Read it at federalregister.gov/documents/2026/05/11/2026-09290.
2. Confirm the effective date. The published rule includes the effective date and any phased compliance requirements. Calendar this date for every collection site in your network and every DER on your team.
3. Inventory your collection-site network. For each authorized collection site, confirm whether oral fluid testing is currently available. The rule's directly observed fallback applies specifically when oral fluid is required but unavailable — your SOP needs to know which sites that describes.
4. Update collection-site SOPs. Build the directly observed fallback into the site's workflow. Train collectors on when the escalation applies, how to document it, and how to brief the donor consistent with Part 40's existing direct-observation requirements.
5. Update DER playbooks. When a collector calls a DER about an unavailable testing method, the DER needs a clear, scripted answer. Update the playbook so the DER can authorize the directly observed urine collection without delay.
6. Brief MROs and SAPs. Both roles see directly observed collection records as part of their existing workflows. Make sure they recognize the new circumstance — "oral fluid required but unavailable" — and do not treat the directly observed result as an anomaly.
7. Update driver-facing communications. Pre-test communications, training materials, and any donor-facing handouts should reflect that a directly observed urine collection may occur in specific circumstances. Drivers should not be surprised when it happens.
8. Review return-to-duty and follow-up testing protocols. Return-to-duty and follow-up tests already include direct observation under Part 40. Make sure your SAP-coordinated return-to-duty process distinguishes the long-standing direct-observation requirement (return-to-duty / follow-up) from the new one (oral-fluid-unavailable fallback).
9. Update terminology across forms and training. The terminology updates in the rule should propagate into your custody-and-control documentation, internal training decks, DER scripts, and donor-facing materials. Keep internal language consistent with the updated Part 40.
10. Calendar a 30-day audit. Thirty days after the rule's effective date, audit a representative sample of collection events to confirm your sites and DERs are executing the updated procedure. If you find drift, retrain.

Operators with multi-modal programs — for example, a parent company that operates an FMCSA-regulated trucking subsidiary and an FAA-regulated charter air operation — should run this update through both modal compliance leads. The Part 40 procedural change applies identically across modes, but each modal program has its own internal training and audit cadence.

How Foley helps

Foley supports DOT-regulated employers with drug and alcohol testing program management, including access to a national collection-site network, MRO services, SAP coordination, and support for required testing workflows and documentation. When a procedural rule changes mid-year,the operational lift is in SOP updates, DER training, and maintaining consistent compliance processes. Foley's compliance team helps employers build the change into their existing program without rebuilding it. Visit the DOT Drug & Alcohol Testing hub or contact the compliance team to discuss specifics for your program.

Frequently asked questions

Does this rule require us to buy new collection devices?

No. The rule addresses what the collector does in the specific Part 40 scenarios where oral fluid testing is the required method but cannot be performed at the collection site because oral fluid testing is not yet available. The fallback is a directly observed urine collection, which uses the existing Part 40 urine collection procedure with direct observation added. The Federal Register summary does not indicate a new device requirement. Operators should confirm any equipment implications by reviewing the full rule text.

What does "not yet available" actually mean for our collection sites?

The full rule defines the trigger; the Federal Register summary states only that the fallback applies when oral fluid testing "is not yet available." Operators should confirm the precise definition in the rule text and align it with the actual capability at each authorized collection site in their network. This is a question to verify against the published rule, not to infer.

Does this change what happens during a random drug test?

The rule changes the procedure for one specific situation — required oral fluid, unavailable testing. It does not change how random selections are generated, how donors are notified, or how testing categories are assigned. Random testing continues under the existing Part 40 framework.

Does this change the testing panel or what is detected?

The Federal Register summary does not describe a panel change. Part 40 testing panels are governed by separate procedures within the rule. Operators should confirm their panel configuration is unchanged by reviewing the full text.

What about the terminology updates — what changes for our forms?

The terminology updates align Part 40 with Executive Order 14168. The practical impact for operators is that internal language, training materials, and donor-facing forms should mirror the updated regulatory text. Custody-and-control forms generated under the regulatory framework will reflect the change at the source; operator-generated documents need to be reviewed and updated.

Sources

1. Procedures for Transportation Workplace Drug and Alcohol Testing Programs — Federal Register, May 11, 2026 (FR-2026-09290)
2. 49 CFR Part 40 (eCFR) — Procedures for Transportation Workplace Drug and Alcohol Testing Programs
3. DOT Office of Drug & Alcohol Policy and Compliance (ODAPC)
4. 49 CFR Part 382 (FMCSA Drug & Alcohol Testing)