49 CFR Part 40 – Procedures for Transportation Workplace Drug and Alcohol Testing Programs
Subpart A - Administrative Provisions
This regulation acts as the “gold standard” for transportation safety. It covers every person and entity involved in the DOT drug and alcohol testing process. This includes all DOT-regulated employers, safety-sensitive employees (such as truck drivers, pilots, and mariners), and service agents—including collectors, Medical Review Officers (MROs), Substance Abuse Professionals (SAPs), and laboratories.
This section establishes a uniform language for the industry. It defines critical roles like the Designated Employer Representative (DER), who is the only individual authorized to take immediate action to remove employees from safety-sensitive duties, and technical terms such as “Adulterated Specimen,” which refers to a specimen containing a substance not normally found in human urine.
Official clarifications emphasize that an “employee” is anyone currently performing, or applying to perform (applicants), a safety-sensitive function. It also clarifies that Service Agents are not considered “employers” and cannot sign off on program decisions as a DER.
To prevent conflicting advice, only the DOT Office of the General Counsel (OGC) and the Office of Drug and Alcohol Policy and Compliance (ODAPC) have the power to issue binding, official interpretations. Guidance from other sources is considered “information” but not legally binding.
Exemptions are granted only in extreme circumstances. An applicant must submit a written request to the Secretary of Transportation proving that complying with the current rule is impossible and that their proposed alternative provides a level of safety equal to or greater than the original regulation.
If a private restroom isn’t available, a same-gender monitor stands outside the stall but inside the restroom to listen for sounds that suggest the employee is using a hidden device or pouring water.
Accordion Content
Subpart B - Employer Responsibilities
Employers hold the ultimate legal “buck.” They are responsible for every aspect of the program. Even if an employer hires a third party (C/TPA) to manage their testing, the employer is the one held liable by the DOT if a collector makes a mistake or if a test is missed.
DOT tests must be entirely isolated from “company” (non-DOT) tests. You cannot use a single specimen for both, and you cannot use a Federal CCF for a non-Federal test. This prevents the “mixing” of legal authorities and protects the integrity of the federal program.
For every test, the employer must provide the collector with the employee’s full name or SSN/ID, the specific authority (e.g., FMCSA), the reason for the test (Random, Post-Accident, etc.), and the DER’s contact information.
Yes, employers frequently use Consortia/Third-Party Administrators (C/TPAs). However, the employer cannot delegate the role of the DER; there must be a person within the company who can receive results and pull drivers off the road.
Clarifies that while a service agent can coordinate the random pool, the employer remains responsible for ensuring the employees actually go to the collection site when selected.
Yes. An employer must actively ensure their service agents are qualified. If a collector hasn’t been trained correctly, the employer—not just the collector—can be cited for a violation during an audit.
This is generally prohibited and called “Stand-Down.” Employers cannot remove an employee from safety-sensitive duties based on a laboratory “confirmed positive” alone. They must wait for the MRO to talk to the employee and verify the result, unless the DOT has granted that specific employer a formal waiver.
If an employee admits to drug use before verification, the employer can remove them, but they cannot do so based on a “rumor” or a preliminary lab report.
If the result is a verified positive or a refusal, the employer must immediately remove the employee from safety-sensitive duties. No “one last trip” is allowed. They must also provide a list of SAPs with contact info and locations.
Yes. Before an employee starts safety-sensitive work, the employer must (with written consent) obtain the drug and alcohol testing history from all previous DOT employers for the past two years.
If a previous employer is out of business or refuses to answer, the new employer must document every attempt they made to get those records to prove “good faith” effort.
Employers must use the standardized MIS Data Collection Form (Appendix H) to report their annual testing statistics when required by their specific DOT agency.
No. While employees sign the CCF to authorize the test itself, an employer cannot force them to sign a legal waiver that releases the employer from liability for negligence or malpractice.
Subpart C - Specimen Collection Personnel
Only individuals who have completed the specific “qualification training” and “proficiency demonstration” required by Part 40. Even a licensed doctor or nurse cannot collect unless they have specifically trained in DOT procedures.
Collectors must complete three phases: 1) Basic information/rules, 2) Qualification training, and 3) Five error-free mock collections monitored by a qualified trainer. This must be repeated every five years.
Clarifies that mock collections must include specific “problem” scenarios (like a “shy bladder” or an out-of-temperature specimen) to ensure the collector knows how to handle trouble.
The training mirrors urine collection but focuses on the specific oral fluid device used. Collectors must perform five mock collections and prove they can correctly use the volume indicator and seal the vials.
The collector must have the DER’s name and phone number. This is vital because if an employee walks out (refusal) or cannot provide a specimen, the collector needs to reach the DER immediately to report the situation.
Subpart D - Collection Sites, Forms, Equipment, and Supplies
The Federal Drug Testing Custody and Control Form (CCF). It is a five-part form (or electronic equivalent) that tracks the specimen from the donor’s hands to the laboratory’s analysis.
The DOT confirms that Electronic CCFs (eCCFs) are acceptable as long as the laboratory’s system is HHS-certified and the donor can sign electronically.
No. This is a strict “cross-contamination” rule. Using the wrong form is a violation and requires a formal “memorandum for record” to correct if it happens by mistake.
At a site that provides a “private enclosure” (usually a bathroom stall). It must have a source of water for handwashing outside the stall to prevent the donor from diluting the specimen with tap water.
Collectors must:
1) Secure the site from unauthorized people,
2) Use blue dye in the toilet,
3) Turn off water inlets.
4) Inspect the area for “cheating” materials before and after the collection.
A single-use, wrapped collection cup and two specimen bottles (Bottle A: 30mL, Bottle B: 15mL) that are leak-resistant and tamper-evident.
Shipping containers (courier bags) that are sealed with a shipping label and contain the lab’s copy of the CCF.
Anywhere that ensures privacy. Unlike urine, oral fluid does not require a bathroom, but it does require a site that prevents unauthorized people from seeing the collection.
An HHS-approved device consisting of a collection wand and a tube containing a stabilizing buffer/preservative fluid.
Similar to urine, it requires a primary and secondary leak-resistant container and a secure shipping mailer.
Subpart E - Specimen Collections
- 1. Verify ID.
- 2. Ask the employee to leave bags and coats outside.
- 3. Ask the employee to empty their pockets and display the items to ensure no tampering devices (like “Clean Stream” kits) are present.
The collector must have the employee wash their hands and then provide them with the collection container. The collector stays outside the stall while the employee provides the sample.
1) Check for at least 45 mL of volume.
2) Check the temperature within 4 minutes (must be 90–100°F).
3) Inspect for unusual color, odor, or floating objects.
1) The specimen is out of temperature.
2) The specimen looks tampered with.
3) The MRO orders it.
4) It is a Return-to-Duty or Follow-up test. The observer (same gender) must watch the urine flow from the body into the cup.
If a private restroom isn’t available, a same-gender monitor stands outside the stall but inside the restroom to listen for sounds that suggest the employee is using a hidden device or pouring water.
The specimen is poured into Bottle A and Bottle B. The collector applies the tamper-evident seals and has the employee initial the seals. This must all happen in full view of the employee.
The collector must check the employee’s mouth for “foreign objects” (gum, food, candy). If found, the objects are removed and the collector waits 10 minutes to ensure the oral environment is clear for a valid sample.
The collector (or employee) swabs the cheek and gum area until the device’s volume indicator turns color, showing a sufficient amount of saliva has been absorbed.
The employee signs the CCF certifying the specimen is theirs. The collector then gives the employee their copy and prepares the package for the courier. If an employee refuses to sign the final certification, it is not a refusal, but the collector must document the incident.
Subpart F - Drug Testing Laboratories
Only laboratories that have been inspected and certified by the Department of Health and Human Services (HHS). A list of these labs is published monthly.
1) Marijuana (THC),
2) Cocaine,
3) Amphetamines (including Meth and MDMA),
4) Opioids (Heroin, Codeine, Morphine, Oxycodone, etc.)
5) PCP
The lab first checks the seals. If a seal is broken, they reject the specimen. If intact, they perform a primary screen. If the screen is “non-negative,” they perform a second, highly accurate test (GC/MS or LC/MS) to confirm the specific drug.
| Drug Analyte | Urine Initial Cutoff | Oral Fluid Initial Cutoff |
|---|---|---|
| Marijuana (THC) | 50 ng/mL | 4 ng/mL |
| Cocaine | 150 ng/mL | 15 ng/mL |
Yes. Laboratories must test specimens to ensure they are human and have not been tampered with. For urine, they check pH and creatinine. For oral fluid, they check for specific proteins like Albumin or IgG to prove it is saliva.
Dilute: Low creatinine and low specific gravity (often caused by drinking massive amounts of water).
Substituted: The creatinine and specific gravity are so low (or high) that the specimen is “physiologically impossible” for a human to produce.
The lab reports the final result (Positive, Negative, Dilute, Adulterated) directly to the MRO. They do not call the employer with the results.
They must be “at arm’s length.” To prevent bias, an MRO cannot work for the lab that processes the tests they verify, nor can they have a financial stake in that lab.
Every January and July, labs must send a report to the employer and the DOT summarizing the total number of tests and the number of positives/negatives. This report contains no names—only data.