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The long-awaited approval of oral fluid drug testing for the United States Department of Transportation (DOT) drug testing program has arrived effective June 1, 2023. Although the methodology is approved, oral fluid testing will not be available for six to 12 months as major laboratories apply for approval and certification from the United States Department of Health and Human Resources (HHS).

The drugs in the 4-panel drug test are some of the most commonly abused street drugs. They are seemingly the most accessible to addicts because of their wide distribution. When abused, methamphetamines can be smoked, snorted, injected, or taken orally.

Brief History of Regulated Oral Fluid Drug Testing

DOT drug testing is regulated by DOT regulation 49 CFR Part 40 and individual DOT agency regulations. The drug and alcohol testing process required by DOT comes from the Mandatory Guidelines for Federal Workplace Drug Testing Programs first published in April of 1988 by the United States Department of Health and Human Resources (HHS). These guidelines affect Federal employees (those working for the Federal government), and it’s also the model drug testing program that DOT and other non-DOT drug and alcohol testing programs follow.

Effective January 1, 2020, HHS authorized the use of oral fluids as a specimen for drug testing in their mandatory guidelines. It was not until June 1, 2023, that the DOT approved and incorporated oral fluid testing into the DOT drug testing regulation 49 CFR Part 40. Also, as of June 1, 2023, all of the DOT-specific agencies incorporated the approved use of oral fluids in their specific DOT agency regulations. The Department of Transportation must follow the HHS scientific guidelines for DOT-regulated drug testing laboratory procedures; this was required by the Omnibus Transportation Employee Testing Act of 1991.

June 1, 2023, Status of DOT Oral Fluid Drug Testing

The United States Department of Transportation has approved the use of oral fluid specimens in the DOT drug testing program effective June 1, 2023. 49 CFR Part 40 has been amended. However, the use of oral fluid for drug testing is not yet operational. DOT is requiring two laboratories to be approved and certified by HHS for the use of oral fluid specimens in the DOT drug testing program. The two certified laboratories must be utilizing the same oral fluid collection device. No laboratories are currently certified and HHS certification of two or more labs is not expected before the 4th quarter of 2023.

If you have questions or want to order a test, call 866-566-0261 or order your test online!

What are the Benefits of Oral Fluid Drug Testing?

• The collection is easy and always directly observed, with no gender requirements.
• The non-invasive specimen collection method causes minimal health and safety concerns.
• Employer representatives can be trained to collect specimens on-site at employer premises.
• There’s a shorter window of detection to find recent drug use, which is particularly useful for post-accident and reasonable suspicion drug testing.
• It can eliminate up to a three-hour shy bladder wait.
• It can eliminate uncomfortable direct observed urine collections.

Employer Options for DOT Oral Fluid Drug Testing

Employers will have the sole responsibility to choose the specimen for DOT drug testing – urine or oral fluid. Employers will also have the sole responsibility of a situation to switch from a urine collection to an oral fluid collection and also to switch from an oral fluid collection to a urine collection. Communication with collection site facilities will be very important in this process. The employer may, for different testing reasons (pre-employment, random, post-accident, reasonable suspicion, return to duty, and follow-up), choose either oral fluid or urine specimens.

Employers will have options to choose the specimen to be used for a subsequent collection following a shy bladder, dry mouth, a temperature out of range, and other circumstances that cause a directly observed collection.

It will be a best practice for employers to have “standing orders” or protocols in place with collections sites for what kind of specimen is to be used and when for particular reasons or situations. A professional Consortium/Third Party Administrator (C/TPA) will be able to assist employers with these standing orders. These standing orders should also include employer direction on when to switch from a urine collection to an oral fluid collection and when to switch from oral fluid to urine.

What Do DOT-Regulated Employees and Job Applicants Need to Know?

Employees and job applicants (often called the donor) may be subject to the use of an oral fluid specimen or urine specimen for a DOT-required drug test. The employee or job applicant will not be authorized to choose which specimen they want to use. This choice will always be up to the employer and if the donor refuses one specimen or the other, they may find themselves with a refusal to test with serious consequences.

The use of oral fluid specimens can eliminate the discomfort of a directly observed urine collection and the potential three-hour wait time when a donor has a shy bladder.

DOT Oral Fluid Specimen Collection Devices and Collection Procedures

Oral fluid specimen collectors will be required to complete qualification training, including mock collections. This will be in addition to the qualification training, including mock collections, for urine specimen collections. The current Federal custody and control form (CCF) shall be used for either urine or oral fluid collections. When performing a second oral fluid collection after a first urine specimen has been collected, the collector will use a second CCF and cross-reference the forms with each form’s unique specimen ID number.

All oral fluid collections are directly observed with no gender requirements. The new DOT rule requires employers to use oral fluid testing for transgender or nonbinary individuals when direct observation is required for those individuals.

The oral fluid collection devices to be used will need to meet FDA, HHS, and DOT specifications. One device will be required for each collection with the ability for the specimen to be split into two collection containers in front of the donor. The oral fluid collection device must have a volume indicator to demonstrate to the collector that sufficient oral fluid has been collected. The manufacturer’s instructions for the use of the device will need to be followed by the oral fluid specimen collector.

Oral fluid collection devices will come from the lab that is contracted to do the testing. It is important to note that, unlike laboratory urine specimen collection cups that are provided by the labs at no cost, oral fluid collection devices have a significantly higher cost, and labs or C/TPAs will charge an upfront fee for these. The price they will charge will be determined at a later date.

Oral fluid collection devices will have an expiration date and collectors will be required to check a box on the CCF form that they have checked that the device has not expired. Collectors will also be required to record the expiration date on the CCF form. The use of an expired oral fluid collection device will result in a fatal flaw.

Here is a brief overview of the oral fluid collector procedure:

• Inspection of inside the mouth before the oral fluid collection
  • Flashlight recommended
  • Donor removes anything in their mouth
  • If donor claims dry mouth, they can be provided eight ounces of water to rinse
• Each collection will require a 10-minute wait period before the oral fluid collection
  • Collector provides or donor selects a sealed oral fluid collection kit
  • Collector reviews the collection instructions with donor
  • Collector shows donor the device expiration date and records date on CCF form
• Donor inserts device into mouth
• Collector instructs donor to remove device when volume indicator shows sufficient quantity of specimen
  • Up to 15 minutes is allowed for the device to register sufficient quantity
  • Dry mouth, no sufficient quantity – eight ounces of water to rinse can be provided, 10-minute wait and up to one hour for the donor to be able to try again
• Dry mouth – with employer approval, the collection can pivot to a urine collection
• Once specimen is obtained, collector places in an A and B vial; every collection must be a split specimen
• Vials must be sealed, initialed, dated, and packaged for transport to laboratory with lab copy of CCF
• Suspect specimens where a second specimen collection was performed must also go to a lab; for a urine collection with temperature out of range and a second oral fluid collection, both specimens go to the lab or perhaps two different labs

In the near future, the Office of Drug and Alcohol Policy and Compliance (ODAPC) will publish a DOT Oral Fluid Collection Guidelines manual. This will assist with the training for oral fluid specimen collectors.

Our drug testing specialists are standing by to assist you. Call 866-566-0261 or order your test online!

DOT Oral Fluid Specimen Drug Testing Laboratory Processes

The laboratory process for oral fluid testing is similar to the process for urine. These DOT oral fluid drug tests are not instant tests. They are oral fluid specimen collections that are transported to a certified lab for initial and confirmation testing.

Lab cut-off levels for oral fluid specimens are much lower than for urine specimens. Oral fluid specimens will have a higher concentration of the metabolites of the drugs that are being tested. Like with urine specimens, cut-off levels are established by HHS not to detect exposure but use of the drug. With marijuana only, the oral fluid test target analyte is THC (parent drug) while urine testing detects the metabolite THCA (carboxy-THC).

With oral fluid specimens, the lab shall not perform specimen validity testing unless the specimen is suspect. All non-negative results will go for confirmation testing at the lab. All drug test results in the DOT program are reported to a medical review officer (MRO) for review, verification, and reporting.

DOT Oral Fluid Specimen Drug Testing MRO Process

MROs should keep up to date on the oral fluid drug testing process. The review process, verification, and reporting of the oral fluid drug test results will remain essentially the same as for urine drug test results. DOT oral fluid drug testing will be covered in MRO refresher and re-certification training programs.

If no specimen is collected due to dry mouth, the MRO will assist the employer in finding a physician to evaluate the donor for a medical explanation for not being able to provide a sufficient specimen.

Helping Our Clients Implement DOT Oral Fluid Specimen Drug Testing

US Drug Test Centers currently offers a full suite of DOT testing and DOT consortium services. For new and existing clients, once the DOT oral fluid specimen drug testing is available from a certified lab, comprehensive DOT oral fluid testing services will become available. Our company will help DOT-regulated employers throughout the entire process of adding oral fluid testing to your DOT drug and alcohol testing program.

US Drug Test Centers will assist clients with best practices for standing orders for when to use oral fluid specimens and when to switch to oral fluid specimens. Our goal will be for our clients to take advantage of the various benefits of oral fluid testing — see What are the Benefits of Oral Fluid Drug Testing?

US Drug Test Centers will recommend employers use oral fluid specimens for the following reasons:

• Any drug testing that requires direct observation
• Anytime a donor goes into a shy bladder process
• After a urine specimen shows a temperature out of range or appears to have been adulterated or substituted
• Remote areas where finding a collection site is difficult (employer representatives can be trained to collect oral fluid specimens)
• All post-accident and return-to-duty drug testing

For questions regarding DOT Oral Fluid Specimen Drug Testing, please contact US Drug Test Centers. For additional information, visit our website regarding DOT Oral Fluid Specimen Drug Testing.

FAQs for DOT Oral Fluid Drug Testing

Learn more on our US Drug Test Centers web page: Oral Fluid Drug Testing for DOT Employers

Many other questions can be answered on our US Drug Test Centers web page providing the Facts On DOT Oral Fluid Drug Testing.