49 CFR Part 40 Changes & Updates – Oral Fluid

On June 1, 2023, a final rule amending the 49 CFR Part 40 regulation of the United States Department of Transportation (DOT) takes effect. This final rule amends the DOT’s regulated industry drug testing program to include oral fluid drug testing. There are also other changes and updates to 49 CFR Part 40 regulation that are discussed in this post. 49 CFR Part 40 is the official regulation for the DOT drug & alcohol testing program for the Federally regulated transportation industries.

First and foremost is the inclusion of oral fluid drug testing as an option for DOT-required drug testing. More information about DOT oral fluid drug testing is included on our web page entitled: DOT Oral Fluid Drug Testing, Collections & Mocks

Important Terms:

49 CFR Part 40DOT regulations for drug and alcohol testing program for Federally regulated transportation industry
DOTUnited States Department of Transportation
ODAPCOffice of Drug and Alcohol Policy and Compliance
OTETAOmnibus Transportation Employee Testing Act
HHSUnited States Department of Health & Human Services
MROMedical Review Officer
OFMGOral Fluid Mandatory Guidelines

DOT oral fluid final rule requires the amendment of some provisions of Part 40 to harmonize with the United States Department of Health and Human Services (HHS) urine and oral fluid Mandatory Guidelines. This includes clarifications, removal of unnecessary provisions, and modification of a few substantive provisions to address issues that have arisen in practice. These are listed below. New Part 40 changes not specifically related to oral fluid drug testing can be viewed here:

30 + PART 40 Changes Not Related To Oral Fluid Drug Testing

In order to allow oral fluid drug testing across the DOT-regulated transportation industries, some minor adjustments to some of the DOT agency regulations were needed. Specifically, ODAPC has made conforming changes to 14 CFR part 120 (FAA), 49 CFR part 219 (FRA), 49 CFR part 382 (FMCSA), and 49 CFR part 655 (FTA), all of which are directly subject to the OTETA mandate to follow the HHS Mandatory Guidelines for the scientific and technical requirements for oral fluid testing under Part 40.

What are the 49 CFR Part 40 changes and updates effective June 1, 2023?  

Some clarifications and definitions are not listed as some of these changes are not substantive and only designed to conform Part 40’s wording with that of the HHS guidelines.  Many sections of Part 40 have been redesignated to allow for the oral fluid drug testing information and other clarifications, removal of unnecessary provisions, and modification of a few substantive provisions to address issues that have arisen in practice   

Oral Fluid Specific Changes, Additions, Clarification

Items of change, modification, addition or clarification to Part 40 related to oral fluid drug testing are included in this section below:

  1. The final rule makes it clear that employers will decide whether to use oral fluid testing and in what circumstance.  
  2. The DOT oral fluid drug testing program requires a collection device that permits a single specimen to be collected and subdivided in the presence of the donor.  DOT will allow devices with either one or two pads that can be subdivided and sealed in the presence of the employee.
  3. Training requirements have been added for the qualification of collectors for oral fluid specimen collections for DOT oral fluid drug testing 
  4. Proficiency demonstration or mock collection requirements have been added for collectors for oral fluid specimen collections for DOT oral fluid drug testing
    1. requirement for a collector to obtain “training to proficiency in the operation of the particular oral fluid collection device(s) the collector will be using
    2. the collector must demonstrate proficiency for each device they will be using
  5. Collection sites will have an option to train collectors on both urine and oral fluid specimens collections or just urine or just oral fluid.
  6. New section 40.72 – “What steps does the collector take in the collection process before the  employee provides an oral fluid specimen?” This goes over specimen collection procedures for the oral fluid drug testing program.
  7. For the collection procedures for oral fluid testing the final rule states the collector is required to check the oral cavity to ensure that it is free of any items that could impede or interfere with the collection of an oral fluid specimen.  40.72(a) also states the collector needs to be checking for anything that could be used to adulterate, substitute, or alter the specimen. 
  8. New section 40.72 (b)  requires the employee to rinse with 8 ounces of water if something was in the mouth and a 10-minute period before a second collection.
  9. If a donor states their mouth is dry, then § 40.72(b)(1) requires the collector to give the employee up to 8 ounces of water to rinse their mouth. The collector must then wait 10 minutes before beginning the specimen collection.  If dry mouth occurs after the initial collection is attempted, this will begin a one-hour period to allow a sufficient specimen.
  10. The employer must send the employee for a dry mouth medical evaluation if the employee has not provided a sufficient oral fluid specimen; alternatively, the employer can authorize a second attempt at a collection using urine as the specimen.
  11. New section 40.73 ( c ) (1) requires conducting collections correctly – using the oral fluid device in the manner described by its manufacturer. The oral fluid collection must be done under the observation of the collector. In addition, the employee must properly position the device.
  12. For oral fluid collections, the collector is required to check the expiration date on the collection device and document it on the CCF in Step 4 next to “Split Specimen Device Expiration Date” 
  13. Clarifying fatal flaw language was added that the laboratory must reject a specimen if the collector used an expired device at the time of collection or the collector failed to enter the expiration date in Step 4 of the CCF, but only if the laboratory confirms the device was expired.  
  14. A new Appendix B has been added establishing standards for oral fluid collection kits, based on material in the HHS OFMG and consistent with OTETA requirements for a split specimen. Several Appendixes have been redesignated as a result of this new Appendix B including Appendix C, D, E, F, G, H, I, and J.
  15. New sections of subpart F are §§ 40.91–40.93 which cover cutoff concentrations and specimen validity testing (SVT) for oral fluid specimens.  
  16. A new data element will be required in § 40.97(c)(1)(i)(I) to require a laboratory to report the oral fluid collection device expiration date in laboratory results report to the MRO.

Learn more on our upcoming webinars: DOT Oral Fluid Drug Testing – What you Need to Know!

DOT Oral Fluid Drug Testing
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