Part 40 Final Rule – DOT Summary of Changes

This final rule amends the DOT’s regulated industry drug testing program primarily as it relates to oral fluid testing.

When is the final rule effective?
The final rule is effective December 5, 2024.

What does this mean for collectors?
1)    The rule clarifies that a qualified urine collector (§ 40.33) is not a qualified oral fluid collector (§ 40.35), and vice-versa.

2)    The rule provides temporary qualification requirements for mock oral fluid monitors.

• DOT clarifies that generally, a qualified collector for the oral fluid mock collections required under § 40.35(c) must be a qualified oral fluid collector and have specific experience in oral fluid collections or training.
• Prior to this rulemaking, there were no qualified oral fluid collectors per §40.35(c)(2) to monitor and evaluate a trainee’s mock collections.
• To best facilitate the timely training of oral fluid collectors, the final rule permits an individual who is not a qualified oral fluid collector to serve as the monitor for oral fluid mock collections ONLY if:
  • The individual successfully completes an oral fluid “train the trainer” course (§ 40.35(c)(2)(iii)); OR
  • The individual conducts oral fluid collector training (§ 40.35(c)(2)(ii)).
    • DOT is waiving the requirement that an individual have at least 1 year experience conducting oral fluid collector training.
    • The individual conducting the oral fluid collector training should (1) have a thorough understanding of Part 40, (2) be well versed in the course content they are teaching, and (3) maintain records to demonstrate that the training was conducted.  The course content must meet the requirements specified in § 40.35(b).
• The temporary regulatory relief outlined above will sunset one year after HHS publishes a Federal Register notice that it has certified the first oral fluid drug testing laboratory.
  • After the one-year period, individuals observing oral fluid mock collections (i.e., monitors) will need to comply with the qualified oral fluid collector requirements in § 40.35(c)(2).
  • So that all are aware of the effective dates of the regulatory flexibility, DOT will publish a Federal Register document specifying the date the first oral fluid laboratory was certified by HHS and the effective date that individuals observing mock collections (i.e., monitors) will need to comply with the qualified collector requirements in § 40.35(c)(2) established in the May 2023 final rule.

3)    The rule identifies which individuals may be present during an oral fluid collection

• An oral fluid collector must not allow any person other than the collector, the employee, or a DOT agency representative to actually witness the testing process.

4)    The rule clarifies how collectors are to document that a sufficient volume of oral fluid was collected

• After an employee provides a sufficient oral fluid specimen, the collector must check the “Volume Indicator(s) Observed” box in Step 2 of the Federal CCF to document that the collector observed the volume indicator(s).

Can individuals complete oral fluid collection device training and oral fluid mock collections before HHS certifies oral fluid testing laboratories?

• Yes.  However, training on an oral fluid collection device that has not been approved for use as part of an official HHS laboratory certification package comes with the risk that the device may not be ultimately included by a laboratory with its application package to HHS and/or approved for use by HHS.
• This risk is borne entirely by the trainer and prospective collector, as DOT does not have any role in determining which particular oral fluid collection device is submitted by a laboratory as part of its application to HHS.

Where can I find a copy of the final rule?
You can view the final rule on ODAPC’s web site.

NOTE:   This document informally summarizes some of the important effects of the rule, but it is not a substitute for the rule and should not be relied upon to determine legal compliance with the rule.  ODAPC encourages affected entities, including employers and service agents, to review the final rule.