New final rule posted for the CFR

Jul 3, 2024

The Federal Register posted a revision to the CFR on June 21, 2024, as final rule to be implemented as of August 5, 2024. The DOT published the rule without any proposal or discussion time as it was felt that the revisions being made are so noncontroversial that there would be no negative responses. However, they did still publish a separate document (Proposed Rule) to allow for comment should anyone have it, but there will only be this one period for comment.

There are three revisions being made in this direct final rule and they are all to do with the most recent addition of oral fluid testing which has been added to the CFR. The first change is in section § 40.35 regarding what training requirements a collector must meet for oral fluid collections. The section was built based on the requirements already set out for urine collection certification in § 40.33 which require a mock test to be monitored by a ‘qualified collector’. The requirements for being a ‘qualified collector’, as written, must be someone who has demonstrated the necessary knowledge, skills and abilities by:

(i) regularly conduction DOT drug test collections for period of at least one year;

(ii) conducting collector training under this part for at least one year; or

(iii) successfully completing a “train the trainer” course.

It was then noticed that the requirements as currently written are impossible to be fulfilled since there are no DOT collectors who have been regularly conducting oral fluid testing for a period of at least one year or training for at least one year as this new testing mode has yet to be established. This will be amended to authorize those who have the knowledge, skills and abilities as set out in § 40.35(c)(ii), waiving the requirement for the year of experience conducting oral fluid collector training or oral fluid collections. The DOT does make it very clear, however, that those undertaking this role would still be expected to have a very thorough understanding of part 40. As well, there is still the expectation that those conducting the training will be well versed in the course content and will maintain good records (knowing course content, length of training, dates courses were taught and successfully completed) as one would be expected to do for urine collections today.

The final rule notes that this “regulatory flexibility will sunset one year after the HHS publishes a Federal Register notice that it certified the first oral fluid laboratory”. They further state that they will publish a Federal Register document that specifically identifies the date that this rule will return to the initially published version. DOT oral fluid cannot be implemented until there are two HHS certified laboratories for oral fluid, one for primary specimens and one for split specimen testing, as of this writing there are none yet certified, but when there are they will be added to the list of HHS-certified laboratories here.

The second change is to section § 40.73 How is an oral fluid specimen collected? (persons allowed in the testing room). The DOT had meant for the collection procedure for oral fluid to mirror that of alcohol testing procedure as laid out in § 40.223(b) which includes the specification that there be only the BAT/STT, the employee or a DOT representative to witness the testing. This specification was inadvertently missed in the oral fluid section but will be added with this final rule, specifying the requirement for privacy for the employee and parallels the alcohol testing procedure found in § 40.223(b).

The third update is also the section § 40.73 but regarding specifications of the collection of a sufficient amount of oral fluid. Currently in § 40.73(c)(2) it does indicate that the collector is to ensure that a sufficient volume of specimen has been collected, however it did not specify how this will be confirmed. In this final rule they are adding the requirement that the collector check the ‘volume indicator(s) observed’ box in Step 2 of the custody and control form. This requirement will now be specifically stated in the regulation, instructing the collector that it is required to document their confirmation of observing this volume indicator in Step 2 during the collection.