Although the 49 CFR Part 40 Department of Transportation (DOT) rules were changed over nine (9) months ago to allow the use of oral fluid specimens for federal drug testing under the Procedures for Transportation Workplace Drug and Alcohol Testing Programs, no oral fluid collections may be conducted as of the publication of this newsletter (March 18, 2024). We realize that everyone in this industry is anxiously awaiting the green light to begin training collectors to conduct oral fluid collections, but the public has no idea at this point when this will happen. We continue to receive questions from customers, such as:
What are we waiting for???
Before a trained oral fluid specimen collector may begin collections using this particular bodily fluid, there must be at least two laboratories certified by the Department of Health and Human Services (HHS), and this has not occurred yet. Under the federal regulations, there must also be one laboratory to serve as a primary laboratory and a second lab to serve as a split-specimen testing laboratory.
In addition, there are currently no oral fluid collection devices approved and available that meet the DOT rule requirements. Appendix B of the Part 40 Rules requires a single oral fluid collection device that may be subdivided in the donor’s presence. Once device(s) are available that meet the Appendix B requirements, the next hurdle is that they must be approved by HHS for use by the specific laboratory that will test the specimen that was collected by this particular, approved device. As you may imagine, this is a lengthy process.
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