NDASA is pleased to announce both the most recent DOT final rule addressing oral fluid collections and the beginning of oral fluid collector training – effective December 5, 2024!
In today’s Federal Register, the U.S. Department of Transportation’s (DOT) Office of Drug and Alcohol Policy and Compliance (ODAPC) finalized its proposed rule regarding collector training issues, which includes changes and clarifications requested by NDASA. (89 FR 87792, Nov. 5, 2024) The modifications to oral fluid testing being made in this final rule will become EFFECTIVE ON DECEMBER 5, 2024. We encourage you to read the entire final rule and are providing only excerpts from the preamble below.
In this final rule, ODAPC has made amendments “to provide temporary qualification requirements for mock oral fluid monitors, provide for consistent requirements by identifying which individuals may be present during an oral fluid collection, and clarify how collectors are to document that a sufficient volume of oral fluid was collected.”
As you know, NDASA and several of our dedicated members filed comments to this Notice of Proposed Rulemaking in July. DOT’s ODAPC thoroughly considered the comments and issued a final rule that addressed many of our concerns.
Specifically, in this oral fluid collection final rule, DOT has clarified:
“DOT did not intend to prevent individuals from training on devices to collect oral fluid specimens before HHS certifies a laboratory and use of an associated oral fluid collection device… there is no regulatory requirement to wait until the first laboratory is certified by HHS before beginning training on the use of oral fluid collection devices.” [Preamble – p. 87793] Consequently, with this supportive language in place, oral fluid collector training can begin on December 5, 2024!
DOT cautions and NDASA urges, that NO DOT-REGULATED oral fluid testing can be conducted until HHS certifies both a primary and a secondary laboratory for oral fluid testing.
To be qualified to monitor the mock proficiency demonstrations for a collector or a collector trainee, DOT acknowledges “it is appropriate to authorize individuals to monitor mock oral fluid collections without meeting the requirement of being a qualified oral fluid collector [for a limited time of one year after HHS approves the first laboratories – after that, DOT will reinstate the one-year of collections requirement].” [Preamble – p. 87795]. DOT’s final rule allows an individual to be a monitor if they have taken a train-the- trainer course and they “meet the necessary knowledge, skills, and abilities” that are set forth in § 40.35(c)(2)(ii) or (iii), even if they have not been an oral fluid collector for one year. DOT also said of these monitors, “we expect those individuals to have a thorough understanding of Part 40 and to be well versed in the course content they are teaching.” [Preamble – p. 87793]. In other words, those who have taken the NDASA-Certified Train-the-Trainer course are qualified to monitor the mock proficiency demonstration of a collector or a collector trainee after December 5th!
DOT acknowledged there is no regulatory requirement for trainers to keep documentation of the training records and curriculum on the date of the training for each trainee. However, that would be “a business best practice”. [Preamble – p. 87795] NDASA and those who filed supportive comments have been heard on this subject!
DOT amended section 40.73(a)(1) regarding who can be present for a collection to match the alcohol testing requirement in Part 40.
Also, DOT accepted language offered by NDASA and supporting commenters regarding checking the volume indicator for the sufficiency of the specimen.
NDASA appreciates the supportive comments from members who took the time to make those filings. You helped to make a difference and we are grateful that DOT’s ODAPC heard you and us!
NDASA NOTE
For those who have taken the NDASA-Certified Train-the-Trainer course, once you have obtained your devices, please contact NDASA to conduct your mock proficiency demonstrations.