Part 40 Final Rule: DOT Summary of Changes and What It Means for Employers and Collectors

On November 5, 2024, the Department of Transportation (DOT) published a final rule in the Federal Register (89 FR 87792) that introduces significant updates to its regulated industry drug testing program. This new rule focuses on the implementation of oral fluid drug testing, an alternative to the traditional urine-based testing. These updates aim to enhance the flexibility, accuracy, and oversight of drug testing practices within the DOT-regulated industries. Below, we summarize the key changes and their implications for employers, service agents, and collectors.

The DOT's final rule will become effective on December 5, 2024. Employers, collectors, and other stakeholders should familiarize themselves with the rule’s requirements and prepare for compliance as of that date.

The final rule introduces several new requirements and clarifications for collectors involved in the drug testing process. These updates are particularly relevant for those handling oral fluid collections. Here are the main points:

1. Qualification Distinction Between Collectors

The rule emphasizes that a qualified urine collector (§ 40.33) is not automatically a qualified oral fluid collector (§ 40.35), and vice versa. This distinction highlights the need for specialized training and qualification processes for oral fluid collections.

2. Temporary Qualification Requirements for Oral Fluid Monitors

To address the current lack of qualified oral fluid collectors for mock collection evaluations, the DOT has established temporary measures.

Who Can Monitor Mock Collections?

• Individuals who complete an oral fluid "train the trainer" course (§ 40.35(c)(2)(iii)).
• Individuals conducting oral fluid collector training (§ 40.35(c)(2)(ii)).

The DOT has waived the requirement for one year of prior experience in conducting oral fluid collector training for these monitors. However, monitors must possess a thorough understanding of Part 40, be proficient in the course material, and maintain records of the training provided.

This temporary provision will expire one year after the Department of Health and Human Services (HHS) certifies the first oral fluid drug testing laboratory. After that, all monitors must comply with the qualified oral fluid collector requirements outlined in § 40.35(c)(2).

3. Restrictions on Witnesses During Oral Fluid Collection

The rule limits who may be present during an oral fluid collection to ensure privacy and integrity. Only the collector, the employee, and an authorized DOT agency representative may witness the testing process.

4. Documenting Sufficient Oral Fluid Collection

Collectors must document when a sufficient volume of oral fluid has been collected by checking the “Volume Indicator(s) Observed” box on Step 2 of the Federal Custody and Control Form (CCF). This requirement ensures accurate record-keeping and compliance with testing procedures.

The DOT allows prospective collectors to complete training on oral fluid collection devices and conduct mock collections before HHS certifies any oral fluid testing laboratories. However, this comes with potential risks:

• The devices used in training may ultimately not be included in HHS's approved certification package.
• Collectors and trainers assume full responsibility for the outcomes associated with using unapproved devices.

Employers and collectors should weigh these risks carefully before initiating training with unapproved devices.

The adoption of oral fluid testing provides several advantages:

1. Reduced Adulteration Risks: Oral fluid testing minimizes the risk of specimen tampering compared to urine testing.
2. Enhanced Observability: The collection process is directly observable, ensuring authenticity.
3. Faster Detection Windows: Oral fluid testing can detect recent drug use, making it a valuable tool for post-accident or reasonable suspicion testing.

By expanding the available drug testing methods, the DOT is fostering a more adaptable and robust compliance framework for regulated industries.

Employers and service agents should take the following steps to ensure compliance with the new rule:

• Update Policies: Review and update drug and alcohol testing policies to include oral fluid testing procedures.
• Train Staff: Ensure that collectors are appropriately trained and qualified for oral fluid collections.
• Communicate Changes: Inform employees about the new testing procedures and their implications.
• Stay Informed: Monitor updates from the DOT and HHS regarding laboratory certifications and training requirements.

These proactive measures will help regulated entities adapt smoothly to the upcoming changes.

DISA Global Solutions offers expert support to help employers navigate the DOT’s Part 40 Final Rule changes. From providing comprehensive training programs for oral fluid collectors to assisting with policy updates and ensuring regulatory compliance, DISA is your partner in simplifying drug testing processes. With a full suite of customizable testing solutions and decades of industry expertise, we are here to ensure your workforce remains safe, compliant, and ready to meet regulatory requirements. Contact DISA today to learn how we can help you stay ahead of these changes.

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