Why This Story Matters:
The following article about workplace drug testing on the federal level is authored by Jackie Pirone, Vice President of Current Consulting Group, the number one recognized brand in expert drug testing consulting. This information is provided for educational purposes only. Reader retains full responsibility for the use of the information contained herein.
Federal Drug Testing Compliance Begins Year with Major Changes
By Jackie Pirone, Vice President of Current Consulting Group
The beginning of 2025 is already off to a big start when it comes to workplace drug testing on the federal level. Both the Substance Abuse and Mental Health Services (SAMHSA) and the Department of Transportation (DOT) have issued guidelines for drug testing that will impact some federally regulated employers.
Mandatory Guidelines for Federal Workplace Drug Testing Programs-Authorized Testing Panels
On January 16, 2025, SAMHSA, under the Department of Health and Human Services (HHS), published the “Mandatory Guidelines for Federal Workplace Drug Testing Programs – Authorized Testing Panels” via the Federal Register. These guidelines provide updated test panels and related information for federal agency workplace drug testing programs, detailing changes to urine and oral fluid drug testing.
Effective Date & Scope:
These revisions will take effect on July 7, 2025, and apply only to federal agency workplace drug testing programs. They do not apply to drug testing programs regulated by the DOT, the U.S. Coast Guard (USCG), or the Nuclear Regulatory Commission (NRC).
Key Updates:
- Fentanyl has been added to the testing panel.
- Criteria for grouped analytes have been revised for associated alternate technology initial drug tests.
- Abbreviations for THC and its metabolites have been updated.
- The current panels remain in effect until July 6, 2025.
- As of July 7, 2025, all HHS-certified laboratories must use the revised panels for federal agency specimens accessioned (received), regardless of the collection date.
- HHS has not approved biomarker testing for federal workplace drug testing.
Important Notes:
- These updates apply exclusively to federal agencies governed by HHS Urine Mandatory Guidelines (UrMG) and Oral Fluid Mandatory Guidelines (OFMG).
- DOT and NRC testing programs remain unaffected at this time.
- DOT and NRC must issue their own rules to align with these revisions before they apply to their programs.
- DOT has not yet adopted the 10/12/23 HHS UrMG revision regarding a 4000 ng/mL morphine confirmatory cutoff.
For the full notice in the Federal Register, click here.
DOT Oral Fluid Testing & Collection Guidelines
On May 2, 2023, the DOT published a final rule in the Federal Register (effective June 1, 2023) [88 FR 27596], authorizing DOT-regulated employers to use oral fluid as an alternative to urine specimens for conducting DOT-required drug testing.
On January 15, 2025, the DOT issued guidelines for oral fluid specimen collection procedures. These guidelines, together with the 49 CFR Part 40 and the DOT Operating Administration rules, provide collectors with the necessary procedures and best practices for oral fluid collections.
The DOT Office of Drug and Alcohol Policy and Compliance (ODAPC) developed these guidelines for:
- DOT-regulated employers
- Individuals who conduct oral fluid specimen collections under DOT regulations
The document outlines:
- Standard oral fluid collection procedures
- Common challenges collectors may face
- Best practices for handling various scenarios
- Detailed steps on Part 40 compliance
Key Points for Employers:
Employers, not employees, choose the specimen type (urine or oral fluid) based on the test reason. Employers can use different specimen types for different testing scenarios:
- Example: Pre-employment and random drug tests via oral fluid, while other test types use urine collections.
Employers can also switch collection types for problem collections, such as:
- ‘Shy bladder’ or ‘dry mouth’ cases
- Direct observation collections (§ 40.67) per DER direction
- Suspected tampering with an oral fluid specimen
Best Practices for Employers:
- It is best practice for employers to have ‘standing orders’ (e.g., a written protocol) for when an oral fluid specimen is collected versus a urine specimen.
- An oral fluid specimen is considered a direct observation collection for all purposes under Part 40.
For DOT-Regulated Employers & Collectors:
- Be familiar with the employer’s standing orders.
- Be aware of which oral fluid collection device and laboratory the employer will be using.
- If you are collecting two different specimen types (urine and oral fluid), ensure you send each specimen to the correct laboratory, as not all laboratories conduct oral fluid testing, and some oral fluid testing laboratories may not conduct urine testing.
- Have the Designated Employer Representative (DER) contact information readily available.
For Collectors & Collection Sites:
- Inform each DOT-regulated employer you service about which specimen types you or your personnel are qualified to collect.
- If you also provide urine collections, ensure you have the correct collection kits on hand and available for use.
- When switching from an oral fluid to a urine specimen collection, complete the oral fluid collection including the Federal Drug Testing Custody and Control Form (CCF), then begin the urine specimen collection using a new CCF. In the Remarks section of the CCF, document the reason for the change in the collection process.
Notes:
- “Neat” oral fluid is collected by expectoration (spitting) into an undiluted device (one with no liquid in the tubes).
- “Buffer” oral fluid is collected using a device with pads, then diluted with a buffer preservation solution.
DOT Oral Fluid Collection Guidelines: Sections Overview (51 Pages):
- Section 1: The Collector
- Section 2: The Collection Site
- Section 3: Securing a Collection Site
- Section 4: Collection Supplies
- Section 5: Federal Drug Testing Custody and Control Form
- Section 6: Information Employers Provide to Collectors
- Section 7: Identifying the Employee
- Section 8: Oral Fluid Collection Procedures
- Section 9: Insufficient Quantity of Oral Fluid
- Section 10: Refusal to Test
- Section 11: Unusual Collections
- Section 12: Correcting Collection Problems
- Section 13: Record Maintenance
- Section 14: Questions and Answers
Appendices:
- A – Suggested Format: “Documenting Collector Qualification Training Required by 49 CFR Section 40.35
- B – Collection Site Security and Integrity
- C – DOT Standards for Oral Fluid Collection Devices
- D – Examples of Tampering with Oral Fluid Collections
- E – Operating Administration Rules
- F – Important Reminders
For full DOT guidelines, click here to review and download.
For more guidance on how these changes impact employer drug and alcohol testing programs, contact ClearStar. Our team is ready to keep your program compliant.
Author Bio: Jackie Pirone
Jackie is Vice President at Current Consulting Group, overseeing CCG’s comprehensive suite of marketing and brand promotion support services for drug testing and background screening providers. Jackie has 35 years of experience in the diagnostics industry, with the past 30 years focused on drug and alcohol testing.
Jackie recently served as Sr. Director at OraSure Technologies, where she spent 15 years leading the global direction of the drugs of abuse and risk assessment product lines. Under Jackie’s marketing leadership, OraSure became the number one recognized brand in oral fluid drug testing for the past 10+ years. Prior to her time at OraSure, Jackie was the Global Marketing Manager for the drug testing division of Roche Diagnostics.
Additionally, Jackie has frequently presented at industry association meetings and end user conferences, as well as drug and alcohol screening webinars.
Additional Reading from ClearStar:
DOT Sets Annual Minimum Random Drug and Alcohol Testing Rates for 2025
DOT Proposes Rule to Revise Oral Fluid Requirements for Drug and Alcohol Testing
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