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The Substance Abuse and Mental Health Services Administration (SAMHSA), an agency of the U.S. Dept. of Health and Human Services (HHS), published the Mandatory Guidelines for Federal Workplace Drug Testing Programs—Oral/Fluid (OFMG) on October 25, 2019, establishing the scientific and technical guidelines for the inclusion of oral fluid specimens in federal Workplace Drug Testing Programs (DFWPs). The OFMG effective date is January 1, 2020, however, implementation of oral fluid testing in federal DFWPs will be at least a twelve month process.

Who Do the OFMG Apply To?

The OFMG will allow federal executive branch agencies that are required to conduct drug testing under Executive Order 12564 to collect and test an oral fluid specimen as part of their drug testing programs. The OFMG establish standards and technical requirements for oral fluid collection devices, initial oral fluid drug test specimens and methods, confirmatory oral fluid drug test specimen materials and methods, processes for review by a Medical Review Officer (MRO), and requirements for federal agency actions.

What Do the OFMG Say?

The OFMG in many ways parallel the Mandatory Guidelines for Federal Workplace Drug Testing Programs (MG) first published in 1988 and last revised in 2017 which provide the technical and scientific standards for urine drug testing.  Prior to the publication of the OFMG, only urine drug testing was permitted in federal agency DFWPs.  Likewise, other federally mandated drug testing under the U.S. Department of Transportation (DOT), and the Nuclear Regulatory Commission (NRC) have regulations which reference the SAMHSA MG, which historically permitted only urine drug testing.  

The OFMG impact federal workplace drug testing programs as follows:

1. They provide flexibility for federal agency workplace drug testing programs to address testing needs, and to revise the requirement to collect only a urine specimen. Federal agencies can continue to use urine specimens for their drug testing, they can now use oral fluid specimens for their drug testing programs, or they can use a combination of urine and oral fluid drug testing for their testing programs.
2. Oral fluid specimens, like urine specimens, may be used for all testing circumstances required or authorized under DHSS authority.  Thus, oral fluid specimens may be used for pre-employment, reasonable suspicion, post-accident, random, return-to-duty, and follow-up testing.
3. Oral fluid specimens may be analyzed for the same panel of drugs currently authorized for urine drug testing. Federal agencies are required to test for marijuana and cocaine and they are authorized to test for amphetamines, opiates/opioids, and PCP.  Each federal agency determines the drug testing panel applicable to its testing designated positions as part of their written federal agency plan, approved by SAMHSA’s Division of Workplace Programs (DWP).  The OFMG establish the analytical standards for laboratory screening and confirmation testing of oral fluid specimens, including cut-off levels for determining a positive drug test. 
4. Oral fluid specimen collections may provide savings for federal agencies.  Collection and specimen processing times may be shorter for oral fluid specimens than for urine specimens. Worksite collections may be more feasible for oral fluid specimens than for urine specimens, decreasing lost-time for travel to and from off-site collection facilities. When an employee/applicant is unable to produce an adequate urine specimen, a collection of an oral fluid specimen reduces time and money spent in urine specimen collection and medical evaluation processes associated with “shy bladder” events.
5. Oral fluid specimens are “observed collections,” with the applicant/employee providing his/her specimen in the presence of the collector, and therefore potentially decreasing the opportunity for specimen adulteration, substitution, or other manipulation to subvert the drug testing program. Data from workforce drug testing programs using oral fluid specimens demonstrates fewer adulterated, substituted, dilute, or invalid specimens than in urine drug testing programs.
6. Oral fluid specimens allow detection of drugs within minutes-to-hours of use. This makes oral fluid testing an excellent option for reasonable suspicion and post-accident testing. As employers, including federal agencies, become more focused on recent drug use and its impact on work performance, oral fluid testing may offer some advantages.
7. Flexibility to use both oral fluid and urine drug testing in their DFWP Programs. Federal agencies do not have to choose between a urine testing or an oral fluid testing program – they can mix and match. It is not, however, contemplated that a federal agency would collect both a urine specimen and an oral fluid specimen from an employee for a single drug test event.
8. Oral fluid testing may be perceived by federal employees subject to testing as more “palatable,” and less invasive than urine drug testing.  Thus, use of oral fluid testing for some, if not all, reasons for testing in an agency’s program may foster more favorable acceptance of and commitment to the program as a tool for improved workplace safety and worker morale.

Next Steps for Federal Agency Workplace Drug Testing Programs

1.  Review and revise the agency drug free workplace plan and submit it for approval to SAMHSA’s Division of Workplace Programs. 
2. Monitor the SAMHSA website for notices concerning laboratories approved for oral fluid drug testing. The National Laboratory Certification Program (NLCP) will begin the laboratory certification process in January 2020. This involves processing laboratories’ applications for oral fluid certification, review of candidate laboratories’ standard operating procedures for receiving, analyzing, and reporting oral fluid specimens and results, sending proficiency testing samples to candidate laboratories for analysis and reviewing their performance, and on-site laboratory inspections by NLCP inspectors.
3. Monitor notices from the Federal Drug Administration (FDA) and SAHMSA concerning oral fluid specimen collection devices that meet the OFMG requirements for federal drug testing.
4. If oral fluid testing will be used in the agency’s DFWP program, inform and educate employees in testing designated positions of its use in the agency’s testing. 
5. Before implementation of any oral fluid testing in the agency’s program, ensure that oral fluid specimen collectors and Medical Review Officers (MROs) who will be used for the program’s testing have the necessary qualifications and training specified in the OFMG. 

The OFMG provide the same scientific and forensic supportability of drug test results as the Mandatory Guidelines for Federal Workplace Drug Testing Programs using urine. It is expected that the OFMG will be used by the DOT and NRC as part of their regulated drug testing programs, however, full rulemaking initiatives, including proposed and final rules, will be necessary before the OFMG are applied to testing under the authority of 49 CFR Part 40 and 10 CFR Part 26.

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