The U.S. Department of Health and Human Services (DHHS) published scientific and technical guidelines for oral fluid drug testing in federal workplace drug testing programs in the Federal Register on October 25, 2019. The Mandatory Guidelines for Federal Workplace Drug Testing Programs Using Oral Fluid (OFMG) allows federal executive branch agencies to collect and test oral fluid specimens, and establishes standards and technical requirements for oral fluid collection devices, including initial and confirmatory oral fluid drug test cut-off concentrations and methods, among other things. The Guidelines will take effect on January 1, 2020.

Some agencies, such as the Department of Transportation, are required to follow the Mandatory Guidelines in developing drug testing programs for their regulated industries. We anticipate that DOT’s operating agencies will implement regulations adopting the new Guidelines into their respective testing programs.

DHHS stated there are many reasons why oral fluid testing will be beneficial including: (1) urine testing often poses obstacles, such as adulteration and assessment of medical conditions preventing the production of a urine specimen; (2) oral fluid collection does not require secured restrooms or other special requirements that urine testing requires; (3) all oral fluid collections will be conducted under direct observation which should substantially lessen the risk of substitution and adulteration; (4) oral fluid collection saves time when compared to urine specimen collections; and, (5) oral fluid testing may provide more insight into recent drug use shortly before or at the time the specimen is collected.

Noting that the number of products on the market to adulterate urine specimens continues to proliferate, DHHS stated that the scientific basis for the use of oral fluid as an alternative specimen for drug testing has now been established and it may be used with the same level of confidence that has been applied to urine testing.

A federal agency may collect oral fluid specimens for pre-employment, random, reasonable suspicion/cause, post-accident, return-to-duty and follow-up drug tests. The OFMG requires a specific volume of oral fluid to be collected and provides for split-specimen collections. Collectors must be trained to collect oral fluid specimens in accordance with the OFMG. There are requirements for oral fluid specimen collection devices and collection procedures, including procedures to be followed when a tested individual claims that he or she cannot provide an oral fluid specimen. DHHS-certified laboratories and Medical Review Officers must ensure that they follow the OFMG.