When the HHS finalized its OFMG in 2019, it opened oral fluid testing to Federal agencies as an alternate methodology to choose and not as a replacement for urine drug testing. Similarly, the Department has determined that oral fluid testing will be an option for regulated employers and not a replacement for urine testing.
The commenters expressed many different opinions on whether oral fluid testing should be mandated in some or all circumstances; whether it should be purely the employer’s choice; whether it should be the employee’s choice; and whether it should be the collector’s choice. There were suggestions to allow only oral fluid testing for reasonable suspicion and post-accident testing. Some commenters wanted to see oral fluid testing prohibited for pre-employment and random testing because they preferred the potentially longer windows of detection of urine versus oral fluid testing. Individuals who were concerned with paruresis wanted the employee to be able to choose oral fluid for every test and some of those commenters wanted urine testing banned. Some commenters were concerned that, if we mandated oral fluid testing in any circumstances, then every collector would need to be trained in oral fluid collections and every collection site would need to purchase oral fluid testing kits at an additional expense to such small businesses. The commenters who opposed oral fluid testing generally said they were concerned that oral fluid specimens would be used for DNA testing, or the commenters wanted drug testing of safety sensitive employees to stop.
As discussed earlier, HHS has determined oral fluid drug testing, like urine drug testing, is accurate and defensible. With both drug testing methodologies being scientifically accurate and forensically defensible, there is no reason to eliminate either methodology. Similarly, we see no reason to mandate either methodology. However, we will discuss below, in reference to problem collection scenarios covered by § 40.67 (direct observation collections) and § 40.193 (insufficient specimen “shy bladder” cases), that we strongly suggest employers consider moving to an oral fluid testing methodology. Employers should communicate to their consortium/third party administrator (C/TPA) and to their collection sites whether they want to utilize urine testing, oral fluid testing, or some combination of both. Employers should also provide their service agents with the specific instances that would trigger a different methodology ( e.g., an insufficient oral fluid collection should immediately become a urine collection or vice-versa).
If we were to mandate an alternate methodology be used, but the collection kit was not available at the collection site, the test would likely not occur at that site. If no test occurs, that would not be in the best interest of safety.
Those who commented that not every collection site will offer oral fluid testing have a valid point. It is possible a collection site will make a business decision not to offer oral fluid testing because of costs or training issues. Although it is the ultimate duty of the employer to ensure their collection sites are able and available to perform testing in accordance with part 40, it would be helpful for collections sites to notify their DOT-regulated clients that they will not offer oral fluid collections.
It is also important to remember that under § 40.209(b)(3), if an unqualified collector were to conduct a collection, it would not cancel the test. As we said in our 2000 preamble to § 40.209, “a test is not invalidated because a collector has not fulfilled a training requirement. For example, suppose someone collects a specimen correctly but has not completed required training or retraining. The test would not be cancelled because the training requirement was not met.” 65 FR 79472. To reflect this point, we have updated § 40.209(b)(3) to add a reference to § 40.35 for oral fluid collector training, in addition to the existing reference to § 40.33 for urine collector training. Although it would not cancel the test result if the collector has not been trained in accordance with part 40, the collector, other service agents, and employer involved might be found in noncompliance as the result of the failure to meet training requirements.
Since the inception of DOT-regulated alcohol testing in 1994, we have allowed screening testing to be conducted using saliva testing devices, and we have required all confirmation testing to be conducted on an evidential breath testing (EBT) device. See 49 CFR 40.231. A facility that conducts alcohol saliva screening but that does not have an EBT must work expeditiously with the employer to ensure that the confirmation test takes place on an EBT.
Similarly, if a collection site only offers urine collections and an insufficient specimen is presented or if a direct observation collection is triggered, that collection site is expected to work expeditiously with the employer to ensure that the oral fluid collection occurs if the employer wants an oral fluid collection performed for an employee. Collection sites need to make business decisions about whether they will offer urine collections, oral fluid collections or both. Thus, not every collector needs to be trained on both urine and oral fluid collections unless they offer both.
The Owner-Operator Independent Drivers Association (OOIDA) asked that we “continue educating industry stakeholders about the scientific and forensic supportability of oral fluid testing . . . (and) about how oral fluid testing would be implemented and administered.” OOIDA reminded us that State and local law enforcement execute roadside testing, and OOIDA wanted us to differentiate and address concerns in the trucking industry about the differences between roadside oral fluid drug tests and DOT’s regulated laboratory tests.
The Department will continue educating industry stakeholders, as we have always done, for urine testing and for part 40 compliance. Traditionally, State and local law enforcement have implemented their own testing entirely outside DOT-regulated drug testing and will continue to do so. Often, law enforcement entities have chosen point-of-collection testing (POCT) devices that provide initial screening test results, instead of laboratory-based screening testing. The POCT testing can cover the same drugs for which we test and more (or fewer) substances. The cutoff levels of the drugs being tested for in POCT devices differ widely among POCT devices. Thus, the differences are varying and may be significant. We will educate our regulated industries about DOT’s regulated oral fluid testing alone. However, we welcome our industry partners to continue to educate their memberships about the differences they are encountering beyond DOT-regulated testing.
In buffered collections, the employee’s oral fluid is collected on a device and then the device is subdivided into Bottles A and B, which contain a buffering solution. The buffering solution draws the oral fluid from the device, so that the liquid can be analyzed by the laboratory for the drugs for which we test. OOIDA raised concerns about whether drugs sufficiently enter the buffering solution. In its oversight of laboratory testing under the OFMG, HHS sets the standards for the devices and recovery of drug from the same. These are assessed two times: first, by the manufacturer and second, during laboratory validation of the collection device. While HHS does not certify or validate the collection devices or the buffer, the NLCP laboratory inspection process does ensure accuracy of the results obtained by the laboratories as evidenced by each laboratory’s method of validation documentation which must specify the collection device(s) used. HHS will approve each specific HHS-certified oral fluid laboratory to use only one or more specific devices for which the laboratory can ensure the accuracy of the results. For further discussion of this subject, see the HHS final rule on oral fluid testing at 84 FR 57559, 57584 (Oct. 25, 2019).
Also, OOIDA stated they do not want hair testing in the DOT regulated program. It is important to note hair testing is outside the scope of this rulemaking, as we will discuss further in this preamble.
Finally, in response to the commenters who opposed the proposal to allow oral fluid testing due to concerns about DNA information or who oppose the principle of drug testing of safety-sensitive employees, we disagree on both points. As for DNA testing, part 40 already prohibits the DNA testing of any specimen collected for a DOT-regulated test. In fact, this rulemaking proposed to update the prohibitions on DNA testing contained in §§ 40.13(c) and (e) (now §§ 40.13(c) and (f)) to ensure that they extend to oral fluid testing.
As for the commenters who generally opposed drug testing, they offered no data to support why eliminating drug testing would be in the best interest of transportation safety. Instead, they merely said that transportation safety-sensitive employees should be permitted to use marijuana. However, it is important to remember that the beginning of DOT-regulated testing in 1988 was prompted by marijuana-related accidents that occurred in 1985 (two New York City subway accidents) and 1987 (one railroad accident in Chase, Maryland).