April 22, 2022
Docket Management Facility
U.S. Department of Transportation
1200 New Jersey Ave., SE
West Building, Ground Floor, Room W12-140
Washington, DC 20590–0001
RE: Docket Number COT-OST-2021-0093
Dear Sir or Madam:
The American College of Occupational and Environmental Medicine (ACOEM) welcomes the opportunity to provide comments to the Department of Transportation regarding its Notice of Proposed Rulemaking (NPRM) concerning the addition of oral fluid specimen testing for drugs. As our organization’s membership consists of many physicians who are medical review officers (MRO), we are keenly aware of the issues that have been brought forth in the Final Rule.
We wish to reinforce our support for the addition of oral fluid testing to the federal repertoire with 49 CFR Part 40. As you may be aware, we have been following the science of oral fluid testing keenly over the last several years and agree with the Department that oral fluid testing is now to the level of scientific validity and specificity on par with urine testing. We have long advocated for measures that increase stakeholder ease of implementation of drug testing processes to comply with the purpose of transportation industry drug testing.
We do have some specific comments regarding aspects of the final rule.
Oral Fluid Testing and Ease of Burden
As the Department well knows, issues of urine specimen tampering, and substitution continue to plague the current process. As MROs, we take seriously our gatekeeper role as defined in 49 CFR Part 40.123 and believe that the introduction of oral fluid testing will go a long way to reduce these concerns. Given that all oral fluid collections are “direct observation” it is our impression that a majority of employers will move to oral fluid testing and mostly abandon urine testing procedurally. Also, given the relative reduce costs of oral fluid testing in comparison to urine testing, and the fact that oral fluid collection should be quicker that urine testing because there is no need for the donor to go into a different area to provide a specimen.
We do recognize however, that some employers may wish to continue to use urine as the specimen of choice. These employers, based upon our experiences, wish to do so because of urine’s longer detection window for THC. We would point out that this is likely the single issue regarding utilizing oral fluid that creates the most discussion among MROs from a scientific perspective. Employers who wish do continue use of urine specimens likely will do so to maintain the current level of deterrence of use of marijuana within its employees, whereas other employers will be more acceptable of oral fluid based upon the viewpoint of a concern more focused upon eliminated recent use and may have a more favorable view of marijuana use among its workers as long as it is not recent. Of course, there are trending differences of opinion on THC and issue of impairment that remain unresolved, and the patchwork of states who allow recreational use of THC containing products lends itself to different employer perspectives on the topic. We wish to simply point out that a part of the determination of whether to use oral fluid or urine specimens may be driven at least in part, by this different in detection windows.
Having said the above, we also recognize that for certain testing such as follow-up and return to duty testing, that urine may remain the test of choice because of its longer detection window. The bottom line here is that we believe MROs can assist employers with review of these options and advise them of the scientific differences between the two methods, so that an employer can make the best solution for their particular situation.
Oral Fluid Device Split Specimens
One concerning part of the NPRM has to do with the appendix B that describes what an oral fluid device should consist of specifically with regards to the methodology of obtaining a split specimen. As MROs we are not aware of any device currently on the market that does what Appendix B requires. Typically, oral fluid collection devices have two collection portals contained in a single device, or in some cases have two separate collection devices that are inserted into the oral cavity at the same time. We see no reason to abandon the currently available collection devices as they would in our opinion meet the definition of obtaining a split specimen.
Opposite Gender Directly Observed Urine Collection
The NPRM indicates a proposed change to allow medically licensed personnel to directly observe urine collections even if they are of an opposite gender. This seems to be a correct move, as we are aware of increasing difficulty in some instances where identification of the gender of the donor becomes difficult or problematic. Transgender and non-binary gender identification of employees is an issue for collectors, and we feel that a move to allow any gender person who is properly medically licensed to directly observe a urine collection is move in the right direction.
This change in rule will also help rural collection locations. As MROs, we frequently are asked to manage or oversee remote collection locations that are often managed by very few staff. Rural America consists of many such collection facilities that include small medical facilities that may be staffed by only one or two individuals, and in these cases, the requirement of same gender observation has always been a challenge.
MRO Assistant Contact of Pharmacies
While we appreciate the sentiment and intention of the NPRM to allow MRO Assistants the ability to contact pharmacies directly and accumulate information for the MRO regarding medications that may indicate a legitimate medical explanation for a non-negative test result, we are unsure if this will actually lead to an increase in efficiency. It is our collective experience that we continue to have difficulty in many cases to collect information from pharmacists without the pharmacist invoking HIPAA concerns. While we recognize the intent of this change, we do not believe that pharmacists will entertain speaking with anyone other than a physician in these circumstances, which actually may lead to a reverse in efficiencies to the process.
Instead of focusing upon MRO Assistants, we would suggest that an educational effort be made from the Department toward licensed pharmacists regarding the overall drug testing program and the fact that MRO conversations with pharmacists to confirm prescription medications are not HIPAA issues at all. We feel that efforts in this area would provide an improvement in efficiency much greater than opening this up to non-physician MRO Assistants.
Uncancelling a Result
ACOEM MROs who have been surveyed about this topic are equivocal. When we have encountered situations where there is no consensus on a topic, we simply wish to support that there is no strong feeling one way or the other on the ability for an MRO to uncancel a result.
Support of Oral Fluid Collection When There are Urine Collection Issues
As MROs, we are favorable to the idea that oral fluid collection can be used as a “back up” collection when shy bladder issues occur, or when there is evidence of tampering of the urine specimen.
MRO Training on Oral Fluid
ACOEM MROs have always been strong supporters of MRO education and endorse the fact that MRO training will need to occur when oral fluid testing is implemented.
Concern with Oral Fluid Collection Methodology
There appears to be a universal belief that an oral fluid collection is an “observed” collection, thus, the donor cannot subvert the collection process. This belief is FALSE.
Any health care professional with experience in treating institutionalized (mental health facilities, jails, prisons, etc.) patients is familiar with “cheeking”; hiding medication or contraband in the mouth between the cheek and gums. The moment oral fluid testing becomes more widespread, the purveyors of substitute urine will begin offering packets of substitute saliva (complete with the proper amount of albumin or immunoglobulin biomarker) which is far easier to conceal and maintain body temp than 30 cc of urine.
Will collectors be trained to carefully examine the entire mouth, i.e., using a dental mirror, to assure that the donor has not concealed an adulterant or substitute saliva sample in their mouth? We would thus encourage a thorough review of the proposed collector’s manual in this regard and make sure that the proper initial inspection process of the oral cavity is included
Thank you for the opportunity to comment. We are available to discuss the issues further at your request.
Robert M. Bourgeois, MD, MPH, FACOEM
President, American College of Occupational and Environmental Medicine