Oral Fluid Drug Testing Development Part – 3

21 Nov 2014

- Will oral fluid drug testing be allowed in Federal and DOT drug testing programs

Oral Fluid Drug Testing Development Part – 3 

Oral Fluid Drug Testing Development Part – 2

Oral Fluid Drug Testing Development Part – 1

In late 2010, a decision was made to go ahead with the implementation for oral fluid in the testing matrix.  Presentations were made about the current state of oral fluid testing and issues involved with the implementation of oral fluid into the Federal area of workplace drug testing.

It should be understood that there are different standards in place that are significant between the non-regulated and regulated workforces.  These differences go back to the US Supreme Court decisions regarding Federal workplace drug testing made back in 1989.

On June 10, 2011, SAMHSA published a notice in the Federal Register seeking data for oral fluid testing.  The notice statement is as follows (excerpted): 

“   soliciting written comments and statements from the general public and industry stakeholders regarding a variety of issues related to oral fluid specimen drug testing, including analytes, cutoffs, specimen validity, collection, collection devices, and testing. II.

Solicitation of Comments: As we develop our initial outline for the Mandatory Guidelines, we are seeking additional information that is current, scientific, and peer reviewed in reference to oral fluid specimen drug testing, specifically on the following questions:

Analytes/Cutoffs: What analytes should be measured in oral fluid for the initial and confirmatory tests? What initial and confirmation cutoffs should be used for the oral fluid drug tests? Should the oral fluid drug testing panel be expanded to include schedule II prescription medications?

Specimen Validity: Are bio-markers needed to validate the oral fluid specimen? Are there appropriate bio- markers or tests for the oral fluid specimen that would reveal adulteration, substitution, and/or dilution?

Collection: How should an oral fluid specimen be collected? For an oral fluid split specimen collection, how should the collection of the two specimens be performed? As a donor, would you prefer to provide an oral fluid or a urine specimen?

Collection Devices: What should be the technical requirements for an oral fluid specimen collection device?

Testing: What technologies are available to perform initial and confirmatory testing on oral fluid specimens?”

It is not known how many comments or comment content were received from the public but it is known that work is progressing to implement oral fluid in to the specimen matrix.

Some of the issues that were place was that there was a problem with the detection of marijuana in oral fluid specimens. 

In my opinion, one of the key points is the validity of oral fluid and how specimens are collected, particularly split specimens.

As for the validity of oral fluid, it has been proposed that the specimens be tested for IgG which is a protein immunoglobulin.  IgG is found in all body fluids and forms the basis for many antibodies.  The question is what level of IgG should be present to have oral fluid considered a valid specimen. The rationale is that this will separate oral fluid from spittle which does not have the same amount of IgG if and when present.  Spittle is liquid produced in the mouth versus oral fluid produced by salivary glands.  It has been previously proposed that oral fluid specimens should be considered substituted if the IgG is less than 0.10 mcg/mL.  Because of the abundance of IgG that is produced in the human body, this standard should be a workable level to have to determine if a specimen is valid or substituted.

The other point of concern is the development of “candy” or mouthwashes that contain an adulterating substance.  There is at least one Internet site that advertises a mouthwash that if used twice just before an oral fluid drug test, it will help a person beat the test.  As time passes, this particular market will increase.  One point that could be made here is that oral fluid flushes through the system about every 10-15 minutes so the chance of these mouth washes being very effective are very slim.

A major factor will be split specimens and how oral fluid specimens will be collected or how this will be handled.  This will be decided when the Mandatory Guidelines are published but will be partially dependent upon comments received and the current state of the technology.

Some final notes:

  1. When the use of oral fluid is finalized, all final confirmatory testing will be laboratory based using SAMHSA accredited labs.  The issue of on-site screen oral fluid tests to be allowed or not allowed is still in question but will be reviewed and decided when the Mandatory Guidelines are published for comments.
  2. DOT and the modal agencies will adopt the testing standards for oral fluid testing for Schedules I and II controlled substances.
  3. How and when the use of oral fluids will be used by the DOT modal agencies will most likely be determined by a consensus of the modal agencies but in my opinion, most of the agencies will allow the use of oral fluids for post–accident and/or reasonable suspicion testing purposes.  The use of oral fluids for other test purposes will be determined on an individual modal agency basis. There will be a Notice of Proposed Rulemaking with comments to be solicited from the public by each modal agency.
  4. The determination of which specimen source, urine or oral fluid, will be used for each particular test purpose will be made by individual DOT regulated employers.  DOT/ODAPC will, most likely, provide guidance, but will not regulate that particular aspect of testing.  That guidance will be helpful to employers to make informed decisions on what specimen source to use for different regulated testing scenarios.

The proposed Mandatory Guidelines for Federal Workplace Drug Testing with the use of oral fluids is being developed by the staff of SAMHSA/HHS and is expected to be published in the not too distant future.  At that time, the use of oral fluids will again be discussed and the proposed Mandatory Guidelines will be analyzed for content and adoptability into the testing industry by employers, C/TPAs, and other service agents.

The next series of articles will go into testing as required by the United States Coast Guard for marine employers as there is a certain amount of uncertainty in testing for the maritime industry and applicability.

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About Bob Schoening

Robert Schoening is well renowned for his knowledge and influence in the drug-testing arena. As the Drug and Alcohol Program Manager for the US Coast Guard (December 2001-March 2013) he developed and managed a successful drug testing program for the marine industry nationwide and internationally.  During this time he developed and implemented a new compliance audit checklist as well as the writing and publishing a new Marine Employers Guidebook for Drug Testing.  He is also the author of the federal regulation commonly known as the two-hour alcohol testing for maritime incidents.

Robert’s drug testing career began in the Navy Medical Department, where he received the Navy Achievement Medal for his work on development of the Navy drug-testing program which was the first major workplace drug-testing program in the country. He retired in 1985 after serving 24 years.

Upon his retirement, Robert established his own drug testing consulting company assisting other companies to establish drug-free workplaces and drug testing programs, concentrating primarily on the marine industry. His knowledge of regulations and policy helped build his company to be one of the premier providers of drug testing services for the marine industry. During this time he was instrumental in establishing many of the current federal policies that are in place.

Robert has served on the Board of Directors of the Substance Abuse Program Administrators Association (SAPAA) as well as chairing the Governmental and Legislative Affairs committee. He was one of the first individuals to be recognized as an expert in the Drug and Alcohol testing industry and to receive designation as a Certified Substance Abuse Program Administrator (1996).

Robert is active participant in community service.  He recently served on the Policy Board for the Alcohol Safety Action Program in Fairfax, VA (January 1989-December 2012).  Since moving to Whidbey Island in Washington, he has been named to serve on the Substance Abuse Committee and recently been named to serve on the Ferry Advisory Committee both of these committees are located in Island County, WA.

Robert is currently a consultant for Workplace Drug Testing and Drug Abuse Prevention Programs.