Email Article

Posted: August 26, 2008

DOT delays changes to direct observed drug testing procedures

On June 25, 2008, the Department of Transportation (DOT) issued changes to CFR 49 part 40. The changes were to have been effective Monday, Aug. 25, 2008.

However, the DOT announced it is delaying implementation of the provision covering direct observed testing for follow-up and return-to duty drug tests until Nov. 1, 2008, and extending the comment period on the rulemaking.

The DOT also stated the provision requiring that prosthetic devices be checked for as part of the drug testing procedure did go into effect Aug. 25.

The DOT notice to be published in the Federal Register is available online. The final notice was to have been published today (Aug. 26).

The following is a summary of the changes contained in the rulemaking.

The new rules will affect laboratories, medical review officers, employers and individuals who act as DOT collectors. If you are designated as the DOT collector onboard ship, the new rules apply. The new rules will also affect an individual if an observed collection is required of a donor.

The Department of Transportation is amending certain provisions of its drug and alcohol testing procedures to change instructions to collectors, laboratories, medical review officers and employers regarding adulterated, substituted, diluted, and invalid urine specimen results. A number of changes were made concerning procedures for directly observed collections.

The majority of collections will continue to be collected as before. Note that the circumstances for an "observed collection" are specific, and will now include returning to duty after completing a drug and/or alcohol treatment program, as well as follow-up drug testing.

Below is an outline of the changes as summarized by the DOT Office of Drug and Alcohol Policy and Compliance (ODAPC).
  • This final rule makes it mandatory for laboratories to test all DOT specimens for specimen validity (i.e. adulterants and urine substitutes) and for laboratories to follow all Department of Health and Human Services (HHS) protocols for doing so.
  • Observed collections will now be required, rather than optional, for all return-to-duty and follow-up drug testing.
  • Observed collections will continue to be done if there is a specific reason to believe that an employee may be attempting, or have sufficient reason, to evade the testing process.
  • During observed collections, items such as prosthetic devices designed to carry clean urine will be checked for by observers with both male and female donors. If no device is detected by the same-gender observer, clothing can be returned to its observed-collection position. The observer must always be the same gender as the donor, without exception.
  • In an effort to thwart those who would manufacture products designed to adulterate specimens, the final rule will no longer have easy-to-follow tables and charts outlining the adulterants for which laboratories are testing and the scientific cutoff levels at which laboratories are testing them.
  • Definitions in the final rule have been changed to match those of HHS.
  • The following occurrences are now considered a refusal to test:
    1. The donor is found to possess or wear a prosthetic or other device that could be used to interfere with the collection process
    2. The donor refused to follow the collector instructions during an observed collection process to raise or lower clothing as specified in the regulations
    3. The donor admits to the collector or MRO that he/she adulterated or substituted the specimen
    4. The donor refuses to wash his or her hands after being directed to do so
  • The Final Rule requires drug-testing laboratories to report to DOT semi-annual statistical summaries on all of their DOT testing.
According to the DOT, the final rule is intended to close the loop on invalid specimen results and to streamline and simplify the potential myriad of complicated laboratory-confirmed and MRO-verified drug test results.

The full text version of the DOT final rule can be viewed online at: