DOT Final Rule On Expanded Opiates

The long-awaited revisions to 49 CFR Part 40 were published November 13, 2017. The final rule caps a nine months rulemaking process by the DOT and is in effect January 1, 2018.  The rule primarily harmonizes DOT regulations with the revised HHS Mandatory Guidelines established by the U.S. Department of Health and Human Services for Federal drug testing programs for urine drug testing. The significant changes to Part 40 are:

  1. Adding hydrocodone, hydromorphone, oxycodone, and oxymorphone to the DOT drug testing panel
  2. Adding MDA as an initial (screening) test analyte and removing MDEA as a confirmatory test analyte
  3. Removing the requirement for employers and Consortia/Third Party Administrators (C/TPA) to submit blind specimens to the drug testing laboratories
  4. Requiring key personnel in the DOT drug and alcohol testing process (e.g. specimen collectors, BATs, MROs, SAPs) to subscribe to the Office of Drug and Alcohol Policy and Compliance (ODAPC) list-serve
  5. Revising some MRO procedures, including: clarification of the definition of “prescription” as being consistent with the Controlled Substances Act; allowing MROs to request amphetamine and methamphetamine d &l isomer analysis and THC-V testing on marijuana positive tests; and imposing a delay on the MRO’s reporting a safety-concern or other medication information to a third-party after reporting a verified negative result based on a legitimate medical explanation
  6. Adding 3 fatal flaws which the laboratory reports as rejected for testing and the MRO to cancel the test
  7. Requiring collectors to discard a “suspect specimen” (e.g. temperature out of range, evidence of adulteration) when the attempt to collect a second specimen under direct observation is discontinued because of “shy bladder” or the donor’s leaving the collection site

Key Policy Issues

Modification of the Drug Testing Panel

In keeping with DOT’s obligation under the Omnibus Transportation Employee Testing Act (OTETA) to follow the HHS Mandatory Guidelines for the drugs which DOT mandates drug testing, Part 40 adds four additional drugs to the opiates/opioids class of drugs. The term “opioids” is now used for this class of drugs.  The drugs and cut-off concentrations are provided below. DOT also removed MDEA as a drug analyte and added MDA as an initial and confirmatory analyte in the amphetamines class. Additionally, DOT specimen validity testing will conform to the HHS Guidelines by raising the PH cut-off from 3 to 4 for determining a specimen is adulterated.

Initial Test Analyte
Initial Test Cut-off
Confirmatory Test Analyte
Confirmatory Test Cut-off
Hydrocodone/hydromorphone
300ng/mL
Hydrocodone
Hydromorphone
100 ng/mL
100 ng/mL
Oxycodone/oxymorphone
100 ng/mL
Oxycodone
Oxymorphone
100 ng/mL
100 ng/mL

 

Blind Specimens

The 25 year history of the blind specimen testing requirement shows decreasing reliance on the process as a safeguard of the accuracy, reliability, integrity of the urine drug testing program. The requirement for employers  and/or C/TPAs to submit blind specimens to the laboratory is removed.

ODAPC List-Serve

Specimen collectors, MROs, BATs & STTs, and SAPs are required to subscribe to the ODAPC List-Serve email notification service. It is free and subscription is available at https://www.transportation.gov/odapc/get-odapc-email-updates.  DOT considers the List-Serve requirement as part of the duty identified in Part 40 for service agents to keep current on any changes to Part 40 and the DOT drug and alcohol testing regulations.

MRO Practice Issues

  1. In clarifying that MROs cannot accept “medical marijuana” use as a legitimate medical explanation for a THC positive test, the definition of a “prescription” is specifically linked to the Controlled Substances Act (CSA) which prohibits prescribing of a Schedule I substance.
  2. MROs can, without DOT approval, request that laboratories perform additional testing for d & l isomer amphetamine and methamphetamine and THC-V (a metabolite specific to marijuana and not found in Marinol (pharmaceutical THC)). The decision to request the additional testing is wholly the MRO’s.
  3. The revised Part 40 does not establish a “bright-line” for MROs in considering whether a controlled substance prescription medication that was dispensed a long time (e.g. six months, 2 yrs.) before the positive test result should be accepted as a legitimate medical explanation for a positive test. Part 40 has always left this determination up to the MRO on an individual case basis, and it continues to do so.
  4. The requirement for the MRO to report to third parties significant safety concerns about the use of medications remains; however, the MRO must now provide the employee with up to five days to after reporting the verified negative result to have the prescribing physician contact the MRO to determine if the medications can be changed to one that does not make the employee medically unqualified or that does not pose a significant safety risk before reporting the “safety concern”

Fatal Flaws and Questionable Specimens

  1. To harmonize Part 40 with the DHHS Guidelines, Part 40 added 3 fatal flaws: 1) no CCF; 2) two separate collections were performed using one CCF; and 3) no specimen submitted with the CCF (and a specimen was collected). The laboratory reports a fatal flaw to the MRO and the MRO cancels the test.
  2. Collectors are directed to discard a “suspect/questionable specimen” (e.g. temperature out of range, evidence of adulteration) when the attempt to collect a second specimen under direct observation is discontinued because of “shy bladder” or the donor’s leaving the collection site.

Other Revisions or Clarifications

The revisions to Part 40 reemphasize or clarify the following:

  1. DNA testing cannot be performed on DOT drug test specimens
  2. Only urine specimens are permitted for DOT drug testing under Part 40
  3. The DOT drug testing panel remains “five drug classes” with the opiates category being changed to opioids
  4. Laboratory positives of <15,000 ng/ml morphine or codeine continue to require additional clinical evidence of opiate abuse/misuse for the MRO to verify as positive.
  5. The DOT does not approve, certify or endorse drug/alcohol testing program service agents and use of a DOT or DOT agency logo, title or emblem by service agents is prohibited