United States: DOT Tackles The Opioid Crisis: Agency Issues Guidance On Regulations Adding Semi-Synthetic Opioids To Testing Panel

Last Updated: December 28 2017
Article by Dale L. Deitchler and Jeffrey E. Dilger

Effective January 1, 2018, employers with employees subject to the U.S. Department of Transportation's drug-testing regulations will face new and broader testing obligations based on a Final Rule issued in November 2017.1 This month, in various web-based guidance, DOT clarified what changes, if any, covered employers must make to their DOT testing program policies. This article will discuss DOT's new requirements and what transportation employers can do to prepare for these new obligations.

Four New Opioids and a Change from "Opiates" to "Opioids"

The Final Rule adds four semi-synthetic opioids to DOT's standard 5-panel drug testing program for all DOT modalities and employers in DOT-regulated industries subject to 49 Code of Federal Regulations (CFR) Part 40 (e.g., certain DOT-regulated motor carriers, railroads and mass transit, aviation and pipeline employers).

Currently, in addition to urine testing for amphetamines, cocaine, marijuana and phencyclidine, DOT-regulated employers must test covered employees for "opiates" (codeine, morphine and heroin). Effective January 1, 2018, employees subject to DOT testing also must be tested for the following federal Controlled Substance Act Schedule II semi-synthetic prescription drugs:

  • hydrocodone;
  • hydromorphone;
  • oxymorphone; and
  • oxycodone.

In addition, effective January 1, 2018, the regulations rename the category or class of drugs currently referred to as "opiates" to "opioids." (The Final Rule, also, with respect to amphetamines testing, adds methylenedioxyamphetamine (MDA) as an initial test analyte and removes methylenedioxyethylamphetamine (MDEA) as a confirmatory test analyte.)

"The opioid crisis is a threat to public safety when it involves safety-sensitive employees involved in the operation of any kind of vehicle or transport," explained DOT Secretary Elaine L. Chao in an agency press release. "The ability to test for a broader range of opioids will advance transportation safety significantly and provide another deterrence to opioid abuse, which will better protect the public and ultimately save lives."2

Changes Needed for Current DOT Testing Program Policies?

In web-based guidance issued in early December 2017, DOT's Office of Drug & Alcohol Policy & Compliance (ODAPC) advised employers on DOT testing policy compliance issues with respect to current policies.3 Whether changes are required to an employer's existing policies is a three-fold analysis:

  1. If a covered employer's DOT testing policy references compliance with 49 CFR Part 40, no changes are necessary with respect to, generally, policy provisions relating to testing procedures.
  2. If a covered employer's DOT testing policy refers in the definitions or generically identifies the existing 5-panel categories/classes of drugs (amphetamines, cocaine, marijuana, phencyclidine and opiates), then no changes to those provisions are required to current policies. In contrast, if an employer's policy, within the opiates and amphetamines categories/classes lists (parenthetically or otherwise) specific drugs—e.g., "opiates (codeine, heroin and morphine)"—or incorporates an amphetamines definition that includes "MDEA," then the policy language must be revised to comply with the Final Rule.
  3. If DOT testing policies identify initial and confirmation cut-off levels for specific drugs, the cut-off levels need to be updated. Omitting specific cut-off concentration levels is generally advised. Indeed, policies should merely refer to applying cut-off concentration levels established under 49 CFR Part 40 (or more specifically Section 40.87) as may be amended from time to time.

Implementing New or Updated DOT Testing Policies

The DOT's guidance suggests a similar approach for employers implementing a new or updated DOT testing policy to be effective and administered from and after January 1, 2018:

1.Commitments to Comply with 49 CFR Part 40 in Testing. Ensure that, in general descriptions of testing procedures, there are commitments to comply with 49 CFR Part 40.

2.Generic Definitions/Panel-Description. Keep the definition of "drug" and any description of the categories/classes of drugs DOT requires to be tested generic: "amphetamines, cocaine, marijuana, opioids and phencyclidine." DOT employers that choose to continue to list specific sub-categories of opiates must, according to DOT, ensure the policy language is expanded to: "Opioids (codeine, heroin, morphine, oxycodone, oxymorphone, hydrocodone, hydromorphone)." Similarly, if a DOT employer chooses to include expanded references to amphetamines—e.g., "Amphetamines (amphetamine, methamphetamine, MDMA, MDA"—those references must not include references to "MDEA."

3.Cut-Off Concentrations. Omit or delete cut-off concentrations and when concentrations are mentioned, instead refer to application of initial and cut-off concentrations that apply under 49 CFR Part 40, Section 40.87 as may be amended from time to time. If cut-off concentrations are identified (which we again recommend against), they must match the initial and confirmatory concentrations identified in the amended regulations exactly, and should still mention that DOT may amend those concentrations from time to time.

Please contact Litter with any questions regarding DOT policy development, policy review, and any other workplace issues that may be impacted by the new DOT testing regulations.


1 The Final Rule is available at: www.transportation.gov/odapc/frpubs.

2 DOT testing regulations first implemented in 1988 and subsequent revisions to Part 40 have corresponded with Department of Health and Human Services (HHS) Mandatory Guidelines for Federal Workplace Testing Programs upon which the regulations were based, and the same is true with the new mandate to test for semi-synthetic opioids. HHS, which tracks drug abuse trends, previously concluded the four prescription medications should be added to Federal Programs testing (HHS also removed MDEA from its Guidelines). DOT, like HHS, decided inclusion of the semi-synthetic opioids will help "address the nation-wide epidemic of opioid abuse," involves drugs "already tested for in many transportation employers' non-DOT testing programs because of their widespread use and potentially impairing effect," and "allow the DOT to detect a broader range of drugs being used illegally."

3 The guidance is available at:

www.transportation.gov/odapc/Part_40_DOT_Policies_Notice_2017. Additional employee guidance that may be helpful to employers is available at: www.transportation.gov/odapc/Part_40_DOT_Employee_Notice_2017. Please note that the Final Rule also implemented a number of other changes, including: (1) elimination of the requirement to submit blind samples in connection with DOT testing; (2) mandating that key DOT testing personnel such as collectors, BATs, STTs, MROs and SAPs subscribe to the ODAPC list-serve for updates; (3) changes to Medical Review Officer practices; and (4) addition of three "fatal flaws" causing a test result to be cancelled (no Chain of Custody Form (CCF), two separate collections performed using one CCF and no specimen submitted to the laboratory with the CCF).

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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