FINAL RULE – Procedures for Transportation Workplace Drug and Alcohol Testing Programs: Addition of Certain Schedule II Drugs to the Department of Transportation’s Drug-Testing Panel and Certain Minor Amendments

Office of the Secretary of Transportation (OST), U.S. Department of Transportation (DOT) –  Final rule.

SUMMARY:

The Department of Transportation is amending its drug-testing program regulation to add hydrocodone, hydromorphone, oxymorphone, and oxycodone to its drug-testing panel; add methylenedioxyamphetamine as an initial test analyte; and remove methylenedioxyethylamphetamine as a confirmatory test analyte. The revision of the drug-testing panel 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 testing. This final rule clarifies certain existing drug-testing program provisions and definitions, makes technical amendments, and removes the requirement for employers and Consortium/Third Party Administrators to submit blind specimens. This rule is effective on January 1, 2018.

SUPPLEMENTARY INFORMATION:
I. Purpose

The Department of Transportation (DOT or the Department) issued a notice of proposed rulemaking (NPRM) on January 23, 2017. 82 FR 7771 (Jan. 23, 2017). The NPRM proposed to revise Part 40 of Title 49 of the Code of Federal Regulations (CFR) to harmonize with certain parts of the revised the Department of Health and Human Services (HHS) Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (HHS Mandatory Guidelines), which was published on the same day. 82 FR 7920 (Jan. 23, 2017). DOT currently requires urine testing for safety-sensitive transportation industry employees subject to drug testing under Part 40.

There are two changes to the HHS Mandatory Guidelines with which the NPRM proposed to harmonize Part 40. First, the revised HHS Mandatory Guidelines, in part, allow Federal agencies with drug-testing responsibilities to test for four additional Controlled Substances Act (CSA) Schedule II prescription medications: Hydrocodone, hydromorphone, oxycodone, and oxymorphone. Second, the HHS Mandatory Guidelines remove methylenedioxyethylamphetamine (MDEA) as a confirmatory test analyte from the existing drug-testing panel and add methylenedioxyamphetamine (MDA) as an initial test analyte. In addition to harmonizing with pertinent sections of the HHS Mandatory Guidelines for urine testing, the NPRM proposed to clarify certain existing Part 40 provisions; to remove provisions that no longer are necessary (such as obsolete compliance dates); to move the content of certain provisions out of Part 40 and onto the Office of Drug and Alcohol Policy and Compliance’s (ODAPC) Web site; and to update definitions and web links where necessary. The Department also proposed to remove existing Part 40 requirements related to blind specimen testing.

The Department received 69 comments on the proposed rulemaking. The comments were from multiple sources including transportation industry associations, drug and alcohol testing industry companies and associations, doctors and medical groups, labor organizations, and individuals.

II. Authority for This Rulemaking

This rule is promulgated pursuant to the Omnibus Transportation Employee Testing Act (OTETA) of 1991 (Pub. L. 102-143, Title V, 105 Stat. 952). OTETA sets forth the requirements for DOT reliance on the HHS Mandatory Guidelines for scientific testing issues. Section 503 of the Supplemental Appropriations Act, 1987 (Pub. L. 100-71, 101 Stat 391, 468), 5 U.S.C. 7301, and Executive Order 12564 establish HHS as the agency that directs scientific and technical guidelines for Federal workplace drug-testing programs and standards for certification of laboratories engaged in such drug testing. While DOT has discretion concerning many aspects of the regulations governing testing in the transportation industries’ regulated programs, we must follow the HHS Mandatory Guidelines for the categories of drugs for which we will require testing.

III. Background

Relevant History of the DOT Drug-Testing Program Regulation
The Department first published its drug testing program regulation, 49 CFR part 40 (Part 40) on November 21, 1988 as an interim final rule (53 FR 47002). We based the rule on the HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs (See 53 FR 11970, April 11, 1988), which, in part, required cocaine and marijuana to be screened by Federal agencies. HHS based this requirement on the incidence and prevalence of the abuse of these two substances in the general population and on the experiences, at the time, of the Departments of Defense and Transportation in screening their workforces (53 FR 11973-11974). The 1988 HHS Mandatory Guidelines also authorized Federal agencies to test their employees for the use of phencyclidine, amphetamines, and opiates. The DOT published a final rule on December 1, 1989 (54 FR 49854), which incorporated several provisions from the 1988 HHS Mandatory Guidelines. Among these provisions was a 5-panel test that included all of the drugs for which HHS authorized testing. In 1991, Congress passed the Omnibus Transportation Employee Testing Act (OTETA) which, in part, required the Department and DOT Agencies to look to the HHS for the scientific and technical guidelines regarding the drugs for which we test and specimens we collect.
The Department made comprehensive revisions to Part 40 on August 19, 1994 (59 FR 42996), December 19, 2000 (65 FR 79462), and August 16, 2010 (75 FR 49850). The 2010 revision again harmonized our DOT drug-testing program, where necessary, with the HHS Mandatory Guidelines effective October 1, 2010 (73 FR 7185; 75 FR 22809). Specifically, we required initial and confirmatory testing for methylenedioxymethamphetamine (MDMA); confirmatory testing for MDA and MDEA; and initial testing for 6-acetylmorphine (6-AM). We also lowered the initial and confirmatory test cutoff concentrations for amphetamines and cocaine.

Just as we have revised Part 40 in the past, we are revising Part 40 to harmonize, in pertinent part, with the most recently revised HHS Mandatory Guidelines that have an effective date of October 1, 2017. See 82 FR 7920.

Changes Relevant to the HHS Mandatory Guidelines

HHS monitors drug abuse trends and reviews information on new drugs of abuse from sources such as Federal regulators, researchers, the drug-testing industry, and public and private sector employers. In its May 15, 2015 “Notice of Proposed Revisions” (See 80 FR 28103), HHS indicated that, since its original HHS Mandatory Guidelines were published in 1988, a number of recommendations had been made for additional drugs to be included in Federal workplace drug-testing programs. According to HHS, recommendations for adding the four semi-synthetic drugs were based on a review of scientific information and on input from the Drug Testing Advisory Board (DTAB) [1] on the methods necessary to detect the analytes of drugs and on drug abuse trends. With the DTAB recommendations, private sector experience findings, and analysis of current drug abuse trends, HHS concluded that the additional semi-synthetic opioids, oxycodone, oxymorphone, hydrocodone, and hydromorphone, should be added in the Federal program.
In its Final Rule dated January 23, 2017, HHS acknowledged that, while it had proposed MDA and MDEA as initial test analytes, three commenters disagreed with the addition of MDA and MDEA as target analytes. HHS indicated that the commenters stated that this change would require modification of current immunoassay reagents, laboratory processes, or both. The commenters noted that this would impose an unnecessary burden for compounds with such low incidence in workplace testing. HHS determined that the number of positive MDEA specimens reported by HHS-certified laboratories does not support testing all specimens for MDEA in Federal workplace drug testing programs. Based on the comments and its own studies, HHS removed MDEA from its Mandatory Guidelines. HHS indicated that it understands MDA and some other analytes also have a low incidence of testing positive, but believes the continued testing for these analytes is warranted in a deterrent program. In particular, inclusion of MDA as an initial and confirmatory test analyte is warranted according to HHS because, in addition to being a drug of abuse, it is a metabolite of MDEA and MDMA.

Harmonizing Changes to the DOT Drug-Testing Program Regulation

In keeping with our obligations under OTETA to follow the HHS Mandatory Guidelines for the drugs for which we test, our NPRM proposed to add and remove the drugs adopted in the revised HHS Mandatory Guidelines for urine testing. Inclusion of these four semi-synthetic opioids is intended to help address the nation-wide epidemic of opioid abuse. Also, adding these four drugs, which are already tested for in many transportation employers’ non-DOT testing programs because of their widespread use and potentially impairing effect, will allow the DOT to detect a broader range of drugs being used illegally. This will enhance the safety of the transportation industries and the public they serve. The Department’s final rule makes these harmonizing amendments to Part 40.

IV. Main Policy Issues
A. Modification of the Drug Testing Panel

The NPRM
The Department proposed to add the four semi-synthetic opioids to the DOT panel (i.e., hydrocodone, hydromorphone, oxycodone, and oxymorphone) to maintain consistency with the HHS Mandatory Guidelines. Such consistency is mandated by Federal statute, OTETA, and applies not only to the drugs tested but also to specimen testing validity values and initial and confirmatory testing values. To cover these substances, as well as those previously in the opiate category (i.e., codeine, morphine, 6-AM), the NPRM proposed to rename the category from “opiates” to “opioids.”

As we mentioned in the NPRM preamble, opioid abuse and related problems are a major national concern. Transportation industries are not immune to this trend and the safety issues it raises. Consequently, the Department proposed including these substances in its testing panel not only for consistency with the HHS Mandatory Guidelines but as a response to a national problem that can affect transportation safety.
In addition, to be consistent with changes to the HHS Mandatory Guidelines, the Department proposed to remove MDEA from the testing panel and add MDA as an initial test analyte.

B. Blind Specimens

The NPRM
The NPRM proposed to remove from Part 40 the requirements for blind specimen testing. The purpose of this proposal was to relieve unnecessary costs and administrative burdens on employers, C/TPAs, and other parties.
The blind specimen requirement has been part of the Department’s drug testing program since its inception. The requirement for employers and C/TPAs to submit blinds was intended to help ensure the accuracy of the laboratory testing process. Under the current regulation, an employer will send a blind specimen to an HHS-certified laboratory, accompanied by a Federal Drug Testing Custody and Control Form (CCF) with the name of a fictitious donor, for quality control purposes to see if the laboratory’s results match the known contents of that particular blind specimen.

Over the years, as the accuracy of the laboratory testing process was consistently established, DOT reduced the number of blind specimens that employers were required to send to laboratories to reduce cost and administrative burdens associated with the process. As we stated in the NPRM, not one false positive result was found through the testing of the blind specimens in more than 25 years of drug testing.

As the NPRM noted, laboratories are subject to thorough biannual inspections and quarterly proficiency testing through the HHS National Laboratory Certification Program (NLCP). In addition, if an employee has questions about the accuracy of the positive, adulterated, or substituted test result of his or her own specimen, the employee has the right to request the test of his or her split specimen. Believing that the blind specimen testing requirement was no longer necessary to ensure the accuracy and integrity of the testing process, we proposed eliminating this requirement and sought public comment on the subject.

 

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