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ODAPC Top Policy Issues

Rulemaking – Synthetic Opiate Drug Testing

Issue: The DOT submitted a response to the Office of Management and Budget (OMB) regarding synthetic opiates drug testing rulemaking of the Department of Health and Human Services (HHS) Substance Abuse and Mental Health Services Administration's (SAMHSA) Division of Workplace Programs (DWP). This rulemaking will add four synthetic opiates [Oxycodone, Hydrocodone, Oxymorphone, and Hydromorphone] into DWP's Mandatory Guidelines, which would result in testing Federal government employees for the illegal use of these drugs. The Omnibus Transportation Employee Testing Act of 1991 requires DOT to follow HHS for the panel of drugs for which we require transportation employers to test their safety-sensitive employees. Consequently, ODAPC has prepared a notice of proposed rulemaking (NPRM) to propose including the four synthetic opiates into the transportation workplace drug testing program.

Action Needed: ODAPC is preparing the NPRM for simultaneous publication with the HHS final rule. Continued Secretarial support for ODAPC's efforts in getting its NPRM published simultaneously with the HHS final rule is needed. Also, once ODAPC publishes the NPRM, we will need Secretarial support to expedite the publication of the final rule.

Background: The defined "DOT Agencies" that utilize ODAPC's drug testing procedural regulation are: the Federal Aviation Administration, the Federal Motor Carrier Safety Administration, the Federal Railroad Administration, the Federal Transit Administration, the Pipelines and Hazardous Materials Safety Administration, and the US Coast Guard (under the Department of Homeland Security). The DOT Agencies require regulated employers to conduct pre-employment, random, post-accident, for-cause, return-to-duty, and follow-up testing for a 5-panel of drugs to deter and detect illegal use. Those drugs include Schedule I drugs and unauthorized use of a number of Schedule II drugs, most of which are prescription medications.

Our analysis – and the research, studies, and analysis of many others, including the Office of National Drug Control Policy (ONDCP), the SAMHSA, the Society of Addiction Medication, the Drug Enforcement Agency, and the Association of Poison Control Centers – have cited an ever-rising National threat regarding the use and abuse of Schedule II prescription medications in general and of the synthetic opiates in particular. The four synthetic opiates being added to the Mandatory Guidelines are excessively prescribed [via internet pill mills and doctor shopping], overly diverted to illicit sales and illegal distribution sources, and their use and abuse has become a national epidemic. Data also reveals that these synthetic opiates are prevalent in transportation accidents.

The addition of these synthetic opiates to the DOT-regulated drug testing panels is expected to be very well-received by the transportation industries. Regulated employers, transportation trade associations, Congress and the media have all indicated that they, too, think that testing for the synthetic opiates is long-overdue.

Submitted by: Office of Drug and Alcohol Policy and Compliance

Last updated: October 25, 2016

Rulemaking – Oral Fluid Drug Testing

Issue: The Department of Health and Human Services (HHS) Substance Abuse and Mental Health Services Administration's Division of Workplace Programs has submitted to the Office of Management and Budget (OMB) a final rule to allow oral fluids testing as a permissible methodology for Federal employee's drug testing, in addition to the existing long-used methodology of urine testing. The Omnibus Transportation Employee Testing Act of 1991 (OTETA) requires the DOT to follow HHS for the science of the drug testing that we require transportation employers to use to test their safety-sensitive employees. The DOT has submitted its comments to OMB. Although the DOT welcomes the use of an alternate specimen in its drug testing program, we have some concerns about passive contamination issues and split specimen testing for oral fluids. The key issues of concern are:

  • Under the HHS final rule, an individual could test positive for either exposure to or use of marijuana. But OTETA limits DOT testing to determining use only. Therefore, although DOT can allow transportation employer to use oral fluids testing, those employers would need to choose only the form of confirmation testing that identifies use and not merely exposure.
  • OTETA requires that all specimens be collected with a split specimen available so that an employee can challenge a positive result. The specimen must be simultaneously collected and then subdivided to provide for that split. HHS would allow specimen collection containers that would violate OTETA. DOT would address this by only allowing specimen containers that meet the requirements that OTETA has set for us.

Action Needed: Continued support from the Secretary is necessary to further ODAPC's efforts to work with OMB and HHS to find solutions for oral fluids testing that are consistent with the DOT's limitations under the OTETA.

Background: The defined "DOT Agencies" that utilize ODAPC's drug testing procedural regulation are: FAA, FMCSA, FRA, FTA, PHMSA, and the US Coast Guard (under the Department of Homeland Security). The DOT Agencies' drug testing programs currently drug test using urine specimens exclusively. HHS has approved oral fluids testing, saying that oral fluids testing "was best supported by peer-reviewed literature" among other alternative specimens, such as hair and sweat. Therefore, we are harmonizing with HHS on oral fluids through rulemaking.

Ruling out claims of testing positive due to exposure and requiring split specimen testing in accordance with OTETA are important issues for DOT.

Submitted by: Office of Drug and Alcohol Policy and Compliance

Last updated: October 25, 2016

Rulemaking – Electronic Records

Issue: The Department is planning to propose to amend its drug and alcohol testing regulation, 49 CFR Part 40 (Part 40) to permit the use of electronic forms, signatures and recordkeeping. Among the proposed changes are provisions authorizing the use of an electronic version of the Alcohol Testing Form (ATF), along with updates and minor technical changes to certain provisions of Part 40.

Action Needed: Continued Secretarial support for ODAPC's efforts in getting its NPRM published.

Background: Since the inception of its drug testing program under Part 40 in 1988, and later with the addition of the alcohol testing program to Part 40 in 1994, the regulation required paper documentation and wet signatures. The Department has continually examined ways to allow for electronic submissions and has implemented such methodologies where feasible (e.g., electronic submission of annual aggregate drug and alcohol data), and to the extent possible, via guidance and web-based applications on the ODAPC website.

The Department has made strides to incrementally incorporate the use of electronic forms (i.e., electronic Drug Testing Custody and Control form) and procedures that meet required security measures related to electronic storage and transmission of data. In this same spirit, we would propose to allow an electronic alcohol testing form (eATF) along with electronic signatures. The topic of signing documents electronically is particular challenging, due to the legal, security, and technological ramifications involved with digitization.

The increased use of electronic methods in the program is both inevitable and beneficial. We want to ensure that we put forth viable performance standards for the use of technology, so that the integrity and confidentiality requirements of the program can continue to be met. The importance of ensuring the confidentiality, integrity, and availability of the data and limiting access to any data transmission, storage, and retrieval systems is a high priority for the Department and for our regulated public.

Submitted by: Office of Drug and Alcohol Policy and Compliance

Last updated: October 25, 2016

Critical Initiatives – Outreach

Issue: ODAPC is the Department's resource for DOT's drug and alcohol testing information for the regulated transportation industry. With the Department's most utilized website (with more than 1.8 million page visits in 2015) and the government's largest list serve of its kind (approximately 35,000 subscribers), outreach has been a key priority for this office. ODAPC representatives are historically the guest speakers at many of the transportation industry conferences and seminars on drug and alcohol testing. We also provide training and outreach to DOT Agency inspectors/auditors and investigators. ODAPC has met with foreign government representatives when they wanted to learn more about the DOT's drug and alcohol testing regulations.

Action Needed: Continued Secretarial support is requested for ODAPC' outreach to DOT Agency inspectors/ auditors and investigators, transportation industry education and outreach through public presentations at industry conferences, and international outreach and Coordination (i.e., Second International Latin American Drug Free Workplace Conference in FY 2017; Australian Conference in FY 2018).

Background: The ODAPC staff is part of the S-1 organization and houses the Office of the Secretary's only safety regulation. ODAPC advises the Secretary on national and international drug testing and control issues and is the principal advisor to the Secretary on rules related to the drug and alcohol testing of safety-sensitive transportation employees in aviation, trucking, railroads, mass transit, pipelines, and other transportation industries. The Office publishes regulations and provides official interpretations on drug and alcohol testing, including how to conduct tests, and the evaluation and treatment procedures necessary for returning employees to duty after testing violations. The Office also coordinates the Department's involvement with the President's National Drug Control Strategy annually. ODAPC is also a publications office, with a large following of regulated industry employers who seek our publications, as well as advice.

Submitted by: Office of Drug and Alcohol Policy and Compliance

Last updated: October 25, 2016

Last updated: Friday, January 27, 2017