1 Presented by: Dr. Donna Smith Regulatory Compliance & Program Development Officer DOT UPDATE Drug & Alcohol Testing June 2016 EDPM, Inc., th Street North, Suite 1200, Birmingham, AL |

Proposed Changes in Drug Testing o There are 3 major rulemakings underway that affect DOT drug testing Adding lab-based oral fluid drug testing as a specimen for testing under OTETA Adding lab-based oral fluid drug testing as a specimen for testing under OTETA Expanding the drug testing panel to include Schedule II opiate/opioid drugs (e.g. hydrocodone, hydromorphone, oxycodone, oxymorphone) Expanding the drug testing panel to include Schedule II opiate/opioid drugs (e.g. hydrocodone, hydromorphone, oxycodone, oxymorphone) Requiring positive and refusals to test on drivers to be reported to a central, national database Requiring positive and refusals to test on drivers to be reported to a central, national database

Oral Fluid Drug Testing o Oral fluid specimens would be collected using FDA/HHS approved collection devices—most likely a pad or swab device o Specimen analyzed at a DHHS certified laboratory Drug panel, analytes, and cut-off levels established by DHHS—similar to urine drug testing panel Drug panel, analytes, and cut-off levels established by DHHS—similar to urine drug testing panel Screening and confirmation analysis required Screening and confirmation analysis required o Split specimen collection required Using 2 collection devices simultaneously or sequentially Using 2 collection devices simultaneously or sequentially

Oral Fluid Drug Testing o Many see oral fluid testing as less “invasive/ embarrassing” than urine specimen collection o May be able to be used when donor has a “shy bladder” o Possible use after a negative dilute, invalid or other urine drug test result o Critics are concerned that window of detection for drug use may be shorter than in urine

Oral Fluid Drug Testing o Final HHS Guidelines on oral fluid drug testing may be issued this year (2016) o Effective date will be several months after final Guidelines to accommodate laboratory certification process, proficiency testing by the NLCP, etc. o DOT supports using oral fluid drug testing in programs governed by 49 CFR Part 40. OTETA and administrative procedures will require DOT to publish revisions to Part 40, including an NPRM, final rule and effective/implementation date OTETA and administrative procedures will require DOT to publish revisions to Part 40, including an NPRM, final rule and effective/implementation date Likely not in place before 2017 Likely not in place before 2017

EXPANDED DRUG PANEL o DHHS has recommended additional Schedule II drugs/metabolites for the federal drug testing panel o Data indicates that prescription narcotic painkiller medication abuse is a greater problem and greater threat to public safety than illicit drug use o The opiate drugs/metabolites that will be added are: Hydrocodone, hydromorphone, oxycodone, oxymorphone Hydrocodone, hydromorphone, oxycodone, oxymorphone o The intent is for the urine and oral fluid panels to test for the same drugs/metabolites o No plan to include methadone or tranquillizers on federal drug testing panel at this time

EXPANDED DRUG PANEL o There is no plan to remove any of the drugs/metabolites from the current testing panel o Once HHS has finalized the analytic methods, cut-off levels, etc. a final rule will be published o DOT strongly supports the inclusion of the Schedule II opiate/opioid drugs in the federal testing panel DOT plans to adopt the changes to the HHS Guidelines expanding the federal testing panel DOT plans to adopt the changes to the HHS Guidelines expanding the federal testing panel o Time line for implementation of the expanded drug testing panel for DOT testing is at least 12 months away.

Hair Testing for Drugs of Abuse o DHHS and DOT are pursuing the use of hair testing for federal drug testing programs o Hair testing provides a longer “window of detection” for drug use, however best detects the chronic or frequent drug abuser o Hair testing may be most appropriate for pre- employment and random testing o A proposed hair testing rule may be issued in late 2016 or 2017 by DHHS; final implementation for hair testing under DOT rules is at least 2 years away.

Federal Data Base on Drug & Alcohol Violations o FMCSA has been directed to develop and maintain a federal data base/clearinghouse of CDL drivers (including school bus operators) who have drug/alcohol violations (positive tests, refusals to test, etc.) o Process has been on-going for over 6 years and still no data base. Major obstacle has been funding for the project 2012 legislation again included clearinghouse requirement with a 2014 deadline for FMCSA to issue implementing regulations 2012 legislation again included clearinghouse requirement with a 2014 deadline for FMCSA to issue implementing regulations The FMCSA issued a proposed rule for the “clearinghouse”; in 2014 and the public comment period ended in May 2014 The FMCSA issued a proposed rule for the “clearinghouse”; in 2014 and the public comment period ended in May 2014 The FMCSA is reportedly going to issue a final rule for the clearinghouse in 2016 The FMCSA is reportedly going to issue a final rule for the clearinghouse in 2016

Federal Data Base on Drug & Alcohol Violations o Major objective of the clearinghouse is to prevent drivers from “employer hopping” after violations without going through SAP and rehab process o Prior employer violations check has been ineffective; especially for tracking drivers who test positive on a pre-employment drug test

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