RLS & Associates, Inc.

1. Understanding the Updated USDOT Drug & Alcohol Testing Regulation (49 CFR Part 40) Presented by: Robbie L. Sarles President RLS & Associates, Inc. April 4, 2018 RLS & Associates, Inc.

2. REMEMBER! • RLS is NOT is not an official or representative of: • United States Department of Transportation (USDOT) • USDOT – Office of Drug & Alcohol Policy and Compliance (ODAPC) • Any USDOT – Agency • (i.e., FTA, FMCSA, FRA, FAA, PHMSA, etc.)

3. Best Practices • NOT Required by USDOT, FTA or Any Other Modal Administration • NOT A Regulatory Requirement • Addresses Issues That Might Already Be Covered Under Employer’s Own Company/Agency Authority ATTENTION: ANY TEXT WHICH IS BLUE IS MEANT TO INDICATE THAT IT IS NOT A USDOT REQUIREMENT/REGULATION. THESE PROVISIONS WOULD BE BEST-PRACTICES/SUGGESTIONS AND UNDER THE AUTHORITY OF THE EMPLOYER

4. AGENDA

5. Action Items • When you see a red star throughout this slideshow – this will indicate to you that there is a potential ACTION ITEM for your attention.

6. Background 49 CFR Part 40 U S D O T FAA FMCSA USCG PHMSA FRA FTA RLS & Associates, Inc.

7. Background • “The What?” • 49 CFR Part 40 is USDOT’sD&A regulation covering testing procedures • Part 40 has been updated • “The When?” • Jan 2017 – USDOT issued NPRM • Nov 2017 – Final Rule published in Federal Register • Jan 1, 2018 – Effective Date for all changes

8. Background • “The Who?” • Applicable to entire DOT industry (FTA, FMCSA, FRA, FAA, PHMSA, USCG, etc.) • ANYONE subject to 49 CFR Part 40 • Employers, MROs, SAPs, Collection Sites, etc.

9. Summary of Changes • Drug Testing Panel Modifications • “Opiate” changes to “Opioid” • Four new opioids added to testing panel

10. Summary of Changes • Drug Testing Panel Modifications (continued) • “MDA” added to screening test • “MDEA” removed • Revisions / Updates to Terms & Definitions • “DOT, the Department, DOT agency” • Modified to encompass all DOT agencies, (FAA, FRA, FMCSA, FTA, PHMSA, NHTSA, OST, and any designee of a DOT agency) • Clarified USCG’s relationship with USDOT

11. Summary of Changes • Revisions / Updates to Definitions (continued) • “Drugs” – modified to match the additions and revisions as discussed earlier • “Alcohol Screening Device” & “Evidential Breath Testing Device (EBT)” • List of approved devices now listed on ODAPC’s website (instead of in the federal register) • “Substance Abuse Professional” • List of qualified agencies for drug and alcohol counselor licenses/certificates will now be listed on ODAPC’s website

12. Summary of Changes • ODAPC List-Serve • All service agents REQUIRED to “subscribe” • Sign-up via https://www.transportation.gov/odapc/get-odapc-email-updates • Prohibition of Use of Federal Branding, etc. • Blind Specimen Testing No Longer Required

13. Summary of Changes • Urine Collection / Testing • Urine only allowable specimen (no blood, hair, sweat, etc.) • No DNA testing allowed • 3 new “Fatal Flaws” • No CCF with urine specimen at Lab • No urine specimen with CCF at Lab • Only if a specimen was actually collected • Two separate collections on only one CCF

14. Summary of Changes • Urine Collection / Testing (continued) • Insufficient “Questionable Specimens” - Always discard & remark • New CCF Changes • Removed “DOT” box in Step 1D • Revised list of drugs in Step 5A

15. Summary of Changes • Urine Collection / Testing (continued) • Use of “old” / “new” CCF • “New” CCF authorized for use Jan 1, 2018 • Continued use of old CCF authorized through June 30, 2018 • No ‘memorandum for the record required’ through June 30, 2018 for use of “old” CCF • “New” CCFMUST BE utilized July 1, 2018

16. Summary of Changes • MRO Verification Process • Clarification of the term “prescription” • Prescription (Rx) must be consistent with Controlled Substances Act (CSA) • MRO-ordered additional testing • Authorized without prior ODAPC consent • Meth false positives due to Rx/OTC meds • Illicit THC vs. Marinol

17. Summary of Changes • MRO Rx Verification Process • MRO release of information – Medically unqualified / Significant safety risk • Step 1 – Verify test result • Step 2 - Initial MRO determination • MRO notifies employee of medically unqualified / significant safety risk • Step 3 - Five-days for prescribing physician to contact MRO • Employee facilitates contact

18. Summary of Changes • MRO Rx Verification Process (continued) • MRO release of information – Medically unqualified / Significant safety risk (continued) • Step 4 – Prescribing physician statement to MRO • Step 5 – Possible employer notification • Based on outcome of Steps 1 - 4

19. Summary of Changes • Other Minor Misc. Changes • Removal of outdated compliance dates • Minor editorial corrections • Update/revisions to weblinks • Revisions to Appendix items

20. Workplace Impact • Policy Revisions – • Change “opiate” to “opioid” • Remove (or edit) “breakdown” of 5-panel drug sub-categories • Remove (or edit) drug cut-off levels • Revise your “definitions” (if applicable) • ASD, EBT, SAP, DRUGS, USDOT

21. Workplace Impact • Policy Revisions – BEST PRACTICES (NOT REQUIRED BY USDOT) • If your policy currently has a section on Rx/OTC medication use • Update to address MRO determinations of “Medically Unqualified / Significant Safety Risk” • If your policy DOES NOT have a Rx/OTC medication use section • Consider adding a short paragraph

22. Workplace Impact • OTHER BEST PRACTICES (NOT REQUIRED BY USDOT) (continued) • Service Agent education • Summary of Regulatory changes • Make sure they have a copy of the revised regulation • Give them the link on how to sign-up for ODAPC’s List Serve • Require evidence that they actually signed up for ODAPC’s List-Serve

23. Workplace Impact • “Medically Unqualified / Significant Safety Risk” • Final word is the MRO’s DISCRETION • What are the REAL implications? • Access to prescribing physician • Expiration of Rx • No recent contact to prescribing physician • What to do when/if you get the phone call • This is 100% employer’s determination (No USDOT regulation) • Unless USDOT- CDL medical standards apply

24. Workplace Impact • “Medically Unqualified / Significant Safety Risk” • Employers should be pro-active in creating a “Fitness-for-duty/Wellness” policy (NOT A USDOT REGULATION) • Legal/Union/Collective Bargaining Concerns

25. Implications • MRO Approach To Decision Making Process Is Not Defined In the Regulation • MRO discretion based on medical judgement • ODPAC Guidance Forthcoming • MRO philosophy, assessment of liability and risk management practices will influence approach • Case-by-case determination

26. Implications • Possible MRO Determinations • Silent—No safety risk, no employer knowledge, no employer action • Notification of safety issue—Employer action • Follow procedure for CDL standard violation if appropriate • Liability Considerations • Human Resource • Legal Considerations • Collective Bargaining

27. Best Practice • Proactively Discuss Philosophy and Procedures with MRO • If MRO Philosophy Is Inconsistent with Employer Philosophy or Intent of Regulation, Identify New MRO • If MRO Is Unwilling or Unable to Perform This Function, Identify New MRO • Define MRO Safety Issue Notification Procedures, Documentation and Timeline • Negotiate Cost of MRO Safety Assessment

28. Implications • Employee Facilitation of Prescribing Physician/MRO Contact • Employees May Have Difficulty Accessing the Prescribing Physician In a Timely Manner • If More Than 5 Days Are Needed To Obtain an Appointment or Otherwise Get In Contact • The Prescribing Physician Is Unaware or Does Not Understand the Importance of the Contact • Employee Has Had No Recent Contact or Ongoing Relationship with the Prescribing Physician • Employee Does Not Know How to Facilitate the Contact Between the Physician and the MRO

29. Best Practice • Assist Employees In Being Proactive • Educate Employees on Safety Risks of Rx • Provide A Summary of Regulatory Changes • ODAPC Notice • Review New/Revised Employer Policy • Define Process and Provide Guidance On How to Notify Prescribing Physician to Contact MRO

30. Best Practice • Encourage Employees to Obtain Updated Rx • Current Rx Is More Than One Year Old • Rx States “Take As Needed” For An Injury That Is No Longer Being Treated By the Prescribing Physician • Employee Does Not Have an Ongoing Relationship with the Prescribing Physician • ER/Urgent Care or Doc-in-a-Box Physicians

31. Best Practice • Encourage Employees to Obtain Updated Rx (cont.) • Revisit Treatment Options With Prescribing Physician for Chronic or Reoccurring Conditions To Minimize Safety Impacts While Not Compromising Medical Care • Encourage Employees Using Opioids to Discuss Dosing Option with Prescribing Physician • Timing • Dosage • Alternative Pain Management Options

32. Best Practices • Provide Employees with a Physician Rx Medical Authorization Form • Job Description Highlighting Safety-Sensitive Duties • Area for Prescribing Physician to Indicate Possible Safety Risks With Corresponding Restrictions, If Any • Notification that Prescribing Physician May Be Contacted By MRO If A Safety Concern Exists

33. Best Practices • Inform Applicants of Possible Prescribing Physician/MRO Contact Requirement • Provide Explicit Directions As Early on In the Hiring Process As Possible • Emphasize That a Valid Rx Does Not Necessarily Mean Disqualification. • Rx Is Only An Issue When It Rises to the Level of Safety Risk.

34. Implications • Employer’s Response Not Defined • Assessment of Nature and Scope of Safety Risk • Short-term, Long-term, Permanent • Course of Action/Remedy • Monitoring Process and Revaluation • Medical Advisory and Decision Making Process • Employee Consequences And Due Process • Documentation, Record-keeping, and Confidentiality • Liability and Risk Management

35. Employer Challenge • Best Practice Is to Develop An Effective Rx Fitness-for-Duty Program • A program that minimizes the associated impairment risks of taking legally and illegally obtained prescription medications while performing transit–related, safety-sensitive functions

36. Best Practice • Establish a Fitness-for-Duty Program • Policy • Consequences • Medical Review of Employees Deemed to be a Safety Risk • Procedures • Employee Education • Documentation, Reporting, Confidentiality

37. Questions?

38. Resources • USDOT - ODAPC Resources • Final Rule: https://www.gpo.gov/fdsys/pkg/FR-2017-11-13/pdf/2017-24397.pdf • Brief summary of changes: https://www.transportation.gov/odapc/Part_40_Final_Rule_Summary_of_Changes • CCF Notice: https://www.transportation.gov/odapc/Notice_CCF_December_2017 • Policy Notice: https://www.transportation.gov/odapc/Part_40_DOT_Policies_Notice_2017 • Employee Notice: https://www.transportation.gov/odapc/Part_40_DOT_Employee_Notice_2017

39. Resources • Other Resources • National RTAP Recorded Webinar (Part 40 Update): http://www.nationalrtap.org/Webinars#DrugAlcoholUpdate • National RTAP Recorded Webinar (Fitness For Duty): http://www.nationalrtap.org/Webinars#fitnessforduty • A more in-depth look at key factors in developing a fitness-for-duty policy