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    3. Here is the Secretary’s mission statement Reduce alcohol and drug misuse Here is the Secretary’s mission statement Reduce alcohol and drug misuse

    4. ODAPC Program Services Advise Secretary and DOT Agency Administrators Program issues at the national & international levels DOT Agency / USCG drug & alcohol program activities Provide Consultation and Liaison DOT Agencies: ONE-DOT Approach Executive Branch Agencies and Foreign Governments ONDCP, HHS, DHS, DoD, NRC, DOJ, EPA, NTSB, & etc Mexico, Canada, Australia, England, Nigeria, New Zealand, etc. Industry Stakeholders / Customers Support Issue Conferences and Training Events Collect and Analyze Data and Information Develop “Plain-Language” Regulations, Guidance Documents, and Policy Interpretations 4

    5. At DOT Safety & Security are imperative. At DOT Safety & Security are imperative.

    6. DOT Program Goals (continued) Ensure the Fairness & Integrity of the testing process – Omnibus Transportation Employee Testing Act of 1991. Maintain employee privacy & confidentiality. Have “Gatekeepers” in place to ensure “due process.” Certified Drug Testing Laboratories Medical Review Officers & Substance Abuse Professionals Administrative Law Judges & Arbitrators Federal Courts [e.g., Decision on Direct Observation] Systems must be auditable & reviewable by DOT Agencies. Develop “plain-language” regulations, policies, and guidance documents.

    7. DOT Drug & Alcohol Testing Regulated Industry Program

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    11. The Program Works

    12. Drug Testing Data Since 2005 Here’s what the past 6 years tells us. Positives on the decline – good news. Amphetamine above Cocaine [three straight reporting periods] [consistent with Quest Data] MJ most prevalent & rising [consistent with ONDCP & other indices]Here’s what the past 6 years tells us. Positives on the decline – good news. Amphetamine above Cocaine [three straight reporting periods] [consistent with Quest Data] MJ most prevalent & rising [consistent with ONDCP & other indices]

    13. Drug Testing Data Since 2005 (continued) Positive drug testing rates continue to decline [really good news!]; Amphetamine positive prevalence continues to be above Cocaine [for the third consecutive 6-month reporting period]; Marijuana continues to be most prevalent drug and percentages are going up; and Total tests have declined significantly since 2006, but there is a slight increase between the current 6-month period and the prior 6-month period [2.66M tests for the current period compared with 2.56M for the previous period].

    14. Program History Part 40 - Drug Testing Rules (1988 & 1989) Omnibus Transportation Employees Testing Act of 1991 Part 40 - Alcohol Testing Rules (1994) Over 100 Interpretations (Between 1994 & 2000) Final Rule - Major Re-write (2000) [VP’s Plain Language Award] ONE-DOT Management Information System (2003) Interim Final Rule [State Reporting] - June 13, 2008 Final Rule Amendment [Major Update] - June 25, 2008 U.S. COURT OF APPEALS UNANIMOUS DECISION - May 2009 14

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    18. HHS HARMONIZATION Final Rule – Effective 10/01/2010 PREAMBLE – Principal Policy Issues: Definitive Answers on the Omnibus Transportation Employee Testing Act of 1992! #1 - When does the Omnibus Act require DOT to follow HHS?

    19. HHS HARMONIZATION Final Rule – Effective 10/01/2010 PREAMBLE – Principal Policy Issues: Answer: DOT must follow HHS on the science and methodology of testing We must follow the HHS determination of the drugs for which DOT requires testing We must require the use of HHS-certified Laboratories We must rely on the technical expertise of HHS for certifying and decertifying laboratories

    20. HHS HARMONIZATION Final Rule – Effective 10/01/2010 PREAMBLE – Principal Policy Issues: #2 - When does DOT have the option not to follow HHS?

    21. HHS HARMONIZATION Final Rule – Effective 10/01/2010 PREAMBLE – Principal Policy Issues: Answer: We are not required to follow HHS on matters that are not scientific We differ from HHS on Direct Observation triggers and procedures We have different requirements for how laboratories report to MROs creatinine concentrations How MROs handle invalids related to pH is different from how HHS has MROs handle these

    22. PREAMBLE – Principal Policy Issues : #3 - When does the Omnibus Act limit or prohibit DOT from following HHS? HHS HARMONIZATION Final Rule – Effective 10/01/2010

    23. PREAMBLE – Principal Policy Issues : Answer: We must not follow HHS when the Omnibus Act expressly prohibits or expressly requires something that is different from what HHS adopts We were prohibited from allowing the testing of single specimens because the Omnibus Act required Split Specimen Testing; however, HHS still allowed single specimen collections We were prohibited from allowing the use of IITFs because the Omnibus Act requires all labs to have screening and confirmation capabilities HHS HARMONIZATION Final Rule – Effective 10/01/2010

    24. PREAMBLE – Additional Principal Policy Issues Discussed: MDMA Testing – We added this under the category of Amphetamine testing See 49 CFR sections 40.87 and 40.97 Lowering Laboratory Cutoff Criteria for Cocaine and Amphetamines See 49 CFR sections 40.87 and 40.97 HHS HARMONIZATION Final Rule – Effective 10/01/2010

    25. PREAMBLE – Additional Principal Policy Issues Discussed: Laboratory Testing for 6-Acetylmorphine (6-AM) See 49 CFR sections 40.87, 40.97, 40.139, 40.140 Remember, there is “no legitimate medical explanation for the presence of PCP, 6-AM, MDMA, MDA, or MDEA in a specimen” – 49 CFR section 40.151 HHS HARMONIZATION Final Rule – Effective 10/01/2010

    26. PREAMBLE – Additional Principal Policy Issues Discussed: Approval of Medical Review Officer Training and Examination Groups Medical Review Officer Recurrent Requalification raining and Examination Medical Review Officer Records Maintenance HHS HARMONIZATION Final Rule – Effective 10/01/2010

    27. Other Issues The DOT brought thirteen definitions in-line with those of HHS “in order that laboratories and others in the drug testing industry have consistent terms with which to operate.” 75 Fed Reg 49859 (Aug. 16, 2010) Adulterated specimen; Confirmatory drug test; Initial drug test (also known as a Screening drug test); Initial specimen validity test; Invalid drug test; Laboratory; Limit of Detection (LOD); Limit of Quantitation (LOQ); Negative result; Positive result; Reconfirmed; Rejected for testing; and Split Specimen collection. HHS HARMONIZATION Final Rule – Effective 10/01/2010

    28. Other Issues Those definitions are: Adulterated specimen; Confirmatory drug test; Initial drug test (also known as a Screening drug test); Initial specimen validity test; Invalid drug test; Laboratory; Limit of Detection (LOD); Limit of Quantitation (LOQ); Negative result; Positive result; Reconfirmed; Rejected for testing; Split Specimen collection. HHS HARMONIZATION Final Rule – Effective 10/01/2010

    29. Laboratory: We followed the HHS lead on the following scientific issues: We added mandatory MDMA (Ecstasy) testing (Sections 40.87 and 40.97) We lowered cutoff levels for cocaine and amphetamines (Sections 40.87 and 40.97) HHS HARMONIZATION Final Rule – Effective 10/01/2010

    30. Laboratory: We are requiring mandatory initial testing for heroin for: Positive 6-AM when the lab reports a negative morphine (because morphine was not detected at or above 2000ng/ml on the confirmation test ) the MRO confers with the laboratory if there was a confirmed morphine below 2000ng/mL and requests the Morphine quantitative result (MRO may submit blanket request)   Morphine above LOQ and below 2000 ng/mL: laboratory reports Morphine quantitative result to MRO   Morphine above LOD and below LOQ: laboratory reports Morphine present to MRO   Morphine at or below LOD: laboratory and MRO notify ODAPC   HHS HARMONIZATION Final Rule – Effective 10/01/2010

    31. Laboratory: Reporting of initial testing for heroin For a positive 6-AM and the lab reports a negative morphine (because morphine was not detected at the screening test) Laboratory contacts MRO; MRO should request opiates MS test [MRO may submit blanket request] If you confirm 6-AM and no detectable morphine found, you must contact ODAPC immediately HHS HARMONIZATION Final Rule – Effective 10/01/2010

    32. Laboratory The Final Rule does not allow the use of HHS-Certified Instrumented Initial Testing Facilities (IITFs) to conduct initial drug testing because the Omnibus Act requires laboratories to be able to perform both initial and confirmation testing but IITFs cannot conduct confirmation testing. Laboratories will still be conducting a 5-panel test not a 7-panel test. HHS HARMONIZATION Final Rule – Effective 10/01/2010

    33. Medical Review Officers (MROs) An MRO will not need to be trained by an HHS-approved MRO training organization as long as the MRO meets DOT’s qualification and requalification training requirements.

    34. Medical Review Officers (MROs) Qualification and Requalification [Section 40.121(d)]: We are requiring MROs to simply complete the new requalification training and examination no later than five years from the date of having last met either their qualification training or continuing education requirements. 

    35. Medical Review Officers (MROs) Qualification and Requalification [Section 40.121(d)] (continued): For example: If an MRO completed qualification training & passed an examination March 4, 2009 under the old rule, that MRO would need to complete the requalification training and pass an examination by March 4, 2014, under the new rule.

    36. Medical Review Officers (MROs) Qualification and Requalification [Section 40.121(d)] (examples continued): If an MRO completed qualification training & passed an examination August 16, 2007  and completed the required 12 hours of Continuing Education and assessment during the subsequent three years (August 16, 2010) under the old rule, that MRO would need to complete the requalification training and pass an examination by August 16, 2015, under the new rule.  

    37. Medical Review Officers (MROs) Recordkeeping Requirements [Section 40.163(h)]: MRO recordkeeping requirements did not change from the five years for non-negatives and one year for negatives.    

    38. Medical Review Officers (MROs) Instructions to MRO’s for verifying a 6-AM test result: If the lab confirms 6-AM and there is quantitation of morphine you must verify the result positive (Section 40.140(a))

    39. Medical Review Officers (MROs) Instructions to MRO’s for verifying a 6-AM test result (continued): If the lab confirms 6-AM and morphine is not confirmed at or above 2000 ng/mL you must confer with lab (Section 40.140(b)) If confirmed morphine is below 2000 ng/mL you must verify positive (Section 40.140(b)(1)) If morphine is not confirmed below 2000 ng/mL you discuss with Lab to determine the need for further testing (Section 40.140(b)(2))

    40. Medical Review Officers (MROs) Instructions to MRO’s for verifying a 6-AM test result (continued): If the lab confirms Morphine at LOD you must verify the result positive (Section 40.140(c)) If the lab confirm 6-AM and no detectable morphine found, you must contact ODAPC immediately (Section 40.140(d))

    41. High Morphine / Low 6-AM A case recently reported in an MRO news item - FACTS: Primary specimen tested UNDER OLD RULE POS for Morphine [very high] and 6-AM Prescription for MS Contin [safety concern] Split failed to reconfirm 6-AM Specimen Results Cancelled MRO sent Split Cancellation Report to DOT

    42. High Morphine / Low 6-AM MYTHS: Primary specimen was tested under Oct 1st protocols High morphine caused the 6-AM positive Send donor back for recollection under DO No other MRO obligations DOT ADVICE TO MRO: Due Process – cancel with NO recollection under DO [40.187(b)] Speak with prescribing physician [40.135] Speak with medical professional issuing CDL [40.327] Speak with employer about policy regarding driver use of medications [382.213] Importantly, the MRO received incorrect and incomplete advice from a non-DOT Source [IMPORTANTLY the MRO did not follow the incorrect advice] DOT Advised the MRO [go over each one] Importantly, the MRO received incorrect and incomplete advice from a non-DOT Source [IMPORTANTLY the MRO did not follow the incorrect advice] DOT Advised the MRO [go over each one]

    43. High Morphine / Low 6-AM [Cont] DOT immediately contacted HHS RTI has contact the two labs, and both repeated the re-analyses of the specimen for 6-AM FINDINGS: Lab A initial report 10.0 ng/ml 6-AM Lab A repeat of 6-AM: Test NEG Lab A uses ethyl acetate as a solvent during the injection of sample into the GC/MS Lab B initial report is NEG for 6-AM Lab B repeat analyses is NEG 6-AM Test would not have been positive for 6-AM using new 6-AM screening procedures

    44. HHS HARMONIZATION Final Rule – Effective 10/01/2010 Medical Review Officers (MROs) As a direct result of public comment, we turned the following ODAPC Q&A into rule language: How to handle invalids due to pH greater than or equal to 9.0 but less than or equal to 9.5: As the MRO you may consider the effects of time and temperature that could legitimately account for the pH value (Section 40.159(a)(6))

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    73. U.S. Department of Transportation Office Of Drug and Alcohol Policy and Compliance 1200 New Jersey Avenue, S.E. Washington, DC 20590

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