3Here is the Secretary’s mission statement Office of the Secretary of TransportationLeadership & Responsibilities StatementLeadership of the Department of Transportation is provided by the Secretary of Transportation, who is the principal adviser to the President in all matters relating to federal transportation programs. The Secretary is assisted by the Deputy Secretary in this role. The Office of the Secretary oversees the formulation of national transportation policy and promotes intermodal transportation. Other responsibilities range from negotiation and implementation of international transportation agreements, assuring the fitness of US airlines, enforcing airline consumer protection regulations, issuance of regulations to prevent alcohol and illegal drug misuse in transportation systems and preparing transportation legislation.Here is the Secretary’s mission statementReduce alcohol and drug misuse33
4ODAPC Program Services Advise Secretary and DOT Agency AdministratorsProgram issues at the national & international levelsDOT Agency / USCG drug & alcohol program activitiesProvide Consultation and LiaisonDOT Agencies: ONE-DOT ApproachExecutive Branch Agencies and Foreign GovernmentsONDCP, HHS, DHS, DoD, NRC, DOJ, EPA, NTSB, & etcMexico, Canada, Australia, England, Nigeria, New Zealand, etc.Industry Stakeholders / CustomersSupport Issue Conferences and Training EventsCollect and Analyze Data and InformationDevelop “Plain-Language” Regulations, Guidance Documents, and Policy Interpretations
5DOT Program Goals Ensure the Safety & Security of traveling public. Reduce the demand for drugs by transportation workers.Reduce alcohol misuse in the transportation industry.Create prevention & treatment opportunities.Keep employees who test positive or refuse a test off duty until successful compliance with treatment.At DOT Safety & Security are imperative.55
6DOT 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 LaboratoriesMedical Review Officers & Substance Abuse ProfessionalsAdministrative Law Judges & ArbitratorsFederal Courts [e.g., Decision on Direct Observation]Systems must be auditable & reviewable by DOT Agencies.Develop “plain-language” regulations, policies, and guidance documents.66
7DOT Drug & Alcohol Testing Regulated Industry Program 77
8Program Managers Jim Keenan Jerry Powers Rafael Ramos Lamar Allen FMCSAJerry PowersFTARafael RamosFAALamar AllenFRAStan KastanasPHMSABob SchoeningUSCGLinda CrossDOT Internal ProgramMaggi GunnelsFMCSA Medical88
949 CFR Part 38249 CFR Part 21949 CFR Part 19949 CFR Part 65549 CFR Part 4014 CFR Part 12046 CFR Part 4,16
11The Program Works Sustained Drop in Overall Drug Use ~ Each Horizontal Grid Line Represents 1% ~1111
12Drug 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]12
13Drug 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; andTotal 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].1313
14Program History Part 40 - Drug Testing Rules (1988 & 1989) Omnibus Transportation Employees Testing Act of 1991Part 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, 2008Final Rule Amendment [Major Update] - June 25, 2008U.S. COURT OF APPEALS UNANIMOUS DECISION - May 2009
15The Omnibus Transportation Employee Testing Act of 1991 Drug & Alcohol Testing of Safety-Sensitive PersonnelPrivacy to the Extent PracticableTest TypesHHS Laboratory Protocols / DrugsLabs Certified by HHSSplit Specimen Collections [Drugs]Ensure Safeguards for Alcohol Testing [EBT Confirmation]Confidentiality of Test Results
16Recent Events DOT’s “Medical Marijuana” Guidance – October 2009 Bottom Line: Medical Review Officers will not verify a drug test as negative based upon information that a physician recommended that the employee use “medical marijuana.” It remains unacceptable for any safety‐sensitive employee subject to drug testing under the Department of Transportation’s drug testing regulations to use marijuana.Public Interest Exclusion – Published November 17, 2009
17Recent Events Three Final Rules – February 25, 2010 ATF Form & MIS Form ModificationsState Reporting of Testing Violations of CDL DriversAlcohol Screening Device ProceduresNotice of Proposed Rulemaking – February 4, 2010Harmonization with HHSFinal Rule – August 16, Harmonization with HHS – Effective October 1, 2010Interim Final Rule – September 27, 2010– Effective October 1, 2010– Adopted the new FDTCCF– Comment period closes October 27, 20101717
18HHS HARMONIZATION Final Rule – Effective 10/01/2010 PREAMBLE – Principal Policy Issues:Definitive Answers on the Omnibus Transportation Employee TestingAct of 1992!#1 - When does the Omnibus Actrequire DOT to follow HHS?18
19HHS HARMONIZATION Final Rule – Effective 10/01/2010 PREAMBLE – Principal Policy Issues:Answer: DOT must follow HHS on thescience and methodology of testingWe must follow the HHS determination of the drugs for which DOT requires testingWe must require the use of HHS-certified LaboratoriesWe must rely on the technical expertise of HHS for certifying and decertifying laboratories19
20HHS HARMONIZATION Final Rule – Effective 10/01/2010 PREAMBLE – Principal Policy Issues:#2 - When does DOT have the option not to follow HHS?20
21HHS HARMONIZATION Final Rule – Effective 10/01/2010 PREAMBLE – Principal Policy Issues:Answer: We are not required to follow HHS on matters that are not scientificWe differ from HHS on Direct Observation triggers and proceduresWe have different requirements for how laboratories report to MROs creatinine concentrationsHow MROs handle invalids related to pH is different from how HHS has MROs handle these21
22HHS HARMONIZATION Final Rule – Effective 10/01/2010 PREAMBLE – Principal Policy Issues :#3 - When does the Omnibus Act limit or prohibit DOT from following HHS?22
23HHS HARMONIZATION Final Rule – Effective 10/01/2010 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 adoptsWe were prohibited from allowing the testing of single specimens because the Omnibus Act required Split Specimen Testing; however, HHS still allowed single specimen collectionsWe were prohibited from allowing the use of IITFs because the Omnibus Act requires all labs to have screening and confirmation capabilities23
24HHS HARMONIZATION Final Rule – Effective 10/01/2010 PREAMBLE – Additional Principal Policy Issues Discussed:MDMA Testing – We added this under the category of Amphetamine testingSee 49 CFR sections and 40.97Lowering Laboratory Cutoff Criteria for Cocaine and Amphetamines24
25HHS HARMONIZATION Final Rule – Effective 10/01/2010 PREAMBLE – Additional Principal Policy Issues Discussed:Laboratory Testing for 6-Acetylmorphine (6-AM)See 49 CFR sections 40.87, 40.97, ,Remember, there is “no legitimate medical explanation for the presence of PCP, 6-AM, MDMA, MDA, or MDEA in a specimen” – 49 CFR section25
26HHS HARMONIZATION Final Rule – Effective 10/01/2010 PREAMBLE – Additional Principal Policy Issues Discussed:Approval of Medical Review Officer Training and Examination GroupsMedical Review Officer Recurrent Requalification raining and ExaminationMedical Review Officer Records Maintenance26
27HHS HARMONIZATION Final Rule – Effective 10/01/2010 Other IssuesThe 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 (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.27
28HHS HARMONIZATION Final Rule – Effective 10/01/2010 Other IssuesThose definitions are:Adulterated specimen;Limit of Detection (LOD);Confirmatory drug test;Limit of Quantitation (LOQ);Initial drug test (also known as a Screening drug test);Negative result;Positive result;Initial specimen validity test;Reconfirmed;Rejected for testing;Invalid drug test;Split Specimen collection.Laboratory;28
29HHS HARMONIZATION Final Rule – Effective 10/01/2010 Laboratory:We followed the HHS lead on the following scientific issues:We added mandatory MDMA (Ecstasy) testing (Sections and 40.97)We lowered cutoff levels for cocaine and amphetamines (Sections and 40.97)29
30HHS HARMONIZATION Final Rule – Effective 10/01/2010 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 MROMorphine above LOD and below LOQ: laboratory reports Morphine present to MROMorphine at or below LOD: laboratory and MRO notify ODAPC30
31HHS HARMONIZATION Final Rule – Effective 10/01/2010 Laboratory:Reporting of initial testing for heroinFor 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 immediately31
32HHS HARMONIZATION Final Rule – Effective 10/01/2010 LaboratoryThe 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.32
33HHS HARMONIZATION Final Rule – Effective 10/01/2010 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.33
34HHS HARMONIZATION Final Rule – Effective 10/01/2010 Medical Review Officers (MROs)Qualification and Requalification[Section (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. 34
35HHS HARMONIZATION Final Rule – Effective 10/01/2010 Medical Review Officers (MROs)Qualification and Requalification [Section (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.35
36HHS HARMONIZATION Final Rule – Effective 10/01/2010 Medical Review Officers (MROs)Qualification and Requalification [Section (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.36
37HHS HARMONIZATION Final Rule – Effective 10/01/2010 Medical Review Officers (MROs)Recordkeeping Requirements [Section (h)]:MRO recordkeeping requirements did not change from the five years for non-negatives and one year for negatives.37
38HHS HARMONIZATION Final Rule – Effective 10/01/2010 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 (a))38
39HHS HARMONIZATION Final Rule – Effective 10/01/2010 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 (b))If confirmed morphine is below ng/mL you must verify positive (Section (b)(1))If morphine is not confirmed below ng/mL you discuss with Lab to determine the need for further testing (Section (b)(2))39
40HHS HARMONIZATION Final Rule – Effective 10/01/2010 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 (c))If the lab confirm 6-AM and no detectable morphine found, you must contact ODAPC immediately (Section (d))40
41High Morphine / Low 6-AMA case recently reported in an MRO news item - FACTS:Primary specimen tested UNDER OLD RULEPOS for Morphine [very high] and 6-AMPrescription for MS Contin [safety concern]Split failed to reconfirm 6-AMSpecimen Results CancelledMRO sent Split Cancellation Report to DOT4141
42High Morphine / Low 6-AM MYTHS: DOT ADVICE TO MRO: Primary specimen was tested under Oct 1st protocolsHigh morphine caused the 6-AM positiveSend donor back for recollection under DONo other MRO obligationsDOT 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 [ ]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]4242
43High Morphine / Low 6-AM [Cont] DOT immediately contacted HHSRTI has contact the two labs, and both repeated the re-analyses of the specimen for 6-AMFINDINGS:Lab A initial report 10.0 ng/ml 6-AMLab A repeat of 6-AM: Test NEGLab A uses ethyl acetate as a solvent during the injection of sample into the GC/MSLab B initial report is NEG for 6-AMLab B repeat analyses is NEG 6-AMTest would not have been positive for 6-AM using new 6-AM screening procedures4343
44HHS 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 (a)(6))44
45DOT Horizon Final Rule - HHS Harmonization Inspection Database Civil Penalty Authority - Service AgentsAlternative SpecimensPrescription MedicationEmployee Violation DatabaseClandestine Inspections
46The Public Interest Exclusion Public Interest Exclusion – Published November 17, 2009Who was affected:“…Michael R. Bennett, Workplace Compliance, Inc., in North Carolina, Texas, and all other places it is incorporated, franchised, or otherwise doing business, and all other individuals who are officers, employees, directors, shareholders, partners, or other individuals associated with Workplace Compliance, Inc. “
47The Public Interest Exclusion Publicly excluded from what?“…this decision will hereby immediately exclude (hereinafter referred to as ‘Michael R. Bennett, et al.’) from acting as a service agent or providing any drug or alcohol testing services to any DOT- regulated entity for 60 months from the date of this decision, which will be July 31, 2014.”
48The Public Interest Exclusion Who else is affected?“Furthermore, as provided in 49 CFR § 40.409, this PIE prohibits any DOT-regulated employer from utilizing the drug and alcohol testing services of doing business with Michael R. Bennett, et al. until after July 31, 2014.”
49The Public Interest Exclusion The Criminal CaseCharged with more than 20 criminal countsBennett and the company pled guilty to 3 counts of wire fraud and making false statements
50The Public Interest Exclusion The Criminal Case - Sentencing22 months in prisonPlus supervised release for 3 yearsPlus $209, in Criminal Monetary Penalties in Restitution
51POP QUIZ1. Beginning October 1st, labs lowered the cutoff levels for THC...True or False?
52POP QUIZ1. False: Cutoff concentrations are being lowered for amphetamines and cocaine, and a screening test is imitated for 6-AM.
53POP QUIZ2. Current MROs must have requalification training and pass an examination during the next calendar year – 2011…True or False?
54POP QUIZ2. False: Current MROs will need to have requalification training 5 years from the date they last completed either their part 40 Qualification Training or their part 40 Continuing Education requirement.
55POP QUIZ3. Labs are not required to report the DOT Agencies, which is in Step 1D of the CCF, on their semi-annual data reports to DOT or on their results reports to MROs ...True or False?
56POP QUIZ3. True: There are no part 40 requirements for the DOT Agencies at Step 1-D of the CCF to be reported on lab results reports to MROs or on semi-annual lab data reports to employers or to the DOT.
57POP QUIZ4. The old CCF can be used through September 30, 2011, with no corrective action ...True or False?
584. True: The use of old CCFs is acceptable through POP QUIZ4. True: The use of old CCFsis acceptable throughSeptember 30, Part 40 has special instructions for their use by collectors and MROs.
59POP QUIZ5. Beginning October 1st, testing of urine specimens became a 7-panel drug test regimen ...True or False?
60POP QUIZ5. False: Because so many people refer to testing as the NIDA-5 or 5-panel, to which we are adding Ecstasy as a class of amphetamines, we are still calling this a 5-panel to avoid any confusion by the many employers, employees, collectors, and MROs.
61POP QUIZ6. MROs must contact DOT if a heroin positive result turns out, after additional testing, to have no detectable morphine ...True or False?
626. True: In the very rare event POP QUIZ6. True: In the very rare eventthat there exists no detectable morphine at LOD for a 6-AM confirmed positive, the DOT’s ODAPC must be notified.
63POP QUIZ7. Labs are to report quantization's for confirmed positive drugs/drug metabolites only upon MRO request ...True or False?
64POP QUIZ7. False: In order to harmonize with HHS on this matter, DOT requires labs to report quantitations for ALL confirmed positive drugs/drug metabolites.
65POP QUIZ8. All DOT Agencies and the USCG are requiring that employer policies be updated concerning the new drugs for which we will test ...True or False?
66POP QUIZ8. False: The FRA requires the new drugs to be specified in employer policies; and the other DOT Agencies and USCG require specificity only if the other drugs are already referenced in policies.
67POP QUIZ9. MDMA, MDA, & MDEA are considered to be in the opiate class of drugs ...True or False?
68POP QUIZ9. False: MDMA, MDA, & MDEA are in the amphetamine class of drugs.
69POP QUIZ10. Part 40 has in one place the requirements for information that employers and their service agents are to provide collectors ...True or False?
70“What collection information must employers provide to collectors?” POP QUIZ10. True: See new Section“What collection information must employers provide to collectors?”
72ODAPC Staff Patrice Kelly Jim L. Swart Bob Ashby Mark Snider Deputy DirectorJim L. SwartDirectorBob AshbyOffice of GeneralCounselMark SniderSenior Policy AdvisorBohdan BaczaraPolicy AdvisorCindy IngraoSenior Policy AdvisorYale CaplanLaboratory ConsultantVicki BelletMaria LoftonAdministrativeJohn SheridanStatistician Consultant
73U.S. Department of Transportation Office Of Drug and Alcohol Policy and Compliance 1200 New Jersey Avenue, S.E. Washington, DC 20590