U.S. Department of Transportation ALL THAT IS NEW – PART 1 Program Update Office of Drug and Alcohol Policy and Compliance (ODAPC) Office of the Secretary of Transportation

Here is the Secretary’s mission statement Office of the Secretary of Transportation Leadership & Responsibilities Statement Leadership 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 statement Reduce alcohol and drug misuse 3 3

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

DOT 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. 5 5

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. 6 6

DOT Drug & Alcohol Testing Regulated Industry Program 7 7

Program Managers Jim Keenan Jerry Powers Rafael Ramos Lamar Allen FMCSA Jerry Powers FTA Rafael Ramos FAA Lamar Allen FRA Stan Kastanas PHMSA Bob Schoening USCG Linda Cross DOT Internal Program Maggi Gunnels FMCSA Medical http://www.dot.gov/ost/dapc/oamanagers.html 8 8

49 CFR Part 382 49 CFR Part 219 49 CFR Part 199 49 CFR Part 655 49 CFR Part 40 14 CFR Part 120 46 CFR Part 4,16

PHMSA employers 2,450 employees 190,000 USCG employers 15,000 employees 150,000 FRA employers 750 employees 111,300 FTA employers 3,224 employees 273,300 FMCSA employers 700,000 employees 6,000,000 FAA employers 6,900 employees 450,000

The Program Works Sustained Drop in Overall Drug Use ~ Each Horizontal Grid Line Represents 1% ~ 11 11

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] 12

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]. 13 13

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

The Omnibus Transportation Employee Testing Act of 1991 Drug & Alcohol Testing of Safety-Sensitive Personnel Privacy to the Extent Practicable Test Types HHS Laboratory Protocols / Drugs Labs Certified by HHS Split Specimen Collections [Drugs] Ensure Safeguards for Alcohol Testing [EBT Confirmation] Confidentiality of Test Results

Recent 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

Recent Events Three Final Rules – February 25, 2010 ATF Form & MIS Form Modifications State Reporting of Testing Violations of CDL Drivers Alcohol Screening Device Procedures Notice of Proposed Rulemaking – February 4, 2010 Harmonization with HHS Final Rule – August 16, 2010 - Harmonization with HHS – Effective October 1, 2010 Interim Final Rule – September 27, 2010 – Effective October 1, 2010 – Adopted the new FDTCCF – Comment period closes October 27, 2010 17 17

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? 18

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 19

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

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 21

HHS 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

HHS 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 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 23

HHS HARMONIZATION Final Rule – Effective 10/01/2010 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 24

HHS 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, 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 25

HHS HARMONIZATION Final Rule – Effective 10/01/2010 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 26

HHS HARMONIZATION Final Rule – Effective 10/01/2010 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. 27

HHS HARMONIZATION Final Rule – Effective 10/01/2010 Other Issues Those 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

HHS 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 40.87 and 40.97) We lowered cutoff levels for cocaine and amphetamines (Sections 40.87 and 40.97) 29

HHS 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 MRO Morphine above LOD and below LOQ: laboratory reports Morphine present to MRO Morphine at or below LOD: laboratory and MRO notify ODAPC 30

HHS HARMONIZATION Final Rule – Effective 10/01/2010 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 31

HHS HARMONIZATION Final Rule – Effective 10/01/2010 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. 32

HHS 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

HHS HARMONIZATION Final Rule – Effective 10/01/2010 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.  34

HHS HARMONIZATION Final Rule – Effective 10/01/2010 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. 35

HHS HARMONIZATION Final Rule – Effective 10/01/2010 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.   36

HHS HARMONIZATION Final Rule – Effective 10/01/2010 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.     37

HHS 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 40.140(a)) 38

HHS 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 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)) 39

HHS 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 40.140(c)) If the lab confirm 6-AM and no detectable morphine found, you must contact ODAPC immediately (Section 40.140(d)) 40

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 41 41

High Morphine / Low 6-AM MYTHS: DOT ADVICE TO MRO: 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] 42 42

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 43 43

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)) 44

DOT Horizon Final Rule - HHS Harmonization Inspection Database Civil Penalty Authority - Service Agents Alternative Specimens Prescription Medication Employee Violation Database Clandestine Inspections

The Public Interest Exclusion Public Interest Exclusion – Published November 17, 2009 Who 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. “

The 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.”

The 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.”

The Public Interest Exclusion The Criminal Case Charged with more than 20 criminal counts Bennett and the company pled guilty to 3 counts of wire fraud and making false statements

The Public Interest Exclusion The Criminal Case - Sentencing 22 months in prison Plus supervised release for 3 years Plus $209,030.00 in Criminal Monetary Penalties in Restitution

POP QUIZ 1. Beginning October 1st, labs lowered the cutoff levels for THC... True or False?

POP QUIZ 1. False: Cutoff concentrations are being lowered for amphetamines and cocaine, and a screening test is imitated for 6-AM.

POP QUIZ 2. Current MROs must have requalification training and pass an examination during the next calendar year – 2011… True or False?

POP QUIZ 2. 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.

POP QUIZ 3. 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?

POP QUIZ 3. 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.

POP QUIZ 4. The old CCF can be used through September 30, 2011, with no corrective action ... True or False?

4. True: The use of old CCFs is acceptable through POP QUIZ 4. True: The use of old CCFs is acceptable through September 30, 2011. Part 40 has special instructions for their use by collectors and MROs.

POP QUIZ 5. Beginning October 1st, testing of urine specimens became a 7-panel drug test regimen ... True or False?

POP QUIZ 5. 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.

POP QUIZ 6. MROs must contact DOT if a heroin positive result turns out, after additional testing, to have no detectable morphine ... True or False?

6. True: In the very rare event POP QUIZ 6. True: In the very rare event that there exists no detectable morphine at LOD for a 6-AM confirmed positive, the DOT’s ODAPC must be notified.

POP QUIZ 7. Labs are to report quantization's for confirmed positive drugs/drug metabolites only upon MRO request ... True or False?

POP QUIZ 7. False: In order to harmonize with HHS on this matter, DOT requires labs to report quantitations for ALL confirmed positive drugs/drug metabolites.

POP QUIZ 8. 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?

POP QUIZ 8. 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.

POP QUIZ 9. MDMA, MDA, & MDEA are considered to be in the opiate class of drugs ... True or False?

POP QUIZ 9. False: MDMA, MDA, & MDEA are in the amphetamine class of drugs.

POP QUIZ 10. Part 40 has in one place the requirements for information that employers and their service agents are to provide collectors ... True or False?

“What collection information must employers provide to collectors?” POP QUIZ 10. True: See new Section - 40.14 “What collection information must employers provide to collectors?”

ODAPC Staff Patrice Kelly Jim L. Swart Bob Ashby Mark Snider Deputy Director Jim L. Swart Director Bob Ashby Office of General Counsel Mark Snider Senior Policy Advisor Bohdan Baczara Policy Advisor Cindy Ingrao Senior Policy Advisor Yale Caplan Laboratory Consultant Vicki Bellet Maria Lofton Administrative John Sheridan Statistician Consultant www.dot.gov/ost/dapc/

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