1. 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

3. 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

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

5. 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

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. 6 6

7. DOT Drug & Alcohol Testing Regulated Industry Program7 7

8. 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 8 8

9. 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

10. 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

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

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] 12

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]. 13 13

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

15. 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

16. 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

17. 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, 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

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? 18

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 19

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

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 21

22. 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

23. 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

24. 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 and 40.97
Lowering Laboratory Cutoff Criteria for Cocaine and Amphetamines 24

25. 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, ,
Remember, there is “no legitimate medical explanation for the presence of PCP, 6-AM, MDMA, MDA, or MDEA in a specimen” – 49 CFR section 25

26. 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

27. 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 (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

28. 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

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

30. 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

31. 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

32. 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

33. 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

34. HHS 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

35. HHS 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

36. HHS 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

37. HHS 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

38. 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 (a)) 38

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 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

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

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 41 41

42. 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 [ ]
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

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 43 43

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 (a)(6)) 44

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

46. 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. “

47. 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.”

48. 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.”

49. 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

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

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

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

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

54. 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.

55. 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?

56. 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.

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

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

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

60. 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.

61. 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?

62. 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.

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

64. 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.

65. 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?

66. 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.

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

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

69. 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?

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

72. 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

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