U.S. Department of Transportation

1. U.S. Department of Transportation DOT Drug & Alcohol Testing Update for FEDERAL TRANSIT ADMINSTRATION ANNAUL CONFERENCE Nashville, TN APRIL, 2009

2. Current Topics • Collection Site Security and Integrity • Specimen Validity Final Rule • Myths about Direct Observation • On the Horizon

3. GAO Report RecommendationsMay 2008 • DOT Secretary expedite efforts to: 1. Improve safety audits; and 2. Implement a national database for CDL driver DOT testing violations. • Congress consider: 1. Legislation to ban products designed to beat drug tests; 2. Providing civil penalty authority against service agents; and 3. Encouraging or requiring states to suspend / revoke CDLs of drivers who test positive or refuse tests.

4. DOT Clandestine Inspections Prevalent Egregious Failures • Access to Adulterant & Dilution Materials • Secure Water Sources • Supervise Employees • Empty Pockets

5. DOT Clandestine Inspections Prevalent Egregious Failures • Unauthorized Personnel • Wash Hands • Time Limits

6. EMPHASIS FOR DOT INSPECTIONS OF COLLECTION SITES • “DOT’s 10 Steps to Collection Site Security and Integrity” – sent to over 23,000 collection sites • Flash Video • Increase DOT Agency & USCG Inspector Training and Number of Inspections • Inspection Data Base • Clandestine Inspections • Civil Penalty Authority & PIE

7. Recent DOT Regulation & Policy Updates • Interim Final Rule ~ June 13, 2008 • Permits Employers & TPAs [for Owner-Operators] to report CMV driver testing violations to State CDL licensing authorities. • Final Rule ~June 25, 2008 [effective August 25, 2008] • Test all DOT specimens for SVT. • Labs submit semi-annual data reports to DOT. • Close endless loop for Invalid Results and streamline results reporting. • Direct Observation procedures check for beat-the-test devices. • Collection, SAP, and new Employer Handbook were updated (www.dot.gov/ost/dapc).

8. Recent DOT Regulation & Policy Updates • Interpretive Qs & As ~ July 31, 2008 • New MRO procedures for Invalids with pH in 9.0 - 9.5 range. • Federal Register Notice ~August 26, 2008 • Announced a 30-day comment period on the issue of whether direct observations should be mandatory for all return-to-duty and follow-up tests. • The comment docket closed on September 25. • This Notice postponed the effectiveness of only one of the Final Rule provisions. • The Notice reiterated that the new direct observation provisions are effective August 25, 2008 for all required direct observations.

9. Specimen Validity Testing (SVT) Final Rule – Effective 08/25/2008 • Collector: • Enhanced direct observation protocol • The observer requests the employee to raise his or her shirt, blouse or dress / skirt, as appropriate, above the waist, just above the navel; and lower clothing and underpants to mid-thigh and show the observer, by turning around, that the employee does not have such a device.

10. SVT Final Rule Effective 08/25/2008 • Lab: • Specimen Validity Testing is mandatory • Semi-annual statistics to ODAPC

11. Laboratory Drug Testing Data July – December 2008

12. Laboratory Drug Testing Data July – December 2008

13. Laboratory Drug Testing Data July – December 2008

14. SVT Final Rule Effective 08/25/2008 • MRO: • Close the loop on Invalids • Procedures for when a negative result is required

15. SVT Final Rule - Effective 08/25/2008 Employer: The definition of “refusal” is expanded to include when an employee: • Admits to the collector that he/she adulterated or substituted his/her specimen. • Behaves in a confrontational way that disrupts the collection process. • Fails to follow the observer’s instructions to raise and lower his/her clothing and turn around to permit the observer to determine if he/she has a prosthetic or other device that could be used to interfere with the collection process. • Possesses or wears a prosthetic or other device that could be used to interfere with the collection process. • Fails to wash his/her hands after being directed to do so.

16. Misinformation about the New Final Rule • Misinformation: “DOT proposed and requires Direct Observation for every test.” • Since 1989, direct observation has been, and will continue to be, required for only a handful of DOT tests.  And “No,” Direct Observation was not proposed and is not required for every collection.  • Direct Observation is now, and was in the past, required when: -- Specimens show signs of tampering at collection sites [e.g., cold, hot, discolored specimen] and through laboratory testing [e.g., invalid result with no medical explanation, dilute specimens with creatinine 2-5]; -- The MRO cancels verified positives and refusals to test because the split specimen was not available for testing; and -- Employers direct collection sites to perform Direct Observation for follow-up and return-to-duty testing.  • The DOT proposes to make Direct Observation mandatory for follow-up and return-to-duty testing, believing that enhancements are needed due to the employee’s heightened reasons to cheat a test because of relapse risks from substance abuse.

17. Misinformation about the New Final Rule • Misinformation: “The DOT requirement that observers watch the employee’s urine go directly from the person into the collection cup is brand new.” • Since 1989, the “body to bottle” direct observation procedure has been in place.  • Some collection sites and observers may not have always adhered to the long-standing requirement. • Because of the proliferation of devices designed to beat a drug test, to include realistic-looking prosthetic devices, we added another step to the DO process – to raise and lower clothing.

18. Misinformation about the New Final Rule • Misinformation: “Collection sites and employers are going to have a difficult time finding same gender observers, as required in the new rules, because the old rule permitted opposite gender observers if the observer was a medical professional.” • Since 1989, observers have had to be the same gender as the employee.  • There have never been opposite gender observers. • Not even opposite gender medical professionals could serve as observers. • All collection sites and employers have always had to be on “stand-by” for having same gender observers available.

19. Misinformation about the New Final Rule • Misinformation: “The major TPA & Collection Site organizations say they are not ready for the new Direct Observation procedures.” • The vast majority of the major TPAs, collection site organizations, and associations representing nearly all of collection sites have assured the DOT that they are ready. • Nearly every small collection organization we have talked with has told us they are ready, too. • Collection sites who have indicated to DOT that they will not be ready have also – fairly consistently – told us they often failed to conduct directly observed collections under the old rules, using the old procedures. • If sites were ready under the old rules, they are ready under the new rules!

20. Misinformation about the New Final Rule • Misinformation: “Only trained collectors can be observers.” • Observers have never been required to be trained collectors. • Observers can be trained collectors, but need not be. • Observers simply need to receive instruction from the collector on the correct procedures to follow. • ODAPC has published an instruction sheet for observers that can be downloaded from our website.

21. Misinformation about the New Final Rule • Misinformation: “Collectors can cancel a test if the site does not have a same gender observer.” • Collection site personnel have no authority to cancel a DOT test. • Part 40 states that, in the event a directly observed collection should have been accomplished but was not, it has to be accomplished when the discovery is made.

22. Misinformation about the New Final Rule • Misinformation: “When an employer elects to do a Direct Observation for Return to Duty or Follow-up, the employer can also elect to use the old procedures rather than the new procedures.” • Since August 25, 2008, all Directly Observed collections have been required to use the new procedures for checking for prosthetic and other devices.  • This includes Direct Observations conducted as an employer option in follow-up and return-to-duty testing situations, as well as for mandatory Direct Observations, in situations when the employee submits a cold specimen, or the employee has no legitimate medical reason for an invalid test result, etc.

23. Recent Guidance • **NEW** Collection Site Security and Integrity -Video [March 23, 2009]

24. On the Horizon • Collection Site Compliance Reviews • MRO Guidelines • Collector Guidelines

25. Office of Drug and Alcohol Policy and Compliance Jim Swart Director Patrice Kelly Deputy Director Bob Ashby Office of General Counsel Mark Snider Senior Policy Advisor Bohdan Baczara Policy Advisor Cindy Ingrao Senior Policy Advisor Vicki Bellet Maria Lofton Administrative

27. The ODAPC Websitewww.dot.gov/ost/dapc