Update on DOT Drug & Alcohol Testing Programs

1. Update on DOT Drug & Alcohol Testing Programs FL DOE Meeting February 2010 Dr. Donna Smith FirstLab, Inc. dsmith@firstlab.com

2. 2009 • All DOT Return to duty and follow-up drug tests must be conducted using direct observation specimen collection procedures • After a prolonged court battle, the DOT prevailed in implementing a Part 40 rule change that requires employers to conduct DOT RTD and FU drug tests under direct observation specimen collection procedures • Requirement became effective August 31, 2009 • Direct observation procedures include the requirement for donors to re-position clothing and be visually inspected by the observer to determine if they are wearing a specimen adulteration/substitution device

3. DOT Return to Duty & Follow-up Tests • DOT RTD/FU Tests are only conducted on safety-sensitive employees who have had a previous positive test, refusal to test or other violation of the DOT drug & alcohol regulations • DOT RTD/FU tests are NOT used for: • Employees returning to safety-sensitive duty after lay off, workers’ comp injury, or other absence • Drug tests conducted as part of a DOT driver physical examination • Employees who have self-referred for substance abuse treatment and are returning to work

4. 2010 • Revisions to HHS Guidelines issued October 2008 with an effective date of May 1 2010. • Final revisions DO NOT include any authorization for “alternative” specimens, POCT (instant or rapid tests), or testing for additional drug classes for federal drug testing programs • The HHS Guidelines apply only to federal employees subject to testing under Executive Order 12564 and Public Law 100-71 • DOT issued a Notice of Proposed Rulemaking (NPRM) Feb 4, 2010 to apply the DHHS Guidelines revisions to DOT-mandated testing programs • DOT’s NPRM essentially proposes to adopt most of the DHHS Guidelines revisions • The comment period ends April 5, 2010 • Final rule will likely be issued in May 2010

5. 2010 DHHS Changes • Change in cut-off levels • Lower cut-off levels for cocaine and amphetamine testing • Cocaine 150ng/mL screening; 100 ng/mL confirmation • Amphetamines 500ng/mL screening; 250ng/mL confirmation for methamp & amp • Only require 100 ng/mL of accompanying amphetamine to report methamphetamine positive • Expected Impact of change • Slight increase ( <10%) in amphetamine and methamphetamine confirmed positives • Confirmed amphetamine positives have been increasing in federal drug testing for past 2-3 years • Large percentage (70+%) are being reported as MRO verified negatives because of prescriptions for Aderall • Will increase the window of detection for use; may counter somewhat the effect of specimen dilution

6. 21010 DHHS Changes • Adding testing for Ecstasy (MDMA). • Screening cut-off for MDMA is 500 ng/mL; confirmation for MDMA, MDA, & MDEA at 250 ng/mL. • Impact of Change • Confirmed positive tests for the designer amphetamine analogs. • % positive expected to be very low—Ecstasy “craze” is largely passé’ • Requirement to conduct 6 AM analysis on all screening tests for opiates • Currently 6 AM testing is only conducted when morphine screening result is 2000 ng/mL or greater • Change will require screening analysis for 6AM at 10 ng/mL cut-off • Impact of Change • Potentially more specimens reported positive for 6 AM • Some evidence to suggest that 6 AM is present in urine of recent heroin users even when morphine concentrations are below 2000 ng/mL

7. 2010 DHHS Changes • DHHS certification of Instrumented Initial Testing Facilities (IITF). • IITFs authorized only for initial screening; any confirmation testing required would be done at a DHHS certified drug testing laboratory. • IITFs will report negative results to MROs; will send presumptively positive, adulterated or substituted specimens to certified laboratory for further testing • Certified laboratory will conduct both screening and confirmation analysis on specimens received from IITFs • Impact of change • Large laboratory systems, may use an IITF facility for all their screening and retain only one or two laboratories for confirmation testing • Potential for increased time for positive, adulterated, substituted results reporting—transfer of specimen, rescreening at laboratory, etc. • “Unbundled” invoicing for laboratory analysis • One price for testing at IITF; additional price for testing at certified laboratory

8. 2010 DHHS Changes • Certified laboratories may now use LC/MS, LC/MS/MS, and GC/MS/MS for confirmation analyses in addition to the existing approved methodology GC/MS • Laboratories must validate all confirmation methods/technologies used • Impact of Change • For certain drug/drug metabolites, additional MS methods may conserve specimen volume • May make confirmation faster and less complex for certain target analytes by reducing specimen preparation steps

9. 2010 DHHS Changes • New Federal Custody and Control Form • Will include documentation for reporting results and transferring specimens from an IITF • Includes “testing authority” designation in Step 1 • HHS, NRC, DOT (including DOT agency—FMCSA, PHMSA, etc.) • Impact of Change • Collectors have to familiarize themselves with new form • Accuracy of “testing authority” designation • Use of “old forms” after new form effective date • Collector and donor portions of the form are largely unchanged

10. New Federal CCF

11. NO Changes on the Horizon • Use of hair, saliva or POCT devices for federally-mandated testing • Expansion of drug testing panel for federal testing to include opioids, benzodiazepines, etc. • Use of blood alcohol testing when breath testing is not available or is not feasible • Expansion of specimen validity testing requirements • Expansion of definitions of “safety-sensitive”

12. National Data Base for CDL Holder Drug & Alcohol Violations • Congressional funding authorization for FMCSA now includes a requirement for FMCSA to establish a national data base of drug and alcohol violations by CDL holders • FMCSA has not issued proposed regulations to establish and implement the database. • Employers, MROs and TPAs may have to report violations by CDL holders and employers will have to access database to check for violations when hiring a CDL employee