1. Update on OTETA Drug & Alcohol Testing Programs FL FAPT Conference June 2011 Dr. Donna Smith FirstLab, Inc. dsmith@firstlab.com

2.  Final Rule published Aug 16, 2010; Interim Final Rule published Sep 27, 2010  Changes to Part 40 effective Oct 1, 2010  Part 40 changes necessary to conform to revisions in the DHHS Guidelines published in Nov 2008.  OTETA requires DOT to follow the DHHS requirements for testing procedures/protocols and the drugs tested for in the DOT programs  Most of the changes relate to the DHHS certified laboratory procedures DOT Final Rule

3. Summary of Part 40 Changes  Testing for MDMA (Ecstasy)—MDMA is added as a target analyte in the amphetamines screening assay, with confirmation testing for MDMA, MDA, and MDEA.  Lower cutoff levels for cocaine and amphetamines;  Mandatory initial testing for heroin—The target analyte 6AM is added to the opiates screening test.  Certain definitions in-§40.3 were revised or added to conform to definitions in the DHHS Guidelines

4. Adding MDMA To Drug Test Panel  DOT adopted the HHS laboratory testing requirements of conducting initial testing for MDMA, conducting confirmatory testing for MDMA (Ecstasy), MDA (hug drug), and MDEA (Eve).  MDMA Screening cut-off 500 ng/mL  MDMA, MDA, MDEA confirmation cut-offs 250ng/mL  MDMA is readily available on the US illicit drug market  MDMA is no longer exclusively viewed as a ‘‘rave’’ or club drug, which aids distributors in selling it to nontraditional abusers

5. Lower Cut-offs for Amphetamines and Cocaine  DOT projects that the lower cut-off levels for cocaine and amphetamines will produce a 30% increase in laboratory confirmed positive tests for both cocaine and amphetamine/methamphetamine  Based on DOT data for confirmed cocaine and amp/methamp positives, the lower cut off levels will result in approximately 4,000 additional cocaine positives, and 4,000 additional amp/methamp positives per year. Initial Test Analyte Current Screening Cut-off New Screening Cut-off Confirmatory Test Analyte Current Confirmatory Cut-off New Confirmatory Cut-off Cocaine metabolites 300 ng/mL150 ng/mLBenzoylecgonine150 ng/mL100 ng/mL Amphetamines1000 ng/mL500 ng/mLAmphetamine Methamphetamine 500 ng/mL 250 ng/mL

6. Initial Testing for 6 AM (Heroin metabolite) Prior to 2010 6-AM testing was only conducted when morphine was detected at or above 2000 ng/mL on the opiate screening test Now all specimens will be tested for 6-AM, regardless of whether morphine is detected in the screening test DOT estimates only 30-40 additional 6-AM positives per year

7. No Change in Part 40 Provisions Specimen Collection procedures remain the same Record keeping requirements for employers, MROs, collectors, etc. remain the same DOT did not adopt the use of “instant drug tests” or the use IITF’s (screening only testing facilities) for DOT drug testing programs Alcohol testing procedures remain the same

8. New Custody and Control Form The DHHS revised the federal custody and control form (CCF) Effective date for the new CCF is Oct 1, 2010 DOT-regulated employers may use the “old” federal CCF until Sep 20, 2011 Major changes to the federal CCF include: −Collector/employer must identify the testing authority in Step 1 of the CCF - DOT: FMCSA, FAA, FRA, FTA, PHMSA, & USCG - All CDL testing is marked DOT-FMCSA −Step 4 includes blocks for use of IITF (will not apply to DOT testing) −Specimen container seals/labels more narrow −Laboratory and MRO sections will include additional drug analytes (MDMA, MDA, MDEA)

9. Employer Instructions to Collector In the IFR DOT requires that employers provide collectors with information about the donor and the drug test when the employee presents for a specimen collection 1.Name of employee (or applicant) being tested 2.Employee SSN or other ID number 3.SAMHSA laboratory name and address 4.Employer name, address, phone number, fax number 5.DER name and telephone number 6.MRO name, address, phone number, and fax number 7.The DOT agency (e.g. FMCSA) which regulates the employee’s safety-sensitive duties 8.Test reason (e.g. pre-employment, random, etc.) 9.Whether the test is to conducted under direct observation or not NOTE: # 3, 4, 5, 6, 7 can be preprinted on CCF

10. New Federal CCF

11. Reminder About “Annual” Drug Test Any drug test conducted on Florida school bus drivers as part of physical examination or other annual exam is not a federal DOT drug test. Drug test should be conducted using a non- federal custody and control form or other form issued by the State Even though Florida has adopted the FMCSA standards for physical qualifications of school bus drivers, the drug test is not a test conducted under Part 382.

12. MRO Safety Notices You may receive a negative test result from the MRO that also has a “safety warning or notice” indicated. Safety notices are issued by the MRO when the driver has disclosed in the interview with the MRO medications he/she is taking that MAY cause a “risk to safety” −Either the side effects of the medication may cause mental or motor functioning impairment, or −The medical condition for which the medications are prescribed may be a problem for safely performing driving duties

13. MRO Safety Notices Employer responsibilities when the MRO issues a safety notice: −Tell driver he/she cannot continue to drive until his/her medications/medical condition is evaluated and he/she has been “cleared” to drive Options for evaluating the driver’s “fitness to drive” based on medications/medical conditions: −Have driver submit statement from prescribing physician that he/she is aware of driver’s duties and in the physician’s opinion the driver can safely drive while taking the meds. −Have driver go to an occupational health physician or physician who conducted his/her driver physical examination and be “cleared” for driving duties while taking meds as prescribed

14. Prescription Drug Abuse Narcotic painkillers (Opioids) are leading classification of abused drugs today −Oxycodone, hydromorphone and oxycodone are not detected on DOT drug test panel –Opana (oxymorphone hydrochloride) is also not detectable on the DOT panel Tranquilizers are also frequently abused/misused drugs and are not detected on the DOT drug screen Other prescription drugs with high abuse potential include Tramadol (Ultram) and Soma (sleep-inducing drug)—not detected on DOT drug test

15. New Craze in Illegal Drugs K2 or "Spice" is a mixture of herbs and spices that is typically sprayed with a synthetic compound chemically similar to THC. Chemical compounds typically include HU-210, HU- 211, JWH-018, and JWH-073. Commonly purchased in head shops, tobacco shops, various retail outlets, and over the Internet. Often marketed as incense or "fake weed.“ or synthetic cannabis Street names--Bliss, Black Mamba, Bombay Blue, Fake Weed, Genie, Spice, K-2, Special K

16. Spice, K-2 K2 is typically sold in small, silvery plastic bags of dried leaves and marketed as incense that can be smoked. Resembles potpourri. Usually smoked in joints or pipes, but some users make it into a tea. Psychological effects are similar to those of marijuana and can include paranoia, panic attacks, and giddiness

18. Spice, K-2 DEA listed the major components in Spice and K- 2 as Schedule I illicit drugs in December 2010 No medical or licit use for the compounds found in K-2/Spice Use is not detected in drug test for marijuana Several laboratories have developed assays to detect Spice/K-2 in urine. −Has not been added to DOT drug panel

19. Bath Salts?? What Next? Mephedrone (4-MMC) is a drug that has a chemical lineage that blends amphetamine and cathinone structures together to create a hybrid psychedelic stimulant. Cathinone is the psychostimulant that powers the drug khat, a plant that is grown in Africa and smuggled to the United States. Mephedrone has obvious addictive potential. Anecdotal information indicates that the drug can cause an amphetamine-like constellation of effects, including all the onerous symptoms of paranoia, anorexia, and hyper-vigilance.

20. Bath Salts & Plant Food-- Mephedrone Ivory Wave, Red Dove, and Vanilla Sky are the more common forms of these products. Nominally marketed and sold as bath salts, these substances are not intended for human consumption. Are packaged as bath salts and are relatively easy to prepare and ingest to get high. The white bath powders can be snorted or smoked. Preparation is quite similar to preparation of powdered methamphetamine or cocaine for "snorting." 4-MMC also appears as a product in certain brands of foreign made plant food. Coming from Russia and Cameroon, these substances are typically packaged in small plastic baggies for individual use. They are prepared and snorted in a fashion identical to ingestion of cocaine and methamphetamine.

21. Bath Salts