Update on OTETA Drug & Alcohol Testing Programs FL FAPT ConferenceJune 2011Dr. Donna SmithFirstLab, Inc.dsmith@firstlab.com

Final Rule published Aug 16, 2010; Interim Final Rule published Sep 27, 2010Changes to Part 40 effective Oct 1, 2010Part 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 programsMost of the changes relate to the DHHS certified laboratory procedures DOT Final Rule

Summary of Part 40 ChangesTesting 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 heroinThe 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

Adding MDMA To Drug Test PanelDOT 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/mLMDMA, MDA, MDEA confirmation cut-offs 250ng/mL MDMA is readily available on the US illicit drug marketMDMA is no longer exclusively viewed as a rave or club drug, which aids distributors in selling it to nontraditional abusers

Lower Cut-offs for Amphetamines and CocaineDOT 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/methamphetamineBased 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 AnalyteCurrent Screening Cut-offNew Screening Cut-offConfirmatory Test AnalyteCurrent Confirmatory Cut-offNew Confirmatory Cut-offCocaine metabolites300 ng/mL150 ng/mLBenzoylecgonine150 ng/mL100 ng/mLAmphetamines1000 ng/mL500 ng/mLAmphetamineMethamphetamine500 ng/mL500 ng/mL250 ng/mL250 ng/mL

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 testNow all specimens will be tested for 6-AM, regardless of whether morphine is detected in the screening testDOT estimates only 30-40 additional 6-AM positives per year

No Change in Part 40 ProvisionsSpecimen Collection procedures remain the sameRecord keeping requirements for employers, MROs, collectors, etc. remain the sameDOT did not adopt the use of instant drug tests or the use IITFs (screening only testing facilities) for DOT drug testing programsAlcohol testing procedures remain the same

New Custody and Control FormThe DHHS revised the federal custody and control form (CCF)Effective date for the new CCF is Oct 1, 2010DOT-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 CCFDOT: FMCSA, FAA, FRA, FTA, PHMSA, & USCGAll CDL testing is marked DOT-FMCSAStep 4 includes blocks for use of IITF (will not apply to DOT testing)Specimen container seals/labels more narrowLaboratory and MRO sections will include additional drug analytes (MDMA, MDA, MDEA)

Employer Instructions to CollectorIn 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

Name of employee (or applicant) being testedEmployee SSN or other ID numberSAMHSA laboratory name and addressEmployer name, address, phone number, fax numberDER name and telephone numberMRO name, address, phone number, and fax numberThe DOT agency (e.g. FMCSA) which regulates the employees safety-sensitive dutiesTest reason (e.g. pre-employment, random, etc.)Whether the test is to conducted under direct observation or not

NOTE: # 3, 4, 5, 6, 7 can be preprinted on CCF

New Federal CCF

Reminder About Annual Drug TestAny 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 StateEven 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.

MRO Safety NoticesYou 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 safetyEither the side effects of the medication may cause mental or motor functioning impairment, orThe medical condition for which the medications are prescribed may be a problem for safely performing driving duties

MRO Safety NoticesEmployer 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 driveOptions for evaluating the drivers fitness to drive based on medications/medical conditions:Have driver submit statement from prescribing physician that he/she is aware of drivers duties and in the physicians 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

Prescription Drug AbuseNarcotic painkillers (Opioids) are leading classification of abused drugs todayOxycodone, hydromorphone and oxycodone are not detected on DOT drug test panelOpana (oxymorphone hydrochloride) is also not detectable on the DOT panelTranquilizers are also frequently abused/misused drugs and are not detected on the DOT drug screenOther prescription drugs with high abuse potential include Tramadol (Ultram) and Soma (sleep-inducing drug)not detected on DOT drug test

New Craze in Illegal DrugsK2 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 cannabisStreet names--Bliss, Black Mamba, Bombay Blue, Fake Weed, Genie, Spice, K-2, Special K

Spice, K-2K2 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

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

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.

Bath Salts & Plant Food--MephedroneIvory 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.

Bath Salts

**Pepsi Bottling Group Waste ConnectionsFlorida Department of EducationAsplundh Tree ExpertsAir Products and Chemicals, Inc.Florida Department of Transportation (Florida Transit Association)North Carolina Department of TransportationState of South CarolinaArkansas Transit AssociationIndependence Blue Cross/Blue Shield

Soon to be added:SUNOCOSchneider National (National trucking Company)