ALL THAT IS NEW – PART 1 Program Update Office of Drug and Alcohol Policy and Compliance (ODAPC)...

ALL THAT IS NEW – PART 1Program Update

Office of Drug and Alcohol Policy and Compliance (ODAPC)

Office of the Secretary of Transportation

U.S. Department of Transportation

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Office of the Secretary of TransportationLeadership & 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.

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

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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.

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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.

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DOT Drug & Alcohol Testing Regulated Industry Program

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Jim KeenanFMCSA

Rafael RamosFAA

Lamar AllenFRA

Bob SchoeningUSCG

Linda CrossDOT Internal Program

http://www.dot.gov/ost/dapc/oamanagers.html

Program Managers

Maggi GunnelsFMCSA Medical

Jerry PowersFTA

Stan KastanasPHMSA

http://www.dot.gov/ost/dapc/oamanagers.html

46 CFR Part 4,16

49 CFR Part 655

49 CFR Part 382

49 CFR Part 219

49 CFR Part 199

14 CFR Part 12049 CFR Part 40

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PHMSA

employer

s2,450

employees

190,000

USCG

employers15,000

employees 150,000

FRA

employers750

employees 111,300

FTA

employers

3,224

employees

273,300

FMCSA

employers700,000

employees6,000,000

FAA

employers6,900

employees 450,000

The Program Works

Sustained Drop in Overall Drug Use

11~ Each Horizontal Grid Line Represents 1% ~

Drug Testing Data Since 2005

Drug Testing Data Since 2005 (continued)

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• 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].

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 14

The Omnibus Transportation Employee Testing Act of 1991

1. Drug & Alcohol Testing of Safety-Sensitive Personnel2. Privacy to the Extent Practicable3. Test Types4. HHS Laboratory Protocols / Drugs5. Labs Certified by HHS6. Split Specimen Collections [Drugs]7. Ensure Safeguards for Alcohol Testing [EBT

Confirmation]8. Confidentiality of Test Results

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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

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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, 2010 - 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

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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?

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• 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

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#2 - When does DOT have the option not to follow HHS?

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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 these21

• PREAMBLE – Principal Policy Issues :

#3 - When does the Omnibus Act limit or prohibit DOT from following HHS?


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• 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


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• PREAMBLE – Additional Principal Policy Issues Discussed:

– MDMA Testing – We added this under the category of Amphetamine testing• See 49 CFR sections 40.87 and 40.97

– Lowering Laboratory Cutoff Criteria for Cocaine and Amphetamines• See 49 CFR sections 40.87 and 40.97


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– Laboratory Testing for 6-Acetylmorphine (6-AM)• See 49 CFR sections 40.87, 40.97, 40.139, 40.140

– Remember, there is “no legitimate medical explanation for the presence of PCP, 6-AM, MDMA, MDA, or MDEA in a specimen” – 49 CFR section 40.151


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– Approval of Medical Review Officer Training and Examination Groups

– Medical Review Officer Recurrent Requalification raining and Examination

– Medical Review Officer Records Maintenance


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• 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 49859 (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.


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• Other Issues– Those definitions are:

• 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; • Split Specimen collection.


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• Laboratory:– We followed the HHS lead on the following scientific

issues:

• We added mandatory MDMA (Ecstasy) testing (Sections 40.87 and 40.97)

• We lowered cutoff levels for cocaine and amphetamines (Sections 40.87 and 40.97)


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• 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


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• 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


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• 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.


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• 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.


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–Qualification and Requalification [Section 40.121(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.

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– Qualification and Requalification [Section 40.121(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.

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• Medical Review Officers (MROs)– Qualification and Requalification [Section

40.121(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.

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– Recordkeeping Requirements [Section 40.163(h)]:

• MRO recordkeeping requirements did not change from the five years for non-negatives and one year for negatives.

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– 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 40.140(a))

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• 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 40.140(b))– If confirmed morphine is below 2000 ng/mL you must verify

positive (Section 40.140(b)(1))– If morphine is not confirmed below 2000 ng/mL you discuss

with Lab to determine the need for further testing (Section 40.140(b)(2))

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• 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 40.140(c))• If the lab confirm 6-AM and no detectable morphine

found, you must contact ODAPC immediately (Section 40.140(d))

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High Morphine / Low 6-AM

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• 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

High Morphine / Low 6-AM

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• MYTHS:– 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 [382.213]

High Morphine / Low 6-AM [Cont]

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• DOT immediately contacted HHS• RTI has contact the two labs, and both repeated the

re-analyses of the specimen for 6-AM• FINDINGS:

1. Lab A initial report 10.0 ng/ml 6-AM2. Lab A repeat of 6-AM: Test NEG3. Lab A uses ethyl acetate as a solvent during the

injection of sample into the GC/MS4. Lab B initial report is NEG for 6-AM5. Lab B repeat analyses is NEG 6-AM

• Test would not have been positive for 6-AM using new 6-AM screening procedures



– 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 40.159(a)(6))

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DOT Horizon

Final Rule - HHS Harmonization

Inspection Database

Civil Penalty Authority -

Service Agents

Alternative Specimens

Prescription Medication

Employee Violation Database

Clandestine Inspections

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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. “

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• 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.”

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• 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.”

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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

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The Criminal Case - Sentencing

• 22 months in prison

• Plus supervised release for 3 years

• Plus $209,030.00 in Criminal Monetary Penalties in Restitution

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POP QUIZ

1. Beginning October 1st, labs lowered the cutoff levels for THC...

True or False?

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POP QUIZ

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

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POP QUIZ

2. Current MROs must have requalification training and pass an examination during the next calendar year – 2011…

True or False?53

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.

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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?55

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. 56

POP QUIZ

4. The old CCF can be used through September 30, 2011, with no corrective action ...

True or False?

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POP QUIZ

4. True: The use of old CCFs is acceptable through September 30, 2011. Part 40 has special instructions for their use by collectors and MROs.

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POP QUIZ

5. Beginning October 1st, testing of urine specimens became a 7-panel drug test regimen ...

True or False?59

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.

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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?

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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.

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POP QUIZ

7. Labs are to report quantization's for confirmed positive drugs/drug metabolites only upon MRO request ...

True or False? 63

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.

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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? 65

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.

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POP QUIZ

9. MDMA, MDA, & MDEA are considered to be in the opiate class of drugs ...

True or False?

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POP QUIZ

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

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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?

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POP QUIZ

10. True: See new Section - 40.14

“What collection information must employers provide to

collectors?”

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Patrice KellyDeputy Director

Jim L. SwartDirector

Bob AshbyOffice of General

Counsel

Mark SniderSenior Policy Advisor

Bohdan BaczaraPolicy Advisor

Cindy IngraoSenior Policy Advisor

Vicki BelletMaria Lofton

Administrative

www.dot.gov/ost/dapc/

ODAPC Staff

Yale CaplanLaboratory Consultant

John SheridanStatistician Consultant

http://www.dot.gov/ost/dapc/

U.S. Department of Transportation

Office Of Drug and Alcohol Policy and Compliance1200 New Jersey Avenue, S.E.

Washington, DC 20590

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