New Drug and Alcohol Testing Regulations

New Drug and Alcohol
Testing Regulations
Presented by
Lee Okurowski, MD
New England Baptist Hospital
Occupational Medicine Center
Copyright 2011 by OEHN
Discussion Topics
This document discusses the New
Procedures for Transportation Workplace
Drug and Alcohol Testing Programs
focusing on the following areas:
•
•
•
•
•
Drug Testing Guidelines
Instrumented Initial Test Facility (IITF)
Medical Review Officer Rules
Definitions
Additional Urine Specimen Collection
Guidelines
• Focus of discussion is DOT vs. other
federal drug testing programs
Page
22
Slide
Procedures for Transportation
Workplace Drug and Alcohol Testing
Programs
DEPARTMENT OF TRANSPORTATION
Office of the Secretary
49 CFR Part 40
[Docket OST–2010–0026]
RIN 2105–AD95
Revisions Effective 10/1/10
DOT Changes Drug Testing Procedures
The Department of Transportation (the Department or
DOT) is amending certain provisions of its drug testing
procedures dealing with laboratory testing of urine
specimens.
Some of the changes will also affect the training of
and procedures used by Medical Review Officers.
The changes are intended to create consistency with
many, but not all, of the new requirements established
by the U.S. Department of Health and Human
Services.
This rule is effective October 1, 2010.
Page 4
Omnibus Transportation Employee Testing
Act of 1991
The Department is required by the Omnibus Transportation
Employees Testing Act (Omnibus Act) to follow the U.S.
Department of Health and Human Services (HHS)
requirements for the testing procedures/protocols and
drugs for which we test
However, where the Omnibus Act limits or otherwise
prohibits the Department from following the HHS, the
Department (DOT) must decline to follow the lead of HHS.
THIS CAN CREATE CONFUSION!!!
Page 5
DOT Publishes Final Rule - Effective October
1, 2010--Summary
1) The Department is required by the Omnibus
Transportation Employees Testing Act (Omnibus Act) to
follow the HHS requirements for the testing
procedures/protocols and drugs for which DOT tests.
2) Primary laboratory requirements in this final rule
include:
- Testing for MDMA (aka. Ecstasy);
- Lowering cutoff levels for cocaine and amphetamines;
- Conducting mandatory initial testing for heroin;
3) The Department brought several testing definitions inline with those of HHS.
Page 6
DOT Publishes Final Rule - Effective October
1, 2010--Summary
4) Each Medical Review Officer (MRO) will need to be requalified – including passing an examination given by an
MRO training organization - every five years. The Final Rule
eliminated the requirement for each MRO to take 12 hours
of continuing education every three years.
5) 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.
6) MRO recordkeeping requirements did not change from
the five years for non-negatives and one year for negatives.
Page 7
DOT Publishes Final Rule - Effective October
1, 2010--Summary
7) 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.
Page 8
New Drug Testing Guidelines
Ecstasy (Methylenedioxymethamphetamine or
MDMA). The initial screening cut-off concentration for
MDMA will be 500 ng/ml and the confirmatory cut-off
concentration will be 250 ng/ml for MDMA, as well as
Methylenedioxyamphetamine (MDA) and
Methylenedioxyethylamphetamine (MDEA), drugs that
are chemically similar to Ecstasy
The drug test cutoff concentrations for cocaine have
been lowered. The initial screening test cutoff drops
from 300 ng/ml to 150 ng/ml, and the confirmatory
test cutoff concentration has been lowered from 150
ng/ml to 100 ng/ml
Page 9
New Drug Testing Guidelines
The drug test cutoff concentrations for
amphetamines have been lowered. The initial
screening test cutoff has been lowered from 1,000
ng/ml to 500 ng/ml, and the confirmatory drug test
cutoff concentration has been lowered from 500 ng/ml
to 250 ng/ml; and
Initial drug testing for 6-acetylmorphine (―6-AM,‖ a
unique metabolite of heroin, considered to be
definitive proof of heroin use) is now required.

Specific rules have been added to address the
way in which Medical Review Officers (―MROs‖)
analyze and verify confirmed positive drug test
results for 6-AM, codeine, and morphine.
Page 10
Two New Initial Drug Test Analytes
6-Acetylmorphine (6AM) - heroin metabolite
Revised Guidelines will require initial testing of all
specimens for 6-AM, regardless of morphine
concentration
Current Guidelines only require confirmatory 6-AM
testing of all morphine positive (> or = 2,000 ng/mL)
specimens
Page 11
Revised Cut-Offs for Test
Initial test cutoff
concentration
Confirmatory test
analyte
Confirmatory test
cutoff concentration
Marijuana
metabolites
50 ng/mL
THCA1
15 ng/mL.
Cocaine
metabolites
150 ng/mL
Benzoylecgonine
100 ng/mL.
2000 ng/mL
Codeine
2000 ng/mL.
Morphine
2000 ng/mL.
Initial test analyte
Opiate metabolites
Codeine/Morphine2
6–Acetylmorphine
10 ng/mL
6–Acetylmorphine
10 ng/mL.
Phencyclidine
25 ng/mL
Phencyclidine
25 ng/mL.
500 ng/mL
Amphetamine
250 ng/mL.
Methamphetamine5
250 ng/mL.
MDMA
250 ng/mL.
MDA7
250 ng/mL.
Amphetamines3
AMP/MAMP4
MDMA6
500 ng/mL
MDEA8
Page 12
250 ng/mL
MDMA
RS)-1(benzo[d][
1,3]dioxol5-yl)-Nmethylprop
an-2-amine
Page 13
MDMA--Ecstasy
Crystal Meth/
Ecstacy
Methadone Lab
Page 14
MDMA
•
•
•
•
•
•
•
•
First synthesized by
Merck in 1912
Euphoria
Sense of intimacy
Anxiety
Fatigue
Impaired attention
Dizziness
Insomnia
•
•
•
•
•
•
Hepatic metabolism
Half-Life 6-10 hours
Excretion renal
Neurotoxic?
Hyperthermia
Dehydration
Page 15
Street Names for MDMA-Ecstasy
007s
2CE
2CI
4 Dot
69s
Adam
B-bombs
Batmans
Bean
Bens
Benzedrine
Bermuda triangles
Bibs
Biphetamine
Blue kisses
Blue lips
Blue nile
Boat
Bump up
Bumping up
Candy flipping on a string
Candy Raver
Candy-flipping
Care bears
Page 16
Street Names for MDMA-Ecstasy—Cont.
Cat in the hats
Charge+
Charity
Chocolate Chip Cookies
Chrystal methadrine
Clarity
Cloud nine
Cristal (Spanish)
Dead road
Debs
Decadence
Dex
Dexedrine
Diamonds
Disco biscuit
Disco biscuits
Doctor
Dolls
Domex
Draf
Drivers
E
E-bombs
Page 17
Street Names for MDMA-Ecstasy—Cont.
E-puddle
E-tard
Ecstasy
Egyptians
Elephant flipping
Elephants
Essence
Eve
Exiticity
Fastin
Flipping
Flower flipping
Four leaf clover
Gaggler
Go
Green triangles
Greenies
Gum
GWM
H - bomb
Hammerheading
Happy drug
Happy pill
Hawkers
Herbal bliss
Page 18
Street Names for MDMA-Ecstasy—Cont.
Hippieflip
Hug
Hug drug
Hugs and Kisses
Hydro
Hype
Iboga
Ice
Igloo
Ivory wave
Jellies
Jerry Garcias
K-lots
Kitty flipping
Kleenex
Letter biscuits
Love drug
Love flipping
Love pill
Love trip
Lover's speed
Lovers' special
MAO
MDM
MDMA
Mercedes
Page 19
Street Names for MDMA-Ecstasy—Cont.
Methedrine
Mini beans
Mitsubishi
Monoamine oxidase
Moonstone
Morning shot
Nexus flipping
Nineteen
NOX
Ocean burst
On the ball
Orange bandits
P and P
Parachute down
Party and play
Party pack
Peace
Peeper(s)
Piggybacking
Pikachu
Pink panthers
Playboy bunnies
Playboys
Pollutants
Pure ivory
Purple wave
Page 20
Street Names for MDMA-Ecstasy—Cont.
Rave energy
Red devils
Rib
Ritual spirit
Roca (Spanish)
Rolling
Rolls Royce
Running
Scooby snacks
Sextasy
Shabu
Slammin'/Slamming
Smurfs
Snackies
Speed for lovers
Speedballing
Speedies
Spivias
Stacking
Stacks
Stars
Strawberry shortcake
Super X
Supermans
Swans
Sweeties
Page 21
Street Names for MDMA-Ecstasy—Cont.
Tabs
Tachas
Tens
Tom and Jerries
Triple crowns
Triple rolexes
Triple stacks
Troll
Tutus
Tweety Birds
U.S.P.
Ultimate Xphoria
Ultimate Xphoria
Vanilla sky
Wafers
Waffle dust
Whiffledust
White diamonds
White dove
White Nothing
Wigits
X
X-ing
X-Pills
XTC
Page 22
New Confirmatory Test Analytes of Ecstasy
Methylenedioxymethamphetamine (MDMA) Ecstasy
Methylenedioxyamphetamine (MDA)
Methylenedioxyethylamphetamine (MDEA)
Page 23
MDMA vs. Synthetic Opioids
Hydromorphone???
Hydrocodone???
Oxycodone???
Oxymorphone???
Page 24
Instrumented Initial Test Facility (IITF)
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.
Page 25
New Medical Review Officer (MRO) Rules
Each Medical Review Officer (MRO) will need to be requalified including passing an examination given by an
MRO training organization - every five years.
An MRO will not need to be trained by an HHSapproved MRO training organization as long as the
MRO meets DOTs qualification and requalification
training requirements.
The Final Rule eliminated the requirement for each
MRO to take 12 hours of continuing education every
three years.
MRO recordkeeping requirements did not change from
the five years for non-negatives and one year for
negatives.
Page 26
New Definitions
The Department brought several testing definitions
in-line with those of HHS.
Adulterated specimen
Limit of Detection (LOD)
Confirmatory drug test
Limit of Quantitation
Initial drug test (also
known as a ‗‗Screening
drug test‘‘)
Negative result
Initial specimen
validity test
Reconfirmed
Invalid drug test
Split specimen collection
Positive result
Rejected for testing
Laboratory
Page 27
Urine Specimen Collection Guidelines
United States
Department of Transportation
Office of Drug and Alcohol Policy and
Compliance
Revised October 1, 2010
Section 4. Federal Drug Testing Custody
And Control Form (CCF)
The collector is permitted to use the old CCF until
September 30, 2011. When the old CCF is used on or before
September 30, 2011 the following new rule must be
adhered:
The collector is to write in the ―Remarks‖ section in
Step 2 on Copy 1 of the CCF, the specific DOT Agency
under whose authority the specimen is collected.
The DOT Agency designation is a new feature on the
CCF. So, if an old CCF is used and the employee‘s
specimen is collected under, for example, the
authority of the FMCSA regulation, the collector will
write in ―DOT-FMCSA‖ in the ―Remarks‖ section in
Step 2 of the CCF.
Page 29
Section 4.
(cont.)
Test Facility Copy - accompanies the specimen to the
laboratory
The collector is to check the DOT Agency whose
authority the specimen is collected.
For example, if the employee‘s specimen is collected
under the authority of the Federal Motor Carrier Safety
Administration (FMCSA) regulation, the collector would
check the ―DOT‖ and ―FMCSA‖ boxes.
Page 30
Section 5. Information employers provide to
collectors
49 CFR Part 40 requires the employer or their service agent
– for example a C/TPA -- to ensure the collector has the
following information when conducting a urine specimen
collection for them:
(a) Full name of the employee being tested.
(b) Employee SSN or ID number.
(c) Laboratory name and address (can be pre-printed on
the CCF).
(d) Employer name, address, phone number, and fax
number (this can be pre-printed on the CCF at Step 1-A).
(e) DER name and telephone number (and C/TPA, where
applicable).
Page 31
Section 5
(cont.)
(f) MRO name, address, phone number, and fax number
(can be pre-printed on the CCF at Step 1-B).
(g) The DOT Agency which regulates the employee‘s safetysensitive duties (the checkmark can pre-printed in the
appropriate box on the CCF at Step 1-D)
(h) Test reason, as appropriate: Pre-employment; Random;
Reasonable
Suspicion/Reasonable Cause; Post-Accident; Return-toDuty; and Follow-up.
(i) Whether the test is to be observed or not [see 40.67(a)
& (b)].
(j) (Optional) C/TPA name, address, phone, and fax number
(can be pre-printed on the CCF).
Page 32
Section 7. Collection Procedures
New Note:
The CCF may be pre-printed with the DOT and Agency
designation boxes already checked. If it is not, the
employer must provide this information to the
collector before the collection.
Page 33
Old Federal Drug Testing Custody and
Control Form
Page 34
New Federal Drug Testing Custody and
Control Form
Page 35
The Final Rule was Effective
October 1, 2010
SAMSHA Website: Full of Many Resources
http://www.workplace.samhsa.gov
or
http://www.drugfreeworkplace.gov
Drug Testing
General Drug-Free Workplace Programs
Federal Workplace Drug Testing Programs
Young Adults in the Workplace (YIW)
Prevention Research and Intervention
Workplace Health, Wellness, and Safety
Page 37
Questions?
Page 38
References
(cont)
Review of Significant Changes in the Revised
Mandatory Guidelines for Federal Workplace Drug
Testing Programs
Effective Date: May 1, 2010, Donna M. Bush, Ph.D.,
D-ABFT Drug Testing Team Leader, Division of
Workplace Programs, Center for Substance Abuse
Prevention, SAMHSA;
http://nac.samhsa.gov/DTAB/Presentations/June09/D
onnaBushDTAB06.02-508.ppt#406,5,SAMHSA Has
Oversight Responsibility of Federal Agency Drug-Free
Workplace Programs
Federal Register / Vol. 75, No. 157 / Monday, August
16, 2010 / Rules and Regulations, 49850-49864,
http://edocket.access.gpo.gov/2010/pdf/201020095.pdf
Page 39