Document ID: NHTSA-2012-0062-0001
Agency: nhtsa
Document Type: Notice
Title: Highway Safety Programs: Conforming Products List of Screening Devices to Measure Alcohol in Bodily Fluids
Posted Date: 2012-06-14T04:00Z

[Federal Register Volume 77, Number 115 (Thursday, June 14, 2012)]
[Notices]
[Pages 35745-35747]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14582]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2012-0062]

Highway Safety Programs; Conforming Products List of Screening 
Devices To Measure Alcohol in Bodily Fluids

AGENCY: National Highway Traffic Safety Administration, Department of 
Transportation.

ACTION: Notice.

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SUMMARY: This notice updates the Conforming Products List (CPL) 
published in the Federal Register on December 15, 2009 (74 FR 66398) 
for instruments that conform to the Model Specifications for Screening 
Devices to Measure Alcohol in Bodily Fluids dated, March 31, 2008 (73 
FR 16956).

DATES: Effective Date: June 14, 2012.

FOR FURTHER INFORMATION CONTACT: For technical issues: Ms. De Carlo 
Ciccel, Behavioral Research Division, NTI-131, National Highway Traffic 
Safety Administration, 1200 New Jersey Avenue SE., Washington, DC 
20590; Telephone: (202) 366-1694. For legal issues: Ms. Jin Kim, Office 
of Chief Counsel, NCC-113, National Highway Traffic Safety 
Administration, 1200 New Jersey Avenue SE., Washington, DC 20590; 
Telephone: (202) 366-1834.

SUPPLEMENTARY INFORMATION: On August 2, 1994, the National Highway 
Traffic Safety Administration (NHTSA) published Model Specifications 
for Screening Devices to Measure Alcohol in Bodily Fluids (59 FR 
39382). These specifications established performance criteria and 
methods for testing alcohol screening devices to measure alcohol 
content. The specifications support State laws that target youthful 
offenders (e.g., ``zero tolerance'' laws) and the Department of 
Transportation's workplace alcohol testing program. NHTSA published its 
first Conforming Products List (CPL) for screening devices on December 
2, 1994 (59 FR 61923), with corrections on December 16, 1994 (59 FR 
65128), identifying the devices that meet NHTSA's Model Specifications 
for Screening Devices to

[[Page 35746]]

Measure Alcohol in Bodily Fluids. Five devices appeared on that first 
list. Thereafter, NHTSA updated the CPL on August 15, 1995 (60 FR 
42214), May 4, 2001 (66 FR 22639), September 19, 2005 (70 FR 54972), 
with corrections on December 5, 2005 (70 FR 72502), and January 31, 
2007 (72 FR 4559).
    On March 31, 2008, NHTSA published revised Model Specifications for 
Screening Devices to Measure Alcohol in Bodily Fluids (73 FR 16956). 
These specifications removed testing of interpretive screening devices 
(ISDs) because ISDs did not provide an unambiguous test result. These 
specifications also removed from use the Breath Alcohol Sample 
Simulator as it is not necessary for testing breath alcohol screening 
devices. All other performance criteria and test methods were 
maintained. NHTSA last published an update to the CPL on December 15, 
2009 (74 FR 66398). It listed 39 devices.
    Today, NHTSA adds nine (9) additional alcohol screening devices 
that have been evaluated and found to conform to the Model 
Specifications for Screening Devices to Measure Alcohol in Bodily 
Fluids. One device is distributed by two different companies, so it has 
been listed twice, for a total of ten (10) new entries on this CPL.
    (1) AK Solutions USA, LLC, submitted the AlcoMate SafeGuard (Model 
AL-2500, aka: AlcoScan AL-2500) alcohol screening device. This is a 
handheld, battery powered device with a semiconductor sensor.
    (2) Alcohol Countermeasure Systems Corp., submitted the DRIVESAFE 
alcohol screening device. This is a handheld, battery powered device 
with a fuel cell sensor.
    (3) KHN Solutions, LLC, submitted 2 screening devices for testing. 
Their trade names are: BACTRACK Element and the BACTRACK S75 Pro. Both 
devices are handheld, battery powered with fuel cell sensors.
    (4) PAS Systems International, Inc. submitted the Alcovisor MARS 
screening device. This is a handheld, battery powered device with a 
fuel cell sensor.
    (5) Q3 Innovations, Inc. submitted the CA2010 screening device. 
This is a handheld, battery powered device with a semiconductor sensor.
    (6) Skyfine Inc. Ltd. submitted 3 devices (AT577, AT578, and 
AT579). All three devices are handheld, battery powered, and use fuel 
cell sensors. The AT578 is also distributed by Express Diagnostics 
Int'l, Blue Earth, Minnesota under the trade name of AlcoCheck FC90, so 
it has been listed twice on the CPL, once under each of its 
distributors/manufacturers.
    All of the above devices meet the NHTSA Model Specifications for 
Screening Devices to Measure Alcohol in Bodily Fluids.
    Consistent with the above, NHTSA updates the Conforming Products 
List of Screening Devices to Measure Alcohol in Bodily Fluids to read 
as follows:

          Conforming Products List of Alcohol Screening Devices
------------------------------------------------------------------------
       Distributors/manufacturers                    Devices
------------------------------------------------------------------------
AK Solutions, USA, LLC., Palisades        AlcoScan AL-2500.
 Park, New Jersey \1\.
                                          SafeMate.\2\
                                          SafeDrive.
                                          AlcoMate.\3\ (aka:
                                          AlcoHAWK Pro by Q3
                                          Innovations).
                                          AlcoMate Accu Cell AL-
                                          9000.
                                          AlcoMate Pro.\3\
                                          AlcoMate Core.\4\
                                          AlcoMate Premium AL-
                                          7000, with replaceable Premium
                                          Sensor Modules (SM-7000).4 5
                                          AlcoMate Prestige AL-
                                          6000, with replaceable
                                          Prestige Sensor Modules (SM-
                                          6000).4 6
                                          AlcoMate SafeGuard
                                          (Model AL-2500, aka: AlcoScan
                                          AL-2500).
Alco Check International, Hudsonville,   Alco Check 3000 D.O.T.\7\
 Michigan.
                                         Alco Check 9000.\7\
Akers Biosciences, Inc., Thorofare, New  Breath Alcohol [check] .02
 Jersey.                                  Detection System.\8\
Alcohol Countermeasure Systems Corp.,    DRIVESAFE.
 Toronto, Ontario, Canada.
BAC Solutions, Inc., Birmingham,         BACmaster.
 Michigan.
B.E.S.T. Labs., Boardman, Ohio.........  PB 9000e.
Chematics, Inc., North Webster, Indiana  ALCO-SCREEN 02 TM\9\.
CMI, Inc., Owensboro, Kentucky.........  Intoxilyzer 500 (aka: Alcometer
                                          500--Lion Laboratories).
Express Diagnostics Int'l, Inc., Blue    AlcoCheck FC90 (aka: AT578 by
 Earth, Minnesota.                        Skyfine).
First Innovative Technology Group,       AAT198--Pro.
 Ltd., Hong Kong.
Guth Laboratories, Inc., Harrisburg,      Alco Tector Mark X.
 Pennsylvania.
                                          Mark X Alcohol
                                          Checker.
                                          Alcotector WAT89EC-1.
                                          Alcotector WAT90.
Han International Co., Ltd.,\2\ Seoul,   A.B.I. (Alcohol Breath
 Korea.                                   Indicator) (aka: AlcoHAWK ABI
                                          by Q3 Innovations).
KHN Solutions, LLC, San Francisco,        BACTRACK Select
 California.                              S50.\10\
                                          BACTRACK Select
                                          S80.\10\
                                          BACTRACK Element.
                                          BACTRACK S 75 Pro.
Lion Laboratories, Ltd., Wales, United   Alcometer 500 (aka: Intoxilyzer
 Kingdom.                                 500--CMI, Inc.).
OraSure Technologies, Inc., Bethlehem,   Q.E.D. A150 Saliva Alcohol
 Pennsylvania.                            Test.
PAS Systems International, Inc.,          PAS Vr.
 Fredericksburg, Virginia.
                                          Alcovisor MARS.
Q3 Innovations, Inc., Independence,       AlcoHAWK Precision.
 Iowa.
                                          AlcoHAWK Slim.
                                          AlcoHAWK Slim 2.
                                          AlcoHAWK Elite.
                                          AlcoHAWK ABI (aka:
                                          A.B.I. (Alcohol Breath
                                          Indicator) by Han Intl.).
                                          AlcoHAWK Micro.
                                          AlcoHAWK PRO (aka:
                                          AlcoMate by AK Solutions).

[[Page 35747]]

 
                                          AlcoHAWK PT 500.
                                          CA2010.
Repco Marketing, Inc., Raleigh, North    Alco Tec III.
 Carolina.
Seju Engineering Co., Taejeon, Korea...  Safe-Slim.
Skyfine Inc., Ltd., Kwai Chung, NT,       AT577.
 Hong Kong.
                                          AT578 (aka: AlcoCheck
                                          FC90).
                                          AT579.
Sound Off, Inc., Hudsonville, Michigan.  Digitox D.O.T.\7\
Varian, Inc., Lake Forest, California..  On-Site Alcohol.\10\
------------------------------------------------------------------------
\1\ The AlcoMate was manufactured by Han International of Seoul, Korea,
  but marketed and sold in the U.S. by AK Solutions.
\2\ Manufactured by Seju Engineering, Korea.
\3\ Han International does not market or sell devices directly in the
  U.S. market. Other devices manufactured by Han International are
  listed under AK Solutions, Inc. and Q3 Innovations, Inc.
\4\ Manufactured by Sentech Korea Corp.
\5\ These devices utilize replaceable semiconductor detectors. Instead
  of re-calibrating the device, a new calibrated detector can be
  installed. The device comes with 4 detectors including the one that
  was already installed.
\6\ These devices utilize replaceable semiconductor detectors. Instead
  of re-calibrating the device, a new calibrated detector can be
  installed. This device comes with 5 detectors including the one that
  was already installed.
\7\ While these devices are still being sold, they are no longer
  manufactured or supported.
\8\ The Breath Alcohol [check] .02 Detection System consists of a single-
  use disposable breath tube used in conjunction with an electronic
  analyzer that determines the test result. The electronic analyzer and
  the disposable breath tubes are lot specific and manufactured to
  remain calibrated throughout the shelf-life of the device. This
  screening device cannot be used after the expiration date.
\9\ While the ALCO-SCREEN 02TM saliva-alcohol screening device
  manufactured by Chematics, Inc. passed the requirements of the Model
  Specifications when tested at 40 [deg]C (104 [deg]F), the manufacturer
  has indicated that the device cannot exceed storage temperatures of 27
  [deg]C (80 [deg]F). Instructions to this effect are stated on all
  packaging accompanying the device. Accordingly, the device should not
  be stored at temperatures above 27 [deg]C (80 [deg]F). If the device
  is stored at or below 27 [deg]C (80 [deg]F) and used at higher
  temperatures (i.e., within a minute), the device meets the Model
  Specifications and the results persist for 10-15 minutes. If the
  device is stored at or below 27 [deg]C (80[emsp14] [deg]F) and
  equilibrated at 40 [deg]C (104 [deg]F) for an hour prior to sample
  application, the device fails to meet the Model Specifications.
  Storage at temperatures above 27 [deg]C (80 [deg]F), for even brief
  periods of time, may result in false negative readings.
\10\ While this device passed all of the requirements of the Model
  Specifications, readings should be taken only after the time specified
  by the manufacturer. For valid readings, the user should follow the
  manufacturer's instructions. Readings should be taken one (1) minute
  after a sample is introduced at or above 30 [deg]C (86 [deg]F);
  readings should be taken after two (2) minutes at 18 [deg]C-29 [deg]C
  (64.4 [deg]F-84.2 [deg]F); and readings should be taken after five (5)
  minutes when testing at temperatures at or below 17 [deg]C (62.6
  [deg]F). If the reading is taken before five (5) minutes has elapsed
  under the cold conditions, the user is likely to obtain a reading that
  underestimates the actual saliva-alcohol level.

    Authority:  23 U.S.C. 403; 49 CFR 1.50; 49 CFR part 501.

    Issued on: June 11, 2012.
Jeff Michael,
Associate Administrator, Research and Program Development, National 
Highway Traffic Safety Administration.
[FR Doc. 2012-14582 Filed 6-13-12; 8:45 am]
BILLING CODE 4910-59-P