Document ID: NHTSA-2009-0170-0001
Agency: nhtsa
Document Type: Rule
Title: Highway Safety Programs; Conforming Products List of Screening Devices To Measure Alcohol in Bodily Fluids
Posted Date: 2009-12-15T05:00Z

[Federal Register: December 15, 2009 (Volume 74, Number 239)]
[Notices]               
[Page 66398-66400]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15de09-112]                         

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2009-0170]

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

AGENCY: National Highway Traffic Safety Administration, DOT.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This Notice amends and updates the list of devices that 
conform to the Model Specifications for Screening Devices to Measure 
Alcohol in Bodily Fluids.

DATES: Effective Date: December 15, 2009.

FOR FURTHER INFORMATION CONTACT: 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.

SUPPLEMENTARY INFORMATION: On August 2, 1994, 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 in 
59 FR 65128), identifying the devices that meet NHTSA's Model 
Specifications for Screening Devices to Measure Alcohol in Bodily 
Fluids. Five devices appeared on that first list. Thereafter, NHTSA 
amended the CPL on August 15, 1995 (60 FR 42214) and on May 4, 2001 (66 
FR 22639), adding 7 devices to the CPL in those two actions. On 
September 19, 2005, NHTSA published an updated CPL (70 FR 54972), 
adding several devices to the list and removing several other devices. 
Subsequently NHTSA discovered an error regarding the name of a device 
listed on the CPL and republished the CPL on December 5, 2005 (70 FR 
72502) to correct the error. NHTSA last published an update to the CPL 
on January 31, 2007 (72 FR 4559), adding 3 new devices.
    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.
    Since the publication of the last CPL, NHTSA has evaluated 
additional devices at the Volpe National Transportation Systems Center 
(VNTSC) in Cambridge, Massachusetts, resulting in the addition of 14 
new breath alcohol screening devices to the CPL. One device is being 
removed from the CPL as it is no longer supported or sold by the 
manufacturer and several devices are being renamed.
    (1) AK Solutions USA, LLC, submitted 3 screening devices for 
testing, several trade name revisions, and the removal of 1 device from 
the CPL. The trade names of the new conforming devices are: AlcoMate 
AccuCell AL-9000, a handheld device with a fuel cell sensor; AlcoMate 
Premium AL-7000, a handheld device that utilizes replaceable 
semiconductor detectors, and AlcoMate Prestige (AL-6000), also a 
handheld device that utilizes replaceable semiconductor detectors. The 
replaceable detectors also conform to the model specifications and are 
specific to each device. Alcoscan AL-5000 is being removed from the 
list. This device is no longer being sold or supported by the 
manufacturer. The following three devices are being renamed: SafeMate 
(formerly known as AlcoChecker), SafeDrive (formerly known as AlcoKey), 
and AlcoMate Core (formerly known as Alcoscan AL-6000). (2) BAC 
Solutions, Inc., submitted a screening device for testing. The trade 
name for this device is BACmaster. This is a bench top stationary 
screening device with an infrared detector. (3) B.E.S.T. Labs, Inc., 
submitted a device for testing. The PB 9000e is a handheld device with 
a fuel cell sensor. (4) CMI, Inc., submitted a device for testing. This 
device, the Intoxilyzer 500, with a handheld fuel cell sensor conforms 
to the model specification for alcohol screening devices. This is the 
same device listed below as the Alcometer 500, distributed by Lion 
Laboratories, Ltd. (5) First Innovative Technology Group, Ltd., 
submitted a device, the AAT198 Pro. This is a handheld device with a 
semiconductor detector. (6) Guth Laboratories, Inc., submitted the 
Alcotector WAT90 for testing. This conforming device is handheld with a 
fuel cell sensor. (7) KHN Solutions, LLC, submitted 2 screening devices 
for

[[Page 66399]]

testing. Their trade names are: BACTRACK Select S50 and the BACTRACK 
Select S80 and both devices are handheld. The BACTRACK Select S50 has a 
semiconductor detector while the S80 has a fuel cell sensor. (8) Lion 
Laboratories, Ltd. submitted the Alcometer 500. This is the same device 
as the Intoxilyzer 500 submitted by CMI, Inc., listed above. (9) Q3 
Innovations, Inc. submitted 2 screening devices for testing. The 
AlcoHAWK PT500 and the AlcoHAWK Slim 2 are handheld with semiconductor 
detectors. All of the above devices meet the NHTSA Model Specifications 
for Screening Devices to Measure Alcohol in Bodily Fluids.
    Consistent with paragraphs (1) and (2) above, NHTSA amends 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/manufacturer                     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
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\
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).
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 S50 \10\
 California.                             BACTRACK Select S80.\10\
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.
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).
                                          AlcoHAWK PT 500.
Repco Marketing, Inc., Raleigh, North    Alco Tec III.
 Carolina.
Seju Engineering Co., Taejeon, Korea...  Safe-Slim.
Sound Off, Inc., Hudsonville, Michigan.  Digitox D.O.T.\7\.
Varian, Inc., Lake Forest, California..  On-Site Alcohol.\11\
------------------------------------------------------------------------
\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 Q-3 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. This 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 [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\ Manufactured by DA Tech Co., Ltd., Korea.

[[Page 66400]]

\11\ 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]-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: November 18, 2009.
Jeff Michael,
Associate Administrator for the Office of Research and Program 
Development.
[FR Doc. E9-29822 Filed 12-14-09; 8:45 am]

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