[Federal Register Volume 70, Number 180 (Monday, September 19, 2005)]
[Notices]
[Pages 54972-54974]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-18501]


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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-05-21436]


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

AGENCY: National Highway Traffic Safety Administration, DOT.

ACTION: Notice.

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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.

EFFECTIVE DATE: September 19, 2005.

FOR FURTHER INFORMATION CONTACT: Dr. James F. Frank, Office of Research 
and Technology, Behavioral Research Division (NTI-131), National 
Highway Traffic Safety Administration, 400 Seventh Street, SW., 
Washington, DC 20590; Telephone: (202) 366-5593.

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 (5) 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 seven (7) devices to the CPL in those two (2) 
actions.
    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 following changes 
to the CPL.
    (1) AK Solutions, Inc. of Palisades Park, New Jersey submitted 
seven (7) different electronic screening devices for testing, all of 
which use a semi-conductor sensor. Their trade names are: (a) 
``Alcoscan AL-2500''; (b) ``AlcoChecker''; (c) ``AlcoKey''; (d) 
``AlcoMate''; (e) ``AlcoMate Pro''; (f) ``Alcoscan AL-5000''; and (g) 
Alcoscan AL-6000. All of these devices meet the NHTSA Model 
Specifications for Screening Devices to Measure Alcohol in Bodily 
Fluids.
    (2) Guth Laboratories, Inc. of Harrisburg, Pennsylvania submitted 
for testing the ``Alcotector WAT89EC-1'' screening device, an 
electronic device that uses a fuel cell sensor and has a digital 
display. This device meets the NHTSA Model Specifications for Screening 
Devices to Measure Alcohol in Bodily Fluids.
    (3) Q-3 Innovations, Inc. of Independence, Iowa submitted for 
testing the ``Alcohawk[supreg] Precision,'' an electronic screening 
device that uses a semiconductor sensor and has a digital display. This 
device meets the NHTSA Model Specifications for Screening Devices to 
Measure Alcohol in Bodily Fluids.
    (4) Q-3 Innovations, Inc. certified that it also sells the 
``Alcohawk[supreg] Elite,'' which is the same technical device as the 
``Alcohawk[supreg] Precision,'' and has only cosmetic differences not 
related to the alcohol-measuring capability of the device. Hence, the 
``Alcohawk[supreg] Elite'' will also be listed on the CPL. Q-3 
Innovations, Inc. also sells the ``Alcohawk[supreg] ABI'', which is the 
same device as the ``ABI'' manufactured by Han International Co., Ltd. 
of Seoul, Korea. As the Han ``ABI'' already appears on the CPL, and Han 
International has certified that the ``Alcohawk[supreg] ABI'' is the 
same device, the ``Alcohawk[supreg] ABI'' will also be listed on the 
CPL. Finally, Q-3 Innovations sells the ``Alcohawk[supreg] PRO'', also 
manufactured by Han International. This device was previously submitted 
by AK Solutions, Inc. and approved for inclusion on the CPL. While Han 
International continues to manufacture the device, it is now sold as 
the ``Alcohawk[supreg] PRO'' by Q-3 Innovations,

[[Page 54973]]

Inc. Hence, the ``Alcohawk[supreg] PRO'' will also be added to the CPL.
    (5) Seju Co., of Korea submitted the ``Safe-Slim'' handheld, 
electronic screening device that uses a semi-conductor sensor. It meets 
the NHTSA Model Specifications for Screening Devices to Measure Alcohol 
in Bodily Fluids.
    All of the above devices are being added to the CPL with this 
publication.
    (6) When NHTSA published the CPL on May 4, 2001, it added the 
``Alcohol [radic]'' manufactured by Akers Laboratories, Inc. After that 
date, Akers Laboratories, Inc. changed its name to Akers Biosciences, 
Inc. and continued distributing a device that NHTSA understood to be 
the same device tested and approved for listing on the CPL in May, 
2001. The Akers device listed on the CPL is no longer manufactured. 
Accordingly, the ``Alcohol [radic]'' is being removed from the CPL with 
this publication. No other Akers device currently is approved for 
inclusion on the CPL.
    In addition to the above changes, NHTSA is making the following 
housekeeping changes to the CPL:
    (7) OraSure Technologies, Inc. of Bethlehem, Pennsylvania continues 
to manufacture the Q.E.D. A150 Saliva Alcohol Test. On the previous 
CPL, NHTSA listed STC Technologies, Inc. as a manufacturer of the same 
device. STC Technologies, Inc. changed its name to OraSure 
Technologies, Inc. OraSure Technologies, Inc. has certified that no 
unexpired devices called the Q.E.D. A150 Saliva Alcohol Test and sold 
under the STC Technologies, Inc label exist in the marketplace. Hence, 
NHTSA is removing the name STC Technologies, Inc. from the CPL.
    (8) Alco Check International, Inc. of Hudsonville, Michigan has 
certified that the ``Alco Screen 3000'' is no longer in service, was 
sold under a private label for only a very brief period of time, and 
none has been serviced for at least five years. Accordingly, the 
manufacturer concurs with the removal of the device from the CPL.
    (9) Sound Off, Inc. of Hudsonville, Michigan has certified that the 
``Alco Screen 1000'' is no longer in service, was sold under a private 
label for only a very brief period of time, and none has been serviced 
for at least five years. Accordingly, the manufacturer concurs with the 
removal of the device from the CPL.
    (10) PAS Systems International, Inc. of Fredericksburg, Virginia 
has certified that the ``PAS IIIa'' device has not been manufactured 
for more than five years, and no instruments have been returned for 
service or calibration during the past five years. Accordingly, the 
manufacturer concurs with the removal of the device from the CPL.
    (11) Varian Inc. of Lake Forest, California acquired the ``On-Site 
Alcohol'' saliva-alcohol screening device previously owned by Roche 
Diagnostics Systems. Varian, Inc. has certified that the ``On-Site 
Alcohol'' device they are selling is identical to the device previously 
sold by Roche. Accordingly, this CPL will list the Varian, Inc. ``On-
Site Alcohol'' saliva-alcohol screening device. The Roche Diagnostics 
device will be removed from the CPL. The Roche device had a shelf-life 
of one year, and Varian began selling the device more than one year 
ago. Therefore, any of these devices that might exist in the 
marketplace has expired, warranting removal of the Roche Diagnostics 
device from the CPL.
    Consistent with paragraphs (1) through (11) 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
----------------------------------------------------------------------------------------------------------------
                 Manufacturer                                              Device(s)
----------------------------------------------------------------------------------------------------------------
AK Solutions, Inc., Palisades Park, NJ \1\...  Alcoscan AL-2500.
                                               AlcoChecker.
                                               AlcoKey.
                                               EAlcoMate.
                                               AlcoMate Pro.
                                               Alcoscan AL-5000.
                                               Alcoscan AL-6000.
Alco Check International, Hudsonville, MI....  Alco Check 3000 D.O.T.
                                               Alco Check 9000.
Chematics, Inc., North Webster, IN...........  ALCO-SCREEN 02TM. \2\
Guth Laboratories, Inc., Harrisburg, PA......   Alco Tector Mark X.
                                               Mark X Alcohol Checker.
                                               Alcotector WAT89EC-1.
Han International Co., Ltd., Seoul, Korea \3\  A.B.I. (Alcohol Breath Indicator).
OraSure Technologies, Inc., Bethlehem, PA....  Q.E.D. A150 Saliva Alcohol Test.
PAS Systems International, Inc.,               PAS Vr.
 Fredericksburg, VA.
Q3 Innovations, Inc., Independence, IA \4\...  Alcohawk[supreg] Precision.
                                               Alcohawk[supreg] Elite.
                                               Alcohawk[supreg] ABI.
                                               Alcohawk[supreg] PRO.
Repco Marketing, Inc., Raleigh, NC...........  Alco Tec III.
Seju Co. of Taejeon, Korea...................  Safe-Slim.
Sound Off, Inc., Hudsonville, MI.............  Digitox D.O.T.
Varian, Inc., Lake Forest, CA................   Q.E.D. A150 Saliva Alcohol Test. \5\
 
The devices manufactured by Chematics, Inc., OraSure Technologies, Inc., and Varian, Inc. are all single-use,
 disposable saliva alcohol test devices. All of the other devices listed on the CPL are electronic breath
 testers. The device called the ``Alcotector WAT89EC-1'' manufactured by Guth Laboratories, Inc. and the PAS Vr
 device manufactured by PAS Systems International, Inc. use fuel-cell sensors, whereas all other electronic
 devices listed on the CPL use semi-conductor sensors.
----------------------------------------------------------------------------------------------------------------
\1\ The AlcoMate was manufactured by Han International of Seoul, Korea, but marketed and sold in the U.S. by AK
  Solutions.

[[Page 54974]]

 
\2\ 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] (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.
\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\ The AlcoHawk ABI is the same device as that listed under Han International as the ``ABI'' and is
  manufactured for Q-3 Innovations by Han International. The Alcohawk PRO is the same device as the AlcoMate
  marketed and sold by AK Solutions, and also manufactured by Han International.
\5\ 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.


    Issued on: September 13, 2005.
Marilena Amoni,
Associate Administrator for Program Development and Delivery.
[FR Doc. 05-18501 Filed 9-16-05; 8:45 am]
BILLING CODE 4910-59-P