[Federal Register Volume 70, Number 232 (Monday, December 5, 2005)]
[Notices]
[Pages 72502-72503]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E5-6848]


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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: December 5, 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

[[Page 72503]]

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.
    On September 19, 2005, NHTSA published an updated CPL (70 FR 
54972), adding several devices to the list and removing several other 
devices. Since that publication of the CPL, NHTSA discovered an error 
regarding the name of the device listed on the CPL for the manufacturer 
Varian, Inc. This Notice serves to correct the error by republishing 
the CPL in its entirety with the accurate name of the device.
    The Notice published on September 19, 2005 explained that Varian, 
Inc. of Lake Forest, California acquired the ``On-Site Alcohol'' 
saliva-alcohol screening device previously owned by Roche Diagnostics 
Systems. Varian, Inc. certified that the ``On-Site Alcohol'' device it 
sells is identical to the device previously sold by Roche. The Roche 
Diagnostics device was removed from the CPL because none of the Roche 
devices exist in the marketplace. However, NHTSA intended to list on 
the CPL the Varian, Inc. ``On-Site Alcohol'' saliva-alcohol screening 
device but instead listed the ``Q.E.D. A150 Saliva Alcohol Test.'' 
Accordingly, NHTSA amends the CPL to correct this error. The CPL is 
reprinted in its entirety below.

          Conforming Products List of Alcohol Screening Devices
------------------------------------------------------------------------
              Manufacturer                          Device(s)
------------------------------------------------------------------------
AK Solutions, Inc., Palisades Park, NJ   Alcoscan AL-2500, AlcoChecker,
 \1\.                                     AlcoKey, AlcoMate, AlcoMate
                                          Pro, Alcoscan AL-5000,
                                          Alcoscan AL-6000.
Alco Check International, Hudsonville,   Alco Check 3000 D.O.T., Alco
 MI.                                      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,      A.B.I. (Alcohol Breath
 Korea \3\.                               Indicator).
OraSure Technologies, Inc., Bethlehem,   Q.E.D. A150 Saliva Alcohol
 PA.                                      Test.
PAS Systems International, Inc.,         PAS Vr.
 Fredericksburg, VA.
Q3 Innovations, Inc., Independence, IA   Alcohawk[reg] Precision,
 \4\.                                     Alcohawk[reg] Elite,
                                          Alcohawk[reg] ABI,
                                          Alcohawk[reg] 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..........  On-Site Alcohol \5\
------------------------------------------------------------------------
\1\ The AlcoMate was manufactured by Han International of Seoul, Korea,
  but marketed and sold in the U.S. by AK Solutions.
\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]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.
\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]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.

    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'' 
manufacturered 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.

Marilena Amoni,
Associate Administrator for Program Development and Delivery.
 [FR Doc. E5-6848 Filed 12-2-05; 8:45 am]
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