[Federal Register Volume 66, Number 87 (Friday, May 4, 2001)]
[Notices]
[Pages 22639-22640]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-11318]


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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2001-9324]


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 the Conforming Products List (CPL) of 
devices that conform to the Model Specifications for Screening Devices 
that Measure Alcohol in Bodily Fluids (59 FR 39382).

EFFECTIVE DATE: May 4, 2001.

FOR FURTHER INFORMATION CONTACT: Dr. James F. Frank, Office of Research 
and Traffic Records, Research and Evaluation Division (NTS-31), 
National Highway Traffic Safety Administration, 400 Seventh Street, 
SW., Washington, DC 20590; Telephone: (202) 366-5593.

SUPPLEMENTARY INFORMATION: On August 2, 1994, Model Specifications for 
Screening Devices to Measure Alcohol in Bodily Fluids were published in 
the Federal Register (59 FR 39382). In these model specifications, 
NHTSA recognized industry efforts to develop new technologies. These 
specifications established performance criteria and methods for testing 
alcohol screening devices using either breath or other bodily fluids to 
measure alcohol content. NHTSA established these specifications to 
support State laws that target youthful offenders (i.e., ``zero 
tolerance'' laws) and the Department of Transportation's workplace 
alcohol testing program. NHTSA published its first CPL for screening 
devices on December 2, 1994 (59 FR 61923; with a correction in 59 FR 
65128). Five devices were on that first list.
    On August 15, 1995, NHTSA amended its CPL of screening devices to 
measure alcohol in bodily fluids in the Federal Register (60 FR 42214) 
by adding two additional devices to the list, thereby bringing the list 
to seven devices.
    Since the publication of that list, five additional devices have 
been evaluated at the Volpe National Transportation Systems Center in 
Cambridge, MA and found to conform to the model specifications. 
Accordingly, these five devices, listed in alphabetical order, are 
being added to the CPL.
    The first new listing is the ``Alcohol TM'' 
disposable breath alcohol tubes manufactured by Akers Laboratories, 
Inc., of Thorofare, NJ. These are disposable tubes that use a potassium 
dichromate color change to indicate whether the BAC of a breath sample 
is above the 0.02 threshold. These devices passed all requirements of 
the model specifications except when read under sodium vapor lighting 
conditions. Hence, they are approved for use except under sodium vapor 
lighting conditions, and the manufacturer's package insert specifies 
this limitation.
    The second new listing is the Alco Check 9000 manufactured by Alco 
Check International of Hudsonville, MI. This device differs from the 
Alco Check 3000 D.O.T. and the Alco Screen 3000 (the same device sold 
under two different names) in that it allows for the storage and 
retrieval of test data by use of an added memory chip. As the Alco 
Check 3000 D.O.T. and the Alco Screen 3000 already conform to these 
model specifications, and the added memory chip does not change the 
alcohol-measuring capability of the device, NHTSA did not require the 
new Alco Check 9000 to be retested before listing it on this CPL for 
screening devices.
    The third new device on the CPL is the ABI (Alcohol Breath 
Indicator) manufactured by HAN International Co. Ltd. of Seoul, Korea. 
This is an electronic device with a two-digit numerical display that 
uses a semi-conductor sensor.
    The last two devices are the ``PAS IIIa'' and the ``PAS Vr'' 
manufactured by PAS Systems International, Inc. of Fredericksburg, VA. 
These are both electronic devices that use a fuel cell sensor with a 
two-digit numerical display. The PAS IIIa and PAS Vr are modifications 
of two different passive alcohol sensors made by the same company, but 
with a disposable mouthpiece added so that an appropriate deep-lung air 
sample can be obtained for breath measurements.
    Two housekeeping items are also addressed in this notice. First, 
the company previously listed as STC Diagnostics, Inc. has changed its 
name to OraSure Technologies, Inc. and the new CPL reflects the 
inclusion of the new company name in addition to the old one. The name 
of its product, the Q.E.D. A150 Saliva Alcohol Test, remains the same. 
Second, there are a number of handheld breath test devices on the NHTSA 
CPL for Evidential Breath Testers that frequently are used as screening 
devices. It should be noted that any device on the most recent NHTSA 
CPL for EBTs which was published on July 21, 2000 (65 FR 45419) that 
was tested against the 1993 Model Specifications for Evidential Breath 
Testers (58 FR 48705) also fully meets the requirements of the Model 
Specifications for Screening Devices that Measure Alcohol in Bodily 
Fluids. Both procedures evaluate the performance of instruments at the 
0.020 BAC level.
    The Conforming Products List is therefore amended as follows:

                              Conforming Products List of Alcohol Screening Devices
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                 Manufacturer                                               Device(s)
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Akers Laboratories, Inc., Thorofare, NJ.......  Alcohol TM \2\
Alco Check International\1\, Hudsonville, MI..  Alco Check 3000 D.O.T.
                                                Alco Screen 3000
                                                Alco Check 9000
Chematics, Inc., North Webster, IN............  ALCO-SCREEN 02TM \3\
Guth Laboratories, Inc., Harrisburg, PA.......  Alco Tector Mark X
                                                Mark X Alcohol Checker
Han International Co., Ltd., Seoul, Korea.....  A.B.I. (Alcohol Breath Indicator)
OraSure Technologies, Inc., Bethlehem, PA       Q.E.D. A150 Saliva Alcohol Test
 (Formerly STC Technologies, Inc.).
PAS Systems International, Inc.,                PAS IIIa
 Fredericksburg, VA.                            PAS Vr
Repco Marketing, Inc., Raleigh, NC............  Alco Tec III
Roche Diagnostic Systems, Branchburg, NJ......  On-Site Alcohol \4\
STC Technologies, Inc.........................  Q.E.D. A150 Saliva Alcohol Test

[[Page 22640]]

 
Sound Off, Inc.\1\, Hudsonville, MI...........  Digitox D.O.T.
                                                Alco Screen 1000
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\1\ The devices listed by these manufacturers are the same devices sold under diffreent names.
\2\ It should be noted that the Alcohol  disposable breath alcohol screening device manufactured by
  Akers Laboratories, Inc. passed the model specifications under all lighting conditions except one, namely
  sodium vapor lighting. The device is being listed on this CPL with the understanding that the manufacturer
  will specify in written instructions accompanying the product that the device should not be used under sodium
  vapor lighting conditions. It passed the testing under all other conditions.
\3\ 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) and, 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 devices met the model specifications and the results persisted for
  10-15 minutes. When these devices were stored at or below 27 deg.C (80 deg.F) and were equilibrated at 40
  deg.C (104 deg.F) for an hour prior to sample application, the devices failed 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.
\4\ 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.

    Note that the device made by Akers Laboratories, Inc. is a single-
use, disposable breath test device. The devices manufactured by 
Chematics, Inc., OraSure Technologies, Inc., Roche Diagnostic Systems, 
Inc., and STC Technologies, Inc. are all single-use, disposable saliva 
alcohol test devices. The other devices listed are electronic breath 
testers. Those manufactured by PAS Systems International, Inc. use a 
fuel-cell sensor, whereas those manufactured by Alco Check 
International, Guth Laboratories, Han International Co., Ltd., Repco 
marketing, Inc., and Sound Off, Inc. use semi-conductor sensors.

    Issued on: May 1, 2001.
Rose A. McMurray,
Associate Administrator for Traffic Safety Programs.
[FR Doc. 01-11318 Filed 5-3-01; 8:45 am]
BILLING CODE 4910-59-P