Federal Conforming Products - Alcohol
Screening Devices ( 2001)
[Federal Register: May 4, 2001 (Volume 66,
Number 87)]
[Notices]
[Page 22639-22640]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04my01-164]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Manufacturer Device(s)
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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
|
