DOT/NHTSA CPL Document
[Federal Register: May 4, 2001 (Volume 66,
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]
Programs; Conforming Products List of Screening Devices To Measure
Alcohol in Bodily Fluids
AGENCY: National Highway Traffic Safety Administration, DOT.
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 approved 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 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
The third new device on the CPL is the ABI
model CA2000 (a.k.a Alcohawk) 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
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
Laboratories, Inc., Thorofare, NJ
Disposable Alcohol Tubes(2)
Check International, Hudsonville, MI(1)
Alco Check 9000
Alco Check 3000 D.O.T.
Chematics, Inc., North Webster, IN.
International Co., Ltd., Seoul, Korea(1)
ABI AlcoHawk(Alcohol Breath Indicator)
Laboratories, Inc., Harrisburg, PA.
AlcoTector Mark X
Mark X Alcohol Checker
Technologies, Inc., Bethlehem, PA
A150 Saliva Alcohol Test
Systems International, Inc., Fredericksburg,
Marketing, Inc., Raleigh, NC
Diagnostic Systems, Branchburg, NJ
Off, Inc, Hudsonville, MI(1)
Alco Screen 1000
The devices listed by these
manufacturers are the same devices sold under different names.
It should be noted that the Alcohol
disposable breath alcohol screening tube device
(AKA BreathScan) 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.
While the ALCO-SCREEN 02TM
saliva-alcohol screening device manufactured by Chematics, Inc. passed the
requirements of the model specifications when tested at 40 ºC (104 ºF),
the manufacturer has indicated that the device cannot exceed storage
temperatures of 27 ºC (80 ºF). Instructions to this effect are stated on
all packaging accompanying the device. Accordingly, the device should not
be stored at temperatures above 27 ºC (80 ºF) and, if the device is stored
at or below 27 ºC (80 ºF) 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 ºC (80 ºF) and were equilibrated at 40 ºC (104 ºF) for an hour prior to
sample application, the devices failed to meet the model specifications.
Storage at temperatures above 27 ºC (80 ºF), for even brief periods of
time, may result in false negative readings.
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 ºC (86 ºF);
readings should be taken after two (2) minutes at 18 ºC-29 ºC (64.4
-84.2 ºF); and readings should be taken after five (5) minutes when
testing at temperatures at or below 17 ºC (62.6 ºF). 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
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
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]
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