[Federal Register Volume 60, Number 157 (Tuesday, August 15, 1995)]
[Notices]
[Pages 42214-42215]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-20179]
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DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety Administration
[NHTSA Docket No. 94-004; Notice 4]
Highway Safety Programs; Conforming Products List of Screening
Devices to Measure Alcohol in Bodily Fluids
AGENCY: National Highway Traffic Safety Administration, DOT.
ACTION: Ntoice.
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SUMMARY: This notice amends the Conforming Products List (CPL) of
devices that conform to the Model
[[Page 42215]]
Specifications for Screening Devices that measure alcohol in bodily
fluids (59 FR 39382).
EFFECTIVE DATE: August 15, 1995.
FOR FURTHER INFORMATION CONTACT:
Dr. James F. Frank, Office of Alcohol and State Programs, NTS-21,
National Highway Traffic Safety Administration, 400 Seventh St., SW.,
Washington, DC 20590; Telephone: (202) 366-9581.
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 establish 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 initiative to
prevent alcohol misuse. 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.
Since the publication of that list, two additional disposable,
single-use saliva-alcohol screening devices have been evaluated at the
Volpe National Transportation System Center in Cambridge, MA and found
to conform to the model specifications for screening devices:
Chematics' ``Alco-Screen 02TM'' and Roche Diagnostic Systems'
``On-Site Alcohol''.
It should be noted, however, that 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, the test should be
completed immediately. When these devices were stored at or below
27 deg.C (80 deg.F) and tested at 40 deg.C (104 deg.F) immediately
(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.
It should be noted also that while the ON-SITE ALCOHOL saliva-
alcohol screening device manufactured by Roche Diagnostics Systems
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 18-29 deg.C (64 deg.F-84 deg.F); and readings should be
taken after five (5) minutes when the sample is introduced at
temperatures at or below 17 deg.C (63 deg.F). If the reading is taken
before five minutes have elapsed under the cold conditions, the user is
likely to obtain a reading that underestimates the actual saliva-
alcohol level.
The Conforming Products List is therefore amended as follows:
Conforming Products List of Alcohol Screening Devices
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Manufacturer Devices(s)
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(1) Alco Check International* Hudsonville, MI............ Alco Check 3000 D.O.T.
Alco Screen 3000.
(2) Chematics, Inc., North Webster, IN................... ALCO-SCREEN 02TM.\1\
(3) Guth Laboratories, Inc.*, Harrisburg, PA............. Alco Tector Mark X.
Mark X Alcohol Checker.
(4) Repco Marketing, Inc., Raleigh, NC................... Alco Tec III.
(5) Roche Diagnostic Systems, Branchburg, NJ............. On-Site Alcohol.\2\
(6) Sound Off, Inc.,* Hudsonville, MI.................... Digitox D.O.T.
Alco Screen 1000.
(7) STC Diagnostics, Inc., Bethlehem, PA................. Q.E.D. A150 Saliva Alcohol Test.
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* The devices listed by this manufacturer are the same device sold under tow different names.
\1\ It should be noted, however, that 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, the test should be completed immediately. When these
devices were stored at or below 27 deg. C (80 deg. F) and tested at 40 deg. C (104 deg. F) immediately (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.
\2\ 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.
Note that devices 1, 3, 4 and 6 are breath alcohol testers that use
semiconductor type sensors. Devices 2, 5, and 7 are saliva alcohol
testers that use enzymatic techniques to measure the alcohol
concentration in a saliva sample.
Issued on: August 10, 1995.
James Hudlund,
Acting Associate Administrator for Traffic Safety Programs.
[FR Doc. 95-20179 Filed 8-14-95; 8:45 am]
BILLING CODE 4910-59-M