[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                             
----------------------------------------------------------------------------------------------------------------
                       Manufacturer                                              Devices(s)                     
----------------------------------------------------------------------------------------------------------------
(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.             
----------------------------------------------------------------------------------------------------------------
* 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