E5-6848. 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 and updates the list of devices that conform to the Model Specifications for Screening Devices to Measure Alcohol in Bodily Fluids.

EFFECTIVE DATE:

December 5, 2005.

FOR FURTHER INFORMATION CONTACT:

Dr. James F. Frank, Office of Research and Technology, Behavioral Research Division (NTI-131), National Highway Traffic Safety Administration, 400 Seventh Street, SW., Washington, DC 20590; Telephone: [phone].

SUPPLEMENTARY INFORMATION:

On August 2, 1994, NHTSA published Model Specifications for Screening Devices to Measure Alcohol in Bodily Fluids (59 FR 39382). These specifications established performance criteria and methods for testing alcohol screening devices to measure alcohol content. The specifications support State laws that target youthful offenders (e.g., “zero tolerance” laws) and the Department of Transportation's workplace alcohol testing program. NHTSA published its first Conforming Products List (CPL) for screening devices on December 2, 1994 (59 FR 61923, with corrections on December 16, 1994 in 59 FR 65128), identifying the devices that meet NHTSA's Model Specifications for Screening Devices to Measure Alcohol in Bodily Fluids. Five (5) devices appeared on that first list. Thereafter, NHTSA amended the CPL on August 15, 1995 (60 FR 42214) and on May 4, 2001 (66 FR 22639), adding seven (7) devices to the CPL in those two (2) actions.

On September 19, 2005, NHTSA published an updated CPL (70 FR 54972), adding several devices to the list and removing several other devices. Since that publication of the CPL, NHTSA discovered an error regarding the name of the device listed on the CPL for the manufacturer Varian, Inc. This Notice serves to correct the error by republishing the CPL in its entirety with the accurate name of the device.

The Notice published on September 19, 2005 explained that Varian, Inc. of Lake Forest, California acquired the “On-Site Alcohol” saliva-alcohol screening device previously owned by Roche Diagnostics Systems. Varian, Inc. certified that the “On-Site Alcohol” device it sells is identical to the device previously sold by Roche. The Roche Diagnostics device was removed from the CPL because none of the Roche devices exist in the marketplace. However, NHTSA intended to list on the CPL the Varian, Inc. “On-Site Alcohol” saliva-alcohol screening device but instead listed the “Q.E.D. A150 Saliva Alcohol Test.” Accordingly, NHTSA amends the CPL to correct this error. The CPL is reprinted in its entirety below.

Conforming Products List of Alcohol Screening Devices

Manufacturer	Device(s)
AK Solutions, Inc., Palisades Park, NJ 1	Alcoscan AL-2500, AlcoChecker, AlcoKey, AlcoMate, AlcoMate Pro, Alcoscan AL-5000, Alcoscan AL-6000.
Alco Check International, Hudsonville, MI	Alco Check 3000 D.O.T., Alco Check 9000.
Chematics, Inc., North Webster, IN	ALCO-SCREEN 02TM 2
Guth Laboratories, Inc., Harrisburg, PA	Alco Tector Mark X, Mark X Alcohol Checker, Alcotector WAT89EC-1.
Han International Co., Ltd., Seoul, Korea 3	A.B.I. (Alcohol Breath Indicator).
OraSure Technologies, Inc., Bethlehem, PA	Q.E.D. A150 Saliva Alcohol Test.
PAS Systems International, Inc., Fredericksburg, VA	PAS Vr.
Q3 Innovations, Inc., Independence, IA 4	Alcohawk® Precision, Alcohawk® Elite, Alcohawk® ABI, Alcohawk® PRO.
Repco Marketing, Inc., Raleigh, NC	Alco Tec III.
Seju Co. of Taejeon, Korea	Safe-Slim.
Sound Off, Inc., Hudsonville, MI	Digitox D.O.T.
Varian, Inc., Lake Forest, CA	On-Site Alcohol 5
1 The AlcoMate was manufactured by Han International of Seoul, Korea, but marketed and sold in the U.S. by AK Solutions.
2 While the ALCO-SCREEN 02TM saliva-alcohol screening device manufactured by Chematics, Inc. passed the requirements of the Model Specifications when tested at 40 °C (104 °F), the manufacturer has indicated that the device cannot exceed storage temperatures of 27 °C (80 °F). Instructions to this effect are stated on all packaging accompanying the device. Accordingly, the device should not be stored at temperatures above 27 °C (80 °F). If the device is stored at or below 27 °C (80 °F) and used at higher temperatures (i.e., within a minute), the device meets the Model Specifications and the results persist for 10-15 minutes. If the device is stored at or below 27 °C (80 °F) and equilibrated at 40 °C (104 °F) for an hour prior to sample application, the device fails to meet the Model Specifications. Storage at temperatures above 27 °C (80 °F), for even brief periods of time, may result in false negative readings.
3 Han International does not market or sell devices directly in the U.S. market. Other devices manufactured by Han International are listed under AK Solutions, Inc. and Q-3 Innovations, Inc.
4 The AlcoHawk ABI is the same device as that listed under Han International as the “ABI” and is manufactured for Q-3 Innovations by Han International. The Alcohawk PRO is the same device as the AlcoMate marketed and sold by AK Solutions, and also manufactured by Han International.
5 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 °C (86 °F); readings should be taken after two (2) minutes at 18 °C-29 °C (64.4 °F-84.2 °F); and readings should be taken after five (5) minutes when testing at temperatures at or below 17 °C (62.6 °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.

The devices manufactured by Chematics, Inc., OraSure Technologies, Inc., and Varian, Inc. are all single-use, disposable saliva alcohol test devices. All of the other devices listed on the CPL are electronic breath testers. The device called the “Alcotector WAT89EC-1” manufacturered by Guth Laboratories, Inc. and the PAS Vr device manufactured by PAS Systems International, Inc. use fuel-cell sensors, whereas all other electronic devices listed on the CPL use semi-conductor sensors.

Marilena Amoni,

Associate Administrator for Program Development and Delivery.