E7-1465. 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:

January 31, 2007.

FOR FURTHER INFORMATION CONTACT:

J. De Carlo Ciccel, Impaired Driving Division (NTI-111), 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. Subsequently NHTSA discovered an error regarding the name of a device listed on the CPL and republished the CPL on December 5, 2005 (70 FR 72502) to correct the error.

Since the publication of the last CPL, NHTSA has evaluated additional devices at the Volpe National Transportation Systems Center (VNTSC) in Cambridge, Massachusetts, resulting in the addition of three (3) new breath alcohol screening devices to the CPL.

(1) Q3 Innovations, Inc. submitted two (2) screening devices for testing. Their trade names are: AlcoHAWK Micro and AlcoHAWK Slim. These devices meet the NHTSA Model Specifications for Screening Devices to Measure Alcohol in Bodily Fluids.

(2) Akers Biosciences, Inc. submitted the Breath Alcohol ✓ .02 Detection System for testing. This device meets the NHTSA Model Specifications for Screening Devices to Measure Alcohol in Bodily Fluids.

Consistent with paragraphs (1) and (2) above, NHTSA amends the Conforming Products List of Screening Devices to Measure Alcohol in Bodily Fluids to read as follows:

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.
Akers Biosciences, Inc., Thorofare, NJ	Breath Alcohol ✓ .02 Detection System. 2
Chematics, Inc., North Webster, IN	ALCO-SCREEN 02TM. 3
Guth Laboratories, Inc., Harrisburg, PA	Alco Tector Mark X.
	Mark X Alcohol Checker.
	Alcotector WAT89EC-1.
Han International Co., Ltd., Seoul, Korea 4	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 5	AlcoHAWK Precision.
	AlcoHAWK Slim.
	AlcoHAWK Elite.
	AlcoHAWK ABI.
	AlcoHAWK Micro.
	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. 6
1 The AlcoMate was manufactured by Han International of Seoul, Korea, but marketed and sold in the U.S. by AK Solutions.
2 The Breath Alcohol ✓ .02 Detection System consists of a single-use disposable breath tube used in conjunction with an electronic analyzer that determines the test result. The electronic analyzer and the disposable breath tubes are lot specific and manufactured to remain calibrated throughout the shelf-life of the device. This screening device cannot be used after the expiration date.
3 While the ALCO-SCREEN 02 TM 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.
4 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.
5 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.
6 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°-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.

Issued on: January 24, 2007.

Marilena Amoni,

Associate Administrator for the Office of Research and Program Development.