05-18501. 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:

September 19, 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.

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 following changes to the CPL.

(1) AK Solutions, Inc. of Palisades Park, New Jersey submitted seven (7) different electronic screening devices for testing, all of which use a semi-conductor sensor. Their trade names are: (a) “Alcoscan AL-2500”; (b) “AlcoChecker”; (c) “AlcoKey”; (d) “AlcoMate”; (e) “AlcoMate Pro”; (f) “Alcoscan AL-5000”; and (g) Alcoscan AL-6000. All of these devices meet the NHTSA Model Specifications for Screening Devices to Measure Alcohol in Bodily Fluids.

(2) Guth Laboratories, Inc. of Harrisburg, Pennsylvania submitted for testing the “Alcotector WAT89EC-1” screening device, an electronic device that uses a fuel cell sensor and has a digital display. This device meets the NHTSA Model Specifications for Screening Devices to Measure Alcohol in Bodily Fluids.

(3) Q-3 Innovations, Inc. of Independence, Iowa submitted for testing the “Alcohawk® Precision,” an electronic screening device that uses a semiconductor sensor and has a digital display. This device meets the NHTSA Model Specifications for Screening Devices to Measure Alcohol in Bodily Fluids.

(4) Q-3 Innovations, Inc. certified that it also sells the “Alcohawk® Elite,” which is the same technical device as the “Alcohawk® Precision,” and has only cosmetic differences not related to the alcohol-measuring capability of the device. Hence, the “Alcohawk® Elite” will also be listed on the CPL. Q-3 Innovations, Inc. also sells the “Alcohawk® ABI”, which is the same device as the “ABI” manufactured by Han International Co., Ltd. of Seoul, Korea. As the Han “ABI” already appears on the CPL, and Han International has certified that the “Alcohawk® ABI” is the same device, the “Alcohawk® ABI” will also be listed on the CPL. Finally, Q-3 Innovations sells the “Alcohawk® PRO”, also manufactured by Han International. This device was previously submitted by AK Solutions, Inc. and approved for inclusion on the CPL. While Han International continues to manufacture the device, it is now sold as the “Alcohawk® PRO” by Q-3 Innovations, Inc. Hence, the “Alcohawk® PRO” will also be added to the CPL.

(5) Seju Co., of Korea submitted the “Safe-Slim” handheld, electronic screening device that uses a semi-conductor sensor. It meets the NHTSA Model Specifications for Screening Devices to Measure Alcohol in Bodily Fluids.

All of the above devices are being added to the CPL with this publication.

(6) When NHTSA published the CPL on May 4, 2001, it added the “Alcohol √” manufactured by Akers Laboratories, Inc. After that date, Akers Laboratories, Inc. changed its name to Akers Biosciences, Inc. and continued distributing a device that NHTSA understood to be the same device tested and approved for listing on the CPL in May, 2001. The Akers device listed on the CPL is no longer manufactured. Accordingly, the “Alcohol √” is being removed from the CPL with this publication. No other Akers device currently is approved for inclusion on the CPL.

In addition to the above changes, NHTSA is making the following housekeeping changes to the CPL:

(7) OraSure Technologies, Inc. of Bethlehem, Pennsylvania continues to manufacture the Q.E.D. A150 Saliva Alcohol Test. On the previous CPL, NHTSA listed STC Technologies, Inc. as a manufacturer of the same device. STC Technologies, Inc. changed its name to OraSure Technologies, Inc. OraSure Technologies, Inc. has certified that no unexpired devices called the Q.E.D. A150 Saliva Alcohol Test and sold under the STC Technologies, Inc label exist in the marketplace. Hence, NHTSA is removing the name STC Technologies, Inc. from the CPL.

(8) Alco Check International, Inc. of Hudsonville, Michigan has certified that the “Alco Screen 3000” is no longer in service, was sold under a private label for only a very brief period of time, and none has been serviced for at least five years. Accordingly, the manufacturer concurs with the removal of the device from the CPL.

(9) Sound Off, Inc. of Hudsonville, Michigan has certified that the “Alco Screen 1000” is no longer in service, was sold under a private label for only a very brief period of time, and none has been serviced for at least five years. Accordingly, the manufacturer concurs with the removal of the device from the CPL.

(10) PAS Systems International, Inc. of Fredericksburg, Virginia has certified that the “PAS IIIa” device has not been manufactured for more than five years, and no instruments have been returned for service or calibration during the past five years. Accordingly, the manufacturer concurs with the removal of the device from the CPL.

(11) Varian Inc. of Lake Forest, California acquired the “On-Site Alcohol” saliva-alcohol screening device previously owned by Roche Diagnostics Systems. Varian, Inc. has certified that the “On-Site Alcohol” device they are selling is identical to the device previously sold by Roche. Accordingly, this CPL will list the Varian, Inc. “On-Site Alcohol” saliva-alcohol screening device. The Roche Diagnostics device will be removed from the CPL. The Roche device had a shelf-life of one year, and Varian began selling the device more than one year ago. Therefore, any of these devices that might exist in the marketplace has expired, warranting removal of the Roche Diagnostics device from the CPL.

Consistent with paragraphs (1) through (11) 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.
	EAlcoMate.
	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	Q.E.D. A150 Saliva Alcohol Test. 5
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” manufactured 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.
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 ° (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 °-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: September 13, 2005.

Marilena Amoni,

Associate Administrator for Program Development and Delivery.