E9-29822. 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.

DATES:

Effective Date: December 15, 2009.

FOR FURTHER INFORMATION CONTACT:

Ms. De Carlo Ciccel, Behavioral Research Division, NTI-131, National Highway Traffic Safety Administration, 1200 New Jersey Avenue SE., 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 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 7 devices to the CPL in those two 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. NHTSA last published an update to the CPL on January 31, 2007 (72 FR 4559), adding 3 new devices.

On March 31, 2008, NHTSA published revised Model Specifications for Screening Devices to Measure Alcohol in Bodily Fluids (73 FR 16956). These specifications removed testing of interpretive screening devices (ISDs) because ISDs did not provide an unambiguous test result. These specifications also removed from use the Breath Alcohol Sample Simulator as it is not necessary for testing breath alcohol screening devices. All other performance criteria and test methods were maintained.

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 14 new breath alcohol screening devices to the CPL. One device is being removed from the CPL as it is no longer supported or sold by the manufacturer and several devices are being renamed.

(1) AK Solutions USA, LLC, submitted 3 screening devices for testing, several trade name revisions, and the removal of 1 device from the CPL. The trade names of the new conforming devices are: AlcoMate AccuCell AL-9000, a handheld device with a fuel cell sensor; AlcoMate Premium AL-7000, a handheld device that utilizes replaceable semiconductor detectors, and AlcoMate Prestige (AL-6000), also a handheld device that utilizes replaceable semiconductor detectors. The replaceable detectors also conform to the model specifications and are specific to each device. Alcoscan AL-5000 is being removed from the list. This device is no longer being sold or supported by the manufacturer. The following three devices are being renamed: SafeMate (formerly known as AlcoChecker), SafeDrive (formerly known as AlcoKey), and AlcoMate Core (formerly known as Alcoscan AL-6000). (2) BAC Solutions, Inc., submitted a screening device for testing. The trade name for this device is BACmaster. This is a bench top stationary screening device with an infrared detector. (3) B.E.S.T. Labs, Inc., submitted a device for testing. The PB 9000e is a handheld device with a fuel cell sensor. (4) CMI, Inc., submitted a device for testing. This device, the Intoxilyzer 500, with a handheld fuel cell sensor conforms to the model specification for alcohol screening devices. This is the same device listed below as the Alcometer 500, distributed by Lion Laboratories, Ltd. (5) First Innovative Technology Group, Ltd., submitted a device, the AAT198 Pro. This is a handheld device with a semiconductor detector. (6) Guth Laboratories, Inc., submitted the Alcotector WAT90 for testing. This conforming device is handheld with a fuel cell sensor. (7) KHN Solutions, LLC, submitted 2 screening devices for testing. Their trade names are: BACTRACK Select S50 and the BACTRACK Select S80 and both devices are handheld. The BACTRACK Select S50 has a semiconductor detector while the S80 has a fuel cell sensor. (8) Lion Laboratories, Ltd. submitted the Alcometer 500. This is the same device as the Intoxilyzer 500 submitted by CMI, Inc., listed above. (9) Q3 Innovations, Inc. submitted 2 screening devices for testing. The AlcoHAWK PT500 and the AlcoHAWK Slim 2 are handheld with semiconductor detectors. All of the above devices meet 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

Distributors/manufacturer	Devices
AK Solutions, USA, LLC., Palisades Park, New Jersey.1	• AlcoScan AL-2500.
	• SafeMate.2
	• SafeDrive.
	• AlcoMate.3 (aka: AlcoHAWK Pro by Q3 Innovations).
	• AlcoMate Accu Cell AL-9000.
	• AlcoMate Pro.3
	• AlcoMate Core.4
	• AlcoMate Premium AL-7000, with replaceable Premium Sensor Modules (SM-7000).4 5
	• AlcoMate Prestige AL-6000, with replaceable Prestige Sensor Modules (SM-6000).4 6
Alco Check International, Hudsonville, Michigan	Alco Check 3000 D.O.T.7
	Alco Check 9000.7
Akers Biosciences, Inc., Thorofare, New Jersey	Breath Alcohol ✓ .02 Detection System.8
BAC Solutions, Inc., Birmingham, Michigan	BACmaster.
B.E.S.T. Labs., Boardman, Ohio	PB 9000e.
Chematics, Inc., North Webster, Indiana	ALCO-SCREEN 02 TM.9
CMI, Inc., Owensboro, Kentucky	Intoxilyzer 500 (aka: Alcometer 500—Lion Laboratories).
First Innovative Technology Group, Ltd., Hong Kong	AAT198—Pro.
Guth Laboratories, Inc., Harrisburg, Pennsylvania	• Alco Tector Mark X.
	• Mark X Alcohol Checker.
	• Alcotector WAT89EC-1.
	• Alcotector WAT90.
Han International Co., Ltd.,2 Seoul, Korea	A.B.I. (Alcohol Breath Indicator) (aka: AlcoHAWK ABI by Q3 Innovations).
KHN Solutions, LLC, San Francisco, California	BACTRACK Select S50 10 BACTRACK Select S80.10
Lion Laboratories, Ltd., Wales, United Kingdom	Alcometer 500 (aka: Intoxilyzer 500—CMI, Inc.).
OraSure Technologies, Inc., Bethlehem, Pennsylvania	Q.E.D. A150 Saliva Alcohol Test.
PAS Systems International, Inc., Fredericksburg, Virginia	PAS Vr.
Q3 Innovations, Inc., Independence, Iowa	• AlcoHAWK Precision.
	• AlcoHAWK Slim.
	• AlcoHAWK Slim 2.
	• AlcoHAWK Elite.
	• AlcoHAWK ABI (aka: A.B.I. (Alcohol Breath Indicator) by Han Intl.).
	• AlcoHAWK Micro.
	• AlcoHAWK PRO (aka: AlcoMate by AK Solutions).
	• AlcoHAWK PT 500.
Repco Marketing, Inc., Raleigh, North Carolina	Alco Tec III.
Seju Engineering Co., Taejeon, Korea	Safe-Slim.
Sound Off, Inc., Hudsonville, Michigan	Digitox D.O.T.7.
Varian, Inc., Lake Forest, California	On-Site Alcohol.11
1 The AlcoMate was manufactured by Han International of Seoul, Korea, but marketed and sold in the U.S. by AK Solutions.
2 Manufactured by Seju Engineering, Korea.
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 Manufactured by Sentech Korea Corp.
5 These devices utilize replaceable semiconductor detectors. Instead of re-calibrating the device, a new calibrated detector can be installed. This device comes with 4 detectors including the one that was already installed.
6 These devices utilize replaceable semiconductor detectors. Instead of re-calibrating the device, a new calibrated detector can be installed. This device comes with 5 detectors including the one that was already installed.
7 While these devices are still being sold, they are no longer manufactured or supported.
8 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.
9 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.
10 Manufactured by DA Tech Co., Ltd., Korea.
11 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.

Authority: 23 U.S.C. 403; 49 CFR 1.50; 49 CFR part 501.

Issued on: November 18, 2009.

Jeff Michael,

Associate Administrator for the Office of Research and Program Development.