2012-14582. Highway Safety Programs; Conforming Products List of Screening Devices To Measure Alcohol in Bodily Fluids

AGENCY:

National Highway Traffic Safety Administration, Department of Transportation.

ACTION:

Notice.

SUMMARY:

This notice updates the Conforming Products List (CPL) published in the Federal Register on December 15, 2009 (74 FR 66398) for instruments that conform to the Model Specifications for Screening Devices to Measure Alcohol in Bodily Fluids dated, March 31, 2008 (73 FR 16956).

DATES:

Effective Date: June 14, 2012.

FOR FURTHER INFORMATION CONTACT:

For technical issues: Ms. De Carlo Ciccel, Behavioral Research Division, NTI-131, National Highway Traffic Safety Administration, 1200 New Jersey Avenue SE., Washington, DC 20590; Telephone: [phone]. For legal issues: Ms. Jin Kim, Office of Chief Counsel, NCC-113, National Highway Traffic Safety Administration, 1200 New Jersey Avenue SE., Washington, DC 20590; Telephone: [phone].

SUPPLEMENTARY INFORMATION:

On August 2, 1994, the National Highway Traffic Safety Administration (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 (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 updated the CPL on August 15, 1995 (60 FR 42214), May 4, 2001 (66 FR 22639), September 19, 2005 (70 FR 54972), with corrections on December 5, 2005 (70 FR 72502), and January 31, 2007 (72 FR 4559).

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. NHTSA last published an update to the CPL on December 15, 2009 (74 FR 66398). It listed 39 devices.

Today, NHTSA adds nine (9) additional alcohol screening devices that have been evaluated and found to conform to the Model Specifications for Screening Devices to Measure Alcohol in Bodily Fluids. One device is distributed by two different companies, so it has been listed twice, for a total of ten (10) new entries on this CPL.

(1) AK Solutions USA, LLC, submitted the AlcoMate SafeGuard (Model AL-2500, aka: AlcoScan AL-2500) alcohol screening device. This is a handheld, battery powered device with a semiconductor sensor.

(2) Alcohol Countermeasure Systems Corp., submitted the DRIVESAFE alcohol screening device. This is a handheld, battery powered device with a fuel cell sensor.

(3) KHN Solutions, LLC, submitted 2 screening devices for testing. Their trade names are: BACTRACK Element and the BACTRACK S75 Pro. Both devices are handheld, battery powered with fuel cell sensors.

(4) PAS Systems International, Inc. submitted the Alcovisor MARS screening device. This is a handheld, battery powered device with a fuel cell sensor.

(5) Q3 Innovations, Inc. submitted the CA2010 screening device. This is a handheld, battery powered device with a semiconductor sensor.

(6) Skyfine Inc. Ltd. submitted 3 devices (AT577, AT578, and AT579). All three devices are handheld, battery powered, and use fuel cell sensors. The AT578 is also distributed by Express Diagnostics Int'l, Blue Earth, Minnesota under the trade name of AlcoCheck FC90, so it has been listed twice on the CPL, once under each of its distributors/manufacturers.

All of the above devices meet the NHTSA Model Specifications for Screening Devices to Measure Alcohol in Bodily Fluids.

Consistent with the above, NHTSA updates 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/manufacturers	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
	• AlcoMate SafeGuard (Model AL-2500, aka: AlcoScan AL-2500).
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
Alcohol Countermeasure Systems Corp., Toronto, Ontario, Canada	DRIVESAFE.
BAC Solutions, Inc., Birmingham, Michigan	BACmaster.
B.E.S.T. Labs., Boardman, Ohio	PB 9000e.
Chematics, Inc., North Webster, Indiana	ALCO-SCREEN 02 TM9.
CMI, Inc., Owensboro, Kentucky	Intoxilyzer 500 (aka: Alcometer 500—Lion Laboratories).
Express Diagnostics Int'l, Inc., Blue Earth, Minnesota	AlcoCheck FC90 (aka: AT578 by Skyfine).
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
	• BACTRACK Element.
	• BACTRACK S 75 Pro.
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.
	• Alcovisor MARS.
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.
	• CA2010.
Repco Marketing, Inc., Raleigh, North Carolina	Alco Tec III.
Seju Engineering Co., Taejeon, Korea	Safe-Slim.
Skyfine Inc., Ltd., Kwai Chung, NT, Hong Kong	• AT577.
	• AT578 (aka: AlcoCheck FC90).
	• AT579.
Sound Off, Inc., Hudsonville, Michigan	Digitox D.O.T.7
Varian, Inc., Lake Forest, California	On-Site Alcohol.10
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 Q3 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. The 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 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.

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

Issued on: June 11, 2012.

Jeff Michael,

Associate Administrator, Research and Program Development, National Highway Traffic Safety Administration.