2017-23869. Highway Safety Programs; Conforming Products List of Evidential Breath Alcohol Measurement Devices

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 June 14, 2012 (77 FR 35747) for instruments that conform to the Model Specifications for Evidential Breath Alcohol Measurement Devices dated, September 17, 1993 (58 FR 48705). This notice also informs the public that all future updates to the CPL will be posted on NHTSA's Web site.

DATES:

Applicable November 2, 2017.

FOR FURTHER INFORMATION CONTACT:

   For technical issues: Dr. Randolph Atkins, Behavioral Research Division, NPD-310, National Highway Traffic Safety Administration, 1200 New Jersey Avenue SE., Washington, DC 20590; Telephone; [phone].

For legal issues: Megan Brown, Office of Chief Counsel, NCC-300, National Highway Traffic Safety Administration, 1200 New Jersey Avenue SE., Washington, DC 20590; Telephone: [phone].

SUPPLEMENTARY INFORMATION:

On November 5, 1973, the National Highway Traffic Safety Administration (NHTSA) published the Standards for Devices to Measure Breath Alcohol (38 FR 30459). A Qualified Products List of Evidential Breath Measurement Devices comprised of instruments that met this standard was first issued on November 21, 1974 (39 FR 41399).

On December 14, 1984 (49 FR 48854), NHTSA converted this standard to Model Specifications for Evidential Breath Testing Devices (Model Specifications), and published a Conforming Products List (CPL) of instruments that were found to conform to the Model Specifications as Appendix D to that notice. Those instruments are identified on the CPL with an asterisk.

On September 17, 1993, NHTSA published a notice to amend the Model Specifications (58 FR 48705) and to update the CPL. That notice changed the alcohol concentration levels at which instruments are evaluated, from 0.000, 0.050, 0.101, and 0.151 BAC, to 0.000, 0.020, 0.040, 0.080, and 0.160 BAC, respectively. It also included a test for the presence of acetone and an expanded definition of alcohol to include other low molecular weight alcohols, e.g., methyl or isopropyl. Since that time, the CPL has been annotated to indicate which instruments have been determined to meet the Model Specifications published in 1984, and which have been determined to meet the Model Specifications, as revised and published in 1993. Thereafter, NHTSA has periodically updated the CPL with those breath instruments found to conform to the Model Specifications. The most recent update to the CPL was published June 14, 2012 (77 FR 35747).

NHTSA published the 1974 Qualified Products List, the 1984 CPL and all succeeding updates to the CPL in the Federal Register. Future updates of the CPL will be posted on the NHTSA Web site (https://www.nhtsa.dot.gov/​drunk-driving/​alcohol-measurement-devices) rather than to the Federal Register. Online publication will make it easier for users to access the most recent CPL and will allow NHTSA to make more timely updates to the CPL. NHTSA will continue to publish any amendments to the Model Specifications in the Federal Register.

The CPL published today adds twelve (12) new instruments that have been evaluated and found to conform to the Model Specifications, as amended on September 17, 1993 for mobile and non-mobile use. One instrument is distributed by two different companies, so it has been listed twice. One manufacturer changed their legal name. One manufacturer added a new product option for USB and Ethernet connectivity. One manufacturer added a Bluetooth keyboard accessory to two (2) devices and a calibration accessory for seven (7) of its devices. These devices were found to conform with or without the accessories. Another seven (7) instruments are now being listed under a different distributer/manufacturer and those devices will be cross-referenced for legacy purposes. In alphabetical order by company, the new devices are:

(1) The “AlcoMate TS600” distributed by AK GlobalTech Corporation, Palisades Park, New Jersey. This device will be known as the Alcoscan ALP-1 outside of the U.S. The AlcoMate TS600 is a hand-held device with an electrochemical (EC) fuel cell sensor. This device is powered by internal batteries and is intended for mobile or stationary operations.

(2) The “Intoxilyzer 500” manufactured by CMI, Inc., Owensboro, Kentucky. This instrument is currently listed on the CPL for Alcohol Screening Devices and will be removed when that CPL is updated. Improvements to the device's sampling system allow it to conform as an EBT. It is a hand-held instrument intended for use in mobile or stationary operations. It uses a fuel cell sensor and is powered by an internal battery. The Intoxilyzer 500 is also distributed as the Lion Alcolmeter 500 by Lion Laboratories outside the U.S., so it has been listed twice on the CPL, once under each of its distributors/manufacturers.

(3) The “Intoxilyzer 9000” manufactured by CMI, Inc., Owensboro, Kentucky. This is a bench-top device that is intended for use in mobile or stationary operations. This device uses an infrared (IR) sensor to measure ethanol concentration. The Intoxilyzer 9000 can be powered by either 110 volts alternate current (AC) or 12 volts direct current (DC).

(4) The “Alcotest 3820” manufactured by Draeger, Inc., Irving, Texas. The Alcotest 3820 is a hand-held device that uses an electrochemical (EC) fuel cell sensor to measure ethanol concentration. This instrument is powered by internal batteries and is intended for use in stationary or mobile operations.

(5) The “Alcotest 5510” manufactured by Draeger, Inc., Irving, Texas. The Alcotest 5510 is a hand-held device that uses an electrochemical (EC) fuel cell senor to measure ethanol. This device is powered by internal batteries and is intended for use in mobile or stationary operations.

(6) The “Alcotest 5820” manufactured by Draeger, Inc., Irving, Texas. The Alcotest 5820 is a hand-held device that uses an electrochemical (EC) fuel cell senor to measure ethanol. This device is powered by internal batteries and is intended for use in mobile or stationary operations.

(7) The “Alcotest 6820” manufactured by Draeger, Inc., Irving, Texas. The Alcotest 6820 is a hand-held device that uses an electrochemical (EC) fuel cell senor to measure ethanol. This device is powered by internal batteries and is intended for use in mobile or stationary operations.

(8) The “AlcoQuant 6020 Plus” manufactured by EnviteC, Wismar, Germany and distributed by Honeywell GmbH, Fond du Lac, Wisconsin. The AlcoQuant 6020 Plus is a hand-held device with a fuel cell sensor. This device is powered by internal batteries and is intended for use in mobile and stationary operations.

(9) The Alco-Sensor FST manufactured by Intoximeters, Inc., Saint Louis, Missouri. The Alco-Sensor FST is a hand-held Evidential Breath Tester that uses an electrochemical (EC) fuel cell sensor to measure ethanol concentration. This instrument is powered by internal batteries and is intended for use in stationary or mobile operations.

(10) The Intox DMT Dual Sensor manufactured by Intoximeters, Inc., Saint Louis, Missouri. The Intox DMT Dual Sensor is a bench-top Evidential Breath Tester that is intended for use in stationary or mobile operations. This device uses both an infrared (IR) sensor and an electrochemical (EC) fuel cell sensor. The Intox DMT Dual Sensor can be powered by either 110 volts AC or 12 volts DC.

(11) The “Intox EC/IR II.t” manufactured by Intoximeters, Inc, Saint Louis, Missouri. This is a bench-top device intended for use in mobile or stationary operations. This device uses both an electrochemical (EC) fuel cell sensor and an infrared (IR) sensor to measure ethanol concentrations. The Intox EC/IR II.t can be powered by either 110 volts AC or 12 volts DC.

(12) The “FC10Plus” manufactured by Lifeloc Technologies, Inc., Wheat Ridge, Colorado. This is a hand-held device that is intended for use in mobile or stationary operations. This device uses a fuel cell sensor and is powered by internal batteries.

This update indicates that two (2) devices (the Phoenix 6.0 and the FC20, manufactured by Lifeloc Technologies, Inc., Wheat Ridge, Colorado) come with Bluetooth keyboard support and five additional fields that users can use to enter additional information. With these features, these devices will be listed on the CPL as the “Phoenix 6.0BT” and the “FC20BT”. This update indicates also that seven (7) devices manufactured by Lifeloc come with the EASYCAL calibration accessory. Those devices include the FC10, FC10Plus, FC20, FC20BT, EV30, Phoenix 6.0 and the Phoenix 6.0BT. The CPL specifies that each of these devices conforms to the model specifications “w/or without the EASYCAL accessory.”

Intoximeters, Inc., Saint Louis, Missouri acquired the breath alcohol testing business of National Patent Analytical Systems, Inc. (NPAS). Since there have been no changes to the devices other than ownership and a device name change, all six devices previously listed under NPAS (BAC DataMaster (with or without the Delta-1 accessory), BAC Verifier DataMaster (w/or without the Delta-1 accessory), DataMaster cdm (w/or without the Delta-1 accessory), DataMaster DMT w/Fuel Cell option, DataMaster DMT w/Rev A Fuel Cell option, and DataMaster DMT) will now be listed under both Intoximeters and NPAS. The NPAS DataMaster DMT will now be known as the Intoximeters Intox DMT. Accordingly, this device will be listed under Intoximeters under both names.

The CPL has been updated to reflect that Draeger Safety Diagnostics, Inc. will begin operating under the name Draeger, Inc. effective July 1, 2017 in order to align all sales and service operations for Draeger in the United States.

In accordance with the foregoing, the CPL is updated, as set forth below.

Conforming Products List of Evidential Breath Measurement Devices

Manufacturer/Distributor and model	Mobile	Non-mobile
AK GlobalTech Corporation, Palisades Park, New Jersey:
AlcoMate TS600 (aka: Alcoscan ALP-1 outside the U.S.)	X	X
Alcohol Countermeasure Systems Corp., Toronto, Ontario, Canada:
Alert J3AD *	X	X
Alert J4X.ec	X	X
PBA3000C	X	X
SAF'IR Evolution	X	X
BAC Systems, Inc., Ontario, Canada:
Breath Analysis Computer *	X	X
CAMEC Ltd., North Shields, Tyne and Ware, England:
IR Breath Analyzer *	X	X
CMI, Inc., Owensboro, Kentucky:
Intoxilyzer Model:
200	X	X
200D	X	X
240 (aka: Lion Alcolmeter 400+ outside the U.S.)	X	X
300	X	X
400	X	X
400PA	X	X
500 (aka: Lion Alcolmeter 500 outside the U.S.)	X	X
600 (aka: Lion Alcolmeter 600 outside the U.S.)	X	X
1400	X	X
4011 *	X	X
4011A *	X	X
4011AS *	X	X
4011AS-A *	X	X
4011AS-AQ *	X	X
4011 AW *	X	X
4011A27-10100 *	X	X
4011A27-10100 with filter *	X	X
5000	X	X
5000 (w/Cal. Vapor Re-Circ.)	X	X
5000 (w/3/8″ ID Hose option)	X	X
5000CD	X	X
5000CD/FG5	X	X
5000EN	X	X
5000 (CAL DOJ)	X	X
5000VA	X	X
8000	X	X
9000	X	X
9000 (serial numbers 90-000500 and above)	X	X
PAC 1200 *	X	X
S-D2	X	X
S-D5 (aka: Lion Alcolmeter SD-5 outside the U.S.)	X	X
Draeger, Inc. (aka: Draeger Safety Diagnostics, Inc. or National Draeger) Irving, Texas:
Alcotest Model:
3820	X	X
5510	X	X
5820	X	X
6510	X	X
6810	X	X
6820	X	X
7010 *	X	X
7110 *	X	X
7110 MKIII	X	X
7110 MKIII-C	X	X
7410	X	X
7410 Plus	X	X
7510	X	X
9510	X	X
Breathalyzer Model:
900	X	X
900A *	X	X
900BG *	X	X
7410	X	X
7410-II	X	X
EnviteC, Wismar, Germany, distributed by Honeywell GmbH, Fond du Lac, Wisconsin:
AlcoQuant 6020	X	X
AlcoQuant 6020 Plus	X	X
Gall's Inc., Lexington, Kentucky:
Alcohol Detection System-A.D.S. 500	X	X
Guth Laboratories, Inc., Harrisburg, Pennsylvania:
Alcotector BAC-100	X	X
Alcotector C2H5OH	X	X
Guth 38	X	X
Intoximeters, Inc., St. Louis, Missouri:
Auto Intoximeter *	X	X
GC Intoximeter MK II *	X	X
GC Intoximeter MK IV *	X	X
Photo Electric Intoximeter *		X
Intoximeter Model:
3000	X	X
3000 (rev B1) *	X	X
3000 (rev B2) *	X	X
3000 (rev B2A) *	X	X
3000 (rev B2A) w/FM option *	X	X
3000 (Fuel Cell) *	X	X
3000 D *	X	X
3000 DFC *	X	X
Alcomonitor		X
Alcomonitor CC	X	X
Alco-Sensor III	X	X
Alco-Sensor III (Enhanced with Serial Numbers above 1,200,000)	X	X
Alco-Sensor IV	X	X
Alco-Sensor IV XL	X	X
Alco-Sensor V	X	X
Alco-Sensor V XL	X	X
Alco-Sensor AZ	X	X
Alco-Sensor FST	X	X
Intox DMT Dual Sensor	X	X
Intox EC/IR	X	X
Intox EC/IR II	X	X
Intox EC/IR II (Enhanced with serial number 10,000 or higher)		X
Intox EC/IR II.t	X	X
Portable Intox EC/IR	X	X
RBT-AZ	X	X
RBT-III	X	X
RBT III-A	X	X
RBT IV	X	X
RBT IV with CEM (cell enhancement module)	X	X
(Also Listed under National Patent Analytical Systems, Inc.) BAC DataMaster (with or without the Delta-1 accessory)	X	X
BAC Verifier DataMaster (w/or without the Delta-1 accessory)	X	X
DataMaster cdm (w/or without the Delta-1 accessory)	X	X
DataMaster DMT w/Fuel Cell option	X	X
DataMaster DMT w/Rev A Fuel Cell option	X	X
DataMaster DMT (aka: Intox MT)	X	X
Intox DMT (aka: DataMaster DMT)	X	X
Komyo Kitagawa, Kogyo, K.K., Japan:
Alcolyzer DPA-2 *	X	X
Breath Alcohol Meter PAM 101B *	X	X
Lifeloc Technologies, Inc., (formerly Lifeloc, Inc.), Wheat Ridge, Colorado:
EV 30 (w/or without EASYCAL accessory)	X	X
FC 10 (w/or without EASYCAL accessory)	X	X
FC10Plus (w/or without EASYCAL accessory)	X	X
FC 20 (w/or without EASYCAL accessory)	X	X
FC20BT (w/or without EASYCAL accessory)	X	X
LifeGuard Pro	X	X
Phoenix	X	X
Phoenix 6.0 (w/or without EASYCAL accessory)	X	X
Phoenix 6.0BT (w/or without EASYCAL accessory)	X	X
Lion Laboratories, Ltd., Cardiff, Wales, United Kingdom:
Alcolmeter Model:
300	X	X
400	X	X
400+ (aka: Intoxilyzer 240 in the U.S.)	X	X
500 (aka: Intoxilyzer 500 in the U.S.)	X	X
600 (aka: Intoxilyzer 600 in the U.S.)	X	X
EBA *	X	X
SD-2 *	X	X
SD-5 (aka: S-D5 in the U.S.)	X	X
Intoxilyzer Model:
200	X	X
200D	X	X
1400	X	X
5000 CD/FG5	X	X
5000 EN	X	X
Luckey Laboratories, San Bernardino, California:
Alco-Analyzer Model:
1000 *		X
2000 *		X
Nanopuls AB, Uppsala, Sweden:
Evidenzer	X	X
National Patent Analytical Systems, Inc. (NPAS), Mansfield, Ohio:
BAC DataMaster (with or without the Delta-1 accessory)
BAC Verifier DataMaster (w/or without the Delta-1 accessory)	X	X
DataMaster cdm (w/or without the Delta-1 accessory)	X	X
DataMaster DMT (aka: Intox DMT)	X	X
DataMaster DMT w/Fuel Cell option SN: 555555	X	X
DataMaster DMT w/Rev A Fuel Cell option SN: 100630	X	X
Omicron Systems, Palo Alto, California:
Intoxilyzer Model:
4011 *	X	X
4011AW *	X	X
PAS International, Fredericksburg, Virginia:
Alcovisor Jupiter	X	X
Alcovisor Mercury	X	X
Mark V Alcovisor	X	X
Plus 4 Engineering, Minturn, Colorado:
5000 Plus 4 *	X	X
Seres, Paris, France:
Alco Master	X	X
Alcopro	X	X
Siemans-Allis, Cherry Hill, New Jersey:
Alcomat *	X	X
Alcomat F *	X	X
Smith and Wesson Electronics, Springfield, Massachusetts:
Breathalyzer Model:
900 *	X	X
900A *	X	X
1000 *	X	X
2000 *	X	X
2000 (non-Humidity Sensor) *	X	X
Sound-Off, Inc., Hudsonville, Michigan:
AlcoData	X	X
Seres Alco Master	X	X
Seres Alcopro	X	X
Stephenson Corp.:
Breathalyzer 900 *	X	X
Tokai-Denshi Inc., Tokyo, Japan:
ALC-PRO II (US)	X	X
U.S. Alcohol Testing, Inc./Protection Devices, Inc., Rancho Cucamonga, California:
Alco-Analyzer 1000		X
Alco-Analyzer 2000		X
Alco-Analyzer 2100	X	X
Verax Systems, Inc., Fairport, New York:
BAC Verifier *	X	X
BAC Verifier Datamaster	X	X
BAC Verifier Datamaster II *	X	X
* Instruments marked with an asterisk (*) meet the Model Specifications detailed in 49 FR 48854 (December 14, 1984) (i.e., instruments tested at 0.000, 0.050, 0.101, and 0.151 BAC). Instruments not marked with an asterisk meet the Model Specifications detailed in 58 FR 48705 (September 17, 1993), and were tested at BACs = 0.000, 0.020, 0.040, 0.080, and 0.160. All instruments that meet the Model Specifications currently in effect (dated September 17, 1993) also meet the Model Specifications for Screening Devices to Measure Alcohol in Bodily Fluids.

Authority: 44 U.S.C. Section 3506(c)(2)(A).

Issued in Washington, DC, on October 30, 2017.

Jeff Michael,

Associate Administrator, Research and Program Development.