1100 Approved prearrest and evidential breath testing devices?

DEPARTMENT OF HEALTH

Approved Prearrest and Evidential Breath Testing Devices

[41 Pa.B. 3585]
[Saturday, July 2, 2011]

 The Department of Health (Department) has statutory authority to approve both prearrest and evidential breath testing devices for use by law enforcement officials to determine the alcohol content of blood by analysis of a person's breath. This notice contains the combined lists of prearrest breath testing devices and evidential breath testing devices.

 The Department approves prearrest breath testing devices as required by 28 Pa. Code §§ 5.101—5.104 (relating to equipment to determine blood alcohol content under the Vehicle Code and the Fish and Boat Code). Authority to promulgate these regulations is in the Vehicle Code, 75 Pa.C.S. § 1547(k) (relating to chemical testing to determine amount of alcohol or controlled substance), the Fish and Boat Code, 30 Pa.C.S. § 5125(k) (relating to chemical testing to determine amount of alcohol or controlled substance), the Game and Wildlife Code, 34 Pa.C.S. § 2502(j) (relating to chemical test to determine amount of alcohol), and section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)).

 Prearrest breath testing devices approved under this authority may be used by police officers, waterways patrolmen and officers enforcing the Vehicle Code, the Fish and Boat Code and the Game and Wildlife Code in conducting preliminary determinations of the alcohol content of blood of persons suspected of driving, boating, hunting or furtaking, while under the influence of alcohol. Officers and patrolmen use these devices to assist them in determining whether or not a person should be placed under arrest for violation of 75 Pa.C.S. § 3802 (relating to driving under influence of alcohol or controlled substance), for violation of 30 Pa.C.S. § 5502 (relating to operating watercraft under influence of alcohol or controlled substance), for violation of 34 Pa.C.S. § 2501 (relating to hunting or furtaking while under influence of alcohol or controlled substance) or for any other criminal offense under the Vehicle Code, the Fish and Boat Code or the Game and Wildlife Code which involves operating a vehicle or boat, hunting or furtaking while under the influence of alcohol.

 The National Highway Traffic Safety Administration (NHTSA) of the United States Department of Transportation published model specifications for Screening Devices to Measure Alcohol in Bodily Fluids at 59 FR 39382 (August 2, 1994). These specifications established performance criteria and methods for testing alcohol screening devices using either breath or bodily fluids such as saliva to measure blood alcohol content. NHTSA established these specifications to support state laws and the United States Department of Transportation's workplace alcohol testing program. The Department has elected to use the NHTSA criteria for approving devices for the prearrest testing of a person's breath to determine the alcohol content of the person's blood.

 NHTSA published a conforming products list of alcohol screening devices at 72 FR 4559 (January 31, 2007). The breath testing devices included in this Federal approval list have been incorporated into the list in this notice. Since this notice lists only those devices which test breath, items on the NHTSA list that test saliva or other bodily fluids are not included in this notice.

 Additionally, there are a number of breath testing devices on this list of approved equipment that may be used as both prearrest and evidential testing devices. Any device on this list that was evaluated using the 1993 Model Specifications for Evidential Breath Testers (see 58 FR 48705 (September 17, 1993)) also fully meets the requirements of the Model Specifications for prearrest screening devices. Both procedures evaluate the performance of instruments at the 0.020% alcohol level.

 The Department approves evidential breath testing devices under the authority of 75 Pa.C.S. § 1547(c)(1), 30 Pa.C.S. § 5125(c)(1) and 34 Pa.C.S. § 2502(c).

 Evidential breath testing devices approved under this notice may be used by law enforcement officials to obtain test results which will be admissible in evidence in any summary or criminal proceeding in which the defendant is charged with a violation of 75 Pa.C.S. § 3802 or any other violation of the Vehicle Code arising out of the same action; or 30 Pa.C.S. § 5502 or any other violation of the Fish and Boat Code arising out of the same action; or 34 Pa.C.S. § 2501 or any other violation of the Game and Wildlife Code arising out of the same action. Law enforcement agencies should determine that an approved training program in the use of the equipment is available in accordance with the previously referenced statutes before purchasing any of the devices contained on this list.

 The approval of evidential equipment listed in this notice is based on the evaluation of the equipment by NHTSA. Equipment which met Federal requirements was published at 75 FR 11624 (March 11, 2010) as a Conforming Products List. The list contained in this notice is based on NHTSA's Conforming Products Lists.

 Instruments marked with an asterisk (*) meet the Model Specifications detailed at 49 FR 48854 (December 14, 1984) (that is, instruments tested at breath alcohol concentrations of 0.000, 0.050, 0.101 and 0.151 grams of alcohol per 210 liters of air). Instruments not marked with an asterisk meet the Model Specifications detailed at 58 FR 48705, and were tested at breath alcohol concentrations of 0.000, 0.020, 0.040, 0.080 and 0.160 grams of alcohol per 210 liters of air. The amended specifications that were published at 58 FR 48705, added a test for the presence of acetone and other low molecular weight alcohols including methyl and isopropyl. Instruments whose precision and accuracy have been evaluated in the latter concentration range (that is, devices not marked with an asterisk) should be used when reliable results are required at blood alcohol concentrations below 0.050%.

 NHTSA also evaluates equipment to determine if it must be operated at fixed locations (that is, nonmobile equipment) or can be transported to nonfixed operational sites in the field (mobile equipment). Most equipment on the list is approved for mobile and nonmobile operation. The listing at the end of this notice specifies nonmobile equipment only.

 The instruments not marked with an asterisk meet the specifications for use as prearrest or evidentiary breath testing devices. The instruments marked with an asterisk may be used as evidentiary devices for law enforcement purposes that are concerned with blood alcohol concentrations at or above 0.050%. These instruments may also be used as prearrest breath testing devices if they are approved for mobile operations. However, these instruments may not be used for making arrests under the Vehicle Code, the Fish and Boat Code or the Game and Wildlife Code when blood alcohol concentrations below 0.050% must be determined. Nonmobile devices can only be used as evidentiary testing instruments since they are not portable. Before purchasing breath testing devices, law enforcement officials should consult with the manufacturer of the equipment they intend to purchase to verify that the devices can be used for their intended purposes.

 Law enforcement agencies that plan to utilize a device which does not appear on the following list should contact the manufacturer of the equipment to verify that it has been evaluated by NHTSA and found to meet NHTSA's performance requirements. If a device is approved by NHTSA after the date of this publication, the manufacturer of the device will need to forward documentation of NHTSA acceptability to Dr. M. Jeffery Shoemaker at the following address so that the Department has information sufficient to enable it to include the device in the next revision of this notice in the Pennsylvania Bulletin.

 Some of the devices included in this notice are listed under the name of more than one manufacturer. This is due to the fact that the name of the manufacturer has changed or the right to produce a device has been transferred to a different company. In these instances, the device is listed under the name of every company that was ever associated with the device to allow law enforcement agencies to continue using devices bearing the name of a previous manufacturer.

 To facilitate accessibility to information concerning breath alcohol testing devices which are approved for law enforcement purposes in this Commonwealth, the Department will publish revisions of this list of equipment semiannually as notices in the Pennsylvania Bulletin. This practice was implemented in 2009 and will proceed even if an updated conforming products list has not appeared in the Federal Register since the Department's last annual publication of approved breath testing devices.

 Questions regarding this list should be directed to Dr. M. Jeffery Shoemaker, Ph.D., 2Director, Division of Chemistry and Toxicology, Department of Health, Bureau of Laboratories, P. O. Box 500, Exton, PA 19341-0500, [phone].

 Persons with a disability who require an alternative format of this notice (for example, large print, audiotape, Braille) may contact Dr. M. Jeffery Shoemaker at V/TT [phone] or the Pennsylvania AT&T Relay Service at [phone] (TT).

AK Solutions, Inc., Palisades Park, NJ¹

   Alcoscan AL-2500
AlcoChecker
AlcoKey
AlcoMate
AlcoMate³ (aka: AlcoHAWK Pro by Q3 Inovations)
AlcoMate Accu Cell AL-9000
AlcoMate Core⁴ (formerly known as Alcoscan AL- 6000)
AlcoMate Premium AL-7000, with replaceable Pre mium Sensor Modules (SM-7000)^{4 5}
AlcoMate Prestige AL-6000, with replaceable Pres tige Sensor Modules (SM-6000)^{4 6}
AlcoMate Pro
Alcoscan AL-5000
Alcoscan AL-6000
SafeMate² (formerly known as AlcoChecker)
SafeDrive (formerly known as AlcoKey)

Akers Laboratories, Inc., Thorofare, NJ

 Alcohol √^TM

Akers Biosciences, Inc., Thorofare, NJ

   Breath Alcohol √ .02 Detection System⁸

Alco Check International, Hudsonville, MI

   Alco Check 3000 D.O.T.⁷
Alco Check 9000⁷
Alco Screen 3000

Alcohol Countermeasures Systems, Inc., Port  Hurton, MI

   Alert J3AD*
PBA 3000C

Alcohol Countermeasure Systems Corp., Missis sauga, Ontario, Canada

   Alert J3AD*
Alert J4X.ec
PBA3000C

Alcohol Countermeasure Systems, Inc., Cincinnati,  OH

   Alert J4

Approved Technology, Inc., Grand Rapids, MI

   Alco-Check I
Alco-Check II
Alco-Check 3000

BAC Solutions, Inc., Birmingham, Michigan

   BACmaster*

BAC Systems, Inc., Ontario, Canada

   Breath Analysis Computer*

B.E.S.T. Labs., Boardman, Ohio

   PB 9000e

BHP Diagnostix, West Chester, PA

   Prevent

CAMEC Ltd., North Shields, Tyne and Ware, Eng land

   IR Breath Analyzer*

CMI-MPH, Owensboro, KY

   CMI S-D2
CMI S-L2

CMI, Inc., Owensboro, KY

   AlcoBlow

Intoxilyzer Model:

   200
200D
240 (aka Lion Alcolmeter 400 + outside the US)
300
400
400PA
500 (aka: Alcolmeter 500-Lion Laboratories)
1400
4011*
4011A*
4011AS*
4011AS-A*
4011AS-AQ*
4011AW*
4011A27-10100*
4011A27-10100 with filter*
5000
5000 (w/Cal. Vapor Re-Circ.)
5000 (w/3/8" ID hose option)
5000CD
5000CD/FG5
5000EN
5000 (CAL DOJ)
5000 (VA)
8000
PAC 1200*
S-D2
S-D5

Craig Technologies International Ltd., Aurora, CO

   BreathScan

Decator Electronics, Decator, IL

   Alco-Tector model 500*

Draeger Safety Diagnostics Inc., (aka: National  Draeger) Irving, TX

  Alcotest Model:

   6510
6810
7010*
7110*
7110 MKIII
7110 MKIII-C
7410
7410 Plus
7510
9510

  Breathalyzer Model:

   900*
900A*
900BG*
7410
7410-II

EnviteC by Honeywell GmbH. Fond du Lac, WI

   AlcoQuant 6020

First Innovative Technology Group, Ltd. Hong Kong

   AAT198-Pro

Gall's Inc., Lexington, KY

   Alcohol Detection System-A.D.S. 500

Guth Laboratories, Inc., Harrisburg, Pennsylvania

   Alco-Tector
Alco-Tector Mark X
Alcotector BAC-100
Alcotector C₂H₅OH
Alcotector WAT89EC-1
Alcotector WAT90
Mark X Alcohol Checker

Han International Co., Ltd., Seoul, Korea

   A.B.I. (Alcohol Breath Indicator) (aka: AlcoHAWK  ABI by Q3 Innovations).

KHN Solutions, LLC, San Francisco, California

   BACTRACK Select S50⁹
BACTRACK Select S80⁹

Intoximeters, Inc., St. Louis, MO

   Indium Encapsulation System
Photo Electric Intoximeter*
GC Intoximeter MK II*
GC Intoximeter MK IV*
Auto Intoximeter*
Intox EC-IR
Intox EC-IR 2
Portable Intox EC-IR

  Intoximeter Model:

   3000*
3000 (rev B1)*
3000 (rev B2)*
3000 (rev B2A)*
3000 (rev B2A) w/FM option*
3000 (Fuel Cell)*
3000D*
3000DFC*
Alcomonitor
Alcomonitor CC
Alco-Sensor
Alco-Sensor III
Alco-Sensor III (Enhanced with Serial Numbers  above 1,200,000)
Alco-Sensor IV
Alco-Sensor IV-XL
Alco-Sensor V
Alco-Sensor AZ
Alco-Sensor FST
Alco-Sensor Light Display
Intox EC/IR
Intox EC/IR II
Intox EC/IR II (enhanced with serial number  10,000 or higher)
Portable Intox EC/IR II
RBT-AZ
RBT III
RBT III-A
RBT-IV
RBT-IV with CEM (cell enhancement module)

Komyo Kitagawa, Kogyo, K.K.:

   Alcolyzer DPA-2*
Breath Alcohol Meter PAM 101B*

Lifeloc Technologies, Inc. (formerly Lifeloc, Inc.)  Wheat Ridge, CO:

   Life Loc PBA 3000
PBA 3000-B
PBA 3000-P*
PBA 3000-C
Alcohol Data Sensor
Phoenix
Phoenix 6.0
EV 30
FC 10
FC 20

Lion Laboratories, Ltd., Cardiff, Wales, UK

  Alcolmeter Model:

   Auto-Alcolmeter*
300
400
400+ (aka: Intoxilzyer 240 in the U.S.)
500 (aka: Intoxilyzer 500-CMI, Inc.)
SD-2*
SD-5 (aka: S-D5 in the U.S.
EBA*

  Intoxilyzer Model:

   200
200D
1400
5000 CD/FG5
5000 EN

Luckey Laboratories, San Bernardino, CA

  Alco-Analyzer Model:

   Mobat Sober-Meter-SM II
1000*
2000*

Nanopuls AB, Uppsala, Sweden

   Evidenzer

Medi-Scan, Inc., Denver, CO

   BreathScan

National Draeger, Inc., Durango, CO

  Alcotest Model:

   7010*
7110*
7110 MKIII
7110 MKIII-C
7410
7410 Plus
7410 Screener
9510
6510
6810

  Breathalyzer Model:

   900*
900A*
900BG*
7410
7410-II

National Draeger, Inc., Pittsburgh, PA

   Alcotest

National Patent Analytical Systems, Inc., Mansfield,  OH

  BAC DataMaster (with or without the Delta-1 acces sory)

   BAC Verifier DataMaster (with or without the Delta-1 accessory
DataMaster cdm (with or without the Delta-1  accessory)
DataMaster DMT

Omicron Systems, Palo Alto, CA

   Intoxilyzer 4011*
Intoxilyzer 4011AW*

PAS International, Fredericksburg, VA

   Mark V. Alcovisor
PAS IIIa
PAS Vr

Plus 4 Engineering, Minturn, CO

   5000 Plus 4*

Q3 Innovations, Inc., Independence, IA⁴

   AlcoHAWK Precision
AlcoHAWK Slim
AlcoHAWK Slim 2
AlcoHAWK Elite
AlcoHAWK ABI (aka: A.B.I. (Alcohol Breath indica tor) by Han Intl.)
AlcoHAWK Micro
AlcoHAWK PRO (aka: AlcoMate by AK Solutions)
AlcoHAWK PT500

RepCo Marketing, Raleigh, NC

   Alco Tec III
AlcoTec Breath-Alcohol Tester
Breath Alcohol Tester Model BT-2
Breath Alcohol Tester Model BT-3

Seju Co. of Taejeon, Korea

   Safe-Slim

Seres, Paris, France

   Alco Master
Alcopro

Siemans-Allis, Cherry Hill, NJ

   Alcomat*
Alcomat F*

Smith and Wesson Electronics, Springfield, MA

  Breathalyzer Model:

   900*
900A*
1000*
2000*
2000 (Non-Humidity Sensor)*

SoundOff, Inc., Hudsonville, MI

   Alco-Check
Alco-Check II
AlcoData
Alco Screen 1000
Digitox D.O.T.
Preliminary Breath Test II
Seres Alco Master
Seres Alcopro

Stephenson Corp.

   Breathalyzer 900*

Takai-Denshi Inc., Tokyo, Japan:

   ALC-PRO II (US)

Team Building Systems, Inc., Houston, TX

   BreathScan

U.S. Alcohol Testing, Inc./Protection Devices, Inc.,  Rancho Cucamonga, CA

   Alco-Analyzer 1000
Alco-Analyzer 2000
Alco-Analyzer 2100

Verax Systems, Inc., Fairport, NY

   BAC Verifier*
BAC Verifier Datamaster
BAC Verifier Datamaster II*

 ¹ The AlcoMate was manufactured by Han International of Seoul, Korea, but marketed and sold in the United States by AK Solutions.

 ² Manufactured by Seju Engineering, Korea.

 ³ Han International does not market or sell devices directly in the United States 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 recalibrating the device, a new calibrated detector can be installed. This device comes with four detectors including the one that was already installed.

 ⁶ These devices utilize replaceable semiconductor detectors. Instead of recalibrating the device, a new calibrated detector can be installed. This device comes with five 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 Manufactured by DA Tech Co., Ltd., Korea.

Nonmobile only

Decator Electronics

   Alco-Tector model 500*

Draeger Safety, Inc.

   Alcotest Model 9510

Intoximeters, Inc.

   Photo Electric Intoximeter*
Intoximeter Model—Alcomonitor
Intoximeter Model—EC/IR II (enhanced with serial  number 10,000 or higher)

Lion Laboratories, Ltd.

   Auto-Alcolmeter*

Luckey Laboratories

   Alco-Analyzer Model—1000*
Alco-Analyzer Model—2000*

U.S. Alcohol Testing, Inc./Protection Devices, Inc.,  Rancho Cucamonga, CA

   Alco-Analyzer 1000
Alco-Analyzer 2000

ELI N. AVILA, MD, JD, MPH, FCLM, 
Secretary

[Pa.B. Doc. No. 11-1100. Filed for public inspection July 1, 2011, 9:00 a.m.]