DEPARTMENT OF HEALTH
Approved Prearrest and Evidential Breath Testing Devices
[46 Pa.B. 4266]
[Saturday, July 30, 2016]
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 approved lists of prearrest breath testing devices and evidential breath testing devices.
Prearrest 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 contained 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 prohibited 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 to measure alcohol content. The 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.
The NHTSA published its first Conforming Products List (CPL) for screening devices at 59 FR 61923 (December 2, 1994), with corrections at 59 FR 65128 (December 16, 1994), identifying the devices that meet the NHTSA's Model Specifications for Screening Devices to Measure Alcohol in Bodily Fluids. Thereafter, the NHTSA updated the CPL at 60 FR 42214 (August 15, 1995), 66 FR 22639 (May 4, 2001), 70 FR 54972 (September 19, 2005), with corrections at 70 FR 72502 (December 5, 2005) and 72 FR 4559 (January 31, 2007).
The NHTSA published revised Model Specifications for Screening Devices to Measure Alcohol in Bodily Fluids at 73 FR 16956 (March 31, 2008). These specifications removed from use interpretive screening devices (ISD) 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. The NHTSA published an additional update to the CPL at 74 FR 66398 (December 15, 2009). The current list was published at 77 FR 35745 (June 14, 2012).
On January 9, 2014, the NHTSA indicated that it had approved the ALERT J5 from Countermeasure Systems Corp. as a breath screening device. The Department received confirmation of this addition on July 10, 2015.
Evidential Breath Testing Devices
The Department approves evidential breath testing devices under the authority of the Vehicle Code (75 Pa.C.S. § 1547(c)(1)), the Fish and Boat Code (30 Pa.C.S. § 5125(c)(1)) and the Game and Wildlife Code (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.
The NHTSA published the Standards for Devices to Measure Breath Alcohol at 38 FR 30459 (November 5, 1973). A Qualified Products List of Evidential Breath Measurement Devices comprised of instruments that met this standard was first issued at 39 FR 41399 (November 21, 1974).
The NHTSA converted the Standards for Devices to Measure Breath Alcohol to Model Specifications for Evidential Breath Testing Devices (Model Specifications) and published a CPL of instruments that were found to conform to the Model Specifications as Appendix D to that notice at 49 FR 48854 (December 14, 1984). Those instruments are identified in this notice with an asterisk.
The NHTSA published a notice to amend the Model Specifications at 58 FR 48705 (September 17, 1993) and to update the CPL. That notice changed the alcohol concentration levels at which instruments are evaluated for precision and accuracy, from 0.000, 0.050, 0.101 and 0.151 blood alcohol content (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, for example, 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, the NHTSA has periodically updated the CPL with those breath instruments found to conform to the Model Specifications.
The Department's list of evidential breath testing devices contains updates to the CPL published at 77 FR 35747 (June 14, 2012) for instruments that conform to the Model Specifications for Evidential Breath Alcohol Measurement Devices at 58 FR 48705 (September 17, 1993).
The 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 (that is, mobile equipment). Most equipment on the following list is approved for mobile and nonmobile operation. The instruments on the list not marked with an asterisk meet the specifications for use as prearrest or evidentiary breath testing devices. The instruments on the list marked with an asterisk may be used as evidentiary devices for 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 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. Law enforcement agencies that plan to utilize a device that does not appear on the following list should contact the manufacturer of the equipment to verify that it has been evaluated by the NHTSA and found to meet the NHTSA's performance requirements. If a device is approved by the NHTSA after the date of this publication, the manufacturer of the device will need to forward documentation of the NHTSA acceptability to Dr. James R. Lute at the address given as follows 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 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 of 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.
Questions regarding this list should be directed to Dr. James R. Lute, Assistant Bureau Director, Department of Health, Bureau of Laboratories, P.O. Box 500, Exton, PA 19341-0500, (610) 280-3464.
Persons with a disability who require an alternative format of this notice (for example, large print, audiotape, Braille) may contact Dr. James R. Lute at the previously referenced address or phone number. Persons who are speech or hearing impaired may use V/TT (717) 783-6514 or the Pennsylvania AT&T Relay Service at (800) 654-5984 (TT).
CONFORMING PRODUCTS LIST OF ALCOHOL SCREENING DEVICES
Distributors/Manufacturers Devices AK Solutions, USA, LLC., Palisades Park, New Jersey1 • AlcoScan AL-2500.
• 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).45
• AlcoMate Prestige AL-6000, with replaceable Prestige Sensor Modules (SM-6000).46
• 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 02TM9. 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.
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.
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).
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 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 Q3 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. The 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 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 (that is, 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 1 minute after a sample is introduced at or above 30°C (86°F); readings should be taken after 2 minutes at 18°C—29°C (64.4°F—84.2°F); and readings should be taken after 5 minutes when testing at temperatures at or below 17°C (62.6°F). If the reading is taken before 5 minutes has elapsed under the cold conditions, the user is likely to obtain a reading that underestimates the actual saliva-alcohol level.
CONFORMING PRODUCTS LIST OF EVIDENTIAL BREATH MEASUREMENT DEVICES
Manufacturer/Distributor and Model Mobile Nonmobile 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 — 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 PAC 1200* X X S-D2 X X S-D5 (aka: Lion Alcolmeter SD-5 outside the U.S.) X X Draeger Safety, Inc. (aka: National Draeger) Irving, Texas: Alcotest Model: 5510 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 by Honeywell GmbH, Fond du Lac, Wisconsin: AlcoQuant 6020 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: Photo Electric Intoximeter* — X GC Intoximeter MK II* X X GC Intoximeter MK IV* X X Auto Intoximeter* X 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 EC/IR X X Intox EC/IR II X X Intox EC/IR II (Enhanced with serial number 10,000 or higher) 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 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: LifeGuard Pro X X Phoenix X X Phoenix 6.0 X X EV 30 X X FC 10 X X FC 20 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 — 600 (aka: Intoxilyzer 600 in the U.S.) X X SD-2* X X SD-5 (aka: S-D5 in the U.S.) X X EBA* 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., Mansfield, Ohio: 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 X X DataMaster DMT w/Fuel Cell option SN: 555555 X X DataMaster DMT w/Fuel Cell option SN: 100630 X X Omicron Systems, Palo Alto, California: Intoxilyzer Model: 4011* X X 4011AW* X X PAS International, Fredericksburg, Virginia: Mark V Alcovisor X X Alcovisor Jupiter X X Alcovisor Mercury 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 (U.S.) 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) (that is, 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.
KAREN M. MURPHY, PhD, RN,
[Pa.B. Doc. No. 16-1319. Filed for public inspection July 29, 2016, 9:00 a.m.]
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