Highway Safety Programs; Conforming Products List of Screening Devices To Measure Alcohol in Bodily Fluids, 66398-66400 [E9-29822]
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66398
Federal Register / Vol. 74, No. 239 / Tuesday, December 15, 2009 / Notices
sroberts on DSKD5P82C1PROD with NOTICES
environmental documentation provided
in support of a categorical exclusion
under the National Environmental
Policy Act (NEPA). By letter dated
March 9, 2009, BGPAA stated its intent
to supplement and resubmit the
application. On May 5, 2009, FAA
received BGPAA’s supplemented
application. On May 29, 2009, FAA
determined BGPAA’s application to be
complete. Pursuant to 14 CFR
161.313(c)(4)(ii), the FAA’s 180-day
review period starts on the date of
receipt of the last supplement to the
application (May 5, 2009).
The FAA may only approve a
restriction that demonstrates, by
substantial evidence, each of the six
statutory conditions have been met. 14
CFR part 161, § 161.305. These six
statutory conditions of approval are:
Condition 1: The restriction is
reasonable, nonarbitrary, and
nondiscriminatory; Condition 2: The
restriction does not create an undue
burden or interstate or foreign
commerce; Condition 3: The proposed
restriction maintains safe and efficient
use of the navigable airspace; Condition
4: The proposed restriction does not
conflict with any existing Federal
statute or regulation; Condition 5: The
applicant has provided adequate
opportunity for public comment on the
proposed restriction; and Condition 6:
The proposed restriction does not create
an undue burden on the national
aviation system. The FAA evaluated
BGPAA’s application under the
provisions of 14 CFR 161.317 and
determined the application satisfies the
requirements under Condition 4 and
Condition 5. However, the application
does not satisfy the requirements under
Condition 1, Condition 2, Condition, 3,
or Condition 6.
This notice also announces the
availability of the FAA’s final agency
order disapproving the airport access
restriction at https://www.faa.gov/
airports/.
Questions may be directed to the
individual named above under the
heading, FOR FURTHER INFORMATION
CONTACT.
Issued in Washington DC on December 4,
2009.
Benito DeLeon,
Director, Office of Airport Planning and
Programming.
[FR Doc. E9–29397 Filed 12–14–09; 8:45 am]
BILLING CODE 4910–13–P
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DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety
Administration
[Docket No. NHTSA–2009–0170]
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: (202) 366–1694.
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).
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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
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Federal Register / Vol. 74, No. 239 / Tuesday, December 15, 2009 / Notices
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
66399
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 ........................
Alco Check International, Hudsonville, Michigan .....................................
Akers Biosciences, Inc., Thorofare, New Jersey .....................................
BAC Solutions, Inc., Birmingham, Michigan ............................................
B.E.S.T. Labs., Boardman, Ohio ..............................................................
Chematics, Inc., North Webster, Indiana .................................................
CMI, Inc., Owensboro, Kentucky ..............................................................
First Innovative Technology Group, Ltd., Hong Kong ..............................
Guth Laboratories, Inc., Harrisburg, Pennsylvania ..................................
Han International Co., Ltd.,2 Seoul, Korea ..............................................
KHN Solutions, LLC, San Francisco, California .......................................
Lion Laboratories, Ltd., Wales, United Kingdom .....................................
OraSure Technologies, Inc., Bethlehem, Pennsylvania ...........................
PAS Systems International, Inc., Fredericksburg, Virginia ......................
Q3 Innovations, Inc., Independence, Iowa ...............................................
Repco Marketing, Inc., Raleigh, North Carolina ......................................
Seju Engineering Co., Taejeon, Korea ....................................................
Sound Off, Inc., Hudsonville, Michigan ....................................................
Varian, Inc., Lake Forest, California .........................................................
•
•
•
•
•
•
•
•
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 3000 D.O.T.7
Alco Check 9000.7
Breath Alcohol ✓ .02 Detection System.8
BACmaster.
PB 9000e.
ALCO–SCREEN 02 TM.9
Intoxilyzer 500 (aka: Alcometer 500—Lion Laboratories).
AAT198—Pro.
• Alco Tector Mark X.
• Mark X Alcohol Checker.
• Alcotector WAT89EC–1.
• Alcotector WAT90.
A.B.I. (Alcohol Breath Indicator) (aka: AlcoHAWK ABI by Q3 Innovations).
BACTRACK Select S50 10
BACTRACK Select S80.10
Alcometer 500 (aka: Intoxilyzer 500—CMI, Inc.).
Q.E.D. A150 Saliva Alcohol Test.
PAS Vr.
• 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.
Alco Tec III.
Safe-Slim.
Digitox D.O.T.7.
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.
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.
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Federal Register / Vol. 74, No. 239 / Tuesday, December 15, 2009 / Notices
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.
[FR Doc. E9–29822 Filed 12–14–09; 8:45 am]
BILLING CODE 4910–59–P
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
Noise Exposure Map Notice for San
Diego International Airport, San Diego,
CA
sroberts on DSKD5P82C1PROD with NOTICES
AGENCY: Federal Aviation
Administration, DOT.
ACTION: Notice.
SUMMARY: The Federal Aviation
Administration (FAA) announces its
determination that the noise exposure
maps submitted by San Diego County
Regional Airport Authority, for San
Diego International Airport under the
provisions of 49 U.S.C. 47501 et. seq
(Aviation Safety and Noise Abatement
Act) and 14 CFR part 150 are in
compliance with applicable
requirements.
DATES: Effective Date: The effective date
of the FAA’s determination on the noise
exposure maps is November 10, 2009.
FOR FURTHER INFORMATION CONTACT:
Victor Globa, Environmental Protection
Specialist, Federal Aviation
Administration, Los Angeles Airports
District Office, Mailing Address: P.O.
Box 92007, Los Angeles, California
90009–2007. Street Address: 15000
Aviation Boulevard, Hawthorne,
California 90261. Telephone: 310/725–
3637.
SUPPLEMENTARY INFORMATION: This
notice announces that the FAA finds
that the noise exposure maps submitted
for San Diego International Airport are
in compliance with applicable
requirements of 14 Code of Federal
Regulations (CFR) part 150 (hereinafter
referred to as ‘‘Part 150’’), effective
November 10, 2009. Under 49 U.S.C.
section 47503 of the Aviation Safety and
Noise Abatement Act (hereinafter
referred to as ‘‘the Act’’), an airport
operator may submit to the FAA noise
exposure maps which meet applicable
regulations and which depict noncompatible land uses as of the date of
submission of such maps, a description
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of projected aircraft operations, and the
ways in which such operations will
affect such maps. The Act requires such
maps to be developed in consultation
with interested and affected parties in
the local community, government
agencies, and persons using the airport.
An airport operator who has submitted
noise exposure maps that are found by
FAA to be in compliance with the
requirements of Part 150, promulgated
pursuant to the Act, may submit a noise
compatibility program for FAA approval
which sets forth the measures the
operator has taken or proposes to take
to reduce existing non-compatible uses
and prevent the introduction of
additional non-compatible uses.
The FAA has completed its review of
the noise exposure maps and
accompanying documentation
submitted by San Diego County
Regional Airport Authority. The
documentation that constitutes the
‘‘Noise Exposure Maps’’ as defined in
section 150.7 of Part 150 includes:
Figure 2, Existing Condition (2009)
Noise Exposure Map; Figure 3, Forecast
Condition (2014) Noise Exposure Map;
Figure 4, Comparison of Existing (2009)
and Forecast (2014) Noise Exposure
Maps; Figure 5, Existing SAN Airport
Layout; Figure 6, Runway 9 Departure
Arrival Tracks, Figure 7, Runway 27
Departure and Arrival Tracks; Figure 8,
Helicopter Departure and Arrival
Tracks; Table 3, Annual CNEL
Measured at the RMT’s; Table 4,
Comparison of Annual CNEL-Measured
and Modeled; Table 5, 2007 Aircraft
Operations; Table 6, Existing (2009)
Modeled Average Daily Aircraft
Operations; Table 7, Forecast (2014)
Modeled Average Daily Aircraft
Operations; Table 8, Runway
Utilization; Table 9, Number of NonResidential Sensitive Receptors within
2009 and 2014 CNEL Contours; Table
10, Listing of Non-Residential Sensitive
Receptors within 2009 and 2014 CNEL
Contours; Table 11, Estimated
Residential Population within 2009 and
2014 CNEL Contours; Table 12, Number
of Single Family Homes Eligible for
Sound Mitigation; Table 13, Number of
Multi-Family Residential Units Eligible
for Mitigation; Table 14, Noise
Technical Advisory Group Members;
Table 15, Noise Technical Advisory
Group Meetings; Table 16, Community
Information Workshops Content. The
FAA has determined that these Noise
Exposure Maps and accompanying
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documentation are in compliance with
applicable requirements. This
determination is effective on November
10, 2009.
FAA’s determination on an airport
operator’s noise exposure maps is
limited to a finding that the maps were
developed in accordance with the
procedures contained in Appendix A of
Part 150. Such determination does not
constitute approval of the applicant’s
data, information or plans, or a
commitment to approve a noise
compatibility program or to fund the
implementation of that program. If
questions arise concerning the precise
relationship of specific properties to
noise exposure contours depicted on a
noise exposure map submitted under
section 47503 of the Act, it should be
noted that the FAA is not involved in
any way in determining the relative
locations of specific properties with
regard to the depicted noise contours, or
in interpreting the noise exposure maps
to resolve questions concerning, for
example, which properties should be
covered by the provisions of section
47506 of the Act. These functions are
inseparable from the ultimate land use
control and planning responsibilities of
local government. These local
responsibilities are not changed in any
way under Part 150 or through FAA’s
review of noise exposure maps.
Therefore, the responsibility for the
detailed overlaying of noise exposure
contours onto the map depicting
properties on the surface rests
exclusively with the airport operator
that submitted those maps, or with
those public agencies and planning
agencies with which consultation is
required under section 47503 of the Act.
The FAA has relied on the certification
by the airport operator, under section
150.21 of Part 150, that the statutorily
required consultation has been
accomplished.
Copies of the full noise exposure map
documentation and of the FAA’s
evaluation of the maps are available for
examination at the following locations:
Federal Aviation Administration,
Western-Pacific Region Office,
Airports Division, Room 3012, 15000
Aviation Boulevard, Hawthorne,
California 90261.
Federal Aviation Administration, Los
Angeles Airports District Office,
Room 3000, 15000 Aviation
Boulevard, Hawthorne, California
90261.
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]]>Agencies
[Federal Register Volume 74, Number 239 (Tuesday, December 15, 2009)]
[Notices]
[Pages 66398-66400]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-29822]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety Administration
[Docket No. NHTSA-2009-0170]
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: (202) 366-1694.
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
[[Page 66399]]
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 AlcoScan AL-2500.
Park, New Jersey.\1\.
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, Alco Check 3000 D.O.T.\7\
Michigan.
Alco Check 9000.\7\
Akers Biosciences, Inc., Thorofare, New Breath Alcohol [check] .02
Jersey. Detection System.\8\
BAC Solutions, Inc., Birmingham, BACmaster.
Michigan.
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, AAT198--Pro.
Ltd., Hong Kong.
Guth Laboratories, Inc., Harrisburg, Alco Tector Mark X.
Pennsylvania.
Mark X Alcohol
Checker.
Alcotector WAT89EC-1.
Alcotector WAT90.
Han International Co., Ltd.,\2\ Seoul, A.B.I. (Alcohol Breath
Korea. Indicator) (aka: AlcoHAWK ABI
by Q3 Innovations).
KHN Solutions, LLC, San Francisco, BACTRACK Select S50 \10\
California. BACTRACK Select S80.\10\
Lion Laboratories, Ltd., Wales, United Alcometer 500 (aka: Intoxilyzer
Kingdom. 500--CMI, Inc.).
OraSure Technologies, Inc., Bethlehem, Q.E.D. A150 Saliva Alcohol
Pennsylvania. Test.
PAS Systems International, Inc., PAS Vr.
Fredericksburg, Virginia.
Q3 Innovations, Inc., Independence, AlcoHAWK Precision.
Iowa.
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 Alco Tec III.
Carolina.
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\
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\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 [check] .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 [deg]C (104 [deg]F), the manufacturer
has indicated that the device cannot exceed storage temperatures of 27
[deg]C (80 [deg]F). Instructions to this effect are stated on all
packaging accompanying the device. Accordingly, the device should not
be stored at temperatures above 27 [deg]C (80 [deg]F). If the device
is stored at or below 27 [deg]C (80 [deg]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 [deg]C (80 [deg]F) and equilibrated at
40 [deg]C (104 [deg]F) for an hour prior to sample application, the
device fails to meet the Model Specifications. Storage at temperatures
above 27 [deg]C (80 [deg]F), for even brief periods of time, may
result in false negative readings.
\10\ Manufactured by DA Tech Co., Ltd., Korea.
[[Page 66400]]
\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 [deg]C (86 [deg]F);
readings should be taken after two (2) minutes at 18 [deg]C-29 [deg]C
(64.4 [deg]-84.2 [deg]F); and readings should be taken after five (5)
minutes when testing at temperatures at or below 17 [deg]C (62.6
[deg]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.
[FR Doc. E9-29822 Filed 12-14-09; 8:45 am]
BILLING CODE 4910-59-P
