[Federal Register Volume 79, Number 130 (Tuesday, July 8, 2014)]
[Rules and Regulations]
[Pages 38457-38459]
[FR Doc No: 2014-15876]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA-2014-M-0850]

Medical Devices; Neurological Devices; Classification of the
Transcranial Magnetic Stimulator for Headache

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the
transcranial magnetic stimulator for headache into class II (special
controls). The special controls that will apply to the device are
identified in this order, and will be part of the codified language for
the transcranial magnetic stimulator for headache classification. The
Agency is classifying the device into class II (special controls) in
order to provide a reasonable assurance of safety and effectiveness of
the device.

DATES: This order is effective August 7, 2014. The classification was
applicable on December 13, 2013.

FOR FURTHER INFORMATION CONTACT: Michael Hoffmann, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1434, Silver Spring, MD 20993-0002, 301-
796-6476<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval, unless and until the
device is classified or reclassified into class I or II, or FDA issues
an order finding the device to be substantially equivalent, in
accordance with section 513(i) of the FD&C Act, to a predicate device
that does not require premarket approval. The Agency determines whether
new devices are substantially equivalent to predicate devices by means
of premarket notification procedures in section 510(k) of the FD&C Act
(21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144), provides two procedures by which a person may request FDA to
classify a device under the criteria set forth in section 513(a)(1).
Under the first procedure, the person submits a premarket notification
under section 510(k) of the FD&C Act for a device that has not
previously been classified and, within 30 days of receiving an order
classifying the device into class III under section 513(f)(1) of the
FD&C Act, the person requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a premarket
notification under section 510(k) and then a request for classification
under the first procedure, the person determines that there is no
legally marketed device upon which to base a determination of
substantial equivalence and requests a classification under section
513(f)(2) of the FD&C Act. If the person submits a request to classify
the device under this second procedure, FDA may decline to undertake
the classification request if FDA identifies a legally marketed device
that could provide a reasonable basis for review of substantial
equivalence with the device or if FDA determines that the device
submitted is not of ``low-moderate risk'' or that general controls
would be inadequate to control the risks and special controls to
mitigate the risks cannot be developed.
    In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA will
classify the device by written order within 120 days. This
classification will be the initial classification of the device.
    On March 1, 2013, Neuralieve (now eNeura Therapeutics LLC),
submitted a request for classification of the NEURALIEVE CERENA
Transcranial Magnetic Stimulator under section 513(f)(2) of the FD&C
Act. The manufacturer recommended that the device be classified into
class II (Ref. 1).
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the request in order to classify the device under the criteria for
classification set forth in section 513(a)(1). FDA classifies devices
into class II if general controls by themselves are insufficient to
provide reasonable assurance of safety and effectiveness, but there is
sufficient information to establish special controls to provide
reasonable assurance of the safety and effectiveness of the device for
its intended use. After review of the information submitted in the de
novo request, FDA determined that the device can be classified into
class II with the establishment of special controls. FDA believes these
special controls, in addition to general controls, will provide
reasonable assurance of the safety and effectiveness of the device.
    Therefore, on December 13, 2013, FDA issued an order to the
requester classifying the device into class II. FDA is codifying the
classification of the device by adding Sec.  882.5808.
    Following the effective date of this final classification
administrative order, any firm submitting a premarket notification
(510(k)) for a transcranial magnetic stimulator for headache will need
to comply with the special controls named in the final administrative
order.
    The device is assigned the generic name transcranial magnetic
stimulator for headache, and it is identified as a device that delivers
brief duration, rapidly alternating, or pulsed, magnetic fields that
are externally directed at spatially discrete regions of the brain to
induce electrical currents for the treatment of headache.
    FDA has identified the following risks to health associated with
this type of device and the measures required to mitigate these risks
in table 1:

    Table 1--Transcranial Magnetic Stimulator for Headache Risks and
                           Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Failure to identify correct population.  Clinical testing.
                                         Labeling.
Ineffective treatment..................  Clinical testing.
                                         Non-clinical testing.
                                         Software verification,
                                          validation, and hazard
                                          analysis.
                                         Labeling.

Risk of seizure........................  Clinical testing.
                                         Non-clinical testing.
                                         Labeling.
Scalp discomfort, scalp burn,            Clinical testing.
 dizziness, nausea, or other adverse     Non-clinical testing.
 effects.                                Thermal safety.
                                         Software verification,
                                          validation, and hazard
                                          analysis.
                                         Labeling.
Adverse tissue reaction................  Biocompatibility.
                                         Labeling.
Electrical shock, burn.................  Electrical equipment safety.
                                         Thermal safety.
                                         Labeling.
Interference with other electrical       Electromagnetic compatibility.
 equipment.                              Labeling.
Noise irritation and hearing loss......  Non-clinical testing.
                                         Labeling.
------------------------------------------------------------------------

    FDA believes that the following special controls, in addition to
the general controls, address these risks to health and provide
reasonable assurance of safety and effectiveness:
     Appropriate analysis/testing must demonstrate
electromagnetic compatibility, electrical safety, and thermal safety.
     Appropriate verification, validation, and hazard analysis
must be performed on the device software and firmware.
     The elements of the device that contact the patient must
be assessed to be biocompatible.
     Non-clinical testing data must demonstrate that the device
performs as intended under anticipated conditions of use. This includes
full characterization of the magnetic pulse output and resulting
magnetic field map. This also includes characterization of the sound
level of the device during use.
     Clinical testing must demonstrate that the device is safe
and effective for treating headache in the indicated patient
population.
     The physician and patient labeling must include the
following:
    [cir] A summary of the clinical performance testing, including any
adverse events and complications;
    [cir] The intended use population in terms of the types of
headaches appropriate for use with the device;
    [cir] Information on how to report adverse events and device
malfunctions; and
    [cir] A diagram or picture depicting the proper placement of the
device on the user.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) if FDA determines that premarket notification is not necessary
to provide reasonable assurance of the safety and effectiveness of the
device. For this type of device, FDA has determined that premarket
notification is necessary to provide reasonable assurance of the safety
and effectiveness of the device. Therefore, this device type is not
exempt from premarket notification requirements. Persons who intend to
market this type of device must submit to FDA a premarket notification
prior to marketing the device, which contains information about the
transcranial magnetic stimulator for headache they intend to market.

II. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

III. Paperwork Reduction Act of 1995

    This final administrative order establishes special controls that
refer to previously approved collections of information found in other
FDA regulations. These collections of information are subject to review
by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of
information in part 807, subpart E, regarding premarket notification
submissions have been approved under OMB control number 0910-0120, and
the collections of information in 21 CFR part 801, regarding labeling,
have been approved under OMB control number 0910-0485.

IV. Reference

    The following reference has been placed on display in the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and is available electronically at http://www.regulations.gov.

1. K130556 De Novo Petition for the NEURALIEVE CERENA Transcranial
Magnetic Stimulator From Neuralieve, dated March 1, 2013.

List of Subjects in 21 CFR Part 882

    Medical devices, Neurological devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
882 is amended as follows:

PART 882--NEUROLOGICAL DEVICES

0
1. The authority citation for 21 CFR part 882 continues to read as
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Add Sec.  882.5808 to subpart F to read as follows:

Sec.  882.5808  Transcranial magnetic stimulator for headache.

    (a) Identification. A transcranial magnetic stimulator device for
headache is a device that delivers brief duration, rapidly alternating,
or pulsed, magnetic fields that are externally directed at spatially
discrete regions of the brain to induce electrical currents for the
treatment of headache.

    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Appropriate analysis/testing must demonstrate electromagnetic
compatibility, electrical safety, and thermal safety.
    (2) Appropriate verification, validation, and hazard analysis must
be performed on the device software and firmware.
    (3) The elements of the device that contact the patient must be
assessed to be biocompatible.
    (4) Non-clinical testing data must demonstrate that the device
performs as intended under anticipated conditions of use. This includes
full characterization of the magnetic pulse output and resulting
magnetic field map. This also includes characterization of the sound
level of the device during use.
    (5) Clinical testing must demonstrate that the device is safe and
effective for treating headache in the indicated patient population.
    (6) The physician and patient labeling must include the following:
    (i) A summary of the clinical performance testing, including any
adverse events and complications.
    (ii) The intended use population in terms of the types of headaches
appropriate for use with the device.
    (iii) Information on how to report adverse events and device
malfunctions.
    (iv) A diagram or picture depicting the proper placement of the
device on the user.

    Dated: July 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-15876 Filed 7-7-14; 8:45 am]
BILLING CODE 4164-01-P


O2 Reference 1 EPA Acid Rain Files Napolitano, 2003 Acid Rain Division Data  PEMS Petition Acceptance for Mead Coated Board January 28, 2003 2 Open Literature Euhus, 1999, www. pacsim. com/ Articles/ NOx_ PEMS/ NOx_ PEMS. doc 3 Open Literature Macak 1996 The Pros and Cons of Predictive, Parametric, and Alternative Emissions Monitirng Systems for Regulatory Compliance, PNWIS/ A& WMA 40th Annual Conference November 8 10, 2000 Victoria, British Columbia 4 EPA Acid Rain Files Shakenback 2003 PEMS RATA Spread Sheets 5 EPA Acid Rain Files Golden Specialty Consulting Letter to Air LiquideMay 30, 2001 6 EPA Acid Rain Files Golden Specialty Consulting Letter to Air Liquide March 21, 2001 7 EPA Acid Rain Files Golden Specialty Consulting Letter to Air Liquide June 23, 2001 8 EPA Acid Rain Files Golden Specialty Consulting Letter to Air Liquide May 30, 2001 9 EPA Acid Rain Files Golden Specialty Consulting Letter to Air Liquide June 13, 2001 10 EPA Acid Rain Files White Star RATA Sept 26, 1999 GT# 1 11 EPA Acid Rain Files White Star RATA Oct 2 3, 1999 GT# 2 12 EPA Acid Rain Files White Star RATA Sept 28, 1999 GT# 1 13 EPA Acid Rain Files TASC Environmental Services November 22,2000 THW 33 14 EPA Acid Rain Files TASC Environmental Services November 21, 2000 THW 34 15 EPA Acid Rain Files TASC Environmental Services November 21, 2000 THW 43 16 EPA Acid Rain Files RMB Consulting & Research Inc Oct 30, 1997 THW 31 17 EPA Acid Rain Files Radian International LLC Nov. 11, 1977 18 EPA Acid Rain Files Griffin Letters( 2) to Haight, TASC Environmental Services Acid Rain Files 19 EPA Acid Rain Files Douglas Neeley to Angie Eastman  WestPoint Stevens Clemson Report from Air Techniques Inc. Boiler # 1 20 EPA Acid Rain Files Douglas Neeley to Angie Eastman  WestPoint Stevens Clemson Report from Air Techniques Inc. Boiler # 2 21 EPA Acid Rain Files Smith letter to Mobley Degussa 8/ 30/ 2000 Boiler # 3 22 EPA Acid Rain Files Moore ( BP) letter to Region IV March 6, 2001+ Shakenback 2003 spreadsheet 23 EPA Acid Rain Files Moore ( BP) letter to Region IV March 6, 2001+ Shakenback 2003 24 EPA Acid Rain Files TASC Env Services Oct 21, 1999 GT 30 25 EPA Acid Rain Files TASC Env Services Oct 28, 1999 GT 32 26 EPA Acid Rain Files TASC Env Services Oct 22, 1999 GT 33 27 EPA Acid Rain Files TASC Env Services Oct 28, 1999 GT 45 28 EPA Acid Rain Files TASC Env Services Sept 28, 1999 GT 62 29 EPA Acid Rain Files TASC Env Services Oct 8, 1999 GT 63 30 EPA Acid Rain Files TASC Env Services Oct 21, 1999 GT 66 31 EPA Acid Rain Files TASC Env Services Oct 15, 1999 GT 67 32 EPA Acid Rain Files Napolitano, August 2003 Acid Rain Division Data  PEMS Petition Acceptance 33 Pavilion Files TASC Environmental Services November 19 21, 2000 34 Pavilion Files TASC Environmental Services July 28 29, 1999 35 Pavilion Files TASC Environmental Services April 24, 2001 36 Pavilion Files TASC Environmental Services April 26, 2001 37 Pavilion Files TASC Environmental Services July 14 16, 1999 38 Pavilion Files TASC Environmental Services May 2, 2001 39 Pavilion Files TASC Environmental Services August 18 20, 1999 40 Pavilion Files TASC Environmental Services December 16 18, 1998 41 Pavilion Files TASC Environmental Services July 22 24, 1999 42 Pavilion Files TASC Environmental Services March 23, 24, & 29, 1999 43 Pavilion Files TASC Environmental Services September 1 3, 1999 & October 21, 1999 44 Pavilion Files TASC Environmental Services March 8 10, 1999 45 Pavilion Files TASC Environmental Services September 16, 17, & 20, 1999 46 Pavilion Files TASC Environmental Services September 8, 9, & 13, 1999 47 Pavilion Files TASC Environmental Services February 21, 2001 48 Pavilion Files TASC Environmental Services February 16, 2001 49 Pavilion Files TASC Environmental Services January 20 22, 1999 50 Pavilion Files TASC Environmental Services September 23, 24, & 27, 1999 51 Pavilion Files TASC Environmental Services February 9, 2001 52 Pavilion Files TASC Environmental Services March 3 5, 1999 53 Pavilion Files TASC Environmental Services March 6, 2000 54 Pavilion Files TASC Environmental Services August 11 14, 1999 55 Pavilion Files TASC Environmental Services February 27, 2001 56 Pavilion Files TASC Environmental Services November 8 10, 1999 57 Pavilion Files TASC Environmental Services March 16, 2000 58 Pavilion Files TASC Environmental Services April 7 9, 1999 59 Pavilion Files Golden Specialty Consulting February 13, 2001 60 Pavilion Files Golden Specialty Consulting February 17, 2001 61 Pavilion Files Golden Specialty Consulting March 3, 2001 62 Pavilion Files Golden Specialty Consulting February 9, 2001 63 Pavilion Files Golden Specialty Consulting February 8, 2001 64 Pavilion Files Golden Specialty Consulting March 26, 2001 65 Pavilion Files Golden Specialty Consulting March 30, 2001 66 Pavilion Files Golden Specialty Consulting April 7, 2001 67 Pavilion Files Golden Specialty Consulting March 8, 2001 68 Pavilion Files Golden Specialty Consulting March 4, 2001 69 Pavilion Files TASC Environmental Services January 25 26, 2000 ( Revised August 3, 2000)

70 Pavilion Files Golden Specialty Consulting April 3, 2003 71 Pavilion Files Golden Specialty Consulting April 7, 2003 72 Pavilion Files Golden Specialty Consulting April 1, 2003 73 Pavilion Files Golden Specialty Consulting May 1, 2003 74 Pavilion Files Golden Specialty Consulting April 29, 2003 75 Pavilion Files Golden Specialty Consulting April 30, 2003 76 Pavilion Files Golden Specialty Consulting May 2, 2003 77 Pavilion Files Golden Specialty Consulting July 1, 2003 78 Pavilion Files Golden Specialty Consulting June 19, 2003 79 Pavilion Files Golden Specialty Consulting June 13, 2003 80 Pavilion Files Golden Specialty Consulting June 24, 2003 81 Pavilion Files Golden Specialty Consulting June 20, 2003 82 Pavilion Files Golden Specialty Consulting July 30, 2003 83 Pavilion Files Golden Specialty Consulting January 20, 2003 84 Pavilion Files Golden Specialty Consulting January 16, 2003 85 Pavilion Files Golden Specialty Consulting January 14, 2003 86 Pavilion Files Golden Specialty Consulting February 12, 2003 87 Pavilion Files Golden Specialty Consulting February 11, 2003 88 Pavilion Files Golden Specialty Consulting February 6, 2003 89 Pavilion Files Golden Specialty Consulting February 10, 2003 90 Pavilion Files Golden Specialty Consulting April 18, 2003 91 Pavilion Files Golden Specialty Consulting March 31, 2003 92 Pavilion Files Golden Specialty Consulting March 27, 2003 93 Pavilion Files Golden Specialty Consulting March 25, 2003 94 Pavilion Files Golden Specialty Consulting March 24, 2003 95 Pavilion Files Golden Specialty Consulting February 26, 2003 96 Pavilion Files Golden Specialty Consulting February 28, 2003 97 Pavilion Files Golden Specialty Consulting February 14, 2003 98 Pavilion Files Golden Specialty Consulting May 7, 2003 99 Pavilion Files Golden Specialty Consulting May 5, 2003 100 Pavilion Files Golden Specialty Consulting May 9, 2003 101 Pavilion Files TASC Environmental Services April 11, 2002 102 Pavilion Files Golden Specialty Consulting November 27, 2003 103 Pavilion Files Golden Specialty Consulting April 15, 2003 104 Pavilion Files TASC Environmental Services April 25, 2002 105 Pavilion Files TASC Environmental Services December, 1998 106 Pavilion Files TASC Environmental Services February 1, 2000 107 Pavilion Files TASC Environmental Services February 14, 2000 108 Pavilion Files TASC Environmental Services February 7, 2000 109 Pavilion Files TASC Environmental Services November 1998 110 Pavilion Files TASC Environmental Services April 11, 2002 111 Pavilion Files TASC Environmental Services March 8, 2002 112 Pavilion Files TASC Environmental Services April 19, 2002 113 Pavilion Files TASC Environmental Services February 17, 2000 114 Pavilion Files TASC Environmental Services April 12, 2000 115 Pavilion Files TASC Environmental Services April 27, 2000 116 Pavilion Files TASC Environmental Services April 18, 2000 117 Pavilion Files TASC Environmental Services March 1999 118 Pavilion Files TASC Environmental Services October 1998 119 Pavilion Files TASC Environmental Services March 22 26, 2002 120 Pavilion Files TASC Environmental Services April 22, 2002 121 Pavilion Files TASC Environmental Services April 24, 2002 122 Pavilion Files TASC Environmental Services February 15, 2000 123 Pavilion Files TASC Environmental Services February 23, 2000 124 Pavilion Files TASC Environmental Services February 28 & 29  March 1, 2000 125 Pavilion Files TASC Environmental Services April 3, 2002 126 Pavilion Files TASC Environmental Services January 1999 127 Pavilion Files Golden Specialty Consulting March 28, 2002 128 Pavilion Files Golden Specialty Consulting March 29, 2002 129 Pavilion Files Golden Specialty Consulting April 4, 2002 130 Pavilion Files Golden Specialty Consulting April 8, 2002 131 Pavilion Files Golden Specialty Consulting April 10, 2002 132 Pavilion Files TASC Environmental Services March 2, 2000 133 Pavilion Files TASC Environmental Services March 3, 2000 134 Pavilion Files TASC Environmental Services February 9, 11, & 13, 2000 135 Pavilion Files Golden Specialty Consulting February 20, 2003 136 Pavilion Files Golden Specialty Consulting March 15, 2002 137 Pavilion Files Golden Specialty Consulting March 28, 2001 138 Pavilion Files Golden Specialty Consulting July 22, 2000 139 Pavilion Files Golden Specialty Consulting February 24, 2003 140 Pavilion Files Golden Specialty Consulting March 20, 2002 141 Pavilion Files Golden Specialty Consulting August 10, 2002 142 Pavilion Files Golden Specialty Consulting March 11, 2001 143 Pavilion Files Golden Specialty Consulting June 30, 2001 144 Pavilion Files Golden Specialty Consulting October 2, 2001 145 Pavilion Files Golden Specialty Consulting March 11, 2002 146 Pavilion Files Golden Specialty Consulting August 25, 2000 147 Pavilion Files Golden Specialty Consulting March 26, 2003 148 Pavilion Files Golden Specialty Consulting May 10, 2002 149 Pavilion Files Golden Specialty Consulting May 30, 2001 150 Pavilion Files Golden Specialty Consulting November 10, 2000 151 Pavilion Files Golden Specialty Consulting October 1, 2001 152 Pavilion Files Golden Specialty Consulting June 23, 2001 153 Pavilion Files Golden Specialty Consulting March 21, 2001 ( Revised April 7, 2001)

154 Pavilion Files Golden Specialty Consulting February 18, 2003 155 Pavilion Files Golden Specialty Consulting April 10, 2000 156 Pavilion Files Golden Specialty Consulting May 7, 2002 157 Pavilion Files Golden Specialty Consulting December 3, 2000 158 Pavilion Files Golden Specialty Consulting May 28, 2003 159 Pavilion Files Golden Specialty Consulting May 13, 2002 160 Pavilion Files Golden Specialty Consulting June 13, 2001 161 Pavilion Files Golden Specialty Consulting October 22, 2000 162 Pavilion Files Golden Specialty Consulting February 19, 2001 163 Pavilion Files Golden Specialty Consulting February 8, 2002 164 Pavilion Files Golden Specialty Consulting March 4, 2003 165 Pavilion Files Golden Specialty Consulting August 15, 2002 166 Pavilion Files Golden Specialty Consulting August 17, 2001 167 Pavilion Files Golden Specialty Consulting April 10, 2003 168 Pavilion Files Golden Specialty Consulting April 23, 2002 169 Pavilion Files Golden Specialty Consulting April 20, 2001 170 Pavilion Files Golden Specialty Consulting April 16, 2003 171 Pavilion Files Golden Specialty Consulting April 9, 2003 172 Pavilion Files Golden Specialty Consulting April 11, 2001 173 Pavilion Files Golden Specialty Consulting February 18, 2001 174 Pavilion Files Golden Specialty Consulting February 12, 2002 175 Pavilion Files Golden Specialty Consulting March 7, 2003 176 Pavilion Files Golden Specialty Consulting March 27, 2002 177 Pavilion Files Golden Specialty Consulting February 28, 2001 178 Pavilion Files Golden Specialty Consulting March 5, 2003 Source Type PEMS System/

Model Manufacturer Condition or Capacity O2 RATA Results % Units O2 F Test F l a g O2 R2 Corr. F l a g Bias Adj.

Factor PEMS Input Factors Number of Tests/ Number of Continuous Operating Hours Ref.

HAB Fired Boiler 8301 Decatur, AL Pavilion Technologies Software CEM 83% of Capacity 3.412 ppm 9 RATA Tests* 22 Natural Gas

Fired Boiler 8301 Decatur, AL Pavilion Technologies Software CEM 9.927 ppm 22 Average 4.73 ppm 1 5 30 day compliance test 18 19.9% Capacity 0.37 ppm 18 61.6% Capacity 3.13 ppm 18 90.5% Capacity 10.69 ppm 18 Gas Fired Package Boiler Callidus Technologies Inc.

Using Pavilion Technologies Average 9.79 ppm 0.992 P 1 7 30 day compliance test 21 Gas Turbine Texas Average 0.19 ppm 9 RATA Tests* 5 Gas Turbine Texas Average 0.53 ppm 0.0043 P 0.996 P 9 RATA Tests* 6 Gas Turbine Texas Average 0.89 ppm 0.0028 P 0.977 P 9 RATA Tests* 7 Gas Turbine Texas Average 0.21 ppm 9 RATA Tests* 8 Gas Turbine Texas Average 0.14 ppm 9 RATA Tests* 9 Gas Turbine Texas Average 1.06 ppm 0.008 P 0.906 P 1 9 RATA Tests* 24 Gas Turbine Texas Average 1.34 ppm 0.014 P 0.94 P 1 9 RATA Tests* 25 Gas Turbine Texas Average 1.16 ppm 0.008 P 0.94 P 1 9 RATA Tests* 26 Natural Gas Fired Package Boiler Henderson, KY Pavilion Technologies Software CEM Table 2. O2 PEMS RATA Summary 6 of 29 Source Type PEMS System/

Model Manufacturer Condition or Capacity O2 RATA Results % Units O2 F Test F l a g O2 R2 Corr. F l a g Bias Adj.

Factor PEMS Input Factors Number of Tests/ Number of Continuous Operating Hours Ref.

Gas Turbine Texas Average 1.21 ppm 0.014 P 0.84 P 1 9 RATA Tests* 27 Gas Turbine Texas Average 0.86 ppm 0.029 P 0.970 P 1 9 RATA Tests* 28 Gas Turbine Texas Average 0.23 ppm 0.001 P 0.883 P 1 9 RATA Tests* 29 Gas Turbine Texas Average 1.43 ppm 0.014 P 0.972 P 1 9 RATA Tests* 30 Gas Turbine Texas Average 0.78 ppm 0.065 P 0.967 P 1 9 RATA Tests* 31 Gas Turbine Houston Texas Average 0.42 ppm 9 RATA Tests*

Assumed 13 Gas Turbine Houston Texas Average 1.512 ppm 9 RATA Tests*

Assumed 14 Gas Turbine Houston Texas Average 0.72 ppm Check Graphs 9 RATA Tests*

Assumed 15 668.2 MMBTU Boiler Pavilion Technologies 11% Combustion Airflow 11 ppm 0.018 P 0.944 P 5 9 RATA Tests* 33 668.2 MMBTU Boiler Pavilion Technologies 31% Combustion Airflow 19.8 ppm 0.004 P 0.944 P 5 9 RATA Tests* 33 668.2 MMBTU Boiler Pavilion Technologies 88% Combustion Airflow 0.35 ppm 0.212 P 0.944 P 5 9 RATA Tests* 33 217 MMBTU ( Max) Furnace Pavilion Technologies 155 MMBTU Heat Input 4.719 ppm 0.005 P 0.988 P 4 9 RATA Tests* 34 217 MMBTU ( Max) Furnace Pavilion Technologies 175 MMBTU Heat Input 0.099 ppm 0.003 P 0.988 P 4 9 RATA Tests* 34 217 MMBTU ( Max) Furnace Pavilion Technologies 135 MMBTU Heat Input 2.672 ppm 0.027 P 0.988 P 4 9 RATA Tests* 34 217 MMBTU ( Max) Furnace Pavilion Technologies 162 MMBTU Heat Input 2.767 ppm 9 RATA Tests*

Ongoing RATA Tests Only 35 217 MMBTU ( Max) Furnace Pavilion Technologies 148 MMBTU Heat Input 3.514 ppm 9 RATA Tests*

Ongoing RATA Tests Only 36 7 of 29 Source Type PEMS System/

Model Manufacturer Condition or Capacity O2 RATA Results % Units O2 F Test F l a g O2 R2 Corr. F l a g Bias Adj.

Factor PEMS Input Factors Number of Tests/ Number of Continuous Operating Hours Ref.

217 MMBTU ( Max) Cracking Furnace Pavilion Technologies 6400 lb/ hr fuel gas to burners 6.168 ppm 0.001 P 0.983 P 4 9 RATA Tests* 37 217 MMBTU ( Max) Cracking Furnace Pavilion Technologies 5600 lb/ hr fuel gas to burners 4.631 ppm 0.003 P 0.983 P 4 9 RATA Tests* 37 217 MMBTU ( Max) Cracking Furnace Pavilion Technologies 7000 lb/ hr fuel gas to burners 9.807 ppm 0.034 P 0.983 P 4 9 RATA Tests* 37 217 MMBTU ( Max) Furnace Pavilion Technologies 142 MMBTU Heat Input 2.593 ppm 9 RATA Tests*

Ongoing RATA Tests Only 38 Cracking Furnace Pavilion Technologies 158 MMBTU Heat Input 3.917 ppm 0.003 P 0.858 P 4 9 RATA Tests* 39 Cracking Furnace Pavilion Technologies 174 MMBTU Heat Input 6.856 ppm 0.004 P 0.858 P 4 9 RATA Tests* 39 Cracking Furnace Pavilion Technologies 140 MMBTU Heat Input 2.92 ppm 0.007 P 0.858 P 4 9 RATA Tests* 39 217 MMBTU ( Max) Boiler Pavilion Technologies 12% Combustion Airflow 8.58 ppm 0.007 P 0.943 P 5 9 RATA Tests* 40 217 MMBTU ( Max) Boiler Pavilion Technologies 33% Combustion Airflow 12.3 ppm 0.016 P 0.943 P 5 9 RATA Tests* 40 217 MMBTU ( Max) Boiler Pavilion Technologies 83% Combustion Airflow 19.8 ppm 0.042 P 0.943 P 5 9 RATA Tests* 40 204.8 MMBTU ( Max) Furnace Pavilion Technologies 170 MMBTU Heat Input 1.847 ppm 0.01 P 0.984 P 4 9 RATA Tests* 41 204.8 MMBTU ( Max) Furnace Pavilion Technologies 120 MMBTU Heat Input 3.072 ppm 0.007 P 0.984 P 4 9 RATA Tests* 41 204.8 MMBTU ( Max) Furnace Pavilion Technologies 155 MMBTU Heat Input 3.59 ppm 0.02 P 0.984 P 4 9 RATA Tests* 41 245 MMBTU ( Max) Furnace Pavilion Technologies 198 MMBTU Heat Input 13.58 ppm 0.001 P 0.16 F 4 9 RATA Tests* 42 245 MMBTU ( Max) Furnace Pavilion Technologies 188 MMBTU Heat Input 0.413 Mean Diff ppm 0.004 P 0.16 F 4 9 RATA Tests* 42 245 MMBTU ( Max) Furnace Pavilion Technologies 133 MMBTU Heat Input 0.569 Mean Diff ppm 0.016 P 0.16 F 4 9 RATA Tests* 42 217 MMBTU ( Max) Furnace Pavilion Technologies 188 MMBTU Heat Input 3.67 ppm 0.001 P 0.62 F 4 9 RATA Tests* 43 217 MMBTU ( Max) Furnace Pavilion Technologies 165 MMBTU Heat Input 5.299 ppm 0.004 P 0.62 F 4 9 RATA Tests* 43 217 MMBTU ( Max) Furnace Pavilion Technologies 145 MMBTU Heat Input 5.26 ppm 0.003 P 0.62 F 4 9 RATA Tests* 43 217 MMBTU ( Max) Furnace Pavilion Technologies 183 MMBTU Heat Input 11.041 ppm 0.001 P 0.948 P 4 9 RATA Tests* 44 8 of 29 Source Type PEMS System/

Model Manufacturer Condition or Capacity O2 RATA Results % Units O2 F Test F l a g O2 R2 Corr. F l a g Bias Adj.

Factor PEMS Input Factors Number of Tests/ Number of Continuous Operating Hours Ref.

217 MMBTU ( Max) Furnace Pavilion Technologies 153 MMBTU Heat Input 9.426 ppm 0.025 P 0.948 P 4 9 RATA Tests* 44 217 MMBTU ( Max) Furnace Pavilion Technologies 133 MMBTU Heat Input 4.074 ppm 0.006 P 0.948 P 4 9 RATA Tests* 44 217 MMBTU ( Max) Furnace Pavilion Technologies 170 MMBTU Heat Input 2.887 ppm 0.006 P 0.998 P 4 9 RATA Tests* 45 217 MMBTU ( Max) Furnace Pavilion Technologies 200 MMBTU Heat Input 1.612 ppm 0.001 P 0.998 P 4 9 RATA Tests* 45 217 MMBTU ( Max) Furnace Pavilion Technologies 150 MMBTU Heat Input 2.968 ppm 0.013 P 0.998 P 4 9 RATA Tests* 45 217 MMBTU ( Max) Furnace Pavilion Technologies 183 MMBTU Heat Input 5.03 ppm 0.012 P 0.961 P 4 9 RATA Tests* 46 217 MMBTU ( Max) Furnace Pavilion Technologies 165 MMBTU Heat Input 4.315 ppm 0.002 P 0.961 P 4 9 RATA Tests* 46 217 MMBTU ( Max) Furnace Pavilion Technologies 134 MMBTU Heat Input 14.57 ppm 0.071 P 0.961 P 4 9 RATA Tests* 46 217 MMBTU ( Max) Furnace Pavilion Technologies 207 MMBTU Heat Input 4.842 ppm 9 RATA Tests*

Ongoing RATA Tests Only 47 217 MMBTU ( Max) Furnace Pavilion Technologies 200 MMBTU Heat Input 4.326 ppm 9 RATA Tests*

Ongoing RATA Tests Only 48 217 MMBTU ( Max) Furnace Pavilion Technologies 188 MMBTU Heat Input .629 mean diff ppm 0.017 P  0.092 F 3 9 RATA Tests* 49 217 MMBTU ( Max) Furnace Pavilion Technologies 163 MMBTU Heat Input 3.72 ppm 0.004 P  0.092 F 3 9 RATA Tests* 49 217 MMBTU ( Max) Furnace Pavilion Technologies 20 MMBTU Heat Input 14.2 ppm 0.004 P  0.092 F 3 9 RATA Tests* 49 217 MMBTU ( Max) Furnace Pavilion Technologies 150 MMBTU Fuel Gas to Burners 3.135 ppm 0.001 P 0.996 P 4 9 RATA Tests* 50 217 MMBTU ( Max) Furnace Pavilion Technologies 185 MMBTU Fuel Gas to Burners 9.376 ppm 0.001 P 0.996 P 4 9 RATA Tests* 50 217 MMBTU ( Max) Furnace Pavilion Technologies 165 MMBTU Fuel Gas to Burners 0.837 ppm 0.001 P 0.996 P 4 9 RATA Tests* 50 668.2 MMBTU Boiler Pavilion Technologies 290 MMBTU Heat Input 9.748 ppm 9 RATA Tests*

Ongoing RATA Tests Only 51 217 MMBTU ( Max) Furnace Pavilion Technologies 198 MMBTU Heat Input 8.536 ppm 0.003 P 0.068 F 4 9 RATA Tests* 52 217 MMBTU ( Max) Furnace Pavilion Technologies 160 MMBTU Heat Input 10.894 ppm 0.002 P 0.068 F 4 9 RATA Tests* 52 217 MMBTU ( Max) Furnace Pavilion Technologies 123 MMBTU Heat Input 9.167 ppm 0.038 P 0.068 F 4 9 RATA Tests* 52 217 MMBTU ( Max) Furnace Pavilion Technologies 202 MMBTU Heat Input 4.496 ppm 9 RATA Tests*

Ongoing RATA Tests Only 53 9 of 29 Source Type PEMS System/

Model Manufacturer Condition or Capacity O2 RATA Results % Units O2 F Test F l a g O2 R2 Corr. F l a g Bias Adj.

Factor PEMS Input Factors Number of Tests/ Number of Continuous Operating Hours Ref.

217 MMBTU ( Max) Furnace Pavilion Technologies 185 MMBTU Fuel Gas to Burners 1.213 ppm 0.003 P 0.988 P 4 9 RATA Tests* 54 217 MMBTU ( Max) Furnace Pavilion Technologies 160 MMBTU Fuel Gas to Burners 0.81 ppm 0.008 P 0.988 P 4 9 RATA Tests* 54 217 MMBTU ( Max) Furnace Pavilion Technologies 145 MMBTU Fuel Gas to Burners 1.248 ppm 0.051 P 0.988 P 4 9 RATA Tests* 54 217 MMBTU ( Max) Furnace Pavilion Technologies 213 MMBTU Heat Input 6.374 ppm 9 RATA Tests*

Ongoing RATA Tests Only 55 217 MMBTU ( Max) Furnace Pavilion Technologies 190 Fuel MMBTU/ hr 13.03 ppm 0.001 P 0.991 P 5 9 RATA Tests* 56 217 MMBTU ( Max) Furnace Pavilion Technologies 170 Fuel MMBTU/ hr 11.45 ppm 0 P 0.991 P 5 9 RATA Tests* 56 217 MMBTU ( Max) Furnace Pavilion Technologies 150 Fuel MMBTU/ hr 10.43 ppm 0.003 P 0.991 P 5 9 RATA Tests* 56 217 MMBTU ( Max) Furnace Pavilion Technologies 180 MMBTU Heat Input 7.477 ppm 9 RATA Tests* 57 Furnace Pavilion Technologies 228.7 MMBTU fuel gas 2.047 ppm 0.011 P 0.999 F 9 RATA Tests* 58 Furnace Pavilion Technologies 183.2 MMBTU fuel gas 2.156 ppm 0.004 P 0.999 F 9 RATA Tests* 58 Furnace Pavilion Technologies 125.1 MMBTU fuel gas 0.925 ppm 0.007 P 0.999 F 9 RATA Tests* 58 220 MMBTU ( Max) Furnace Pavilion Technologies 198 MMBTU heat release 2.134 ppm 9 RATA Tests*

Ongoing RATA Tests Only 59 220 MMBTU ( Max) Furnace Pavilion Technologies 215 MMBTU heat release 1.049 ppm 9 RATA Tests*

Ongoing RATA Tests Only 60 220 MMBTU ( Max) Furnace Pavilion Technologies 220 MMBTU heat release 2.797 ppm 9 RATA Tests*

Ongoing RATA Tests Only 61 220 MMBTU ( Max) Furnace Pavilion Technologies 219 MMBTU heat release 1.266 ppm 9 RATA Tests*

Ongoing RATA Tests Only 61 220 MMBTU ( Max) Furnace Pavilion Technologies 198 MMBTU heat release 2.939 ppm 9 RATA Tests*

Ongoing RATA Tests Only 62 220 MMBTU ( Max) Furnace Pavilion Technologies 200 MMBTU heat release 5.96 ppm 9 RATA Tests*

Ongoing RATA Tests Only 63 220 MMBTU ( Max) Furnace Pavilion Technologies 206 MMBTU heat release 0.43 ppm 9 RATA Tests*

Ongoing RATA Tests Only 64 10 of 29 Source Type PEMS System/

Model Manufacturer Condition or Capacity O2 RATA Results % Units O2 F Test F l a g O2 R2 Corr. F l a g Bias Adj.

Factor PEMS Input Factors Number of Tests/ Number of Continuous Operating Hours Ref.

220 MMBTU ( Max) Furnace Pavilion Technologies 206 MMBTU heat release 3.381 ppm 9 RATA Tests*

Ongoing RATA Tests Only 64 225 MMBTU ( Max) Furnace Pavilion Technologies 220 MMBTU heat release 1.142 ppm 9 RATA Tests*

Ongoing RATA Tests Only 64 220 MMBTU ( Max) Furnace Pavilion Technologies 132 MMBTU heat release 1.114 ppm 9 RATA Tests*

Ongoing RATA Tests Only 65 220 MMBTU ( Max) Furnace Pavilion Technologies 200 MMBTU heat release 0.831 ppm 9 RATA Tests*

Ongoing RATA Tests Only 66 11 of 29 Source Type PEMS System/

Model Manufacturer Condition or Capacity O2 RATA Results % Units O2 F Test F l a g O2 R2 Corr. F l a g Bias Adj.

Factor PEMS Input Factors Number of Tests/ Number of Continuous Operating Hours Ref.

225 MMBTU ( Max) Furnace Pavilion Technologies 220 MMBTU heat release 1.985 ppm 9 RATA Tests*

Ongoing RATA Tests Only 67 225 MMBTU ( Max) Furnace Pavilion Technologies 223 MMBTU heat release 8.938 ppm 9 RATA Tests*

Ongoing RATA Tests Only 68 200 MMBTU ( Max) Furnace Pavilion Technologies 190 MMBTU heat release 1.952 ppm 9 RATA Tests*

Ongoing RATA Tests Only 67 220 MMBTU ( Max) Furnace Pavilion Technologies 207 MMBTU heat release 1.382 ppm 9 RATA Tests*

Ongoing RATA Tests Only 67 220 MMBTU ( Max) Furnace Pavilion Technologies 208 MMBTU heat release 0.558 ppm 9 RATA Tests*

Ongoing RATA Tests Only 67 220 MMBTU ( Max) Furnace Pavilion Technologies 213 MMBTU heat release 5.484 ppm 9 RATA Tests*

Ongoing RATA Tests Only 67 220 MMBTU ( Max) Furnace Pavilion Technologies 198 MMBTU heat release 3.376 ppm 9 RATA Tests*

Ongoing RATA Tests Only 59 220 MMBTU ( Max) Furnace Pavilion Technologies 198 MMBTU heat release 3.83 ppm 9 RATA Tests*

Ongoing RATA Tests Only 59 1,510 MMBTU ( Max) Process Heater Pavilion Technologies 1000 MMBTU/ hr Fuel 7.835 ppm 0.016 P  0.416 F 9 RATA Tests* 69 1,510 MMBTU ( Max) Process Heater Pavilion Technologies 1250 MMBTU/ hr Fuel 17.812 ppm 0.106 P  0.416 F 9 RATA Tests* 69 1,510 MMBTU ( Max) Process Heater Pavilion Technologies 1500 MMBTU/ hr Fuel 6.533 ppm 0.01 P  0.416 F 9 RATA Tests* 69 250 MMBTU ( Max) Furnace Pavilion Technologies 240.9 MMBTU heat release 22.495 ppm 9 RATA Tests*

Ongoing RATA Tests Only 70 250 MMBTU ( Max) Furnace Pavilion Technologies 168.7 MMBTU heat release 3.929 ppm 9 RATA Tests*

Ongoing RATA Tests Only 71 250 MMBTU ( Max) Furnace Pavilion Technologies 228.6 MMBTU heat release 3.243 ppm 9 RATA Tests*

Ongoing RATA Tests Only 72 250 MMBTU ( Max) Furnace Pavilion Technologies 229.0 MMBTU heat release 12.9 ppm 9 RATA Tests*

Ongoing RATA Tests Only 73 250 MMBTU ( Max) Furnace Pavilion Technologies 228.1 MMBTU heat release 2.646 ppm 9 RATA Tests*

Ongoing RATA Tests Only 74 12 of 29 Source Type PEMS System/

Model Manufacturer Condition or Capacity O2 RATA Results % Units O2 F Test F l a g O2 R2 Corr. F l a g Bias Adj.

Factor PEMS Input Factors Number of Tests/ Number of Continuous Operating Hours Ref.

250 MMBTU ( Max) Furnace Pavilion Technologies 218.1 MMBTU heat release 3.059 ppm 9 RATA Tests*

Ongoing RATA Tests Only 75 250 MMBTU ( Max) Furnace Pavilion Technologies 210.9 MMBTU heat release 11.838 ppm 9 RATA Tests*

Ongoing RATA Tests Only 76 250 MMBTU ( Max) Furnace Pavilion Technologies 221.8 MMBTU heat release 9.688 ppm 9 RATA Tests*

Ongoing RATA Tests Only 75 250 MMBTU ( Max) Furnace Pavilion Technologies 202.8 MMBTU heat release 3.487 ppm 9 RATA Tests*

Ongoing RATA Tests Only 76 250 MMBTU ( Max) Furnace Pavilion Technologies 211.8 MMBTU heat release 8.67 ppm 9 RATA Tests*

Ongoing RATA Tests Only 77 250 MMBTU ( Max) Furnace Pavilion Technologies 205.7 MMBTU heat release 5.13 ppm 9 RATA Tests*

Ongoing RATA Tests Only 78 13 of 29 Source Type PEMS System/

Model Manufacturer Condition or Capacity O2 RATA Results % Units O2 F Test F l a g O2 R2 Corr. F l a g Bias Adj.

Factor PEMS Input Factors Number of Tests/ Number of Continuous Operating Hours Ref.

250 MMBTU ( Max) Furnace Pavilion Technologies 210.1 MMBTU heat release 5.402 ppm 9 RATA Tests*

Ongoing RATA Tests Only 79 250 MMBTU ( Max) Furnace Pavilion Technologies 156.3 MMBTU heat release 3.617 ppm 9 RATA Tests*

Ongoing RATA Tests Only 80 250 MMBTU ( Max) Furnace Pavilion Technologies 203.2 MMBTU heat release 5.007 ppm 9 RATA Tests*

Ongoing RATA Tests Only 80 250 MMBTU ( Max) Furnace Pavilion Technologies 224.1 MMBTU heat release 2.233 ppm 9 RATA Tests*

Ongoing RATA Tests Only 80 250 MMBTU ( Max) Furnace Pavilion Technologies 215.5 MMBTU heat release 5.694 ppm 9 RATA Tests*

Ongoing RATA Tests Only 81 250 MMBTU ( Max) Furnace Pavilion Technologies 220.5 MMBTU heat release 9.13 ppm 9 RATA Tests*

Ongoing RATA Tests Only 82 250 MMBTU ( Max) Furnace Pavilion Technologies 156.3 MMBTU heat release 1.765 ppm 9 RATA Tests*

Ongoing RATA Tests Only 83 250 MMBTU ( Max) Furnace Pavilion Technologies 177.3 MMBTU heat release 5.38 ppm 9 RATA Tests*

Ongoing RATA Tests Only 84 250 MMBTU ( Max) Furnace Pavilion Technologies 196.1 MMBTU heat release 4.673 ppm 9 RATA Tests*

Ongoing RATA Tests Only 85 250 MMBTU ( Max) Furnace Pavilion Technologies 156.6 MMBTU heat release 3.461 ppm 9 RATA Tests*

Ongoing RATA Tests Only 83 250 MMBTU ( Max) Furnace Pavilion Technologies 216.1 MMBTU heat release 3.66 ppm 9 RATA Tests*

Ongoing RATA Tests Only 86 250 MMBTU ( Max) Furnace Pavilion Technologies 212.6 MMBTU heat release 3.018 ppm 9 RATA Tests*

Ongoing RATA Tests Only 87 250 MMBTU ( Max) Furnace Pavilion Technologies 156.2 MMBTU heat release 2.338 ppm 9 RATA Tests*

Ongoing RATA Tests Only 88 250 MMBTU ( Max) Furnace Pavilion Technologies 151.9 MMBTU heat release 1.018 ppm 9 RATA Tests*

Ongoing RATA Tests Only 89 250 MMBTU ( Max) Furnace Pavilion Technologies 229.4 MMBTU heat release 11.462 ppm 9 RATA Tests*

Ongoing RATA Tests Only 72 250 MMBTU ( Max) Furnace Pavilion Technologies 201.3 MMBTU heat release 5.526 ppm 9 RATA Tests*

Ongoing RATA Tests Only 90 14 of 29 Source Type PEMS System/

Model Manufacturer Condition or Capacity O2 RATA Results % Units O2 F Test F l a g O2 R2 Corr. F l a g Bias Adj.

Factor PEMS Input Factors Number of Tests/ Number of Continuous Operating Hours Ref.

250 MMBTU ( Max) Furnace Pavilion Technologies 211.1 MMBTU heat release 3.306 ppm 9 RATA Tests*

Ongoing RATA Tests Only 91 250 MMBTU ( Max) Furnace Pavilion Technologies 204.8 MMBTU heat release 7.817 ppm 9 RATA Tests*

Ongoing RATA Tests Only 92 250 MMBTU ( Max) Furnace Pavilion Technologies 212.4 MMBTU heat release 2.268 ppm 9 RATA Tests*

Ongoing RATA Tests Only 93 250 MMBTU ( Max) Furnace Pavilion Technologies 157.2 MMBTU heat release 4.652 ppm 9 RATA Tests*

Ongoing RATA Tests Only 94 1,510 MMBTU ( Max) Process Heater Pavilion Technologies 1393.7 MMBTU/ hr Fuel 0.991 ppm 9 RATA Tests*

Ongoing RATA Tests Only 95 250 MMBTU ( Max) Furnace Pavilion Technologies 194 MMBTU heat release 4.201 ppm 9 RATA Tests*

Ongoing RATA Tests Only 96 15 of 29 Source Type PEMS System/

Model Manufacturer Condition or Capacity O2 RATA Results % Units O2 F Test F l a g O2 R2 Corr. F l a g Bias Adj.

Factor PEMS Input Factors Number of Tests/ Number of Continuous Operating Hours Ref.

250 MMBTU ( Max) Furnace Pavilion Technologies 221.2 MMBTU heat release 2.454 ppm 9 RATA Tests*

Ongoing RATA Tests Only 97 360 MMBTU ( Max) Steam Superheater Pavilion Technologies 188 MMBTU heat release 0.951 ppm 9 RATA Tests*

Ongoing RATA Tests Only 98 500 MPPH Steam ( Max) Boiler Pavilion Technologies 301.6 MPPH Steam prod rate 2.293 ppm 9 RATA Tests*

Ongoing RATA Tests Only 78 500 MPPH Steam ( Max) Boiler Pavilion Technologies 301.6 MPPH Steam prod rate 4.634 ppm 9 RATA Tests*

Ongoing RATA Tests Only 78 120 MW ( Max)

Gas Turbine Pavilion Technologies 88.0 MW 0.279 ppm 9 RATA Tests*

Ongoing RATA Tests Only 99 360 MMBTU ( Max) Steam Superheater Pavilion Technologies 197.2 MMBTU heat release 1.74 ppm 9 RATA Tests*

Ongoing RATA Tests Only 100 750 MMBTU ( Max) Gas Fired Boiler Pavilion Technologies 300K lbs steam per hr 3.237 ppm 9 RATA Tests*

Ongoing RATA Tests Only 101 750 MMBTU ( Max) Gas Fired Boiler Pavilion Technologies 300K lbs steam per hr 7.491 ppm 9 RATA Tests*

Ongoing RATA Tests Only 101 250 MMBTU ( Max) Furnace Pavilion Technologies 235.8 MMBTU heat release 2.602 ppm 9 RATA Tests*

Ongoing RATA Tests Only 102 217 MMBTU ( Max) Furnace Pavilion Technologies 150 MMBTU heat release 5.765 ppm 9 RATA Tests*

Ongoing RATA Tests Only 103 217 MMBTU ( Max) Furnace Pavilion Technologies 148 MMBTU heat release 2.453 ppm 9 RATA Tests*

Ongoing RATA Tests Only 104 668.2 MMBTU Boiler Pavilion Technologies Low Load 8.58 ppm 0.007 P 0.943 P 9 RATA Tests* 105 668.2 MMBTU Boiler Pavilion Technologies Mid Load 12.33 ppm 0.016 P 0.943 P 9 RATA Tests* 105 668.2 MMBTU Boiler Pavilion Technologies High Load 19.8 ppm 0.042 P 0.943 P 9 RATA Tests* 105 668.2 MMBTU Boiler Pavilion Technologies 217.8 MMBTU/ hr Fuel 2.584 ppm 9 RATA Tests*

Ongoing RATA Tests Only 106 668.2 MMBTU Boiler Pavilion Technologies 335 MMBTU/ hr Fuel 1.784 ppm 9 RATA Tests*

Ongoing RATA Tests Only 107 668.2 MMBTU Boiler Pavilion Technologies 293 MMBTU/ hr Fuel 0.0819 ppm 9 RATA Tests*

Ongoing RATA Tests Only 108 16 of 29 Source Type PEMS System/

Model Manufacturer Condition or Capacity O2 RATA Results % Units O2 F Test F l a g O2 R2 Corr. F l a g Bias Adj.

Factor PEMS Input Factors Number of Tests/ Number of Continuous Operating Hours Ref.

Furnace Pavilion Technologies Low Load 12.697 ppm 0.002 P 1 P 9 RATA Tests* 109 Furnace Pavilion Technologies Mid Load 9.471 ppm 0.001 P 1 P 9 RATA Tests* 109 Furnace Pavilion Technologies High Load 10.076 ppm 0.004 P 1 P 9 RATA Tests* 109 17 of 29 Source Type PEMS System/

Model Manufacturer Condition or Capacity O2 RATA Results % Units O2 F Test F l a g O2 R2 Corr. F l a g Bias Adj.

Factor PEMS Input Factors Number of Tests/ Number of Continuous Operating Hours Ref.

217 MMBTU ( Max) Furnace Pavilion Technologies 194 MMBTU/ hr Fuel 4.327 ppm 9 RATA Tests*

Ongoing RATA Tests Only 110 217 MMBTU ( Max) Furnace Pavilion Technologies 151 MMBTU/ hr Fuel .614 mean diff ppm 9 RATA Tests*

Ongoing RATA Tests Only 111 217 MMBTU ( Max) Furnace Pavilion Technologies 189 MMBTU/ hr Fuel 18.528 ppm 9 RATA Tests*

Ongoing RATA Tests Only 112 217 MMBTU ( Max) Furnace Pavilion Technologies 198 MMBTU/ hr Fuel 0.407 ppm 9 RATA Tests*

Ongoing RATA Tests Only 113 217 MMBTU ( Max) Furnace Pavilion Technologies 191 MMBTU/ hr Fuel 9.423 ppm 9 RATA Tests*

Ongoing RATA Tests Only 114 217 MMBTU ( Max) Furnace Pavilion Technologies 190 MMBTU/ hr Fuel 4.178 ppm 9 RATA Tests*

Ongoing RATA Tests Only 115 217 MMBTU ( Max) Furnace Pavilion Technologies 158 MMBTU/ hr Fuel 2.064 ppm 9 RATA Tests*

Ongoing RATA Tests Only 116 Furnace Pavilion Technologies Low Load 8.536 ppm 0.003 P 0.06 F 9 RATA Tests* 117 Furnace Pavilion Technologies Mid Load 10.894 ppm 0.002 P 0.06 F 9 RATA Tests* 117 Furnace Pavilion Technologies High Load 9.156 ppm 0.035 P 0.06 F 9 RATA Tests* 117 Furnace Pavilion Technologies Low Load 17.895 ppm 0.006 P 0.995 P 9 RATA Tests* 118 Furnace Pavilion Technologies Mid Load 2.382 ppm 0.121 P 0.995 P 9 RATA Tests* 118 Furnace Pavilion Technologies High Load 11.451 ppm 0.001 P 0.995 P 9 RATA Tests* 118 Furnace Pavilion Technologies 165 gpm 4.76 ppm 0.076 P 0.996 P 9 RATA Tests* 105 Furnace Pavilion Technologies 105 gpm 1.65 ppm 0.005 P 0.996 P 9 RATA Tests* 105 Furnace Pavilion Technologies 192 gpm 4.38 ppm 0.034 P 0.996 P 9 RATA Tests* 105 750 MMBTU ( Max) Gas Fired Boiler Pavilion Technologies 240K lbs steam per hr 5.06 ppm 0.081 P 0.95 P 9 RATA Tests* 119 750 MMBTU ( Max) Gas Fired Boiler Pavilion Technologies 190K lbs steam per hr 3.122 ppm 0.095 P 0.95 P 9 RATA Tests* 119 750 MMBTU ( Max) Gas Fired Boiler Pavilion Technologies 150K lbs steam per hr 1.087 ppm 0.013 P 0.95 P 9 RATA Tests* 119 18 of 29 Source Type PEMS System/

Model Manufacturer Condition or Capacity O2 RATA Results % Units O2 F Test F l a g O2 R2 Corr. F l a g Bias Adj.

Factor PEMS Input Factors Number of Tests/ Number of Continuous Operating Hours Ref.

217 MMBTU ( Max) Furnace Pavilion Technologies 214 MMBTU/ hr Fuel 2.885 ppm 9 RATA Tests*

Ongoing RATA Tests Only 120 217 MMBTU ( Max) Furnace Pavilion Technologies 207 MMBTU/ hr Fuel 1.158 ppm 9 RATA Tests*

Ongoing RATA Tests Only 121 217 MMBTU ( Max) Furnace Pavilion Technologies 156 MMBTU/ hr Fuel 3.097 ppm 9 RATA Tests*

Ongoing RATA Tests Only 122 19 of 29 Source Type PEMS System/

Model Manufacturer Condition or Capacity O2 RATA Results % Units O2 F Test F l a g O2 R2 Corr. F l a g Bias Adj.

Factor PEMS Input Factors Number of Tests/ Number of Continuous Operating Hours Ref.

217 MMBTU ( Max) Furnace Pavilion Technologies 180 MMBTU/ hr Fuel 3.511 ppm 9 RATA Tests*

Ongoing RATA Tests Only 123 Boiler Pavilion Technologies Low Load 1.057 ppm 0.006 P 0.985 P 9 RATA Tests* 124 Boiler Pavilion Technologies Mid Load 2.151 ppm 0.007 P 0.985 P 9 RATA Tests* 124 Boiler Pavilion Technologies High Load 7.408 ppm 0.005 P 0.985 P 9 RATA Tests* 124 120 MW ( Max)

Gas Turbine Pavilion Technologies 95 MW 0.489 ppm 9 RATA Tests*

Ongoing RATA Tests Only 125 Furnace Pavilion Technologies Low Load 4.976 ppm 0.003 P 0.999 P 9 RATA Tests* 126 Furnace Pavilion Technologies Mid Load 2.509 ppm 0.002 P 0.999 P 9 RATA Tests* 126 Furnace Pavilion Technologies High Load 4.139 ppm 0.002 P 0.999 P 9 RATA Tests* 126 Furnace Pavilion Technologies Low Load 0.557 ppm 0.006 P 0.999 P 9 RATA Tests* 117 Furnace Pavilion Technologies Mid Load 2.003 ppm 0.009 P 0.999 P 9 RATA Tests* 117 Furnace Pavilion Technologies High Load 0.216 ppm 0.009 P 0.999 P 9 RATA Tests* 117 Furnace Pavilion Technologies Low Load 0.982 ppm 0.016 P 0.999 P 9 RATA Tests* 117 Furnace Pavilion Technologies Mid Load 6.342 ppm 0.008 P 0.999 P 9 RATA Tests* 117 Furnace Pavilion Technologies High Load 2.317 ppm 0.004 P 0.999 P 9 RATA Tests* 117 217 MMBTU ( Max) Furnace Pavilion Technologies 198 MMBTU/ hr Fuel 15.181 ppm 9 RATA Tests*

Ongoing RATA Tests Only 127 217 MMBTU ( Max) Furnace Pavilion Technologies 207 MMBTU/ hr Fuel 1.168 ppm 9 RATA Tests*

Ongoing RATA Tests Only 128 217 MMBTU ( Max) Furnace Pavilion Technologies 203 MMBTU/ hr Fuel 3.648 ppm 9 RATA Tests*

Ongoing RATA Tests Only 129 217 MMBTU ( Max) Furnace Pavilion Technologies 187 MMBTU/ hr Fuel 6.993 ppm 9 RATA Tests*

Ongoing RATA Tests Only 130 217 MMBTU ( Max) Furnace Pavilion Technologies 146 MMBTU/ hr Fuel 7.604 ppm 9 RATA Tests*

Ongoing RATA Tests Only 131 Furnace Pavilion Technologies Low Load < 1.0% mean diff ppm 0.017 P  0.101 F 9 RATA Tests* 126 Furnace Pavilion Technologies Mid Load 3.721 ppm 0.004 P  0.101 F 9 RATA Tests* 126 20 of 29 Source Type PEMS System/

Model Manufacturer Condition or Capacity O2 RATA Results % Units O2 F Test F l a g O2 R2 Corr. F l a g Bias Adj.

Factor PEMS Input Factors Number of Tests/ Number of Continuous Operating Hours Ref.

Furnace Pavilion Technologies High Load 14.156 ppm 0.004 P  0.101 F 9 RATA Tests* 126 217 MMBTU ( Max) Furnace Pavilion Technologies 146 MMBTU/ hr Fuel 7.987 ppm 9 RATA Tests*

Ongoing RATA Tests Only 132 21 of 29 Source Type PEMS System/

Model Manufacturer Condition or Capacity O2 RATA Results % Units O2 F Test F l a g O2 R2 Corr. F l a g Bias Adj.

Factor PEMS Input Factors Number of Tests/ Number of Continuous Operating Hours Ref.

217 MMBTU ( Max) Furnace Pavilion Technologies 145 MMBTU/ hr Fuel 4.542 ppm 9 RATA Tests*

Ongoing RATA Tests Only 133 217 MMBTU ( Max) Furnace Pavilion Technologies 137 MMBTU/ hr Fuel 3.917 ppm 9 RATA Tests*

Ongoing RATA Tests Only 111 Furnace Pavilion Technologies Low Load 11.041 ppm 0.001 P 0.948 P 9 RATA Tests* 117 Furnace Pavilion Technologies Mid Load 9.426 ppm 0.025 P 0.948 P 9 RATA Tests* 117 Furnace Pavilion Technologies High Load 4.074 ppm 0.006 P 0.948 P 9 RATA Tests* 117 Furnace Pavilion Technologies 187.7 MMBTU/ hr Fuel 4.306 ppm 0.007 P 0.937 P 9 RATA Tests* 134 Furnace Pavilion Technologies 155 MMBTU/ hr Fuel 12.448 ppm 0 P 0.937 P 9 RATA Tests* 134 Furnace Pavilion Technologies 129.5 MMBTU/ hr Fuel 9.302 ppm 0.001 P 0.937 P 9 RATA Tests* 134 Boiler Pavilion Technologies Low Load 10.976 ppm 0.018 P 0.937 P 9 RATA Tests* 109 Boiler Pavilion Technologies Mid Load 19.835 ppm 0.013 P 0.937 P 9 RATA Tests* 109 Boiler Pavilion Technologies High Load 0.35 mean diff ppm 0.212 P 0.937 P 9 RATA Tests* 109 442.9 MMBTU ( Max) Process Steam Boiler Pavilion Technologies 204.5 MMBTU heat release 2.24 ppm 9 RATA Tests*

Ongoing RATA Tests Only 135 442.9 MMBTU ( Max) Process Steam Boiler Pavilion Technologies 204.5 MMBTU heat release 2.256 ppm 9 RATA Tests*

Ongoing RATA Tests Only 135 442.9 MMBTU ( Max) Process Steam Boiler Pavilion Technologies 172.4 MMBTU heat release 1.932 ppm 9 RATA Tests*

Ongoing RATA Tests Only 136 430 MMBTU ( Max) Process Steam Boiler Pavilion Technologies 85 MMBTU heat release 0.872 ppm 9 RATA Tests*

Ongoing RATA Tests Only 137 Process Steam Boiler Pavilion Technologies Mid Load ( 150 kpph) 1.025 ppm 1.0374 P 0.99981 P 9 RATA Tests* 138 Process Steam Boiler Pavilion Technologies Low Load ( 60 kpph) 0.452 ppm 0.0927 P 0.99981 P 9 RATA Tests* 138 Process Steam Boiler Pavilion Technologies High Load ( 250 kpph) 2.349 ppm 0.008 P 0.99981 P 9 RATA Tests* 138 442.9 MMBTU ( Max) Process Steam Boiler Pavilion Technologies 164.7 MMBTU heat release 4.492 ppm 9 RATA Tests*

Ongoing RATA Tests Only 139 442.9 MMBTU ( Max) Process Steam Boiler Pavilion Technologies 148.3 MMBTU heat release 1.855 ppm 9 RATA Tests*

Ongoing RATA Tests Only 140 22 of 29 Source Type PEMS System/

Model Manufacturer Condition or Capacity O2 RATA Results % Units O2 F Test F l a g O2 R2 Corr. F l a g Bias Adj.

Factor PEMS Input Factors Number of Tests/ Number of Continuous Operating Hours Ref.

430 MMBTU ( Max) Process Steam Boiler Pavilion Technologies 215 MMBTU heat release 1.53 ppm 9 RATA Tests*

Ongoing RATA Tests Only 137 Process Steam Boiler Pavilion Technologies Low Load ( 70 MPPH) 4.506 ppm 0.8964 P 0.9997 P 9 RATA Tests* 141 Process Steam Boiler Pavilion Technologies Mid Load ( 140 MPPH) 3.593 ppm 0.9591 P 0.9997 P 9 RATA Tests* 141 Process Steam Boiler Pavilion Technologies High Load ( 250 MPPH) 1.482 ppm 0.9531 P 0.9997 P 9 RATA Tests* 141 430 MMBTU ( Max) Process Steam Boiler Pavilion Technologies Low Load ( 56 MPPH) 0.807 ppm 1.0011 P 0.9993 P 9 RATA Tests* 142 430 MMBTU ( Max) Process Steam Boiler Pavilion Technologies Mid Load ( 140 MPPH) 1.443 ppm 0.0055 P 0.9993 P 9 RATA Tests* 142 430 MMBTU ( Max) Process Steam Boiler Pavilion Technologies High Load ( 275 MPPH) 4.238 ppm 0.0001 P 0.9993 P 9 RATA Tests* 142 430 MMBTU ( Max) Process Steam Boiler Pavilion Technologies Low Load ( 56 MPPH) 1.453 ppm 0.0399 P 0.99964 P 9 RATA Tests* 143 430 MMBTU ( Max) Process Steam Boiler Pavilion Technologies Mid Load ( 138 MPPH) 1.535 ppm 0.0209 P 0.99964 P 9 RATA Tests* 143 430 MMBTU ( Max) Process Steam Boiler Pavilion Technologies High Load ( 278 MPPH) 3.31 ppm 0.0012 P 0.99964 P 9 RATA Tests* 143 430 MMBTU ( Max) Process Steam Boiler Pavilion Technologies Low Load ( 51 MPPH) 0.212 ppm 0.0048 P 0.99986 P 9 RATA Tests* 144 430 MMBTU ( Max) Process Steam Boiler Pavilion Technologies High Load ( 280 MPPH) 1.793 ppm 0.0004 P 0.99986 P 9 RATA Tests* 144 430 MMBTU ( Max) Process Steam Boiler Pavilion Technologies Mid Load ( 121 MPPH) 3.035 ppm 0.0129 P 0.99986 P 9 RATA Tests* 144 442.9 MMBTU ( Max) Process Steam Boiler Pavilion Technologies 175.2 MMBTU heat release 1.556 ppm 9 RATA Tests*

Ongoing RATA Tests Only 139 442.9 MMBTU ( Max) Process Steam Boiler Pavilion Technologies 83.76 MMBTU heat release 2.133 ppm 9 RATA Tests*

Ongoing RATA Tests Only 145 Process Steam Boiler Pavilion Technologies Low Load ( 58 K) 1.52 ppm 0.9733 P 0.99992 P 9 RATA Tests* 146 Process Steam Boiler Pavilion Technologies Mid Load ( 140 K) 2.417 ppm 0.9972 P 0.99992 P 9 RATA Tests* 146 23 of 29 Source Type PEMS System/

Model Manufacturer Condition or Capacity O2 RATA Results % Units O2 F Test F l a g O2 R2 Corr. F l a g Bias Adj.

Factor PEMS Input Factors Number of Tests/ Number of Continuous Operating Hours Ref.

Process Steam Boiler Pavilion Technologies High Load ( 275 K) 1.805 ppm 0.9611 P 0.99992 P 9 RATA Tests* 146 80 MW ( Max)

Gas Turbine Pavilion Technologies High Load ( 73 MW) 0.373 ppm 0.4221 P 0.99929 P 9 RATA Tests* 147 80 MW ( Max)

Gas Turbine Pavilion Technologies Low Load ( 58 MW) 0.278 ppm 0.6188 P 0.99929 P 9 RATA Tests* 147 80 MW ( Max)

Gas Turbine Pavilion Technologies Mid Load ( 65 MW) 0.208 ppm 0.488 P 0.99929 P 9 RATA Tests* 147 80 MW ( Max)

Gas Turbine Pavilion Technologies 71.1 MW 0.17 ppm 9 RATA Tests*

Ongoing RATA Tests Only 148 85 MW ( Max)

Gas Turbine Pavilion Technologies 77 MW 0.231 ppm 9 RATA Tests*

Ongoing RATA Tests Only 149 Gas Turbine Pavilion Technologies High Load ( 77 MW) 0.376 ppm 1.0059 P 0.99672 P 9 RATA Tests* 150 Gas Turbine Pavilion Technologies Low Load ( 50 MW) 0.137 ppm 0.9955 P 0.99672 P 9 RATA Tests* 150 Gas Turbine Pavilion Technologies Mid Load ( 67 MW) 0.072 ppm 1.0356 P 0.99672 P 9 RATA Tests* 150 85 MW ( Max)

Gas Turbine Pavilion Technologies Low Load ( 53 MW) 0.697 ppm 0.0026 P 0.9594 P 9 RATA Tests* 151 85 MW ( Max)

Gas Turbine Pavilion Technologies High Load ( 72 MW) 0.384 ppm 0.0012 P 0.9594 P 9 RATA Tests* 151 85 MW ( Max)

Gas Turbine Pavilion Technologies Mid Load ( 64 MW) 0.266 ppm 0.0004 P 0.9594 P 9 RATA Tests* 151 85 MW ( Max)

Gas Turbine Pavilion Technologies Low Load ( 50 MW) 0.72 ppm 0.0044 P 0.97827 P 9 RATA Tests* 152 85 MW ( Max)

Gas Turbine Pavilion Technologies High Load ( 70 MW) 0.555 ppm 0.0026 P 0.97827 P 9 RATA Tests* 152 85 MW ( Max)

Gas Turbine Pavilion Technologies Mid Load ( 57 MW) 1.394 ppm 0.0014 P 0.97827 P 9 RATA Tests* 152 85 MW ( Max)

Gas Turbine Pavilion Technologies High Load ( 75 MW) 0.403 ppm 0.0098 P 0.99585 P 9 RATA Tests* 153 85 MW ( Max)

Gas Turbine Pavilion Technologies Mid Load ( 58 MW) 0.319 ppm 0.0003 P 0.99585 P 9 RATA Tests* 153 85 MW ( Max)

Gas Turbine Pavilion Technologies Low Load ( 50 MW) 0.805 ppm 0.0034 P 0.99585 P 9 RATA Tests* 153 80 MW ( Max)

Gas Turbine Pavilion Technologies High Load ( 71 MW) 0.261 ppm 0.4568 P 0.99851 P 9 RATA Tests* 154 80 MW ( Max)

Gas Turbine Pavilion Technologies Mid Load ( 61 MW) 0.249 ppm 0.5596 P 0.99851 P 9 RATA Tests* 154 80 MW ( Max)

Gas Turbine Pavilion Technologies Low Load ( 58 MW) 0.635 ppm 0.0996 P 0.99851 P 9 RATA Tests* 154 80 MW ( Max)

Gas Turbine Pavilion Technologies 67.8 MW 0.133 ppm 9 RATA Tests*

Ongoing RATA Tests Only 148 Gas Turbine Pavilion Technologies Low Load ( 50 MW) 2.914 ppm 0.0031 P 0.961 P 9 RATA Tests* 155 24 of 29 Source Type PEMS System/

Model Manufacturer Condition or Capacity O2 RATA Results % Units O2 F Test F l a g O2 R2 Corr. F l a g Bias Adj.

Factor PEMS Input Factors Number of Tests/ Number of Continuous Operating Hours Ref.

Gas Turbine Pavilion Technologies Mid Load ( 60 MW) 1.87 ppm 0.0005 P 0.961 P 9 RATA Tests* 155 Gas Turbine Pavilion Technologies High Load ( 80 MW) 4.092 ppm 0.0005 P 0.961 P 9 RATA Tests* 155 80 MW ( Max)

Gas Turbine Pavilion Technologies 60.6 MW 0.119 ppm 9 RATA Tests*

Ongoing RATA Tests Only 156 85 MW ( Max)

Gas Turbine Pavilion Technologies 77 MW 0.19 ppm 9 RATA Tests*

Ongoing RATA Tests Only 149 Gas Turbine Pavilion Technologies High Load ( 82 MW) 0.528 ppm 1.0091 P 0.99688 P 9 RATA Tests* 157 Gas Turbine Pavilion Technologies Mid Load ( 65 MW) 0.119 ppm 0.9995 P 0.99688 P 9 RATA Tests* 157 Gas Turbine Pavilion Technologies Low Load ( 50 MW) 0.314 ppm 0.9921 P 0.99688 P 9 RATA Tests* 157 80 MW ( Max)

Gas Turbine Pavilion Technologies High Load ( 66 MW) 0.217 ppm 0.4193 P 0.99807 P 9 RATA Tests* 158 80 MW ( Max)

Gas Turbine Pavilion Technologies Low Load ( 57 MW) 0.163 ppm 0.3392 P 0.99807 P 9 RATA Tests* 158 80 MW ( Max)

Gas Turbine Pavilion Technologies Mid Load ( 62 MW) 0.393 ppm 0.3299 P 0.99807 P 9 RATA Tests* 158 80 MW ( Max)

Gas Turbine Pavilion Technologies 70.3 MW 0.413 ppm 9 RATA Tests*

Ongoing RATA Tests Only 159 85 MW ( Max)

Gas Turbine Pavilion Technologies 77 MW 0.179 ppm 9 RATA Tests*

Ongoing RATA Tests Only 160 Gas Turbine Pavilion Technologies High Load ( 77 MW) 0.897 ppm 0.0006 P 0.99479 P 9 RATA Tests* 161 Gas Turbine Pavilion Technologies Mid Load ( 67 MW) 0.92 ppm 0.0009 P 0.99479 P 9 RATA Tests* 161 Gas Turbine Pavilion Technologies Low Load ( 50 MW) 0.09 ppm 0.0013 P 0.99479 P 9 RATA Tests* 161 245 MMBTU ( Max) Furnace Pavilion Technologies 218 MMBTU heat release 4.819 ppm 9 RATA Tests*

Ongoing RATA Tests Only 162 245 MMBTU ( Max) Furnace Pavilion Technologies 229.7 MMBTU heat release 4.08 ppm 9 RATA Tests*

Ongoing RATA Tests Only 163 245 MMBTU ( Max) Furnace Pavilion Technologies 241.9 MMBTU heat release 3.727 ppm 9 RATA Tests*

Ongoing RATA Tests Only 164 245 MMBTU ( Max) Furnace Pavilion Technologies 230.1 MMBTU heat release 8.167 ppm 9 RATA Tests*

Ongoing RATA Tests Only 165 245 MMBTU ( Max) Furnace Pavilion Technologies 230 MMBTU heat release 1.128 ppm 9 RATA Tests*

Ongoing RATA Tests Only 166 25 of 29 Source Type PEMS System/

Model Manufacturer Condition or Capacity O2 RATA Results % Units O2 F Test F l a g O2 R2 Corr. F l a g Bias Adj.

Factor PEMS Input Factors Number of Tests/ Number of Continuous Operating Hours Ref.

245 MMBTU ( Max) Furnace Pavilion Technologies 230.6 MMBTU heat release 7.714 ppm 9 RATA Tests*

Ongoing RATA Tests Only 165 245 MMBTU ( Max) Furnace Pavilion Technologies 225 MMBTU heat release 1.108 ppm 9 RATA Tests*

Ongoing RATA Tests Only 60 26 of 29 Source Type PEMS System/

Model Manufacturer Condition or Capacity O2 RATA Results % Units O2 F Test F l a g O2 R2 Corr. F l a g Bias Adj.

Factor PEMS Input Factors Number of Tests/ Number of Continuous Operating Hours Ref.

245 MMBTU ( Max) Furnace Pavilion Technologies 230 MMBTU heat release 0.676 ppm 9 RATA Tests*

Ongoing RATA Tests Only 166 400 Kpph Steam ( Max) Process Boiler Pavilion Technologies 210 Kpph steam prod 4.845 ppm 9 RATA Tests*

Ongoing RATA Tests Only 167 400 Kpph Steam ( Max) Process Boiler Pavilion Technologies 197 Kpph steam prod 3.023 ppm 9 RATA Tests*

Ongoing RATA Tests Only 168 400 Kpph Steam ( Max) Process Boiler Pavilion Technologies 161 Kpph steam prod 4.032 ppm 9 RATA Tests*

Ongoing RATA Tests Only 169 400 Kpph Steam ( Max) Process Boiler Pavilion Technologies 160 Kpph steam prod 1.398 ppm 9 RATA Tests*

Ongoing RATA Tests Only 170 400 Kpph Steam ( Max) Process Boiler Pavilion Technologies 176 Kpph steam prod 1.737 ppm 9 RATA Tests*

Ongoing RATA Tests Only 168 400 Kpph Steam ( Max) Process Boiler Pavilion Technologies 131 Kpph steam prod 0.272 ppm 9 RATA Tests*

Ongoing RATA Tests Only 169 245 MMBTU ( Max) Furnace Pavilion Technologies 201.6 MMBTU heat release 5.115 ppm 9 RATA Tests*

Ongoing RATA Tests Only 171 245 MMBTU ( Max) Furnace Pavilion Technologies 187.7 MMBTU heat release 2.962 ppm 9 RATA Tests*

Ongoing RATA Tests Only 120 245 MMBTU ( Max) Furnace Pavilion Technologies 217 MMBTU heat release 5.376 ppm 9 RATA Tests*

Ongoing RATA Tests Only 172 245 MMBTU ( Max) Furnace Pavilion Technologies 216.6 MMBTU heat release 3.513 ppm 9 RATA Tests*

Ongoing RATA Tests Only 165 245 MMBTU ( Max) Furnace Pavilion Technologies 240 MMBTU heat release 0.746 ppm 9 RATA Tests*

Ongoing RATA Tests Only 166 245 MMBTU ( Max) Furnace Pavilion Technologies 224.2 MMBTU heat release 4.712 ppm 9 RATA Tests*

Ongoing RATA Tests Only 165 245 MMBTU ( Max) Furnace Pavilion Technologies 212 MMBTU heat release 0.973 ppm 9 RATA Tests*

Ongoing RATA Tests Only 166 245 MMBTU ( Max) Furnace Pavilion Technologies 217 MMBTU heat release 9.261 ppm 9 RATA Tests*

Ongoing RATA Tests Only 173 245 MMBTU ( Max) Furnace Pavilion Technologies 233 MMBTU heat release 1.262 ppm 9 RATA Tests*

Ongoing RATA Tests Only 173 27 of 29 Source Type PEMS System/

Model Manufacturer Condition or Capacity O2 RATA Results % Units O2 F Test F l a g O2 R2 Corr. F l a g Bias Adj.

Factor PEMS Input Factors Number of Tests/ Number of Continuous Operating Hours Ref.

245 MMBTU ( Max) Furnace Pavilion Technologies 226.6 MMBTU heat release 3.09 ppm 9 RATA Tests*

Ongoing RATA Tests Only 174 245 MMBTU ( Max) Furnace Pavilion Technologies 227.7 MMBTU heat release 1.404 ppm 9 RATA Tests*

Ongoing RATA Tests Only 175 245 MMBTU ( Max) Furnace Pavilion Technologies High Load ( 69 KPPH) 5.211 ppm 0.1479 P 0.9986 P 9 RATA Tests* 176 245 MMBTU ( Max) Furnace Pavilion Technologies Mid Load ( 50 KPPH) 3.069 ppm 0.0106 P 0.9986 P 9 RATA Tests* 176 28 of 29 Source Type PEMS System/

Model Manufacturer Condition or Capacity O2 RATA Results % Units O2 F Test F l a g O2 R2 Corr. F l a g Bias Adj.

Factor PEMS Input Factors Number of Tests/ Number of Continuous Operating Hours Ref.

245 MMBTU ( Max) Furnace Pavilion Technologies Low Load ( 28 KPPH) 0.97 ppm 0.0037 P 0.9986 P 9 RATA Tests* 176 245 MMBTU ( Max) Furnace Pavilion Technologies 228 MMBTU heat release 3.821 ppm 9 RATA Tests*

Ongoing RATA Tests Only 173 245 MMBTU ( Max) Furnace Pavilion Technologies 233.4 MMBTU heat release 8.468 ppm 9 RATA Tests*

Ongoing RATA Tests Only 175 245 MMBTU ( Max) Furnace Pavilion Technologies 219 MMBTU heat release 1.206 ppm 9 RATA Tests*

Ongoing RATA Tests Only 177 245 MMBTU ( Max) Furnace Pavilion Technologies 231.8 MMBTU heat release 7.128 ppm 9 RATA Tests*

Ongoing RATA Tests Only 163 245 MMBTU ( Max) Furnace Pavilion Technologies 236.4 MMBTU heat release 8.946 ppm 9 RATA Tests*

Ongoing RATA Tests Only 178 P= Pass F= Fail * Each RATA test consists of 21 consecutive one minute runs. 29 of 29


[Federal Register Volume 80, Number 214 (Thursday, November 5, 2015)]
[Notices]
[Pages 68528-68529]
[FR Doc No: 2015-28209]

-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #2

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER14-1831-001.
    Applicants: PJM Interconnection, L.L.C., Virginia Electric and
Power Company.
    Description: Compliance filing: Dominion's compliance filing
revising H-16A methodology of calculating ADIT to be effective 5/1/
2014.
    Filed Date: 10/30/15.
    Accession Number: 20151030-5284.
    Comments Due: 5 p.m. ET 11/20/15.

    Docket Numbers: ER15-411-003.
    Applicants: Arizona Public Service Company.
    Description: Compliance filing: Rate Schedule No. 274--Planning
Participation Agreement to be effective 1/1/2015.
    Filed Date: 10/30/15.
    Accession Number: 20151030-5275.
    Comments Due: 5 p.m. ET 11/20/15.

    Docket Numbers: ER15-680-001.
    Applicants: PacifiCorp.
    Description: Compliance filing: Idaho Power Asset Exchange
Compliance Filing (Agreements) to be effective 10/30/2015.
    Filed Date: 10/30/15.
    Accession Number: 20151030-5310.
    Comments Due: 5 p.m. ET 11/20/15.

    Docket Numbers: ER15-681-001.
    Applicants: PacifiCorp.
    Description: Compliance filing: Idaho Power Asset Exchange
Compliance Filing (Cancellations) to be effective 10/30/2015.
    Filed Date: 10/30/15.
    Accession Number: 20151030-5312.
    Comments Due: 5 p.m. ET 11/20/15.

    Docket Numbers: ER15-683-001.
    Applicants: Idaho Power Company.
    Description: Compliance filing: Legacy Agreements Replacement
Transaction--Closing Compliance Filing to be effective 10/30/2015.
    Filed Date: 10/30/15.
    Accession Number: 20151030-5324.
    Comments Due: 5 p.m. ET 11/20/15.

    Docket Numbers: ER15-686-001.
    Applicants: Idaho Power Company.
    Description: Compliance filing: Legacy Transaction Cancellations--
Closing Compliance Filing to be effective 10/30/2015.
    Filed Date: 10/30/15.
    Accession Number: 20151030-5386.
    Comments Due: 5 p.m. ET 11/20/15.

    Docket Numbers: ER15-1133-001.
    Applicants: Idaho Power Company.
    Description: Compliance filing: PAC LTF BORA-LGBP Service
Agreement--Closing Compliance Filing to be effective 10/30/2015.
    Filed Date: 10/30/15.
    Accession Number: 20151030-5394.
    Comments Due: 5 p.m. ET 11/20/15.

    Docket Numbers: ER15-1595-001.
    Applicants: Idaho Power Company.
    Description: Compliance filing: PAC LTF BORA-ENPR/LGBP Service
Agreements--Closing Compliance Filing to be effective 10/30/2015.
    Filed Date: 10/30/15.
    Accession Number: 20151030-5397.
    Comments Due: 5 p.m. ET 11/20/15.

    Docket Numbers: ER16-194-000.
    Applicants: Startrans IO, LLC.
    Description: Section 205(d) Rate Filing: Rate Change to be
effective 1/1/2016.
    Filed Date: 10/30/15.
    Accession Number: 20151030-5250.
    Comments Due: 5 p.m. ET 11/20/15.

    Docket Numbers: ER16-195-000.
    Applicants: Public Service Company of Colorado.
    Description: Section 205(d) Rate Filing: 2015-10-30_NSP-StJms-Tran
to Load-592-0.0.0-Filing to be effective 1/1/2016.
    Filed Date: 10/30/15.
    Accession Number: 20151030-5252.
    Comments Due: 5 p.m. ET 11/20/15.

    Docket Numbers: ER16-196-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Section 205(d) Rate Filing: 2804 Basin and WAPA-UGPR
Meter Agent Agreement Cancellation to be effective 10/1/2015.
    Filed Date: 10/30/15.
    Accession Number: 20151030-5269.
    Comments Due: 5 p.m. ET 11/20/15.

    Docket Numbers: ER16-197-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Section 205(d) Rate Filing: 2015-10-30_MISO TOs
Attachment O ADIT Filing to be effective 1/1/2016.
    Filed Date: 10/30/15.
    Accession Number: 20151030-5274.
    Comments Due: 5 p.m. ET 11/20/15.

    Docket Numbers: ER16-198-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Section 205(d) Rate Filing: 3118 Northern States Power
and Basin Electric Meter Agent Agreement to be effective 10/1/2015.
    Filed Date: 10/30/15.
    Accession Number: 20151030-5277.
    Comments Due: 5 p.m. ET 11/20/15.

    Docket Numbers: ER16-199-000.
    Applicants: Arizona Public Service Company.
    Description: Section 205(d) Rate Filing: Rate Schedule No. 274--
Planning Participation Agreement to be effective 10/1/2015.
    Filed Date: 10/30/15.
    Accession Number: 20151030-5279.
    Comments Due: 5 p.m. ET 11/20/15.

    Docket Numbers: ER16-200-000.
    Applicants: Duke Energy Indiana, Inc.
    Description: Section 205(d) Rate Filing: Reactive Rate Filing for
MISO to be effective 1/1/2016.
    Filed Date: 10/30/15.
    Accession Number: 20151030-5280.
    Comments Due: 5 p.m. ET 11/20/15.

    Docket Numbers: ER16-201-000.
    Applicants: Duke Energy Indiana, Inc.
    Description: Section 205(d) Rate Filing: Reactive Rate for Madison
(PJM) to be effective 1/1/2016.
    Filed Date: 10/30/15.
    Accession Number: 20151030-5285.
    Comments Due: 5 p.m. ET 11/20/15.

    Docket Numbers: ER16-202-000.
    Applicants: Arizona Public Service Company.
    Description: Section 205(d) Rate Filing: Service Agreement No.
347--Tohono O'odham to be effective 1/1/2016.
    Filed Date: 10/30/15.
    Accession Number: 20151030-5290.
    Comments Due: 5 p.m. ET 11/20/15.

    Docket Numbers: ER16-203-000.
    Applicants: Duke Energy Carolinas, LLC.
    Description: Section 205(d) Rate Filing: DEC-DEP PTP TSA to be
effective 1/1/2016.
    Filed Date: 10/30/15.
    Accession Number: 20151030-5296.
    Comments Due: 5 p.m. ET 11/20/15.

    Docket Numbers: ER16-204-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Section 205(d) Rate Filing: Tri-State Generation and
Transmission Association Formula Rate to be effective 1/1/2016.
    Filed Date: 10/30/15.
    Accession Number: 20151030-5302.
    Comments Due: 5 p.m. ET 11/20/15.

    Docket Numbers: ER16-205-000.
    Applicants: DATC Path 15, LLC.
    Description: Section 205(d) Rate Filing: Revised Appendix I 2016 to
be effective 1/1/2016.
    Filed Date: 10/30/15.
    Accession Number: 20151030-5319.
    Comments Due: 5 p.m. ET 11/20/15.

    Docket Numbers: ER16-206-000.
    Applicants: Midcontinent Independent System Operator, Inc., ITC
Midwest LLC.
    Description: Section 205(d) Rate Filing: 2015-10-30_SA 2862 ITC
Midwest-WPL Facilities Service

Agreement (G870) to be effective 11/1/2015.
    Filed Date: 10/30/15.
    Accession Number: 20151030-5345.
    Comments Due: 5 p.m. ET 11/20/15.

    Docket Numbers: ER16-207-000.
    Applicants: Dynegy Oakland, LLC.
    Description: Section 205(d) Rate Filing: Annual RMR Section 205
Filing and RMR Schedule F Informational Filing to be effective 1/1/
2016.
    Filed Date: 10/30/15.
    Accession Number: 20151030-5346.
    Comments Due: 5 p.m. ET 11/20/15.

    Docket Numbers: ER16-208-000.
    Applicants: Midcontinent Independent System Operator, Inc.,
International Transmission Company, ITC Midwest LLC, Michigan Electric
Transmission Company, LLC.
    Description: Section 205(d) Rate Filing: 2015-10-30_ITC, ITCM, METC
Attachment O Revisions to be effective 1/1/2016.
    Filed Date: 10/30/15.
    Accession Number: 20151030-5396.
    Comments Due: 5 p.m. ET 11/20/15.

    Docket Numbers: ER16-209-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Section 205(d) Rate Filing: Central Power Electric
Cooperative Formula Rate to be effective 1/1/2016.
    Filed Date: 10/30/15.
    Accession Number: 20151030-5424.
    Comments Due: 5 p.m. ET 11/20/15.

    Docket Numbers: ER16-210-000.
    Applicants: Idaho Power Company.
    Description: Section 205(d) Rate Filing: IPC-PAC JOOA Amendment and
Exhibit G to be effective 10/30/2015.
    Filed Date: 10/30/15.
    Accession Number: 20151030-5425.
    Comments Due: 5 p.m. ET 11/20/15.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: October 30, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-28209 Filed 11-4-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: September 21, 2007 (Volume 72, Number 183)]
[Notices]
[Page 54086-54087]
[DOCID:fr21se07-144]

-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copy Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:

    Form N-14, SEC File No. 270-297, OMB Control No. 3235-0336.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Form N-14 (17 CFR 239.23)--Registration Statement Under the
Securities Act of 1933 for Securities Issued in Business Combination
Transactions by Investment Companies and Business Development
Companies. Form N-14 is used by investment companies registered under
the Investment Company Act of 1940 (15 U.S.C. 80a-1 et seq.)
(``Investment Company Act'') and business development companies as
defined by Section 2(a)(48) of the Investment Company Act to register
securities under the Securities Act of 1933 (15 U.S.C. 77a et seq.) to
be issued in business combination transactions specified in rule 145(a)
(17 CFR 230.145(a)) and exchange offers. The securities are registered
under the Securities Act to ensure that investors receive the material
information necessary to evaluate securities issued in business
combination transactions. The Commission staff reviews registration
statements on Form N-14 for the adequacy and accuracy of the disclosure
contained therein. Without Form N-14, the Commission would be unable to
verify compliance with securities law requirements. The respondents to
the collection of information are investment companies or business
development companies issuing securities in business combination
transactions. The estimated number of responses is 375 and the
collection occurs only when a merger or other business combination is
planned. The estimated total annual reporting burden of the collection
of information is approximately 620 hours per response for a new
registration statement, and approximately 350 hours per response for an
amended Form N-14, for a total of 196,050 annual burden hours.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the Commission's mission, including whether the information will have
practical utility; (b) the accuracy of the Commission's estimate of the
burden of the collection of information; (c) ways to enhance the
quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information

technology. Consideration will be given to comments and suggestions
submitted in writing within 60 days of this publication.
    Please direct your written comments to R. Corey Booth, Director/
Chief Information Officer, Securities and Exchange Commission, C/O
Shirley Martinson, 6432 General Green Way, Alexandria, VA, 22312; or
send an e-mail to<EMAIL_ADDRESS>
    Dated: September 13, 2007.
Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-18687 Filed 9-20-07; 8:45 am]

BILLING CODE 8010-01-P


MEMORANDUM SUBJECT: Review of Data/ Information Submitted by Certis USA to Support a Tolerance Exemption ( Petition No. 2F6477) for Residues of Ammonium Bicarbonate in Olives ( D288947; Case 295326; S631096)

TO: Andrew Bryceland, RAL Biochemical Pesticides Branch ( BPB) Biopesticides and Pollution Prevention Division ( BPPD)

FROM: Roy D. Sjoblad BPB, BPPD Background: The petition by Certis on June 17, 2002 for a tolerance exemption for ammonium bicarbonate in olives failed to pass an initial BPB screen ( deficiencies stated in 10/ 28/ 02 letter from S. Reilly to Certis USA). On 2/ 13/ 03, Certis responded to the deficiencies of the 10/ 28/ 02 letter. This Memorandum comprises review of the data/ information submitted to support the tolerance petition.

BPB Conclusion: The data/ information submitted, and the request for waivers of all further additional studies, are acceptable and support the request for an exemption from the requirement of a tolerance for ammonium bicarbonate when used as a pesticide active ingredient as proposed.

Data/ information submitted:

Volume 4: Physical and Chemical Properties:

Study Title: " Ammonium Bicarbonate Feeding Attractant Physical and Chemical Properties Data Summary and Request for Data Waivers" ( J. M. Wagner, 11/ 11/ 02; Wagner Regulatory Associates, Inc. Delaware). The information presented in volume 4, has been culled from MRID 457120 01 submitted with the original petition.

Ammonium bicarbonate is produced from ammonia in water upon passing through of excess carbon dioxide. The process involves cooling and crystallization, and subsequent thickening and drying of the crystal suspension. There are no other reactants and thus no impurities. The registrant purchases food grade ammonium bicarbonate from a supplier which is certified as at least 99.2 % pure ( preliminary analysis, 930.1700). An enforcement analytical method ( 830.1800) was provided, which involves titration with 1N HCl in a weighed sample of ammonium bicarbonate to which has been added methyl red TS. HCl is added until the solution  2

becomes pink; the solution is boiled and then cooled. The titration continues until the pink color does not fade after boiling. The ammonium bicarbonate is then bound in a polymer, which is attached to a cellulose card. During use, the card is suspended from olive tree limbs. The amount of ammonium bicarbonate applied per orchard acre is 168 grams ( 0.3 lbs). Exposure of the ammonium bicarbonate to ambient sunlight and heat results in the slow release of small amounts of ammonia, which as a signal of decomposing protein, attracts insects.

Following are the physical and chemical properties:

Color/ odor ( 830.6302/ 830.6304)  Clear/ white, with faint ammonia smell Physical state ( 830.6303)  Solid crystals Stability ( 830.6313)  Decomposes to ammonia ( 21.5%), carbon dioxide ( 55.7%) and water ( 22.8%) at 60C Oxidation/ reduction ( 830.6314)  Reacts strongly to strong acids and strong bases. Incompatible also with alkali metals, copper, nickel. Flammability ( 830.6315)  Non combustible Storage stability ( 830.6317)  Stable at normal temperatures and pressure Corrosion characteristics ( 830.6320)  None noted, stable at normal temperatures and pressure. Miscibility ( 830.6319)  Not applicable; EP is not an emulsifiable concentrate and is not to be diluted with petroleum products pH ( 830.7000)  7.8 ( 0.1N) Viscosity ( 830.7100)  Not applicable; product is not a liquid. Melting point ( 830.7200)  107.5C Boiling point ( 830.7220)  Not applicable; Technical is not a liquid. Density/ specific gravity ( 830.7300)  1.573 1.586 Dissociation constant ( 830.7370)  1.45 Partition coefficient ( 830.7550)  Not applicable; technical is not organic. Solubility ( 830.7840)  Soluble water, glycerol. Not soluble in acetone, alcohol. Vapor pressure ( 830.7950)  60 mm Hg @ 20C.

BPB Discussion: There are no deficiencies in requirements to address product identity, manufacturing process, and physical and chemical properties. The data are Acceptable.

Volume 5:

Study title: " Ammonium Bicarbonate Insect Feeding Attractant Summary of Toxicity Data and Request for Data Waivers" ( J. M. Wagner, 11/ 11/ 02; Wagner Regulatory Associates, Inc., Delaware). The information presented in Volume 5 has been culled from MRID 457120 01 and MRID 457120 02 submitted with the original petition.

Acute oral LD50 toxicity study in the rat. No study was submitted, however, the literature and submitted MSD sheets, report an acute oral LD50 value of 1576 mg/ kg in the rat. This information is Acceptable to allow placement of ammonium bicarbonate in Toxicity category  3

III for the oral route.

Genotoxicity. Ammonium bicarbonate ( with or without S9 mix activation) was not mutagenic in the Ames assay when S. typhimurium strains TA97 and TA102 were exposed to 0.1 to 10 mg/ assay plate.

Other: The mouse intravenous LD 50 value was reported as 245 mg/ kg. Ammonium bicarbonate can be irritating to the eyes of rabbits, but the information was not adequate to establish a Toxicity category. An LC50 value ( at 96 hours) of 17300 ug/ L has been reported for the rainbow trout.

The registrant has requested a waiver for any/ and all mammalian toxicity studies typically required to support a tolerance exemption for ammonium bicarbonate. These studies include acute oral, dermal, and inhalation toxicity studies, eye and skin irritation, and mutagenicity studies, a 90 day feeding, a developmental toxicity and an immunotoxicity study.

The reasons set forth for supporting the waiver requests were as follows:

1. The ammonium bicarbonate in the end use product is contained within a polymeric substance, and the end use product is attached to olive tree branches. Thus oral, dermal, and inhalation exposure are unlikely 2. The maximum seasonal use rate of ammonium bicarbonate is 168 g/ acre. .

3. In the product, the ammonium bicarbonate will slowly decompose to ammonia, carbon dioxide, and water. The total yield of ammonia would be 34.5 grams per season. If 36 g of ammonia is distributed in a single point in time over an acre of olive orchard to a height of 15 feet, the calculated concentration of ammonia would be 3 ppb. Assuming a release of ammonia from the product occurs over a 4 5 month period, a theoretical daily concentration can be estimated at about 0.03 ppb/ day during this time.

4. This 0.03 ppb value is about 100 times less than the worldwide ambient atmospheric estimates of 1 3 ppb, and about 10,000 fold lower than ammonia concentrations ( i. e., 300 ppb) reported over an agricultural field after fertilizer application.

5. Acute inhalation LC50 values after 15 minutes of exposure to ammonia are reported as 17,401 ppm in the rat, and after 30 minutes of exposure, 21,430 ppm in the mouse.

6. Ammonium bicarbonate is exempt from the requirement of a tolerance when used as a surfactant, or a suspending or dispensing agent in formulations applied to growing crops or to food commodities after harvest. [ 40 CFR 180.1001( c)].

7. The US FDA considers ammonium bicarbonate as GRAS ( 21 CFR 582.1135), and allows its  4

use as a Direct Food Additive ( 21 CFR 184.1135) with an upper limit of 3.2% ( 3200 ppm), when used, for example, as a leavening agent in baked bread.

The following useful information from human exposure to ammonia, presented in MRID 457120 02, was not culled out by the registrant and was not included in the resubmission:

1. " Ammonia is produced in the human body from metabolism of protein, amino acids and other nitrogen containing chemicals... A large amount of ammonia (> 50 mg/ kg) is produced in the body each day [ from] breakdown of dietary protein and amino acids."

2. Acute and chronic inhalation minimal risk levels ( MRLs) of 0.5 ppm and 0.3 ppm, respectively, have been derived from studies with humans.

3. The Occupational Safety and Health Administration ( OSHA) has set a short term ( 15 minute) exposure level of 35 ppm for ammonia. The National Institute for Occupational Safety and Health ( NIOSH) recommends that ammonia levels in the workplace be limited to 50 ppm for 5 minutes of exposure.

4. Ammonia is slightly irritating to the eyes of humans at 100 ppm, and is immediately irritating to the eyes and throat at 698 ppm.

BPB Discussion: The above reasons serve as an acceptable rationale for waiver of acute and subchronic oral studies, a dermal toxicity study, an acute inhalation study, mutagenicity studies, an immunotoxicity study, and a developmental toxicity study. Exposure to either ammonium bicarbonate, or to the ammonia component of ammonium bicarbonate, from the pesticidal use is not likely to add significantly to ambient exposures already documented and without reported adverse effects. The amounts of ammonia released from the product over time result in calculated concentrations of 0.03 ppb/ day, well below the chronic human inhalation MRL of 0.3 ppm. Since the rationales support waivers for all oral exposure study requirements the tolerance exemption can be supported.

The rationales do not support waivers, however, for the primary dermal and eye irritation studies for ammonium bicarbonate, and for reporting of hypersensitivity incidents. However, the precautionary label statement of " Warning" and the requisite hazard and first aid statements ( e. g., wear protective eyewear, rinse skin with water for 15 20 minutes, repeated skin contact may cause allergic skin reactions)  presumably triggered by adverse reactions that might occur from exposure to a different active ingredient in the product  are sufficient to protect from any adverse reactions that may occur from exposure to ammonium bicarbonate. In addition, the First Aid label statements for treatment of eye and dermal exposures are at least as restrictive as the First Aid measures accompanying the MSD sheets submitted by the registrant for 99 100% ammonium bicarbonate. Any adverse reactions from handling or use of the product must be reported.