**Example Case Study:**

**Application for a PM~2.5~ or PM~10-2.5~ Equivalent Method**

**(FEM) Determination Under 40 CFR Part 53**

January 29, 2007

*Contents*

[Utilities]{.underline}

User Notes Page ii

Example Case Study: File name: ***Example Case Study - PM FEM.doc***
(Word)

Associated resource files: Part 53 Amended Regulatory Language:

File name: ***Part 53 Reg amendments.dot*** (Word)

Data Spreadsheet: File name: ***PM FEM comparability test data
template.xls*** (Excel)

Example Data Spreadsheet: File name: ***PM FEM comparability
test-EXAMPLE data.xls* (**Excel)

Test protocol guidance

and related information:
[www.epa.gov/ttn/amtic](http://www.epa.gov/ttn/amtic) (\> Criteria
Pollutants)

[Example Case Study Application]{.underline}

1.  General Information

2.  Description of Candidate Method

3.  Requirements for the Design, Configuration, Operation, and
    Manufacturing of the Candidate Method

4.  Description of the Field FRM Comparison Tests (Part 53, Subpart C)

5.  Field Comparison Test Data and Test Calculations

6.  Attachments

Prepared for the U.S. EPA/OAQPS by RTI International under EPA Contract
68-D-02-065, WA5-05; RTI Project No. 91U-08637.005.505.

**User Notes**

1\. This Case Study is intended to serve as an aid to applicants
interested in preparing an application for an EPA equivalent method
determination for a candidate PM~2.5~ or PM~10-2.5~ Class II or Class
III ambient air monitoring method. (Class II methods are filter-based,
integrated-sample type manual methods; Class III methods are defined as
automated, continuous, near-real time PM analyzers.) Such an application
would be submitted to the EPA under the regulatory provisions of Title
40, Part 53 of the Code of Federal Regulations (40 CFR Part 53). The EPA
considers the merits and performance capabilities of a candidate method
based on the information and specific test results contained in the
submitted application. If the candidate method is found to satisfy all
the applicable equivalent method requirements, the method is designated
by the EPA as a Federal equivalent method (FEM) under Part 53.
EPA-designation of a method as an FEM allows the method to be used by
State, Local, and Tribal air monitoring agencies in their ambient air
monitoring networks to determine attainment of EPA's national ambient
air quality standards (NAAQS) for particulate matter. FEM designation
also affords a monitoring method enhanced credibility in regard to its
reliability and fidelity in providing air quality measurements similar
in quality to measurements obtained by the Federal reference method
(FRM) for the corresponding PM indicator (PM~2.5~ or PM~10-2.5~).

2\. This Case Study includes example paragraphs typical of the types of
specific information, or of the nature of the information, that is
required to be included in an EPA FEM application. These, or similar,
paragraphs should be revised, rewritten, or augmented and tailored as
appropriate to be specific for the particular subject candidate method.
In particular, the \[**bold, green text** **enclosed in brackets**\] is
merely *hypothetical* *example text* and should be replaced with
similar, appropriate text specifically related to the subject candidate
method, or to its associated testing protocol and test results, for
which the application is being prepared.

3\. The resource file, ***Part 53 Reg amendments.dot***, provides the
formal FEM and application requirements in the actual Part 53 regulation
language for convenient reference. The Case Study incorporates
convenient [hyperlinks](../Part%2053%20Reg%20amendments.dot#Part53) to
context-specific provisions of this regulation to confirm a particular
requirement and to reference the details of the more complex
requirements. Note that this Part 53 resource file contains only the new
provisions and amendments to 40 CFR Part 53 that became effective on
December 18, 2006 (unless otherwise indicated). Generally, these new and
amended provisions are the ones that are of principle concern in the
preparation of applications for FEM designation of Class II and Class
III candidate methods for PM~2.5~ or PM~10-2.5~. However, the unrevised
sections 53.6, 53.7, and 53.10 through 53.16 are also applicable and may
be of interest, as well. The previously existing version of Part 53
(containing the non-amended sections) is available at
<http://www.access.gpo.gov/nara/cfr/cfr-table-search.html#page1>. The
complete content of Part 53, including the 12/18/06 amendments, should
be available at this web site after July 1, 2007.

4\. For the links to the Part 53 regulation language to work, the
***Part 53 Reg amendments.dot*** resource file must reside in the same
folder as this Case Study file. This resource file (template file) will
open *automatically* in Word as a second document along with this Case
Study file (the first link that opens the document may not go to the
correct place in the document). Note: the resource file contains a small
macro, and if you get a macro warning message, you may safely
[enable]{.underline} the macro. (To avoid the macro warning, you may set
your Word macro security to "low" (Tools\>Options\>Security\>Macro
Security.) For best use of this resource file, the "Document Map" should
be visible on the left side. If the document map is not there (because
the macro was disabled), click on the **View** menu and then on
**Document Map** to activate it. The Part 53 resource file has an
outline structure, so that the Document Map may be used to go to
specific sections, tables, figures, or equations of Part 53 (figures
appear only when in the Print Layout view). It is also presented such
that both an Internet-type tool bar and the outline tool bar should be
present and available for use.

5\. In the Case Study, section numbers in brackets (
\[[§53.35...](../Part%2053%20Reg%20amendments.dot#Sec53_35a)\] ) are
hyperlinks directly to that section of the Part 53 regulation language
on the resource file (*Part 53 Reg amendments.dot*) and usually include
tips with additional information. Other [[]{#BK1 .anchor}underlined blue
text](#BK1) also offers tips and links to pertinent regulatory
requirements or other potentially useful information. After viewing a
linked reference to the Part 53 regulation, the Internet-style "back"
button ![](media/image1.png){width="0.22291666666666668in"
height="0.22291666666666668in"} may be used to conveniently return to
this Case Study document. Some links take you to other parts of this
Case Study document; and if you don't have a "back" button
![](media/image1.png){width="0.22291666666666668in"
height="0.22291666666666668in"} to take you back to your previous place
in this document, you can get one by clicking on View\>Toolbars and then
on "Web."

6\. If this Case Study is used as a framework for the preparation of an
actual EPA FEM application, it is suggested that one copy of the Case
Study file be kept intact to serve as a reference and model, and a
second copy might be revised and rewritten as necessary to tailor it to
the subject candidate method and applicant. As this is carried out, the
bracketed section references and underlined hyperlinks should, of
course, be deleted.

7\. The Case Study is structured to provide a basic skeleton to address
the various different types of information required in an application.
No particular format or structure for this information is mandated by
Part 53, as long as all the required information is contained in the
application and submitted. Although the body of this Case Study document
with the example information paragraphs is rather modest in length, a
substantial amount of other, highly detailed information is required in
the application. This includes information regarding such aspects as the
nature and design of the candidate method, the manufacturing quality
system applicable to the candidate method, its operating or instruction
manual, the manufacturing facility ISO registration documentation,
location information for the test sites, details of the installation,
calibration, and operation of the test instruments or samplers at each
test site, the test data obtained at each test site, and (in the case of
Class III candidate methods) hourly data obtained during the field
tests. The use of attachments to a base application framework, as
suggested by this Case Study, is only one of perhaps other ways that
this very detailed supplemental information may be included in the
application. While most information is typically expected to be in hard
copy, certainly some types of information, *e.g.* test data, might be
better attached and submitted on some form of computer-readable
electronic media.

8\. Questions regarding the submission of an FEM application or
clarification of the FEM testing or other Part 53 regulatory
requirements should be directed to the Reference and Equivalent Method
Program, MD D205-03, U. S. Environmental Protection Agency, Research
Triangle Park, NC 27711 (Phone: 919-541-3737, e-mail:
<Hunike.Elizabeth@epa.gov>). See also the **Notice to Potential
Applicants** and the **PM FEM FAQs** documents, as well as other
information or guidance documents that may be posted from time to time,
at [www.epa.gov/ttn/amtic](http://www.epa.gov/ttn/amtic) (\>Criteria
Pollutants).

**Application for a \[PM~2.5~ or PM~10-2.5~\] Equivalent Method
Determination Under 40 CFR Part 53**

1\. [General Information](../Part%2053%20Reg%20amendments.dot#Sec53_4)

1.1 This application is [submitted
to](../Part%2053%20Reg%20amendments.dot#Sec53_4a) the Director, National
Exposure Research Laboratory, Reference and Equivalent Method Program
(MD-D205-03), U. S. Environmental Protection Agency, Research Triangle
Park, North Carolina 27711 for an equivalent method determination under
40 CFR Part 53 on a candidate method based on the \[**Fine Instrument
Company's Model XYZ-123 PM~2.5~ Ambient Air Monitor\]**.
[\[](../Part%2053%20Reg%20amendments.dot#Sec53_4a)§53.4(a)\]

1.2 This application is submitted by \[**Mr. M. T. Fine**\] under his
signature as an authorized representative of:
[\[](../Part%2053%20Reg%20amendments.dot#Sec53_4b)§53.4(b)\]

\[**Fine Instrument Company, Inc.**

**Air Monitoring Instrument Division**

**12345 67^th^ Street**

**Paradise, Montana, 99999\]**

**[\[M. T. Fine\]]{.underline}**

**\[M. T. Fine, Director of Ambient Air Instruments**\]

1.3 This application, including all its contents and any additional
information submitted subsequently that is intended to become an
integral part of the application, is hereby identified as [confidential
or privileged information in accordance with 40 CFR
§53.15](../Part%2053%20Reg%20amendments.dot#Sec53_15).

1.4 The candidate method for which this application is submitted is
[identified as](../Part%2053%20Reg%20amendments.dot#Sec53_4b1) the
\[**Fine Instrument Company's Model XYZ-123 PM~2.5~ Ambient Air
Monitor\].**
\[[§53.4(b)(1)](../Part%2053%20Reg%20amendments.dot#Sec53_4b1)\] This
method is described in the associated \[**Model XYZ-123 Operation and
Instruction Manual (configured for PM~2.5~) (**[[]{#At8
.anchor}Attachment 8](#Atach8)**)**\] and \[[[]{#At1 .anchor}Attachment
1](#Atach1)\], both of which are included as parts of this application.
\[[§53.4(b)(2)](../Part%2053%20Reg%20amendments.dot#Sec53_4b2)\]

1.5 The required, comprehensive \[**Model XYZ-123 Operation and
Instruction Manual**\] is included \[[as Attachment 8](#Atach8)\] and
describes complete and detailed operational, maintenance, and
calibration procedures for using the \[**Model XYZ-123 instrument**\].
\[[§53.4(b)(3)](../Part%2053%20Reg%20amendments.dot#Sec53_4b3)\]

1.6 The candidate method described in this application has been tested
in accordance with the procedures described in the applicable portions
of Subparts C, \[**D, E and F**\].
\[[§53.4(b)(4)](../Part%2053%20Reg%20amendments.dot#Sec53_4b4)\]

1.7 Descriptions of the test facilities, test configurations, the test
data obtained, test records, calculations, and test results are provided
in \[[[]{#At5 .anchor}Attachment 5](#Atach5)\] in association with the
discussion of each specific required test.
\[[§53.4(b)(5)](../Part%2053%20Reg%20amendments.dot#Sec53_4b5)\]

1.8 The \[**Model XYZ-123 PM~2.5~ Ambient Air Monitors**\] tested in
accordance with Part 53 are representative of the \[**Model XYZ-123
PM~2.5~ Ambient Air Monitor**\] described in this application.
\[[§53.4(b)(6)](../Part%2053%20Reg%20amendments.dot#Sec53_4b6)\]

1.9 A detailed description of the quality system that will be used to
ensure that all instruments offered for sale under an equivalent method
designation for this candidate method will have essentially the same
performance characteristics as the instruments tested for this
application is contained in \[[[]{#At2 .anchor}Attachment 2](#Atach2)\].
\[**Attachment 2**\] also describes the durability characteristics of
the instrument and its warranty program that ensures that the instrument
will meet the required specifications throughout the warranty period.
\[[§53.4(c)](../Part%2053%20Reg%20amendments.dot#Sec53_4c)\]

1.10 Upon request of the EPA Reference and Equivalent Method Program, an
instrument that is representative of this candidate method will be
shipped to EPA for test purposes in connection with this equivalent
method application.
\[[§53.4(d)](../Part%2053%20Reg%20amendments.dot#Sec53_4d)\]

2\. Description of the Candidate Method

2.1 \[**The Model XYZ-123 PM Monitor is an automatic beta attenuation
type PM analyzer that can be configured with various inlets and particle
size separators. For this equivalent method application, the candidate
analyzer is configured with a PM~2.5~ particle size separator to provide
near-real time measurements of ambient concentrations of PM~2.5~. This
configuration is identified as the Model XYZ-123 PM~2.5~ Monitor and
described completely in the Model XYZ-123 Operation and Instruction
Manual (configured for PM~2.5~), with supplemental information provided
in** [Attachment 1](#Atach1)**, both of which are included as integral
parts of this application. In consideration of the nature of the Model
XYZ-123 PM~2.5~ Monitor, we believe this candidate method should be
categorized as a Class III candidate equivalent method for PM~2.5~.**\]
\[[§53.1(II) -- Class
II](../Part%2053%20Reg%20amendments.dot#Sec53_1_II)\] \[[§53.1(III) --
Class III](../Part%2053%20Reg%20amendments.dot#Sec53_1_III)\]

3\. Requirements for the Design, Configuration, Operation, and
Manufacturing of the Candidate Method

3.1 \[**The Model XYZ-123 PM~2.5~ Monitor meets all "reasonably
applicable" requirements of 40 CFR Part 50, Appendix L and Part 53,
Subpart E as described in this section 3.**\] [\[§53.3(a)(3) --
PM](../Part%2053%20Reg%20amendments.dot#Sec53_3a3)~2.5~ Class II
methods\] \[[§53.3(a)(5) --
PM](../Part%2053%20Reg%20amendments.dot#Sec53_3a5)~10-2.5~ Class II
methods\] \[[§53.3(b)(3) --
PM](../Part%2053%20Reg%20amendments.dot#Sec53_3b3)~2.5~ or PM~10-2.5~
Class III methods\]

3.2. \[**The Model XYZ-123 PM~2.5~ Monitor**\] is manufactured in an ISO
9001-registered facility. See [[]{#At3 .anchor}\[Attachment
3](#Atach3)\] for the ISO 9001 registration documentation.
\[[§53.3(a)(6) or
(b)(4)](../Part%2053%20Reg%20amendments.dot#Sec53_3b4)\]

4\. Description of the Field FRM Comparison Tests (Part 53, [Subpart
C](../Part%2053%20Reg%20amendments.dot#Sec53_30a)) \[[§53.3(a) (for
manual methods)](../Part%2053%20Reg%20amendments.dot#Sec53_3a) or [§53.3
(b) (for automated
methods)](../Part%2053%20Reg%20amendments.dot#Sec53_3b)\]

4\. 1 \[**The Model XYZ-123 PM~2.5~ Monitor**\] was tested for
comparability to the \[**PM~2.5~ or PM~10-2.5~**\] reference method at
each of \[**two or four**\] test sites, as required by [Table
C-4](../Part%2053%20Reg%20amendments.dot#TC4) of Subpart C. \[[§53.35(a)
-- Overview](../Part%2053%20Reg%20amendments.dot#Sec53_35a)\]
\[[§53.35(b) -- Required test
sites](../Part%2053%20Reg%20amendments.dot#Sec53_35b)\] The test site
locations are identified and described in \[[[]{#At4 .anchor}Attachment
4](#Atach4)\] along with pertinent information, data, and a narrative
summary to show that each site has characteristics that meet the
specific site requirements of [Table
C-5](../Part%2053%20Reg%20amendments.dot#TC5) of Subpart C. [\[§53.30(b)
-- General site
requirements](../Part%2053%20Reg%20amendments.dot#Sec53_30b)\]
\[[§53.35(b)(1) -- Specific site
requirements](../Part%2053%20Reg%20amendments.dot#Sec53_35b1)\] \[**Note
that these test site locations and the associated supporting information
have been submitted to EPA previously under**
[§53.30(b)(2)](../Part%2053%20Reg%20amendments.dot#Sec53_30b2)**, and
the test sites have been tentatively approved by EPA, as evidenced by
the EPA Letter of Approval dated \[date of Letter\] and included in**
[Attachment 4](#Atach4)\].

4.2 The comparability tests at each site were conducted in the required
seasons, as required by [Table
C-5](../Part%2053%20Reg%20amendments.dot#TC5) and defined in
[§53.35(b)(2)](../Part%2053%20Reg%20amendments.dot#Sec53_35b2), as
follows: \[**Site A, winter and summer; Site B, winter; Site C, winter;
Site D, summer.**\] The actual dates of the test days for each site are
given in the test data Excel spreadsheets submitted under Section 5,
below.

4.3 All test concentrations obtained at all required test sites were
within the 3 to 200 μg/m^3^ concentration range required by [Table
C-4](../Part%2053%20Reg%20amendments.dot#TC4), as shown in the test data
Excel spreadsheets submitted under Section 5, below \[**except for 3
test days at test site D, on which the mean concentration measurements
of the FRM samplers were less than 3 μg/m^3^**\].
[\[§53.35(b)(3)](../Part%2053%20Reg%20amendments.dot#Sec53_35b3)\]

4.4 At each test site, three collocated reference method (FRM)
single-filter samplers and three collocated \[**Model XYZ-123 PM~2.5~
Monitors**\] (candidate method) were installed and operated concurrently
to obtain simultaneous test measurements of PM~2.5~ concentrations at
the site. The ambient air inlet points of all samplers and monitors were
positioned at approximately the same height above ground level and were
separated horizontally [between 1 and 4 meters, as
required](../Part%2053%20Reg%20amendments.dot#Sec53_35c1),
[\[](../Part%2053%20Reg%20amendments.dot#Sec53_30a1)**except at site C,
where physical limitations of the available space at the test site
required two of the test instruments to be horizontally separated by
about 5 meters**\]. Diagrams, photos, and other information describing
the details of the setup of the samplers and monitors at each test site
are included in \[[Attachment 4](#Atach4)\].
\[[§53.35(c)(1)](../Part%2053%20Reg%20amendments.dot#Sec53_35c1)\]

4.5 All FRM samplers were installed, calibrated, and subsequently
operated in accordance with 40 CFR Part 50, Appendix L, with their
manufacturer's operation and instruction manual, and with applicable
portions of "Quality Assurance Document 2.12." The \[**Model XYZ-123
PM~2.5~ Monitors**\] were setup, calibrated, and operated in accordance
with the \[**Model XYZ-123 Operation and Instruction Manual (configured
for PM~2.5~)**\], a copy of which is included in this application as
\[[Attachment 8](#Atach8)\]. \[[§53.30(e) and
(f)](../Part%2053%20Reg%20amendments.dot#Sec53_30e)\]
\[[§53.35(c)(1)](../Part%2053%20Reg%20amendments.dot#Sec53_35c1)\]

4.6 Information regarding the calibration of the FRM samplers and the
\[**Model XYZ-123 PM~2.5~ Monitors**\], the calibration data, and the
calibration standards used in calibrating the test instruments is
contained in \[[Attachment 5](#Atach5)\].
\[[§53.30(g)](../Part%2053%20Reg%20amendments.dot#Sec53_30g)\]

5\. Field Comparison Test Data and Test Calculations

5.1 All comparison test data obtained from the comparability tests have
been entered into site-specific copies of the EPA-provided Excel
spreadsheet (*PM Comparability Test data template.xls*), one spreadsheet
set for each test site. \[www.epa.gov/ttn/amtic (\>Criteria
Pollutants)\]

5.2 As is shown by the test data spreadsheets, not less than 23 valid
daily sets of comparison data were obtained at test sites \[**B, C, and
D**\], \[**and not less than 46 valid daily sets of comparison data were
obtained at test site A, even though a few of the data sets were not
valid at some sites for various reasons noted in the Comments column of
the spreadsheets**\].
\[[§53.35(c)(2)](../Part%2053%20Reg%20amendments.dot#Sec53_35c2)\] All
valid data sets obtained during each test campaign are included in the
respective test data spreadsheets.
\[[§53.35(c)(3)](../Part%2053%20Reg%20amendments.dot#Sec53_35c3)\]

5.3 All daily integrated PM concentration test measurements were of at
least \[**23 hours duration, typically running from 11:00 am to 10:00 am
the following day and identified by the date when the sample was
started**\]. The sample filters were retrieved each day, stored and
transported to the weigh laboratory every 3 days in an ice cooler, and
kept in refrigerated storage at the weigh laboratory. All FRM sampler
filters were weighed by \[**weigh laboratory**\] at least
\[**weekly**\]. Filter handling and other aspects of the FRM test
measurements were in compliance with the FRM reference method and in
general accordance with "Quality Assurance Document 2.12."
\[[§53.35(c)(4)](../Part%2053%20Reg%20amendments.dot#Sec53_35c4)\]

5.4 Measurements corresponding to the FRM measurements were obtained by
the \[**Model XYZ-123 PM~2.5~ Monitors**\] in accordance with the
\[**Model XYZ-123 Operation and Instruction Manual (configured for
PM~2.5~) (**[Attachment 8](#Atach8)**)**\]. \[**Twenty-three hour
averages corresponding to the collection time of the FRM samples (*i.
e.,* 23-hour averages over the same 11:00 to 10:00 am time period as the
corresponding FRM samples) were calculated for each daily data set from
the one-hour averages provided by the Model XYZ-123 PM~2.5~ Monitors.
These calculated averages were entered into the spreadsheets.**\] The
original hourly measurement data are contained \[**on a CD as** [[]{#At7
.anchor}Attachment 7](#Atach7)\].
\[[§53.35(c)(5)](../Part%2053%20Reg%20amendments.dot#Sec53_35c5)\]

5.5 As noted above, all comparison test data obtained from the
comparability tests have been entered into the EPA-provided Excel
spreadsheets, using a separate spreadsheet set for each site. \[**Data
from both winter and summer test campaigns at site A have been combined
and entered into the Site A spreadsheet set.**\] \[**Other than
calculating the 23-hour average concentration measurements from the
1-hour measurements provided by the Model XYZ-123 PM~2.5~ Monitors
corresponding to the time periods of the FRM integrated samples,**\] all
measurements are reported as obtained from the respective samplers or
test monitors.
\[[§53.35(c)(6)](../Part%2053%20Reg%20amendments.dot#Sec53_35c6)\]

5.6 All calculations of the test data are carried out by the EPA
spreadsheets \[[[]{#At6 .anchor}Attachment 6](#Atach6)\] and are
therefore presumed to be correct. The summary tab in each of the
spreadsheets indicates that the \[**Model XYZ-123 PM~2.5~ Monitor**\]
passed all required tests, \[**although the [slope of the comparison for
Site C was marginal](../Part%2053%20Reg%20amendments.dot#Sec53_30a1).
This resulted from a prolonged period of rainy weather that occurred
during the test, which caused relatively low PM~2.5~ concentrations with
relatively little day-to-day variation. Although additional test data
(in excess of the minimum 23 days) were obtained, the CCV for the test
was still quite low and the slope was not well defined statistically
because of the clustered nature of the test data.**\] \[[§53.35(d) --
(h)](../Part%2053%20Reg%20amendments.dot#Sec53_35d)\]

6\. Attachments

[]{#Atach1 .anchor}**\[[Attachment 1](#At1) Technical Aspects of the
Model XYZ-123 PM~2.5~ Monitor\]**

***\[This attachment may include additional technical details to
describe the design, configuration, construction, function, operation or
other aspects of the candidate method to supplement the information
contained in the manual or to include technical information that can't
be in the manual because of the confidential nature of the
information.***
\[[§53.4(b)(2)](../Part%2053%20Reg%20amendments.dot#Sec53_4b2)\]
***\]***

[]{#Atach2 .anchor}**\[[Attachment 2](#At2) Manufacturing quality system
and analyzer durability characteristics for the Model XYZ-123 PM~2.5~
Monitor\]**

***\[This attachment should include detailed information as required
by*** ***[Section 53.4(c)](../Part%2053%20Reg%20amendments.dot#Sec53_4c)
of the Part 53 regulation.\]***

[]{#Atach3 .anchor}**\[[Attachment 3](#At3) ISO-9001 registration
documentation\]**

***\[This attachment should include detailed information as required by
Section [53.3(a)(6) or
(b)(4)](../Part%2053%20Reg%20amendments.dot#Sec53_3b4) of the Part 53
regulation.\]***

[]{#Atach4 .anchor}**\[[Attachment 4](#At4) Test site locations and
supporting information\]**

***\[This attachment should include details and documentation to support
the selection of each test site location, including maps or other
information to identify its location, photos or other information to
describe the nature and character of each test site, and information to
justify its acceptability as a test site that meets the specified
requirements. The latter may include a narrative justification
supplemented with recent, nearby pollutant measurements, weather and
climatic data characteristic of the site, emission inventory data or a
description of predominant pollutant sources in the area, and the
influence of particularly nearby sources or obstructions.***
[\[§53.30(b) -- General site
requirements](../Part%2053%20Reg%20amendments.dot#Sec53_30b)\]
[\[§53.35(b)(1) -- Specific site
requirements](../Part%2053%20Reg%20amendments.dot#Sec53_35b1)\] \[[Table
C-5](../Part%2053%20Reg%20amendments.dot#TC5)\] ***Note that
pre-approval of a test site or all test sites may be obtained from the
EPA prior to conducting the tests to provide assurance that one or more
test sites or site locations will not be disapproved after the test data
is obtained and the application is submitted.*
\[**[§53.30(b)(2)](../Part%2053%20Reg%20amendments.dot#Sec53_30b2)**\]*\]***

**\[**[[]{#Atach5 .anchor}**Attachment 5**](#At5) **Instrument
calibrations, calibration data, calibration standards, and other test
documentation\]**

***\[This attachment should contain the documentation of all pertinent
details of the test setup at each site, including: diagrams or other
information on the arrangement and installation of both the candidate
method instruments and the FRM samplers, records of the calibration of
each instrument or sampler, certifications of the calibration standards
used, operational protocols for each test instrument and sampler for
each test day, qualifications of the instrument operator(s), and full
details and explanation of any malfunctions, service or repair
requirements, unusual circumstances or occurrences, or any events that
may have an effect on the test data obtained and what such effect might
be.*** \[[§53.4(b)(5)](../Part%2053%20Reg%20amendments.dot#Sec53_4b5)\]
***\]***

**\[**[[]{#Atach6 .anchor}**Attachment 6**](#At6) **Comparability test
data\]**

> ***\[This attachment should contain the actual test data obtained in
> the comparability tests at each site. The data may be submitted on
> paper, but more typically would be submitted in a spreadsheet or other
> appropriate data format on a CD or other electronic medium. It is
> suggested that the EPA-provided spreadsheet (*PM Comparability Test
> data template.xls*) be used to submit the test data, using a separate
> copy of the spreadsheet for each site, as this spreadsheet is
> pre-programmed with a suitable data format and also automatically
> carries out the required checks and test calculations using the test
> data. This special spreadsheet may be downloaded from the EPA website
> at ***[www.epa.gov/ttn/amtic](http://www.epa.gov/ttn/amtic),
> (\>Criteria Pollutants). ***If the EPA spreadsheet is not used, the
> various calculations for each test should be carried out by other
> means and reported along with the test data. All calculations should
> be shown in sufficient detail so that they can be verified.***

**\[**[[]{#Atach7 .anchor}**Attachment 7**](#At7) **Hourly data from the
Model XYZ-123 PM~2.5~ Monitors\]**

***\[If the candidate method is a Class III (automated analyzer),
submission of hourly averages measured by each test analyzer during the
comparability tests is required. These data may be submitted as hard
copy but more typically would be submitted in one or more spreadsheets
or other appropriate format on a CD or computer readable medium, as
Attachment 7.***
\[[§53.35(c)(5)](../Part%2053%20Reg%20amendments.dot#Sec53_35c5)\]
***\]***

**\[**[[]{#Atach8 .anchor}**Attachment 8**](#At8) **Model XYZ-123
Operation and Instruction Manual (configured for PM~2.5~)**\]

***\[The Operation and Instruction Manual is a very important part of
the candidate method. Section*
[53.4(b)(3)](../Part%2053%20Reg%20amendments.dot#Sec53_4b3) *of the Part
53 regulation describes the content requirements for this manual.\]***