[Code of Federal Regulations]
[Title 40, Volume 5]
[Revised as of July 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR53.4]
[Page 9-11]
TITLE 40--PROTECTION OF ENVIRONMENT
CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
PART 53--AMBIENT AIR MONITORING REFERENCE AND EQUIVALENT METHODS--Table of Contents
Subpart A--General Provisions
Sec. 53.4 Applications for reference or equivalent method determinations.
(a) Applications for reference or equivalent method determinations
shall be submitted in duplicate to: Director, National Exposure Research
Laboratory, Department E (MD-77B), U.S. Environmental Protection Agency,
Research Triangle Park, North Carolina 27711.
(b) Each application shall be signed by an authorized representative
of the applicant, shall be marked in accordance with Sec. 53.15 (if
applicable), and shall contain the following:
(1) A clear identification of the candidate method, which will
distinguish it from all other methods such that the method may be
referred to unambiguously. This identification must consist of a unique
series of descriptors such as title, identification number, analyte,
measurement principle, manufacturer, brand, model, etc., as necessary to
distinguish the method from all other methods or method variations, both
within and outside the applicant's organization.
(2) A detailed description of the candidate method, including but
not limited to the following: The measurement principle, manufacturer,
name, model number and other forms of identification, a list of the
significant components, schematic diagrams, design drawings, and a
detailed description of the apparatus and measurement procedures.
Drawings and descriptions pertaining to candidate methods or samplers
for PM2.5 must meet all applicable requirements in reference
1 of appendix A of this subpart, using appropriate graphical,
nomenclature, and mathematical conventions such as those specified in
references 3 and 4 of appendix A of this subpart.
(3) A copy of a comprehensive operation or instruction manual
providing a complete and detailed description of the operational,
maintenance, and calibration procedures prescribed for field use of the
candidate method and all instruments utilized as part of that method
(under Sec. 53.9(a)).
(i) As a minimum this manual shall include:
(A) Description of the method and associated instruments.
(B) Explanation of all indicators, information displays, and
controls.
(C) Complete setup and installation instructions, including any
additional materials or supplies required.
(D) Details of all initial or startup checks or acceptance tests and
any auxiliary equipment required.
(E) Complete operational instructions.
(F) Calibration procedures and required calibration equipment and
standards.
(G) Instructions for verification of correct or proper operation.
(H) Trouble-shooting guidance and suggested corrective actions for
abnormal operation.
(I) Required or recommended routine, periodic, and preventative
maintenance and maintenance schedules.
(J) Any calculations required to derive final concentration
measurements.
(K) Appropriate references to appendix L of part 50 of this chapter;
reference 6 of appendix A of this subpart; and any other pertinent
guidelines.
(ii) The manual shall also include adequate warning of potential
safety hazards that may result from normal use and/or malfunction of the
method and a description of necessary safety precautions. (See
Sec. 53.9(b).) However, the previous requirement shall not be
interpreted to constitute or imply any warranty of safety of the method
by
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EPA. For samplers and automated methods, the manual shall include a
clear description of all procedures pertaining to installation,
operation, preventive maintenance, and troubleshooting and shall also
include parts identification diagrams. The manual may be used to satisfy
the requirements of paragraphs (b)(1) and (b)(2) of this section to the
extent that it includes information necessary to meet those
requirements.
(4) A statement that the candidate method has been tested in
accordance with the procedures described in subparts B, C, D, E, and/or
F of this part, as applicable.
(5) Descriptions of test facilities and test configurations, test
data, records, calculations, and test results as specified in subparts
B, C, D, E, and/or F of this part, as applicable. Data must be
sufficiently detailed to meet appropriate principles described in
paragraphs 4 through 6 of reference 2 of appendix A of this subpart,
part b, sections 3.3.1 (paragraph 1) and 3.5.1 (paragraphs 2 and 3) and
in paragraphs 1 through 3 of reference 5 (section 4.8, Records) of
appendix A of this subpart. Salient requirements from these references
include the following:
(i) The applicant shall maintain and include records of all relevant
measuring equipment, including the make, type, and serial number or
other identification, and most recent calibration with identification of
the measurement standard or standards used and their National Institute
of Standards and Technology (NIST) traceability. These records shall
demonstrate the measurement capability of each item of measuring
equipment used for the application and include a description and
justification (if needed) of the measurement setup or configuration in
which it was used for the tests. The calibration results shall be
recorded and identified in sufficient detail so that the traceability of
all measurements can be determined and any measurement could be
reproduced under conditions close to the original conditions, if
necessary, to resolve any anomalies.
(ii) Test data shall be collected according to the standards of good
practice and by qualified personnel. Test anomalies or irregularities
shall be documented and explained or justified. The impact and
significance of the deviation on test results and conclusions shall be
determined. Data collected shall correspond directly to the specified
test requirement and be labeled and identified clearly so that results
can be verified and evaluated against the test requirement. Calculations
or data manipulations must be explained in detail so that they can be
verified.
(6) A statement that the method, analyzer, or sampler tested in
accordance with this part is representative of the candidate method
described in the application.
(c) For candidate automated methods and candidate manual methods for
PM10 and PM2.5, the application shall also contain
the following:
(1) A detailed description of the quality system that will be
utilized, if the candidate method is designated as a reference or
equivalent method, to ensure that all analyzers or samplers offered for
sale under that designation will have essentially the same performance
characteristics as the analyzer(s) or samplers tested in accordance with
this part. In addition, the quality system requirements for candidate
methods for PM2.5 must be described in sufficient detail,
based on the elements described in section 4 of reference 1 (Quality
System Requirements) of appendix A of this subpart. Further
clarification is provided in the following sections of reference 2 of
appendix A of this subpart: part A (Management Systems), sections 2.2
(Quality System and Description), 2.3 (Personnel Qualification and
Training), 2.4 (Procurement of Items and Services), 2.5 (Documents and
Records), and 2.7 (Planning); part B (Collection and Evaluation of
Environmental Data), sections 3.1 (Planning and Scoping), 3.2 (Design of
Data Collection Operations), and 3.5 (Assessment and Verification of
Data Usability); and part C (Operation of Environmental Technology),
sections 4.1 (Planning), 4.2 (Design of Systems), and 4.4 (Operation of
Systems).
(2) A description of the durability characteristics of such
analyzers or samplers (see Sec. 53.9(c)). For methods for
PM2.5, the warranty program must ensure that the required
specifications (see table A-1 of this subpart) will be
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met throughout the warranty period and that the applicant accepts
responsibility and liability for ensuring this conformance or for
resolving any nonconformities, including all necessary components of the
system, regardless of the original manufacturer. The warranty program
must be described in sufficient detail to meet appropriate provisions of
the ANSI/ASQC and ISO 9001 standards (references 1 and 2 in appendix A
of this subpart) for controlling conformance and resolving
nonconformance, particularly sections 4.12, 4.13, and 4.14 of reference
1 in appendix A of this subpart.
(i) Section 4.12 in appendix A of this subpart requires the
manufacturer to establish and maintain a system of procedures for
identifying and maintaining the identification of inspection and test
status throughout all phases of manufacturing to ensure that only
instruments that have passed the required inspections and tests are
released for sale.
(ii) Section 4.13 in appendix A of this subpart requires documented
procedures for control of nonconforming product, including review and
acceptable alternatives for disposition; section 4.14 in appendix A of
this subpart requires documented procedures for implementing corrective
(4.14.2) and preventive (4.14.3) action to eliminate the causes of
actual or potential nonconformities. In particular, section 4.14.3
requires that potential causes of nonconformities be eliminated by using
information such as service reports and customer complaints to eliminate
potential causes of nonconformities.
(d) For candidate reference or equivalent methods for
PM2.5, the applicant shall provide to EPA for test purposes
one sampler or analyzer that is representative of the sampler or
analyzer associated with the candidate method. The sampler or analyzer
shall be shipped FOB destination to Department E, (MD-77B), U.S. EPA, 79
T.W. Alexander Drive, Research Triangle Park, NC 27711, scheduled to
arrive concurrent with or within 30 days of the arrival of the other
application materials. This analyzer or sampler may be subjected to
various tests that EPA determines to be necessary or appropriate under
Sec. 53.5(f), and such tests may include special tests not described in
this part. If the instrument submitted under this paragraph
malfunctions, becomes inoperative, or fails to perform as represented in
the application before the necessary EPA testing is completed, the
applicant shall be afforded an opportunity to repair or replace the
device at no cost to EPA. Upon completion of EPA testing, the analyzer
or sampler submitted under this paragraph shall be repacked by EPA for
return shipment to the applicant, using the same packing materials used
for shipping the instrument to EPA unless alternative packing is
provided by the applicant. Arrangements for, and the cost of, return
shipment shall be the responsibility of the applicant. EPA does not
warrant or assume any liability for the condition of the analyzer or
sampler upon return to the applicant.