SUPPORTING STATEMENT

Application for Reference and Equivalent Method Determination

1. IDENTIFICATION OF THE INFORMATION COLLECTION

1(a) Title: Application for Reference and Equivalent Method Determination (Renewal);

OMB Control Number 2080-0005, EPA ICR No. 0559.11.

1(b) Short Characterization (Abstract)

Under the ambient air monitoring regulations in 40 CFR Part 58, certain state and local 

air monitoring agencies are required to operate and maintain ambient air monitoring networks to 

determine attainment or non-attainment with the National Ambient Air Quality Standards 

(NAAQS) in 40 CFR 50. To help ensure the accuracy and quality of the air monitoring data 

obtained in these monitoring networks, the regulations require that the pollutant measurement 

methods used be designated by the EPA as either reference or equivalent methods. Regulatory

requirements for designation of air monitoring methods by the EPA as reference or equivalent 

methods are set forth in 40 CFR Part 53. The principle requirement is testing of the method 

according to prescribed test procedures to demonstrate that the method meets indicated design 

and performance specifications, is quantitatively comparable (provides equivalent pollutant 

measurements) to a reference method, or both (depending on the type of method). Respondents 

(applicants) who seek to have an ambient air pollutant measurement method designated by the 

EPA as a reference or equivalent method must conduct the required tests of the candidate method 

and submit the test results and associated information to the EPA in an application for reference 

or equivalent method determination. Usually, the applicant is a manufacturer or vendor of an 

instrumental air analyzer (called an automated method) or an air sampler (manual method) who 

wishes to have its method (product) designated by the EPA so that state and local air monitoring 

agencies can purchase the analyzer or sampler for use in their air monitoring networks under 

40 CFR Part 58. Approximately 6.33 major and 16.67 minor applications (22 total responses) 

are expected annually.

Accordingly, the primary type of collection is an application for EPA-designation of a 

method used for ambient air pollutant measurement. The information is collected by the Process 

Modeling Research Branch, Human Exposure and Atmospheric Sciences Division, National 

Exposure Research Laboratory (NERL) of EPA’s Office of Research and Development, which 

receives and processes the applications. The information being collected via the application is a 

detailed description of the nature of the method and measurement principle employed by the 

method, the operational instructions and calibration procedure associated with the method, 

method test results, descriptions of the test apparatus and test procedures used, and other related 

information required by 40 CFR Part 53. This information is used by the Process Modeling 

Research Branch to determine whether the method is qualified to be designated by the EPA as a 

reference or equivalent method. Such designation of the method allows it to be used by state and 

local air monitoring agencies in their required air surveillance networks. The information is 
submitted in the form of text, data tables, diagrams, copies of strip chart or data acquisition 

system records, instruction or operation manuals, or other items as appropriate. The information 

is usually stored as submitted, but some information may be microfilmed or stored electronically.

Subsequent to designation of a method as a reference or equivalent method, a 

manufacturer or user of the method may submit a request for approval of a modification to the 

method (minor application). The information submitted in such a request is similar in nature to 

that in an application, but is usually of a greatly reduced scope, since it deals only with the 

specific aspects of the changes to the method. Usually, the frequency of submission of requests 

for approval of modifications is higher than that for applications.

Vendors of designated methods must maintain a list of the names and addresses of all 

ultimate purchasers of such methods so that they can be notified in the event that the designation 

has been canceled or that the method must be modified or adjusted to maintain designated status.

Consistent with the final revisions to the NAAQS for particulate matter (PM), the 

amendments added new requirements for both coarse PM (PM10-2.5) and PM2.5 to the application 

requirements. The final amendments also added a new category of monitoring methods for 

which reference or equivalent method applications would be accepted and would likely increase 

the annualized number of applications received by the EPA. The new category is continuous (or 

semi-continuous) Class III equivalent methods (analyzers) for PM2.5 and PM10-2.5.

2. NEED FOR AND USE OF THE COLLECTION

2(a) Need/Authority for the Collection

The information submitted under this request for information collection is needed to 

determine whether specific methods intended for use in measuring the quantitative 

concentrations of certain atmospheric pollutants are adequate for purposes of pollutant 

monitoring to determine attainment or non-attainment with the NAAQS set forth in 40 CFR 50. 

These methods are primarily commercial instrumental air analyzers used for continuous 

atmospheric monitoring or commercial air samplers used to collect integrated air samples for 

laboratory analyses, but they may also include noncommercial manual methods used for noncontinuous air monitoring. Under the provisions of 40 CFR 53, an applicant conducts prescribed 

performance tests of a monitoring method and submits the test results, a detailed description of 

the method, and other associated information to EPA. If EPA determines, on the basis of the 

submitted information and test results, that the method meets the design, performance, and/or 

comparability requirements specified in 40 CFR 53, the method is designated as either a 

reference or equivalent method, as appropriate. Under 40 CFR 58 Appendix B, EPA requires 

state and local air monitoring and control agencies to use either reference or equivalent methods 

in their federally required air monitoring networks to help ensure the accuracy and quality of the 

air monitoring data they collect for determining attainment or non-attainment.

The authority to collect this information is Section 301(a) of the Clean Air Act [42 U.S.C. 

sec. 1857g(a)], as amended by sec. 15(c)(2) of Public Law 91-604, 84 Stat. 1713. The 

information is collected according to the provisions set forth in 40 CFR Part 53.

2(b) Practical Utility/Users of the Data
Upon receipt by the Process Modeling Research Branch, an application is logged and an 

acknowledgment of receipt is sent to the applicant, as required by the regulation. The 

application is then technically reviewed by the Branch, and any additional tests or information 

needed to complete the technical review or to make the reference or equivalent method 

determination is formally requested from the applicant in accordance with the provisions of the 

regulation. If the technical evaluation of the application indicates that all requirements are 

satisfied and that the method fully qualifies for designation as a reference or equivalent method, 

a notice of designation for the method is prepared and sent through the Laboratory Director of 

ORD’s (Office of Research and Development) National Exposure Research Laboratory for 

publication in the Federal Register. If not, a request for additional tests or information may be 

sent to the applicant, the applicant may be notified that additional tests will be conducted by EPA 

before a determination can be made, or the applicant may be notified that the application is 

rejected.

Following approval of a designation by the NERL Laboratory Director and publication of 

the notice of designation, notification of the designation is sent to the applicant, and the method 

is added to the List of Designated Reference and Equivalent Methods maintained by the Process 

Modeling Research Branch. This list identifies all methods that have been designated as 

reference or equivalent methods and is posted at http://www.epa.gov/ttn/amtic/criteria.html, 

where it is available to the EPA Regional Offices, state and local air monitoring agencies, and 

other interested users of air monitoring methods. Based on applications received under this 

program, EPA has designated 170 reference and equivalent methods as of March 2008. Many of 

these methods are currently in service in ambient air monitoring networks in all 50 states, 

obtaining air quality data used by EPA to determine attainment or non-attainment of the NAAQS 

in all regions of the United States.

There is also an associated recordkeeping requirement such that an applicant who offers 

designated reference or equivalent methods for sale must maintain an accurate and current list of 

the names and mailing addresses of all ultimate purchasers of such methods. For a period of 

seven years after publication of a reference or equivalent method designation, the applicant must 

notify all ultimate purchasers of the method within 30 days if the designation is canceled or if 

adjustment of the method is determined by EPA to be necessary to avoid cancellation of the 

method designation. This purchaser name and address information is not required to be reported 

to EPA.

3. NON DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION 

CRITERIA

3(a) Non duplication

A computer search of the Federal Information Locator System indicated that, with the 

exception of the existing rule, there are no similar information requests being carried out by the 

Federal government. A similar search of EPA’s ongoing ICR’s revealed no duplication of 

information-gathering efforts.
Since the purpose and nature of the information requested, as specified in the regulation, 

is highly specialized, it is very unlikely that any other agency collects or is planning to collect 

such information. The regulatory requirements for the information are very explicit in describing 

the tests that must be conducted, how they are to be conducted, and the way that the test results 

are to be submitted and interpreted. It is therefore difficult or impossible to use similar data not 

obtained in accordance with the regulation requirements. However, if information necessary for a 

specific application is duplicative of information contained in a previously submitted application 

or otherwise already in the EPA's possession, the previously submitted information may be cited 

and need not be resubmitted. Also, where possible, method test or performance information 

obtained by or for other testing or regulatory organizations, including foreign organizations, may

be used to support or corroborate submitted test information or to obviate the need for special or 

supplemental test results which may otherwise be required.

3(b) Public Notice Required Prior to ICR Submission to OMB

This section is not applicable because this is a rule-related ICR.

3(c) Consultations

Process Modeling Research Branch personnel frequently have discussed method 

performance and testing issues with representatives of many of the air monitoring manufacturers 

during application processing, during preliminary consultations, during EPA testing campaigns, 

at technical meetings, and during occasional visits by such representatives to the Branch Office. 

Some of the most recent consultations are listed here:

Larry Hackworth, Zedek Corporation, Durham, NC

Bill Roe, Grimm Technologies, Inc., Douglasville, GA

Tom Merrifield, BGI Incorporated, Waltham, MA

David Gobeli, MetOne Instruments, Grants Pass, OR

Kevin J. Goohs, Thermo Environmental Corp., Franklin, MA

Peter Phaedonos, Ecotech Pty. Ltd., Blackburn, Victoria, Australia

Lucien Lonigro, SERES, Provence, France

In addition, many comments and consultations were received from members of the 

Ambient Air Monitoring and Methods Subcommittee of EPA’s Clean Air Scientific Advisory

Committee. The members of that subcommittee are listed in Appendix A. 

3(d) Effects of Less Frequent Collection

Since the information is collected only once for each application, less frequent collection 

is not possible. Modest recordkeeping is required, but the information in these records is not 

required to be reported.

3(e) General Guidelines

Record retention over 7 years. Section 53.9 of 40 CFR 53 requires applicants who offer 

analyzers or samplers for sale as reference or equivalent methods to maintain records of the 

names and current mailing addresses of all ultimate purchasers of such analyzers or samplers for 
a period of seven years from the date of designation of the method as a reference or equivalent 

method. This recordkeeping requirement is necessary because the regulation further requires 

such an applicant to notify all purchasers of the designated analyzer or sampler during that seven 

year period if the reference or equivalent method designation is canceled or if adjustment or 

modification of the designated analyzer or sampler is required to maintain its designated status. 

Seven years is representative of the estimated average useful life of such instruments. This 

recordkeeping requirement is quite modest, and there are no periodic reporting requirements 

associated with the recordkeeping.

Submission of confidential information. Submission of information that is claimed by the 

applicant to be confidential business information may be necessary to make a reference or 

equivalent method determination. This information collection adheres to all of the other general 

guidelines.

3(f) Confidentiality and Sensitive Questions

Confidentiality. The Process Modeling Research Branch has instituted procedures to 

protect the confidentiality of any submitted information identified as such, in full accordance 

with 40 CFR 53.15 and all applicable provisions of 40 CFR Part 2.

Sensitive Questions. No information concerning sexual behavior or attitudes, religious 

beliefs, or other information of a similarly sensitive nature is collected.

4. THE RESPONDENTS AND THE INFORMATION REQUESTED

4(a) Respondents/NAICS Codes

Since the collection of this information is voluntary and related to application for a 

benefit, the information is collected only from entities for which the benefit is sufficient to justify

the costs of the required testing and submission of an application. The largest category of 

applicants is manufacturers or vendors (NAIC #334513) of air monitoring instruments suitable 

for use by state and local air monitoring agencies in their federally required air surveillance 

monitoring networks, and agents acting for instrument manufacturers or vendors. Other potential 

applicants include state or local air monitoring agencies (NAIC #924110), analytical laboratories 

(NAIC #541380), and the EPA (NAIC #924110).

4(b) Information Requested

(i) Data Items, Including Recordkeeping Requirements

The type or nature of the information requested for the new categories of applications 

would be generally the same as that required for other categories of applications, and particularly 

for applications for PM2.5 methods, as set forth in the current regulation. That information is 

summarized below.

Information requested:
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. 

[§53.4(b)(1)]

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 or PM10-2.5 must meet all applicable requirements 

in Reference 1 of Appendix A of Part 53 subpart A, using appropriate graphical, 

nomenclature, and mathematical conventions such as those specified in 

References 3 and 4 of Appendix A of Part 53 subpart A. [§53.4(b)(2)]

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 [§53.4(b)(3)].

(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 a description of the required or 

recommended 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 the applicable Appendix of Part 50, 

Reference 6 of Appendix A of Part 53 subpart A, and any other pertinent 

EPA 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 also §53.9(b).] 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. [§53.4(b)(3)]

4. Statements that the candidate method has been tested in accordance with 

the procedures described in subparts B, C, D, E, and/or F of 40 CFR 53 (as 

applicable), and that the method, analyzer, or sampler tested is representative of 

the candidate method described in the application. [§53.4(b)(4) and (6)]

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 40 

CFR Part 53, as applicable. 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.

(ii) Test data shall be collected according to the standards of good practice and by

qualified personnel. Calculations or data manipulations shall be explained in 

detail so they can be verified. Test anomalies or irregularities shall be 

documented and explained or justified. [§53.4(b)(5)]

6. For candidate automated methods and candidate manual methods for 

PM10, PM2.5, and PM10-2.5, the application shall (or would be required to) also 

contain the following [§53.4(c)]:

(i) A detailed description of the quality system that will be utilized in 

production of the method, if the candidate method is designated as a reference or 

equivalent method.

(ii) A description of the durability characteristics of such analyzers or 

samplers. [See also §53.9(c).] 

7. For candidate reference and equivalent methods for PM2.5 or PM10-2.5, the 

applicant must (or would be required to) submit documentation verifying that the 

reference or equivalent method samplers will be manufactured in an ISO-9001-

registered and maintained facility. [§53.51(b)(1)]

8. For candidate reference and equivalent methods for PM2.5 or PM10-2.5, the 

applicant must (or would be required to) submit information related to designation 

testing and product manufacturing, confirmed by an ISO-certified auditor. 

[§53.51(f)]

9. Also for candidate reference or equivalent methods for PM2.5 or PM10-2.5, 

the applicant shall (or would be required to) provide to EPA for test purposes one 

sampler or analyzer that is representative of the sampler or analyzer associated 

with the candidate method. This analyzer or sampler may be subjected to various 

tests that EPA determines to be necessary or appropriate under §53.5(f), and such 

tests may include special tests not described in this part. Arrangements for, and 

the cost of, return shipment are the responsibility of the applicant. [§53.4(d)]

10. Identification of confidential or proprietary information (if applicable). 

[§53.15]
Maintain records on:

1. Section 53.9(f) of 40 CFR 53 requires applicants who offer analyzers or 

samplers for sale as reference or equivalent methods to maintain records of the 

names and current mailing addresses of all ultimate purchasers of such analyzers 

or samplers for a period of seven years from the date of designation of the method 

as a reference or equivalent method. This recordkeeping requirement is necessary

because that Section of the regulation further requires such an applicant to notify

all purchasers of the analyzer or sampler if the reference or equivalent method 

designation is canceled or if adjustment or modification of the analyzer or sampler 

is required to maintain its designated status. This recordkeeping requirement is 

quite modest, and there are no periodic reporting requirements associated with the 

recordkeeping. [53.9(f)]

2. For PM2.5 or PM10-2.5 methods, quality control and quality assurance 

records and documentation must (or would be required to) be maintained as 

required by ISO 9001 facility registration or equivalent standards [§53.51(b), 

§53.9(h), and §53.9(i)].

(ii) Respondent Activities

Typical or representative respondent activities are as follows:

1. Obtain a copy of the 40 CFR 50 and 40 CFR 53 regulations.

2. Study the application requirements and become familiar with the specific 

test procedures; obtain assistance from the Branch, if needed.

3. Plan the required tests and determine requirements for test equipment, 

instruments, facilities, standards, materials, personnel, and any contractual 

services needed.

4. Obtain required test equipment, instruments, facilities, standards, and 

materials and arrange for required personnel. Arrange for contractual services, if 

needed.

5. Train personnel.

6. Assemble the test equipment, set up the test apparatus and facilities, and 

run practice tests as may be needed.

7. Carry out all required tests and obtain required test results.

8. Compile all test results, test parameters, instrument readings, measurement 

data, and other pertinent test documentation.

9. Prepare descriptions, tables, diagrams, illustrations, strip chart records, 

calculations, statements, and other documents as necessary.

10. Assemble final application and submit it to EPA.

11. Respond to any requests from EPA for additional tests or information that 

may be determined to be necessary to make the final reference or equivalent 

method determination.
12. Maintain records of ultimate purchasers of designated analyzers or 

samplers.

13. Obtain or maintain ISO 9001 registration for the test and manufacturing 

facility (for PM2.5 and PM10-2.5 method designation only).

14. Calibrate and maintain testing instruments.

(Because of their specific nature, none of these items may be considered 

“customary and usual business practice,” although somewhat similar types of tests and 

facilities may be used during product design, development, and production quality

control.)

5. THE INFORMATION COLLECTED – AGENCY ACTIVITIES, COLLECTION 

METHODOLOGY, AND INFORMATION MANAGEMENT

5(a) Agency Activities

1. Make available copies of the 40 CFR 53 regulation and other helpful 

material, establish specific interpretation of regulatory requirements if necessary, 

and provide guidance or technical assistance to applicants.

2. Receive applications, file applications and associated information, send 

acknowledgment of receipt to applicant, maintain confidentiality of application 

material identified as confidential business information.

3. Carry out comprehensive technical review of application information; 

identify any inadequacies and request additional tests or information as 

determined to be required. If necessary, arrange for special auxiliary tests, as may

be determined to be required.

4. Upon determination of designation, prepare and publish a notice of 

designation in the Federal Register and notify the applicant of designation.

5. Maintain a List of Designated Reference and Equivalent Methods and 

make the list available on the Internet (www.epa.gov/ttn/amtic/criteria.html).

6. Technically evaluate and approve requests (or take other action, as 

appropriate) for modifications to designated reference or equivalent methods from 

applicants, manufacturers, and users.

7. Provide program support, including management, program planning, 

computer software and data calculation systems, regulation development and 

maintenance, administrative support, and quality assurance guidance.

5(b) Collection Methodology and Management

The nature of this information collection does not lend itself readily to use of high 

technology and automation. The number of applications submitted per year is few, and the 

information contained in each application is extensive, diverse, varies for different types of 

methods, and is highly specific to the subject method. Where possible, applicants are allowed to 

submit test results or measurement data obtained with automated digital data acquisition systems, 

analog or digital chart recorders, or other automated or semi-automated devices. Entire test 
sequences may by automated, if feasible, at the applicant’s discretion. Optional data entry forms 

(hard copy) are suggested to help define the test readings required, to facilitate calculations, and 

to present summarized results. Use of electronic spreadsheets is encouraged for compilation and 

submission of test data.

Similarly, there is no need to store the information in machine-readable form because the 

information submitted is normally used only once, it is not compiled with information from other 

applications, no composite statistical analysis or report of the information is generated, and no 

rapid retrieval of selected data is needed. For the occasional need to retrieve the archived 

information after the initial analysis, paper or microfilm files serve acceptably. The cost of a 

rapid data or record retrieval system is not justified.

The information in each application is evaluated for accuracy, completeness, 

appropriateness, and credibility by a technical analyst. To the extent possible, techniques used 

are evaluated, calculations are verified, measurements are confirmed, test results are 

corroborated, and supporting information is substantiated. Electronic spreadsheet templates may

be used to calculate test results accurately and uniformly. Additional technical analysts may

evaluate portions of the application or the entire application when results appear to be inadequate 

or marginal. If the information provided by the applicant is insufficient or inconclusive, 

additional information, explanations, or tests may be requested to clarify data or resolve issues to 

complete the evaluation of the application. If necessary, the Process Modeling Research Branch 

may conduct its own tests of the method, or carry out supplemental testing that may be 

determined to be needed because of unique technical issues not resolved by the formally 

specified tests. Finally, monitoring data quality is assessed continually as the method is used in 

state and local monitoring networks, and follow up tests can be conducted if any performance 

questions arise.

The submitted information is accessible to the public by inspection and copying of 

Process Modeling Research Branch files; modest requests for copies of specific information to 

be mailed or faxed are generally fulfilled by branch personnel. Information identified as 

Confidential Business Information is available only to the extent allowed under the Freedom of 

Information Act in accordance with 40 CFR Part 2.

5(c) Small Entity Flexibility

The amendments impose no enforceable duty on small businesses. Although the 

applicable regulations contain no special provisions for small entities, the information collection 

burden for small entities is minimized in several ways. These include providing additional, 

specialized assistance such as augmented and customized guidance, instructions, and suggestions 

for conducting tests; carefully defining the minimum information requirements for specific 

applications; furnishing certain hard-to-obtain or special reagents or other materials, standards, 

or calibration equipment; making available special test sites, facilities or equipment; identifying 

applicable information already on file that need not be duplicated; offering recommendations for 

compiling the application information; providing suggested language for instruction or operation 

manuals; and accepting handwritten or similarly informal but acceptable information submission.

5(d) Collection Schedule
For the most part, applications are voluntary and are accepted whenever they are received 

from applicants, rather than on any required schedule. Following receipt of an application, the 

regulation requires EPA to respond to the applicant within 120 calendar days with one of the 

following actions: (1) designation of the method as a reference or equivalent method, (2) 

rejection of the method, (3) notification and specification of additional information required, (4) 

notification and specification of additional tests required, or (5) notification and specification of 

additional tests to be conducted by EPA, before a determination can be made [§53.5]. Response 

to requests for approval of modifications to designated methods must be within 30 days 

[§53.14(c)], although this limit was increased in the final Rule to 90 days for modifications other 

than minor ones. The Final Rule also added the requirement that EPA publish Federal Register 

notices upon receipt of application and 15-day requirement for publication of a notice after a 

determination. 

6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION

6(a) Review of Anticipated Burden Changes as a Function of Pollutant or Sub-Pollutant

In attempting to estimate respondent burden, it is important to recognize that each 

application is unique. The actual number of burden hours and cost required for submitting a 

specific application will vary widely, depending on many factors. Particularly salient factors 

include the specific pollutant (or sub-pollutant) for which the method is applicable, whether the 

method qualifies as a reference method or an equivalent method, the measurement principle 

utilized, the design and configuration of the analyzer or sampler, the test facilities available to 

the applicant, availability and location of suitable field testing sites, weather and other conditions 

at field testing sites, the level of training or experience of the personnel involved, problems 

encountered during the tests, and other special or unique situations related to the testing of the 

method.

Changes to the previously established base ICR burden estimates are likely if any of the 

regulations associated with reference and equivalent method applications (40 CFR Parts 50 and 

53, respectively) are amended, or new regulations are promulgated, such that the nature, number, 

or type of applications in this collection is affected. The regulatory rule-making process is 

typically quite lengthy, and it is therefore often difficult to predict with accuracy the effect such 

regulatory changes will have on the information collection or when in the ICR approval period 

such changes will take effect, at least until late in the rule-making process. Also, there is usually

a lag in time between the promulgation of a regulatory change and the time when EPA starts 

receiving the first applications based on or affected by the change. To help in the process of 

determining the adjustment in burden estimates that would be due to such changes, a review of 

potential regulatory changes for each of the major pollutant or sub-pollutant categories follows. 

The review puts particular emphasis on those categories that may be potentially impacted by new 

regulations that have either been recently promulgated or are likely to be promulgated within the 

next period of approval for this ICR.

TSP. Applications for measurement methods specifically for total suspended particulate matter 

(TSP) are not included in the reference and equivalent method program, and therefore are not 

included in this ICR. However, methods for TSP are described in an appendix to Part 50 
(Appendix B), and TSP sampling methods are typically included as part of methods for 

measuring lead (Pb) in the atmosphere (see next paragraph). No changes in the regulations 

associated with TSP are currently planned nor are any likely to occur within this ICR approval 

period.

Lead. An older, established Pb reference method in Appendix G of Part 50 has now been joined 

by a new, second reference method for Pb in Appendix Q, promulgated in November of 2008. 

The older reference method specifies a TSP sampler, described in Appendix B of Part 50; the 

new reference method specifies a PM10c sampler as described in Appendix O of Part 50. These 

reference methods are manual methods, which are generally fully described in the respective Part 

50 appendixes and don’t require a reference method application (hence no collection burden). 

However, the PM10c sampler specified for the new Pb reference method does require an 

application, which is typically submitted and approved as part of an application for a coarse 

particulate matter (PM10-2.5) reference method sampler.

Burden estimates associated with applications for equivalent methods for Pb and for the 

PM10c sampler are already incorporated into the base ICR estimates. Although a NAAQS 

review for Pb by the Office of Air Quality Planning and Standards (OAQPS) is scheduled to take 

place during this ICR approval period, no associated changes in any of the regulations (nor any 

new regulations) associated with monitoring methods for Pb are currently planned or are likely to 

occur within this ICR approval period. Therefore, no changes in the burden estimates associated 

with applications for equivalent methods for Pb are expected.

PM10. Although some changes in the form of the NAAQSs for PM10 may be likely by OAQPS, 

no changes in the regulations associated with reference or equivalent methods for PM10 are 

currently under consideration or are likely to occur within this ICR approval period. Burden 

estimates associated with applications for reference and equivalent methods for PM10 are already 

incorporated into the base ICR estimates.

PM2.5 Reference Methods and Class I Equivalent Methods. No changes in the regulations 

associated with reference or Class I equivalent methods for PM2.5 are currently under 

consideration, nor are any such changes likely to occur within this ICR approval period. Burden 

estimates associated with applications for these types of methods for PM2.5 are already 

incorporated into the base ICR estimates.

PM2.5 Class II Equivalent Methods. No changes in the regulations associated with Class II 

equivalent methods for PM2.5 are currently under consideration nor are any such likely to occur 

within this ICR approval period. Burden estimates associated with applications for this type of 

method for PM2.5 are already incorporated into the base ICR estimates.

PM2.5 Class III Equivalent Methods. No changes in the regulations associated with Class III 

equivalent methods for PM2.5 are currently under consideration nor are likely to occur within this 

ICR approval period. Burden estimates associated with applications for this type of method for 

PM2.5 are already incorporated into the base ICR estimates.

PM2.5 Monitoring Methods for a Possible Secondary NAAQS for Visibility. PM2.5

monitoring methods of this type are not currently addressed in the monitoring methods 

regulations or in the reference and equivalent methods application program. A possible future 

secondary NAAQS for PM2.5 in regard to degradation of ambient visibility is under consideration 
by EPA. Any such new NAAQS would require promulgation of a new reference method for 

PM2.5 specifically for this application. EPA has not yet established a consensus regarding either 

a new NAAQS or a particular type of monitoring method for this application. Therefore, it is 

unlikely that any new regulations for monitoring this particular pollutant indicator or for 

applications for approval of either reference or equivalent methods for it will be promulgated 

within the approval period for this ICR. 

PM10-2.5. No changes in the regulations associated with PM10-2.5 reference or equivalent 

methods are currently under consideration nor are any regulatory changes likely to occur within 

this ICR approval period. Burden estimates associated with applications for methods for PM10-2.5

are already incorporated into the base ICR estimates.

SO2. A new (second) SO2 reference method was promulgated on June 22, 2010, along with 

some associated changes to Part 53, Subpart B that were applicable to candidate SO2 reference 

and equivalent methods. The very minimal effects that these regulatory changes had on the 

burden estimates associated with applications for SO2 reference and equivalent methods has 

already been considered in the existing estimates; therefore, no changes in the burden estimates 

for the ICR renewal period are necessary.

O3. A new (second) O3 reference method, possible minor modification of the existing reference 

method, and some associated changes to some of the performance requirements of Part 53, 

Subpart B that would be applicable to candidate reference and equivalent methods for O3 are 

currently under consideration by EPA. These regulatory changes are (tentatively) scheduled to 

be promulgated in November, 2015, which is within the renewal period of this ICR. However, 

the effect that these new or modified regulations would have on the ICR burden estimates of O3

method applications would be very minimal. The new O3 reference method specifies an

automated chemiluminescence method that is quite similar to the existing chemiluminescence 

reference method, and two analyzers utilizing this tentative new reference method have already 

been designated by EPA as equivalent methods. The existing O3 chemiluminescence reference 

method would be left in place to make sure that all the existing O3 equivalent methods would 

retain their equivalent method designation without interruption. The tentative new performance 

requirements for designation of new reference and equivalent method analyzers are more 

stringent than the existing requirements for both reference and equivalent method analyzers. 

However, it is very likely that any new chemiluminescence analyzers designed for routine 

ambient monitoring would meet the new requirements. 

Optional new (tentative) test requirements with even more stringent performance 

requirements would be added to Part 53, Subpart B and would be applicable to any candidate O3

reference or equivalent method for which the applicant elects to have one or more lower, more 

sensitive measurement ranges approved (in addition to the standard range) under its reference or 

equivalent method designation. Testing and designation of lower ranges has always been 

permitted, but the new testing requirements would be more formal, and the performance 

requirements for such lower ranges would be more stringent. Although this additional testing is 

voluntary, there is some market for low-range O3 analyzers, and it seems likely that many, if not 

most, applicants would want to have at least one lower range approved. These more stringent 

requirements and the additional testing would add a very modest additional burden for the 

applicant. The magnitude of these minor, potential ICR burden variations are deemed quite 
inconsequential relative to the considerable uncertainties in the assumptions of the number of O3

reference and equivalent method applications that EPA will receive in the next ICR approval 

period and in the burden for preparing a typical (composite) application. These small changes in 

the burden estimates are almost certainly well within the inevitable margin of uncertainty already 

inherent in the burden estimates of the base ICR.

CO. Changes to the Part 53 requirements for reference and equivalent methods for CO were 

promulgated on August 31, 2011. The relatively minor effect that these regulatory changes had 

on the burden estimates associated with applications for CO reference and equivalent methods 

has already been considered in the existing estimates; therefore, no changes in the burden 

estimates for this ICR approval period are necessary.

NO2. Potential changes to the regulatory requirements for reference and equivalent methods for

NO2 that might affect the burden estimates are under consideration by EPA. However, any such 

changes are tentatively scheduled for promulgation in June, 2017 (at the very earliest, more 

likely somewhat later) and would likely take effect a month or more after that. Therefore those 

changes (if any) would occur too late in the current ICR approval period (through 10/31/2017) to 

have any significant effect on the associated burden estimates. Moreover, any such changes are 

expected to be similar to, but less extensive than, those described above for O3 methods (e.g., no 

substantive changes are expected to the reference method description for NO2 in Part 50). 

Accordingly, such changes would have minimal effect on estimated burdens. Thus, no changes 

to the current burden estimates are needed for this renewal period.

Open-Path analyzers. Open-path analyzers, by nature, are typically capable of monitoring 

multiple gaseous pollutants simultaneously. No changes in the regulations associated 

specifically with open-path equivalent methods are currently under consideration nor are any

changes likely to occur within this ICR approval period. Open-path analyzers would be subject

to the pending changes in the O3 equivalent method application requirements (to the extent that 

they are candidate methods for that pollutant). However, as noted previously, any changes in the 

burden estimates associated with applications for designation of O3 methods are deemed 

insignificant. Further, applications for open-path candidate methods are received very

infrequently. The burden estimates associated with applications for open-path methods are 

already adequately incorporated into the base ICR estimates.

Methods for dry deposition of SOx and NOx. 

No secondary NAAQS for dry deposition for SO2 and NOx are anticipated during this 

ICR’s period of performance. Therefore, it is estimated that no substantive changes in existing 

applicant or Agency labor and/or cost burden would be associated with the new secondary

NAAQS for dry deposition currently under consideration.

6(b) Summary

The previous section provided a comprehensive review of any potential regulatory

changes for each of the major pollutant or sub-pollutant categories. Emphasis was placed on 

those categories that may be potentially impacted by regulations which have either been recently 

promulgated or are likely to be promulgated within the period of approval for this ICR (i.e. 

through10/31/2017). In all cases except for methods for O3, no changes in the NAAQS 

regulations are anticipated that would materially affect the estimates for either respondent or 
agency burdens for the approval period of this ICR. For methods for O3, some regulatory

changes are anticipated, but any changes in burden estimates are expected to be inconsequential 

relative to the magnitude of existing burdens. Collectively, therefore, there are no estimated 

changes in respondent and/or Agency burdens associated with pollutants or subpollutants during 

this ICR’s period of performance.

6(b) Estimated Respondent Burden Hours and Costs

As summarized in the previous section, no overall changes in respondent burdens (either 

labor or cost) are estimated for this ICR’s period of performance based on a review of regulatory

revisions. As Table 1 indicates, no changes in subcategories of labor hours, labor costs, O&M 

costs, or capital and startup costs are expected.

Table 1. Summary of Estimated Annual Respondent Burden Hours and Costs

for Annual Reporting and Recordkeeping

Labor 

hours

Labor 

cost O & M

Capital & 

startup

Total nonlabor Total cost

Total increase, all 

responses 0 $0 $0 $0 $0 $0

Current ICR 7,492 $517,831 $109,185 $23,483 $132,668 $650,494

Combined grand totals 7,492 $517,831 $109,185 $23,483 $132,668 $650,494

6(c) Estimating Agency Burden and Cost

As is the case of respondent burden discussed in the previous section, no changes in 

Agency burdens (either labor or cost) are estimated for this ICR’s period of performance based 

on a review of programmatic regulatory revisions. As Table 2 indicates, no changes in 

administrative activities, application technical reviews and evaluations, or programmatic support 

are estimated.
Table 2. Representative Annual Agency Burden and Cost

Collection Activities Hours Cost

Provide copies of regulation and assistance materials; 

regulation interpretation; technical assistance

32 $1,717

Receive applications; administrative activities 10 $510

Technical review and evaluation 93 $5,393

Designation activities 4 $211

Maintain & distribute List of Designated

Methods

32 $1,590

Review and process modification requests 30 $1,759

Program support 22 $1,240

In-house Agency Subtotal 1,067 $55,871

Agency Contract Support Subtotal - $177,631

Grand total, base ICR + increase 1,067 $233,502

6(d) Bottom-Line Burden Hours and Costs

Based on OMB’s current inventory for ICR 2080-0005, and a review of respondent and 

Agency burdens for this ICR’s period of performance, the grand total burden for respondents and 

the agency is shown in Table 3. 

Table 3. Total Respondent and Agency Burden and Cost

New Base ICR New Total

Hours Cost Hours Cost Hours Cost

Total Respondent 0 $0 7,492 $650,494 7,492 $650,494

Total Agency inhouse 0 $0 1,067 $55,871 1,067 $55,871

Total Agency contract 0 $0 0 $177,631 0 $177,631

Totals 0 $0 8,559 $883,996 8,559 $883,996

6(e) Burden Statement

The annual public reporting and recordkeeping burden for this collection of information 

is estimated to average 341 hours per response. Burden means the total time, effort, or financial 

resources expended by persons to generate, maintain, retain, or disclose or provide information 

to or for a Federal agency. This includes the time needed to review instructions; develop, 

acquire, install, and utilize technology and systems for the purposes of collecting, validating, and 

verifying information, processing and maintaining information, and disclosing and providing 

information; adjust the existing ways to comply with any previously applicable instructions and 
requirements; train personnel to be able to respond to a collection of information; search data 

sources; complete and review the collection of information; and transmit or otherwise disclose 

the information. An agency may not conduct or sponsor, and a person is not required to respond 

to, a collection of information unless it displays a currently valid OMB control number. The 

OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15. 

To comment on the Agency's need for this information, the accuracy of the provided 

burden estimates, and any suggested methods for minimizing respondent burden, including the 

use of automated collection techniques, EPA has established a public docket for this ICR under 

Docket ID Number EPA-HQ-ORD-2005-0530 which is available for online viewing at 

www.regulations.gov, or in person viewing at the Office of Research and Development Docket 

in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Ave., NW, 

Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 

p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading 

Room is (202) 566-1744, and the telephone number for the Office of Research and Development 

Docket is (202) 566-1752. An electronic version of the public docket is available at 

www.regulations.gov. This site can be used to submit or view public comments, access the index 

listing of the contents of the public docket, and to access those documents in the public docket 

that are available electronically. Also, you can send comments to the Office of Information and 

Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 

20503, Attention: Desk Officer for EPA. Please include the EPA Docket ID Number EPA-HQORD-2005-0530 and OMB control number 2080-0005 in any correspondence.
Appendix A

Clean Air Scientific Advisory 

Committee Ambient Air Monitoring Subcommittee

Mr. Richard Poirot

Vermont Agency of Natural Resources

Bldg. 3

103 South Main Street

Waterbury, VT 05671

Dr. Barbara Zielinska

Division of Atmospheric Sciences

Desert Research Institute

2215 Raggio Parkway

Reno, NV 89512

Mr. George Allen

NESCAUM

101 Merrimac St., 10th Floor

Boston, MA 02114

Dr. Judith Chow

Desert Research Institute

2215 Raggio Parkway

Reno, NV 89512

Dr. Ellis Cowling

Colleges of Natural Resources and Agricultural and Life Sciences

North Carolina State University

1509 Varsity Drive

Raleigh, NC 27695

Mr. Bart Croes

California Air Resources Board

P.O. Box 2812

Sacramento, CA 95812

Dr. Kenneth Demerjian

Atmospheric Sciences Research Center

State University of New York

251 Fuller Rd.

Albany, NY 12203

Dr. Delbert Eatough

Chemistry and Biochemistry Department

Brigham Yound University

E114 BNSN

Provo, UT 84602

Mr. Eric Edgerton
Atmospheric Research and Analysis, Inc.

410 Midenhall Way

Cary, NC 27513

Mr. Henry Felton

Bureau of Air Quality Surveillance

NY State Dept. of Env. Conservation

625 Broadway

Albany, NY 12233

Dr. Philip Hopke

Department of Chemical Engineering

Clarkson University

Potsdam, NY 13699

Dr. Rudolf Hussar

Engineering and Applied Science

Washington University

1 Brookings Drive

St. Louis, MO 63130

Dr. Kazuhiko Ito

School of Medicine

New York University

57 Old Forge Road

Tuxedo, NY 10987

Dr. Donna Kenski

Lake Michigan Air Directors Consortium

2250 E. Devon Ave., Suite 250

Des Plaines, IL 60018

Dr. Thomas Lumley

Sch. of Pub. Health and Community Med.

University of Washington

1705 NE Pacific St.

Seattle, WA 98195

Dr. Peter McMurray

Dept. of Mechanical Engineering

Institute of Technology

University of Minnesota, MN

Minneapolis, MN 55455

Dr. Kimberly Prather

Dept. of Chemistry and Biochemistry

University of California, San Diego

9500 Gilman Drive 

La Jolla, CA 92093

Dr. Ted Russell

School of Civil and Environmental Eng.
Georgia Institute of Technology

311 Ferst Drive

Atlanta, GA 30332

Dr. Jay Turner

Chemical Engineering Department

School of Engineering

Washington University, CB 1180

One Brookings Drive

St. Louis, MO 63130

Dr. Warren White

Crocker Nuclear Laboratory

University of California, Davis

Davis, CA 95616

Dr. Yousheng Zeng

Providence Eng. and Env. Group LLC

6160 Perkins Road, Suite 100

Baton Rouge, LA 70808