Document ID: EPA-HQ-ORD-2005-0530-0021
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2021-02-12T05:00Z

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. 0559.14.

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 activity is an application for EPA-designation of a method used for ambient air pollutant measurement.  The information is collected by the Ambient Air Branch, Air Methods and Characterization Division, Center for Environmental Measurements and Modeling 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 Ambient Air 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 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 can be of 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.
	
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 non-continuous air monitoring.  Under the provisions of 40 CFR Part 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 Part 53, the method is designated as either a reference or equivalent method, as appropriate.  Under 40 CFR Part 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 Ambient Air 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 Center Director of ORD's (Office of Research and Development) Center for Environmental Measurements and Modeling 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 Director of the Center for Environmental Measurements and Modeling 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 Ambient Air Branch.  This list identifies all methods that have been designated as reference or equivalent methods and is posted at https://www.epa.gov/amtic/air-monitoring-methods-criteria-pollutants where it is available to the EPA Regional Offices, state and local air monitoring agencies, and other interested users of air monitoring methods. 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 ICR is being submitted to the Office of Management and Budget (OMB) as required by the Paperwork Reduction Act of 1995 (PRA) and the subsequent rule issued by the OMB on August 29, 1995 (60 FR 44978). In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.), the Agency has notified the public of the proposed ICR through the Federal Register on Month Day, 2020 (XX FR XXXX). 

3(c) Consultations
	Personnel in EPA' Ambient Air Branch frequently discuss method performance and testing issues with representatives of many of the air monitoring instrument manufacturers.  These information exchanges occur during application development and processing, during preliminary consultations, during EPA testing campaigns, at technical meetings, and during occasional visits by such representatives to the EPA's Program Office.  Collectively, these periodic discussions with the respondents provide useful information for estimating respondent burdens and costs associated with development and submittal of Reference and Equivalent Method applications.  Some of the most recent consultations are listed below:

      David Gobeli, MetOne Instruments, Grants Pass, OR
      Grant Kassell, Ecotech Pty Ltd, Melbourne, Australia
      Judy Hackworth, Zedek Corporation, Durham, NC
      Steve Toner, Teledyne-API, San Diego, CA
      Bill Roe, Grimm Technologies, Inc., Douglasville, GA
      Tom Merrifield, Merrifield and Associates, Douglasville, GA
	Kevin J. Goohs, Thermo Fisher, Franklin, MA	
	
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.
	
3(f) Confidentiality
	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.

      The Ambient Air 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.

3(f) 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) At 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 Part 50 and 40 CFR Part 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 Part 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 (https://www.epa.gov/amtic/air-monitoring-methods-criteria-pollutants)
	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 limited, 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 Ambient Air 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 Ambient Air 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
	Applications are voluntary and are accepted whenever they are received from applicants, rather than on any required schedule.  Following receipt of an application, 40 CFR Part 53 regulations require 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 90 days [§53.14(c)]. 

6.	ESTIMATING THE BURDEN AND COST OF THE COLLECTION

6(a) Estimating Respondent Burden
      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 was 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.  Therefore, no changes in the burden estimates associated with applications for equivalent methods for Pb are expected.
PM10.  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.  No changes in the regulations associated with SO2 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 SO2 are already incorporated into the base ICR estimates.
O3.   A new (second) O3 reference method, was promulgated in November 2015.  The new O3 reference method specified an automated chemiluminescence method that was quite similar to the existing chemiluminescence reference method.  As a result, the effect that this new regulations on the ICR burden estimates was expected to be very minimal. Regulations for this pollutant are not scheduled for review during this ICR approval period and no expected changes in respondent or Agency burden is estimated.
CO.  Changes to the Part 53 requirements for reference and equivalent methods for CO were promulgated in August 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.  Regulations for this pollutant are not scheduled for review during this ICR approval period and no expected changes in respondent or Agency burden is estimated. 
NO2.  Potential changes to the regulatory requirements for reference and equivalent methods for NO2 that might affect the burden estimates are currently under consideration by EPA.  However, 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.

	This section provided a comprehensive review of 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. through 6/30/2024).  In all cases, no changes in the NAAQS regulations are anticipated that would materially affect the estimates for respondent hourly burdens for the approval period of this ICR.  For methods for NO2, some minor 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 hour burdens associated with pollutants or subpollutants during this ICR's period of performance.  As shown in Table 1, the estimated respondent labor hours for 2020 is 341 hours per application.

   Table 1.  Summary of Estimated Annual Respondent Burden Hours and Costs 
            for Annual Reporting and Recordkeeping Per Application
                                       
                                       
                                  Labor hours
                                  Labor Cost
                                    O&M
                             Capital & startup
                                Total non-labor
                                  Total Cost
                        Total Increases, all responses
                                       0
                                    $2,135
                                     $450
                                      $97
                                     $547
                                    $2,681
                                  Current ICR
                                      341
                                    $24,859
                                    $5,242
                                    $1,127
                                    $6,369
                                    $31,228
                             Combined grand totals
                                      341
                                    $26,994
                                    $5,692
                                    $1,224
                                    $6,916
                                    $33,910

6(b) Estimating Respondent Costs

6(b)(i) Estimating Labor Costs
	Although no changes in respondent hour burdens per activity are expected, changes in respondent labor costs have been calculated based on Bureau of Labor Statistics (BLS) historical data since the previous ICR (i.e., 2017 to 2020).  This information is available online at https://www.bls.gov.  Based on a review of historical indices for 2017 and 2020, employment cost index factors were used to estimate 2020 respondent costs based on the costs previously calculated for 2017.  As presented in Table 1, respondent labor costs per activity of $26,994 were estimated for 2020 based on the current ICR's labor cost of $24,859, representing an increase of 8.6% for respondent labor costs.

6(b)(ii) Estimating Capital and Operations and Maintenance Costs
      For Capital and Operations and Maintenance Costs, BLS cost index factors were used to estimate 2020 respondent costs based on the costs during the previous ICR's period of performance.  As presented in Table 1, a $97 increase in respondent Capital and Operations and Maintenance Costs Per Application was estimated for 2020.  This resulted in a cost in this category of $1,224 for 2020 compared to the estimated $1,127 during the current ICR's period of performance.

6(b)(iii) Capital/Start-up Operating and Maintenance (O&M) Costs
      Based on a review of historical BLS indices for 2017 and 2020, cost index factors were used to estimate 2020 respondent costs for Capital/Start-up Operating and Maintenance (O&M) Costs based on the costs previously calculated for 2017.  As presented in Table 1, respondent costs in this category of $5,692 were estimated for 2020 based on the current ICR's cost of $5,242, representing a $450 cost increase per application.
      
6(e)(iv) Annualized Capital Costs
Annualized capital costs refer to the amount of an annual payment (i.e., annuity) that would have to be paid over a specific time period to equal the amount of a one-time, start-up capital cost.  According the Paperwork Reduction Act of 1995, however, annualized capital costs only need to be included in the burden estimates if the start-up capital cost was incurred for the purpose of collecting information required by the EPA.  In the case of the ICR for the Reference and Equivalent Methods Designation Program, there are no respondent or Agency start-up capital costs that are incurred for information collection purposes.  In the ICR for this program, there are thus no annualized capital costs to report.
      
6(c) Estimating Agency Burden and Cost
      As in the case of respondent burden discussed in Section 6(a), no changes in Agency hourly burdens per application are estimated for this ICR's period of performance based on a review of programmatic regulatory revisions.  As Table 2 indicates, no changes in hourly administrative activities, application technical reviews and evaluations, or programmatic support are estimated per application.  Minor increases in total Agency labor costs are estimated based on noted changes in Agency personnel hourly costs, available from the Office of Management and Budget at https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/#url=2020.  Based on this data, an increase in Agency labor cost of approximately 3.1% was estimated for the ICR's new period of performance.  Accounting for the estimated increase in Agency contract support (Table 2), the Agency labor burden and cost per application is estimated to be 48.5 hours and $11,755, respectively.  
      
	Table 2.  Representative Annual Agency Burden and Cost Per Application

                             Collection Activities
                                      New
                                   Base ICR
                                   New Total

                                     Hours
                                     Cost
                                     Hours
                                     Cost
                                     Hours
                                     Cost
Provide copies of regulation and assistance materials; regulation interpretation; technical assistance
                                       0
                                      $20
                                      7.0
                                     $362
                                      7.0
                                     $382
Receive applications; administrative activities
                                       0
                                      $6
                                      2.2
                                     $107
                                      2.2
                                     $113
Technical review and evaluation
                                       0
                                      $62
                                     20.2
                                    $1,136
                                     20.2
                                    $1,199
Designation activities
                                       0
                                      $2
                                      0.9
                                      $44
                                      0.9
                                      $47
Maintain & distribute List of Designated Methods
                                       0
                                      $18
                                      7.0
                                     $335
                                      7.0
                                     $353
Review and process modification requests
                                       0
                                      $20
                                      6.5
                                     $371
                                      6.5
                                     $391
Program support
                                       0
                                      $14
                                      4.8
                                     $261
                                      4.8
                                     $276
In-house Agency Subtotal
                                       0
                                     $143
                                     48.5
                                    $2,617
                                     48.5
                                    $2,760
Agency Contract Support Subtotal
                                       0
                                     $467
                                      0.0
                                    $8,528
                                      0.0
                                    $8,995
Grand total, base ICR + increase
                                       0
                                     $610
                                     48.5
                                    $11,145
                                     48.5
                                    $11,755

6(d) Estimating the Respondent Universe and Total Burden and Costs
      For the ICR for the Reference and Equivalent Methods Designation program, the respondent universe represents the number of applications estimated annually from the respondents.  As detailed in Section 6(a), a comprehensive review of upcoming regulatory changes concluded that no change in the number of applications was to be expected during the renewed ICR's period of performance.  For the new ICR's period of performance, therefore, the number of expected applications from respondents is twenty-two (22), as was the case during the current ICR's period of performance.

6(e) Bottom-Line Burden Hours and Cost Tables
      For this ICR's period of performance, bottom-line burden hours and costs were calculated by multiplying the number of expected applications by the burden hours and costs per application.

6(e)(i) Respondent Tally
      Based on OMB's current inventory for ICR 2080-0005, and a review of respondent (Table 1) and Agency burdens (Table 2) for this ICR's period of performance, the grand total burden for respondents and the Agency is shown in Table 3. Total respondent burdens and costs for the ICR's new period of performance are estimated to be 7,492 hours and $746,029, respectively.

             Table 3.  Total Respondent and Agency Burden and Cost
                                       
 
                                      New
                                   Base ICR
                                   New Total
 
                                     Hours
                                     Cost
                                     Hours
                                     Cost
                                     Hours
                                     Cost
Total Respondent
                                       0
                                    $58,992
                                     7,492
                                   $687,037
                                     7,492
                                   $746,029
Total Agency in-house
                                       0
                                    $3,152
                                     1,067
                                    $57,575
                                     1,067
                                    $60,727
Total Agency contract
                                       0
                                    $10,272
                                       0
                                   $187,610
                                       0
                                   $197,882
Totals
                                       0
                                   $72,416 
                                     8559
                                   $932,222
                                     8559
                                  $1,004,638

6(e)(ii) The Agency Tally
      From Table 3, total Agency hourly burdens and costs (including in-house costs and Agency contract costs) for the ICR's new period of performance are estimated to be 1,067 hours and $258,609, respectively.

6(e)(iii) Variations in the Annual Bottom Line
      No significant variations in the annual respondent burdens or cost are anticipated during the new ICR's period of performance.
      
6(f) Reasons for Change in Burden
	As outlined in Section 6(a), no changes in applicant or Agency hourly burdens is expected during the ICR's period of performance.  Tables 1 and 2 indicate that slight increases in both respondent labor costs and Agency labor costs were estimated, resulting in slight increases in overall labor costs since the previous ICR's period of performance.  

6(g) Burden Statement
      The annual public reporting and recordkeeping burden for respondents for this collection of information is estimated to total 7,492 hours, resulting in an average of 341 hours per the 22 expected responses. 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-HQ-ORD-2005-0530 and OMB control number 2080-0005 in any correspondence.