0559ss11

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 (PM_10-2.5) and PM_2.5 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 PM_2.5 and PM_10-2.5.

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 non-continuous 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 PM_2.5 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 PM_2.5 or PM_10-2.5 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, PM_2.5, and PM_10-2.5, 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 PM_2.5 or PM_10-2.5, 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 PM_2.5 or PM_10-2.5, 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 PM_2.5 or PM_10-2.5, 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 PM_2.5 or PM_10-2.5 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 PM_2.5 and PM_10-2.5 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 PM_10c 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 PM_10c 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 (PM_10-2.5) reference method sampler.

Burden estimates associated with applications for equivalent methods for Pb, and for the PM_10c sampler, are already incorporated into the base ICR estimates. Equivalent methods may be tested against either the new or the old reference method, so no additional application burden is generated by the new Pb reference method. No further changes in any of these regulations (or new regulations) associated with monitoring methods for Pb are currently planned nor are likely to occur within this ICR approval period. The next NAAQS review for Pb by the Office of Air Quality Planning and Standards (OAQPS), with which any potential changes in the Pb monitoring methods or equivalent method application regulations are normally associated, is scheduled for January 2014 (NPR), with promulgation of any potential regulatory changes by late 2014. This schedule indicates that any further regulatory changes that could or might affect the collection burden estimates for Pb methods would occur beyond the end of the next approval period for this ICR.

PM₁₀. Although some changes in the form of the NAAQSs for PM₁₀ are under consideration by OAQPS, no changes in the regulations associated with reference or equivalent methods for PM₁₀ are currently under consideration nor 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.

PM_2.5 Reference Methods and Class I Equivalent Methods. No changes in the regulations associated with reference or Class I equivalent methods for PM_2.5 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 PM_2.5 are already incorporated into the base ICR estimates.

PM_2.5 Class II Equivalent Methods. No changes in the regulations associated with Class II equivalent methods for PM_2.5 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 PM_2.5 are already incorporated into the base ICR estimates.

PM_2.5 Class III Equivalent Methods. No changes in the regulations associated with Class III equivalent methods for PM_2.5 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 PM_2.5 are already incorporated into the base ICR estimates.

PM_2.5 Monitoring Methods for a Possible Secondary NAAQS for Visability. PM_2.5 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 PM_2.5 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 PM_2.5 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.

PM_10-2.5. No changes in the regulations associated with PM_10-2.5 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 PM_10-2.5 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. However, the effect of these new regulations on the ICR burden estimates is quite minimal. The new SO₂ reference method specifies the automated ultraviolet fluorescence (UVF) method. This method is already used for nearly all the current compliance network monitoring; using UVF analyzers approved as equivalent methods. The old SO₂ reference method (a wet chemical, manual method) was left in place to make sure that all the existing SO₂ equivalent methods would retain their equivalent method designation without interruption. One minor impact on burden estimates for the next ICR approval period is that new applications for EPA designation of UVF analyzers will be considered as reference method applications rather than equivalent method applications. The new performance requirements for designation of new reference method analyzers are more stringent than the previous requirements for equivalent method analyzers; however, it is very likely that most new UVF analyzers designed for routine ambient monitoring can meet the new requirements. Since Part 53 does not require a Subpart C comparability (field) test for candidate reference method analyzers, and one of the previously required tests has been eliminated, the testing burden would actually be reduced a bit for new UVF candidate reference method analyzers relative to the previous requirements for equivalent method UVF analyzers.

Optional new test requirements with even more stringent performance requirements were added to Part 53, Subpart B and are applicable to a candidate SO₂ 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 now the testing requirements are more formal, and the performance requirements for such lower ranges are more stringent. Although this additional testing is voluntary, there is some market for low-range SO₂ 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 modest additional burden for the applicant. It is estimated that this small additional burden would approximately offset the reduced burden from relief from the equivalent method comparability test requirements (mentioned above), such that no adjustment of the burden estimates is deemed to be necessary in this regard.

The new regulatory requirements also apply to candidate equivalent method SO₂ analyzers. Almost all new candidate SO₂ analyzers are likely to be candidate reference (UVF) analyzers and would be covered by the above discussion. However, there could possibly be a few (very few) new candidate equivalent method SO₂ analyzers, such as DOAS monitors or some other new SO₂ measurement technology. The equivalent method application burden on applicants for such less common methods is already factored into the base ICR burden estimates, although the burden for these methods could increase very slightly because they now have to meet the new, more stringent performance requirements of the amended Part 53, Subpart B.

Another small impact to the burden estimates might be as follows: As suggested above, manufacturers who currently offer a designated equivalent method UVF analyzer for sale can continue to offer it as an equivalent method with no action required on their part. However, at least some of those manufacturers are expected to seek re-designation of their analyzers as reference method analyzers. Such method re-designation would likely provide them some marketing advantage, such as 1) they could cite the higher level of performance required by Part 53 for SO₂ new reference method analyzers; 2) they might enjoy additional unit sales of reference method analyzers needed for monitoring network QA applications, testing of new candidate equivalent methods, and for special applications that require a more sensitive SO₂ measurement range with the extra-high performance now optionally required by Part 53; and 3) the (perhaps) additional prestige of offering the analyzer as an EPA reference method rather than an equivalent method. Such re-designation of an existing equivalent method as a new reference method would require some additional testing to show that the analyzer meets the new, more stringent performance requirements (if the original equivalent method testing did not already do so). That would perhaps add some small additional burden to the previous base ICR estimates for designation of SO₂ methods.

On the EPA-burden side, there could be a slightly increased burden on EPA from processing a few extra applications from previous UVF equivalent method applicants requesting re-designation of their analyzers as reference methods. But also, EPA will have slightly less burden from processing new SO₂ reference method applications because there would be no Subpart C comparability test to evaluate.

The magnitude of these minor, potential ICR burden variations discussed above are deemed quite inconsequential relative to the considerable uncertainties in the assumptions of the number of SO₂ 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.

O₃. Some of the monitoring regulations for O₃ were amended in March 2008, but no changes were made to the regulations governing reference or equivalent methods for O₃. The Process Modeling Research Branch intends to make changes to the Parts 50 and 53 regulations pertaining to the requirements for reference and equivalent methods for O₃, in connection with the next time the O₃ NAAQS (or related monitoring regulations) are brought up for reconsideration by OAQPS. Currently, that next reconsideration has not yet been scheduled by OAQPS. The planned changes would be similar, and generally parallel, to the changes promulgated in 2010 for methods for SO₂, and the effect on the ICR burden estimates is expected to be similarly quite modest. Further, it is very unlikely that any regulatory changes potentially affecting methods for O₃ will be promulgated within the next period of approval for this ICR.

CO. Review of the NAAQS for CO, along with the associated monitoring regulations, are under current EPA review, with a Notice of Proposed Rule-making (NPR) scheduled for publication by January 28, 2011 (a court-ordered deadline). Included in this NPR are several proposed amendments to regulations that affect, or could affect, designation of reference and equivalent methods, described as follows:

First, the text of the CO reference method in Appendix C of Part 50 is proposed to be re-promulgated, with minor revisions to update the language; to better reflect the current, more highly developed state of the non-dispersive infrared (NDIR) absorption reference method technology; and to correct some very minor errors. If promulgated essentially as proposed, these changes would have no affect on the substance of the reference method at all and would also have no effect on either the designation status of existing CO reference method analyzers or on the designation of new CO analyzers. Hence, there would be no change to ICR burden estimates due to this proposed regulatory change.

Secondly, the text of Subpart B of 40 CFR Part 53 is proposed to be re-promulgated. Subpart B specifies the test protocols and performance requirements applicable to both reference and equivalent methods for CO as well as for SO₂, O₃ and NO₂. Similar to the textual changes to the CO reference method described in the previous paragraph, these changes are largely editorial in nature and are intended to update and clarify the language of the test protocols and to correct some very minor errors. No substantive changes to the nature or substance of the test protocols are proposed. Accordingly, these text changes would not affect the designation of either reference or equivalent methods for CO and, likewise, would therefore not affect the burden estimates of the base ICR.

Finally, changes are being proposed to the performance requirements for CO reference and equivalent methods that could affect the testing of new candidate reference methods for CO, and hence the associated burden estimates. These changes are similar, to some extent, to those made for SO₂ described previously and are part of an on-going effort by the Process Modeling Research Branch to update, clarify, and modernize some of the older provisions of the reference and equivalent method regulations.

New performance requirements are proposed for designation of new CO reference and equivalent method analyzers that are more stringent than the previous requirements. However, it has been determined that most new NDIR analyzers designed for routine CO monitoring can already meet the new requirements, and previously designated reference methods will not be affected by the change. One of the tests is proposed to be eliminated, but otherwise the required test protocols are unchanged. The testing burden for new candidate methods would be marginally reduced because of the eliminated test, but potentially also slightly increased because of the possibility of extended testing to meet the more stringent performance requirements,

relative to the previous requirements. The overall effect on the testing burden is estimated to be insignificant and is already incorporated into the base ICR burden estimates.

Optional new test requirements and even more stringent performance requirements are proposed for Part 53, Subpart B that are applicable to a candidate CO 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 proposed new testing requirements for lower ranges 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 CO 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 which is estimated to be insignificant relative to the overall test burden estimates.

These proposed changes to the Parts 50 and 53 regulations affecting designation of CO reference and equivalent methods are scheduled for promulgation by August 12, 2011 (again, a court-ordered or settlement agreement deadline). If promulgated essentially as proposed, by this deadline, the changes would occur early in the next approval period of this ICR. However, any changes to the collection burden are estimated to be insignificant and adequately included in the previously established burden estimates for the base ICR.

NO₂. No changes in the regulations associated with NO₂ reference or equivalent methods are currently under consideration nor are any changes likely to occur within this ICR approval period. Burden estimates associated with applications for methods for NO₂ are already incorporated into the base ICR burden estimates.

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 are subject to the recent changes in the SO₂ application requirements and would be subject the pending changes in the CO application requirements (to the extent that they are candidate methods for those pollutants). However, as noted previously, any changes in the burden estimates associated with applications for designation of SO₂ or CO 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 SO_x and NO_x. A new secondary NAAQS for dry deposition is under consideration by EPA. Such an indicator would likely be a combination of ambient air monitoring methods to include SO₂ and particulate sulfates, and NO_x. If a new secondary NAAQS were proposed, a suitable reference method for the indicator, or separate reference methods for each of the various components of the indicator, would need to be developed. An integrated, filter-pack monitoring method (an in-series train of 2 or more treated filters), similar to the method currently used in EPA’s CASTNET monitoring network, has been suggested for monitoring SO₂ and particulate sulfate. For NO_x, a continuous method (analyzer) to measure NO_y as the indicator, rather than NO_x, has been suggested in lieu of an integrated method such as that used by the CASTNET network filter-pack methodology.

None of these methods are currently included in the Parts 50 or 53 reference and equivalent method regulations nor, therefore, are they included in the base ICR burden estimates. EPA is under a court-ordered or settlement agreement deadline of July 12, 2011 to propose this new NAAQS, the associated reference methods, and any reference and equivalent method designation criteria, with final promulgation to be by March 20, 2012. In consideration of this timeline and the substantial development effort needed to produce reference methods based on used of continuous analyzers, it is anticipated that ORD will recommend that the existing CASTNET filter-pack methodology will be adopted if a new secondary NAAQS for dry deposition is formally proposed. This approach was also generally supported by the Clean Air Scientific Advisory Committee (CASAC) Air Monitoring and Methods Subcommittee (AMMS) during its recent meeting with Agency staff in order to provide advice on the scientific adequacy and appropriateness of EPA draft documents on monitoring and methods for Oxides of Nitrogen (NOx) and Sulfur (SOx). Because the CASTNET filter-pack methodology uses commercially-available technology and can be operated using substantive, readily available standard operating procedures (SOPs), no additional developmental or testing burden would be placed on the applicant. For similar reasons, it is estimated that any associated burdens to the Agency related to reviewing associated FRM and FEM applications would be minimal. Overall, 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 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 7/31/2014). In the cases of TSP, PM_2.5 FRM, PM_2.5 FEM, PM₁₀, PM_10-2.5, and NO₂, no changes in the NAAQS regulations are anticipated which would influence either respondent or agency burdens. Regarding Pb, burden estimates associated with applications for equivalent methods for Pb, and for this pollutant’s PM_10c sampler, are already incorporated into the base ICR estimates. Pb equivalent methods may be tested against either the new or the old reference method, so no additional application burden is generated by the new Pb reference method. For all other pollutant and subpollutant categories (i.e., secondary PM_2.5, O₃, CO, SO₂, open-path analyzers, and dry deposition for SO_x and NO_x), any changes in burdens are expected to be non-existent or 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 non-labor	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 in-house	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-HQ-ORD-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., 10^th 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