SF 83 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); EPA ICR Number 0559.08; OMB Control Number 2080 0005.

1( b) Short Characterization ( Abstract) Under the air pollutant 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) ( 40 CFR 50). To help ensure the accuracy and quality of the air monitoring data obtained in these monitoring networks, the regulations further require that the pollutant measurement methods used must 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 ( http:// www. gpoaccess. gov/ cfr/ retrieve. html). 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). 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 ( 40 CFR § 50.4). 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. Only about 5 applications 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 2 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. 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 proposed change or changes to the method. Usually, the frequency of submission of requests for approval of modifications is higher than that for applications. An associated recordkeeping requirement ( 40 CFR 53.9( f)) stipulates that 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 ( http:// www. gpoaccess. gov/ cfr/ retrieve. html). These methods are primarily commercial instrumental air analyzers used for continuous atmospheric monitoring or commercial air samplers used to collect integrated air samples for laboratory analyses, but they may also include noncommercial manual methods used for noncontinuous air monitoring. Under the provisions of 40 CFR 53, an applicant conducts prescribed performance tests of a monitoring method and submits the test results, a detailed description of the method, and other associated information to EPA. If EPA determines, on the basis of the submitted information and test results, that the method meets the design, performance, and/ or comparability requirements specified in 40 CFR 53, the method is designated as either a reference or equivalent method, as appropriate. Under 40 CFR 58 Appendix B, EPA requires state and local air monitoring and control agencies to use either reference or equivalent methods in their federally required air monitoring networks to help ensure the accuracy and quality of the air monitoring data they collect for determining attainment or non attainment. The authority to collect this information is Section 301( a) of the Clean Air Act [ 42 U. S. C. sec. 1857g( a)], as amended by sec. 15( c)( 2) of Public Law 91 604, 84 Stat. 1713. The information is collected according to the provisions set forth in 40 CFR part 53.

2( b) Practical Utility/ Users of the Data Upon receipt by the Process Modeling Research Branch, an application is logged and an acknowledgment of receipt is sent to the applicant, as required by the regulation. The application is then technically reviewed by the Branch, and any additional tests or information needed to 3 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 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 the 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 151 reference and equivalent methods as of July 2004. 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. NONDUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA 3( a) Nonduplication 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 4 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 Public notice of this Information Collection Request was published in the Federal Register on August 27, 2004 ( 69 FR 52663). A 60 day public comment period was announced.

3( c) Consultations During both the original development of the 40 CFR 53 regulation and several subsequent amendments, multiple non EPA persons and agencies were consulted for advice and review of draft regulations and support documents. These included state and local air monitoring or control agency personnel in the Standing Air Monitoring Work Group ( SAMWG). As the regulation proceeded through the formal rule making process, additional public comments were received from additional non EPA individuals and agencies. These comments and suggestions were carefully reviewed and incorporated into the regulation to the greatest extent possible. The regulation has been amended several times since its initial promulgation, and each time additional comments have been solicited, evaluated, and appropriate changes incorporated into the regulation. The most recent amendment of the regulation occurred on July 18, 1997 ( 62 FR 38784). These amendments to 40 CR part 53 were proposed on December 13, 1996, and comments were received from 7 respondents ( Docket A 96 51). A list of the names and affiliations of the respondents is provided in Appendix A to this supporting statement. Also, the SAMWG was again consulted for comments and advice. A list of the non EPA SAMWG personnel is included in Appendix A to this Supporting Statement. In addition, Process Modeling Research Branch personnel frequently discuss method performance and testing issues with representatives of many of the air monitoring manufacturers during application processing, during preliminary consultations, 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 Edward Hoopes, Advanced Pollution Instrumentation, San Diego, CA Gerald McGowan, Teledyne Monitor Labs, Englewood, CO Peter Phaedonos, Ecotech Pty. Ltd., Blackburn, Victoria, Australia Lucien Lonigro, SERES, Provence, France 3( d) Effects of Less Frequent Collection 5 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 3 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 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. The Process Modeling Research Branch has instituted procedures to protect the confidentiality of any submitted information identified as such, in accordance with 40 CFR 53.15 and 40 CFR part 2. 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/ NAIC 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). 6 4( b) Information Requested ( i) Data Items, Including Recordkeeping Requirements 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 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. 7 ( 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 PM 10 and PM 2.5, the application shall 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, the applicant must 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, the applicant must 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, the applicant shall provide to EPA for test purposes one sampler or analyzer that is representative of the sampler or analyzer associated with the candidate method. This analyzer or 8 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 methods, quality control and quality assurance records and documentation must 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. 9 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 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 proposed 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. 10 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. Custom designed computer programs 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 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 11 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)]. 12 6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION 6( a, b) Estimating Respondent Burden and Cost 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 to submit a specific application will vary widely, depending on many factors. These factors include the 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. To obtain information for use in estimating costs, nine vendors of monitoring devices who have submitted applications for designation in the past were contacted ( see Appendix B). The information obtained in this informal survey was compiled in conjunction with Process Modeling Research Branch estimates to produce a composite estimate of costs for application submittal. For purposes of estimating this composite respondent burden, a representative breakdown of weighted composite respondent burden hours is given in Table 1, which shows a weighted average total burden of 859.5 hours per application. Descriptions of the various application categories and the weighting factors used to derive the composite weighted burden hours are given in Appendix B. Average total burdens for various categories of applications could range from 150 hours for PM 10 monitors to possibly 1800 hours or more for PM 2.5 Class II equivalent samplers. It is estimated that 5 applications will be received per year. Respondent burdens for submitting requests for approval of modifications to designated reference or equivalent methods are usually ( although not necessarily) much lower; however, they vary even more widely. Estimates for such burdens range from 2 hours to perhaps 200 hours, with most less than 50 hours. For purposes of this ICR, we have estimated a weighted respondent burden breakdown as shown in Table 2. It is estimated that an average of 14 modification requests will be received per year, with an average burden of 30 hours each. 13 Table 1. Composite Weighted Respondent Burden Hours and Costs for a Full Application.

Activity Management Professional/

Technical Clerical Total Labor Contractor O& M cost In house O& M Total O& M Capital/

Startup ($) O& M +

Startup Total $

Average fully loaded hourly rate ($/ hr.) $ 123.31 $ 72.05 $ 37.11 hr/ yr $/ yr hr/ yr $/ yr hr/ yr $/ yr hr/ yr $/ yr $/ yr $/ yr $/ yr $/ yr $/ yr $/ yr 1. Obtaining Regulations & Other Relevant Materials from EPA; Searching Data Sources 5.9 $ 731 14.7 $ 1,056 4.7 $ 173 25.3 $ 1,960 $ 0 $ 0 $ 0 $ 0 $ 0 $ 1,960 2. Becoming Familiar with Test Procedures and Application Requirements 6.2 $ 761 42.9 $ 3,091 4.7 $ 173 53.8 $ 4,026 $ 0 $ 0 $ 0 $ 0 $ 0 $ 4,026 3. Planning Tests, Determining Requirements for Test Equipment, Supplies, Personnel 1.9 $ 231 20.0 $ 1,437 0.6 $ 23 22.5 $ 1,692 $ 0 $ 0 $ 0 $ 0 $ 0 $ 1,692 4. Obtaining Required Equipment, Instruments,

Facilities, Materials; Arranging for Personnel 3.4 $ 424 20.0 $ 1,437 0.6 $ 23 24.0 $ 1,884 $ 0 $ 0 $ 0 $ 1,993 $ 1,993 $ 3,877 5. Training Personnel 0.0 $ 0 7.2 $ 517 0.0 $ 0 7.2 $ 517 $ 0 $ 0 $ 0 $ 0 $ 0 $ 517 6. Assembling Test Equipment; Setting Up Test Apparatus & Facilities; Running Practice Tests 0.6 $ 77 51.4 $ 3,706 0.0 $ 0 52.1 $ 3,783 $ 665 $ 969 $ 1,634 $ 1,563 $ 3,196 $ 6,979 7. Carrying Out Tests & Obtaining Test Results 3.1 $ 385 111.9 $ 8,065 0.0 $ 0 115.1 $ 8,450 $ 6,858 $ 0 $ 6,858 $ 0 $ 6,858 $ 15,308 8. Compiling Test Results, Parameters, Instrument Readings, & Other Test Documentation 2.5 $ 308 29.2 $ 2,104 1.3 $ 46 33.0 $ 2,458 $ 399 $ 0 $ 399 $ 0 $ 399 $ 2,857 9. Preparing Text, Data, Calculations, Diagrams,

Tables, & Other Test Documents 3.4 $ 424 28.9 $ 2,081 1.3 $ 46 33.6 $ 2,552 $ 166 $ 0 $ 166 $ 0 $ 166 $ 2,718 10. Assembling Final Application and Submitting Application to EPA 3.8 $ 462 22.8 $ 1,640 4.3 $ 158 30.8 $ 2,260 $ 0 $ 0 $ 0 $ 0 $ 0 $ 2,260 11. Responding to EPA Requests for Additional Tests or Information 0.9 $ 116 6.7 $ 483 0.6 $ 23 8.3 $ 622 $ 0 $ 0 $ 0 $ 0 $ 0 $ 622 12. Recordkeeping Including Lists of Customers,

Notifications for Recall, Etc. 0.0 $ 0 1.3 $ 90 8.3 $ 308 9.6 $ 398 $ 0 $ 0 $ 0 $ 0 $ 0 $ 398 13. ISO 9001 Registration or Equivalent:

a. Startup Cost for Establishing ISO 9001 20.5 $ 2,530 11.3 $ 817 0.0 $ 0 31.9 $ 3,347 $ 2,333 $ 2,333 $ 0 $ 2,333 $ 5,680 b. ISO 9001 Maintenance Cost 34.2 $ 4,217 115.2 $ 8,300 162.9 $ 6,045 312.3 $ 18,562 $ 2,167 $ 0 $ 2,167 $ 2,167 $ 20,729 14. Calibrating, Maintaining, & Recertifying Equipment 1.3 $ 154 79.3 $ 5,710 1.3 $ 46 81.8 $ 5,910 $ 653 $ 133 $ 786 $ 0 $ 786 $ 6,697 15. Additional Costs: ( Please Describe) 0.0 $ 0 10.6 $ 766 8.1 $ 302 18.8 $ 1,067 $ 0 $ 604 $ 604 $ 0 $ 604 $ 1,671 Totals 87.8 $ 10,821 573.2 $ 41,299 198.6 $ 7,368 859.5 $ 59,489 $ 13,241 $ 1,705 $ 14,946 $ 3,555 $ 18,502 $ 77,990 14 Table 2. Composite Weighted Respondent Burden Hours and Costs for a Modification Request Activity Management Professional/

Technical Clerical Total Labor Contractor O& M cost In house O& M Total O& M Capital/

Startup ($) O& M &

Startup Total $

Average fully loaded hourly rate ($/ hr.) $ 123.31 $ 72.05 $ 37.11 hr/ yr $/ yr hr/ yr $/ yr hr/ yr $/ yr hr/ yr $/ yr $/ yr $/ yr $/ yr $/ yr $/ yr $/ yr 1. Obtaining Regulations & Other Relevant Materials from EPA; Searching Data Sources 0.0 $ 0 0.0 $ 0 0.0 $ 0 0.0 $ 0 0.0 0.0 $ 0 0.0 0.0 $ 0 2. Becoming Familiar with Test Procedures and Application Requirements 0.2 $ 29 1.6 $ 117 0.2 $ 7 2.0 $ 152 0.0 0.0 $ 0 0.0 0.0 $ 152 3. Planning Tests, Determining Requirements for Test Equipment, Supplies, Personnel 0.1 $ 9 0.8 $ 54 0.0 $ 1 0.8 $ 64 0.0 0.0 $ 0 0.0 0.0 $ 64 4. Obtaining Required Equipment, Instruments,

Facilities, Materials; Arranging for Personnel 0.1 $ 16 0.8 $ 54 0.0 $ 1 0.9 $ 71 0.0 0.0 $ 0 75.3 75.3 $ 147 5. Training Personnel 0.0 $ 0 0.3 $ 20 0.0 $ 0 0.3 $ 20 0.0 0.0 $ 0 0.0 0.0 $ 20 6. Assembling Test Equipment; Setting Up Test Apparatus & Facilities; Running Practice Tests 0.0 $ 3 1.9 $ 140 0.0 $ 0 2.0 $ 143 25.1 36.6 $ 62 59.1 120.8 $ 264 7. Carrying Out Tests & Obtaining Test Results 0.1 $ 15 4.2 $ 305 0.0 $ 0 4.3 $ 319 259.2 0.0 $ 259 0.0 259.2 $ 579 8. Compiling Test Results, Parameters, Instrument Readings, & Other Test Documentation 0.1 $ 12 1.1 $ 80 0.0 $ 2 1.2 $ 93 15.1 0.0 $ 15 0.0 15.1 $ 108 9. Preparing Text, Data, Calculations, Diagrams,

Tables, & Other Test Documents 0.1 $ 16 1.1 $ 79 0.0 $ 2 1.3 $ 96 6.3 0.0 $ 6 0.0 6.3 $ 103 10. Assembling Final Application and Submitting Application to EPA 0.1 $ 17 0.9 $ 62 0.2 $ 6 1.2 $ 85 0.0 0.0 $ 0 0.0 0.0 $ 85 11. Responding to EPA Requests for Additional Tests or Information 0.0 $ 4 0.3 $ 18 0.0 $ 1 0.3 $ 24 0.0 0.0 $ 0 0.0 0.0 $ 24 12. Recordkeeping Including Lists of Customers,

Notifications for Recall, Etc. 0.0 $ 0 0.0 $ 0 0.0 $ 0 0.0 $ 0 0.0 0.0 $ 0 0.0 0.0 $ 0 13. ISO 9001 Registration or Equivalent:

a. Startup Cost for Establishing ISO 9001 0.0 $ 0 0.0 $ 0 0.0 $ 0 0.0 $ 0 $ 0 0.0 0.0 $ 0 b. ISO 9001 Maintenance Cost 1.3 $ 159 4.4 $ 314 6.2 $ 229 11.8 $ 702 81.9 0.0 $ 82 81.9 $ 784 14. Calibrating, Maintaining, & Recertifying Equipment 0.0 $ 6 3.0 $ 216 0.0 $ 2 3.1 $ 223 24.7 5.0 $ 30 0.0 29.7 $ 253 15. Additional Costs: ( Please Describe) 0.0 $ 0 0.4 $ 29 0.3 $ 11 0.7 $ 40 0.0 22.8 $ 23 0.0 22.8 $ 63 Totals 2.3 $ 286 20.6 $ 1,487 7.0 $ 260 30.0 $ 2,033 $ 412 $ 64 $ 477 $ 134 $ 611 $ 2,644 14 16 Table 3. Summary of Annual Respondent Burden Hours and Cost.

Labor hours Labor cost O & M Capital & startup Total nonlabor Total cost Composite application 859.5 $ 59,489 $ 14,946 $ 3,555 $ 18,502 $ 77,990 Number of respondents 5 5 5 5 5 5 Subtotal 4,298 $ 297,445 $ 74,730 $ 17,775 $ 92,510 $ 389,950 Composite modification request 30 $ 2,033 $ 477 $ 134 $ 611 $ 2,644 Number of respondents 14 14 14 14 14 14 Subtotal 420 $ 28,462 $ 6,678 $ 1,876 $ 8,554 $ 37,016 Totals, all responses 4,718 $ 325,907 $ 81,408 $ 19,651 $ 101,064 $ 426,966 As summarized in Table 3, the total weighted composite burden estimate for applications from Table 1,859.5 hours, was multiplied by the expected number of applications ( 5) yielding 4298 total labor hours for applications. The estimated average burden for applications for approval of modifications of existing methods ( 30 hours) was multiplied by the number of modification applications expected ( 14) resulting in 420 additional burden hours. The grand total estimated labor burden is thus 4,298 + 420 = 4,718 hours, reported on line 13c of Form OMB 83 I, for a total of 19 responses, reported on lines 13a and 13b. The current OMB inventory for ICR 2080 0005 lists 4,718 hours as well ( line 13d), and the difference is thus 0 hours, reported on line 13e of Form OMB 83 I. Lines 13f1 and 13f2 are both zero because there is no difference to explain. Respondent labor costs associated with the weighted composite representative burden hours breakdown discussed above are also shown in Table 1, using fully loaded hourly labor rates of $ 123.31 for managerial staff, $ 72.05 for professional/ technical staff, and $ 37.11 for clerical staff. These rates were derived from cost estimates provided in direct consultation with manufacturers who have previously submitted applications for reference or equivalent method designations ( see Appendix B to this supporting statement). Since these cost estimates were provided about 6 years ago, they have been adjusted by factors of 1.280, 1.264, and 1.237, respectively, which represent the 6 year, non seasonally adjusted change in the Employment Cost Index for these labor categories in private industry, obtained from Bureau of Labor Statistics ( BLS) data. Although use of seasonally adjusted ECI data are recommended for this adjustment, such seasonally adjusted data for these labor categories were not available from the BLS. Since the time period of adjustment is an integral number of years, seasonal adjustments should have no significant effect. 17 Test equipment capital costs and associated operating and maintenance costs related to this information collection are very difficult to estimate. There is no specifically prescribed equipment or apparatus that must be used, and in some cases there are a number of alternatives. Many applicants are also the developers of the candidate analyzers or samplers and, accordingly, have some of the test equipment needed as part of their normal equipment inventory. A few tests, such as those for particulate matter inlet performance, require a highly specialized wind tunnel test facility, but the applicant may elect to avoid these tests by using a previously tested inlet. Some applicants may lack some of the required equipment and have to acquire it directly, but they may also consider borrowing, renting, or otherwise gaining access to suitable equipment without purchasing it. Finally, some applicants choose to contract out a portion of or the entire testing and application process. Similarly, costs for supplies consumed during testing and application preparation vary with the particular test situation. To some extent, these costs can be significantly different, depending on which of several alternative approaches to some of the test procedures is selected by the applicant. These estimates are derived primarily from an informal survey of nine manufacturers of instruments previously designated as reference or equivalent methods ( see Appendix B). Our experience based on conducting these tests or similar tests in our own laboratory and preparing equivalent or similar test reports also influenced the estimates. Survey results covered manufacturers of several types of instruments. The survey results were compiled and summarized to estimate costs for general categories of instruments ( i. e., gas analyzers, PM 10 monitors). The category descriptions and weighting factors used are given in Appendix B to this supporting statement. Since these cost estimates were provided about 6 years ago, the non labor costs ( except capital/ startup costs) have been adjusted by a factor of 1.064, which was derived as a weighted average of the 1997 to 2003 change in the Producer Price Index for " measuring and controlling instruments" ( 1.064, 40%), " engineering and scientific instruments" ( 1.061, 50%), and " total manufacturing industries" ( 1.075, 10%) obtained from Bureau of Labor Statistics data. Projected future application plans from the instrument manufacturers and Process Modeling Research Branch records of past applications were used to estimate the number of expected applications and the likely distribution of the total number of applications among each of the application categories. These distribution estimates were used with the category cost estimates to arrive at a weighted composite cost estimate for a " typical" or model reference or equivalent method application, as presented in Table 1. Note that these burden hours and cost estimates include those for recordkeeping. As summarized in Table 3, the composite estimated total annualized capital and startup cost for applications ( Table 1), multiplied by the estimated 5 applications per year, results in a total estimated annualized capital and startup cost of $ 17,775. The corresponding cost for the estimated 14 modification applications ( Table 2) is $ 1,876. The total annualized capital and startup cost for all respondents, $ 19,651, is reported as $ 20 ( thousand) on line 14a of form OMB 83 I. Similarly, the composite estimated operating and maintenance cost for applications from Table 1 ($ 14,946), multiplied by the estimated 5 applications per year, gives an estimated total annualized O& M cost of $ 74,730, and the corresponding O & M cost estimates for the 14 estimated modification applications from Table 2 is $ 6,678. The total O & M cost for all 18 respondents, $ 81,408, is reported as $ 81 ( thousand) on line 14b of for OMB 83 I. The total estimated annualized non labor cost is thus $ 101,064, which is reported as $ 101 ( thousand) on line 14c of form OMB 83 I. The current OMB inventory for ICR 2080 0005 is listed as $ 89 ( thousand) on line 14d, and the difference, $ 101

$ 89 = $ 12 ( thousand), is reported on line 14e. This difference is reported as an adjustment ( line 14f2) because it is due to revised cost estimates for some respondents as well as adjustments made in the labor and non labor cost estimates over the last three years, based on the Bureau of Labor Statistics Employment Cost Index and Producer Price Index data. None of the difference is due to program change; hence, zero is reported on line 14f1.

6( c) Estimating Agency Burden and Cost The agency burden and cost estimates are given in Table 4. They are based on our experience in collecting this information and operating the Reference and Equivalent Method Program for many years and include processing of both full applications and modification requests. The costs are based on technical staff labor at the GS 12/ 13 level, at $ 35/ hr., using the locally applicable hourly salary table for 2004 for the locality pay area of " Rest of U. S." This rate was raised to $ 56 per hour to include a 1.6 multiplier for overhead. Similarly determined clerical costs were based on a loaded labor rate of $ 25/ hr. As indicated previously, there is no way to predict the exact number of applications that will be received in a given year, so actual cost could deviate from these estimates.

6( d) Estimating the Respondent Universe and Total Burden and Cost Based on historical data for application submittals and other information available to the Process Modeling Research Branch, it is estimated that 5 applications for reference or equivalent method determination, and 14 minor applications for approval of modifications, will be received annually during the time period covered by this ICR. Labor and other costs for a typical designation application are described in Section 6( a, b). Total annual burden and cost for the Information Collection are summarized in Table 5.

6( e) Bottom Line Burden Hours and Costs The total annual burden for respondents and agency is shown in Table 5. 19 Table 4. Representative Annual Agency Burden and Cost Collection Activities Burden Hours and Costs per Year Total Hours and Costs Tech. Staff Clerical ($ 56/ hr)* ($ 25/ hr)*

Provide copies of regulation and assistance materials regulation interpretation; technical assistance 100 27 127 $ 5,600 $ 675 $ 6,275 Receive applications; administrative activities 29 13 42 $ 1,624 $ 325 $ 1,949 Technical review and evaluation 304 32 336 $ 17,024 $ 800 $ 17,824 Designation activities 11 5 16 $ 616 $ 125 $ 741 Maintain & distribute List of Designated Methods 94 32 126 $ 5,264 $ 800 $ 6,064 Review and process modification requests 108 6 114 $ 6,048 $ 150 $ 6,198 Program support 72 11 83 $ 4,032 $ 275 $ 4,307 Totals Hours Costs 718 126 844 $ 40,208 $ 3,150 $ 43,358 * Burdened labor rates ( salary × 1.6). 20 Table 5. Total Annual Burden and Cost Summary Hours Cost Total respondent burden and cost ( including recordkeeping) ( from Table 3) 4,718 $ 426,966 Total Agency in house burden and cost ( Table 4) 844 $ 43,358 Total Agency contract cost 0 $ 100,000 Totals 5,562 $ 570,324 6( f) Reasons for Change in Burden ( i) Respondent burden Since there has been no change in program requirements nor in the estimated number or mix of applications expected, the current estimate of respondent burden hours ( 4,718) is the same as the previous ( December 2001) estimate. The total annualized cost estimate is somewhat higher than the previous estimate because of the adjustment in the labor rates and the non labor ( except capital/ startup) costs based on the BLS ECI and PPI data and because of a revision in the cost estimates for the minor applications for approval of modifications. As noted previously, the actual respondent cost varies widely, depending on the type and nature of the application submitted. A simple request for approval of a minor modification to a currently designated method may cost only a few dollars. At the other extreme, the full cost for conducting the complete complement of tests and submission of a complete application for designation for a new PM 2.5 analyzer, for example, could cost $ 100,000 or more, depending on the exact circumstances and facilities available to the applicant. New applications are often related to previously designated instruments that have been redesigned to incorporate new technology and features. Many monitoring instrument manufacturers redesign and update their air monitoring instruments to incorporate advances in electronics and in digital and microprocessor circuitry, adding many new data processing and user programmable capabilities Manufacturers must reapply to have these redesigned analyzers designated ( or redesignated as reference or equivalent methods, either via approval of modifications or, more likely, via a complete reference or equivalent method application. Such redesign may extend to a manufacturer's entire line of designated pollutant analyzers. Burdens may or may not be somewhat lower for these types of applications. On the other hand, air monitoring instrument manufacturers occasionally produce new or unconventional types of instruments for which they seek reference or equivalent method designation; and burdens may be somewhat higher for these applications. Since each application is unique, there are many variables associated with each situation that substantially affect the cost of a particular application or submission. 21 ( ii) Agency burden The agency's cost to process the information depends on the number and type of applications or requests received. The agency burden has similarly increased somewhat from the previous estimate, reflecting the increase in the staff labor rates. Based on the overall submission processing experience over the last several years and the anticipated number and allocation of applications in the next 3 years, the annual agency burden is estimated to be about $ 43,000, with an additional $ 100,000 for contract support.

6( g) Burden Statement The annual public reporting burden for full applications, ranging from 150 to1820 hours, is estimated to average 859.5 hours per application. This includes a recordkeeping burden related to full applications estimated to be 9.6 hours per application. For modifications of applications, ranging from a few hours to several hundred hours, the burden is estimated to average 30 hours per application or a total of 48 hours per year based on an estimated 5 full applications per year. Based on total hours of 4,717.5 with19 responses, the average burden is 524 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 No. ORD 2004 0013, which is available for public viewing at the Office of Environmental Information ( OEI) Docket in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Avenue, 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 Environmental Information ( OEI) Docket is ( 202) 566 1752. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the elements of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select " search," then key in the docket ID number identified above. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, 22 DC 20503, Attention: Desk Office for EPA. Please include the EPA Docket ID No. ORD 2004 0013 and OMB control number ( 2080 0005) in any correspondence. 23 Appendix A List of commenters responding to EPA's December 13, 1996 Proposed part 53 Regulations, Revised Requirements for Designation of Reference and Equivalent Methods for PM 2.5, Docket A 96 51. Final rules were promulgated July 18, 1997.

Docket ID Name Organization IV D 177 Unknown Ventura County Air Pollution Control District IV D 218 O'Connor, M. Indiana Department of Environmental Management IV D 220 Unknown State of Alaska IV D 222 Unknown Cal/ EPA IV D 228 Meyer, M. B. Rupprecht and Patashnick Company NA* Lundgren, D. A. Academia but commenting on behalf of National Mining Association NA* DiBattista, C. State of Connecticut, Department of Environmental Protection * No Number Assigned 24 Standing Air Monitoring Work Group ( SAMWG) ( Non EPA Personnel, 1996)

Mr. Gustave Von Bodungen LA Dept. of Environmental Quality 7290 Bluebonnet Baton Rouge, LA 70810 Mr. Miquel Flores, Chief Monitoring & Data Analysis Branch National Park Service  Air 12795 West Alameda Parkway Lakewood, CO 80228 Mr. Douglas L. Tubbs Ventura Co. APCD 669 County Square Drive Ventura, CA 93003 Mr. Jeff Cook California Air Resources Board 2020 L Street Sacramento, CA 95814 Mr. Robert Ostrowski Air Management Services 500 South Broad Street Philadelphia, PA 19146 Mr. Charles Pietarinen, Chief Bureau of Air Monitoring NJ Dept. of Environmental Protection 401 East State Street, CN027 Trenton, NJ 08625 Mr. Ray Bishop Tulsa City County Health Dept. 4616 East 15th Street Tulsa, OK 74112 6199 Mr. Robert Hannah Dept. of Environmental Quality Office of Air Quality & Rad. Protection 7290 Bluebonnet Baton Rouge, LA 70810 Mr. Larry Byrum Div. of Environmental Quality 4545 N. Lincoln Blvd., Suite 250 Oklahoma City, OK 73105 3483 Ms. Susan S. G. Wierman Executive Director, MARAMA 711 West 40th Street, Suite 318 Baltimore, MD 21211 Mr. Doyle Pendleton Texas Natural Resources Commission Monitoring Operations/ MC165 PO Box 13087 Austin, TX 78711 3087 Mr. Harry St. Clair Air Quality Programs Hamilton Co. Dept. of Env. Services 1632 Central Parkway, Room 201 Cincinnati, OH 45210 1604 Lee Alter NESCAUM 129 Portland Street, Suite 105 Boston, MA 02114 Mr. Mike Gilroy Puget Sound Air Pollution Control Agency 110 Union Street, Suite 500 Seattle, WA 98101 2038 Mr. Brian Jennison Director, Air Quality Division Washoe Co. Dist. Health Dept. PO Box 11130 Reno, NV 89520 0027 25 Appendix B Assumptions and Notes: Determination of Burden Hours and Cost Estimates for Applications for Reference and Equivalent Methods Based on information provided by an informal survey of nine previous applicants, representative burden hours and cost estimates were prepared for five categories of applications: Gas Analyzers, Open Path Analyzers, PM 10 Monitors, PM 2.5 Reference and Class I Equivalent Samplers, and PM 2.5 Class II Equivalent Samplers. These average category estimates are not included here but are available in the associated Excel spreadsheet file, ICR0559 2004Supplemental Tables. xls, as Tables E 1 through E 5. These category estimates were derived as described below.

1) Gas Analyzers: These numbers represent mean values received from survey respondents for gas analyzer designation application burden and costs.

2) Open Path Analyzers: No useful cost figures for open path analyzers were received from survey respondents. It was assumed that the cost for preparing an open path analyzer designation application is roughly three times that for a standard gas analyzer. However, a typical open path analyzer would likely be submitted for designation for three or more pollutants at little additional cost per pollutant. Consequently, the cost per designation application for open path analyzers was assumed to be the same as that for a typical gas analyzer.

3) PM 10 Monitors: These numbers represent mean values received from survey respondents for PM 10 monitor designation application costs and include both PM 10 samplers and analyzers.

4) PM 2.5 Reference and Class I Equivalent Samplers: These numbers represent mean values received from survey respondents for PM 2.5 Reference and Class I Equivalent Method Sampler designation application costs.

5) PM 2.5 Class II Equivalent Samplers: No useful cost figures for PM 2.5 Class II Equivalent Samplers were received from survey respondents. It was estimated that the costs for PM 2.5 Class II Equivalent samplers are approximately 1.35 times higher than for Reference/ Class I samplers.

Weighted average, composite burden and cost estimates for a typical designation application were developed by summing up the estimates for all the different analyzer categories, after multiplying each by a factor based on the expected fraction of total applications expected over the next 3 years for each analyzer category. The fractions used for this purpose are as follows:

20% Gas Analyzers 5% Open Path Analyzers 30% PM 10 Monitors 40% PM 2.5 Reference/ Class I Equivalent Samplers 5% PM 2.5 Class II Equivalent Samplers 26 6) ISO 9001: No useful cost figures were received from respondents. Instead, data provided to EPA by four ISO 9001 consultants were reviewed and used to develop ISO 9001 cost estimates as detailed below:

Contractor

s Startup Cost for Establishing ISO 9001 includes ( 1) a pre assessment meeting; ( 2) preliminary evaluations; ( 3) registration assessment; ( 4) PM 2.5 checklist including evaluation and registration; and ( 5) training costs. These costs are one time fees and can range from a combined total of $ 15,250 to $ 34,500 depending on the size of the facility. The average cost is therefore about $ 24,900. Annualizing this cost over a three year period results in approximately $ 8,300 per year. Assuming that 40 percent of the companies already have ISO 9001 programs in place, the annual cost is $ 4,980. Assuming further that these costs will be incurred only by companies applying for PM 2.5 methods results in an annual cost of approximately $ 2,241.

Contractor

s ISO 9001 Maintenance Cost includes ( 1) continuous assessment; ( 2) ISO file maintenance fee; and ( 3) continuous checks for PM 2.5 checklist. These costs are annual fees and can range from a combined total of $ 2,375 to $ 6,875 depending on the size of the facility. The average cost is therefore $ 4,625 per year. Assuming that these costs will be incurred only by companies applying for PM 2.5 methods results in an annual cost of approximately $ 2,081.

In House Startup Cost for Establishing ISO 9001 includes labor cost for management, technical/ professional, and clerical staff.

a) Management Startup Cost for Establishing ISO 9001: Management labor hours range from 32 hours per year to 120 hours per year depending on the size of the facility. These hours are used for management reviews. The average management labor hours is therefore 76 hours per year. Assuming that 40 percent of the companies already have ISO 9001 programs in place, the annual burden is 45.6 hours, and assuming further that these hours will be incurred only by companies applying for PM 2.5 methods results in an annual burden of 20.5 hours.

b) Technical/ Professional Startup Cost for Establishing ISO 9001: Technical/ professional labor hours include training internal ISO coordinators and auditors. It is assumed that 2 to 5 technical/ professional staff are involved at 24 to 40 hours per staff, resulting in 48 to 200 hours depending on the size of the facility. The average technical/ professional labor hours are therefore 124 hours per year. Annualizing this cost over a three year period results in approximately 42 hours per year. Assuming that 40 percent of the companies already have ISO 9001 programs in place, gives a burden of 25.2 hours per year, and assuming further that these hours will be incurred only by companies applying for PM 2.5 methods results in an annual burden of 11.3 hours.

c) Clerical Startup Cost for Establishing ISO 9001: None identified In House Maintenance Cost for Establishing ISO 9001 includes labor cost for management, technical, and clerical staff.

a) Management ISO 9001 Maintenance Cost: Management labor hours range from 32 hours per year to 120 hours per year depending on the size of the facility. These hours are used for management reviews. The average management labor hours is therefore 76 hours per year. Assuming that these hours will be incurred only by companies applying for PM 2.5 methods results in an annual burden of 34.2 hours. 27 b) Technical/ Professional ISO Maintenance Cost: Technical/ professional labor hours include reviewing, recommending revisions, and approving internal audits. It is assumed that 2 to 20 technical/ professional staff are involved at 16 to 24 hours per staff, resulting in 32 to 480 hours per year depending on the size of the facility. The average technical/ professional labor hours is therefore 256 hours per year. Assuming that these hours will be incurred only by companies applying for PM 2.5 methods results in an annual burden of 115.2 hours.

c) Clerical ISO Maintenance Cost: Clerical labor hours include drafting new or revising existing SOPs, and training SOP writers. It is assumed that 48 to 675 clerical hours are needed for these tasks depending on the size of the facility. The average clerical labor hours is therefore 362 hours per year. Assuming that these hours will be incurred only by companies applying for PM 2.5 methods results in an annual burden of 162.9 hours.


[Federal Register Volume 78, Number 4 (Monday, January 7, 2013)]
[Notices]
[Pages 970-971]
[FR Doc No: 2012-31751]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68553; File No. SR-FICC-2012-10]

Self-Regulatory Organizations; Fixed Income Clearing Corporation;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
To Remove the Fee Related to the DTCC GCF Repo Index[supreg] From the
Fee Structure of the Government Securities Division

December 31, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder \2\ notice is hereby given that
on December 21, 2012 Fixed Income Clearing Corporation (``FICC'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed change as described in Items I and II below, which Items have
been prepared primarily by FICC. The Commission is publishing this
notice to solicit comments on the proposed change from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    FICC proposes to remove the fee related to the DTCC GCF Repo
Index[supreg] from the Fee Structure of the Government Securities
Division. The text of the proposed rule change was filed with the
Commission as Exhibit 5 to the filing.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, FICC included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. FICC has prepared summaries, set forth in sections (A),
(B), and (C) below, of the most significant aspects of these
statements.\3\
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    \3\ The Commission has modified the text of the summaries
prepared by FICC.
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(A) Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    The purpose of this filing is to discontinue the $250.00 monthly
fee that GCF Repo[supreg] participants are required to pay in
connection with the DTCC GCF Repo Index[supreg].
    On October 18, 2010, FICC filed SR-FICC 2010-07 \4\ which permitted
FICC to charge a monthly fee of $250 to all GCF Repo[supreg]
participants. This fee covered the development and maintenance costs of
the DTCC GCF Repo Index[supreg]. Because DTCC and NYSE Liffe have
entered into an agreement whereby NYSE Liffe agrees to list futures
based on the DTCC GCF Repo Index[supreg], it is no longer necessary for
FICC to charge a monthly fee to the GCF Repo[supreg] participants. As a
result, the fee will be discontinued as of January 2, 2013 and the GSD
Fee Structure will be revised to reflect this change.
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    \4\ See Securities Exchange Act Release No. 34-63215 (October
29, 2010); 75 FR 213 (November 4, 2010) (SR-FICC-2010-07).
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    FICC believes that the proposed rule is consistent with the Act and
the rules and regulations promulgated thereunder because it promotes
the prompt and accurate clearance and settlement of securities
transactions by helping ensures that participants are not charged
unnecessary fees.

(B) Self-Regulatory Organization's Statement on Burden on Competition

    FICC does not believe that the proposed rule change would impose
any burden on competition.

(C) Self-Regulatory Organization's Statement on Comments on the
Proposed Rule Change Received From Members, Participants or Others

    Written comments on the proposed rule change have not been
solicited or received. FICC will notify the Commission of any other
written comments received by FICC.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act \5\ and Rule 19b-4(f)(2) \6\ thereunder
because they constitute a change a due, fee, or other charge applicable
only to a member. At any time within 60 days of the filing of the
proposed rule change, the Commission summarily may temporarily suspend
such rule change if it appears to the Commission that such action is
necessary or appropriate in the public interest, for the protection of
investors, or otherwise in furtherance of the purposes of the Act.\7\
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    \5\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \6\ 17 CFR 240.19b-4(f)(2).
    \7\ 15 U.S.C. 78s(b)(3)(C).
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Electronic Comments

     Use the Commissions Internet comment form (http://www.sec.gov/rules/sro.shtml) or Send an email to<EMAIL_ADDRESS>
Please include File Number SR-FICC-2012-10 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-FICC-2012-10. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of FICC and on
FICC's Web site at http://www.dtcc.com/downloads/legal/rule_filings/2012/ficc/SR-FICC-2012-10.pdf
    All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You

should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-FICC-2012-10
and should be submitted on or before January 28, 2013.

    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\8\
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    \8\ 17 CFR 200.30-3(a)(12).
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Elizabeth M. Murphy,
Secretary.
[FR Doc. 2012-31751 Filed 1-4-13; 8:45 am]
BILLING CODE 8011-01-P