## 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 I CR No. 0559. 1 1

. 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 Par t 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 typ e of method). Respondents (applicants) who seek to have an ambient air pollutant measurement method designated b y 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 anal yz er (called an automated meth od) 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 anal yz er or sampler for use in their air monitoring networks under 40 CFR Part 58. Approxi mately 6.33 major and 1 6.67 minor applications ( 22 total responses) are expected annuall y

. Accordingl y, the primary ty pe of collection is an application for EPA

- designation of a method used for ambient air pollutant measurement. The information is collec ted b y 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 c ollected via the application is a detailed description of the nature of the method and measurement principle employed b y 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 b y 40 CFR Part 53. This information is used by the Process Modeling Research Branch to determine whether the method is qualified to be designated b y 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 issubmitted in the form of text, data tables, diagrams, copies of strip chart or data acquisition

sy stem 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 electronicall y. 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 greatl y 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 designate d 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 sta tus. 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 b y the EPA. The new category is continuous (or semi

- continuous) Class III equivalent methods (analyze rs) 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 measurin g 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 anal yz ers used for continuous atmospheric monitoring or commercial air samplers used to collect integrated air samples for laboratory

anal ys es, but they

may also include noncommercial manual methods used for non

continuous air monitoring. Under the provis ions 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. I f EPA determines, on the basis of the submitted info rmation 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 require s 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 attainme nt 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 L aw 91

- 604, 84 Stat. 1713. The information is collected according to the provisions se t forth in 40 CFR Part 53.

2(b) Practical Utility/Users of the DataUpon receipt by the Process Modeling Research Branch, an application is logged and an acknowledgment of receipt is sent to the applicant, as required b y 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 provisio ns 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 L aboratory for publication in the Federal Register . If not, a request for additional tests or information may be sent to the applicant, the a pplicant may

be notified that additional tests will be conducted b y EPA before a determination can be made, or the applicant may be notified that the application is rejected. Following approval of a designation b y the NERL L aboratory Director and publication of the notice of designation, notification of the designation is sent to the applicant, and the method is added to the L ist of Designated Reference and Equivalent Methods m aintained b y 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 m ethods as of March 200 8 . Man y 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 m ethods. 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 day s if the designation is canceled or if adjustment of the method is determin ed b y 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 Sy stem 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 dupl ication 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. Itis 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 previousl y submitted application or otherwise already in the EPA's posse ssion, 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 t o 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 IC R.
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 prel iminary 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 B ill 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, Vi ctoria, 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 onl y 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 anal yz ers 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 fora 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 anal yz er or sampler during that seven ye ar period if the reference or equivalent method designation is canceled or if adjustment or modification of the designated anal yz er or sampler is required to maintain its designated status. Seven years is representative of the es timated 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 i s claimed b y 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 Que stions 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. Se nsitive 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 S Codes Since the col lection of this information is voluntary and related to application for a benefit, the information is collected onl y from entities for which the benefit is sufficient to justify the costs of the required testing and submission of an application. The large st category of applicants is manufacturers or vendors (NAIC #334513) of air monitoring instruments suitable for use b y state and local air monitoring agencies in their federall y required air surveillance monitoring networks, and agents acting for instrument manufacturers or vendors. Other potential applicants include state or local air monitoring agencies (NAI C #924110), analy tical laboratories (NAIC #541380), and the EPA (NAIC #924110).

4(b) Information Requested
(i) Data Items, Including Recordkeeping Requirements
The ty pe 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 particularl y for applications for PM 2.5 methods, as set forth in th e current regulation. That information is summarized below.

In formation 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 identif

ication must consist of a unique series of descriptors such as title, identification number, analy te, 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 cop y of a comprehen sive 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 display s, 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

recomme nded 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 preventati ve 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 an y other pertinent EP A 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 autom ated methods, the manual shall include a clear description of allprocedures 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, anal yz er, 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 referenc es 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

(NI ST) traceability

. (ii) Test data shall be collected according to the standards of good practice and by qualified personnel. Calculations or data manipulations shall be exp lained 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 , 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 s ys tem that will be utilized in production of the method, if the candidate method is designated as a reference or equivalent method. (ii) A descrip tion of the durability characteristics of such anal yz ers 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 refere nce 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 informati on related to designation testing and product manufacturing, confirmed b y an I SO

- 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 anal yz er 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. Id entification of confidential or proprietary information (if applicable). [§53.1 5]Maintain records on :

1. Section 53.9(f) of 40 CFR 53 requires applicants who offer anal yz ers 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 ye ars 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 noti fy 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 m odest, 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

I SO 9001 facility

registration or equivalent standards [§53.51(b), §53.9(h), and §53.9(i)].

(ii) Respondent Activities Ty pical or representative respondent activities are as follows:

1. Obtain a cop y 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, an d 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

re quests 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 anal yz ers or samplers.13. Obtain or maintain I SO 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 ty pes 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 an y 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 L ist of Designated Reference and Equivalent Methods and make the list available on the Internet ( www.epa.gov/ttn/amtic/criteria.html ). 6. Technicall y 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 suppor t, including management, program planning, computer software and data calculation sy stems, regulation development and maintenance, administrative support, and quality assurance guidance.

5(b) Collection Methodology and Management The nature of this infor

mation collection does not lend itself readil y 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 highl y specific to the subject method. Where possible, applicants are allowed to submit test results or measurement data obtained with automated digital data acquisition sy stems, analog or digital chart recorders, or other automated or semi

- automat ed devices. Entire test sequences may

by automated, if feasible, at the applicant’s discretion. Optional data entry forms (hard cop y) are suggested to help define the test readings required, to facilitate calculations, andto 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 onl y once, it is not compiled with information from other applications, no composite statistical analy sis 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 anal ys is, p aper or microfilm files serve acceptably . The cost of a rapid data or record retrieval sy stem is not justified. The information in each application is evaluated for accuracy , completeness, appropriateness, and credibility by a technical analy st. 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 accur atel y and uniformly. Additional technical anal ys ts 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, addition al 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 b y the formall y specified tests. Finally , monitoring data quality i s assessed continuall y 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 copyingof Process Modeling Research Branch files; modest requests for copies of specific information to be mailed or fax ed are generall y fulfilled b y branch personnel. Information identified as Confidential Business Information is available only to the extent allowed under the Freedom of In formation Act in accordance with 40 CFR Part 2.

5(c) Sm all 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 way s. These include providing ad ditional, 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; identify ing applicable information already on file that need not be duplicated; offering recommendations for compiling the appli cation information; providing suggested language for instruction or operation manuals; and accepting handwritten or similarl y informal but acceptable information submission.

5(d) Collection Schedule For the most part, applications are voluntary and are a ccepted 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 thefollowing actions: (1) designat ion 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 specificatio n of additional tests to be conducted b y EPA, before a determination can be made [§53.5]. Response to requests for approval of modifications to designated methods must be within 30 day s [§53.14(c)], although this limit was increased in the final Rule to 9 0 day s for modifications other than minor ones. The F inal 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 widel y, 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 o ther 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 establishe d base ICR burden estimates are likely if any of the regulations associated with reference and equivalent method applications (40 CFR Parts 50 and 53, respectivel y) are amended, or new regulations are promulgated, such that the nature, number, or ty pe of a pplications in this collection is affected . The regulatory rule

- making process is ty picall y quite length y, 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 rev iew puts particular emphasis on those categories that may be potentially

impacted b y new regulations that have either been recentl y promulgated or are likel y to be promulgated within the next period of approval for this I CR.
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 I CR. However, methods for TSP are described in an appe ndix 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 regulationsassociated with TSP are currentl y planned nor are any likel y to occur within this I CR 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 specif ies 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 generall y full y described in the respective Part 50 appe ndixes 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 ty

pically 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 test ed against either the new or the old reference method, so no additional application burden is generated b y the new Pb reference method. No further changes in any of these regulations (or new regulations) associated with monitoring methods for Pb are curre ntly planned nor are likel y to occur within this I CR 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 b y late 2014. This schedule indicates that any further regulatory changes that could or might affect the collection burden esti mates for Pb methods would occur beyond the end of the next approval period for this ICR.

PM 10 . Although some changes in the form of the NAAQSs for PM 10 are under consideration by OAQPS, no changes in the regulations associated with reference or equivalent methods for PM 10 are currentl y under consideration nor are likel y to occur within this I CR approval period. Burden estimates associated with applications for reference and equivalent methods for PM 10 are already incorporated into the base I CR estimates.

PM 2.5 Reference Methods and Class I Equivalent Methods . No changes in the regulations associated with reference or Class Iequivalent methods for PM 2.5 are currently under consideration
, nor are any such changes likel y to occur within this I CR approval p eriod. Burden estimates associated with applications for these types of methods for PM 2.5 are already incorporated into the base I CR estimates.

PM 2.5 Class II Equivalent Methods . No changes in the regulations associated with Class II equivalent methods f

or PM 2.5 are currently under consideration nor are any such likely to occur within this I CR approval period. Burden estimates associated with applications for this ty pe 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 ty pe of method for PM 2.5 are already incorporated into the base IC R estimates.PM 2.5 Monitoring Methods for a Possible Secondary NAAQS for Visability . PM 2.5

monitoring methods of this ty pe are not currentl y 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. An y such new NAAQS would require promulgation of a new reference me thod 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 an y 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 I CR.
PM 10

- 2.5
. No changes in the regulations associated with PM 10

- 2.5 reference or equivalent methods are currentl y under consideration nor are any regulatory changes likely to occur within this I CR approval period. Burden estimates associated with applications for methods for PM 10

- 2.5 are already incorporated into the bas e I CR estimates.
SO 2 . A new (second) SO 2 reference method was promulgated on June 22, 2010, along with some associated changes to Part 53, Subpart B that were applicable to candidate SO 2 reference and equivalent methods. However, the effect of these new regulations on the I CR burden estimates is quite minimal. The new SO 2 reference method specifies the automated ultraviolet fluorescence (UVF) method. This method is already used for nearl y all the current compliance network monitoring; using UVF anal yz er s approved as equivalent methods. The old SO 2 reference method (a wet chemical, manual method) was left in place to make sure that all the existing SO 2 equivalent methods would retain their equivalent method designation without interruption. One minor impact on burden estimates for the next I CR approval period is that new applications for EPA designation of UVF anal yz ers will be considered as reference method applications rather than equivalent method applications. The new performance requirements for de signation of new reference method analyzers are more stringent than the previous requirements for equivalent method analyzers; however, it is very likel y that most new UVF analyzers designed for routine ambient monitoring can meet the new requirements. Si nce Part 53 does not require a Subpart C comparability (field) test for candidate reference method anal yz ers, and one of the previousl y required tests has been eliminated, the testing burden would actually be reduced a bit for new UVF candidate reference m ethod analyzers relative to the previous requirements for equivalent method UVF anal yz ers. Optional new test requirements with even more stringent performance requirements were added to Part 53, Subpart B and are applicable to a candidate SO 2 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 alway s 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 SO 2 anal yz ers, and it seems likely

that many , if n ot 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 approxi mately

offset the reduced burden from relief from the equivalent method comparabilitytest requirements (mentioned above), such that no adjustment of the burden estimates is deemed

to be necessary

in this regard. The new regulatory

requirements also appl y to candidate equivalent method SO 2 anal yz ers. Almost all new candidate SO 2 anal yz ers are likel y to be candidate reference (UVF) anal yz ers and would be covered by the above discussion. However, there could possibly be a few (very few) new candidate equiv alent method SO 2 analy zers, such as DOAS monitors or some other new SO 2 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, manufa cturers 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 anal yz ers as reference method analyzers. Such method re

- designation would likel y provide them some marketing advantage, such as 1) they could cite the higher level of performance required by Part 53 for SO 2 new reference method anal yz ers; 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 SO 2 measurement range with the extra

- high pe rformance now optionall y 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 wou ld require some additional testing to show that the anal yz er 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 SO 2 methods. On the EPA

- burden side, there could be a slightl y increased burden on EPA from processing a few extra applications from previous UVF equivalent method applicants requesting

re

- designation of their analyzers a s reference methods. But also, EPA will have slightl y less burden from processing new SO 2 reference method applications because there would be no Subpart C comparability

test to evaluate. The magnitude of these minor, potential I CR burden variations disc ussed above are deemed quite inconsequential relative to the considerable uncertainties in the assumptions of the number of SO 2 reference and equivalent method applications that EPA will receive in the next ICR approval period and in the burden for prepari ng 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.
O 3 . Some of the monitoring regulations for O 3 were amended in March 2008, but no changes were made to the regulations governing reference or equivalent methods for O 3 . 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 O 3 , in connection with the next time the O 3 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 generall y parallel, to the changes promulgated in 2010 formethods for SO 2 , and the effect on the ICR burden estimates is expected to be similarly quite modest. Further, it is very unlikel y that an y regulatory changes potenti all y affecting methods for O 3 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 b y 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 highl y developed state of the non

- dispersive infrared (NDIR) absorption reference me thod 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 C O reference method anal yz ers or on the designation of new CO anal yz ers. 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 SO 2 , O 3 and NO 2 . Similar to the textual changes to the CO reference method described in the previous paragraph, these changes are largel y 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 IC R. 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 SO 2 described previously and are part of an on

- going effort b y the Process Modeling Research Branch to update, clarify , and modernize some of the older provisions of the reference and equivalent method regulations. N ew performance requirements are proposed for designation of new CO reference and equivalent method anal yzers that are more stringent than the previous requirements. However, it has been determined that most new NDIR anal yz ers designed for routine CO monitoring can already meet the new requirements, and previously designated reference methods will not be affected b y 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, b ut 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 an d 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 t o have one or more lower, more sensitive measurement ranges approved (inaddition to the standard range) under its reference or equivalent method designation. Testing and

designation of lower ranges has alway s 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 anal yz ers, 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 insignifi cant 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 settlem ent agreement deadline). If promulgated essentially as proposed, by

this deadline, the changes would occur earl y in the next approval period of this ICR. However, any changes to the collection burden are estimated to be insignificant and adequately inclu ded in the previously

established burden estimates for the base I CR.
NO 2
. No changes in the regulations associated with NO 2 reference or equivalent methods are currentl y under consideration nor are an y changes likely to occur within this I CR approval peri od. Burden estimates associated with applications for methods for NO 2 are already incorporated into the base I CR burden estimates. Open

- Path analyzers

. Open

- path anal yz ers, by nature, are typicall y capable of monitoring multiple gaseous pollutants simult aneously

. No changes in the regulations associated specificall y with open

- path equivalent methods are currently under consideration nor are any changes likel y to occur within this I CR approval period. Open

- path anal yz ers are subject to the recent changes in the SO 2 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 associ ated with applications for designation of SO 2 or CO methods are deemed insignificant. Further, applications for open

- path candidate methods are received very infrequently . The b urden estimates associated with applications for open

- path methods are already adequatel y incorporated into the base I CR 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 SO 2 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 currentl y used in EPA’s CASTNET monitoring network, has been suggested for monitoring SO 2 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 refere nce and equivalent methoddesignation 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 anal yzers, it is anti cipated 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 generall y 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 Su lfur (SOx). Because the CASTNET filter

- pack methodology uses commerciall y
available technology

and can be operated using substantive, readil y 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 b y regulations which have either been recently promulgated or are likel y to be promulgated within the period of approval for this I CR (i.e. through 7/31/2014) . In the cases of TSP, PM 2.5 FRM, PM 2.5 FEM, PM 10 , PM 10

- 2.5 , and NO 2 , no changes in the NAAQS regulations are anticipated which would influence either respondent or agency burdens. Regarding Pb, b urden estimates associated with a pplications for equival ent 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 b urden is generated b y the new Pb reference method. For all other pollutant and subpollutant categories (i.e., secondary PM 2.5 , O 3 , CO, SO 2 , open

- path anal yz ers, 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 I CR’s period of performance.

6(b ) Estimate d 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 E stimated A nnual R espondent B urden H ours and C ost s

for Annual Reporting and RecordkeepingLabor 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 $ 1 09 , 185 $23,483 $13 2 , 668 $ 650,494 Combined grand totals 7,492 $517,831 $1 09 , 185 $23,483 $13 2 , 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 I CR’s period of performance based on a review of programmatic regulatory rev isions

. 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

Revie w 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 $ 233,5026( 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 $6 50,494 7

, 492 $ 6 50

, 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 b y persons to generate, maintain, retain, or disclo se or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and s ys tems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing way s to compl y with any previously

applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data
sources; c omplete 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 currentl y 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 I CR 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 holiday s. 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 Informati on andRegulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Office r for EPA. Please include the EPA Docket ID Number EPA

- HQ

ORD

- 2005

- 0530 and OMB control number 2080

- 0005 in an y 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 Dese rt 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 L ife 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 Univ ersity

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 EdgertonAtmospheric Research and Analy sis, 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 Scie nce Washington University 1 Brookings Drive St. Louis, MO 63130

Dr. Kazuhiko Ito School of Medicine New York Universit y 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. Kimberl y 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 Prov idence Eng. and Env. Group LL C 6160 Perkins Road, Suite 100 Baton Rouge, LA 70808