 1 SUPPORTING STATEMENT EPA ICR 0559.07  OMB No. 2080 0005 Application for Reference or Equivalent Method Determination 1. IDENTIFICATION OF THE INFORMATION COLLECTION 1( a) Title ICR: Application for Reference or Equivalent Method Determination; OMB Control Number 2080 0005, EPA ICR No. 0559.07.

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 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, the regulations further require that the pollutant measurement methods used in these air monitoring networks 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. 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 other information to the EPA in an application for reference or equivalent method determination. Usually, the applicant is a manufacturer or vendor of an instrumental air analyzer ( called an automated method) or sampler who wishes to have its method ( product) designated by the EPA so that state and local air monitoring agencies can purchase the analyzer for use in their air monitoring networks under 40 CFR Part 58. Accordingly, the type of collection is an application for EPA designation of a method used for ambient air pollutant measurement. The information is collected by the Atmospheric Methods and Monitoring Branch, Human Exposure and Atmospheric Sciences Division, National Exposure Research Laboratory, Office of Research and Development, which receives and processes the applications. The information being collected via the application is method test results, descriptions of the test apparatus and test procedures used, a description of the nature of the method and measurement principle employed by the method, the operational instructions and calibration procedure associated with the method, and other information required by 40 CFR Part 53. This information is used by the Atmospheric Methods and Monitoring Branch to determine whether the method is qualified to be designated by the EPA as a reference or equivalent method. Such designation of the method allows it to be used by state and local air monitoring agencies in their required air surveillance networks. The information is submitted in the form of text, data tables, diagrams, copies of strip chart or data acquisition system records, instruction or operation manuals, or other items as appropriate The information is usually stored as submitted, but some information may be microfilmed or stored electronically.  2 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 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. 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. Under 40 CFR 58 Appendix C, 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 Atmospheric Methods and Monitoring Branch, an application is logged, an acknowledgment of receipt is sent to the applicant, and a Notice of Receipt of the application is sent for publication in the Federal Register, as required by the regulation. The application is then technically reviewed by the Branch, and any additional tests or information needed to complete the technical review or to make the reference or equivalent method determination is formally requested from the applicant in accordance with the provisions of the regulation. If the technical evaluation of the application indicates that all requirements are satisfied and that the method fully qualifies for designation as a reference or equivalent method, a notice of designation for the method is prepared and sent through the EPA Assistant Administrator for Research and Development for publication in  3 the Federal Register. If not, a request for additional tests or information may be sent to the applicant, or the applicant may be notified that additional tests will be conducted by EPA before a determination can be made, or that the application is rejected. Following approval of the designation by the Assistant Administrator 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 Atmospheric Methods and Monitoring Branch. This list identifies all methods that have been designated as reference or equivalent methods and is made available to the EPA Regional Offices, state and local air monitoring agencies, and other interested users of air monitoring methods. The list is posted at http:// www. epa. gov/ ttn/ amtic/ criteria. html. 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 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 is highly specialized, it is very unlikely that any other agency collects or is planning to collect the information as specified in the regulation. 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 to use similar data not obtained in accordance with the regulation requirements. However, if information necessary for a specific application is duplicative of information contained in a previously submitted application or otherwise already in the EPA's possession, the previously submitted information may be cited and need not be resubmitted. Also, where possible, method test or performance information obtained by or for other testing or regulatory organizations, including foreign organizations, may be used to support or corroborate submitted test information or to obviate the need for special or supplemental test results which may otherwise be required.

3( b) Public Notice Required Prior to ICR Submission to OMB Public notice of this Information Collection Request was published in the Federal Register on Monday, June 25, 2001 ( 66 FR 33681). A 60 day public comment period was announced. No comments were received.

3( c) Consultations During the 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  4 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 Attachment B 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 Attachment B to this Supporting Statement. In addition, Atmospheric Methods and Monitoring 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 these most recent consultations are listed in Attachment B. Consultations used for burden estimates are listed in Attachment C.

3( d) Effects of Less Frequent Collection Since the information is collected only once for each application, less frequent collection is not possible. Modest recordkeeping is required, but the information in these records is not required to be reported.

3( e) General Guidelines Record retention over 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 the records required to be kept are records that would likely be kept by the manufacturer or vendor of the analyzer or sampler even without such a requirement. Further, 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 Atmospheric Methods and Monitoring 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.  5 3( f) Confidentiality and Sensitive Questions Confidentiality. The Atmospheric Methods and Monitoring 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/ SIC 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 ( SIC # 382) 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 ( SIC # 951), analytical laboratories ( SIC # 8734), and the EPA ( SIC # 951).

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  6 prescribed for field use of the candidate method and all instruments utilized as part of that method [ § 53.4( b)( 3)]. ( i) As a minimum this manual shall include: ( A) Description of the method and associated instruments. ( B) Explanation of all indicators, information displays, and controls. ( C) Complete setup and installation instructions, including any additional materials or supplies required. ( D) Details of all initial or startup checks or acceptance tests and any auxiliary equipment required. ( E) Complete operational instructions. ( F) Calibration procedures and a description of the required or recommended calibration equipment and standards. ( G) Instructions for verification of correct or proper operation. ( H) Trouble shooting guidance and suggested corrective actions for abnormal operation. ( I) Required or recommended routine, periodic, and preventative maintenance and maintenance schedules. ( J) Any calculations required to derive final concentration measurements. ( K) Appropriate references to Appendix L of Part 50; Reference 6 of Appendix A of Part 53 subpart A; and any other pertinent 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 § 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. 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.  7 ( ii) A description of the durability characteristics of such analyzers or samplers. [ See also § 53.9( c).] 7. For candidate reference or equivalent methods for PM 2.5, the applicant must submit a Designation Testing Checklist and a Product Manufacturing Checklist, each signed by an ISO certified auditor. [ § 53.51( f)] 8. 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 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)] 9. 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 the records required to be kept are records that would likely be kept by the manufacturer or vendor of the analyzer or sampler even without such a requirement. Further, 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 and any supplemental application materials available from the Atmospheric Methods and Monitoring Branch. 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 contractual services. 4. Obtain required test equipment, instruments, facilities, standards, and materials and arrange for required personnel. Arrange for contractual services, if needed.  8 5. Train personnel. 6. Assemble the test equipment, set up the test apparatus and facilities, and run practice tests as may be needed. 7. Carry out all required tests and obtain required test results. 8. Compile all test results, test parameters, instrument readings, measurement data, and other pertinent test documentation. 9. Prepare descriptions, tables, diagrams, illustrations, strip chart records, calculations, statements, and other documents as necessary. 10. Assemble final application and submit it to EPA. 11. Respond to any requests from EPA for additional tests or information that may be determined to be necessary to make the final reference or equivalent method determination. 12. Maintain records, including lists of customers. 13. Obtain and maintain ISO 9001 registration for the test and manufacturing facility ( for PM 2.5 designation only). 14. Calibrate and maintain testing instruments.

( Because of their specific nature, none of these items would 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. ISO 9001 facility registration appears likely to become common business practice in the future.)

5. THE INFORMATION COLLECTED B 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 technical assistance to applicants. 2. Receive applications, file applications and associated information, send acknowledgment of receipt to applicant, publish Notice of Receipt in the Federal Register, maintain confidentiality of application material identified as confidential business information. 3. Carry out comprehensive technical review of application information; identify inadequacies and request additional tests or information as determined to be required. If necessary, arrange for special auxiliary tests, as may be determined to be required. 4. Upon determination of designation, prepare and publish a Notice of Designation in the Federal Register and notify the applicant of designation. 5. Maintain a List of Designated Reference and Equivalent Methods and make the list available on the Internet ( www. epa. gov/ ttn/ amtic/ criteria. html). 6. Technically evaluate and approve requests ( or take other action, as appropriate) for modifications to designated reference or equivalent methods from applicants, manufacturers, and users.  9 7. Provide program support, including management, program planning, computer software and data calculation systems, regulation development and maintenance, administrative support, and quality assurance guidance.

5( b) Collection Methodology and Management The nature of this information collection does not lend itself readily to use of high technology and automation. The number of applications submitted per year is low, 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 chart recorders, or other automated or semi automated devices. 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 information after the initial analysis, paper or microfilm files serve acceptably. The cost of a rapid 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 Atmospheric Methods and Monitoring 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 information is accessible to the public by inspection and copying of Atmospheric Methods and Monitoring 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  10 suggestions for conducting tests; carefully defining the minimum information requirements for specific applications; furnishing certain hard to obtain or special reagents or other materials, standards, or calibration equipment; making available special test sites, facilities or equipment; identifying applicable information already on file that need not be duplicated; offering recommendations for compiling the application information; providing suggested language for instruction or operation manuals; and accepting handwritten or similarly informal but acceptable information submission.

5( d) Collection Schedule For the most part, applications are voluntary and are accepted whenever they are received from applicants, rather than on any required schedule. Following receipt of an application, the regulation requires EPA to respond to the applicant within 120 calendar days with one of the following actions: ( 1) designation of the method as a reference or equivalent method, ( 2) rejection of the method, ( 3) notification and specification of additional information required, ( 4) notification and specification of additional tests required, or ( 5) notification and specification of additional tests to be conducted by EPA, before a determination can be made [ § 53.5]. Response to requests for approval of modifications to designated methods must be within 30 days [ § 53.14( c)].

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 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 facilities available to the applicant, 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. Several vendors of monitoring devices who have submitted applications for designation in the past were contacted to obtain information for use in estimating costs. ( See Attachment C to this supporting statement for a list of vendors and sample survey form.) The results of this survey were compiled in conjunction with Ambient Monitoring and Methods Branch estimates to produce a composite estimate of costs for application submittal. For purposes of estimating 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 burden hours are given in Attachment D, and the generic category burden breakdowns are provided in the tables of Attachment E. Average total burdens for various categories of applications could range from 150 hours for PM 10 monitors ( Table E 1 of Attachment E) to possibly 1800 hours or more for PM 2.5 Class II equivalent samplers ( Table E 2 of Attachment E). We have 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  11 hours, with most less than 50 hours. For purposes of this ICR, we have estimated that an average of 14 modification requests will be received per year, with an average burden of 30 hours each. The total weighted composite burden estimate for applications ( from Table 1, 859.5 hours) was multiplied by the expected total number of applications ( 5) yielding 4298 total labor hours for applications. The estimated average burden for applications for modifications of existing methods ( 30 hours) was multiplied by the total number of modification applications expected ( 14) resulting in 420 additional burden hours. The grand total estimated labor burden is thus 4298 + 420 = 4718 hours, reported on line 13c of Form OMB 83 I. The current OMB inventory for ICR 2080 0005 is listed as 6,772 hours ( line 13d), and the difference is thus 2054 hours ( 4718

6,772 =

2054), reported on line 13e of Form OMB 83 I. This difference is reported as a program change ( line 13f) because the category weighting factors used to determine the composite burden estimates were changed to more typical values after having been temporarily distorted for the previous cost estimate by a program change ( regulatory amendment) in 1997. This determination of the total burden estimate is further detailed in Table E 6 in Attachment E to this supporting statement. 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 $ 108.62 for managerial staff, $ 64.27 for technical staff, and $ 33.83 for clerical staff. These rates were derived from cost estimates provided in direct consultation with manufacturers likely to submit applications for reference or equivalent method designations ( see Attachment C to this supporting statement). Since these cost estimates were provided about 3 years ago, they have been adjusted by a factor of 1.1275, which represents the 3 year, seasonally adjusted change in the Employment Cost Index for total compensation costs for " white collar occupations" in private industry obtained from Bureau of Labor Statistics data. 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 much 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. Some applicants may lack some of the required equipment and have to acquire it directly, but they are often successful in 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 a survey of fewer than nine manufacturers of instruments previously certified as reference or equivalent methods. 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 Attachment D to this supporting statement, and the category cost estimates are presented in Tables E 1 to E 5 of  12 Attachment E to this supporting statement. Since these cost estimates were provided about 3 years ago, the non labor costs ( except capital/ startup costs) have been adjusted by a factor of 1.022, which was derived as a weighted average of the 1997 to 2000 change in the Producer Price Index for " measuring and controlling instruments" ( 1.0232, 40%), " engineering and scientific instruments" ( 1.0154, 50%), and " total manufacturing industries" ( 1.0471, 10%) obtained from Bureau of Labor Statistics data. Projected future application plans from the instrument manufacturers and Atmospheric Methods and Monitoring 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" reference or equivalent method application, as presented in Table 1. The composite estimated total annualized capital and startup cost was computed by subtracting the operating and maintenance cost from Table 1 ($ 2,836) from the total non labor cost ($ 17,912), which is $ 15,075 ($ 17,912

$ 2836 = $ 15,075). This result was multiplied by the estimated 5 applications per year, resulting a total estimated annualized capital and startup cost of $ 75,400 ($ 15,075 × 5 = $ 75,400), which is reported on line 14a of form OMB 83 I. The operating and maintenance cost from Table 1 ($ 2,836) multiplied by the estimated 5 applications per year gives an estimated total annualized O& M cost of $ 14,200 ($ 2,836 × 5 = $ 14,200), which is reported on line 14b of form OMB 83 I. The total estimated annualized cost is $ 89,600 ($ 75,400 + $ 14,200 = $ 89,600) and is reported on line 14c of form OMB 83 I. The current OMB inventory for ICR 2080 0005 is listed as $ 19,000 ( line 14d), and the difference ($ 89,600

$ 19,000 = $ 70,600) is reported on line 14e. This difference is reported as a program change ( line 14f) because the category weighting factors used to determine the composite cost estimates were changed to more typical values after having been temporarily distorted for the previous cost estimate by a program change ( regulatory amendment) in 1997. These composite cost estimates are further detailed in Table E 6 in Attachment E to this supporting statement.

6( c) Estimating Agency Burden and Cost The agency burden and cost estimates are given in Table 2. They are based on our experience in collecting this information and operating the reference and equivalent method program for many years. The costs are based on technical staff labor at the GS 12/ 13 level, at $ 30.00/ hr. This rate was raised to $ 48 per hour to include a 1.6 multiplier for overhead. Clerical costs were based on a loaded labor rate of $ 22/ 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. Also, the cost estimates now reflect a decrease in in house processing costs and an increase in contract costs. These changes are based on reorganizations in the Atmospheric Methods and Monitoring Branch, redirection of priorities, and loss of Branch personnel previously assigned to the reference and equivalent methods project.

6( d) Estimating the Respondent Universe and Total Burden and Cost Based on a survey of fewer than nine manufacturers of instruments previously designated as reference or equivalent methods and historical data on application submittals, EPA estimates that 5 applications for reference or equivalent method determination will be received annually during the time period covered by this ICR. Labor and other costs for a typical designation application are  13 described in Section 6( a, b). Total annual burden and cost for the Information Collection are calculated below:

Hourly Burden 1 = 5 applications/ year x 850 hours/ application = 4250 hours Hourly Burden 2 = 14 modification requests/ year x 30 hours = 420 hours Annual recordkeeping burden: = 5 record keepers x 9.6 hours/ year = 48 hours Total annual burden = 4718 hours Total annual non labor cost = 5 applications/ year x $ 17,912 = $ 89,560 Total annual cost = 5 applications/ year x $ 70,999 = $ 354,995  14 Table 2. Representative Annual Agency Burden and Cost Collection Activities Burden Hours and Costs per Year Total Hours and Costs Tech. Staff Clerical ($ 48/ hr)* ($ 22/ hr)*

Provide copies of regulation and assistance materials regulation interpretation; technical assistance 100 27 127 $ 4,800 $ 594 $ 5,394 Receive applications; administrative activities 29 13 42 $ 1,392 $ 286 $ 1,678 Technical review and evaluation 304 32 336 $ 14,592 $ 704 $ 15,296 Designation activities 11 5 16 $ 528 $ 110 $ 638 Maintain & distribute List of Designated Methods 94 32 126 $ 4,512 $ 704 $ 5,216 Review and process modification requests 108 6 114 $ 5,184 $ 132 $ 5,316 Program support 72 11 83 $ 3,456 $ 242 $ 3,698 Totals Hours Costs 718 126 844 $ 34,464 $ 2,772 $ 37,236 * Burdened labor rates ( salary × 1.6).  15 6( e) Bottom Line Burden Hours and Costs The total burden for respondents and agency is shown in Table 3.

Table 3. Total Burden and Cost Summary Hours Cost Total respondent burden and cost ( excluding recordkeeping) 4670 $ 353,190 Recordkeeping burden and cost ($ 361 × 5) 48 $ 1,805 Total Agency burden and cost ( in house) 844 $ 37,236 ( contract) 0 $ 210,000 Totals 5562 $ 602,231 6( f) Reasons for Change in Burden ( i) Respondent burden The current estimate of respondent burden hours ( 4,728) is lower than the previous ( December, 1997) estimate of 6,772 hours. This decrease is largely a consequence of a change in the program that occurred in July of 1997 via amendment of the 40 CFR Part 53 regulation. The amendment added two new categories of designated methods B reference method and Class I equivalent method samplers for PM 2.5 and Class II/ Class III equivalent method samplers for PM 2.5 B and a new PM 2.5 monitoring requirement for state monitoring agencies. The previous burden estimate correctly anticipated a significant surge in applications in these new categories during the two year period following the change as instrument manufacturers designed and tested PM 2.5 samplers to meet the newly created need for PM 2.5 monitoring methods. Now, the frequency of applications submitted has returned to a more normal, maintenance level. Also, the allocation of estimated applications among the five categories has shifted away from a predominance in the PM 2.5 Reference and Class I Equivalent Method Sampler category, where burden costs are the highest of all the categories. This reallocation significantly reduced most of the weighted average burden estimates, as reflected in Table 1. 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  16 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 re designated) 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 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.

( 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 decreased somewhat from the previous estimate, reflecting the decrease in the estimated total number of applications and the shift in the estimated allocation of applications away from the PM 2.5 categories which are somewhat more complex to process than others. 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 $ 37,000, with an additional $ 210,000 for contract support.

6( g) Burden Statement Public reporting burden for this collection of information is estimated to average from 150 hours to 1820 hours per reference or equivalent method application, depending on which of several categories it falls into. The weighted average burden is estimated to be about 850 hours per application. These estimates include becoming familiar with the applicable regulations, test procedures, and specific requirements; obtaining required test equipment, supplies, and standards; setting up test apparatus; carrying out the required tests; contracting testing or related services, if required; compiling and documenting test results; and preparing an application for submission to EPA. Public reporting burden for requests for approval of modifications to previously designated methods may range from a few hours to several hundred hours, with the average estimated to be about 30 hours.

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.  17 Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, Collection Strategies Division, U. S. Environmental Protection Agency ( 2822), 1200 Pennsylvania Avenue, N. W., Washington, DC 20460; and to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, N. W., Washington, DC 20503, Attention: Desk Officer for EPA. Include the EPA ICR number and OMB control number in any correspondence.


[Federal Register Volume 76, Number 53 (Friday, March 18, 2011)]
[Notices]
[Page 14961]
[FR Doc No: 2011-6436]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings No. 1

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP11-1874-000.
    Applicants: Transcontinental Gas Pipe Line Company,
    Description: Transcontinental Gas Pipe Line Company, LLC submits
tariff filing per 154.203: Compliance Filing to Update Volume No. 2
Table of Contents to be effective 3/1/2011.
    Filed Date: 03/08/2011.
    Accession Number: 20110308-5034.
    Comment Date: 5 p.m. Eastern Time on Monday, March 21, 2011.

    Docket Numbers: RP11-1875-000.
    Applicants: Trunkline LNG Company, LLC.
    Description: Trunkline LNG Company, LLC submits tariff filing per
154.204: Negotiated Rate Filing to be effective 3/11/2011.
    Filed Date: 03/08/2011.
    Accession Number: 20110308-5037.
    Comment Date: 5 p.m. Eastern Time on Monday, March 21, 2011

    Docket Numbers: RP11-1876-000.
    Applicants: Golden Pass Pipeline LLC.
    Description: Request of Golden Pass Pipeline LLC for an Extension
of Time to Provide Support for Mozilla Firefox as a Browser Option.
    Filed Date: 03/08/2011.
    Accession Number: 20110308-5137.
    Comment Date: 5 p.m. Eastern Time on Monday, March 21, 2011.

    Docket Numbers: RP11-1877-000.
    Applicants: Natural Gas Pipeline Company of America LLC.
    Description: Natural Gas Pipeline Company of America LLC submits
tariff filing per 154.204: Expired Negotiated Rate Agreements Filing to
be effective 4/1/2011.
    Filed Date: 03/09/2011.
    Accession Number: 20110309-5021.
    Comment Date: 5 p.m. Eastern Time on Monday, March 21, 2011.

    Docket Numbers: RP11-1878-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Natural Gas Pipeline Company of America LLC submits
tariff filing per 154.204: Negotiated Rate Agreement Filing to be
effective 4/1/2011.
    Filed Date: 03/09/2011.
    Accession Number: 20110309-5033.
    Comment Date: 5 p.m. Eastern Time on Monday, March 21, 2011.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: March 9, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-6436 Filed 3-17-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 124 (Wednesday, June 29, 2022)]
[Notices]
[Page 38807]
[FR Doc No: 2022-13813]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-95144; File No. SR-FICC-2021-009]

 Self-Regulatory Organizations; Fixed Income Clearing
Corporation; Notice of Designation of Longer Period for Commission
Action on Proceedings To Determine Whether To Approve or Disapprove a
Proposed Rule Change To Enhance Capital Requirements and Make Other
Changes

June 23, 2022.
    On December 13, 2021, Fixed Income Clearing Corporation (``FICC'')
filed with the Securities and Exchange Commission (``Commission'')
proposed rule change SR-FICC-2021-009 (the ``Proposed Rule Change'')
pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder.\2\ The Proposed Rule Change
was published for comment in the Federal Register on December 29,
2021,\3\ and the Commission received no comment letters regarding the
changes proposed in the Proposed Rule Change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 93857 (December 22,
2021), 86 FR 74130 (December 29, 2021) (File No. SR-FICC-2021-009)
(``Notice'').
---------------------------------------------------------------------------

    On January 26, 2022, pursuant to Section 19(b)(2) of the Act,\4\
the Commission designated a longer period within which to approve,
disapprove, or institute proceedings to determine whether to approve or
disapprove the Proposed Rule Change.\5\ On March 23, 2022, the
Commission instituted proceedings, pursuant to Section 19(b)(2)(B) of
the Act,\6\ to determine whether to approve or disapprove the Proposed
Rule Change.\7\
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78s(b)(2).
    \5\ Securities Exchange Act Release No. 94066 (January 26,
2022), 87 FR 5523 (February 1, 2022) (File No. SR-FICC-2021-009).
    \6\ 15 U.S.C. 78s(b)(2)(B).
    \7\ Securities Exchange Act Release No. 94497 (March, 23, 2022),
87 FR 18409 (March, 30, 2022) (File No. SR-FICC-2021-009).
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \8\ provides that proceedings to
determine whether to approve or disapprove a proposed rule change must
be concluded within 180 days of the date of publication of notice of
filing of the proposed rule change. The time for conclusion of the
proceedings may be extended for up to 60 days if the Commission
determines that a longer period is appropriate and publishes the
reasons for such determination.\9\ The 180th day after publication of
the Notice in the Federal Register is June 27, 2022.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(2).
    \9\ 15 U.S.C 78s(b)(2)(B)(ii)(II).
---------------------------------------------------------------------------

    The Commission is extending the period for Commission action on the
Proposed Rule Change. The Commission finds that it is appropriate to
designate a longer period within which to take action on the Proposed
Rule Change so that the Commission has sufficient time to consider the
issues raised by the Proposed Rule Change and to take action on the
Proposed Rule Change. Accordingly, pursuant to Section
19(b)(2)(B)(ii)(II) of the Act,\10\ the Commission designates August
26, 2022, as the date by which the Commission should either approve or
disapprove the Proposed Rule Change SR-FICC-2021-009.
---------------------------------------------------------------------------

    \10\ Id.
    \11\ 17 CFR 200.30-3(a)(57).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-13813 Filed 6-28-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 202 (Monday, October 19, 2020)]
[Notices]
[Pages 66330-66331]
[FR Doc No: 2020-23005]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[FRL-10015-52-Region 5]

Public Meeting of the Great Lakes Advisory Board

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Public Meeting of the Great Lakes Advisory Board.

-----------------------------------------------------------------------

SUMMARY: Pursuant to the Federal Advisory Committee Act (FACA), the
Environmental Protection Agency (EPA) is announcing a public meeting of
the Great Lakes Advisory Board (GLAB) on October 29, 2020 from 9:00
a.m. to 12:00 p.m. Central Daylight Time to be conducted via remote/
virtual participation only. Due to unforeseen administrative
circumstances, EPA is announcing this meeting with less than 15
calendar days' notice.

DATES: This remote/virtual public meeting will be held on October 29,
2020 from 9:00 a.m. to 12:00 p.m. Central Daylight Time. Members of the
public seeking to view the meeting (but who do not desire to provide
oral comments) must register by 3:00 p.m. Central Daylight Time on
October 28, 2020. Members of the public who desire to make oral
comments during the remote/virtual meeting must register and request to
make oral comments by contacting the Designated Federal Officer (DFO)
directly by 3:00 p.m. Central Daylight Time on October 22, 2020 to be
placed on a list of registered commenters and receive special
instructions for participation. For information on how to register,
please see ``How do I participate in the remote public meeting?''
below.

FOR FURTHER INFORMATION CONTACT: Edlynzia Barnes, Designated Federal
Officer (DFO), at<EMAIL_ADDRESS>or<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. General Information

    The GLAB is chartered in accordance with the Federal Advisory
Committee Act (FACA) of 1972 (5 U.S.C., Appendix 2, as amended) and 41
CFR 102-3.50(d). The GLAB provides advice and recommendations on
matters related to the Great Lakes Restoration Initiative

and on domestic matters related to implementation of the Great Lakes
Water Quality Agreement between the U.S. and Canada. The major
objectives of the GLAB are to provide advice and recommendations on:
Great Lakes protection and restoration activities; long-term goals,
objectives, and priorities for Great Lakes protection and restoration;
and other issues identified by the Great Lakes Interagency Task Force/
Regional Working Group.

II. How do I participate in the remote public meeting?

A. Remote Meeting

    This meeting will be conducted as a remote/virtual meeting on
October 29, 2020 from 9:00 a.m. to 12:00 p.m. Central Daylight Time.
You must register by 3:00 p.m. Central Daylight Time on October 28,
2020 to receive information on how to participate. You may also submit
written or oral comments for the committee by contacting the DFO
directly per the processes outlined below.

B. Registration

    To register and receive information on how to attend this remote/
virtual meeting, please send an email to the DFO at
[email protected] with the SUBJECT line of ``Request to Register
for October 2020 GLAB Meeting'' and include the following information:
Name, Title, Organization, Email, and Phone Number. Attendees must
register by 3:00 p.m. Central Daylight Time on October 28, 2020 to
receive instructions for participation.

C. Procedures for Providing Public Comments

    Oral Statements: In general, oral comments at this remote virtual
meeting will be limited to the ``Public Comments'' portion of the
meeting agenda. During the ``Public Comments'' portion of the meeting
agenda, members of the public may provide oral comments no longer than
three minutes duration per individual or group and submit further
information in written comments. Persons interested in providing oral
statements should contact the DFO directly at<EMAIL_ADDRESS>by
3:00 p.m. Central Daylight Time on October 22, 2020 with the SUBJECT
line of ``Request to Register for October 2020 GLAB Meeting--Provide
Oral Statement'' to be placed on the list of registered speakers and
receive special instructions for participation. The following
information should be included in the email: Name, Title, Organization,
Email, and Phone Number. Oral commenters will be provided an
opportunity to speak in the order in which their request was received
by the DFO and to the extent permitted by the number of comments and
the scheduled length of the meeting. Persons not able to provide oral
comments during the meeting, will be given an opportunity to provide
written comments after the meeting.
    Written Statements: Persons interested in providing written
statements pertaining to this committee meeting may email them to the
DFO prior to 3:00 p.m. Central Daylight Time on October 22, 2020 with
the SUBJECT line of ``Request to Register for October 2020 GLAB
Meeting--Provide A Written Statement''. The following information
should be included in the email: Name, Title, Organization, Email, and
Phone Number.

D. Availability of Meeting Materials

    The meeting agenda and other materials for the virtual conference
will be posted on the GLAB website at www.glri.us/glab.

E. Accessibility

    Persons with disabilities who wish to request reasonable
accommodations to participate in this event may contact the DFO at
[email protected] or<PHONE_NUMBER> by 3:00 p.m. Central Standard
Time on October 22, 2020. All final meeting materials will be posted to
the GLAB website in an accessible format following the meeting, as well
as a written summary of this meeting.

Kurt Thiede,
Regional Administrator, Great Lakes National Program Manager.
[FR Doc. 2020-23005 Filed 10-16-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 43 (Friday, March 4, 2011)]
[Notices]
[Pages 12094-12095]
[FR Doc No: 2011-4857]

-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12790-001]

Andrew Peklo III; Notice of Application Tendered for Filing With
the Commission and Soliciting Additional Study Requests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Exemption From Licensing.
    b. Project No.: 12790-001.
    c. Date Filed: February 16, 2011.
    d. Applicant: Andrew Peklo III.
    e. Name of Project: Pomperaug Hydro Project.
    f. Location: On the Pomperaug River, in the Town of Woodbury,
Litchfield County, Connecticut. The project would not occupy lands of
the United States.
    g. Filed Pursuant to: Public Utility Regulatory Policies Act of
1978, 16 U.S.C. 2705, 2708.
    h. Applicant Contact: Andrew Peklo III, 29 Pomperaug Road,
Woodbury, CT 06798,<PHONE_NUMBER><EMAIL_ADDRESS>    i. FERC Contact: Steve Kartalia,<PHONE_NUMBER> or
<EMAIL_ADDRESS>    j. Cooperating agencies: Federal, State, local, and tribal agencies
with jurisdiction and/or special expertise with respect to
environmental issues that wish to cooperate in the preparation of the
environmental document should follow the instructions for filing such
requests described in item l below. Cooperating agencies should note
the Commission's

policy that agencies that cooperate in the preparation of the
environmental document cannot also intervene. See, 94 FERC ] 61,076
(2001).
    k. Pursuant to Section 4.32(b)(7) of 18 CFR of the Commission's
regulations, if any resource agency, Indian Tribe, or person believes
that an additional scientific study should be conducted in order to
form an adequate factual basis for a complete analysis of the
application on its merit, the resource agency, Indian Tribe, or person
must file a request for a study with the Commission not later than 60
days from the date of filing of the application, and serve a copy of
the request on the applicant.
    l. Deadline for filing additional study requests and requests for
cooperating agency status: April 18, 2011.
    All documents may be filed electronically via the Internet. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site (http://www.ferc.gov/docs-filing/ferconline.asp). Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>call toll-free at (866) 208-
3676; or, for TTY, contact<PHONE_NUMBER>. Although the Commission
strongly encourages electronic filing, documents may also be paper-
filed. To paper-file, mail an original and seven copies to: Kimberly D.
Bose, Secretary, Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    m. The application is not ready for environmental analysis at this
time.
    n. The Pomperaug Hydro Project would consist of: (1) The existing
90-foot-long, 15-foot-high Pomperaug River dam equipped with three
existing gates; (2) an existing 4-acre impoundment with a normal water
surface elevation of 226 feet msl; (3) an existing 40-foot-long, 42 to
50-inch-diameter penstock; and (4) an existing powerhouse integral to
the dam containing one new 76-kilowatt turbine generating unit. Project
power would be transmitted through a new 35-foot-long, 260-kilovolt
underground transmission line. The proposed project is estimated to
generate an average of 300,000 kilowatt-hours annually.
    The applicant proposes to: (1) Rehabilitate the existing gates
including constructing a new intake structure with a trashrack; and (2)
construct a new fish passage facility adjacent to the existing
powerhouse.
    o. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC Online Support. A copy is also available for inspection and
reproduction at the address in item h above.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via e-mail of new filings and
issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    p. With this notice, we are initiating consultation with the
Connecticut State Historic Preservation Officer (SHPO), as required by
106, National Historic Preservation Act, and the regulations of the
Advisory Council on Historic Preservation, 36, CFR, at 800.4.
    q. Procedural schedule: The application will be processed according
to the following Hydro Licensing Schedule. Revisions to the schedule
will be made as appropriate (e.g., if scoping is waived, the schedule
would be shortened).

------------------------------------------------------------------------

------------------------------------------------------------------------
Issue Deficiency Letter................  April 2011.
Issue Notice of Acceptance.............  June 2011.
Issue Scoping Document.................  July 2011.
Issue Notice ready for environmental     September 2011.
 analysis.
Issue Notice of the availability of the  February 2012.
 EA.
------------------------------------------------------------------------

    Dated: February 24, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-4857 Filed 3-3-11; 8:45 am]
BILLING CODE 6717-01-P


MEMORANDUM

DATE:		February 2, 2015

TO:		Clean Power Plan for Existing Power Plants; Docket Id: OAR - 2013-0602

FROM:	Bill Lamason, OAQPS

SUBJECT:	Meeting with Energy Industries of Ohio
--------------------------------------------------------------------------------

SUMMARY
Phone call with Energy Industries of Ohio to discuss the Ultra Super Critical Technology and its direct relevance in achieving compliance with 111 EPA Rules.

ATTENDEES:

John Shingledecker - Electric Power Research Institute, Program Manager, Fossil Materials & Repair Program
Jeff Phillips - Senior Program Manager, Electric Power Research Institute
Revis James - Director Generation R&D Sector, Electric Power Research Institute
Ram Narula - Chief Technology Officer, for Energy Industries of Ohio
Bob Purgert - President, Energy Industries of Ohio
Chris Sinagra - Legislative Affairs, Energy Industries of Ohio
Nick Hutson, EPA
Ravi Srivastava, EPA
Steve Fruh, EPA
Christian Fellner, EPA
Bill Lamason, EPA
Lisa Conner, EPA
Bob Wayland, EPA


BIOPESTICIDES REGISTRATION ACTION DOCUMENT

Calcium Acetate

											PC Code: 011470

	U.S. Environmental Protection Agency

	Office of Pesticide Programs

Biopesticides and Pollution Prevention Division

TABLE OF CONTENTS

 TOC \f I.     EXECUTIVE SUMMARY

II.    ACTIVE INGREDIENT OVERVIEW

III.   REGULATORY BACKGROUND

IV.   RISK ASSESSMENT

A. ACTIVE INGREDIENT CHARACTERIZATION

B.  HUMAN HEALTH ASSESSMENT

			1.  Toxicology

			2.  Dose Response

3.  Dietary Exposure and Risk Characterization

			4.  Drinking Water Exposure and Risk Characterization

			5.  Acute and Chronic Dietary Exposure and Risks for Sensitive

		Subpopulations, Particularly Infants and Children

6.  Occupational, Residential, School, and Daycare Exposure and Risk
Characterization

7.  Aggregate Exposure from Multiple Routes Including Dermal, Oral, and
Inhalation

			8.  Cumulative Effects

			9.  Risk Characterization

	C.  ENVIRONMENTAL ASSESSMENT

1.  Ecological Hazards (Relative to the Biochemical Pesticides Nontarget
Organisms and Environmental Fate Data Requirements

2.  Environmental Fate and Ground Water Data

                                    3.  Ecological Exposure and Risk
Characterization

4.  Threatened and Endangered Species Assessment

	D.  PRODUCT PERFORMANCE DATA (EFFICACY)

V.     RISK MANAGEMENT DECISIPON

A. DETERMINATION OF ELIGIBILITY

B. REGULATORY DECISION

C. LABELING

D. ENVIRONMENTAL JUSTICE

VI.   ACTIONS REQUIRED BY THE REGISTRANT

A. REPORTING OF ADVERSE EFFECTS

B. REPROTING OF HYPERSENSITIVITY INCIDENTS

VII.  APPENDIX A. DATA REQUIREMENTS

VIII. GLOSSARY OF ACRONYMS AND ABBREVIATIONS

IX.   APPENDIX B.

X.    APPENDIX C.

BIOPESTICIDES REGISTRATION ACTION DOCUMENT TEAM

Office of Pesticide Programs:

Biopesticides and Pollution Prevention Division

Biochemical Pesticides Branch (BPB)

Chief

Linda A. Hollis, M.S.

Senior Biologist

Russell Jones, Ph.D

Regulatory Action Leader

Menyon Adams

Product Analyst

Jacob Moore

Product Performance

Clara Fuentes, Ph.D.

I.	     EXECUTIVE SUMMARY:

 This biochemical active ingredient Calcium Acetate is the calcium salt
of acetic acid. Calcium Acetate is odorless and white in color. This
application is for non-food outdoor use to attract eight species of
yellow jackets.

BPPD granted waivers for all Tier I human health toxicity data
requirements due to the fact that no significant human exposure by any
route is anticipated from use of the trap containing this active
ingredient.  An adequate efficacy study was submitted which also
supported the non-target toxicity data requirements demonstrating
nontarget organisms, including honey bees, other beneficial insects and
endangered species, when used according to the label directions are not
attracted to this trap baited with the attractant. BPPD waived most
ecological effects data requirements. All data waiver rationales are
predicted on little exposure potential.

The Agency considered human exposure to calcium acetate in light of the
relevant safety factors in FQPA and FIFRA.  A determination has been
made that there are no unreasonable adverse effects to the U.S.
population in general, and to infants and children.  No significant
exposure via drinking water is expected from the use of the yellow
jacket attractant.

Based on the information discussed above, the Agency has determined that
registered use of calcium acetate as an active ingredient will have No
Adverse Effects (NAE) on threatened and/or endangered species.  Exposure
to endangered or threatened species is not expected since this is an
attractant for yellow jackets and does not attract other nontarget
insect species.

On October 1, 2009, EPA announced a new policy to provide a more
meaningful opportunity for the public to participate on major
registration decisions before they occur.  According to this new policy,
EPA intends to provide a public comment period prior to making a
registration decision for, at minimum, the following types of
applications: new active ingredients, first food use, first outdoor use,
and first residential use.

Consistent with the new policy of making registration actions more
transparent, Calcium Acetate is subject to a 30 day comment period as a
“new active ingredient” whose registration would result in a
“first outdoor use” and a “first residential use.”  While a
final decision on registration is contingent upon review and
consideration of public comments, EPA presently believes that based on
the risk assessment and information submitted in support of the
registration of Calcium Acetate that it is in the best interests of the
public and the environment to issue the registration for Calcium
Acetate. The basis for this preliminary decision can be found in the
risk assessment for Calcium Acetate, which is characterized in this
BRAD.  As discussed above, acute toxicity data for demonstrate that it
is toxicity category IV.  Calcium Acetate does not demonstrate
subchronic or developmental toxicity, and it is not mutagenic or
genotoxic.  EPA has no concerns for any non-target organisms exposed to
Calcium Acetate in accordance with approved label directions.  EPA has
not identified any toxic endpoints for non-target mammals, birds,
plants, aquatic, or soil organisms. Nor or there concerns for any
threatened and endangered species.  Thus, given that Calcium Acetate has
very low toxicity and presents little if any risk to non-target
organisms, and efficacy data confirm its effectiveness against target
pests, EPA concludes that it is in the best interests of the public and
the environment to issue the registration for Calcium Acetate.

The Environmental Protection Agency (EPA) considered information
submitted for granting registration under Section 3(c)(5) of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA) and determined that
the information submitted in support of Calcium Acetate yellow jacket
attractant adequately satisfy current data requirements (refer to 40 CFR
Subpart U § 158.2000).

II.		ACTIVE INGREDIENT OVERVIEW

Common Names: 		 Calcium Acetate

					 Calcium Ethanoate

					 Acetate of lime

Chemical Names: 	 Calcium Acetate

Trade & Other Names: 	 Calcium Acetate

CAS Registry Number:    62-54-4

OPP Chemical Code:       011470

Type of Pesticide: 		 Attractant

Application rates and methods vary depend ing on the product.  For
specific information regarding the product(s) refer to Appendix B.

     REGULATORY BACKGROUND

On June 16, 2007, the Agency received an application filed by Bull Run
Scientific, VBT, 7400 Beaufont Springs Drive, Suite 300, Richmond,
Virginia  23225-5519.  Bull Run retained Cynthia Smith of Conn & Smith
as their agent.  Bull Run wishes to register the product Disposable Bull
Run Yellow jacket Trap E containing the new biochemical active
ingredient Calcium Acetate at 0.198%.   A notice of receipt of this
application was published in the Federal Register March 16, 2009 (74 FR
49).  No comments were received following the publication of this
notice.

A.	Classification

The Biochemical Classification Committee determined that Calcium Acetate
is a biochemical pesticide due to its apparent non-toxic mode of action
and natural occurrence in the environment.

B.	Food Clearances/Tolerances

Currently, this active ingredient is not registered for use on food or
feed commodities because applications are for non-food outdoor use.
Therefore a tolerance or exemption from the requirement of a tolerance
is not required.

IV.			RISK ASSESSMENT

A.	Active Ingredient Characterization

The new active ingredient calcium acetate will be formulated as an EP
for use as an attractant for yellow jackets. The technical grade active
ingredient (TGAI) is a white odorless powder.

Calcium acetate occurs naturally as the calcium salt of acetic acid, and
has a non-toxic mode of action.

The descriptions of the product formulation and production process as
well as the formation of impurities were examined by BPPD and found to
be acceptable in meeting current guideline standards.

All product chemistry data requirements for registration of the new
active ingredient Calcium Acetate have been satisfied.

Guideline Reference No./Property	Description of Result

830.6302	Color	White

830.6303	Physical State	Powder

830.6304	Odor	Odorless

830.6313	Stability	Stable

Not addressed for metals and metal ions

830.6314	Oxidation/Reduction:

Chemical Incompatibility	Not required for TGAI

830.6315	Flammability	Autoignition temperature = 680-730°C

830.6316	Explodability	Not required for TGAI

830.6317	Storage Stability	Not required for TGAI

830.6319	Miscibility	Not required for TGAI

830.6320	Corrosion Characteristics	Not required for TGAI

830.6321	Dielectric Breakdown Voltage	Not required for TGAI

830.7000	pH	7.2 ± 0.1 at 21°Cb

830.7100	Viscosity	Not applicable, the ingredient is a solid

830.7200	Melting Range	Decomposes to acetone at 160°C

830.7220	Boiling Range	Not applicable, the ingredient is a solid

830.7300	Density/Relative Density/Bulk Density	Approximately 30 lb/ft3

830.7370	Dissociation Constant in Water	pKa = 4.76 at 25°C

830.7550	Partition Coefficient	Log Kow = -1.3774

830.7840	Water Solubility	400 g/L

830.7950	Vapor Pressure	0.00548 mm Hg

B.	Human Health Assessment

Toxicology

Since no significant human exposure by any route is anticipated from use
of this active ingredient because it is confined to a water soluble
pouch inside the trap via the securely attached entrance structure, the
active ingredient is not likely to result in adverse human health
effects based upon available reports and information.  With regard to
the Human Health Toxicity profile for Calcium Acetate, all toxicity data
requirements have been waived by EPA.

	a.	Acute Toxicity

Data waiver rationales were granted by BPPD for all Tier I data
requirements.  This includes the Acute Oral Toxicity, Acute Dermal
Toxicity, Acute Inhalation Toxicity, Acute Eye Irritation, Acute Dermal
Irritation, Dermal Sensitization, Prenatal Developmental Toxicity,
Bacterial Reverse Mutation Test, and the In Vitro Mammalian Cell Gene
Mutagenicity.  No additional toxicity data are required to support the
nonfood use registration of this active ingredient.

	b.	Subchronic Toxicity

No subchronic toxicity data were submitted with this application for
registration of this new active ingredient . No repeated human oral
exposure is anticipated.

      c.   Developmental Toxicity and Mutagenicity

No developmental toxicity data were submitted with this application for
registration because of little to no exposure, low toxicity, and the use
pattern as a non-food use. In addition, Calcium Acetate is a
naturally-occurring substance that is also approved for food-use by FDA
under 40 CFR 184.1185. Also, The Agency considered human exposure to
calcium acetate in light of the relevant safety factors in FIFRA.  It is
not expected that use of the product would result in significant human
exposure when the product is used as directed.  No reasonable adverse
effect is expected from exposure to this active ingredient when the
product is used according to label instructions.

Chronic exposure and oncogenicity assessment

No chronic exposure and oncogenicity data were submitted with this
application for registration because these data are not required.

	e.	Effects on the Endocrine System tc \l4 "e.	Effects on the Endocrine
System

EPA will issue test orders between today and February 2010.  The
schedule for issuance of test orders, and details regarding status will
be available at http://www.epa.gov/endo/.  EPA has also established a
docket for the test orders in www.regulations.gov under docket number
EPA-HQ-OPP-2009-0634.

Data required under the test orders will provide information to help EPA
identify whether chemicals have the potential to interact with the
estrogen, androgen, and/or thyroid hormone systems, which regulate
growth, metabolism, development, and reproduction.  The data generated
from the screens will provide robust and systematic scientific
information that will help EPA identify whether additional testing is
necessary.

Calcium Acetate is a naturally occurring substance.  To date, there is
no evidence to suggest that our natural exposure to Calcium Acetate
affects the immune system, functions in a manner similar to any known
hormone, or that it acts as an endocrine disruptor.  Moreover, the use
of Calcium Acetate is not expected to result in any significant
exposures, effectively obviating any opportunity for negative effects on
humans or the environment.  Therefore, it is unlikely that Calcium
Acetate will have estrogenic or endocrine effects.

2.	Dose Response Assessment

A dose response assessment was not conducted because based on the
proposed use of the product, human exposure is not expected.

3.	Dietary Exposure and Risk Characterization

The active ingredient Calcium Acetate is intended for non-food uses.
Accordingly, it is not expected to pose any direct dietary risk to
humans.

With regard to any incidental exposure, all routes of exposure
associated with the active ingredient’s use as an attractant are
negligible.  Additionally, the active ingredient occurs naturally in
fruit and is a well-recognized flavor agent in food additives.  Its
regular consumption in a human diet is not associated with any hazards.
Finally, the acute toxicity information on file indicates that the risks
associated with even incidental exposures would be negligible.

4.	Drinking Water Exposure Risk Characterization

No significant drinking water exposure is expected from Calcium Acetate
because of its contained in a water soluble pouch inside the trap.

5.	Acute and Chronic Dietary Exposure and Risks for Sensitive
Subpopulations, Particularly Infants and Children

Based on the non-food use pattern, the limited potential for even
incidental exposure, and the dietary toxicity information discussed
above, EPA concludes that there is a reasonable certainty that no harm
will result to the United States population, including infants and
children, from aggregate exposure to any incidental residues of Calcium
Acetate.

6.	Occupational, Residential, School and Day Care Exposure and Risk
Characterization

Occupational Exposure and Risk Characterization

There is little likelihood of occupational exposure via oral, dermal, or
ocular routes due to the fact that the end product is in a trap.
Inhalation exposure is minimal and not likely to occur at levels that
would be toxic due to the low concentration of Calcium Acetate in the
end-use product (0.198%).

	b.	Residential, School and Day Care Exposure and Risk Characterization

No indoor residential uses are currently approved. No exposure is
anticipated to children at school or day care facilities because the
pesticide is enclosed in a water soluble pouch inside a trap.

7.   Aggregate Exposure from Multiple Routes Including Dermal, Oral, and
Inhalation

The potential for aggregate exposure is expected to be insignificant.
Calcium Acetate is not expected to be present in quantities greater than
2.466 x 109 g/liter air/week, and limited only to those times when
yellow jackets, hornets and wasps are active.  Given a lack of acute
toxicological endpoints for Calcium Acetate, the aggregate exposure
scenario presents no significant concerns for risk.

8.	Cumulative Effects

Calcium Acetate is intended for non-food uses as an attractant in a
trap.  No dietary exposures are expected.  To the degree that there
might be any incidental dietary exposure, Calcium Acetate does not share
any known common mechanism of toxicity with other substances.

9.    Risk Characterization

The Agency considered human exposure to Calcium Acetate in light of the
relevant safety factors in FQPA and FIFRA.  A determination has been
made that no unreasonable adverse effects to the U.S. population in
general, and to infants and children in particular, will result from the
use of the calcium acetate insecticide

C.	ENVIRONMENTAL ASSESSMENT

Ecological Hazards (Relative to the Biochemical Pesticides Nontarget
Organisms and Environmental Fate Data Requirements- 40 CFR§158.2060)

Calcium Acetate is contained in a water soluble pouch in a trap. After
Calcium Acetate attractant trap has been placed in the pouch at the
manufacturing facility, the user must cut open the trap entrance
structure, add the appropriate amount of water to activate the
attractant, and hang the trap. The trap is for a single use and is not
designed to be reused or refilled. The used trap is disposed via trash
collection.  Efficacy data were submitted which demonstrated that
nontarget organisms are not attracted to the Calcium Acetate trap. (MRID
47255003)

Environmental Fate and Ground Water Data

The need for environmental fate and groundwater data was not triggered
because results of the acute toxicity assessment did not trigger any
additional Tier I studies.

Ecological Exposure and Risk Characterization

The active ingredient is intended for formulation of end use products
which are placed in insect traps for residential or agricultural use.
When used according to the proposed label directions, no direct
exposures are expected for nontarget organisms. Moreover, the active
ingredient is used at a low concentration as an attractant, and is not
expected to accumulate in the environment. Given these characteristics
of Calcium Acetate, nontarget exposure and ecological effects studies
were waived.

	4. Threatened and Endangered Species Assessment

Based on the available data, a No Effects (NE) determination was made
Calcium Acetate on threatened and endangered species when the product is
used according to label use directions.  Specifically, in MRID 47451404,
efficacy testing showed no honeybees or other non-target insect species
were attracted or caught by the Calcium Acetate product.  Since the
active ingredient in contained in a trap, there is no exposure to birds,
fish, aquatic invertebrates, or other non-target organisms.

D.	PRODUCT PERFORMANCE DATA (EFFICACY)

Submission of product performance data (OPPTS 810.3000) is listed as a
requirement for all pesticide products. Customarily, the Agency requires
efficacy data to be submitted for review only in connection with the
registration of products directly pertaining to the mitigation of
disease bearing human health organisms and certain designated quarantine
pests, i.e., ticks, mosquitoes, fleas, Mediterranean fruit flies, gypsy
moths, Japanese beetles, etc.  For a list of organisms considered by the
Agency as “public health pests”, please refer to Pesticide
Registration Notice 2002-1 (  HYPERLINK
"http://www.epa.gov/PR_Notices/pr2002-1.pdf"
http://www.epa.gov/PR_Notices/pr2002-1.pdf ).

A report on the efficacy of the product was submitted because the yellow
jacket wasp is a public health pest. The study consisted of 7 field
trials conducted on different dates and at different locations
representing different habitats. Traps were emptied and rebaited
periodically. Traps were rotated independently of replenishment, to
avoid possible positional effects. Insects were collected for
identification. Data was analyzed on mean number of insects per trap per
day. Treatment means were compared to control means using a Paired
t-Test with P set 0.05 significance level. Replicates with no recorded
catch were omitted from the analyses. Data was summarized by average
species caught per trap per treatment, and by average species per trap
across all the treatment pooled together. The study results showed
statistically significant difference between treatment and control traps
in number of catches for all wasps.

V.	    Risk Management Decision

A.	Determination of Eligibility for Registration

Section 3(c)(5) of FIFRA provides for the registration of a new active
ingredient if it is determined that (A) its composition is such as to
warrant the proposed claims for it; (B) its labeling and other materials
required to be submitted comply with the requirements of FIFRA; (C) it
will perform its intended function without unreasonable adverse effects
on the environment; and (D) when used in accordance with widespread and
commonly recognized practice it will not generally cause unreasonable
adverse effects on the environment.

The four criteria of the Eligibility Determination for Pesticidal Active
Ingredients are satisfied by the science assessments supporting the
product containing Calcium Acetate.  This product is not expected to
cause unreasonable adverse effects and is likely to act as a yellow
jacket attractant when used according to label instructions. Therefore,
EPA preliminarily concludes that calcium acetate is eligible for
registration for the labeled uses.

B.	Regulatory Decision

On October 1, 2009, EPA announced a new policy to provide a more
meaningful opportunity for the public to participate on major
registration decisions before they occur.  According to this new policy,
EPA intends to provide a public comment period prior to making a
registration decision for, at minimum, the following types of
applications:  new active ingredients; first food use; first outdoor
use; and first residential use.  Accordingly, this pesticide is subject
to a 30-day comment period as a new active ingredient with both outdoor
uses and residential uses.  Any regulatory decision will be informed by
the comments EPA receives.

At this time, EPA believes, the data submitted fulfill the requirements
of registration for products containing Calcium Acetate for use to
attract yellow jackets, wasps and hornets. Acute toxicity data for
Calcium Acetate demonstrate that it is toxicity category IV for all
routes of exposure. Calcium Acetate does not demonstrate subchronic or
developmental toxicity, and it is not mutagenic or genotoxic.  EPA has
no concerns for any non-target organisms exposed to Calcium Acetate in
accordance with approved label directions.  EPA has not identified any
toxic endpoints for non-target mammals, birds, plants, aquatic, or soil
organisms. Nor are there concerns for any threatened and endangered
species.  Given, the non-toxic character of Calcium Acetate, EPA
supports its registration under Section 3(c) (5) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA).  Refer to Appendix
B for product-specific information.

       1.	Conditional/Unconditional Registration

All data requirements are fulfilled and EPA has preliminarily determined
that an unconditional registration for Calcium Acetate is warranted
under Section 3(C) (5) of FIFRA.

C.  Labeling

 Before releasing pesticide products containing Calcium Acetate for
shipment, the applicant is required to provide appropriate labels.

D.  Environmental Justice

A seeks to achieve environmental justice, the fair treatment and
meaningful involvement of all people, regardless of race, color,
national origin, or income, in the development, implementation, and
enforcement of environmental laws, regulations, and policies. To help
address potential environmental justice issues, the Agency seeks
information on any groups or segments of the population who, as a result
of their location, cultural practices, or other factors, may have
atypical, unusually high exposure to calcium acetate compared to the
general population.  Please comment if you are aware of any
sub-populations that may have atypical, unusually high exposure compared
to the general population.

VI. 	ACTIONS REQUIRED BY REGISTRANTS

The Agency evaluated all of the data submitted in connection with the
initial registration of Calcium Acetate and determined that these data
are sufficient to satisfy current registration data requirements.  No
additional data are required to be submitted to the Agency at this time.

Notwithstanding the information stated in the previous paragraph, it
should be clearly understood that certain specific data are required to
be reported to the Agency as a requirement for maintaining the Federal
registration for a pesticide product. A brief summary of these types of
data are listed below.

A.  Reporting of Adverse Effects

Reports of all incidents of adverse effects to the environment must be
submitted to the Agency under the provisions stated in FIFRA, Section
6(a)(2).

B.	Reporting of Hypersensitivity Incidents

Additionally, all incidents of hypersensitivity (including both
suspected and confirmed incidents) must be reported to the Agency under
the provisions of 40 CFR Part 158.2050(d).

VII.	 Appendix A. Data Requirements (40 CFR Part 158-Subpart U)

*NOTE:  MRID numbers listed in the following tables are representative
of supporting data for the original registration of the product
containing this active ingredient.  Subsequent to this registration,
there may be additional MRIDs that support registration of other
products containing this active ingredient.

Table 2. Human Toxicology Data Requirements for  Calcium Acetate (40 CFR
§ 158.2050)

Study Type, Species, OPPTS Guideline	Regulatory Decision
LD50/LC50/LOAEL/NOAEL Results	Toxicity Category	MRID

Review Date

Acute Oral Toxicity,  rat, OPPTS 870.1100	Acceptable

Waiver	N/A	WAIVED	47451405

Acute Dermal Toxicity,  rat,

OPPTS 870.1200	Acceptable

Waiver	N/A	WAIVED	47451405

Acute Inhalation Toxicity,  rat,

OPPTS 870.1300	Acceptable Waiver	N/A	WAIVED	47451405

Acute Eye Irritation, rabbit,

OPPTS 870.2400	Acceptable

Waiver	N/A	WAIVED	47451405

Acute Dermal Irritation, rabbit,

OPPTS 870.2500	Acceptable

Waiver	N/A	WAIVED	47451405

Dermal Sensitization

OPPTS 870.2600	Acceptable

Waiver	N/A	WAIVED	47451405

Prenatal Development

OPPTS 870.3700	Acceptable

Waiver	N/A	WAIVED	47451405

Reproductive Toxicity

OPPTS

870.3800	Acceptable

Waiver	N/A	WAIVED	47451405

Table 2. Human Toxicology Data Requirements for  Calcium Acetate (40 CFR
§ 158.2050)

Study Type, Species, OPPTS Guideline	Regulatory Decision
LD50/LC50/LOAEL/NOAEL Results	Toxicity Category	MRID

Review Date

Bacterial Reverse Mutation Test

OPPTS

870.5100	Acceptable

Waiver	N/A	WAIVED	47451405

In vitro Mammalian Cell Gene Mutation Assay

OPPTS

870.5300	Acceptable

Waiver	N/A	WAIVED	47451405

Acute Neurotoxicity

OPPTS

870.6200	Acceptable

Waiver	N/A	WAIVED	47451405

Table 3. Nontarget Organism, Fate and Expression Data Requirements for
Calcium Acetate (40 CFR § 158.2060)

Study/OPPTS Guideline No.	Results	MRID #(s)

Avian acute oral toxicity

(850.2100)	Waived	47451404

Vegetative Vigor

(850.4150)	Waived	47451404

Nontarget insect toxicity (Honey bee)

(850.3020)	Waived	47451404

Aquatic Invertebrate Acute Toxicity

(850.1010)	Waived	47451404

Seeding Emergence

 (850.4100)	Waived	47451404

Oyster Acute Toxicity

(850.1025)	Waived	47451404

Fish Acute Toxicity, Freshwater

(850.1075)	Waived	47451404

Daphnid Chronic Toxicity

(850.1300)	Waived	47451404

Fish Early-Life Stage Toxicity

(850.1400)	Waived	47451404

Avian Dietary Toxicity

(850.2200)	Waived	47451404

Avian Reproduction

(850.2300)	Waived	47451404

Aquatic Plant Toxicity

(850.4400)	Waived	47451404

Algal Toxicity

(850.5400)	Waived	47451404

Nontarget insect testing

(850.4350)	Waived	47451404

VIII.    GLOSSARY OF ACRONYMS AND ABBREVIATIONS

BPPD	Biopesticides and Pollution Prevention Division

BRAD	Biopesticide Registration Action Document

CFR	Code of Federal Regulations

cm3 	cubic centimeter

CSF	Confidential Statement of Formula

°C 	degrees Celsius

EDSP	Endocrine Disruptor Screening Program

EDSTAC	Endocrine Disruptor Screening and Testing Advisory Committee

EPA	Environmental Protection Agency (the “Agency”)

FFDCA	Federal Food, Drug, and Cosmetic Act

FIFRA	Federal Insecticide, Fungicide, and Rodenticide Act

FQPA 	Food Quality Protection Act

FR	Federal Register

g 	gram

kg	kilogram

L                  liter

LD50	median lethal dose. A statistically derived single dose that can be
expected

	to cause death in 50% of the test animals when administered by the
route

	indicated (oral, dermal, or inhalation). It is expressed as a weight of

	substance per unit weight of animal (e.g., mg/kg).

MRID No.	Master Record Identification Number

mg	milligram

mL	milliliter

MP	manufacturing-use product

MPCA	microbial pest control agent

NE	“No Effect”

NIOSH 	National Institute for Occupational Safety and Health

OPP	Office of Pesticide Programs

OPPTS 	Office of Prevention, Pesticides, and Toxic Substances

PCR	polymerase chain reaction

PPE 	personal protective equipment

TGAI 	technical grade of the active ingredient

IX.		 Appendix B.

For product specific information, please refer to   HYPERLINK
"http://www.epa.gov/pesticides/pestlabels"
http://www.epa.gov/pesticides/pestlabels

X.	       Appendix C.

REFERENCES

MRID 47451401.	 Smith, C.  June 13, 2008.  Calcium Acetate: Product
Identity, Composition and Analysis.

MRID 47451402. Smith, C.  June 13, 2008.   Calcium Acetate: Color,
Physical, State, Odor, Stability, UV/Visible Lights Absorption, Melting
Point, Density, Dissociation Constant, Partition Coefficient, Water
Solubility and Vapor

MRID 47451403.  Smith, C. June 13, 2008.  Calcium Acetate:  pH.

MRID 47451404.  Smith, C. June 13, 2008.  Calcium Acetate (TGAI) &
Disposable Bull Run Yellow jacket Trap E.  Environmental Fate & Effects
on Non target organisms.

MRID 47451405.  Smith, C. June 13, 2008. Calcium Acetate (TGAI)
Mammalian Toxicology.

Calcium Acetate	Page   PAGE  12  of   NUMPAGES  17

Biopesticides Registration Action Document

 PAGE


From: "Belden, Bradley"<EMAIL_ADDRESS>Sent:  08/13/2008 05:50 PM
To: Jeff Telander/RTP/USEPA/US@EPA
Cc:
Subject ICR - Brick & Structural Clay Products (Belden Brick)

Mr. Telander,

Please find the attached ICR for the BSCP for The Belden Brick Company. Other requested documents are being sent via US Mail at the provided address.

Please let me know if you have any questions.

Regards,

Bradley H. Belden
Corporate Manager - Occupational & Regulatory Services The Belden Brick Company
(330) 456-0031

 (See attached file: Brick ICR- Belden.xls)