1EPA requests comment on how a system would conduct a DOP of a unit process while ensuring the other parts of the treatment process were achieving their assumed Cryptosporidium treatment. For example, maximizing removal in a pre sedimentation basin can cause reduced removal in the subsequent sedimentation basin and filters.

LT2ESWTR Toolbox Guidance Manual Proposal Draft 12 1 June 2003 12.0 Demonstration of Performance ( DOP): Microbial Removal 12.1 Introduction The purpose of the " demonstration of performance" ( DOP) toolbox component is to allow a system to demonstrate that a plant, or a unit process1 within a plant, should receive a higher Cryptosporidium treatment credit than is presumptively awarded under the LT2ESWTR. Presumptive treatment credits are applicable to granular media filtration plant types indicated in Table 12.1 that comply with the provisions of the Interim Enhanced Surface Water Treatment Rule ( IESWTR) and Long Term 1 Enhanced Surface Water Treatment Rule ( LT1ESWTR) ( 40 CFR 141.720). These credits are also applicable to unit processes in the microbial toolbox when they meet specified design and operational criteria, as discussed in other chapters of this manual.

Table 12.1 Filtration Plant Types Eligible for DOP Plant Type Minimum Elements of Process Train Conventional Coagulation/ Flocculation Sedimentation High Rate Granular Media Filtration Slow Sand Filtration Slow Sand Filtration Diatomaceous Earth Diatomaceous Earth Filtration Softening/ Granular Media Filtration Single Stage Lime Softening High Rate Granular Media Filtration Direct Filtration Coagulation/ Flocculation High Rate Granular Media Filtration Where a system can demonstrate that a plant, or a unit process within a plant, consistently achieves a Cryptosporidium treatment efficiency greater than the presumptive credit specified in the LT2ESWTR, the State may allow the system to receive a higher Cryptosporidium treatment credit for compliance with the LT2ESWTR ( 40 CFR 141.727( c)). To demonstrate the higher level of Cryptosporidium treatment, systems should conduct a site specific study using a protocol approved by the State. This study should account for all expected operating conditions and, at the discretion of the State, determine ongoing monitoring and/ or performance requirements to ensure conditions under which the DOP was awarded are maintained during routine operations. Chapter 12  Demonstration of Performance ( DOP): Microbial Removal LT2ESWTR Toolbox Guidance Manual Proposal Draft 12 2 June 2003 In general, the term " treatment" in the LT2ESWTR refers to both physical removal and inactivation of Cryptosporidium. Treatment credits discussed in this chapter pertain to physical removal by the process trains listed in Table 12.1 ( or individual components of these trains), presedimentation bank filtration, secondary filtration, and two stage softening. Treatment credits for physical removal by membranes and bag and cartridge filtration are addressed in the Membrane Filtration Guidance Manual and Chapter 8 of this manual, respectively. Inactivation of Cryptosporidium by chlorine dioxide, ozone, and UV may also be used to provide additional treatment credits, as discussed in Chapters 10, 11, and 13 of this manual.

This chapter provides guidance for implementing the DOP toolbox option and is organized as follows:

12.2 LT2ESWTR Compliance Requirements  discusses DOP treatment credit with respect to other toolbox options and reporting requirements.

12.3 Toolbox Selection Considerations  describes selection considerations for plants to consider before conducting a DOP study, the duration of a DOP study, and an approach for conducting a DOP study.

12.4 DOP Criteria Development  discusses key issues of DOP design including process evaluation criteria, selection of performance indicators, and full scale versus pilotscale testing.

12.5 Demonstration Protocol  discusses the minimum elements that should be included in the DOP protocol  DOP test matrix, DOP monitoring plan, DOP implementation, and data analysis and reporting.

12.2 LT2ESWTR Compliance Requirements 12.2.1 Credits The LT2ESWTR does not specify how treatment performance must be demonstrated; however the protocol used must be approved by the State ( 40 CFR 141.727( c)). Determination of an increased Cryptosporidium treatment credit will be made by the State.

The LT2ESWTR does not allow systems to claim presumptive credit for the toolbox options listed below, if that component is included in the DOP credit ( 40 CFR 141.727( c)( 2)). Chapter 12  Demonstration of Performance ( DOP): Microbial Removal LT2ESWTR Toolbox Guidance Manual Proposal Draft 12 3 June 2003

Presedimentation

Two stage lime softening

Bank filtration

Combined or individual filter performance

Membrane filters

Bag and cartridge filters

Second stage filtration For example, if a plant receives a DOP credit for a treatment train, the system may not also receive credit for a presedimentation basin or achieving the lower finished water turbidity of the combined filter performance option.

States may award a lower level of Cryptosporidium treatment credit towards compliance for the LT2ESWTR to a system where, based on site specific information, a plant or a unit process achieves a Cryptosporidium treatment efficiency less than a presumptive credit specified in the LT2ESWTR ( 40 CFR 141.727( c)( 1)).

12.2.2 Reporting Requirements The LT2ESWTR requires results from the testing be submitted no later than [ date 72 months after promulgation] for large systems and [ date 102 months after promulgation] for small systems ( 40 CFR 141.730).

The State may require systems to report operational data on a monthly basis to verify that conditions under which DOP credit was awarded are maintained during routine operation ( 40 CFR 141.730).

12.3 Toolbox Selection Considerations The DOP toolbox option is intended for plants that operate at a high level of performance. A system should review existing performance data to verify that it can meet high performance levels under a range of operating conditions ( including filters out of service, returning to service, and flow rate changes) before conducting a DOP study. EPA recommends systems achieve less than 0.1 NTU in each individual filter effluent as an indicator for considering whether the DOP option is practical.

Before applying the DOP approach to an individual unit process, facilities should carefully consider the potential advantages and disadvantages of such an approach. The microbial toolbox allows for treatment credits for unit processes based on specified design and/ or operational criteria described in other chapters of this manual. It is possible that a detailed DOP program may result in a lower credit than already granted by the LT2ESWTR. Chapter 12  Demonstration of Performance ( DOP): Microbial Removal LT2ESWTR Toolbox Guidance Manual Proposal Draft 12 4 June 2003 A DOP study should be conducted for a minimum of one year. Systems should have a contingency plan for achieving compliance with the LT2ESWTR if the DOP does not provide the anticipated credit.

12.3.1 Overview of the Demonstration Protocol This chapter presents one approach for conducting a DOP study. Other approaches or modifications to this approach may be approved by the State. Major elements of the DOP protocol include the following:

$ Development of DOP evaluation criteria and test matrix $ DOP implementation $ Data analysis and reporting Figure 12.1 presents a flowchart relating these elements to the overall microbial toolbox framework. Each of these topics is discussed in detail in this chapter. Chapter 12  Demonstration of Performance ( DOP): Microbial Removal LT2ESWTR Toolbox Guidance Manual Proposal Draft 12 5 June 2003 Figure 12.1 Flowchart for DOP Protocol 12.4 DOP Criteria Development Source water Cryptosporidium levels and water quality characteristics vary from system to system. Accordingly, DOP programs should be tailored to address site specific process issues associated with each water treatment plant ( WTP). Major questions that should be resolved during the design of the DOP include ( but are not limited to) the following:

$ What are the governing process evaluation criteria and treatment objectives?

$ What microorganism or surrogate parameter( s) should be used to demonstrate removal efficiency of Cryptosporidium?

$ Should the DOP be conducted at full scale or pilot scale?

Each of these questions is addressed in the following sections. Chapter 12  Demonstration of Performance ( DOP): Microbial Removal LT2ESWTR Toolbox Guidance Manual Proposal Draft 12 6 June 2003 12.4.1 Process Evaluation Criteria Process evaluation encompasses the treatment objectives of the plant, influent water quality, system demand, and operating conditions or treatment techniques. The DOP plan should address all critical operating conditions, whether conducted in full scale or pilot scale. Influent water quality, flow rates, process configurations, and operating conditions need to be clearly defined during the development of the DOP plan. Common process evaluation criteria are discussed in this section.

<IP_ADDRESS> Treatment Objectives The DOP toolbox option primarily relates to Cryptosporidium removal by physical methods such as clarification and filtration. However, WTPs are tasked to remove or control multiple contaminants in the source water besides Cryptosporidium. The impact of operational strategies and treatment methods for other contaminants on the efficiency of Cryptosporidium removal should be considered during the DOP criteria development stage. The system should not change its operational strategy between the DOP study conditions and routine operation after the study has endedCthe DOP credit is based on the operational strategy used in the study. For example, a system that uses enhanced coagulation throughout the study period should also use it during routine operation for compliance with the LT2ESWTR.

Other examples of treatment techniques that can affect Cryptosporidium removal and thus should be considered in the development stage include the following:

$ Prechlorination may be used to enhance floc formation ( and Cryptosporidium removal) in filtration trains. However, prechlorination may also promote trihalomethane ( THM) and haloacetic acid ( HAA) formation. Therefore, prechlorination doses used during the DOP study should be set to balance floc and disinfection byproduct formation. Operational guidelines should be documented in the DOP plan.

$ Granular media filter run times may be extended to increase unit filter run volumes ( UFRVs) and filter efficiency. However, increased UFRVs also increase the potential for Cryptosporidium breakthrough. Maximum UFRVs should be established to minimize Cryptosporidium breakthrough.

$ Alternative coagulation strategies may be used to enhance Cryptosporidium removal in granular media filters but may also result in post filtration flocculation that can cause deposition or scaling in water distribution systems. Coagulant dosing rates should be set during the DOP study to minimize downstream floc formation. Chapter 12  Demonstration of Performance ( DOP): Microbial Removal LT2ESWTR Toolbox Guidance Manual Proposal Draft 12 7 June 2003 Additionally, if a treatment process or plant technique is used intermittently for a seasonal or sporadically occurring contaminant, this treatment should also be used as needed during the DOP study, consistent with routine operation.

<IP_ADDRESS> Influent Water Quality Characteristics Source water quality characteristics that may affect Cryptosporidium removal efficiencies should be identified. These will depend on the treatment processes employed and may include ( but are not limited to) turbidity, pH, alkalinity and temperature. Critical ( or worst case) ranges for these parameters that are anticipated over the plant design life or permit period should be clearly defined. The demonstration study should include tests run under the worst case source water conditions. In pilot scale DOP studies, raw source water can be modified to simulate worst case water qualities.

<IP_ADDRESS> System Flow Rate The system flow rate or range of flow rates to be evaluated during the DOP should be clearly defined. Where possible, plant performance should be demonstrated for the critical flow condition that defines permitted plant capacity ( e. g., peak instantaneous flow or peak daily flow). For full scale studies, this may not be feasible for facilities that operate significantly below permitted or maximum capacity. For pilot scale studies, the range of system unit process flow rates should replicate the full scale low, intermediate, and maximum flow and recycles rates.

<IP_ADDRESS> Plant Operating Conditions WTP operations can vary significantly over the course of the demonstration period due to various factors including, but not limited to, raw water quality, system flow rate, and maintenance activities. The critical operating conditions that may impact Cryptosporidium removal at the WTP should be defined. Issues to consider include the following:

$ What are the normal and worst case operating conditions for each unit process with respect to Cryptosporidium removal?

$ How many process trains or elements are normally in service? How will the plant perform when units are out of service for maintenance and repair, thereby increasing unit process flow rates ( particularly in filters)?

$ What is the process control strategy for chemical addition? How does this relate to Cryptosporidium removal?

$ What is the process control strategy for filter operations? How does this relate to Cryptosporidium removal? Chapter 12  Demonstration of Performance ( DOP): Microbial Removal LT2ESWTR Toolbox Guidance Manual Proposal Draft 12 8 June 2003 $ How will the plant's recycle, backwash, and filter to waste schemes affect Cryptosporidium removal?

In the case of pilot scale studies, performance demonstrations should replicate full scale operating conditions in any respect that may influence Cryptosporidium removal.

12.4.2 Selection of Performance Indicators Although the LT2ESWTR mandates treatment controls for Cryptosporidium, it is not currently feasible to demonstrate actual Cryptosporidium removal at full scale facilities. In most cases, influent Cryptosporidium levels are not consistently high enough to demonstrate significant ( such as 4 log) removal across the process train. Raw water spiking of Cryptosporidium is not a feasible option at full scale facilities due to the potential health risk to system users and the number of oocysts required. Consequently, alternative indicators of Cryptosporidium removal will be needed for facilities that plan to conduct DOP studies at full scale.

<IP_ADDRESS> Surrogate Parameters for Cryptosporidium EPA has reviewed a number of studies that suggest aerobic bacteria spores are a suitable indicator of Cryptosporidium removal in conventional treatment trains ( coagulation, flocculation, sedimentation and filtration). Some characteristics of aerobic spores ( as summarized by Cornwell et al., 2001) are:

$ Naturally occurring ( Nieminski and Bellamy 2000, Jakubowski et al. 1996).

$ Do not pose health risks ( Jakubowski et al. 1996, Rice et al. 1996).

$ Can be detected at low concentrations (< 1 cfu/ 100 mL).

$ Are slightly smaller than Cryptosporidium oocysts ( Rice et al., 1996).

$ Spore removal by water treatment is a conservative indicator of Cryptosporidium removal ( Rice et al. 1996, Dugan et al. 1999, Nieminski and Bellamy 2000, Emelko 2001).

$ Reduction of indigenous spores by inactivation is expected to be negligible in comparison with removal of spores by physical processes ( Jakubowski et al. 1996, Rice et al. 1996).

$ Aerobic spores do not undergo re growth during treatment. Chapter 12  Demonstration of Performance ( DOP): Microbial Removal LT2ESWTR Toolbox Guidance Manual Proposal Draft 12 9 June 2003 Although aerobic spores appear to be a suitable indicator for Cryptosporidium removal in filtration plants, raw source water spore concentrations will likely not be high enough throughout the study period to demonstrate high log removal across a full scale treatment train.

The State may accept alternative indicators for Cryptosporidium; however, they should not be more easily removed than Cryptosporidium. The surrogate parameter should give a direct view of removal and should be an element that is not created in the plant ( e. g., particle counts caused by chemical precipitation). Furthermore, the method of measurement should be sensitive enough to detect temporal variations in the parameter. Parameters such as turbidity or particle counts may be used in the DOP study, but are not suitable as stand alone surrogates.

<IP_ADDRESS> Long Term Performance Indicators As discussed previously, plants that implement a DOP plan should document long term performance of filtration facilities for turbidity and/ or particle count reduction. While turbidity and particle counts are not suitable as stand alone indicators for full scale Cryptosporidium removal, such data can be used to identify changes in the filtration performance.

It is recommended that individual filter efficiency be monitored frequently to identify differences in individual filter performance. This will allow the plant to assess temporal variations in filter effluent quality and will provide improved process control.

12.4.3 Full Scale Versus Pilot Scale Testing In general, full scale testing is preferred over pilot scale testing since the performance of existing process trains is demonstrated directly. However, full scale studies may not be feasible for many facilities for the following reasons:

$ Influent Cryptosporidium levels will not be high enough to demonstrate high log removal. Likewise, influent aerobic spore concentrations may not be high enough to demonstrate significant log removal.

$ Full scale spiking with aerobic spores may not be feasible due to larger flows.

$ Facilities may operate well below design or permitted flow capacity for the entire study period.

$ Demonstration of worst case operating conditions at full scale may be difficult to plan, especially with regard to raw water quality and flow rates. Chapter 12  Demonstration of Performance ( DOP): Microbial Removal LT2ESWTR Toolbox Guidance Manual Proposal Draft 12 10 June 2003 The major concern with the use of pilot scale testing is the uncertainty associated with scale up of pilot results to predict the performance of full scale systems. Other potential limitations of pilot scale studies are:

$ Pilot scale data generally represent steady state conditions; however, sudden changes in flow or water quality may have a significant effect on Cryptosporidium removal; such changes are difficult to capture in a pilot scale plant.

$ Pilot scale plants generally have much tighter process controls and higher levels of attention than full scale plants; and thus, may not be indicative of actual full scale performance.

$ A pilot scale plant cannot represent expected individual differences between multiple filters in a full scale plant.

$ Particle loadings to the treatment process in a pilot scale study may be much higher than actual full scale loadings, and thus, may not represent actual operating conditions.

$ It may be too difficult to construct a pilot plant that represents the entire full scale process train.

Pilot system dimensions and flow rates should be sufficiently large to minimize scale up issues. Some recommended guidelines for pilot filter sizing include the following ( USEPA 1991):

$ Unit filtration rate in the pilot system should be identical to that of the full scale plant.

$ Pilot filter diameter should be greater than or equal to 100 times the media diameter.

$ Media diameter and depth should be identical to that of the full scale system.

Pilot systems should also incorporate all major process elements of the full scale process train, including chemical addition systems and recycle streams. Such systems must be able to simulate flow rate and water quality perturbations ( i. e., temporal disturbances to steady state conditions).

12.5 Demonstration Protocol Once the DOP criteria have been developed, the DOP protocol can be formulated. This section outlines the minimum elements that should be included in the DOP protocol. Participation from the governing regulatory agency should be solicited during the DOP protocol development phase. Chapter 12  Demonstration of Performance ( DOP): Microbial Removal LT2ESWTR Toolbox Guidance Manual Proposal Draft 12 11 June 2003 12.5.1 DOP Test Matrix The first step in the formulation of the specific DOP protocol is the development of a matrix of test conditions to be evaluated during the DOP period. These test conditions should be formulated to assess Cryptosporidium removal ( or other suitable parameters) under a range of normal and worst case scenarios. The DOP matrix should clearly define specific test scenarios to be evaluated, incorporating the following criteria:

$ Source water quality rangesB including minimum/ maximum limits for critical water quality parameters that influence Cryptosporidium removal in the plant.

$ Influent flow ratesB including the maximum flow rate that defines plant capacity.

$ Operating scenariosB including all operations that may cause process upset in the treatment train ( e. g., events that cause temporal changes in water quality, and flow loadings to process units). These operations include, but are not limited to: filter backwashing, filter to waste practices, intermittent recycles, returning filters to service, and routine maintenance practices.

Critical influent flow ranges and operating conditions should be identified during the DOP criteria development phase, as described in section 12.2. The demonstration period should be at least one year, and should encompass all critical operating conditions. An example test matrix format is presented in Table 12.2.

Table 12.2 Example DOP Test Matrix Scenario Condition ( Normal or Worst Case) Influent Concentration Range Flow Rate Range Units in Service Backwash Conditions Date of Scenario Test Surrogate Turbidity S1 Normal Average Average Average 4 ( All) S2 Normal Average Average Average 3 S3 Worst Case A Average Average High 3 S4 Worst Case B High High Average 3 S5 Worst Case C Low Low Average 3 12.5.2 DOP Monitoring Plan The DOP involves sampling and analysis of Cryptosporidium indicators in the raw source water and filtration train effluent over the course of a demonstration period defined by the DOP Chapter 12  Demonstration of Performance ( DOP): Microbial Removal LT2ESWTR Toolbox Guidance Manual Proposal Draft 12 12 June 2003 test matrix. Once the test matrix is established, the DOP monitoring plan should be formulated to define the following protocol details:

$ Monitoring locations ° Test parameters ( field and laboratory)

$ Monitoring frequency $ Quality assurance/ quality control ( QA/ QC) procedure for/ during sampling A sample DOP monitoring plan is presented in Table 12.3. Chapter 12.0  Demonstration of Performance ( DOP): Microbial Removal LT2ESWTR Toolbox Guidance Manual Proposal Draft 12 13 June 2003 Table 12.3 Example DOP Monitoring Plan Monitor Event Number Date Test Scenario ID ( see Table 12.2) Effluent Sample LocationsA Number of Samples per Location Filter 1 Filter 2 Filter 3 Filter 4 Crypto/ Aerobic Spores Particle Count pH Temp.

1 Week 1 S1 X X X X 2B 1 1 1 2 Week 2 S3 X X X 1 1 1 1 3 Week 3 S2 X X X 1 1 1 1   ...   ...   ...   ...   ...

52 Week 52 S4 X X X X 2B 1 1 1 A  Influent sample location identical for all test scenarios B  duplicate samples Chapter 12  Demonstration of Performance ( DOP): Microbial Removal LT2ESWTR Toolbox Guidance Manual Proposal Draft 12 14 June 2003 <IP_ADDRESS> Sampling Location Paired samples should be collected from the plant influent ( raw source) and the combined filter effluent for a DOP study of an entire plant. The plant influent location should be before the pre sedimentation basins and off stream storage facilities and follow any process recycles added prior to the first major unit process element of the treatment train. For pilot studies involving microbial dosing, the influent monitoring point should follow complete mixing of the source water and injection stream. The plant effluent sample should be comprised of composite samples from the effluent of all operating filters. It is recommended that at least five sample pairs ( influent/ effluent) be collected during each test run to capture temporal changes in filter and effluent quality.

<IP_ADDRESS> Monitoring Parameters Samples should be analyzed for all parameters required to assess Cryptosporidium removal in the treatment trains, as discussed in section 12.2. Parameters such as pH, alkalinity, temperature, and turbidity should be measured and recorded in the field.

<IP_ADDRESS> Monitoring Frequency A monitoring event is defined as a paired ( concurrent) sampling of plant influent and filter effluent samples. At a minimum, monitoring should be performed once per week for 52 consecutive weeks. More frequent monitoring may be required to capture all critical operating scenarios defined by the DOP Test Matrix. The DOP database should be sufficiently large to allow for statistical analysis.

If a DOP credit is issued by the State, the credit will be conditional on continuing demonstration of a higher level of performance. The DOP Monitoring Plan can be modified to document continuing performance at a reduced sampling frequency. However, sampling events should still capture critical operating scenarios.

<IP_ADDRESS> Quality Assurance/ Quality Control Quality assurance/ quality control ( QA/ QC) sampling should be performed to allow assessment of data variability and quantification errors due to sample collection procedures and analytical methods. At a minimum, duplicate samples should be collected during one monitoring event per month.

12.5.3 DOP Implementation The DOP should commence only after the State approves the DOP test matrix and monitoring protocol. The DOP plan should be administered by a qualified water treatment plant Chapter 12  Demonstration of Performance ( DOP): Microbial Removal LT2ESWTR Toolbox Guidance Manual Proposal Draft 12 15 June 2003 operator or water process engineer. Data review and QA/ QC practices should be conducted routinely to ensure that the objectives of the DOP program are met. Particular attention should be given to verification of the plant operating conditions ( influent loadings, unit process loadings, etc.) to confirm that all critical operating scenarios identified in the DOP test matrix are evaluated during the demonstration period.

Personnel responsible for implementing the DOP monitoring plan should be properly trained in sample collection techniques, QA/ QC procedures and operational data acquisition. Specific procedures should be used to collect and analyze samples as described in the following sections:

° Sample collection and preservation methods ° Analytical methods ° Microbial dosing methods ( for pilot tests)

° Documentation procedures <IP_ADDRESS> Sample Collection Methods Influent and effluent samples should be collected in a manner that is representative of the entire cross sectional flow at each monitoring point. If possible, monitoring points should be located in straight sections of pipe or channel well downstream of bends. For open channel flows, samples should be collected from mid depth and mid width of the channel. For pipe flow, samples should be collected from the tap directly into the sample containers. In each case, the sampling method should not reduce or prevent transfer of suspended solids from the process stream to the sample container. Parameters such as pH, turbidity, alkalinity and temperature should be directly measured in the field.

All samples should be grab samples. The individual effluent grab samples should not be combined to make up composite samples.

<IP_ADDRESS> Analytical Methods The analytical methods for monitoring Cryptosporidium under the LT2ESWTR are prescribed in the Public Water System Guidance Manual for Source Water Monitoring under the Long Term 2 Enhanced Surface Water Treatment Rule. Analytical methods for all other water quality parameters should be performed in accordance with Standard Methods for the Examination of Water and Wastewater, 20th edition, or the most recent edition. Chapter 12  Demonstration of Performance ( DOP): Microbial Removal LT2ESWTR Toolbox Guidance Manual Proposal Draft 12 16 June 2003 <IP_ADDRESS> Microbial Dosing For pilot testing that involves spiking of Cryptosporidium, aerobic spores or other indicators, microbial dosing procedures should be clearly established. Guidelines for microbial stock preparation and dosing are presented in this section.

A concentrated mixture of microorganisms should be prepared and fed to the raw source stream at a known feed rate, based on the microbial density in the concentrated stock, the flow rate of the pilot system, and the desired microorganism concentration in the pilot system. An equation that describes this relationship is:

Equation 12.1 where: C pilot = the microbial concentration in the pilot system C feed = the microbial concentration in the concentrated stock solution Q pilot = the flow rate of the pilot system ( includes all process recycles present at the influent feed point, if applicable) Q feed = the flow rate of the concentrated stock solution For each trial, the test microorganisms should be completely mixed in a volume of raw water sufficient to supply the pilot plant for the duration of the experiment. The tank containing the suspension of test microorganisms should be continuously mixed for the duration of each experiment to promote homogeneity of the mixture. The concentrated stock should be delivered by a positive displacement pump ( e. g., peristaltic) to the main process flow at a flow rate dictated by Equation 12.1. C pilot and C feed should be selected to provide a high enough influent microbial concentration to demonstrate at least 4 log removal in the pilot system. Based on this approach, C pilot should be set at least 104 higher than the method detection limit for the test microorganism. The microbial density in the stock solution should be sampled at least twice, and preferably three times, during a feeding interval to verify consistent densities.

<IP_ADDRESS> Documentation of WTP Operating Conditions It is important to document WTP operating conditions during monitoring events to evaluate the effect of varying operating scenarios on Cryptosporidium removal. Standardized reporting forms should be developed to provide, at a minimum, the following information:

° System flow rate ( instantaneous/ flow chart, hourly and daily average)

° Operating mode ( process scheme, number of trains, number of units in service)

° Water pH, alkalinity, turbidity and temperature Chapter 12  Demonstration of Performance ( DOP): Microbial Removal LT2ESWTR Toolbox Guidance Manual Proposal Draft 12 17 June 2003 ° Performance data ° Chemical addition rates/ doses ° Mechanical equipment in operation, with flow rates ( major pumps, blowers, etc.)

° Recycle and backwash flows/ rates ° Related maintenance activities occurring prior to or during sampling event.

12.5.4 Data Analysis and Reporting <IP_ADDRESS> Evaluation of Performance To receive DOP treatment credits above presumptive credits in the LT2ESWTR, a plant should demonstrate consistent attainment of a specific log reduction of Cryptosporidium ( or suitable indicators). To meet this objective, log reduction should first be computed for each monitoring event according to:

Log Removal =  log ( C inf/ C eff) Equation 12.2 where: C inf = influent Cryptosporidium or indicator concentration C eff = effluent Cryptosporidium or indicator concentration For effluent samples in which no Cryptosporidium, spores, or other indicators are detected, the concentration should be set to the method detection limit.

The State will determine the level of DOP credit a facility receives based on review of the log removal data.

For the case of pilot testing and the use of multiple indicators for Cryptosporidium removal calculations will be site specific.

<IP_ADDRESS> Reporting for the DOP At the conclusion of the DOP test period, a detailed report summarizing the major findings of the DOP program must be submitted to the governing regulatory agency. At a minimum, the DOP report should include the following information: Chapter 12  Demonstration of Performance ( DOP): Microbial Removal LT2ESWTR Toolbox Guidance Manual Proposal Draft 12 18 June 2003 ° Detailed description of full scale WTP, including process flow schematics ° Summary of treatment objectives and WTP design criteria ° DOP test matrix and monitoring plan ° DOP data summary ° Detailed pilot plant design data ( if applicable)

° Data analysis for estimate of Cryptosporidium log reduction ° Appendices for raw full scale/ pilot scale analytical and operational data ° Monitoring plan to verify that on going performance is equivalent to treatment credit. Source water indicators used in the study should be monitored to ensure performance is met.

° Plan for addressing operating conditions ( e. g., influent water turbidity) out of the range tested in the study. The DOP test matrix generally sets the range of operating conditions under which the LT2ESWTR treatment credit is applicable. Therefore, it is advisable to develop a plan for addressing potential out of compliance conditions. For example, if the influent source water quality conditions ranged from 5 NTU to 25 NTU during the study, the system may plan to make operational adjustments for influent water with turbidity greater than 25 NTU and increase filter effluent monitoring. Any such deviations would be reported to the State.

<IP_ADDRESS> Ongoing Reporting As discussed previously, if a DOP credit is issued by the State, the credit will be conditional on continuing demonstration of a high level of performance. The DOP Monitoring Plan should be modified to document continuing performance at a reduced sampling frequency, while still capturing critical operating conditions. States may require systems receiving a DOP credit to report operational and progress monitoring data on a routine basis. Operational data should verify that continuous process control and optimization procedures are in place.

The DOP credit is applicable to minimum and maximum raw source water and finished water quality limits defined in the DOP Test Matrix. Routine reporting should be performed to verify that plants operate within these limits. If an exception occurs, it should be reported to the State in a timely manner. Frequent exceptions may prompt the State to require the plant to conduct a comprehensive performance evaluation ( CPE) to identify causes and solutions for exceptions. Chapter 12  Demonstration of Performance ( DOP): Microbial Removal LT2ESWTR Toolbox Guidance Manual Proposal Draft 12 19 June 2003 References American Public Health Association, American Water Works Association, and Water Environment Federation. 1998. Standard Methods for the Examination of Water and Wastewater. Washington D. C.

Cornwell, D. A., MacPhee, M., Brown, R. 2001. Cryptosporidium Removal Credit Assignable in the LT2ESWTR Toolbox, Report to AWWA Government Affairs Office, Washington, D. C.

Dugan, N., Fox, K, Miltner, R., Lytle, D., Williams, C., Parrett, C., Feld, Owens, J. 1999. Control of Cryptosporidium oocysts by steady state conventional treatment. Proc. of 1999 AWWA Annual Conference and Exposition. Denver, CO: AWWA.

Dugan, N., Fox, K., Owens, J., Miltner, R. 2001. Controlling Cryptosporidium oocysts through conventional treatment. Journal AWWA, 93( 12): 64 76.

Emelko, M., Huck, P., Slawson, R. 1999. Design and operational strategies for optimizing Cryptosporidium removal by filters. Proceedings of the 1999 AWWA Water Quality Technology Conference. Denver, CO: AWWA.

Emelko, M. 2001. Removal of Cryptosporidium parvum by Granular Media Filtration. Ph. D. Dissertation. University of Waterloo, Waterloo, Ontario, Canada.

Jakubowski, W., Boutros, S., Faber, W., Fayer, R., Ghiorse, W., LeChevallier, M., Rose, J., Schaub, S., Singh, A., Stewart, M. 1996. Environmental methods for Cryptosporidium. Journal AWWA. 88( 9): 107 121.

Mazounie, P., Bernazeau, F. , Alla, P. 2000. Removal of Cryptosporidium by high rate contact filtration: The Performance of the Prospect Water Filtration Plant During the Sydney Water Crisis. Water Science and Technology. 41( 7): 93 101.

Nieminski, E., Bellamy, W. 2000. Application of Surrogate Measures to Improve Treatment Plant Performance. Denver, CO: AwwaRF and AWWA.

Rice, E., Fox, K., Miltner, R., Lytle, D., Johnson, C. 1996. Evaluating plant performance with endospores. Journal AWWA. 88( 9): 122 130.

USEPA, 1991. Guidance Manual for Compliance with the Filtration and Disinfection Requirements for Public Water Systems Using Surface Water Sources. Washington, D. C. Chapter 12  Demonstration of Performance ( DOP): Microbial Removal LT2ESWTR Toolbox Guidance Manual Proposal Draft 12 20 June 2003 Yates, R., Scott, K., Green, J., Bruno, J., De Leon, R. 1998. Using aerobic spores to evaluate treatment plant performance. Proceedings of the 1998 AWWA Annual Conference and Exposition. Denver, CO: AWWA.


[Federal Register: June 14, 2006 (Volume 71, Number 114)]
[Notices]
[Page 34403]
[DOCID:fr14jn06-138]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53945; File No. SR-Amex-2006-20]

Self-Regulatory Organizations; American Stock Exchange LLC; Order
Approving Proposed Rule Change and Amendment Nos. 1 and 2 Thereto To
Amend the Annual Fee for Certain Listed Bonds and Debentures

June 6, 2006.
    On March 22, 2006, the American Stock Exchange LLC (``Amex'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to increase the annual fee for listed bonds and
debentures of companies whose equity securities are not listed on the
Exchange from $3,500 to $5,000. On April 5, 2006, the Exchange filed
Amendment No. 1 to the proposed rule change. On April 24, 2006, the
Exchange filed Amendment No. 2 to the proposed rule change. The
proposed rule change, as amended was published for comment in the
Federal Register on May 5, 2006.\3\ The Commission received no comments
regarding the proposal.
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    \1\ 15 U.S.C. 78s(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 53735 (April 27, 2006),
71 FR 26574.
---------------------------------------------------------------------------

    The Commission finds that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder applicable to a national securities exchange.\4\ In
particular the Commission believes that the proposal is consistent with
section 6(b)(4) of the Act,\5\ which requires that the rules of an
exchange provide for the equitable allocation of reasonable dues, fees,
and other charges among its members and issuers and other persons using
it facilities.
---------------------------------------------------------------------------

    \4\ In approving this proposed rule change, the Commission notes
that it has considered the proposed rule's impact on efficieincy,
competition, and capital formation. See 15 U.S.C. 78c(f).
    \5\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The bonds and debentures listed on the Exchange are primarily
structured debt products (e.g., notes with returns tied to the
performance of an underlying index, basket of commodities, etc.) The
Exchange has asserted that the proposal would align the annual fees for
listed bonds and debentures in accordance with the actual costs of
delivering services and facilitating the transactions of such products,
and that the annual fee for such bonds and debentures will be similar
to the annual fees charged by certain other self-regulatory
organizations in connection with listing similar structured products.
Based on these assertions, the Commission believes that the proposed
rule change is an equitable allocation of reasonable fees among issuers
of the Exchange. The Commission notes that the increased fees will be
assessed commencing January 2007.
    It is therefore ordered, pursuant to section 19(b)(2) of the
Act,\6\ that the proposed rule change (SR-Amex-2006-20), as amended,
be, and hereby is, approved.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 06-5371 Filed 6-13-06; 8:45 am]

BILLING CODE 8010-01-M


[Federal Register Volume 79, Number 115 (Monday, June 16, 2014)]
[Notices]
[Pages 34312-34313]
[FR Doc No: 2014-13929]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0420]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Testing Communications on Food and Drug
Administration-Regulated Products Used in Animals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on communication studies involving FDA-
regulated products intended for use in animals. This information will
be used to explore concepts of interest and assist in the development
and modification of communication messages and campaigns to fulfill the
Agency's mission to protect the public health.

DATES: Submit written or electronic comments on the collection of
information by August 15, 2014.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Testing Communications on FDA/Center for Veterinary Medicine (CVM)--
Regulated Products Used in Animals--21 U.S.C. 393(d)(2)(D) (OMB Control
Number 0910-0689)--Extension

    FDA is authorized by section 393(d)(2)(D) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)(D)) to conduct educational
and public information programs relating to the safety of CVM-regulated
products. FDA must conduct needed research to ensure that such programs
have the highest likelihood of being effective. FDA expects that
improving communications about the safety of regulated animal drugs,
feed, food additives, and devices will involve many research methods,
including individual indepth interviews, mall-intercept interviews,
focus groups, self-administered surveys, gatekeeper reviews, and
omnibus telephone surveys.
    The information collected will serve three major purposes. First,
as formative research it will provide critical knowledge needed about
target audiences to develop messages and campaigns about the use of
FDA-regulated products for use in animals. Knowledge of consumer and
veterinary professional decision-making processes will provide the
better understanding of target audiences that FDA needs to design
effective communication

strategies, messages, labels, and labeling. These communications will
aim to improve public understanding of the risks and benefits of using
regulated animal drugs, feed, food additives, and devices by providing
users with a better context in which to place risk information more
completely.
    Second, as initial testing, it will allow FDA to assess the
potential effectiveness of messages and materials in reaching and
successfully communicating with their intended audiences. Testing
messages with a sample of the target audience will allow FDA to refine
messages while still in the developmental stage. Respondents will be
asked to give their reaction to the messages in either individual or
group settings.
    Third, as evaluative research, it will allow FDA to ascertain the
effectiveness of the messages and the distribution method of these
messages in achieving the objectives of the message campaign.
Evaluation of campaigns is a vital link in continuous improvement of
communications at FDA.
    FDA estimates the burden of this collection of information based on
recent prior experience with the various types of data collection
methods described in this document:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
            21 U.S.C. 393(d)(2)(D)                Number of     responses per   Total annual          Average burden per response           Total hours
                                                 respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Individual Indepth Interviews................             360               1             360  0.75 (45 minutes)........................             270
General Public Focus Group Interviews........             288               1             288  1.5......................................             432
Intercept Interviews: Central Location.......             600               1             600  0.25 (15 minutes)........................             150
Intercept Interviews: Telephone..............      \2\ 10,000               1          10,000  0.08 (5 minutes).........................             800
Self-Administered Surveys....................           2,400               1           2,400  0.25 (15 minutes)........................             600
Gatekeeper Reviews...........................             400               1             400  0.50 (30 minutes)........................             200
Omnibus Surveys..............................           2,400               1           2,400  0.17 (10 minutes)........................             408
Total (General Public).......................          16,448  ..............          16,448  .........................................           2,860
Veterinarian/Scientific Expert Focus Group                288               1             288  0.75.....................................             216
 Interviews.
Total (Veterinarians/Scientific Experts).....             288               1             288  .........................................             216
                                              ----------------------------------------------------------------------------------------------------------
    Total (Overall)..........................          16,736               1          16,736  .........................................           3,076
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ These are brief interviews with callers to test message concepts and strategies following their call-in request to an FDA Center 1-800 number.

    Annually, FDA projects about 30 studies with 16,736 respondents,
using a variety of research methods and lasting an average of 0.17
hours each (varying from 0.08-1.5 hours).

    Dated: June 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13929 Filed 6-13-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 174 (Thursday, September 8, 2011)]
[Proposed Rules]
[Pages 55621-55622]
[FR Doc No: 2011-22973]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-0594; FRL-9456-5]

Revisions to the California State Implementation Plan, Yolo-
Solano Air Quality Management District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing to approve a revision to the Yolo-Solano Air
Quality Management District portion of the California State
Implementation Plan (SIP). This revision concerns volatile organic
compound emissions from expandable polystyrene product manufacturing
operations. We are proposing to approve a local rule to regulate these
emission sources under the Clean Air Act as amended in 1990.

DATES: Any comments on this proposal must arrive by October 11, 2011.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
0594, by one of the following methods:
    1. Federal eRulemaking Portal: http:[sol][sol]www.regulations.gov.
Follow the on-line instructions.
    2. E-mail<EMAIL_ADDRESS>    3. Mail or deliver: Andrew Steckel (Air-4), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at
http:[sol][sol]www.regulations.gov, including any personal information
provided, unless the comment includes Confidential Business Information
(CBI) or other information whose disclosure is restricted by statute.
Information that you consider CBI or otherwise protected should be
clearly identified as such and should not be submitted through
http:[sol][sol]www.regulations.gov or e-mail.
http:[sol][sol]www.regulations.gov is an ``anonymous access'' system,
and EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send e-mail directly to
EPA, your e-mail address will be automatically captured and included as
part of the public comment. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
    Docket: Generally, documents in the docket for this action are
available electronically at http:[sol][sol]www.regulations.gov and in
hard copy at EPA Region IX, 75 Hawthorne Street, San Francisco,
California. While all documents in the docket are listed at
http:[sol][sol]www.regulations.gov, some information may be publicly
available only at the hard copy location (e.g., copyrighted material,
large maps), and some may not be publicly available in either location
(e.g., CBI). To inspect the hard copy materials, please schedule an
appointment during normal business hours with the contact listed in the
FOR FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Mae Wang, EPA Region IX, (415) 947-
4124<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This proposal addresses the following local
rule: Yolo-Solano Air Quality Management District Rule 2.41, Expandable
Polystyrene Manufacturing Operations. In the Rules and Regulations
section of this Federal

Register, we are approving this local rule in a direct final action
without prior proposal because we believe this SIP revision is not
controversial. If we receive adverse comments, however, we will publish
a timely withdrawal of the direct final rule and address the comments
in subsequent action based on this proposed rule. Please note that if
we receive adverse comment on an amendment, paragraph, or section of
this rule and if that provision may be severed from the remainder of
the rule, we may adopt as final those provisions of the rule that are
not the subject of an adverse comment.
    We do not plan to open a second comment period, so anyone
interested in commenting should do so at this time. If we do not
receive adverse comments, no further activity is planned. For further
information, please see the direct final action.

    Dated: August 8, 2011.
Jared Blumenfeld,
Regional Administrator, Region IX.
[FR Doc. 2011-22973 Filed 9-7-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 145 (Friday, July 29, 2022)]
[Rules and Regulations]
[Pages 45663-45665]
[FR Doc No: 2022-16273]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2018-0689; FRL-9654-02-R5]

Air Plan Approval; Minnesota; Approval of Infrastructure SIP
Requirements for the 2015 Ozone NAAQS

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is approving most
elements of a State Implementation Plan (SIP) submission from Minnesota
regarding the infrastructure requirements of section 110 of the Clean
Air Act (CAA) for the 2015 ozone National Ambient Air Quality Standards
(NAAQS). The infrastructure requirements are designed to ensure that
the structural components of each state's air quality management
program are adequate to meet the state's responsibilities under the
CAA. EPA proposed this action on May 24, 2022 and received no comments.

DATES: This final rule is effective August 29, 2022.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R05-OAR-2018-0689. All documents in the docket are listed on
the www.regulations.gov website. Although listed in the index, some
information is not publicly available, i.e., Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the internet and will be publicly available only in hard
copy form. Publicly available docket materials are available either
through www.regulations.gov or at the Environmental Protection Agency,
Region 5, Air and Radiation Division, 77 West Jackson Boulevard,
Chicago, Illinois 60604. This facility is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding Federal holidays and facility
closures due to COVID-19. We recommend that you telephone Olivia
Davidson, Physical Scientist, at<PHONE_NUMBER> before visiting the
Region 5 office.

FOR FURTHER INFORMATION CONTACT: Olivia Davidson, Physical Scientist,
Attainment Planning and Maintenance Section, Air Programs Branch (AR-
18J), Environmental Protection Agency, Region 5, 77 West Jackson
Boulevard, Chicago, Illinois 60604,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.

I. Background Information

    On May 24, 2022 (87 FR 31462), EPA proposed to approve most
elements of an October 1, 2018, submission from the Minnesota Pollution
Control Agency (MPCA) intended to address all applicable infrastructure
requirements for the 2015 ozone NAAQS. An explanation of the CAA
requirements, a detailed analysis of the revisions, and EPA's reasons
for proposing approval were provided in the notice of proposed
rulemaking and will not be restated here. The public comment period for
this proposed rule ended on June 23, 2022. EPA received no comments on
the proposal. Therefore, we are finalizing our action as proposed.

II. Final Action

    EPA is approving most elements of a submission from MPCA certifying
that its current SIP is sufficient to meet the required infrastructure
elements under sections 110(a)(1) and (2) for the 2015 ozone NAAQS. EPA
is not acting on the interstate transport requirements of section
110(a)(2)(D)(i)(I) and visibility impairment requirements of section
110(a)(2)(D)(i)(II). EPA's actions for the state's satisfaction of
infrastructure SIP requirements, by element of section 110(a)(2), are
contained in the table below.

------------------------------------------------------------------------
                        Element                             2015 Ozone
------------------------------------------------------------------------
(A)--Emission limits and other control measures........               A
(B)--Ambient air quality monitoring/data system........               A
(C)1--Program for enforcement of control measures......               A
(C)2--Minor NSR........................................               A
(C)3--PSD..............................................               A
(D)1--I Prong 1: Interstate transport--significant                   NA
 contribution to nonattainment.........................
(D)2--I Prong 2: Interstate transport--interference                  NA
 with maintenance......................................
(D)3--II Prong 3: Interstate transport--interference                  A
 with PSD..............................................
(D)4--II Prong 4: Interstate transport--interference                 NA
 with visibility protection............................
(D)5--Interstate and international pollution abatement.               A
(E)1--Adequate resources...............................               A
(E)2--State board requirements.........................               A
(F)--Stationary source monitoring system...............               A
(G)--Emergency powers..................................               A
(H)--Future SIP revisions..............................               A
(I)--Nonattainment planning requirements of part D.....               *
(J)1--Consultation with government officials...........               A
(J)2--Public notification..............................               A
(J)3--PSD..............................................               A
(J)4--Visibility protection............................               *
(K)--Air quality modeling/data.........................               A
(L)--Permitting fees...................................               A
(M)--Consultation/participation by affected local                     A
 entities..............................................
------------------------------------------------------------------------

    In the above table, the key is as follows:

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

------------------------------------------------------------------------
A...............................  Approve.
NA..............................  No Action/Separate Rulemaking.
*...............................  Not germane to infrastructure SIPs.
------------------------------------------------------------------------

III. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
    This action is subject to the Congressional Review Act, and EPA
will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action is not a ``major
rule'' as defined by 5 U.S.C. 804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by September 27, 2022. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Reporting and recordkeeping requirements, Volatile organic compounds.

    Dated: July 25, 2022.
Debra Shore,
Regional Administrator, Region 5.

    For the reasons stated in the preamble, 40 CFR part 52 is amended
as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

0
2. In Sec.  52.1220, the table in paragraph (e) is amended by adding an
entry at the end of the table for ``Section 110(a)(2) Infrastructure
Requirements for the 2015 Ozone NAAQS'' to read as follows:

Sec.  52.1220   Identification of plan.

* * * * *
    (e) * * *

                                 EPA-Approved Minnesota Nonregulatory Provisions
----------------------------------------------------------------------------------------------------------------
                                                          State submittal
   Name of nonregulatory SIP      Applicable geographic    date/effective   EPA approved date       Comments
           provision              or nonattainment area         date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Section 110(a)(2)                Statewide..............        10/1/2018  7/29/2022, [INSERT  Fully approved
 Infrastructure Requirements                                                FEDERAL REGISTER    for all CAA
 for the 2015 Ozone NAAQS.                                                  CITATION].          elements except
                                                                                (D)(i)(I) and
                                                                                the visibility
                                                                                protection
                                                                                requirements of
                                                                                (D)(i)(II).

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2022-16273 Filed 7-28-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 138 (Friday, July 18, 2014)]
[Proposed Rules]
[Pages 41946-41948]
[FR Doc No: 2014-16940]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0451; Directorate Identifier 2013-NM-122-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
The Boeing Company Model DC-9-81 (MD-81), DC-9-82 (MD-82), DC-9-83 (MD-
83), DC-9-87 (MD-87), and MD-88 airplanes. This proposed AD was
prompted by reports of cracks emanating from the aft-most barrel nut
holes of the left and right upper rear spar caps of the horizontal
stabilizer. This proposed AD would require repetitive high frequency
eddy current (ETHF) inspections for cracks in the areas around the two
aft-most barrel nut holes of the upper rear spar caps, and corrective
actions if necessary; and repetitive ETHF inspections for cracks in the
areas around the two aft-most barrel nut holes of any repaired or
replaced upper rear spar cap, and corrective actions if necessary. We
are proposing this AD to detect and correct cracks in the horizontal
stabilizer, which could propagate until an upper rear spar cap severs,
and result in failure of the horizontal stabilizer upper center or aft
skin panel and adversely affect the structural integrity of the
airplane.

DATES: We must receive comments on this proposed AD by September 2,
2014.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
3855 Lakewood Boulevard, MC D800-0019, Long Beach, CA 90846-0001;
telephone<PHONE_NUMBER>, extension 2; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may view this referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (phone:<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

FOR FURTHER INFORMATION CONTACT: George Garrido, Aerospace Engineer,
Airframe Branch, ANM-120L, FAA, Los Angeles Aircraft Certification
Office, 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-
627-5357; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2014-0451;
Directorate Identifier 2013-NM-122-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    We have received reports of cracks emanating from the aft-most
barrel nut holes of the left and right upper rear spar caps of the
horizontal stabilizer. One airplane had accumulated 40,144 total flight
hours and 32,253 total landing cycles, while another airplane had
accumulated 58,296 total flight hours and 43,512 total landing cycles.
Investigations have determined that the cracks were caused by fatigue.
In both cases, the cracks originated inside of the barrel nut holes,
and radiated vertically and in the aft direction from the barrel nut
holes. This condition, if not corrected, could result in cracks in the
horizontal stabilizer, which could propagate until an upper rear spar
cap severs, and result in failure of the horizontal stabilizer upper
center or aft skin panel and adversely affect the structural integrity
of the airplane.

Relevant Service Information

    We reviewed Boeing Alert Service Bulletin MD80-55A070, Revision 1,
dated December 17, 2013. For information on the procedures and
compliance times, see this service information at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0451.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would require repetitive ETHF inspections for
cracks in the areas around the two aft-most barrel nut holes of the
left and right upper rear spar caps, and corrective actions if
necessary; and repetitive ETHF inspections for cracks in the areas
around the two aft-most barrel nut holes of any the repaired or
replaced upper rear spar cap, and corrective actions if necessary.
    The phrase ``corrective actions'' is used in this proposed AD.
``Corrective actions'' are actions that correct or address any
condition found. Corrective actions in an AD could include, for
example, repairs.

Costs of Compliance

    We estimate that this proposed AD affects 668 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
             Action                      Labor cost          Parts cost    Cost per product        operators
----------------------------------------------------------------------------------------------------------------
Inspection......................  5 work-hours x $85 per             $0   $425 per            $283,900 per
                                   hour = $425 per                         inspection cycle.   inspection cycle.
                                   inspection cycle.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary repairs and
replacements that would be required based on the results of the
proposed inspection. We have no way of determining the number of
aircraft that might need these repairs and replacements:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
               Action                        Labor cost                Parts cost           Cost per product
----------------------------------------------------------------------------------------------------------------
Repair.............................  Up to 394 work[dash]hours   Up to $32,440........  Up to $65,930.
                                      x $85 per hour = $33,490.
Replacement........................  Up to 394 work[dash]hours   Up to $60,222........  Up to $93,712.
                                      x $85 per hour = $33,490.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

The Boeing Company: Docket No. FAA-2014-0451; Directorate Identifier
2013-NM-122-AD.

(a) Comments Due Date

    We must receive comments by September 2, 2014.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all The Boeing Company Model DC-9-81 (MD-81),
DC-9-82 (MD-82), DC-9-83 (MD-83), DC-9-87 (MD-87), and MD-88
airplanes; certificated in any category.

(d) Subject

    Air Transport Association (ATA) Code 55, Stabilizers.

(e) Unsafe Condition

    This AD was prompted by reports of cracks emanating from the
aft-most barrel nut holes of the left and right upper rear spar caps
of the horizontal stabilizer. We are issuing this AD to detect and
correct cracks in the horizontal stabilizer, which could propagate
until an upper rear spar cap severs, and result in failure of the
horizontal stabilizer upper center or aft skin panel and adversely
affect the structural integrity of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Inspection

    At the applicable compliance time specified in paragraph 1.E.,
``Compliance,'' of Boeing Alert Service Bulletin MD80-55A070,
Revision 1, dated December 17, 2013; except as provided by paragraph
(i) of this AD: Do a high frequency eddy current inspection (ETHF)
for cracks in the areas around the two aft-most barrel nut holes of
the left and right upper rear spar caps, in accordance with the
Accomplishment Instructions of Boeing Alert Service Bulletin MD80-
55A070, Revision 1, dated December 17, 2013. Thereafter, repeat the
ETHF inspection at the applicable time specified in paragraph 1.E.,
``Compliance,'' of Boeing Alert Service Bulletin MD80-55A070,
Revision 1, dated December 17, 2013; except as provided by paragraph
(i) of this AD. If any cracking is found during any inspection,
before further flight, do all applicable corrective actions, in
accordance with the Accomplishment Instructions of Boeing Alert
Service Bulletin MD80-55A070, Revision 1, dated December 17, 2013.

(h) Post-Repair/Replacement Actions

    For airplanes on which a splice repair or replacement was done,
as specified in Boeing Alert Service Bulletin MD80-55A070: At the
applicable compliance time specified in paragraph 1.E.,
``Compliance,'' of Boeing Alert Service Bulletin MD80-55A070,
Revision 1, dated December 17, 2013, do a ETHF inspection for cracks
at the two aft-most barrel nut holes of any repaired or replaced
upper rear spar cap, in accordance

with the Accomplishment Instructions of Boeing Alert Service
Bulletin MD80-55A070, Revision 1, dated December 17, 2013.
Thereafter, repeat the ETHF inspection at the applicable time
specified in paragraph 1.E., ``Compliance,'' of Boeing Alert Service
Bulletin MD80-55A070, Revision 1, dated December 17, 2013. If any
cracking is found during any inspection, before further flight, do
all applicable corrective actions, in accordance with the
Accomplishment Instructions of Boeing Alert Service Bulletin MD80-
55A070, Revision 1, dated December 17, 2013.

(i) Exception to the Service Information Specifications

    Where Boeing Alert Service Bulletin MD80-55A070, Revision 1,
dated December 17, 2013, specifies a compliance time ``after the
original issue date of this service bulletin,'' this AD requires
compliance within the specified compliance time after the effective
date of this AD.

(j) Credit for Previous Actions

    This paragraph provides credit for the actions specified in
paragraph (g) of this AD, if those actions were performed before the
effective date of this AD using Boeing Alert Service Bulletin MD80-
55A070, dated May 22, 2013, which is not incorporated by reference
in this AD.

(k) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Los Angeles Aircraft Certification Office
(ACO), FAA, has the authority to approve AMOCs for this AD, if
requested using the procedures found in 14 CFR 39.19. In accordance
with 14 CFR 39.19, send your request to your principal inspector or
local Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in paragraph (l)(1) of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD if it is approved by the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that has been authorized by the Manager, Los Angeles ACO to
make those findings. For a repair method to be approved, the repair
must meet the certification basis of the airplane, and 14 CFR
25.571, Amendment 45, and the approval must specifically refer to
this AD.

(l) Related Information

    (1) For more information about this AD, contact George Garrido,
Aerospace Engineer, Airframe Branch, ANM-120L, FAA, Los Angeles
Aircraft Certification Office, 3960 Paramount Boulevard, Lakewood,
CA 90712-4137; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
3855 Lakewood Boulevard, MC D800-0019, Long Beach, CA 90846-0001;
telephone<PHONE_NUMBER>, extension 2; fax<PHONE_NUMBER>; Internet
https://www.myboeingfleet.com.You may review copies of the
referenced service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue SW., Renton, WA. For information on
the availability of this material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on July 11, 2014.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-16940 Filed 7-17-14; 8:45 am]
BILLING CODE 4910-13-P


(i) Fees

(5) Maintenance fee

(A) In general.— Subject to other provisions of this paragraph, each registrant of a pesticide shall pay an annual fee by January 15 of each year for each registration, except that no fee shall be charged for more than 200 registrations held by any registrant.

(B) In the case of a pesticide that is registered for a minor agricultural use, the Administrator may reduce or waive the payment of the fee imposed under this paragraph if the Administrator determines that the fee would significantly reduce the availability of the pesticide for the use.

(C) Total amount of fees.— The amount of each fee prescribed under subparagraph (A) shall be adjusted by the Administrator to a level that will result in the collection under this paragraph of, to the extent practicable, an aggregate amount of—

(i) for fiscal year 2004, $26,000,000;

(ii) for fiscal year 2005, $27,000,000;

(iii) for fiscal year 2006, $27,000,000;

(iv) for fiscal year 2007, $21,000,000; and

(v) for fiscal year 2008, $15,000,000.

(D) Maximum amount of fees for registrants.— The maximum annual fee payable under this paragraph by—

(i) a registrant holding not more than 50 pesticide registrations shall be—

(I) for fiscal year 2004, $84,000;

(II) for each of fiscal years 2005 and 2006, $87,000;

(III) for fiscal year 2007, $68,000; and

(IV) for fiscal year 2008, $55,000; and

(ii) a registrant holding over 50 registrations shall be—

(I) for fiscal year 2004, $145,000;

(II) for each of fiscal years 2005 and 2006, $151,000;

(III) for fiscal year 2007, $117,000; and

(IV) for fiscal year 2008, $95,000.

(E) Maximum amount of fees for small businesses.—

(i) In general.— For a small business, the maximum annual fee payable under this paragraph by—

(I) a registrant holding not more than 50 pesticide registrations

shall be— (aa) for fiscal year 2004, $59,000; (bb) for each of fiscal years 2005 and 2006, $61,000;

(cc) for fiscal year 2007, $48,000; and  (dd) for fiscal year 2008, $38,500; and

(II) a registrant holding over 50 pesticide registrations shall be—

(aa) for fiscal year 2004, $102,000; (bb) for each of fiscal years 2005 and 2006, $106,000;

(cc) for fiscal year 2007, $82,000; and  (dd) for fiscal year 2008, $66,500.

(ii) Definition of small business.—

(I) In general.— In clause (i), the term “small business” means a

corporation, partnership, or unincorporated business that—  (aa) has 500 or fewer employees; and  (bb) during the 3-year period prior to the most recent

maintenance fee billing cycle, had an average annual global gross revenue from pesticides that did not exceed $60,000,000.

(II) Affiliates.—

(aa) In general.— In the case of a business entity with 1 or more affiliates, the gross revenue limit under subclause (I)(bb) shall apply to the gross revenue for the entity and all of the affiliates of the entity, including parents and subsidiaries, if applicable.

(bb) Affiliated persons.— For the purpose of item (aa), persons are affiliates of each other if, directly or indirectly, either person controls or has the power to control the other person, or a third person controls or has the power to control both persons.

(cc) Indicia of control.— For the purpose of item (aa), indicia of control include interlocking management or ownership, identity of interests among family members, shared facilities and equipment, and common use of employees.

(F) The Administrator shall exempt any public health pesticide from the payment of the fee prescribed under paragraph (3) if, in consultation with the Secretary of Health and Humans  [3] Services, the Administrator determines, based on information supplied by the registrant, that the economic return to the registrant from sales of the pesticide does not support the registration or reregistration of the pesticide.

(G) If any fee prescribed by this paragraph with respect to the registration of a pesticide is not paid by a registrant by the time prescribed, the Administrator, by order and without hearing, may cancel the registration.

(H) The authority provided under this paragraph shall terminate on September 30, 2008.


[Federal Register Volume 75, Number 220 (Tuesday, November 16, 2010)]
[Notices]
[Pages 70011-70013]
[FR Doc No: 2010-28762]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0448]

Guidance for Industry, Mammography Quality Standards Act
Inspectors, and Food and Drug Administration Staff; The Mammography
Quality Standards Act Final Regulations: Modifications and Additions to
Policy Guidance Help System 13; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``The Mammography Quality
Standards Act Final Regulations: Modifications and Additions to Policy
Guidance Help System 13.'' This document is intended to assist
mammography facilities and their personnel in meeting the requirements
of the Mammography Quality Standards Act (MQSA) regulations.

DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency

guidance documents are welcome at any time.

ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``The Mammography Quality Standards Act Final
Regulations: Modifications and Additions to Policy Guidance Help System
13'' to the Division of Small Manufacturers, International,
and Consumer Assistance, Center for Devices and Radiological Health
(CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, rm. 4613, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your request, or fax
your request to<PHONE_NUMBER>. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Charles Finder, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 4646, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    MQSA (Pub. L. 102-539) was signed into law on October 27, 1992, to
establish national quality standards for mammography. It is codified at
42 U.S.C. 263b. The MQSA requires that, in order to lawfully provide
mammography services after October 1, 1994, all facilities, except
facilities of the Department of Veterans Affairs, must be accredited by
an approved accreditation body and certified by the Secretary of Health
and Human Services (the Secretary) or by an approved State
certification Agency (section 354(b) of the MQSA, (42 U.S.C. 263b(b))).
In June 1993, the authority to approve accreditation bodies and State
certification agencies and to certify facilities was delegated by the
Secretary to FDA (June 10, 1993, 58 FR 32543). On October 28, 1997, FDA
first published final regulations implementing the MQSA in the Federal
Register (part 900 (21 CFR part 900)). The MQSA has twice been amended
since its enactment, through the Mammography Quality Standards
Reauthorization Acts of 1998 and 2004 (Pub. L. 105-248 and 108-365).
    This guidance updates the Policy Guidance Help System (PGHS) and
addresses or contains the following:
    1. Updated contact information for accreditation bodies and
certification agencies;
    2. General guidance regarding Additional Mammography Reviews;
    3. Previously approved alternative standards;
    4. Centers for Medicare and Medicaid Services reimbursement;
    5. Mechanisms to inform physicians and patients of mammography
results;
    6. Mammographic modality and its impact on personnel requirements;
    7. Clarification of the personnel 6-month exemption period;
    8. Information on calibrating the air kerma measuring instrument;
    9. Medical physicist involvement as it applies to cassette
replacement;
    10. Full Field Digital Mammography (FFDM) and use of single-use
cushion pads;
    11. Quality control testing of computer controlled compression
devices;
    12. Mammography equipment evaluations of laser printers;
    13. Quality control testing of monitors and laser printers;
    14. Mammography equipment evaluations of new FFDM units; and
    15. Mammography equipment evaluations of off-site laser printers
and monitors.
    The draft of this guidance was made available in the Federal
Register of October 9, 2009 (74 FR 52242). The comment period closed on
January 7, 2010. During the public comment period, 4 respondents
submitted a total of 14 comments. In addition, the National Mammography
Quality Assurance Advisory Committee reviewed the draft guidance during
its January 25, 2010, meeting and provided additional comments. FDA
reviewed and considered all the comments and in response FDA has
modified the draft guidance as follows by:
    1. Providing the most current accreditation body and certification
Agency contact information;
    2. Clarifying that original or lossless compressed digital image
files may be acceptable for record transfer;
    3. Clarifying the conditions under which an Additional Mammography
Review conducted by an outside entity would be acceptable to FDA;
    4. Deleting the question and answer dealing with image labeling;
    5. Modifying the section on the use of attestation to include
attesting to the specific mammographic modality included in personnel's
initial training;
    6. Clarifying the guidance on the use of non-invasive kilovolts
peak (kVp) meters; and
    7. Recommending the inclusion of cushion pad(s) when performing
automatic exposure control testing.
    In November 1998, FDA compiled all to-date final FDA guidances
related to MQSA and put them into a computerized searchable database
called the PGHS. The PGHS is available on the Internet at: http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/Guidance/PolicyGuidanceHelpSystem/default.htm.
    FDA periodically updates the information in the PGHS and this
document serves as a further update. Individuals wishing to receive
automatic notification of future updates may subscribe to our E-mail
ListServ by visiting http://service.govdelivery.com/service/subscribe.html?code=USFDA_45 and following the directions.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking. It does not create or confer any rights for
or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
using the Internet. A search capability for all CDRH guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. To receive
``The Mammography Quality Standards Act Final Regulations:
Modifications and Additions to Policy Guidance Help System
13,'' you may either send an e-mail request to
<EMAIL_ADDRESS>to receive an electronic copy of the document or
send a fax request to<PHONE_NUMBER> to receive a hard copy. Please use
the document number 1695 to identify the guidance you are requesting.

IV. Paperwork Reduction Act

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork

Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of
information in part 900 have been approved under OMB control number
0910-0309.

V. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: November 10, 2010.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2010-28762 Filed 11-15-10; 8:45 am]
BILLING CODE 4160-01-P