Kitsap County Health District Water Quality Program WATER QUALITY TREND MONITORING PLAN, STREAMS AND MARINE WATERS Last Updated October 26, 2004 1. Introduction The purpose of the Water Quality Trend Monitoring Plan, Streams and Marine Waters ( plan) is to describe ongoing long term water quality trends for marine waters and streams in Kitsap County. This plan details the goals, objectives, and methodologies of the trend monitoring program and serves as a guide to Health District monitoring staff. As needed, this plan will be reviewed and amended in response to changes in monitoring goals and objectives.

Consistent with the Health District's mission, the primary focus of this monitoring program is assessing long term trends in parameters associated with human sewage and animal waste from nonpoint pollution sources. The Health District assesses water quality trends by analyzing fecal coliform bacteria, E. coli bacteria ( lake stations only), turbidity, dissolved oxygen, pH, and temperature data from streams, lakes, and marine waters throughout Kitsap County. Monitoring data is provided to the Kitsap County Surface and Storm Water Management Program ( SSWM), residents of Kitsap County, and staff from other local, state, and tribal water quality programs.

Because Kitsap County municipalities do not participate in the SSWM Program, no data is collected on Bainbridge Island or from surface waters exclusively within the jurisdiction of a municipality. Additionally, stormwater monitoring is the responsibility of the Kitsap County Department of Public Works and is not addressed in this plan. Coordination with these agencies occurs to the extent necessary to meet the goals and objectives stated in this plan and in the SSWM Program scope of work. Groundwater monitoring is also not included in this plan. The Health District's lake monitoring activities are discussed in a separate plan.

In Kitsap County, as elsewhere, surface water quality provides an early warning in determining how effectively development, land uses, and other human activities are being managed to protect public health and the environment. Because County streams are relatively small, pollution impacts manifest themselves more readily, and damage occurs more quickly. Because all County streams discharge to the marine waters of either Puget Sound or Hood Canal, polluted streams have the potential to impact nearshore marine areas as well.

The major types, and sources, of pollution affecting Kitsap County's surface waters and their resources are: Kitsap County Health District Water Quality Program Marine Water and Stream Water Quality Monitoring Plan ( Last Updated October 26, 2004) Page 2 of 22   Human Sewage and Animal Waste from failing on site sewage systems, inadequate livestock keeping practices, pet and wildlife waste, combined sewer overflows, inadequate community wastewater treatment systems, sewage spills from municipal wastewater treatment plants and sewage collection systems, and sewage discharges from boats. Assessing trends associated with this pollution source is the primary focus of the program.

  Sedimentation and soil erosion from improper land clearing and logging activities, poor construction practices, inadequate livestock keeping practices, insufficient stream buffers and storm water control/ treatment, wetlands elimination, and the re channeling and culverting of natural streams. Assessing trends associated with this pollution source is not the primary focus of the program.

  Toxic chemicals and metals from industrial and military wastewater and storm water discharges, urban storm water runoff, closed or abandoned landfill sites, and the illegal dumping or mismanagement of solid and hazardous wastes. Due to funding constraints and the overlap with other local, state, and federal monitoring efforts in this area, these pollution sources are not monitored or assessed under this program.

This plan does not address monitoring conducted by the Health District for the following programs:

  Pollution Identification and Correction Program.   Recreational Shellfish Program.   Swimming Beach ( Lake) Monitoring Program.   All Other Water Quality Monitoring Projects.

Monitoring plans for these programs are discussed in separate Health District documents.

2. Monitoring Goals and Objectives The goals and objectives of the monitoring program are provided below.

2. A. Monitoring Goals The goal of this program is to develop and implement a comprehensive, County wide, water quality monitoring plan that will:

  Protect and preserve public health and the environment;   Identify and correct sources of water pollution caused by human sewage and animal waste; Kitsap County Health District Water Quality Program Marine Water and Stream Water Quality Monitoring Plan ( Last Updated October 26, 2004) Page 3 of 22   Inform and educate the public, private industry, and governmental agencies on specific Kitsap County surface water quality issues;   Provide the public, private industry, and governmental agencies with current surface water quality information in a timely and effective manner; and   Promote stewardship of the County's waterways and their respective resources.

2. B. Monitoring Objectives The objectives of the monitoring program are:

  Implement a long term monitoring program to measure, assess, and characterize surface water quality trends in Kitsap County with the primary focus on the impacts caused by human sewage and animal waste pollution;   Compare and assess surface water quality results to applicable surface quality standards, criteria, and guidelines with the primary focus on the impacts caused by human sewage and animal waste pollution;   Provide monitoring data to prioritize nonpoint pollution problem areas in Kitsap County for Health District pollution source investigation and correction efforts;   Identify specific surface water public health concerns based on the assessment of monitoring results and trends;   Provide the public with specific health advisory information related to surface water and shellfish tissue quality through the local press, signage, Internet home page, public presentations, and the Health District's 1 800 2BE WELL hotline number;   Provide data and comment to SSWM and the State Department of Ecology to evaluate waterbodies included on the state's Clean Water Act Section 303( d) List ( Ecology, 1997) for bacterial contamination, i. e., specifically compare fecal coliform bacteria results against the state standard for this parameter;   Provide data and comment to the State Department of Health and SSWM to justify the upgrade, or prevent the downgrade, of commercial or recreational shellfish areas as applicable; and   Provide surface water information to SSWM, the public, or other private or governmental entities by responding to data requests and by preparing summary reports.

3. Water Quality Standards and Criteria The Washington Department of Ecology establishes surface water quality standards in Chapter 173 201A of the Washington Administrative Code ( WAC). In August 2003, revisions to the surface water quality standards were implemented by Ecology. However, they have not received approval from the USEPA. Until such approval is given, the Health District will continue to compare against the current ( 1997) standards. Kitsap County Health District Water Quality Program Marine Water and Stream Water Quality Monitoring Plan ( Last Updated October 26, 2004) Page 4 of 22 Surface waters in Kitsap County are designated in the WAC as either Class A or Class AA waters. Class AA waters are considered " extraordinary" and Class A waters are considered " excellent". Both earn this designation by markedly and uniformly exceeding established criteria related to watershed use and water quality. Applicable surface water quality standards are summarized in Table 1.

The temperature standard in WAC 173 201A can only be violated as a result of human activities. However, the highest temperature in the temperature standard " range" is often exceeded as a result of natural conditions. Likewise, dissolved oxygen and pH levels may also exceed the range established in the standards as a result of natural conditions.

TABLE 1 Surface Water Quality Standards and Related Criteria Parameter Freshwater Standard Marine Water Standard Fecal Coliform Bacteria ( FC) Part 1: < 50 FC/ 100 mL ( geomean). Part 2: Not more than 10% of all samples obtained for calculating a geomean > 100 FC/ 100 mL. Part 1: < 100 FC/ 100 mL ( geomean). Part 2: Not more than 10% of all samples obtained for calculating a geomean > 200 FC/ 100 mL. Part 1: < 14 FC/ 100 mL ( geomean). Part 2: Not more than 10% of all samples obtained for calculating a geomean > 43 FC/ 100 mL. Part 1: < 14 FC/ 100 mL ( geomean). Part 2: Not more than 10% of all samples obtained for calculating a geomean > 43 FC/ 100 mL.

E. Coli Bacteria < 126 organisms/ 100 mL ( geomean) 1 None None Dissolved Oxygen > 9.5 mg/ L > 8.0 mg/ L > 7.0 mg/ L > 6.0 mg/ L pH 6.5   8.5 units 6.5   8.5 units 7.0   8.5 units 7.0   8.5 units Temperature 16.0o C2 18.0o C2 13.0o C2 16.0o C2 Turbidity Not > 5 NTU over background when background turbidity < 50 NTU, or not > 10% increase in turbidity when background turbidity > 50 NTU Not > 5 NTU over background when background turbidity < 50 NTU, or not > 10% increase in turbidity when background turbidity > 50 NTU Not > 5 NTU over background when background turbidity < 50 NTU, or not > 10% increase in turbidity when background turbidity > 50 NTU Not > 5 NTU over background when background turbidity < 50 NTU, or not > 10% increase in turbidity when background turbidity > 50 NTU 1 U. S. EPA criterion ( U. S. EPA 1986A). 2 Shall not exceed standard due to human activities. When natural conditions exceed these standards, no temperature increases are allowed which will raise the receiving water temperature by greater than 0.3o C.

The turbidity standard in Chapter 173 201A WAC for freshwater and marine water states that turbidity shall not exceed 5 ( five) nephelometric turbidity units ( NTU) over background turbidity when the background turbidity is 50 NTU or less, or have more than a 10% increase in turbidity when the background turbidity is more than 50 NTU. Since no background samples are collected as part of this monitoring program, Health District turbidity data cannot be compared to this standard. Health District staff currently monitor turbidity in streams only to assess impacts from land uses changes in Kitsap County Health District Water Quality Program Marine Water and Stream Water Quality Monitoring Plan ( Last Updated October 26, 2004) Page 5 of 22 our watersheds. Annual ranges for turbidity readings are provided in our annual reports.

4. Monitoring Strategy A stratified random sampling strategy is used to determine current conditions and track longterm water quality trends.

Stratified random sampling involves some limited grouping of the population of interest, and then randomly sampling each group or stratum. This type of approach is often used in water quality sampling because certain parameters are known to vary by the time of day, season, precipitation levels and duration, or some other factor( s). The advantages of a stratified random sampling strategy include ( MacDonald, 1991; Journel, 1989):

  Improves the efficiency of sampling;   Provides separate data ( i. e., data collected during different times, seasons, and weather conditions) on each stratum ( or matrix); and   Enhances the sensitivity of future statistical tests by separating the variability among the strata ( e. g., station locations, surrounding land uses, etc.) from variability within the strata ( e. g., season, time of day, tide cycle, precipitation conditions, etc).

A stratified random sampling approach is employed by both the state Department of Health ( DOH) Shellfish Program in their classification of commercial and recreational shellfish areas, and the state Department of Ecology Environmental Investigations and Laboratory Services Program for their ambient marine water monitoring for the Puget Sound Ambient Monitoring Program ( PSAMP).

Stream stations are monitored monthly and marine water stations are monitored bi monthly to provide a base of continuous, widespread, long term water quality monitoring results for Kitsap County. [ Marine water monitoring frequency has varied since program inception in 1996: 1996 through mid 1999 it was monthly; Mid 1999 through September 2002 it was semi monthly; October 2002   September 2003 monthly monitoring was conducted   except for selected stations in the Upper Hood Canal watershed. Please see Appendix A for additional detail]. Monitoring results provide a basis for determining the following:

  Compliance with the state surface water quality standards ( Chapter 173 201A WAC), National Shellfish Sanitation Program surface water criteria, and other applicable standards, criteria, or guidelines where applicable;   Classification on the state's 303( d) List;   Temporal changes and spatial differences in water quality between offshore and nearshore sampling locations, and between urbanized and rural based watersheds or waterbodies;   Annual, seasonal, and rainfall related variability of marine water and stream quality; Kitsap County Health District Water Quality Program Marine Water and Stream Water Quality Monitoring Plan ( Last Updated October 26, 2004) Page 6 of 22   Changing water quality conditions and emerging problems or improvements; and   Relationships with spatial patterns and temporal trends from other monitoring programs ( i. e., DOH Shellfish Program, PSAMP, etc.).

Most of the data collection and analyses is completed in the field through the use of specialized monitoring equipment ( a multi parameter Hydrolab   unit). Fecal coliform samples are analyzed at the Health District Laboratory, which is accredited by the Department of Ecology. Weather and tidal information are collected through the use of published information and access to Internet sites. Rainfall data for Kitsap County is provided by the Kitsap Public Utility District # 1, located in Poulsbo, Washington. If necessary, targeted parameters that cannot be analyzed by the Health District are sent to other Department of Ecology accredited laboratories. All applicable Puget Sound Estuary Program protocols and methods are followed.

5. Monitoring Parameters The parameters monitored and analyzed under the marine and stream monitoring component include the following:

  Biologicals: fecal coliform bacteria.

  Conventionals: temperature, pH, conductivity, salinity, dissolved oxygen, and turbidity.

  Environmentals: rainfall amounts, air temperatures, wind speed and direction, and tidal conditions.

5. A. Biologicals The analysis for fecal coliform bacteria is the Health District's primary indicator of nonpoint pollution when evaluating surface water quality. The sample is taken in a 100 mL sterile water bottle, placed on ice, and transported to the Health District laboratory for analysis.

The Health District laboratory uses the multiple tube fermentation technique also called the Most Probable Number ( MPN) method of fecal coliform analysis for surface water samples. For the work described in this plan, the Health District uses Fecal Coliform Procedure 9221 E, " Fecal Coliform Direct Test ( A 1 Medium)", described in Standard Methods for the Examination of Water and Wastewater ( APHA, 1998). This method of fecal coliform analysis uses dilutions of the water sample to obtain statistically valid MPN estimates of fecal coliform densities through gas production in the incubated samples.

Another approved method for fecal coliform analysis commonly used is the Membrane Filter ( MF) technique. The process consists of pouring the water sample through a filter, placing the filter into a growth media, and counting the colonies of bacteria. However, the MF method has limitations, especially when testing waters with high amounts of non coliform Kitsap County Health District Water Quality Program Marine Water and Stream Water Quality Monitoring Plan ( Last Updated October 26, 2004) Page 7 of 22 bacteria or turbidity. The Health District does not use this method for fecal coliform bacteria analyses of surface water.

5. B. Conventionals Conventional parameters are measured in the field at each monitoring station using a Hydrolab   multi probe and Surveyor 3 field data processor. Conventionals consist of temperature, pH, conductivity, salinity, dissolved oxygen, and turbidity.

5. C. Environmentals Environmental parameters are collected in the field to assess current daily weather, tidal, and stream flow characteristics that can influence water quality. These conditions are reviewed when conducting water quality analyses.

In summary, the parameters, analysis procedures, method detection limits, and method accuracies are summarized in Table 2 below.

TABLE 2 Analysis Methods, Detection Limits, and Accuracy Parameter Method of Analysis Method Detection Limits Accuracy Fecal Coliform Bacteria APHA Procedure 9221 E, MPN Fecal Coliform Direct Test ( A 1 Medium) 2 to 1,600 col/ 100 mL ( without dilution) 1 col/ 100 mL Temperature Field Meter: Hydrolab Model # H20, Temperature sensor  5 to 50o C + 0.1o C pH Field Meter: Hydrolab Model # H20, pH probe / redox sensor 0 to 14 units + 0.1 units Dissolved oxygen Field Meter: Hydrolab Model # H20, Clark cell w/ standard flow membrane 0 to 20 mg/ L + 0.01 mg/ L Specific Conductance Field Meter: Hydrolab Model # H20, six electrode sensor 0 to 100 µ mho/ cm + 1 µ mho/ cm Turbidity Field Meter: Hydrolab Model # H20, nephelometric and ratio 0 to 1000 NTU + 5 NTU Salinity Field Meter: Hydrolab Model # H20, six electrode sensor 0 to 70 ppt 0.2 ppt 6. Monitoring Station Locations The Health District has established 161 trend monitoring station locations ( 67 marine water and 94 stream). The station locations are described in Appendix A. Station location maps are provided in each annual water quality monitoring report prepared by the Health District. Station locations are determined through review and consideration of the following:

  Geographical and hydrological characteristics of each watershed;   Kitsap County waterbodies on the state 303( d) List ( see Appendix B); Kitsap County Health District Water Quality Program Marine Water and Stream Water Quality Monitoring Plan ( Last Updated October 26, 2004) Page 8 of 22   Water quality results and findings from earlier watershed assessment projects;   Types, locations, and densities of land uses within each watershed;   Locations of public parks and recreational shellfish beaches;   Monitoring station locations from other monitoring efforts ( PSAMP, Public Utility District No. 1 of Kitsap County, etc.);   " Positioning Protocols for Sampling in Puget Sound" ( EPA, 1986A); and   " Technical Guidance for Assessing the Quality of Aquatic Environments" ( Ecology, 1992).

In addition to the 161 active stations, the Health District also has 301 " inactive" stations that were sited and monitored during earlier monitoring programs. Due to program priorities, they have been classified as " inactive" and are currently not monitored. Some of the inactive stations may be sampled periodically to assist with other programs or studies. Inactive station location descriptions are provided in Appendix C.

Precision, comparability, and reproducibility of station locations are achieved through the identification and documentation of major landmarks and road crossings, visual and descriptive on water triangulation, and identification of Geographic Positioning System ( GPS) coordinates of latitude and longitude. The Health District boat is equipped with a Garmin GPSMAP unit to site, and re site, marine water stations in a consistent manner. Detailed station maps and descriptions ensure consistent siting at stream stations.

6. A. Marine Water Stations The majority of marine water stations are located in nearshore areas adjacent to potential nonpoint ( and point) sources of pollution such as:

  Stream mouths;   Major stormwater outflows;   Wastewater treatment plant outfalls or combined sewer overflows;   Marinas;   Densely developed/ urbanized areas; and   Recreation/ public access areas.

The purpose of siting the majority of marine water stations in these nearshore areas is to assess water quality and public health impacts to the areas most accessible to, or accessed by, Kitsap County residents and visitors.

Several offshore marine water stations have also been established to provide a background reference point, to assess impacts from other watershed areas during tide changes, and to compliment the ambient type of monitoring information currently being collected through PSAMP. Tide changes mix marine waters, and water quality problems from one watershed area may affect the water quality in another due to this movement of water. Kitsap County Health District Water Quality Program Marine Water and Stream Water Quality Monitoring Plan ( Last Updated October 26, 2004) Page 9 of 22 6. B. Stream Stations Most of the stream stations are located at, or near, the mouths of the streams prior to their discharge to the marine environment. The purpose of siting stream stations at the mouths is to assess the cumulative impacts of each stream basin on its respective marine embayment.

The remaining stream stations are sited at either strategic segment locations upstream of the respective mouth station and/ or near the headwaters of the stream. Segment stations help to assess an individual segment's contribution to overall stream water quality and help to separate and identify pollution problem areas. Headwater stations provide a " background" comparison for all stations downstream within a stream corridor.

Nearly all of the stream stations are located in public access areas, such as road right ofways to ensure unlimited and continued access to these sites over the long term. Photo logs for all stream monitoring stations are also collected and updated for future reference.

7. Monitoring Schedule Monitoring is conducted in nine of the ten Kitsap County watersheds ( the Bainbridge Island watershed is not monitored). All stream stations ( 94) are monitored monthly, and sixty seven ( 67) marine stations are monitored bi monthly.

This schedule will enable Health District staff to capture major seasonal hydrographic conditions and parallel similar monitoring programs such as PSAMP and DOH Shellfish, thereby making data more comparable. Marine water stations are usually monitored following stream monitoring events to capture as much of the cause/ effect relationship between the quality of the nearshore marine areas and their respective stream discharges.

8. Monitoring Procedures The monitoring procedures provided herein were developed from Health District and other established monitoring protocols identified in this document. These procedures do not address every possible monitoring situation. As such, guidance from the program manager should be sought in determining the best course of action during unusual circumstances.

8. A. Monitoring Event Preparation Prior to conducting a complete and successful monitoring event, certain preparations must be made. Monitoring event preparations are coordinated by program staff and shall include the following:

  Checking and following the applicable monitoring schedule.   Identifying the number and location of intended monitoring event stations. Kitsap County Health District Water Quality Program Marine Water and Stream Water Quality Monitoring Plan ( Last Updated October 26, 2004) Page 10 of 22   Identifying and scheduling field staff.   Ensuring that the necessary field equipment will be available, calibrated, and ready for monitoring.   Obtaining the correct type and number of sampling containers.   Coordinating sample delivery and analysis/ holding times with the receiving laboratory.   Ensuring that tide charts are reviewed before planned monitoring events.   Developing a monitoring route.

8. B. Equipment and Supplies Checklist The Equipment and Supplies Checklist provided in Table 3 below should be referenced by field staff prior to performing fresh and marine water monitoring events.

TABLE 3 Equipment and Supplies Checklist General Monitoring Checklist Additional Fresh Water Monitoring Checklist Additional Marine Water Monitoring Checklist Cooler with Ice Packs Electrical Tape ( Hydrolab Cable) Sample Bottles Tool Box Sampling Wand Hydrolab ( Fresh Water Equipped) Boat Safety Box ( Green) 1 Marking Pen ( Sample ID's) Health District/ Personal Vehicle Stirrer Attachment Mechanical Pencil ( Field Book) Waders Hydrolab ( Marine Water Equipped) Field Book Health District Vehicle Station List/ Map Health District Boat Keys to Truck and/ or Boat Boat Motor Oil ( Truck) Fuel Card Life Jackets ( Truck) Cellular Phone and/ or Pager Cleaning Supplies2 Digital Camera " Quick link" ( Hydrolab Cable)

1 The Health District's Boat Safety Box includes the following equipment and supplies: Garmin GPS Unit, Flares, Fire Extinguisher, Air Signal Horn, Flashlight, First Aid Kit, Boat Binder, Manuals/ Instruction Books, and Marine Charts. 2 Cleaning supplies are used to clean the boat and truck after a marine event and include the following: wash bucket, soap, sponge, and scrub brush.

8. C. Pre Monitoring Activities Once in the field, protocol dictates that all field monitoring activities be conducted in the same manner for all monitoring stations. The standard sequence of events for each monitoring site, where applicable, is as follows:

  Put on field gear and protective clothing conducive to the event and weather conditions.   Park vehicle in a safe and clearly visible location that provides staff a safe exit from the vehicle.   Enter monitoring event introduction information in field notebook ( see Section 8. E). Kitsap County Health District Water Quality Program Marine Water and Stream Water Quality Monitoring Plan ( Last Updated October 26, 2004) Page 11 of 22   Gather all applicable field equipment and approach specific monitoring station.

8. D. Monitoring Activities The following text will summarize the applicable monitoring protocols used for fresh water streams and marine waters. Variations from approved monitoring protocols, when necessary, are noted. For specific information related to a monitoring protocol, please refer to the published document.

Fresh Water Streams Fresh water stream samples are collected and analyzed according to the following monitoring protocols ( as cited or as amended):

  " Recommended Protocols for Measuring Conventional Water Quality Variables and Metals in Fresh Water of the Puget Sound Region" ( EPA, 1990); and   " Guidance for Conducting Water Quality Assessments and Watershed Characterizations Under the Nonpoint Rule ( Chapter 400 12 WAC)" ( Ecology, 1995).

Fresh water stream stations will be monitored and sampled as follows:

  Each station shall be sited and located as described in Section 6.   Stations shall be approached from a down stream direction. Care shall be taken to avoid stirring up bottom sediments.   Once at the station location, sample containers which need to be filled with water shall be labeled per section Section 8. E. Next, to address the fact that bacteria concentrate in the surface micro layer, sample bottles will be filled using the " U" scoop motion. The " U" scoop motion ensures that the sample will not be biased with micro layer bacteria. The sample will then be sealed, placed in a cooler with ice/ water slurry ( once back at the vehicle), and held at four degrees Celsius. Samples analysis will begin no later than 24 hours of collection. Samples shall be collected while facing upstream ( against the flow) at approximately 12 inches below the water surface, or at half the depth of the water column ( when the depth of the stream is 23 inches or less).   After all water samples are collected, the Hydrolab meter shall be deployed upstream of the path of approach.   Parameter readings from the Hydrolab, along with any notes of interest, shall be entered into a field notebook and/ or the Hydrolab Surveyor meter.   After the readings are entered, the Hydrolab shall be pulled from the water and placed in its travel container until deployment at the next station. Kitsap County Health District Water Quality Program Marine Water and Stream Water Quality Monitoring Plan ( Last Updated October 26, 2004) Page 12 of 22 Marine Water Monitoring Procedures Marine water samples will be collected and analyzed according to the following monitoring protocols ( as cited or as amended):

  " Recommended Protocols for Microbiological Studies in Puget Sound" ( EPA, 1986B); and   " Recommended Guidelines for Measuring Conventional Marine Water Column Variables in Puget Sound" ( EPA, 1991).

In summary, marine water stations are monitored and sampled as follows:

  Each station is sited and located through the use of the Magellan Sport Track Pro GPS unit and the station information as described in Section 6.   Stations shall be approached from a " down current" direction. Care shall be taken to avoid stirring up bottom sediments by remaining in at least six feet of water.   Once at the station location, sample containers are labeled and filled with the sample using the " U" scoop motion. Sample bottles are then sealed, immediately put into a cooler with ice/ water slurry, and held at four degrees Celsius. Samples shall be collected at approximately 15  18 inches below the water surface.   After sample collection, the Hydrolab meter shall be deployed outside of the influence of the motor prop and direct sunlight.   Parameter readings from the Hydrolab, along with any notes of interest, shall then be entered into a field notebook and/ or the Hydrolab Surveyor meter.   After the readings are entered, the Hydrolab shall be pulled from the water and placed in its travel container until deployment at the next station.

8. E. Field Data Documentation Procedures Water resistant field books will be used during every monitoring event. Entries shall be made in pencil. Field books will be used to record, at minimum, the following:

  Sampling date and time;   Field personnel present;   Sampling location identification number;   Type of matrix ( e. g., marine water, fresh water streams, shellfish tissue, etc.);   Watershed of area being monitored;   General weather conditions ( e. g., dry or rainy, windy or calm, cloudy or sunny, air temperature);   Tidal stage during the sampling of each station ( marine water and shellfish tissue sampling, only); Kitsap County Health District Water Quality Program Marine Water and Stream Water Quality Monitoring Plan ( Last Updated October 26, 2004) Page 13 of 22   Parameters monitored ( e. g., water temperature, salinity or conductivity, dissolved oxygen concentration, flow, etc.); and   Related field observations ( e. g., color and/ or smell of water, tidal conditions, potential sources of pollution observed, number and type of animals observed, observed occurrences of illegal dumping, notes on sampling collection, etc.).

Air temperatures may be retrieved from the weather page of the local newspapers or via the Internet. Area specific precipitation amounts are retrieved from a local weather network established by the Kitsap County PUD No. 1. The area specific rainfall stations for each watershed are shown in Appendix D. Tidal stage readings are retrieved from localized tide charts and field observations.

8. F. Sample Container Identification and Labeling Procedures All sample containers must be marked with a pre assigned monitoring site identification number. A complete list of all monitoring locations and their assigned sample identification numbers can be found in Appendix A of this document.

Trip blank samples are always assigned the identification number AA01, and field duplicate samples always end with the letter " R" ( e. g., field samples DF01 & DF01R). Refer to Section 9., " Quality Assurance/ Quality Control", for additional information regarding trip blank and field duplicate samples.

Sample containers from contract laboratories will already be affixed with a label similar to the one shown in Figure 1. Health District staff need only fill out the pre affixed label when performing special monitoring studies other than those conducted as part of the long term trend monitoring program. FIGURE 1 Example Sample Container Label Date: Time: Matrix: Station I. D. Number: Parameter: Project Name: Field Personnel: Kitsap County Health District Water Quality Program Marine Water and Stream Water Quality Monitoring Plan ( Last Updated October 26, 2004) Page 14 of 22 9. Quality Assurance and Quality Control Quality assurance ( QA) provides a process for ensuring the reliability and value of measured data ( Lombard, 2001). Sound QA practices are essential to acquire data of the necessary type and quality for there intended use. To be scientifically and legally defensible, data must be of documented quality.

9. A. Data Quality Objective The primary data quality objective of this monitoring program is to estimate the concentration of fecal coliform bacteria and specified field parameters at the stream and marine water monitoring sites described in this plan, and to compare these results with state water quality standards. These results will be used to report compliance with the state standards and to report water quality trends over the long term.

9. A. 1 Bias Bias is considered the consistent deviation of measured values from the true value, caused by systematic errors in a procedure. Bias within the monitoring program will be reduced to the extent practicable by the following:

  Strict adherence to the sampling procedures of this plan;   Complete data collection and organization;   Regular and documented field meter calibration and maintenance. Additionally, post monitoring event calibration of the Hydrolab will be performed to assess " drift" in field measurements. This will be performed at the conclusion of 10% of all monitoring events ( i. e., marine and fresh water).   Periodic reviews and evaluations of field sampling procedures; and   Analyzing data in an appropriate manner based upon essential considerations, such as temporal variations.

9. A. 2 Precision Precision is a measure of the variability in the results of replicate measurements due to random error ( Lombard, 2001). Random errors are always present due to normal variability in the many factors affecting the measurement results. Precision will be determined by the following:

  Collection and analysis of field duplicates ( not splits) for fecal coliform at minimum of 10% for each monitoring day or event. Consistent with the data quality objectives, when possible, duplicates will be collected from sites with expected higher concentrations of fecal coliform in order to determine variability in the range, or above, the fecal coliform water quality standards. Kitsap County Health District Water Quality Program Marine Water and Stream Water Quality Monitoring Plan ( Last Updated October 26, 2004) Page 15 of 22   Calculation of the percent relative standard deviations (% RSD) of the pooled log transformed fecal coliform measurement results. Results pooled by magnitude will be evaluated allowing the higher percentage % RSDs of low values to be taken into account.   Documentation of ongoing field equipment maintenance, calibration, and operation.

The total precision for field duplicate measurements should not exceed 10% RSD for results at or above 10 times the reporting limit. Precision up to 50% of the RSD for any lower field replicate results, and for the fecal coliform duplicates, is acceptable. At levels close to the method detection limit ( marine water FC data typically is close to detection limit), % RSDs greater than 50% are to be expected and are acceptable. Duplicate samples that are " non detects" shall not be used to measure precision.

Using this methodology, the overall variability will be calculated. Overall variability includes the natural environmental variability of the measured parameter, sampling variability, and lab variability ( lab method and lab analyst). The overall variability of the parameter will be taken into consideration in the interpretation of the results.

9. B. Data Representativeness, Completeness, and Comparability Representativeness of the analytical data is simply described as an adequate number of samples and monitoring events to depict program reports. Representativeness will be primarily achieved through the following:

  Strict adherence to the specific procedures of this plan including the selection of correct monitoring stations and methods;   Thorough documentation of applicable environmental factors ( e. g., weather and tidal conditions, observable changes, fish present, etc.); and   Entering all applicable environmental information for each monitoring station, into the water quality database for use in reporting carried out under this plan.

Completeness is considered and will be expressed as the percent of valid data obtained as compared to the amount of data planned for each particular reporting period. Completeness will be obtained through strict adherence to the plan, as amended, for a five year period. A minimum of five years is required for this plan to account for spatial and temporal variability. Successful completeness of this plan is enhanced in that it is based on previously successful projects conducted within Kitsap County and Puget Sound.

Comparability of the data collected through this plan will be attained through strict adherence to the specificity of the plan, and through adequate documentation of adherence to the plan. The plan has been based on accepted protocols and procedures, and has attempted to take Kitsap County Health District Water Quality Program Marine Water and Stream Water Quality Monitoring Plan ( Last Updated October 26, 2004) Page 16 of 22 into account, and be consistent with, other applicable monitoring efforts without generating an unnecessary duplication of efforts.

9. C. Field Quality Assurance Quality assurance for the field monitoring activities covered under this plan will be achieved through documentation of the following:

  Consistent use of the standard operating procedures identified within;   Consistent use of, and adherence to, the applicable monitoring protocols identified within; and   A determination of whether the project objectives and data quality objectives have been met for specific set of data and information at the time of reporting.

With the beginning of the 2005 water year ( October 1, 2004), " blue ice" packs and water are being used to cool and hold fecal coliform samples at 4 ° C. Previously only " blue ice" packs were used. " Blue ice" is placed in the bottom of the cooler, samples are placed in a wire mesh rack on top of the " blue ice", then cold water is added until the bottles are approximately 1" submerged.

To verify that samples are not experiencing cross contamination between collection and arrival at the laboratory, field or trip blanks for fecal coliform will be used through September 30, 2005. A field or trip blank is simply a 100ml sample bottle filled with sterile de ionized water and placed in the cooler at the beginning of the monitoring event. Trip blank results will be tracked closely and any " positive" results will necessitate the invalidation of all other FC data collected during that sample run. " Positive" results will also mean procedural changes to avoid problems in the future. Trip blank results will be entered into the WQ Database as station AA01.

9. C. 1. Personnel Training All field personnel will be trained in, and be required to demonstrate competency of, the monitoring components contained herein. The Program Manager will ensure that personnel are given first hand field and data management training. The Program Manager will ensure that only trained personnel having demonstrated competency are allowed to perform the work contained in this plan.

The Program Manager will conduct periodic performance checks to ensure that staff adhere to the procedures described herein. The performance checks will be performed, at minimum, concurrent with the standard employee performance evaluation process. Kitsap County Health District Water Quality Program Marine Water and Stream Water Quality Monitoring Plan ( Last Updated October 26, 2004) Page 17 of 22 9. C. 2. Maintaining and Calibrating Field Equipment Having well maintained and properly calibrated monitoring equipment is an essential element to collecting scientifically valid and defensible data of known precision and accuracy. Staff will reference the black binder entitled " Hydrolab Probe Calibration & Maintenance Records" located in the Poulsbo Health District laboratory, for detailed instructions regarding equipment calibration and maintenance activities. A copy of these procedures is provided in Appendix F.

9. C. 3. Monitoring Procedures Consistent and properly implemented monitoring procedures are an essential element to collecting scientifically valid and defensible data of known precision and accuracy. Staff will reference Section 8.0 for detailed instructions regarding monitoring activities.

9. D. Laboratory Quality Assurance Laboratory QA/ QC for the work covered under this plan will be assured through the lab's participation in the Washington State Department of Ecology accreditation program. The Health District lab is currently accredited for the MPN method of fecal coliform analysis. The Health District lab will follow the QA/ QC requirements specified in the fecal coliform MPN method. See Appendix E for a description of the Health District Lab's Standard Operating Procedures including QA procedures.

9. E. Data Management Quality Assurance As discussed in Section 10 below, only acceptable good quality data will be entered into the water quality database and used for reporting purposes. Data will be reviewed by field staff for acceptance prior to being entered into the database. Health District staff should reference Appendix G, " Water Quality Database Data Entry and QA/ QC Procedures," for a detailed explanation of the QA process for data entry.

10. Data Management, Assessment, and Reporting Proper data management is essential to water quality assessment activities necessary for the completion of written reports. In house data management activities include the following:

10. A. Data Review, Reduction, Database Entry, and Storage All water quality data will be reviewed by staff prior to being accepted and entered into an Access   database developed by the Health District. Trend monitoring data in the database is organized by watershed area consistent with the County's historical watershed planning Kitsap County Health District Water Quality Program Marine Water and Stream Water Quality Monitoring Plan ( Last Updated October 26, 2004) Page 18 of 22 processes, and to reflect the water quality management philosophy of the State of Washington. Data review simply requires that staff perform a visual scan of all field notes and laboratory results prior to entering the data electronically. Staff will review this information to ensure the following:

  All required data sets have been included;   Parameters monitored are characteristic of expected results; and   Laboratory analytical results are characteristic of expected results.

Should Health District staff determine the data is either incomplete or consists of uncharacteristic results, the Program Lead or Program Manager will be consulted for a determination regarding the validity of the data. Data may only be excluded with the approval of the Program Lead or Program Manager. Once it is determined that the data is acceptable, staff may begin performing data entry procedures. Health District staff should reference Appendix G of this document for specific data entry procedures.

All acceptable data collected through this program will be stored in two ways:

  Original hard copy of documented data organized in a watershed binder by, watershed, matrix, and monitoring date.   Electronically through the use of a Microsoft Access

database.

All hard copy and electronic monitoring data are kept in binders specific to each watershed. Each of the current year's monitoring events are segmented within the watershed binder by both matrix and date the monitoring event took place. After receiving the laboratory's analytical results for a specific monitoring event, Health District staff will place, in order, the items listed below into the appropriate watershed binder:

  Matrix and Date identifying " tab" and page break sheet;   " Water Quality Database Data Entry and QA/ QC Record" form;   Original copy of the " Chain Of Custody/ Laboratory Analytical Results" form; and   Original field notes copied from the event specific field book.

Once these documents have been placed into the appropriate watershed binder, staff may begin entering the data electronically. Preserving both the original record of data and an electronic version will preserve acceptability of the data. The previous years' data is stored in the Water Quality Program files.

The water quality database serves as the repository for acceptable data. Only data that meets the data quality objectives and quality assurance and control requirements ( see Section 9.0) will be entered into the database. In this way, only quality data will be retrievable through the database. All data input to the database will have a 100% review after input is complete to assure no transcript errors have occurred. The water quality database is automatically Kitsap County Health District Water Quality Program Marine Water and Stream Water Quality Monitoring Plan ( Last Updated October 26, 2004) Page 19 of 22 backed up on a daily basis to minimize the loss of data caused by electrical or computer malfunctions.

10. B. Data Assessment and Reporting Once data is entered into the database, it will be assessed by running standardized queries with the Microsoft Access

database, and exporting the desired information from the water quality database to an Excel   spreadsheet. This process is discussed in the data entry procedures in Appendix G.

Annual Water Quality Monitoring Reports are prepared by Health District staff and distributed to SSWM, the local press, and other interested parties. Watershed and/ or segment specific data summaries are processed by request. Additional water quality related information is available through the Water Quality Program Homepage located at http:// www. kitsapcountyhealth. com/ environmenta_ health/ water_ quality/ wq_ index. htm, and the Health District's public health advisory hotline number ( 800 223 9355).

The Annual Water Quality Monitoring Report provides information to meet the monitoring objectives listed in Section 2. B. The Health District has established an approved format for the Annual Water Quality Monitoring Reports. These reports shall include discussions of the following for each of the nine watersheds in Kitsap County:

  Watershed Background Information   Watershed Focus Areas ( State 303 D listed waterbodies, shellfish classifications, and specific watershed water quality improvement projects)   Annual Stream Monitoring Data and Long Term FC Trends   Annual Marine Monitoring Data and Long Term FC Trends   Annual Lake Monitoring Data and Long Term Trends   Monitoring Station Maps Long term FC trends are determined according to procedures described in Appendix H. To better define the precision of the fecal coliform sample results, the Annual Water Quality Monitoring Report will also include a discussion of the variability of the fecal coliform data collected. See Section 9. A. 2 for a discussion of the procedure used to estimate variability.

In addition to the Annual Water Quality Monitoring Reports, staff may receive requests from the public and/ or other agencies for specific data sets related to a particular watershed or water segment. These types of data sets can be prepared from the Health District's database. Health District staff should reference Appendix G for procedures regarding data filtering and exporting procedures. A few examples of past data set requests include:

  A determination of mean values and ranges for each parameter for every monitoring station during a specific reporting/ analysis period. Kitsap County Health District Water Quality Program Marine Water and Stream Water Quality Monitoring Plan ( Last Updated October 26, 2004) Page 20 of 22   A determination of which stations/ parameters are meeting, or not meeting, applicable state water quality standards in a particular watershed.

Additionally, data regarding inter and intra watershed comparisons, seasonal comparisons, wet weather versus dry weather comparisons, tidal condition comparisons, and other data can be provided as requested. In the future, the Health District hopes to link the database with Kitsap County's geographic information system and to make water quality data available over the Internet. These activities will occur as soon as resources allow. Kitsap County Health District Water Quality Program Marine Water and Stream Water Quality Monitoring Plan ( Last Updated October 26, 2004) Page 21 of 22 BIBLIOGRAPHY American Public Health Association, American Water Works Association, and Water Environment Federation, Standard Methods for the Examination of Water and Wastewater, 20th Edition, Washington DC, 1998.

Cowgill, U. M., Personal Communication, July 1989.

Journel, A. G., and Alabert, F., Terra Nova, 1, 2: 123  134, 1989.

Lombard, S. M., and Kirchmer, C. J., Guidelines for Preparing Quality Assurance Project Plans for Environmental Studies ( Draft), Washington State Department of Ecology Environmental Assessment Program, Ecology Publication No. 01 03 003, 2001.

MacDonald, L. H., Monitoring Guidelines to Evaluate Effects of Forestry Activities on Streams in the Pacific Northwest and Alaska, EPA 910/ 9 91 001, 1991.

Parr, J. L., Carlberg, K., and Bollinger, M., Personal Communication, September, 1989.

United States Environmental Protection Agency, Ambient Water Quality Criteria for Bacteria  1986, EPA 440/ 5 84 002, 1986.

United States Environmental Protection Agency, Puget Sound Estuary Program, Puget Sound Monitoring Program, 1986.

United States Environmental Protection Agency, Puget Sound Estuary Program, Recommended Protocols for Microbiological Studies in Puget Sound, 1986.

United States Environmental Protection Agency, Puget Sound Estuary Program, Recommended Protocols for Measuring Conventional Water Quality Variables and Metals in Fresh Water of the Puget Sound Region, 1990.

United States Environmental Protection Agency, Puget Sound Estuary Program, Recommended Guidelines for Measuring Conventional Marine Water Column Variables in Puget Sound, 1991.

Washington State, Chapter 173 201A of the Washington Administration Code, 1997.

Washington State Department of Ecology, Environmental Assessment Program, Technical Guidance for Assessing the Quality of Aquatic Environments, Ecology Publication No. 91 78, 1992. Kitsap County Health District Water Quality Program Marine Water and Stream Water Quality Monitoring Plan ( Last Updated October 26, 2004) Page 22 of 22 BIBLIOGRAPHY ( Continued)

Washington State Department of Ecology, Environmental Investigations and Laboratory Services Program/ Water Quality Program, Guidance for Conducting Water Quality Assessment and Watershed Characterization Under the Nonpoint Rule ( Chapter 400 12 WAC), Ecology Publication No. 95 307, 1995.

Washington State Department of Ecology, Candidate 1998 Section 303( d) List   WRIA 15, 1997.

Swwqbdc1/ user/ os_ wq/ common/ water quality/ trend plan/ wqtrendplan01. doc/ 9\ 27\ 04


[Federal Register Volume 77, Number 233 (Tuesday, December 4, 2012)]
[Notices]
[Pages 71803-71804]
[FR Doc No: 2012-29157]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0080]

Guidance on Food and Drug Administration Oversight of Positron
Emission Tomography Drug Products--Questions and Answers; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``FDA Oversight of PET Drug
Products--Questions and Answers.'' This guidance provides questions and
answers that address nearly all aspects of the FDA approval and
surveillance processes, including application submission, review,
compliance with good manufacturing practices, inspections, registration
and listing, and user fees.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your requests. See
the SUPPLEMENTARY INFORMATION section for electronic access to this
guidance document.
    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.

FOR FURTHER INFORMATION CONTACT: Elizabeth Giaquinto, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6164, Silver Spring, MD 20993-0002, 301-
796-3416.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance entitled ``FDA
Oversight of PET Drug Products--Questions and Answers.'' In 1997,
Congress passed the Food and Drug Administration Modernization Act (the
Modernization Act) (Public Law 105-115). Section 121 of the
Modernization Act directed FDA to establish appropriate approval
procedures and current good manufacturing practices (CGMP) for PET
drugs. The procedures were finalized and an implementation timeline was
instituted on December 10, 2009, when FDA published regulations that
described the minimum CGMP standards that each PET drug manufacturer is
to follow during the production of a PET drug (see part 212 (21 CFR
part 212)).\1\ Under the requirements of section 121 of the
Modernization Act, within 2 years following that publication date, a
new drug application (NDA) or abbreviated new drug application (ANDA)
must be submitted for any PET drug marketed for clinical use in the
United States.
---------------------------------------------------------------------------

    \1\ The regulation, CGMP guidance, and supportive information,
including historical documents, are available at http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm085783.htm.
---------------------------------------------------------------------------

    Recognizing that many PET drug producers are unfamiliar with the
drug approval process, FDA issued several guidance documents specific
to PET drug producers \2\ and held a public meeting in March 2011 to
assist applicants in preparing NDAs and ANDAs for the three most
commonly used PET drugs. Numerous questions have been raised since that
public meeting on all aspects of FDA oversight of PET drugs. This
guidance is being issued to respond to the questions that have been
submitted to date, and it will be revised periodically to respond to
additional questions that have been submitted and are expected to be
submitted in the future.
---------------------------------------------------------------------------

    \2\ We update guidances periodically. To make sure you have the
most recent version of a guidance, check FDA's Drugs guidance Web
page at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
---------------------------------------------------------------------------

    A draft guidance of the same title was announced in the Federal
Register on February 27, 2012 (77 FR 11553), and Docket No. FDA 2012-D-
0080 was open for public comment until May 29, 2012. We received one
set of comments from industry. We have carefully considered the
comments, and where appropriate, we have made corrections, added
information, or clarified the information in this guidance in response
to the comments or on our own initiative. In addition, we have added
six new questions and answers (see questions 63, 64, 65, 66, 88, and
89).
    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 on the FDA oversight of PET drugs. 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 statutes
and regulations.

II. Comments

    Interested persons may submit either written comments regarding
this document to the Division of Dockets Management (see ADDRESSES) or
electronic comments to http://www.regulations.gov. It is only necessary
to send one set of 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, and will be posted to the docket at
http://www.regulations.gov.

III. Paperwork Reduction Act of 1995

    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 21 CFR part 314 were approved under OMB
control numbers 0910-0001 and 0910-0338; the collections of information
in 21 CFR part 312 were approved under OMB control number 0910-0014;
the collections of information in part 212 were approved under OMB
control number 0910-0667; the collections of information in 21 CFR
parts 210 and 211 were approved under 0910-0139; and the collections of
information in 21 CFR part 207 were approved under OMB control number
0910-0045. The guidance also refers to collections of information
associated with submitting Form FDA 3397 (Prescription Drug User Fee
Cover Sheet), approved under OMB control number 0910-0297.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: November 28, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-29157 Filed 12-3-12; 8:45 am]
BILLING CODE 4160-01-P


Page 1 of 10 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES September August 29, 2003 MEMORANDUM SUBJECT: Tolerance Reassessment Decisions Completed by the Lower Toxicity Pesticide Chemical Focus Group FROM: Peter Caulkins, Associate Director Registration Division TO: Richard Keigwin, Acting Associate Director Special Review and Reregistration Division Please find attached the Focus Group Decision Documents for ( 1) beeswax and ( 2) carnauba wax. The two tolerance exemptions for these chemicals in 40 CFR 180.1001 are reassessed.

If you have any comments or questions, please contact Kathryn Boyle at 703 305 6304.

Attachments ( 2) Page 2 of 10 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES September 27, 2003 MEMORANDUM FROM: Kathryn Boyle, Chair Lower Toxicity Pesticide Chemical Focus Group Registration Division TO: Susan Lewis, Acting Chief Minor Use, Inerts, and Emergency Response Branch Registration Division SUBJECT: Recommendation for Tolerance Reassessment The attached science assessment discusses the toxicity of beeswax. Based on its long history of safe use as a food additive and in cosmetics, and on the low toxicity of beeswax, a qualitative assessment was performed.

Based on its review and evaluation of the available information, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to residues of beeswax from its uses as an inert ingredient in pesticide products. The beeswax exemption from the requirement of a tolerance as established in 40 CFR 180.1001 ( c) is reassessed. Based on its low toxicity, the classification of beeswax as List 4A is confirmed. Page 3 of 10 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES September 22, 2003 Memorandum Subject: Beeswax: Lower Toxicity Pesticide Chemical Focus Group Document for Inert Tolerance Reassessment CAS No.: 8012 89 3 PC Code: 900031 From: Mark Perry Special Review and Reregistration Division ( 7508C)

To: Lower Toxicity Pesticide Chemical Focus Group Kathryn Boyle, Chair Registration Division ( 7505C)

Background:

Attached is the Lower Toxicity Pesticide Chemical Focus Group's assessment for beeswax. This assessment summarizes the available information on use, physical/ chemical properties, toxicological effects and exposure potential of beeswax. Page 4 of 10 I. Executive Summary:

Beeswax is a complex mixture composed of a variety of monoesters, diesters, hydroxylated esters, hydrocarbons, and free fatty acids. It is a wax, not a fat, as it is composed primarily of esters and long chained hydrocarbons which are classic wax components. Honey bees synthesize beeswax in four pairs of glands located on the ventral side of their abdomen. The wax is used by the bees as their primary building material for making combs, in which they rear their brood and store honey and pollen. It is resistant to hydrolysis and natural oxidization, and is completely insoluble in water. Yellow beeswax is produced by melting strained combs in hot water and using acid or alkali to extract impurities. White beeswax is produced by bleaching the pigments in yellow beeswax with sunlight or peroxides.

Beeswax has many commercial uses. It is used in wood polishes, cosmetics, baby products, bath preparations, adhesives, sizing and finishing textiles, candles, chewing gum, confections, and on fresh & frozen fruit. The Food and Drug Administration ( FDA) has classified beeswax as a Generally Recognized As Safe ( GRAS) direct food additive with limitations ( 21 CFR 184.1973). The only significant effects noted in the available toxicology data on beeswax are minimal eye and dermal irritation observed in a relatively small number of animals in certain irritation studies.

Based on available information on beeswax, its safe history of use as a food additive, its extensive use in cosmetics, and its low toxicity, the Lower Toxicity Pesticide Chemical Focus Group has determined that a screening level quantitative risk assessment is not required for this compound.

II. Use Information:

The pesticidal and non pesticidal uses of beeswax are summarized briefly below.

Use Pattern ( pesticidal  inert ingredient)

Chemical Name Inert PC Code 40 CFR 180.1001 Inert Use Pattern ( Pesticidal) Current Inert List Beeswax 900031 ( c) coating agent 4A Use Pattern ( non pesticidal):

The beeswax GRAS classification allows limited ( levels not to exceed good manufacturing practice) use in foods as a flavoring agent and adjuvant, as a lubricant and as a surface finishing agent. The classification allows use in chewing gum, in confections and frostings, in hard/ soft Page 5 of 10 candy and in other food categories at reduced levels. Cosmetic uses of beeswax include eye/ facial makeup, lipstick, hair/ skin/ nail products, shaving products and in baby lotions, oils and bath products at concentrations ranging from less than 0.1% to greater than 50%. Other non food uses include sizing/ finishing textiles, leather polishing, candle making and as a vehicle for drug administration.

III. Physical/ Chemical Properties:

Table 1. Physical/ Chemical Properties.

Beeswax Melting range 62 65 C Solubility in water insoluble Density 0.95 Physical state wax IV. Hazard Assessment:

As mentioned above, beeswax is classified by the U. S. FDA as Generally Recognized as Safe for use as a direct food additive at levels not to exceed good manufacturing practice ( 21 CFR 184.1973). It is believed that beeswax is not digested or absorbed by humans since the structural components of beeswax are not susceptible to hydrolysis in the mammalian digestive tract. Furthermore, it is prevented from dissolution within the body due to its insolubility in water and high melting point. As an ingredient of comb honey, beeswax has a long history of consumption without evidence of adverse effects.

The 1975 FDA evaluation of beeswax as a food ingredient by the Select Committee on GRAS Substances concluded that "( T) here is no evidence in the available information on beeswax ( yellow or white) that demonstrates, or suggests reasonable grounds to suspect, a hazard to the public when it is used at levels that are now current or might reasonably be expected in the future." The Select Committee based this decision on considerations such as history of use, consumer exposure information and the experimental data available at the time. The consumer exposure information used by the Committee included estimates that beeswax is added to soft candy and chewing gum at levels ranging from 389 to 446 ppm.

The International Programme on Chemical Safety ( IPCS) in conjunction with the World Health Organization ( WHO) addressed beeswax in a 1993 evaluation performed to determine acceptable daily intakes of certain food additives ( Food Additive Series 30). This evaluation considered the biochemical aspects of beeswax in human digestion, available toxicity data, history of use without apparent adverse effect and current food uses. The uses cited in this evaluation Page 6 of 10 included use in bakery products, on fresh/ frozen fruit, in candy and as a chewing gum base. The evaluation concluded that the present uses of beeswax are not of toxicological concern.

Toxicological Profile:

The Cosmetic Ingredient Review ( CIR) performed a safety assessment of beeswax in 1984 which references data performed with undiluted beeswax resulting in an oral LD50 ( rat) greater than 5 g/ kg, and studies on products containing 0.3% to 13% beeswax which produced no oral toxicity in rats at doses up to 15 g/ kg. This assessment also reports that skin ( 100% beeswax) and eye irritation ( 50% beeswax) studies in the rabbit, resulted in little or no irritation; that two 13% formulations tested for subchronic dermal toxicity ( rabbit/ rat) demonstrated no topical or systemic effects; and that beeswax was not mutagenic when tested with Salmonella typhimurium and Saccharomyces cerevisiae with and without activation. The CIR assessment referenced human dermal patch studies as well, which resulted in minimal or no irritation at concentrations of 6.4%, 13% and 100% beeswax. Overall, the assessment concluded that beeswax is safe as used in cosmetics under present practices of concentration and use.

The Agency is aware that some beeswax may contain environmental contaminants ( chemical residues) or impurities such as pollen which could effect its toxic/ allergenic potential. The presence and levels of such contaminants are extremely difficult to predict for a natural product like beeswax, and due to the refinement process, it is considered unlikely that significant contaminant levels would persist in commercial grade beeswax. Therefore, the Lower Toxicity Pesticide Chemical Focus Group does not consider it feasible to account for these potential impurities in an assessment of risk for generic beeswax .

Special Considerations for Infants and Children:

At this time, there is no concern for potential sensitivity to infants and children. A safety factor analysis has not been used to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary.

Hazard Characterization:

Taking into consideration all available information on beeswax, including FDA's GRAS designation, its use in food products and cosmetics, the history of use without incident and its apparent indigestible nature, use of beeswax as an inert ingredient in pesticide products is unlikely to pose a significant hazard to the general public or any population subgroup.

V. Risk Characterization:

Exposure to beeswax would result from its FDA approved GRAS use as a food additive and through its use in the numerous cosmetic products mentioned above. The use of beeswax in Page 7 of 10 pesticide products is expected to result in much lower exposure than through the food and cosmetic uses of this material. Exposures from pesticide inert uses are expected to result in human exposure below any dose level that could possibly produce an adverse effect. Therefore, a screening level quantitative exposure assessment has not been conducted. Page 8 of 10 VI. Environmental Fate/ Ecotoxicity/ Drinking Water Considerations:

The natural waxes, such as beeswax, are naturally occurring and, as a result it is believed that there is no concern for exposures to non target organisms and the environment from releases through approved uses.

Natural waxes, including beeswax, unlike most synthetic waxes ( i. e., paraffins) are ester of the general formula:

O 5 R C C O R 0 These compounds are insoluble in water, non volatile, have a low air: water partitioning coefficient ( Henry's Law Coefficient) and are poorly mobile in soils and sediments. The ultimate sink for beeswax released into the environment is soil and sediments. Beeswax will undergo primary biodegradation of various components in days to weeks aerobically and longer anaerobically. Because beeswax is a " mixture" of compounds, component analysis is considered the optimal approach to understanding the behavior and toxicity in the environment.

The primary component of beeswax is myricyl palmitate ( CH 3 ( CH 2 ) 14  CO 2 ( CH 2 ) 29  CH 3 ). This component, like its parent, is insoluble in water ( est. water solubility: 2.2E 17), non volatile ( est. vapor pressure 2.2E 15 mmHg), and poorly mobile in soils and sediments ( est. Log K oc : 11). Primary degradation occurs in days to weeks and ultimate degradation in weeks to months. The principle sink in the environment for myricyl palmitate is also soil and sediments. It is unlikely to undergo hydrolysis and photolysis, but will react in the atmosphere with hydroxyl radicals with a half life of hours. Bioconcentration and/ or biomagnification is unlikely for both compounds based on estimated K ow s greater than the analytical stability of available models ( est. Log K ow : > 20).

Toxicity of beeswax and the primary component to aquatic organisms is not expected due the low water solubility and high log K ow. Toxicity to wild mammals, using the rat as a surrogate species, is likewise not expected. By analogy, birds and other terrestrial organisms are unlikely to exhibit adverse effects when exposed.

VII. Cumulative Exposure:

Section 408( b)( 2)( D)( v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider " available information" concerning the cumulative effects of a particular pesticide's residues and " other substances that have a common mechanism of toxicity." Page 9 of 10 EPA does not have, at this time, available data to determine whether beeswax has a common mechanism of toxicity with other substances. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to beeswax and any other substances and beeswax does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that beeswax has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website. Page 10 of 10 References:

( Note to the Reader: MRID ( Master Record Identification) Numbers were added to the references on October 17, 2003. These numbers were not available at the time of document signature. No other changes were made to the document.)

U. S. Food and Drug Administration ( FDA). 1975. Evaluation of the Health Aspects of Beeswax ( yellow and white) as Food Ingredients. Federation of American Societies for Experimental Biology, Available through National Technical Information Service ( Doc. PB262656). ( MRID No. 46067501)

Cosmetic Ingredient Review ( CIR). 1984. Final Report on the Safety Assessment of Candelilla Wax, Carnauba Wax, Japan Wax, and Beeswax. Journal of the American College of Toxicology 3( 3)

World Health Organization ( WHO). 1993. Toxicological Evaluation of Certain Food Additives and Naturally Occurring Toxicants. International Programme on Chemical Safety, WHO Food Additive Series 30.


[Federal Register: February 4, 2010 (Volume 75, Number 23)]
[Rules and Regulations]
[Page 5690-5692]
[DOCID:fr04fe10-6]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-1081; Directorate Identifier 2009-CE-058-AD;
Amendment 39-16187; AD 2010-03-04]
RIN 2120-AA64

Airworthiness Directives; PIAGGIO AERO INDUSTRIES S.p.A. Model P-
180 Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD results from mandatory continuing
airworthiness information (MCAI) issued by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as:

    An operator reported a short circuit between a generator power
cable and an anti-ice shutoff valve, which was caused by chafing
between the cable and the valve; the insulation of the cable and
surrounding sleeve were worn off.
    An investigation revealed that a scarce clearance between the
cables and adjacent parts, together with vibrations of generator
power cables favoured by insufficient clamping, was the root cause
of the damage.
    If left uncorrected, this situation could lead to short circuits
with possible fire and/or loss of important aircraft systems.

    We are issuing this AD to require actions to correct the unsafe
condition on these products.

DATES: This AD becomes effective March 11, 2010.
    On March 11, 2010, the Director of the Federal Register approved
the incorporation by reference of certain publications listed in this
AD.

ADDRESSES: You may examine the AD docket on the Internet at http://
www.regulations.gov or in person at Document Management Facility, U.S.
Department of Transportation, Docket Operations, M-30, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC
20590.

FOR FURTHER INFORMATION CONTACT: Sarjapur Nagarajan, Aerospace
Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas
City, Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on November 19, 2009
(74 FR 59941). That NPRM proposed to correct an unsafe condition for
the specified products. The MCAI states:

    An operator reported a short circuit between a generator power
cable and an anti-ice shutoff valve, which was caused by chafing
between the cable and the valve; the insulation of the cable and
surrounding sleeve were worn off.
    An investigation revealed that a scarce clearance between the
cables and adjacent parts, together with vibrations of generator
power cables favoured by insufficient clamping, was the root cause
of the damage.
    If left uncorrected, this situation could lead to short circuits
with possible fire and/or loss of important aircraft systems.
    This Airworthiness Directive (AD) requires an inspection to
detect damaged cables/sleeves, and replacement/repair as necessary;
in addition, this AD requires to ensure that acceptable minimum
clearances between cables and parts exist, and to improve clamping
to minimize vibrations of the cables.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM or on the determination of
the cost to the public.

Conclusion

    We reviewed the available data and determined that air safety and
the public interest require adopting the AD as proposed.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have required different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a NOTE within the AD.

Costs of Compliance

    We estimate that this AD will affect 63 products of U.S. registry.
We also estimate that it will take about 2 work-hours per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour.
    Based on these figures, we estimate the cost of this AD to the U.S.
operators to be $10,710 or $170 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 6 work-hours and require parts costing $10, for a cost of
$520 per product. We have no way of determining the number of products
that may need these actions.

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 AD will not have federalism implications
under Executive Order 13132. This AD will 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 AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866;
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979); and
    (3) 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.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD Docket.

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 the NPRM, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Office (telephone<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 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 AD:

2010-03-04 PIAGGIO AERO INDUSTRIES S.p.A.: Amendment 39-16187;
Docket No. FAA-2009-1081; Directorate Identifier 2009-CE-058-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective March
11, 2010.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Model PIAGGIO P-180 airplanes, all serial
numbers through 1180, certificated in any category.

Subject

    (d) Air Transport Association of America (ATA) Code 24: Electric
Power.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

    An operator reported a short circuit between a generator power
cable and an anti-ice shutoff valve, which was caused by chafing
between the cable and the valve; the insulation of the cable and
surrounding sleeve were worn off.
    An investigation revealed that a scarce clearance between the
cables and adjacent parts, together with vibrations of generator
power cables favoured by insufficient clamping, was the root cause
of the damage.
    If left uncorrected, this situation could lead to short circuits
with possible fire and/or loss of important aircraft systems.
    This Airworthiness Directive (AD) requires an inspection to
detect damaged cables/sleeves, and replacement/repair as necessary;
in addition, this AD requires to ensure that acceptable minimum
clearances between cables and parts exist, and to improve clamping
to minimize vibrations of the cables.

Actions and Compliance

    (f) Unless already done, do the following actions:
    (1) Within 3 months after March 11, 2010 (the effective date of
this AD), inspect for minimum clearance and insulation damage to the
generator power cables in accordance with Part A of the
ACCOMPLISHMENT INSTRUCTIONS of PIAGGIO AERO INDUSTRIES S.p.A.
Service Bulletin (Mandatory) N.: 80-0271, dated May 18, 2009.
    (2) If, as a result of the inspection required by paragraph
(f)(1) of this AD, any discrepancy (inadequate clearance or
insulation damage) is found, before further flight, do all necessary
corrective actions in accordance with Part B of the ACCOMPLISHMENT
INSTRUCTIONS of PIAGGIO AERO INDUSTRIES S.p.A. Service Bulletin
(Mandatory) N.: 80-0271, dated May 18, 2009.

FAA AD Differences

    Note: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Sarjapur Nagarajan, Aerospace Engineer, FAA,
Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.), the Office of Management and Budget (OMB) has
approved the information collection requirements and has assigned
OMB Control Number 2120-0056.

Related Information

    (h) Refer to MCAI European Aviation Safety Agency AD No.: 2009-
0212, dated October 6, 2009; and PIAGGIO AERO INDUSTRIES S.p.A.
Service Bulletin (Mandatory) N.: 80-0271, dated May 18, 2009, for
related information.

Material Incorporated by Reference

    (i) You must use PIAGGIO AERO INDUSTRIES S.p.A. Service Bulletin
(Mandatory) N.: 80-0271, dated May 18, 2009, to do the actions
required by this AD, unless the AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Piaggio Aero Industries S.p.a., Via Cibrario, 4--16154 Genoa, Italy;
telephone +39 010 06481 741; fax: +39 010 6481 309; Internet: http:/
/www.piaggioaero.com, or e-mail<EMAIL_ADDRESS>    (3) You may review copies of the service information
incorporated by reference for this AD at the FAA, Central Region,
Office of the Regional Counsel, 901 Locust, Kansas City, Missouri
64106. For information on the availability of this material at the
Central Region, call<PHONE_NUMBER>.
    (4) You may also review copies of the service information
incorporated by reference for this AD at the National Archives and
Records Administration (NARA). For information on the availability
of this material at NARA, call<PHONE_NUMBER>, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

    Issued in Kansas City, Missouri, on January 21, 2010.
James E. Jackson,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2010-1691 Filed 2-3-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: December 15, 2008 (Volume 73, Number 241)]
[Notices]
[Page 76067-76068]
[DOCID:fr15de08-98]

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

SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon written request, copies available from: U.S. Securities and
Exchange Commission, Office of Investor Education and Advocacy,
Washington, DC 20549-0213.

Extension: Rule 11a1-1(T); OMB Control No. 3235-0478; SEC File No.
270-428.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget (``OMB'') a request for approval of extension of the
previously approved collection of information provided for in the
following rule: Rule 11a1-1(T) (17 CFR 240.11a1-1(T)) under the
Securities Exchange Act of 1934 (15 U.S.C. 78a et seq.) (``Exchange
Act'').
    On January 27, 1976, the Commission adopted Rule 11a1-1(T), to
certain exempt transactions of exchange members for their own accounts
that would otherwise be prohibited under section 11(a) of the Exchange
Act. The rule provides that a member's proprietary order may be
executed on the exchange of which the trader is a member, if, among
other things: (1) The member discloses that a bid or offer for its
account is for its account to any member with whom such bid or offer is
placed or to whom it is communicated; (2) any such member through whom
that bid or offer is communicated discloses to others participating in
effecting the order that it is for the account of a member; and (3)
immediately before executing the order, a member (other than a
specialist in such security) presenting any order for the account of a
member on the exchange clearly announces or otherwise indicates to the
specialist and to other members then present that he is presenting an
order for the account of a member.
    Without these requirements, it would not be possible for the
Commission to monitor its mandate under the Exchange Act to promote
fair and orderly markets and ensure that exchange members have, as the
principle purpose of their exchange memberships, the conduct of a
public securities business.
    There are approximately 1,151 respondents that require an aggregate
total of 32 hours to comply with this rule. Each of these approximately
1,151 respondents makes an estimated 20 annual responses, for an
aggregate of 23,020 responses per year. Each response takes
approximately 5 seconds to complete. Thus, the total compliance burden
per year is 32 hours (23,020 x 5 seconds/60 seconds per minute/60
minutes per hour = 32 hours). The approximate cost per hour is $519,
resulting in a total cost of compliance for the annual burden of
$16,608 (32 hours @ $519).
    Compliance with Rule 11a-1(T) is necessary for exchange members to
make transactions for their own accounts under a specific exemption
from the general prohibition of such transactions under Section 11(a)
of the Exchange Act. Compliance with Rule 11a-1(T) does not involve the
collection of confidential information. Rule 11a-1(T) does not have a
record retention requirement per se. However, responses made pursuant
to Rule 11a-1(T) may be subject to the recordkeeping requirements of
Rules 17a-3 and 17a-4. An agency may not conduct or sponsor, and a
person is not required to respond to, a collection of information
unless it displays a currently valid control number.
    Comments should be directed to (i) Desk Officer for the Securities
and Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503 or by sending an e-mail to:
<EMAIL_ADDRESS>and (ii) Lewis W. Walker, Acting Director, Chief
Information Officer, Securities and Exchange Commission, c/o Shirley
Martinson, 6432 General Green Way, Alexandria, VA 22312 or send an e-
mail to<EMAIL_ADDRESS>Comments must be submitted within 30
days of this notice.

    Dated: December 8, 2008.
Florence E. Harmon,
Acting Secretary.
 [FR Doc. E8-29505 Filed 12-12-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 187 (Thursday, September 26, 2013)]
[Notices]
[Pages 59422-59423]
[FR Doc No: 2013-23458]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Delayed Applications

AGENCY: Office of Hazardous Materials Safety, Pipeline and Hazardous
Materials Safety Administration (PHMSA), DOT.

ACTION: List of applications delayed more than 180 days.

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

SUMMARY: In accordance with the requirements of 49 U.S.C. 5117(c),
PHMSA is publishing the following list of special permit applications
that have been in process for 180 days or more. The reason(s) for delay
and the expected completion date for action on each application is
provided in association with each identified application.

FOR FURTHER INFORMATION CONTACT: Ryan Paquet, Director, Office of
Hazardous Materials Special Permits and Approvals, Pipeline and
Hazardous Materials Safety Administration, U.S. Department of
Transportation, East Building, PHH-30, 1200 New Jersey Avenue
Southeast, Washington, DC 20590-0001,<PHONE_NUMBER>.

Key to ``Reason for Delay''

1. Awaiting additional information from applicant
2. Extensive public comment under review
3. Application is technically complex and is of significant impact or

precedent-setting and requires extensive analysis
4. Staff review delayed by other priority issues or volume of special
permit applications

Meaning of Application Number Suffixes

N--New application
M--Modification request
R--Renewal Request
P--Party To Exemption Request

    Issued in Washington, DC, on September 19, 2013.
Donald Burger,
Chief, General Approvals and Permits.

----------------------------------------------------------------------------------------------------------------
                                                                                Reason for    Estimated date
                Application No.                             Applicant                  delay       of completion
----------------------------------------------------------------------------------------------------------------
                                         New Special Permit Applications
----------------------------------------------------------------------------------------------------------------
15720-N.......................................  Digital Wave Corporation,                    3,1      09-30-2013
                                                 Centennial, CO.
15767-N.......................................  Union Pacific Railroad Company,                1      09-30-2013
                                                 Omaha, NE.
15807-N.......................................  U.S. Department of Defense                     4      09-30-2013
                                                 (DOD), Scott AFB, IL.
15832-N.......................................  Baker Petrolite, Sugar Land, TX.               4      09-30-2013
15747-N.......................................  UPS, Inc. Atlanta, GA...........             2,3      09-30-2013
----------------------------------------------------------------------------------------------------------------
                                      Renewal Special Permits Applications
----------------------------------------------------------------------------------------------------------------
13997-R.......................................  Maritime Helicopters, Inc.                     4      09-30-2013
                                                 Homer, AK.
9198-R........................................  Washington State Department of                 4      09-30-2013
                                                 Natural Resources, Olympia, WA.
12412-R.......................................  Davis Supply, Inc., Fort Myers,                1      09-30-2013
                                                 FL.
14996-R.......................................  Skydance Helicopters of Northern             1,4      09-30-2013
                                                 Nevada, Minden, NV.
11136-R.......................................  Fireworks by Grucci, Brookhaven,               4      09-30-2013
                                                 NY.
14155-R.......................................  American Promotional Events,                 2,3      09-30-2013
                                                 Inc., North-West dba/TNT
                                                 Fireworks, Florence, AL.
15626-R.......................................  EC Source Aviation, LLC, Mesa,                 4      09-30-2013
                                                 AZ.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2013-23458 Filed 9-25-13; 8:45 am]
BILLING CODE 4910-60-P