1 CREOSOTE: REVIEW OF WORKER EXPOSURE STUDY 1.0 INTRODUCTION The purpose of this report is to review the worker exposure study submitted to the U. S. Environmental Protection Agency in support of the re registration requirements of the wood preservative, creosote. The creosote worker exposure study was submitted to fulfill agency guideline requirements under Series 875.1100 Dermal Exposure Outdoor 1; Series 875.1300 Inhalation Exposure Outdoor 2; and Series 875 Occupational and Residential Exposure Test Guidelines, Group B Post application Exposure Monitoring Test Guidelines 3. The major points in " Checklist for Applicator Monitoring Data" were used to evaluate compliance with Series 875.

The following information can be used to identify the protocol:

Title Formulation, Active Ingredient Identifying Codes Corporate Sponsor Performing Laboratory Assessment of Potential Creosote Inhalation and Dermal Exposure Associated with Pressure Treatment of Wood with Creosote ( 1) Koppers Coal Tar Creosote with 98.5% active ingredient ( a. i.) creosote ( AWPA P1/ P13)

( 2) VFT Coal Tar Creosote Wood Preservative with 100 % a. i. creosote ( P1/ P13)

( 3) Koppers Creosote Solution with 95% a. i. creosote ( AWPA P2) MRID No. 453234 01; AASI Study No. AA990308; EN CAS Analytical Laboratories Project No. 98 0079 Creosote Council II John H. Butala, DABT 7 Glasgow Road Gibsonia, PA 15044 Phone: ( 724) 443 0097 FAX: ( 724) 443 0926 Field Mark G. Bookbinder ( Field Investigator) c/ o American Agricultural Services, Inc. 404 E. Chatham Street Cary, NC 27511 Phone/ FAX: ( 301) 540 5622 Analytical Bert Clayton, B. S. Stephanie Guilyard ( Dermal Exposure Support) ( Inhalation Exposure Support) EN CAS Laboratories USX Engineers and (" ENCAS") Consultants, Inc. ( UEC) 2359 Farrington Point Drive 4000 Tech Ctr. Dr.

Winston Salem, NC 27107 Monroeville, PA 15146 Phone: ( 336) 785 3252 Phone: ( 412) 825 2808 FAX: ( 336) 785 3262 FAX: ( 412) 825 2022 2.0 EXECUTIVE SUMMARY This study was designed to estimate the exposure to creosote of individuals performing job functions involved in commercial pressure treatment of lumber, utility poles, and railroad ties at four typical commercial treatment facilities in the United States and Canada ( referred to as Sites A through D). Three end use products for coal tar creosote were used. Twenty five workers and 11 job functions ( tasks) were monitored for up to 4 or 5 consecutive work days each ( 8 hour shifts). Many of the job functions may have been performed by one or more worker( s). Where a single worker performed the duties of more than one job function, the title of the job function which represented the majority of their work efforts was used to identify the worker. 2 Dermal and inhalation exposure levels were estimated. Dermal exposure levels were estimated by passive dosimetry using whole body dosimeters ( WBDs) and cloth dosimeter gloves. The WBDs and cloth dosimeter gloves were worn under the workers' protective clothing and chemical resistant gloves. Inhalation exposure levels were estimated by active dosimetry using a sampling train ( placed in the worker's breathing zone) that consisted of a PTFE air filter upstream from two in line XAD 2 resin filled air sampling tubes. The air was pulled through the sampling train by a portable air sampling pump.

Creosote cannot be measured directly because it is a mixture of many component compounds. Dermal exposure to " total creosote" was estimated by measuring the levels of ten individual polynuclear aromatic hydrocarbon ( PNA) compounds. Each analyte was determined in each WBD and glove sample as if it represented total creosote. Inhalation exposure was estimated for 11 individual PNA compounds as well as for benzene soluble PNAs and related compounds collectively known as coal tar pitch volatiles ( CTPVs). The PTFE filter retained the CTPVs, while the PNAs were retained in the XAD 2 resin tubes.

Known quantities of a characterized creosote formulation could not be measured because the study was set up in a continuously operating commercial setting. The creosote was applied in closed systems where excess treatment solution from the wood and treatment vessels were recovered and retained while sealed. Therefore, the amount of product or active ingredient handled by each worker is not known. According to the Study Report, the major source of creosote for worker exposure in this type of facility is due to preservative remaining on or escaping from treated wood or equipment that had been in a cylinder during treatment. This is presumably a very small fraction of the quantity actually applied to and retained by the charge. The treated wood retained between approximately 5794 pounds ( Site B) and 53290 pounds ( Site C) of creosote per charge, depending on treatment parameters. This study monitored 12 ( Site A) to 23 ( Site D) charges.

The unadjusted creosote level for each WBD segment and glove pair from each worker was corrected for the mean field fortification recovery of the appropriate analytical standard( s) from samples fortified in the field at that test site. The analytical method was subject to some variability at levels near the LOQ, suggesting that recoveries obtained at that level were likely to be less reliable than those at the higher level. Therefore, the field fortification recoveries at 1,000 times the LOQ were used to make the corrections. The registrant did not make corrections to the raw data when field fortification recoveries were > 100%. U. S. EPA guidelines state that corrections are not needed when field fortification recoveries are above 90%.

Each calculated exposure level was normalized to

g/ kg body weight/ day, normalizing results to the EPA recommended mean adult weight of 71.8 kg and to a standard work day length of 8 hours. The " total" dermal exposure for each replicate for each worker was calculated by summing the normalized residue levels in the WBD arms, WBD top, WBD bottom ( torso portion and legs, cut apart at EN CAS and analyzed as separate samples), and all glove dosimeters worn during that replicate. Geometric mean dermal creosote exposures across all of the job functions at all four sites ranged from 25 ( Load Out Area Helper) to 901 ( Oil Unloader)

g/ kg bw/ day. 3 The highest individual levels were found for the Site C Treatment Operator. This operator also performed the duties of the Oil Unloader while not wearing chemical resistant gloves on at least one monitored occasion. Within each job class monitored, and over all classes at each site, those individuals whose activities involved the greatest proximity to creosote sources were exposed to the highest levels of creosote.

No useful inhalation data were generated at Site A due to problems with the air sampling methodology. The methodology was changed prior to sampling at Sites B, C, and D ( added second XAD 2 resin tube to sampling train). The unadjusted inhalation residue level for each air sampler from each worker was corrected for the mean field fortification recovery of the appropriate analytical standard( s) from samples fortified in the field at that test site. Calculated inhalation exposure levels were normalized by scaling up the pump flow rate of 1 L/ min to the EPA recommended minute ventilation rate of 1100 L/ hr ( approximately 18.34 L/ min) for " light activities", and then adjusting for the standard EPA recommended adult weight of 71.8 kg.

Chrysene and benzo( a) pyrene were not detected in worker samplers. Pyrene and anthracene were detected in 1 and 2 sampler( s), respectively. However, naphthalene was detected in every sampler, and 2 methylnaphthalene was detected in most samplers, suggesting that only the lower molecular weight (" low boiling") PNAs are commonly volatilized during pressure treatment, or are able to remain volatile when exposed to ambient temperatures. Naphthalene represented the single greatest contribution to inhalation exposure. CTPVs were present at quantifiable levels in only one sampler, suggesting that this class of compounds may be a minor constituent of creosote emissions. Measured aerial concentrations of naphthalene ( approximately 0.04 to 1.29 mg/ m3) and CTPVs ( 0.0003 to 0.0006 mg/ m3) were well below the ACHIH TLVs of 52 mg/ m3 and 0.2 mg/ m3, respectively, for these materials for all monitored workers. The geometric mean daily inhalation exposure was greatest in worker classes performing tasks in close proximity to sources of creosote.

The concerns related to requirements under the Series 875 guidelines are as follows:

( 1) CTPV inhalation field fortification recoveries and some dermal field fortification recoveries were unacceptable;

( 2) Unable to quantitate the total amount of active ingredient handled by each worker monitored in the study; ( 3) There were not enough field fortification samples and field blanks collected; and ( 4) The amount of product applied was not measured.

The study did address most of the issues in Series 875 ( the method validation, field spikes, and QA/ QC were more thorough then most studies), but the poor recoveries were major issues that did not meet Series 875 guidelines. The calculation of inhalation exposure results was not described well. The raw data supplied in the study did not directly match up with the bar graphs presented. 4 3.0 BACKGROUND 3.1 Introduction Four commercial facilities in the U. S. and Canada were used in this study to determine the dermal and inhalation exposure of workers applying creosote end use products to wood poles and/ or railroad ties by pressure treatment systems. Three of the facilities ( referred to herein as Sites A, C, and D) were located in the U. S. ( Florence, South Carolina; Denver, Colorado; and Somerville, Texas). The fourth facility ( referred to herein as Site B) was located in Delson, Quebec, Canada. The four facilities and the end use products used in this study were said to represent a range of geographic locations, formulations used, species of wood products treated, and application parameters used for treatment of wood with creosote.

At each site, pressure treatment of wood products was performed using the same basic process. Workers operating self propelled or stationary loaders moved untreated poles or ties from holding areas and stacked them onto wheeled metal trams on a railroad track leading into the treatment cylinder( s). When enough trams were loaded to fill a cylinder, the poles or ties on each tram were tied together with chains of metal or plastic bands. A charge cable ( or " lead cable") was connected to the tram farthest from the cylinder door, and laid along the top of the stacked items on the trams. The filled trams were considered a " charge" of wood products.

The cylinder door was opened and its drawbridge was positioned so that it connected the drip pad track with the cylinder's interior rails. The charge was then pushed into the cylinder by a self propelled loader. Workers placed the free end of the lead cable into the cylinder, closed the cylinder door( s), and started the treatment process. Treating solution ( P1 or P2, as unloaded from tank cars in which it was delivered to the plant) was heated to 190  210 oF and pumped from storage tanks into the cylinder, after which pressure ( 150  190 psi) was applied to the cylinder to allow the preservative to permeate the wood of the poles.

After treatment, excess treating solution was removed from the cylinders and wood products by maintaining a vacuum in the cylinder for approximately 1 to 7 hours. The duration of a treatment cycle ranged from approximately 7 to 80 hours, depending on the species of wood treated and the procedures used by each site. At the end of treatment, the cylinder was opened, and excess water and creosote vapors and condensates evolved from the cooling wood products ( charges typically generated condensate plumes for up to several hours after treatment).

Workers removed the charge from the cylinder by removing the end of the lead cable from the cylinder and attached it to a hook on a self propelled loader, which then pulled the loaded trams out of the cylinder. At Sites A, B, and C, each charge was pulled onto a concrete " drip pad," where excess treatment solution was allowed to drip from the wood products and trams onto the pad for up to several hours. After site personnel removed lead cables and chains, the cooled poles were pushed by loader to a storage area, where workers using hand or electricpowered drills took narrow cores of wood from selected poles or ties to determine the depth of 5 penetration of the preservative, and the amount of preservative that actually was absorbed by the wood. Charges that did not contain enough creosote or did not penetrate deep enough were retreated as above. At Site D, ties were pushed down the length of the drip pad to more distant areas of the plant for stacking. The ties were immediately transfered to rail cars following their withdrawal from the cylinder. Test boring was not routinely performed at this site, per customer specifications.

Twenty five workers were monitored for this study. The 11 treatment plant job categories monitored in this study include treatment operators, treating assistants, loader operators ( cylinder and load out areas), cylinder area helpers, checker, load out area helpers, test borers, oil unloaders, drip pad laborer and water treatment system operators. Workers performed typical tasks related to these activities and were monitored for up to 4 5 consecutive work days each. Descriptions of the tasks monitored are bulleted below :

° Treatment operators ( TOs)  TOs operated and monitored application system valves and controls, they sometimes opened and closed cylinder doors, and they supervised the insertion and removal of charges ( loads of dried, debarked poles or untreated ties) of poles from the treatment cylinders.

° Treating assistant ( TA)  TAs performed many of the same functions as the TOs and sometimes assisted the TO in charge preparation, cylinder cleaning and maintenance, filter cleaning, mixing of treatment solution, and also participated in some loader operations moving charges.

° Loader operators ( CLOs in the cylinder area, and LLOs in the load out areas)  LOs stacked untreated wood onto charge trams, moved charges into and out of treatment cylinders, distributed treated wood to load out area, and loaded treated wood for shipment.

° Cylinder area helpers ( CHs in the cylinder area, and LHs in the load out areas)  CHs/ LHs aided the LOs by opening/ closing cylinder door, cleaning door debris and performing door maintenance, handling charge leads and cables, and banding stacked wood.

° Checker ( CK)  CKs performed many of the duties of a CH.

° Load out area helpers ( LHs)  LHs aided their LOs by banding treated wood and removing culls.

° Test borers ( TBs)  TBs took cores from freshly treated poles or ties to be tested for creosote content and penetration depth.

° Oil unloaders ( OUs)  OUs operated the equipment that transferred creosote from rail tank cars to treating system tanks. 6 ° Drip pad laborer ( DP)_ DPs steam cleaned drip pads and tracks. They also picked up and disposed of treated wood waste and performed various labor clean up duties in treatment areas.

° Water treatment system operators ( WOs)  WOs controlled equipment that collected drip pad effluent water, and removed creosote and other contaminants.

Creosote is a complex mixture of chemicals and therefore can not be measured directly. Dermal exposure levels were estimated by passive dosimetry using whole body dosimeters ( WBD) which were worn under the worker's clothing and lightweight cotton glove dosimeters which were worn under work gloves. The dermal creosote exposure levels were estimated by measuring the levels of ten individual polynuclear aromatic hydrocarbon ( PNA) compounds. Each of these analytes were determined in each WBD and glove sample as if it represented total creosote. The levels for each of the individual analytes were then averaged together to estimate the level of total creosote present in/ on the individual sample.

Inhalation exposures for each worker was estimated by active dosimetry. Each worker wore a sampling train consisting of a PTFE filter upstream from two in line XAD 2 resin filled air sampling tubes. The inhalation exposure levels were estimated by determining the presence of specific individual creosote components ( 11 individual PNAs representing the boiling point ranges of known creosote components). Inhalation exposure to benzene soluble PNAs and related components collectively known as coal tar pitch volatiles ( CTPVs) were measured as well. The PTFE filter retained the CTPVs, while the PNAs were retained in the XAD 2 resin tubes. A more complete description of the monitoring techniques used in this study is described in Section 5.

3.2 Physical and Chemical Characteristics of Creosote Coal tar creosote is a blend of over 200 compounds, and approximately 85% of it is composed of polynuclear aromatic hydrocarbons ( PNAs). Some of the more significant compounds in creosote are: naphthalene, acenaphthene, fluorene, phenanthrene, fluoranthene, and pyrenes. 4 Vapor pressures for naphthalene, phenanthrene, pyrene, and chrysene are 8.7E 02, 9.6E 04, 6.8E 07, 6.3E 09 mm Hg respectively. 5 The volatiles are the single ring compounds and the semi volatiles are the two to six ring compounds. 6 The vapor pressure tends to become larger as aromatic rings are added to the compound. The more soluble compounds of creosote include phenols, cresols, and N heterocyclics. PNA compounds have various physical and chemical characteristics. The lower molecular weight PNAs are more biodegradable, volatile, and water soluble than the heavier compounds. PNAs are biodegradable, especially under aerobic conditions ( in the presence of oxygen). The high molecular weight PNAs tend to have low aqueous solubilities. Several of the lower molecular weight PNAs are also biodegradable under anaerobic conditions ( in the lack of oxygen). 7 3.3 Chemical Structure, Fate, and Dissipation Chemical Name: Creosote CAS: 8001 58 9 Structures for creosote are presented below.

The compounds with the higher molecular weights tend to be more persistent. Water solubility, and thus bio availability has been found to be inversely proportional to the size of the molecule. PAHs with two rings, generally have half lives less than 10 days. Three ring PAHs generally exhibit longer half lives in most cases, but these compounds have half lives of less than 100 days. Four or five ring PAHs have half lives from 100 days or more. However, under certain conditions this group has exhibited half lives under 10 days. 6 8 4.0 PURPOSE This study was conducted to estimate the exposure to creosote of individuals performing routine tasks involved in the commercial pressure treatment of lumber, utility poles, and railroad ties at four typical commercial treatment facilities in the U. S. and Canada, per the requirements of the U. S. Environmental Protection Agency, California Department of Pesticide Regulation, and Health Canada's Pesticide Management Regulatory Authority regulations. Dermal and inhalation exposure monitoring data were gathered for each job function of interest. This study review will provide a summary of the procedures used in the study, results obtained by the study, a review based on Series 875 guidelines, and a conclusion indicating identified gaps.

5.0 PROCEDURE 5.1 Mixing/ Loading/ Application Method The procedures used for mixing and loading the product were not discussed in detail in the study. The study reported that the treating solution ( P1 or P2) was unloaded from tank cars in which it was delivered to the plant and was heated to 190  210 oF and pumped from storage tanks into the cylinder, after which pressure ( 150  190 psi) was applied to the cylinder to allow the preservative to permeate the wood of the poles.

Known quantities of the creosote formulations used at each of the sites were not measurable for this study because the study was set up in continuously operating commercial settings. The creosote was applied in closed systems which recovered and retained excess treatment solution from the wood and treatment vessels while sealed. Therefore, the amount of product or active ingredient handled by each worker is not known.

5.2. Exposure Monitoring Dermal The creosote dermal exposure to each worker was determined using a whole body dosimeter ( WBD), consisting of a 100% cotton thermal shirt and long pants. Each worker at Sites A, C, or D wore his WBD under a fresh work uniform consisting of a cotton long sleeved work shirt and cotton work trousers ( or one piece cotton coverall) provided by the test site. The workers at Site B were not provided uniforms therefore, for the purpose of this study, each worker wore a WBD under a fresh lightweight cotton/ polyester sweat shirt and pants purchased locally by study personnel. Each worker at all four sites wore a lightweight 100% cotton glove dosimeter on each hand , under his chemical resistant or work gloves as appropriate.

At the beginning of each work cycle ( or 8 hour shift), each worker washed his hands with a detergent and then put on his WBD, followed by his fresh uniform and other work clothes. 9 Once the worker was ready to start his work cycle, study personnel placed his glove dosimeters on his hands. At each rest or other break, study personnel removed the worker's glove dosimeters, wrapped the pair in aluminum foil ( except for certain samples from Sites A and B), placed them in a locking polyethylene storage bag and froze them on dry ice. When the break ended, the worker put on a fresh pair of glove dosimeters. At the end of the work day, study personnel collected the worker's glove dosimeters and handled them as noted above. The study personnel helped each worker remove his outer work clothes and then cut the WBD from him in sections, including paired arms, remainder of shirt (" torso top"), briefs and paired legs. Each section was packaged as described above, labeled, and placed on dry ice for shipment to EN CAS Laboratories.

Inhalation Inhalation exposure monitoring at Site A was unsuccessful due to fact that a single XAD 2 tube was used along with a non solvent resistant filter cassette. Therefore, the sampling methodology was changed to include the use of a second XAD 2 resin tube in the sampling train prior to sampling at Sites B, C, and D. Inhalation exposure monitoring was performed successfully at these sites. Each worker at Sites B, C, and D was equipped with an air sampling train consisting of a PTFE filter in an opaque, solvent resistant plastic cassette connected upstream from two in line XAD 2 resin filled air sampling tubes. The intake orifice of the filter was placed in the worker's breathing zone, directed downward. Air was pulled through the sampling train by a portable air sampling pump which was attached to the worker's belt. The pump drew air through the sampling tube at approximately 1 L/ minute while the worker performed his tasks. Pumps were calibrated immediately prior to and after each monitoring period using a mass flow meter or bubble calibrator. The pumps were turned on at the beginning of each work cycle and was left running during restroom, coffee, or other short breaks but were turned off or set on " hold" during lunch breaks. The pumps and samplers were removed from the worker during the lunch break. At the conclusion of the lunch break, the pump and sampling train were reinstalled and the pump was restarted. All start and stop times were recorded.

During each work cycle, start times and end times of each task performed by the worker were recorded. Pump parameters during use were also recorded. At the end of each work cycle, the pumps and sample trains were collected. Each filter cassette and sampling tube were capped, labeled, bagged, and placed on dry ice for shipment to USX Engineers and Consultants, Inc. ( UEC) for extraction and analysis. After the collection of the air samples the air sampling pump was re calibrated.

5.3 Analytical Methods Dermal Residues of creosote components in dermal exposure monitoring matrices were 10 determined by the validated EN CAS Method ENC 2/ 99, dated 04/ 18/ 00. For this procedure, a dermal sample is placed into glass jar ( size of jar is dependant upon the size of the sample). The dermal sample consists of either ( 1) one brief with the elastic waistband removed or ( 2) two leg sections cut off at the crotch, or ( 3) two arm sections, or ( 4) one torso section or ( 5) two glove liners.

An appropriate amount ( depending on the type of dermal sample) of 90: 10 acetonitrile ( ACN): dichloromethane ( DCM) extraction solvent was added to the jar. The jar was then capped and shaken for 30 minutes at 250 rpm. An aliquot of the extract was mixed with de ionized water, saturated NaCl solution, and hexane in a separatory funnel. The mixture was shaken vigorously for approximately 30 seconds, and the layers were allowed to separate for 5 10 minutes. The organic layer from the separatory funnel was passed through a rinsed Na 2 SO 4 powder funnel, containing a glass wool plug, into a clean glass flask. The aqueous layer was partitioned a second time with hexane. The hexane layer was drained through the funnel into the same glass flask and aqueous layer was discarded. The rinsate was reduced in volume by rotary evaporation. The concentrated sample was transferred to a conditioned cartridge and eluted with a 90: 10 solution of hexane: diethyl ether.

The eluate was evaporated to approximately 1 mL and then brought to 9.0 mL with HPLC grade hexanes. A 1.0 mL aliquot of HPLC grade EtOAc was added to the eluate and the solution was capped and shaken vigorously. An aliquot of the shaken solution was placed in a 2 mL GC vial for GC/ MSD analysis.

Each of the ten individual creosote components was quantitated as if it expressed the total amount of creosote in the sample. The normalized residues for each of the individual creosote components were averaged together to represent " total creosote" for that particular dermal sample. The " total" dermal exposure for each replicate for each worker was calculated by summing the normalized residue levels in his WBD arms, WBD top, WBD bottom ( torso portion and legs, cut apart at EN CAS and analyzed as separate samples), and all glove dosimeters worn during that replicate.

Inhalation The benzene soluble creosote fractions ( coal tar pitch volatiles, or CTPVs) in/ on the PTFE air sampling filters were determined using the validated UEC SOP # 02 006, dated 3/ 18/ 99. The eleven individual creosote components ( PNAs) were determined in the XAD 2 resin air sampling tubes using the validated UEC SOP # 04 022, dated 10/ 9/ 98.

Each PTFE filter was transferred from its cassette to a beaker. Benzene was added to the beaker and the beaker was sonicated for 20 minutes. The extract was decanted through a benzene rinsed glass fiber filter in a sintered glass funnel, and vacuum filtered into a concentrator tube. Additional benzene was added to the beaker, swirled, and added to the concentrator tube. Additional benzene was also added to rinse the funnel, and was collected int concentrator tube. The extract was reduced to < 3.0 mL with nitrogen, and made up to 3.0 mL with benzene. The 11 extract was then drawn into a syringe and used to rinse the sides of the concentrator tube, to recover any creosote on the sides of the tube. One half of the extract was transferred to a preweighed cup. The cup was retained in a desiccator overnight, and then re weighed. The other half of the extract was placed in a vial and capped to be used for the determination of the 11 individual PNAs.

For each XAD 2 resin tube, the plastic cap was removed from the rear end of the tube. The rear glass wool plug was then removed and discarded. The rear section XAD 2 resin and the middle glass wool plug were transferred to an amber vial and capped. The front section XAD 2 resin and the front glass wool plug were transferred to another amber vial and capped. Toluene was added to each vial. The vial was immediately screw capped, and placed into an ultrasonic bath for 30 to 60 minutes. The PTFE filters subjected to SOP # 02 006, described above, were diluted with toluene and sonicated. A portion of each of these sonicated samples was pipetted into an amber glass vial for analysis using an HP GC with a flame ionization detector.

6.0 RESULTS 6.1 Method Validation 6.1.1 EN CAS Method ENC 2/ 99  ( determination of creosote in fabrics)

This method was validated by fortifying sets of 7 control WBD sections and glove pairs with reference standard creosote at each of the following concentrations: 60

g/ sample, 6000

g/ sample, 60000

g/ sample, and 0

g/ sample ( control). The limit of quantitation ( LOQ) for total creosote in cotton WBD fabric samples and glove pairs was 60

g/ sample. The limit of detection was set at 50% the LOQ ( 30

g/ sample). Recoveries for the control samples were below the LOQ. Table 1 shows a summary of the total creosote recoveries from these fortified samples.

Table 1. Method Validation Results for Total Creosote Detection in Fabrics Matrix Fortified Level (

g/ sample) % Recovery of Total Creosote Mean S. D. % cv WBD Sections 60 83 ( n= 7) 8.9 10.70 6000 78 ( n= 7) 3.6 4.62 60000 75 ( n= 7) 4.5 6.00 Glove Pairs 60 101 ( n= 7) 6.8 6.73 6000 86 ( n= 7) 7.0 8.14 60000 85 ( n= 7) 10.6 12.4 12 n = number of replicates per fortification level.

6.1.2 UEC SOP # 02 006  ( determination of CTPVs in/ on PTFE air sampling filters)

This method was validated by fortifying sets of 7 control filters with reference standard creosote ( in benzene) at each of the following concentrations: 79

g/ sample, 793

g/ sample, 7930

g/ sample, and 0

g/ sample ( control). The LOQ for CTPVs in air sampling filters was 79

g/ sample. The LOD was calculated as 20

g/ sample. Recoveries of benzene soluble fraction from fortified samples are summarized in Table 2. Recoveries of CTPVs from all control samples were less than the LOQ.

Table 2. Method Validation Recoveries for CTPVs in/ on PTFE Air Filters Fortified Level (

g/ sample) % Recovery of CTPVs Mean S. D. % cv 79 116.8 ( n= 7) 6.40 5.48 793 103.1 ( n= 7) 3.14 3.05 7930 90.1 ( n= 7) 1.97 2.18 n = number of replicates per fortification level.

6.1.3 UEC SOP # 04 022  ( determination of individual creosote components in XAD 2 resin air sampling tubes and PTFE air sampling filters)

This method was validated for determination of specific target PNAs in XAD 2 resin tubes by fortifying sets of 7 unexposed samples of XAD 2 resin tubes extracted from single sections of unexposed sampling tubes with mixed reference standard PNAs ( in toluene) at each of the following concentrations: the LOQ of each compound, 5 times the LOQ of each compound ( the highest concentrations that could be prepared without precipitation), and at 0

g/ sample ( control). Table 3 summarizes the LODs, LOQs, and method validation percent recoveries for the specific target PNAs in XAD 2 resin tubes. Recoveries from all control samples were below the LOQ.

This method was also validated for determination of specific target PNAs in or on PTFE air sampling filters by fortifying sets of 7 unexposed filters with mixed reference standard PNAs ( in toluene) at each of the following concentrations: the LOQ of each compound, 5 times the LOQ of each compound, and 0

g/ sample ( control). Table 4 summarizes the LODs, LOQs, and method validation percent recoveries for the specific target PNAs in/ on PTFE air sampling filters. 13 Recoveries of all the control samples were below the LOQ. The results from this method validation demonstrated the adequacy of the method for determining all analytes in/ on PTFE air sampling filters at the 5 times the LOQ fortification level. Recoveries of naphthalene, 1 and 2 methylnaphthalenes, dibenzofuran, and to a lesser extent acenaphthene, were unacceptable at the lower ( LOQ) fortification level, presumably due to their lower molecular weights and resulting increased volatility. ( The other analytes were recovered at acceptable levels from samples spiked at both levels.)

Table 3. Method Validation Recoveries for PNAs in XAD 2 Resin Tubes PNAs LOD (

g) LOQ (

g) Fortification Levels (

g/ sample) % Recoveries of PNAs Mean S. D. % cv Naphthalene 0.41 20.5 20.5 100.0 ( n= 7) 0.745 0.742 102.5 99.0 ( n= 7) 2.29 2.31 2 Methylnaphthalene 0.47 22.1 22.1 99.8 ( n= 7) 0.684 0.692 110.5 98.3 ( n= 7) 2.15 2.19 1 Methylnaphthalene 0.53 20.1 20.1 100.0 ( n= 7) 0.882 0.881 100.5 99.0 ( n= 7) 2.21 2.23 Acenaphthene 0.47 22.7 22.7 101.0 ( n= 7) 0.751 0.747 113.5 99.0 ( n= 7) 2.12 2.14 Dibenzofuran 0.69 21.2 21.2 97.8 ( n= 7) 0.977 0.998 106.0 98.9 ( n= 7) 2.07 2.09 Fluorene 0.48 20.9 20.9 99.7 ( n= 7) 0.716 0.718 104.5 98.2 ( n= 7) 2.10 2.14 Phenanthrene 0.36 21.0 21.0 100.0 ( n= 7) 0.530 0.529 104.5 99.4 ( n= 7) 2.05 2.06 Anthracene 0.51 20.0 19.2 99.8 ( n= 7) 0.895 0.897 96.0 98.9 ( n= 7) 2.04 2.07 Pyrene 0.47 21.0 21.0 101.0 ( n= 7) 0.673 0.664 105.0 99.1 ( n= 7) 1.86 1.88 Chrysene 0.36 23.4 19.1 101.0 ( n= 7) 0.676 0.672 95.5 99.3 ( n= 7) 1.90 1.91 Benzo( a) pyrene 0.51 25.8 25.8 102.0 ( n= 7) 0.687 0.676 129.0 99.2 ( n= 7) 1.97 1.99 n = number of replicates per fortification level. 14 15 Table 4. Method Validation Recoveries for PNAs in/ on PTFE Air Filters PNAs LOD (

g) LOQ (

g) Fortification Levels (

g/ sample) % Recoveries of PNAs Mean S. D. % cv Naphthalene 0.41 20.5 20.5 2.58 ( n= 7) 6.82 265 103 0.7 ( n= 7) 15.90 2.98 2 Methylnaphthalene 0.47 22.1 22.1 28.4 ( n= 7) 10.0 35.4 111 2.7 ( n= 7) 9.75 3.31 1 Methylnaphthalene 0.53 20.1 20.1 24.8 ( n= 7) 12.0 48.4 101 3.1 ( n= 7) 12.03 3.54 Acenaphthene 0.47 22.7 22.7 62.4 ( n= 7) 6.17 9.88 114 61.9 ( n= 7) 2.27 3.67 Dibenzofuran 0.69 21.2 21.2 72.1 ( n= 7) 3.06 4.25 106 70.8 ( n= 7) 2.04 2.88 Fluorene 0.48 20.9 20.9 79.6 ( n= 7) 2.47 3.10 105 79.5 ( n= 7) 2.70 3.39 Phenanthrene 0.36 21.0 21.0 90.2 ( n= 7) 2.95 3.27 105 88.8 ( n= 7) 2.80 3.16 Anthracene 0.51 20.0 19.2 89.5 ( n= 7) 3.42 3.82 96 90.4 ( n= 7) 2.78 3.08 Pyrene 0.47 21.0 21.0 98.0 ( n= 7) 3.71 3.79 105 95.1 ( n= 7) 2.83 2.98 Chrysene 0.36 23.4 21 93.3 ( n= 7) 4.48 4.80 105 92.6 ( n= 7) 3.07 3.31 Benzo( a) pyrene 0.51 25.8 25.8 89.3 ( n= 7) 2.64 2.95 129 91.5 ( n= 7) 3.24 3.54 n = number of replicates per fortification level.

These results demonstrated that the proposed combination of filter and resin tube filter train would be necessary for adequate retention of all selected analytes during field sampling. 16 6.2 Breakthrough/ Retention Testing Breakthrough/ retention testing was performed in order to insure that creosote components would not migrate from the XAD 2 resin particles. All of the control recoveries of all analytes were below the LOD for this test. At the LOQ spike level, all of the analytes were retained in the filters or front tubes. Very low levels of naphthalene were found in one of the high level spiked rear tube but no other creosote component was detected. This naphthalene recovery was thought to possibly be due to contamination during handling in the analytical laboratory.

6.3 Pre field Recovery of Creosote in Dermal Matrices A pre field recovery study of creosote in dermal matrices was performed in order to determine that creosote applied to glove dosimeters and WBD fabric would be retained by those matrices during field sampling and transport. The mean percent recoveries showed some loss of creosote compontents on full day exposure to ambient conditions. However, according to the Study Report, the results were within the range generally considered acceptable for field samples. The average recovery for the WBDs exposed to ambient conditions for 8 hours was 69.2% + 9.1%. The average recovery for the WBDs which were spiked but not exposed to ambient conditions was 87.6% + 10.3%. The average recovery for the gloves exposed to ambient conditions for 8 hours was 63.4% + 9.4%. The average recovery for the gloves which were spiked but not exposed to ambient conditions was 85% + 3.23%.

6.4 Laboratory Spikes Laboratory fortified samples of each matrix used in the study were analyzed concurrently with field samples to monitor procedural recoveries. The mean recovery of total creosote from laboratory fortified glove and WBD samples is summarized in Table 5. The mean recoveries of total creosote ranged from 85.4% to 89.3%. These recoveries were well within the acceptable range.

Table 5. Recovery of Total Creosote from Laboratory Fortified Dermal Matrices Matrix Mean % S. D. No. of Reps.

Glove ( 2) 89.1 11.7 69 Whole Body Dosimeter ( WBD):

arm( 2) 89.3 7.47 28 top 85.4 8.08 30 brief 88.2 7.03 24 leg ( 2) 86.0 7.09 24 17 The mean recoveries of creosote components from laboratory fortified XAD 2 resin tubes are summarized in Table 6. The laboratory fortification levels were at the LOQ and 5 times the LOQ for each component. The mean recoveries at the LOQ level ranged from 76 to 98.7%. The mean recoveries at 5 times the LOQ level ranged from 72.7 to 87%. The overall mean recoveries for both fortification levels ranged from 74.3 to 92.8%. All of the mean recoveries for the creosote components are within the acceptable range. Chrysene had the lowest recovery at both fortification levels.

The mean recovery from 12 samples fortified in the laboratory at 10 times the LOQ ( 0.790 mg) of CTPVs in PTFE air sampling filters was 84.0 + 7.3%. According to the registrant, the results from all of these laboratory fortified recoveries agree favorably with the method validation recoveries.

6.5 Field Spikes Field fortification samples were prepared once at each facility. Unexposed WBD sections, paired glove dosimeters, single air sampling filters, and complete air sampling trains were fortified in the field to assess potential degradation or reduced extractability of residues due to exposure to environmental conditions, handling, packaging, shipping, and frozen storage.

Dermal Field Fortification Samples Field fortified sets of 3control WBD sections and glove pairs with reference standard creosote were prepared at each site at each of the following concentrations: 60

g/ sample, 60000

g/ sample, and 0

g/ sample ( control). Results from dermal field fortification samples are presented below in Table 7. Overall field fortification recoveries at Site A for whole body dosimeters ( WBD's) and gloves were 68 and 78%, respectively. Overall field fortification recoveries at Site B for whole body dosimeters ( WBD's) and gloves were 96 and 62 %, respectively. Overall field fortification recoveries at Site C for whole body dosimeters ( WBD's) and gloves were 72 and 69 %, respectively. Overall field fortification recoveries at Site D for whole body dosimeters ( WBD's) and gloves were 71 and 66 %, respectively. There were however some fortification levels which yielded extremely high recoveries for WBD's and some low recoveries for gloves. For example, at a 60 µ g/ sample " total creosote" fortification for Site B, there were recoveries for the WBD's as high as 150% and recoveries for the gloves as low as 52.3%. There were measurable amounts of total creosote found in each of the control samples prepared at each facility. The field fortification values were corrected based on these control samples. Therefore, the field fortification recovery value is minus the amount of total creosote found in the control samples. 18 Table 6. Recovery of PNAs from Laboratory Fortified XAD 2 Resin Tubes Fortification level % Recoveries of: *

N 2 MN 1 MN AC DBF F PH AN PY CH BAP LOQ Mean ( n= 22) 89.3 86.1 86.0 86.0 98.7 84.0 81.0 82.0 85.0 76.0 81.9 SD 21.1 20.5 20.4 20.1 33.3 20.5 19.8 19.7 18.5 16.4 20.0 5 x LOQ Mean ( n= 22) 83.8 82.6 82.4 82.2 87.0 80.4 72.9 80.5 77.4 72.7 75.9 SD 25.4 25.2 25.5 25.9 25.4 25.1 25.7 26.2 25.2 24.5 24.6 Overall Mean Recovery 86.5 84.3 84.2 84.1 92.8 82.2 76.9 81.2 81.2 74.3 78.9 * N= naphthalene; 2 MN = 2 methylnaphthalene; 1 MN = 1 methylnaphthalene; AC= acenaphthene; DBF = dibenzofuran; F = fluorene; PH = phenanthrene; AN = anthracene;

PY = pyrene; CH = chrysene; and BAP = Benzo( a) pyrene.

( n)= number of replicates 19 Table 7. Field Fortification Recoveries for Total Creosote Detection in Fabrics Matrix Fortified Level (

g/ sample) % Recovery of Total Creosote Mean S. D. Overall Site A WBD Sections 60 65.8 1.7 67.6 ( n= 6) 60000 69.4 1.0 Glove Pairs 60 68.7 11.1 78.4 ( n= 6) 60000 88.2 1.1 Site B WBD Sections 60 122 24.3 96.3 ( n= 6) 60000 70.6 2.8 Glove Pairs 60 54.5 2.6 62.4 ( n= 6) 60000 70.4 1.9 Site C WBD Sections 60 66.8 4.0 71.8 ( n= 6) 60000 76.9 3.9 Glove Pairs 60 63.8 10.5 69.1 ( n= 6) 60000 74.4 6.1 Site D WBD Sections 60 74.3 5.8 71.5 ( n= 6) 60000 68.8 6.5 Glove Pairs 60 61.1 11.0 66.5 ( n= 6) 60000 72.0 5.5 Inhalation Field Fortification Samples At Sites B through D, triplicate XAD 2 resin tubes were fortified with a solution of mixed PNAs ( in toluene) at 0 ppm ( control), the LOQ of each compound, and 5 times the LOQ of each compound. Each sampling tube was connected to a Buck S. S. pump that then ran for 8 hours at 20 approximately 1 L/ minute. Results from inhalation field fortification XAD 2 resin filled sampling tubes are presented below in Table 8. Overall field fortification recoveries for all of the polynuclear aromatic hydrocarbons ( PNAs) ranged from 78 to 180% at Site B, from 62 to 96% at Site C, and from 69 to 124% at Site D. At Site B, the high recovery was for dibenzofuran. At Site C, the lowest recoveries were for fluorene and phenanthrene. At Site D, the high recoveries were for chrysene.

Additional triplicate sampling trains, each consisting of two air sampling filters in in line cassettes, were spiked with a solution of standard creosote ( in benzene) at 0 ppm, the LOQ, or 10 times the LOQ. Each train was connected to a Buck S. S. pump that then ran for 8 hours at approximately 1.0 L/ minute. Results from these field fortification recoveries for CTPV in/ on the PTFE filters which were attached to sampling tubes are presented in Table 9. The Overall percent recoveries for the coal tar pitch volatiles ( CTPVs) were poor. The overall recovery for Site B was 57%. The overall recoveries for Sites C and D were 51 and 57%, respectively. The registrant did not address these poor inhalation field fortification results.

6.6 Formulation Testing The field phase of this study was performed using commercial wood treatment systems that could not economically be shut down, solvent cleaned, and filled with analyzed lots of test substances for this study. Instead, study personnel collected 100 to 200 mL sample aliquots of the mixed application solutions which were used during the monitored work cycles, and shipped them to EN CAS for later analysis. Study personnel and/ or test site personnel collected at least one sample of the on site product used to treat lumber products during monitoring at each site. Four such samples were subjected to GLP compliant compositional analysis ( results were provided in the study raw data). The creosote used at each test site was analyzed by the producer for compliance with AWPA specifications, and was determined to be within those specifications, as noted on the certificates of analysis supplied with the creosote.

The Koppers Creosote Solution (" P2") used for application to railroad ties as Sites A, C, and D had a purity of nominally 95% AWPA P2 creosote. The Koppers Coal Tar Creosote (" P1") used at Site C for application to utility poles had a purity of nominally 98.5% AWPA P1/ P13 creosote. The Coal Tar Creosote ( P 1/ P13) Wood Preservative used for application to wood at Site B had a purity of nominally 100% P1/ P13 creosote. 21 Table 8. Field Fortification Recoveries for PNAs in XAD 2 Resin Tubes Fortificatio n level % Recoveries of: *

N 2 MN 1 MN AC DBF F PH AN PY CH BAP Site B Average Recovery LOQ ( n= 3) 104 94.9 100 87.3 221.8 74.1 73 81.1 89.4 91 96.1 5 x LOQ ( n= 3) 130 122 126 112 139 88.3 83.9 74.5 80.4 83.7 88.2 Overall Recovery 117 109 113 100 180 81 78 78 85 87 92 S. D. 42.8 39.3 40.7 35.1 60.9 21.1 10.8 6.0 7.0 5.8 6.7 Site C Average Recovery LOQ ( n= 3) 97.7 83.6 82.2 69.5 67.5 58.3 59.2 71.6 79.2 93.5 101 5 x LOQ ( n= 3) 90.1 81.9 81.4 72.1 70.4 65.3 68.5 80.0 80.8 86.2 91 Overall Recovery 94 83 82 71 69 62 64 76 80 90 96 S. D. 8.1 5.1 5.3 5.6 5.3 5.8 7.0 7.2 5.8 5.7 7.9 Site D Average Recovery LOQ ( n= 3) 74.6 85.6 82.4 79.3 78.1 72.7 61.4 68.7 77.5 123 107 5 x LOQ ( n= 3) 106 102 100 92.6 87.6 82.7 76.8 84.9 84.4 126 110 Overall Recovery 91 94 91 86 83 78 69 77 81 124 109 S. D. 22.6 18.7 18.5 17.9 16.8 15.8 15.1 11.6 7.4 2.9 2.6 * N= naphthalene; 2 MN = 2 methylnaphthalene; 1 MN = 1 methylnaphthalene; AC= acenaphthene; DBF = dibenzofuran; F = fluorene; PH = phenanthrene; AN = anthracene;

PY = pyrene; CH = chrysene; and BAP = Benzo( a) pyrene. 22 Table 9. Field Fortification Recoveries for CTPV in/ on PTFE Filters Attached to Air Sampling Tubes Test Site Fortification Level Average Recovery (%) S. D. Overall Recovery (%)

B LOQ 52.3 ( n= 3) 8.2 57 10 x LOQ 61.5 ( n= 3) 1.7 C LOQ 51 ( n= 3) 3.9 51 10 x LOQ 50.9 ( n= 3) 0.9 D LOQ 52.3 ( n= 3) 8.2 57 10 x LOQ 61.5 ( n= 3) 1.7 6.7 Storage Stability Dermal The stability of total creosote was determined in WBD sections ( arm pairs) and pairs of glove dosimeters stored frozen after fortification with 3,000

g/ sample ( 50 times the LOQ). Five sets of WBD sections and glove pairs were stored frozen by EN CAS for up to 329 days, respectively, at <  11.1 oC prior to residue extraction at the following storage intervals: 0, 10, 30, 90, and 329 days. Each set consisted of one control, 2 WBD sections and glove pairs exposed at the time of setup, and 2 WBD sections and glove pairs exposed just prior to residue extraction. The mean creosote recoveries for the WBD sections and glove pairs ranged from 87.6 to 97.4% through out the stability study period ( 0 to 329 days). Mean creosote levels in WBD samples and glove pairs stored at <  11.1 oC for 90 and 329 days declined by approximately 5% and approximately 10%, respectively. WBD and glove pair samples collected from the field were stored frozen at EN CAS for up to 161 days and 92 days, respectively, at <  11.1 oC prior to residue extraction. According to the registrant, the results from the dermal media storage stability study demonstrate the stability of creosote residues in frozen dermal exposure monitoring media.

Inhalation The stability of creosote components was determined in XAD 2 resin tubes and PTFE air sampling filters stored frozen after fortification with 5 times the LOQ of each component. Five sets of resin tubes and air filters were stored frozen by UEC for up to 60 days, at <  17 oC, prior to residue extraction at the following storage intervals: 0, 10, 30, and 60 days. Each set consisted of one control, 2 resin tubes ( or 2 air filters) exposed at the time of setup, and 2 resin 23 tubes ( or 2 air filters) exposed just prior to residue extraction.

The average percent recoveries for the individual creosote components in the XAD 2 resin tubes ranged from 92.1 to 98.5% after 30 days of frozen storage. The average percent recoveries for the individual PNAs ranged from 79.3 to 86.6% after 60 days of frozen storage. The average percent recovery of each of the PNAs in the XAD 2 resin tubes showed that PNA levels in XAD 2 resin declined < 10% after 30 days, and ( with the exception of benzo( a) pyrene) , 20% after 60 days of frozen storage. Values for worker samples stored over 30 days were corrected for the results of this test.

The average percent recoveries for the individual PNAs in the PTFE air filters ranged from 0.0 to 145% after 30 days of frozen storage. After 60 days of frozen storage, the average percent recoveries for the individual PNAs ranged from 2.4 to 142%. On the PTFE air sampling filters, anthracene, pyrene, chrysene, and benzo( a) pyrene showed no decline over 60 days. Phenanthrene declined by < 10% over 60 days. The lighter molecular weight PNAs declined markedly during frozen storage; however, because the air filters used were expected to pass volatile PNAs during exposure, and because PNAs were not present at > LOQ in any samples collected, worker sample values were not corrected for these results.

In preliminary testing, reference standard creosote was applied to PTFE air sampling filters at 3 times the LOQ and 5 times the LOQ. After 15, 30, and 60 days of storage at <  17 oC, recoveries of CTPVs from fortified filters were 75.1%, 75.8%, and 66.1%, respectively, of the original fortification level. Again, because CTPVs were > LOQ in only two samples collected, worker sample values were not corrected for these results.

XAD 2 resin tubes and PTFE air filters collected in the field were stored frozen by UEC for up to 51 days, at <  17 oC, prior to residue extraction.

6.8 Exposures Known quantities of a characterized creosote formulation was not measurable for this study because the study was set up in a continuously operating commercial setting. The creosote was applied in closed systems which recovered and retained excess treatment solution from the wood and treatment vessels while sealed. Therefore, the amount of product or active ingredient handled by each worker is not known. According to the study, the major source of creosote for worker exposure in these types of facilities is preservative remaining on or escaping from treated wood or equipment that had been in a cylinder during treatment. This is presumably a very small fraction of the quantity actually applied to and retained by the charge. The mean pounds of creosote retained per charge per site are as follows:

Site A 19004 lbs Site B 11289 lbs Site C 25999 lbs Site D 25978 lbs 24 Sites A and B had shortened monitoring periods due to weather and maintenance related facility closures. Differences among Sites B, C, and D in the amount of creosote applied per charge were largely due to differences in the available cylinder volume at each site.

Dermal Results Dermal worker exposure was measured for each of the workers' tasks identified in section 3.1. During each replicate of monitoring, exposure of the subject's body ( excluding that of the face, neck, and hands) to creosote components was determined by collection of material in/ on his cotton WBD. Exposure of his hands was determined from material collected in/ on his cotton glove dosimeters ( worn under his chemical resistant gloves if appropriate).

The unadjusted creosote level for each WBD segment and glove pair from each worker was corrected for the mean recovery of the appropriate analytical standard( s) from samples of the appropriate matrix fortified in the field at that test site. The analytical method was subject to some variability at levels near the LOQ, suggesting that recoveries obtained at that level were likely to be less reliable than those at the higher level. Therefore, the field fortification recoveries at 1,000 times the LOQ were used to make the adjustment. The registrant did not make any adjustments when field fortification recoveries were > 100%. U. S. EPA guidelines state that corrections are not needed when field fortification recoveries are above 90%. For any sample in which the " total creosote" level was below the LOQ but above the LOD, ½ the LOQ was used as an upper bound estimate of the residue in the sample for calculation of calculated exposure. In addition, for any sample in which the " total creosote" level was below the LOD, ½ the LOD was used as the upper bound estimate for calculation. The use of ½ LOD and ½ LOQ values was the same for the inhalation data.

Each calculated exposure level was normalized to

g/ kg worker body weight/ day, normalizing results to the U. S. EPA's recommended mean adult weight of 71.8 kg and to a standard work day length of 8 hours. The " total" dermal exposure for each replicate for each worker was calculated by summing the normalized residue levels in his WBD arms, WBD top, WBD bottom ( torso portion and legs, cut apart at EN CAS and analyzed as separate samples), and all glove dosimeters worn during that replicate.

The levels of total creosote found in workers' gloves and WBDs ( combined) are shown in Tables XIX, XX, XX1, and XXII ( pages 126 through 140) in the Study Report. The calculated geometric mean daily dermal exposure levels of monitored workers at all sites are summarized in Table 10, below. Geometric mean dermal exposures across all of the job functions at all four sites ranged from 25 ( Load Out Area Helper) to 901 ( Oil Unloader)

g/ kg bw/ day. The highest individual levels were found in the Site C TO, who was also performing the duties of the OU while not wearing chemical resistant gloves on at least one monitored occasion. Within each job class monitored, and over all classes at each site, those individuals whose activities involved the greatest proximity to creosote sources were exposed to the highest levels of creosote.

Differences in exposures were pronounced from site to site, with the smallest exposure 25 levels observed at Site B, which applied the smallest amount of creosote, and which included an air handling system to remove creosote vapors from the cylinder door area. The highest exposures were found at Site C, which was the site which used the second highest quantity of creosote and where the CHs regularly contacted and handled freshly treated ties. 26 Table 10. Geometric Mean Daily Dermal Exposure Levels of Monitored Workers at all Sites Parameter Dermal Exposure (

g/ kg bw/ day) to Creosote of : *

TO TA TB WO OU CLO CH LLO LLO ( F) LH DP CK # Replicates 18 4 9 8 9 18 10 14 5 4 4 5 Minimum 15.1 20.8 94.9 27.1 349.4 45.9 40.1 14.1 102.4 18.8 213.2 269.1 Maximum 49573 33 3118 377 2560 3987 3446 591 771 37 395 2341 Mean 5051 27 759 170 1203 773 1190 119 278 26 280 877 S. D. 12877 6 1005 152 943 1115 1075 149 278 8 86 850 G. M. 360 27 385 108 901 313 626 69 208 25 271 638 Median 369 28 365 107 680 191 1213 60 169 25 257 586 * Abbreviations: CH = cylinder area loader helper; CK = checker; CLO = cylinder area loader operator; DP = drip pad labor; LLO = load out area loader operator; LLO( F) = load out area forklift operator; OU = oil unloader; TA = treating assistant; TB = test borer; TO = treating operator; WO = water treatment system operator; LH = load out area loader helper. 27 Inhalation Results Inhalation to monitored workers was measured for each of the tasks identified in section 3.1 at Sites B, C, and D. No useful inhalation data were generated at Site A due to problems with the air sampling methodology. The methodology was changed prior to sampling at Sites B, C, and D. The unadjusted residue level for each air sampler from each worker was corrected for the mean recovery of the appropriate analytical standard( s) from samples of the appropriate matrix fortified in the field at that test site. Inhalation exposure for each target compound was calculated from material found in the entire sampling train ( filter + front tube + rear tube). Calculated inhalation exposure levels were normalized by scaling up the pump flow rate of 1 L/ minute to the U. S. EPA's recommended minute ventilation rate of approximately 18.34 L/ minute for " light activities". Then an adjustment was made for the standard EPA recommended adult weight of 71.8 kg. According to the Study Report, due to the fact that none of the workers monitored in this study performed continuous light activity, the use of the recommended ventilation rate probably resulted in a notable over estimation of exposure. The fact that values were generated even for those compounds that were never detected or quantifiable in field samples contributes to the over estimation of inhalation exposures as well.

No air samplers showed quantifiable levels of most of the PNAs monitored. Chrysene and benzo( a) pyrene was not detected in worker samplers. Pyrene and anthracene were detected in 1 and 2 samples, respectively. However, naphthalene was detected by every sampler, and 2 methylnaphthalene was detected in most samplers, suggesting that only the lower molecular weight (" low boiling") PNAs are commonly volatilized during pressure treatment, or are able to remain volatile when exposed to ambient temperatures. These results suggest that the highest molecular weight PNAs did not volatilized during the treatment process, and may have continued to be emitted from treated materials during cooling, increasing their availability for worker exposure. Naphthalene was the single greatest contributor to inhalation exposure measurement. CTPVs were present at quantifiable levels in only one sampler, suggesting that this class of compounds may be a minor constituent of creosote emissions. Measured aerial concentrations of naphthalene ( approximately 0.04 to 1.29 mg/ m3) and CTPVs ( 0.0003 to 0.0006 mg/ m3) were well below the ACHIH TLVs of 52 mg/ m3 and 0.2 mg/ m3, respectively, for these materials for all monitored workers. As noted for dermal exposure, geometric mean daily inhalation exposure was greatest in those worker classes who performed those tasks most likely to put them in close proximity to sources of creosote.

The calculated levels of inhalation exposure to creosote components by monitored workers at each site are presented in Tables XXVI, XXVII, and XXVIII ( pages 144 through 146) in the Study Report. The levels of each analyte in the air sampled during each monitored work cycle, expressed as

g/ m3 of air, are presented in Table XXIX ( pages 147 to 149) in the Study Report. 28 7.0 REVIEW OF THE STUDIES COMPLIANCE WITH SERIES 875 Compliance with Series 875 Occupational and Residential Exposure Test Guidelines of the Pesticide Assessment Guidelines ( U. S. EPA, 1998) is critical if a study is to be considered acceptable to the Agency. Table 11 is based on the " Checklist for Applicator Monitoring Data" used by the U. S. EPA/ OPP/ HED in reviewing Series studies. This table is designed to summarize Series 875 guidelines, identify whether the study addresses these issues, and is compliant with these guidelines and it also present comments on how to bring the study into compliance.

8.0 SUMMARY OF DATA GAPS WITH RESPECT TO SERIES 875 Pertinent items with regard to scientific validity and Series 875 compliance, not addressed above, are discussed below. The following issues were noted:

° The amount of product applied and the amount of active ingredient handled by each worker was not calculated because the creosote was applied in a closed system which recovered and retained excess treatment solution from the wood and treatment vessel while sealed.

° The number of field fortification samples collected at the sites were not enough to satisfy the Series 875 guidelines. According to the guidelines, there should have been field at least one fortification sample per worker per monitoring period ( 8 hour shift) per fortification level ( three levels) for each matrix and at least one field blank per worker per monitoring period for each matrix. There were more workers monitored than there were field fortification and field blank samples collected.

° There were some dermal fortification levels which yielded extremely high recoveries for WBD's and some with unacceptably low recoveries for gloves. For example, at a 60 µ g/ sample " total creosote" fortification for Site B, there were recoveries for the WBD's as high as 150% and recoveries for the gloves as low as 52.3%. There were measurable amounts of total creosote found in each of the control samples prepared at each facility. All dermal fortification recoveries above 120% and below 70% should be considered unacceptable according to Series 875 guidelines and undermine the validity of the results.

° The inhalation exposure data was summarized in the form of bar graphs in the Study Report. However, data points used for the graphs were not provided. The raw data was provided but the raw data tables did not reflect the data presented in the bar graphs. Therefore, it was difficult to validate the conclusions made in Study Report.

° The Overall inhalation field fortification percent recoveries for the coal tar pitch volatiles ( CTPVS) were poor. The overall recovery for Site B was 57%. The overall recoveries for Sites C and D were 51% and 57%, respectively. All inhalation fortification recoveries below 70% should be considered unacceptable according to Series 875 guidelines and undermine the validity of the results. 29 Table 11. Compliance with Series 875 FIFRA Compliance Checklist Does the study address this compliance issue? Does the study comply with this part of Series 875? Comments Prior " informed consent" must be obtained in writing from all subjects who will be exposed in the study. yes yes Informed consent was obtained in writing from each of the workers monitored in the study.

All conditions specified on the product label must be observed, including whatever protective clothing is specified for workers to wear. yes mostly Each worker was supplied with protective clothing,

gloves, respirators as needed. However, according to the study, not all workers wore the proper protective gloves while working.

Studies must be designed so that an exposure is measured separately for each activity associated with an application. yes yes 10 job categories were monitored.

Data collection in accordance with 40 CFR 160,

Good Laboratory Practice Standards. yes partly The creosote used at each test site was analyzed for compliance with AWPA specifications, and these analyses were not performed per FIFRA GLPs.

Characterization of reference standards were not done per FIFRA GLPs. GLP compliant calibration of creosote storage and application equipment was not configured. Corrections to field data were not done per FIFRA GLPs.

Typical end use product of the active ingredient used. yes yes The study identifies 3 end use products used in this study. They are Koppers Coal Tar Creosote ( P1/ P13), VFT Coal Tar Creosote ( P1/ P13) Wood Preservative, and Koppers Creosote Solution.

Labels for all three end use products were provided.

End use product handled and applied using recommend equipment, application rates, and typical work practices. yes yes Typical wood treatment process assessed. Table 11: Compliance with Series 875 ( Continued)

FIFRA Compliance Checklist Does the study address this compliance issue? Does the study comply with this part of Series 875? Comments 30 For exposure monitoring at least five replicates ( e. g, individuals) at each of at least three sites for each job function should be monitored. yes mostly There were 25 workers total ( for all four sites)

monitored for up to 4  5 consecutive work days.

There were 10 job categories monitored. For each job category there were 4 to 19 replicates per site.

Monitoring period is sufficient to collect measurable residues but not excessive so that residue loss occurs. yes yes Exposure periods seemed long enough for the tasks required.

Dermal and/ or inhalation exposure must be monitored by validated methodologies. Biological monitoring is consistent with and supported by pharmacokinetic data accepted by the Agency. yes yes Dermal and inhalation methods used were identified in Series 875 regulations.

Quantity of active ingredient handled and duration of monitoring period reported for each replication no partly Quantity of active ingredient handled was not described. Duration of exposure was identified for both dermal and inhalation exposures.

Quantitation level of detection is at least 1 µ g/ cm2 not applicable not applicable Since whole body dosimeters and inhalation samples were used this is not applicable. This LOQ is used only for dermal patch studies.

Clothing worn by each study participant and location of dosimeters reported. yes yes Study used whole body dosimeters ( cotton thermal shirts, pants, and gloves). Sections ( gloves, arms,

bottoms) were measured appropriately.

Storage of samples consistent with storage stability data. yes yes Storage of samples and storage stability are addressed in the study and samples were corrected when appropriate according to storage stability results. Table 11: Compliance with Series 875 ( Continued)

FIFRA Compliance Checklist Does the study address this compliance issue? Does the study comply with this part of Series 875? Comments 31 Efficiency of extraction in laboratory provided as mean plus or minus one standard deviation. Lower 95 percent confidence limit is not less than 70 percent based on a minimum of seven replications per fortification level or prior Agency approval of extraction methodology provided. yes yes Method validation testing appeared to be in the acceptable range.

At least one field fortification sample per worker per monitoring period per fortification level for each matrix. At least one field blank per worker per monitoring period for each matrix. no no This study did not provide for at least one field fortification sample per worker monitored per fortification level for each matrix. There were only three fortification samples per fortification level.

The field fortification samples were only prepared once.

When collecting urine for biological monitoring,

collection should involve 24 hour urine samples. A minimum of one baseline, pre exposure 24 hour sample must be collected. Twenty four hour samples must be collected for the day of application and for sufficient days postapplication as determined by the excretion profile of the pesticide. not applicable not applicable 32 9.0 REFERENCES 1. U. S. Environmental Protection Agency, 1995. Occupational and Residential Exposure Test Guidelines. OPPTS 875.1100 Dermal Exposure Outdoor. Washington DC. May 1995. EPA 712 C 95 262.

2. U. S. Environmental Protection Agency, 1995. Occupational and Residential Exposure Test Guidelines. OPPTS 875.1300 Inhalation Exposure Outdoor. Washington DC. May 1995. EPA 712 C 95 263.

3. U. S. Environmental Protection Agency, 1998. Series 875 Occupational and Residential Exposure Test Guidelines. Group B Post application Exposure Monitoring Test Guidelines. Version 5.4. Washington DC. February 1998.

4. " The Chemistry, Toxicity, and Biodegradation of Creosote", 1998. http:// inweh1. uwaterloo. ca/ biol447new/ assignments/ creosote. html.

5. U. S. Environmental Protection Agency, 1987. Processes, Coefficients, and Models for Stimulating Toxic Organics and Heavy Metals in Surface Waters. Office of Research and Development. Athens, Georgia. June 1987. EPA/ 600/ 3 87/ 015.

6. " The Environmental Degradation of Creosote", 1998. http:// inweh1. uwaterloo. ca/ biol447new/ assignments/ creo2. html.

7. James, J. W., 1996. " Method Validation Study for the Determination of Creosote Residue on Cotton Undergarments," EN CAS Project 96 0074, for the Creosote Council II, November, 1996.


[Federal Register Volume 76, Number 140 (Thursday, July 21, 2011)]
[Notices]
[Pages 43689-43690]
[FR Doc No: 2011-18537]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0530]

Draft Guidance for Industry and Food and Drug Administration
Staff; Mobile Medical Applications; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Mobile Medical
Applications.'' FDA is issuing this draft guidance to inform
manufacturers, distributors, and other entities about how the FDA
intends to apply its regulatory authorities to select software
applications intended for use on mobile platforms (mobile applications
or ``mobile apps''). At this time, FDA intends to apply its regulatory
requirements solely to a subset of mobile apps that the Agency is
calling mobile medical applications (mobile medical apps). This draft
guidance is not final nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by October 19, 2011

ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Mobile Medical Applications'' to the
Division of Small Manufacturers, International, and Consumer
Assistance, Center for Devices and Radiological Health (CDRH), Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613,
Silver Spring, MD 20993-0002; or to the Office of Communication,
Outreach and Development (HFM-40), Center for Biologics Evaluation and
Research (CBER), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852-1448. Send one self-addressed adhesive label to
assist that office in processing your request, or fax your request to
301-847-8149. See the SUPPLEMENTARY INFORMATION section for information
on electronic access to the guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:
For devices regulated by CDRH: Bakul Patel, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5456, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.
For devices regulated by CBER: Stephen Ripley, Center for Biologics
Evaluation and Research (HFM-17), Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville, MD 20852,<PHONE_NUMBER>.

I. Background

    Given the rapid expansion and broad applicability of mobile apps,
FDA is issuing this draft guidance to clarify the types of mobile apps
to which FDA intends to apply its authority. At this time, FDA intends
to apply its regulatory requirements to a subset of mobile apps that
the Agency is calling mobile medical apps. For purposes of this
guidance, a ``mobile medical app'' is defined as a mobile app that
meets the definition of ``device'' in section 201(h) of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321); \1\ and
either:
---------------------------------------------------------------------------

    \1\ Products that are built with or consist of computer and/or
software components or applications are subject to regulation as
devices when they meet the definition of a device in section 201(h)
of the FD&C Act. That provision defines a device as ``* * * an
instrument, apparatus, implement, machine, contrivance, implant, in
vitro reagent * * *,'' that is ``* * * intended for use in the
diagnosis of disease or other conditions, or in the cure,
mitigation, treatment, or prevention of disease, in man * * *'' or
`` * * * intended to affect the structure or any function of the
body of man or other animals * * *.''
---------------------------------------------------------------------------

     Is used as an accessory to a regulated medical device or
     Transforms a mobile platform into a regulated medical
device.
    This narrowly-tailored approach focuses on a subset of mobile apps
that either have traditionally been considered medical devices or
affect the performance or functionality of a currently regulated
medical device.
    Although some mobile apps that do not meet the definition of mobile
medical app may meet the FD&C Act's definition of a device, the FDA
intends to exercise enforcement discretion \2\ towards those mobile
apps.
---------------------------------------------------------------------------

    \2\ This means that FDA intends to exercise its discretion to
decline to pursue enforcement actions for violations of the FD&C Act
and applicable regulations by a manufacturer of a mobile medical
app, as specified in this guidance. This does not constitute a
change in the requirements of the FD&C Act or any applicable
regulations.
---------------------------------------------------------------------------

    We welcome comments on all aspects of this guidance as well as the
following specific issues:
    1. FDA generally considers extensions of medical devices as
accessories to those medical devices. Accessories have been typically
regulated under the same classification as the connected medical
device. However, we recognize potential limitations to this policy for
mobile medical apps. FDA seeks comments on how the Agency should
approach accessories and particularly mobile medical apps that are
accessories to other medical devices so safety and effectiveness can be
reasonably assured. For example, one possible approach could be the
following:
     An accessory that does not change the intended use of the
connected device, but aids in the use of the connected medical device
could be regulated as class I. For example, such an accessory would be
similar to an infusion pump stand, which is currently classified as a
class I device because it supports the intended use of an infusion pump
(class II medical device). A mobile medical app that simply supports
the intended use of a regulated medical device could be classified as
class I with design controls as part of the quality systems
requirements.
     An accessory that extends the intended use of the
connected medical device could be classified with the connected device.
For example, if a mobile medical app that performs more detailed
analysis than the connected medical device while maintaining the
original intended use, which is data analysis, could be classified in
the same classification as the connected medical device.
     An accessory that creates a new intended use from that of
the connected

device(s) could be classified according to the risk posed to patient
safety by the new intended use, for example, if the intended use of a
mobile medical app is to provide prognosis relating to a certain
disease or condition and the mobile medical app is connected to a
device that does not have that intended use, the mobile medical app may
have a different level of risk than the connected device, resulting in
a different classification to assure of safety and effectiveness of the
mobile medical app.
    2. FDA has not addressed in this guidance stand-alone software
(mobile or traditional workstation) that analyzes, processes, or
interprets medical device data (collected electronically or through
manual entry of the device data) for purposes of automatically
assessing patient specific data or for providing support in making
clinical decisions. FDA plans to address such stand-alone software in a
separate guidance. In order to provide a reasonable assurance of the
safety and effectiveness of such software, and to ensure consistency
between this guidance and the planned guidance on stand-alone software
that provides clinical decision support (CDS), FDA is seeking comments
on the following issues:
     What factors should FDA consider in determining the risk
classification of different types of software that provide CDS
functionality? Please provide examples of how those factors would be
applied for such software that you believe should be in class I, class
II, and class III.
     How should FDA assess stand-alone software that provides
CDS functionality, to assure reasonable safety and effectiveness? For
example, to what extent can FDA rely on a manufacturer's demonstration
that it has a robust quality system with appropriate quality assurance
and design controls? Under what circumstances should the submission of
clinical data be required?
     Are there specific controls that manufacturers should
implement that could change the risk classification or reduce the
premarket data requirements for particular types of stand-alone
software that provide CDS functionality?

II. Significance of Guidance

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

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. A search capability for all CDRH guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at either http://www.regulations.gov or
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. To receive
``Mobile Medical Applications'' from CDRH, you may either send an e-
mail request to<EMAIL_ADDRESS>to receive an electronic copy of the
document or send a fax request to<PHONE_NUMBER> to receive a hard copy.
Please use the document number 1741 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved information
collections found in FDA regulations. The collections of information in
21 CFR part 801 are approved under OMB control number 0910-0485; the
collection of information in 21 CFR part 803 are approved under OMB
control number 0910-0437; the collections of information in 21 CFR part
806 are approved under OMB control number 0910-0359; the collections of
information in 21 CFR part 807, subpart B, are approved under OMB
control number 0910-0387; the collections of information in 21 CFR part
807, subpart E, are approved under OMB control number 0910-0120; and
the collections of information in 21 CFR part 820 are approved under
OMB control number 0910-0073.

V. Comments

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

    Dated: July 18, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-18537 Filed 7-19-11; 4:15 pm]
BILLING CODE 4160-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY AIR, PESTICIDES & TOXICS MANAGEMENT DIVISION 61 Forsyth St., S. W. Atlanta, Georgia 30303 Fax Number: 404/ 562 9095 Electronic Transmission MEMORANDUM DATE: October 18, 1999 SUBJ: Initial EPA Comments on CP& L's H. B. Robinson Power Plant FROM: Scott Miller, Environmental Engineer Operating Source Section, ARTB TO: Mr. Matt Wike South Carolina Department of Health and Environmental Control cc: Mr. Robert Brown, Permit Manager South Carolina Department of Health and Environmental Control Below are initial comments from EPA Region 4 on the above referenced source. Our comments are divided into two categories: 1) Significant Comments and 2) General Comments. Significant comments are defined as those comments that would trigger an objection under 40 CFR Part 70. Given that we have several significant comments on this permit, which was originally submitted as a draft/ proposed permit, EPA no longer considers the permit eligible for parallel review. Please contact me at your convenience in order that we may seek to resolve these issues prior to your submittal of a proposed permit for this source. You may reach me at ( 404) 562 9120. Thank you for your attention to this matter.

Significant Comments 1. The periodic monitoring for particulate matter from the electric utility boilers in permit condition 6. B. 1 on page 29 is inadequate. The only monitoring is an annual stack test. This monitoring is not frequent enough since the sources can not in good faith certify compliance with the particulate matter standard for all times during the year. EPA understands that the utility companies desire to have the same monitoring requirements in their title V permits in South Carolina as they do in North Carolina. It should be noted that although the North Carolina electric utility permits were initially issued with this annual test requirement, these same North Carolina permits have been rescinded, and EPA has informed North Carolina that the monitoring requirements must be changed. EPA maintains that once a year monitoring is not adequate, and EPA does not plan on approving this level of monitoring in any state in Region 4. One approach that the State may want to consider is the use of continuous opacity monitoring data to show compliance with the particulate emission standard. The condition given below is one acceptable way for the State to implement periodic monitoring at the utilities to show compliance with the relevant particulate emission rate:

" Pursuant to Regulation 401 KAR 50: 035, Section 7( 1)( c), to meet the periodic monitoring requirement for particulate, the permittee shall use a continuous opacity monitor ( COM). Excluding the startup, shutdown, and once per hour exemption periods, if any six minute average opacity value exceeds the opacity standard, the permittee shall, as appropriate, initiate an inspection of the control equipment and/ or the COM system and make the necessary repairs. If five ( 5) percent or greater of COM data ( excluding startup, shutdown, and malfunction periods, data averaged over six minute period) recorded in a calendar quarter show excursions above the opacity standard, the permittee shall perform a stack test in the following calendar quarter to demonstrate compliance with the particulate standard while operating at representative conditions. The permittee shall submit a compliance test protocol as required by condition Section G( a)( 20) of this permit before conducting the test. The Division may waive this testing requirement upon a demonstration that the cause( s) of the excursions has been corrected, or may require stack tests at any time pursuant to Regulation 401 KAR 50: 045, Performance tests."

The Region's comments on this approach are attached to this letter.

Another similar approach accepted by the Region for facilities that do not generally operate near the allowable particulate emission rate is as follows:

E6. The particulate emissions from this fuel burning installation shall not exceed 0.105 pounds per million Btu of heat input as specified in Paragraph 1200 3 6. 02( 1) of the Tennessee Air Pollution Control Regulations ( TAPCR).

Compliance Method: Monitoring of this fuelburning source for compliance with the applicable particulate emissions limitations shall be conducted by stack testing in accordance with 40 CFR60, Appendix A, Method 17. This testing shall be performed on a biennial basis and a particulate source test report shall be filed with the Technical Secretary within 60 days after completion of the testing. The source test shall be conducted in accordance with specifications for source sampling given in Chapter 1200 3 12 of the Tennessee Air Pollution Control Regulations. The continuous in stack opacity monitor( s) shall be fully operational prior to and during this compliance testing. The opacity data generated during this compliance testing shall be incorporated into the test report.

Ten ( 10) days prior to conducting the source test, the permittee shall provide notice of such test of the Technical Secretary to afford him the opportunity to have an observer present.

Should atmospheric sulfates ever become an issue, the Division will reassess the applicability of the test procedure as it relates to this issue. This is per the October 25, 1977 letter to Dr. Peter A. Krenkel, P. E.

Compliance with condition E8 of the permit shall be used as an indicator to determine whether compliance with this condition should be confirmed with a Method 17 test. Within sixty ( 60) days of an exceedance of the de minimis criteria specified in condition E8, the facility will conduct a Method 17 test.

TAPCR 1200 3 9. 02( 11)( e) 1.( iii)

E8. The visible emissions from each stack of this fuel burning installation shall not exceed twenty ( 20) percent opacity except for one  six ( 6) minute period per one ( 1) hour of not more than forty ( 40) percent opacity as specified in Paragraph 1200 3 5. 01( 1) of the Tennessee Air Pollution Control Regulations.

Compliance Method: Consistent with the provisions of Paragraph 1200 3 5. 03( 5) of the Regulations, compliance with the applicable visible emissions standards shall be determined from data generated by the opacity monitoring system, provided the quality assurance and operational availability requirements set forth in this permit are met.

Consistent with the provisions of Rule 1200 3 20. 06 of the Tennessee Air Pollution Control Regulations, no notice of violation shall be automatically issued for periods of visible emissions from this fuel burning installation that are in excess of the applicable visible emission standard so long as the total amount of time that the fuel burning installation is exceeding the applicable visible emission standard ( excluding periods of permitted startup, permitted shutdown, or malfunction and periods when the fuel burning installation is not operating) is not in excess of two ( 2) percent of the total amount of time in a calendar quarter. This exemption is applicable provided that good operational and maintenance practices are utilized for both the fuel burning equipment and the associated air pollution control equipment, the required ninety five ( 95) percent operational availability of the opacity monitoring system is maintained, and that no more than one exceedance of greater than twenty four ( 24) hours duration occurs per calendar year.

Written responses to the quarterly reports of excess emissions shall constitute prima facie evidence of compliance with the applicable visible emission standard. For purposes of annual certification of compliance with the applicable visible emissions condition, the acceptance, by the Division, of the quarterly reports of excess emissions shall be the basis of said certification.

TAPCR 1200 3 20. 06 2. In Table 6.1 Monitoring and Reporting, the facility is required to make one annual visible emissions inspection to demonstrate compliance with 20% and 40% opacity regulations for emission unit 03 ( the coal handling system). The Region believes that more frequent periodic monitoring is necessary to determine the compliance status of the coal handling system with applicable opacity standards. One acceptable approach to periodic monitoring for the facility in determining compliance with the opacity standard:

" The facility shall do a qualitative emissions evaluation on a daily basis for those emission sources controlled by a control device ( i. e. baghouse). Should the observer see visible emissions, the emissions observer must perform an EPA Method 9 reading and log the results of such a reading. For emission units that are uncontrolled, the facility will conduct an annual EPA Method 9 reading to determine compliance with the applicable opacity standard."

3. Condition 2 indicates the NOx limit for H. B. Robinson/ Darlington unit 1. The third paragraph of this section notes that " if the unit fails to meet the annual average alternative contemporaneous emission limitation of 0.5 lb/ mmBtu and/ or has an annual heat input greater/ less than 10,065,000 mmBtu, then excess emissions will be assessed in accordance with 40 CFR 77.6." This condition should be corrected to indicate " greater than," rather than " greater/ less than".

4. The Btu weighted annual emission rate indicated in the left hand box on page one of the Phase II NOx Averaging Plan for Carolina Power and Light should be corrected. The corrected value should be 0.43 lb/ mmBtu rather than 0.44 lb/ mmBtu. This correction was made on the Carolina Power and Light Phase II Averaging Plans and incorporated into the Phase II permit for the other facilities in the plan. ( Please see comments submitted on January 9, 1999 to John Hiers and Matthew Wike, of SC DHEC from Jenny Jachim, EPA Region 4).

General 1. Permit condition 6. B. 5 on page 30 should be updated to clarify that the continuous opacity monitoring system data is being used to satisfy the opacity periodic monitoring requirement under title V of the Clean Air Act to demonstrate compliance with the applicable opacity limit of 40%. The title V permit should be clear on this point since the language in permit condition 6. B. 7 may give one the mistaken belief that compliance with the 40% opacity standard will be determined based on an annual Method 9 test. One way to effect such a clarification would be to add the following language to permit condition 6. B. 5:

" The data generated by the COMS is the periodic monitoring method chosen to assure compliance with the 40% opacity standard."

2. Permit condition 6. B. 4 on page 30 should be updated to clarify that the quarterly continuous emissions monitoring report for sulfur dioxide is to be based on the CEMS data except when the CEMS data is not available. When the CEMS data is not available, fuel sampling analysis would serve as an acceptable substitute during CEMS unavailability.

3. Please note that the allowance allocation to the Jefferies Generating Station units 3 and 4 have been changed in a 1998 reallocation ( see Federal register, Vol. 63, No. 187, page 51706). Although the footnote indicated in this section refers to the possibility of a reallocation, we recommend that you take the opportunity of this reopening of the Phase II permit to make the amendment to indicate the revised allowance allocation.


[Federal Register Volume 81, Number 90 (Tuesday, May 10, 2016)]
[Notices]
[Page 28856]
[FR Doc No: 2016-10906]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL16-60-000]

Vineland Municipal Electric Utility v. Atlantic City Electric
Company; Notice of Complaint

    Take notice that on April 26, 2016, pursuant to sections 205, 206,
306, and 309 of the Federal Power Act (FPA) \1\ and Rules 206 and 217
of the Federal Energy Regulatory Commission's (Commission) Rules of
Practice and Procedure,\2\ Vineland Municipal Electric Utility
(Vineland or Complainant) filed a formal complaint against Atlantic
City Electric Company (ACE or Respondent). Vineland is seeking an order
granting full and immediate refunds of all amounts paid in violation of
the Interconnection Agreement and PJM Open Access Transmission Tariff
(PJM OATT). Vineland is alleging ACE's decision to, without prior
notice or approval from Vineland, apply a Reconciliation Factor to
Vineland's five coincident hourly metered loads for the purpose of
calculating Vineland's capacity obligation, is in violation of the
Interconnection Agreement and the PJM OATT, as more fully explained in
the complaint.
---------------------------------------------------------------------------

    \1\ 16 U.S.C. 824d, 824e, 825e, and 825h (2016).
    \2\ 18 CFR 385.206, 385.217 (2016).
---------------------------------------------------------------------------

    Complainant certifies that copies of the Complaint were served on
the contacts for the Respondents.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on May 16, 2016.

    Dated: April 28, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-10906 Filed 5-9-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 145 (Monday, July 29, 2013)]
[Notices]
[Page 45521]
[FR Doc No: 2013-18044]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ID-7188-000]

Marricle, David; Notice of Filing

    Take notice that on July 19, 2013, David Marricle submitted for
filing, an application for authority to hold interlocking positions,
pursuant to section 305(b) of the Federal Power Act (FPA), 16 U.S.C.
825d(b), Part 45 of the Federal Energy Regulatory Commission's
(Commission) Rules of Practice and Procedure, 18 CFR part 45, and Order
No. 664.\1\
---------------------------------------------------------------------------

    \1\ Commission AuthoriDeputy Secretary.zation to Hold
Interlocking Positions, 112 FERC ] 61,298 (2005) (Order No. 664);
order on reh'g, 114 FERC ] 61,142 (2006) (Order No. 664-A).
---------------------------------------------------------------------------

    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on August 9, 2013.

    Dated: July 22, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-18044 Filed 7-26-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 94 (Tuesday, May 18, 2021)]
[Notices]
[Page 26995]
[FR Doc No: 2021-10387]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-91871; File No. SR-NYSE-2021-20]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Withdrawal of a Proposed Rule Change To Amend Section 102.04
of the NYSE Listed Company Manual To Establish Limits on Investments in
Unregistered Investment Vehicles by Listed Closed End Funds

May 12, 2021.
    On April 9, 2021, New York Stock Exchange LLC (``NYSE'') filed with
the Securities and Exchange Commission (``Commission''), pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 \1\ and Rule
19b-4 thereunder,\2\ a proposed rule change to establish limits on
investments in unregistered investment vehicles by listed closed end
funds. The proposed rule change was published for comment in the
Federal Register on April 26, 2021.\3\ On May 6, 2021, NYSE withdrew
the proposed rule change (SR-NYSE-2021-20).
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 91618 (April 20,
2021), 86 FR 22080 (April 26, 2021).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\4\
---------------------------------------------------------------------------

    \4\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-10387 Filed 5-17-21; 8:45 am]
BILLING CODE 8011-01-P